WO2020198042A1

WO2020198042A1 - Needleless connector valve for uv disinfection

Info

Publication number: WO2020198042A1
Application number: PCT/US2020/023950
Authority: WO
Inventors: Julia A. RASOOLY; Theodore J. Mosler; James Fentress; Joseph Vincent Ranalletta; Jay Colton ZIGNEGO; Michael G. Fourkas; Eri Ashley TAKAMI
Original assignee: Puracath Medical, Inc.
Priority date: 2019-03-22
Filing date: 2020-03-20
Publication date: 2020-10-01
Also published as: CN113853233A; EP3941563A1; CA3133307A1; JP2022527246A; EP3941563A4

Abstract

Embodiments of a UV-transmissive needleless connector are provided. The connector comprises an outer housing that is at least partially UV-transmissive. The connector comprises a valve core configured to buckle to create a fluid path through the connector.

Description

NEEDLELESS CONNECTOR VALVE FOR UV DISINFECTION

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application Nos.

62/822,658, filed March 22, 2019 and 62/911,059 filed October 4, 2019. This application may be related to U.S. Application No. 16/316,918, filed July 11, 2017, which is a National Phase filing of International Application No. PCT/US2017/041556 filed on July 11, 2017, which claims the benefit of U.S. Provisional Patent Application No. 62/360,922 filed July 11, 2016.

INCORPORATION BY REFERENCE

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

FIELD

[0003] Systems and methods related generally to uses for sterilizing access sites are described herein. More particularly, the various methods and devices for sterilizing intraluminal and percutaneous access sites using ultraviolet radiation

BACKGROUND

[0004] One of the first interventions that occurs when a patient is admitted into a hospital is the placement of an intravenous access line (IV). This percutaneously-placed IV line gives the caregivers a direct path to the patient's bloodstream via a peripheral vein for rapid administration of fluids, medication or for drawing blood samples. In more serious cases, where direct access to a high blood flow supply is needed, for example, in chemotherapy delivery, temporary kidney dialysis or heart monitoring catheterization, a Central Venous Catheter (CVC or Central Line) is inserted. This line is typically inserted percutaneously into a major branching vessel, frequently the subclavian vein (but can also be placed in a peripheral vein), and then the distal segment of the catheter is directed into the superior vena cava.

[0005] Both peripheral and central catheterization procedures create an open pathway or lumen from an external access site into the bloodstream. This intraluminal access site provides an attachment point for various therapeutic or diagnostic medical devices, including, but not limited to, stopcocks, needle-less access sites, IV bags, infusion pumps, drug delivery pumps, kidney dialysis equipment, thermal dilution catheters, and the like. Unfortunately, this access site also provides an entry point for bacterial infections. Therefore, each time the access site is opened to accommodate the attachment of a medical device there is an opportunity for bacteria to enter the catheter lumen and be transferred into the bloodstream.

[0006] In addition to the contamination of the catheter lumen via the external access site, bacteria can also enter by the skin puncture and sub-cutaneous tract that is created by the catheter when the IV or CVC is placed. Bacteria can then find their way down the outside wall of the catheter to its distal end, infecting the tract along the catheter wall as they migrate.

[0007] In an attempt to mitigate the serious problems identified in the preceding paragraphs, conventional IV lines and CVCs use some type of molded plastic fitting at their proximal end terminated with a female Luer-lock or Luer-slip connector. These connectors must be closed by a Luer cap when not in use to prevent access site contamination. Each time the line is to be accessed, the Luer cap must be removed and discarded as it must be assumed that the outside of the Luer cap is contaminated and that once removed it is nearly impossible to prevent the male Luer configuration from touching a contaminated surface. Therefore, conventional infection control practice is to always replace the Luer cap whenever the line is accessed. This procedure is not only costly, but the removal and replacement process provides additional chances for bacteria to enter the lumen of the connector.

[0008] In some cases, IV access sites have been converted to needle-less access valves, which incorporate an elastomeric seal that can be opened via the tip of a male Luer connector mounted on a syringe or like device. These needle-less access valves are meant to be cleaned with an alcohol saturated swab before the valve is opened by the sterile male Luer tip of a syringe. Unfortunately, compliance with the swabbing procedures can be sporadic as it requires significant time, additional supplies and proper technique from the clinician performing the swabbing procedure.

[0009] As a result of the continued challenges related to preventing infection in patients having indwelling catheters, improvements in disinfecting and preventing infection are needed.

SUMMARY

[0010] In a first aspect, a needleless connector valve is provided. The valve comprises an inlet; an outlet; a body; and a sealed valve core positioned within the body, the valve core comprising a cut out portion, the valve core configured to buckle to allow fluid flow through the body.

[0011] In some embodiments, the valve core comprises an opaque material. The valve core can comprise an opaque material. In some embodiments, the body comprises a top portion and a bottom portion. The top portion of the housing can comprise a thickness of about 0.050”. [0012] In another aspect, a needleless connector valve is provided. The connector valve comprises an inlet; an outlet; a body; and a sealed valve core positioned within the body, the valve core comprising a first cut out portion and a second cut our portion, the valve core configured to buckle to allow fluid flow through the body.

[0013] In some embodiments, the valve comprises an electronic element. The electronic element can be a chip. The electronic element can be a resistor. In some embodiments, the electronic element comprises encryption capability. The electronic element can be configured to ensure the proper use of the connector with a handpiece of a disinfection unit. In some embodiments, the electronic element comprises a timeout feature. The timeout feature can be configured to ensure the connector valve is not switched out for a different connector valve. In some embodiments, the electronic element is configured to engage with a mating feature of a disinfection unit. The mating feature can comprise pogo pins. In some embodiments, the valve comprises gentle ramping feature around the electronic element to enable the pogo pins to slide over the connector when the connector is placed into the disinfection unit. In some

embodiments, the body comprises an electronic element. In some embodiments, the body comprises an indexing feature. The connector valve can further comprise a feature configured to ensure proper positioning of the connector valve within a disinfection unit. In some

embodiments, the feature comprises a pocket.

[0014] The connector valve can comprise an indexing feature. In some embodiments, the indexing feature is configured to interact with a corresponding feature on a disinfection unit.

The corresponding feature can comprise a nesting feature configured to interact with a protrusion on the connector valve. In some embodiments, the indexing feature is positioned near a bottom portion of the connector valve.

[0015] The body can comprise a UV transparent portion. In some embodiments, the body comprises a top portion and a bottom portion. The top and bottom portions can be separate components that are joined. A top portion of the body can comprise partial threads. In some embodiments, the top portion of the body comprises full threads. The top portion of the body can comprise a cross section of a square shape with rounded comers. In some embodiments, partial threads are positioned at the rounded corners. A top portion of the body can comprise a UV transmissive material. In some embodiments, a bottom portion of the body comprises the outlet. The outlet can be configured to attach to other connectors. In some embodiments, a bottom portion of the body comprises a UV transmissive material.

[0016] The first cutout and/or the second cutout of the valve core can comprise a scallop shape. In some embodiments, the core can be configured to buckle at the first cutout first, the first cutout larger than the second cutout. [0017] In some embodiments, the valve core comprises a cavity. The valve core can comprise a beam connecting two sides of the valve core and extending along most of a length of the valve core. In some embodiments, the valve core comprises a beam extending partially along a side of the valve core. The beam can be positioned near a top portion of a cavity of the valve core. In some embodiments, the connector valve is configured to cause positive displacement. The connector valve can be configured to cause negative displacement. In some embodiments, the connector valve is configured to cause neutral displacement.

[0018] In another aspect, a method of accessing a needleless connector valve is provided.

The connector valve comprises connecting a connector to an inlet of the connector valve, the connector valve providing access to a patient’s vasculature; and advancing the connector relative to the inlet of the connector valve, the advancing causing a valve core of the connector valve to buckle at a first cutout and a second cutout, the buckling allowing fluid access to an outlet of the connector valve.

[0019] In some embodiments, causing the connector valve to buckle comprises causing the first cutout to buckle and then causing the second cutout to buckle. The first cutout can be larger than the second cutout. In some embodiments, connecting a connector comprises connecting a male luer connector. The method can further comprise disinfecting the connector valve in a UV disinfection unit prior to connecting the connector. In some embodiments, disinfecting the connector valve in a UV disinfection unit comprises inserting the connector valve into an opening of the disinfection unit. Disinfecting the connector valve in a UV disinfection unit can comprise electrically connecting an electrical element of the connector valve with a

corresponding feature in the UV disinfection unit. In some embodiments, disinfecting the connector valve in a UV disinfection unit comprises engaging an indexing feature of the connector valve with a mating feature in the UV disinfection unit.

BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative

embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

[0021] FIGS. 1A and IB show various views of an assembled needleless connector valve.

[0022] FIGS. 2A-2D depict various views of a valve core for use with the needleless connector valve of FIGS. 1A and IB. [0023] FIGS. 3 A and 3B show various views of a top portion of a housing of the needleless connector valve of FIGS. 1A and IB.

[0024] FIGS. 4A and 4B illustrate various views of a bottom portion of a housing of the needleless connector valve of FIGS. 1A and IB.

[0025] FIGS. 5 A and 5B illustrate side views of an embodiment of a needleless connector valve.

[0026] FIGS. 6A-6D show a syringe being connected to a needleless connector valve as described herein.

[0027] FIGS. 7A-7E show various views of an embodiment of a needleless connector valve.

[0028] FIGS. 8 A, 8B and 8C show various views of an embodiment of an identification chip assembly.

[0029] FIGS. 9A and 9B show various views of an embodiment of the top portion of a needleless connector.

[0030] FIG.10 shows a view of an embodiment of the bottom portion of a needleless connector.

[0031] FIGS. 1 lA-1 IE show various views of an embodiment of a needleless connector valve.

DETAILED DESCRIPTION

[0032] FIGS. 1A and IB show perspective and front views, respectively, of an embodiment of a needleless connector valve 100. The valve comprises an outer housing 102 and a valve core 104. The housing 102 comprises an upper section 106 and a lower section 108. The connector comprises an inlet port 110 and an outlet port 112.

[0033] The upper section 106 of the housing and the valve core 104 comprise a generally square shaped cross section with rounded comers. This shape can advantageously optimize the connector shape for disinfection (e.g, using one or more LEDs in a UV disinfection device). The connector also has very little space (e.g., 80 microliters) between the valve core 104 and the housing 102. This minimization of space decreases the size of the fluid path, decreasing the amount of fluid that needs to be disinfected. Decreasing the amount of fluid to be disinfected can advantageously allow for minimization of UV energy and treatment time required for effective US disinfection.

[0034] FIGS. 2A illustrates perspective and side views, respectively, of an embodiment of a valve core 104. A top surface of the valve core 104 comprises a generally flat surface that sits substantially flush with the top of the housing 102. A lip 202 near the top surface can be configured to engage a corresponding feature on the housing 102. In a closed position, the lip 202 is configured to engage the housing 102 around an entire circumference of the lip 202.

When the needleless connector is mated to a male luer connector, the valve core is designed to buckle in a predictable and repeatable manner, the buckling of the valve core moving a portion of the lip 202 away from the housing 102, creating a fluid path for fluid introduced via the male luer connector to flow. The valve core comprises an upper portion 206 and a lower portion 208. The upper portion 206 of the valve core comprises a cut out 204 portion. As shown in FIGS. 2A and 2B, the cut out 204 can comprise a V-shape with a rounded tip. The side view of FIG. 2B shows that the rounded tip portion 210 is positioned near a central longitudinal axis 212 of the valve core. The sides 214 of the cut out 204 extended from the rounded tip towards an outer surface 216 of the valve core. Other shapes (e.g., U-shaped, V-shaped, parabolic, etc.) are also possible. The shape can be optimized to minimize shadows and maximize UV light

transmission.

[0035] The upper portion 206 of the valve core is configured to buckle upon mating of the inlet port 110 to a male luer connector. The shape of the cut out 204 can be configured to exhibit predictable and consistent buckling to create a fluid path for liquid entering through the inlet port 110.

[0036] FIGS. 2C and 2D show side and perspective views of another embodiment of a valve core 104. A top surface of the valve core 104 comprises a generally flat surface that sits substantially flush with the top of the housing 102. A lip 202 near the top surface can be configured to engage a corresponding feature on the housing 102. In a closed position, the lip 202 is configured to engage the housing 102 around an entire circumference of the lip 202.

When the needleless connector is mated to a male luer connector, the valve core is designed to buckle in a predictable and repeatable manner, the buckling of the valve core moving a portion of the lip 202 away from the housing 102, creating a fluid path for fluid introduced via the male luer connector to flow. The valve core comprises an upper portion 206, an intermediate portion 208, and a lower portion 210. The intermediate portion 208 comprises a larger diameter than the upper portion 206. The lower portion 210 comprises a larger diameter than the intermediate and upper portions 206, 208. The intermediate portion 208 cross section comprises a generally square shape with rounded corners. The upper portion 206 of the valve core comprises a cut out 204 portion. As shown in FIGS. 2A and 2B, the cut out 204 can comprise a scalloped shape.

The side view of FIG. 2B shows that the cut out 204 generally comprises an arc shape. Other shapes (e.g., U-shaped, V-shaped, parabolic, etc.) are also possible. The shape can be optimized to minimize shadows and maximize UV light transmission.

[0037] The upper portion 206 of the valve core is configured to buckle upon mating of the inlet port 110 to a male luer connector. The shape of the cut out 204 can be configured to exhibit predictable and consistent buckling to create a fluid path for liquid entering through the inlet port

110.

[0038] The valve cores described herein can comprise silicone, in some embodiments. Other materials are also possible (e.g., styrenic block copolymers, thermoplastic olefinic elastomers, thermoplastic polyester elastomer, thermoplastic amide elastomer, and thermoplastic urethane elastomer). Material selection may be used to optimize the UVC treatment. For instance, the valve core can be comprised of materials that are optically clear, translucent or opaque to UVC light such as different silicone materials. In addition, additives such as colorants may be added to the valve material that enhance the absorption or reflection of UVC light. The valve core material could also be selected or modified to enhance the physical characteristics such as the elasticity or the lubricity of the valve. The valve core material could also be selected or modified so that there is a low or high surface tension. One reason regulation of the surface tension could be desirable is so that a bead of residual liquid is not present at the end of the valve (CIP12) after injection of liquid. A high surface tension could result in the bead having insufficient adhesion such that it falls off, a low surface tension could result in a thin film of residual liquid.

[0039] The surfaces of the valve can also be modified for performance. For instance, the surfaces of the valve that are substantially flat may contact the internal surfaces of the top portion of the valve either at rest or during buckling. The surfaces of the valve may also contact other surfaces of the valve during buckling. If there is adherence of the valve material to itself or to the housing, it may be preferential to have a textured surface, such as could be produced by bead blasting or otherwise processing the surface of the mold used to fabricate the valves. Texturing the surface may enhance the ability of the valve to buckle and unbuckle during use. The surface finish of the mating surface of the connector to the syringe tip could be used to effect the ability of liquid to bead on the valve surface (CIP12).

[0040] FIGS. 3 A and 3B show side and perspective views of the upper section 106 of the housing 102. An opening 302 at the top portion of the housing 102 forms the inlet port 110. The housing section 106 comprises a top portion 306 near the inlet port. The top portion 306 gradually increases in diameter to an intermediate portion 308. A bottom portion 310 comprises a greater diameter than the intermediate portion 308, forming a lip 312 between the intermediate 308 and bottom 310 portions. The top and intermediate portions 308 comprise a generally square shaped cross section with rounded comers. The bottom portion 310 comprises a generally rounded or circular cross section. In other configurations the bottom portion comprises a generally square shaped cross section with rounded comers. This could be advantageous for indexing to the mating hand piece. [0041] In some embodiments, the top portion of the housing does not comprise full threads for mating to a male luer connector. Instead, the top portion comprises partial threads, as shown in FIGS. 3 A and 3B. Partial threads can advantageously provide less material for the UV disinfection light to penetrate and produce fewer shadows than full threads, minimizing the amount of UV energy and treatment time required for disinfection. The partial threads 304 can comprise ridged protrusions and be positioned at the four rounded comers of the top portion of the housing, as shown best in FIG. 3B. It will be appreciated that, in some embodiments, the top portion comprises full threads or another means of connection. The threads or partial threads can be configured to connect to a male threaded luer connector such as that found on a syringe or infusion tubing set.

[0042] In the top and intermediate portions 306, 308 of the housing, fluid is configured to flow in the space between the valve core and the housing. The bottom portion 310 of the housing comprises one or more channels 314 positioned around a perimeter or circumference of the bottom portion 310. FIG. 3B shows 2 channels positioned at approximately 90° increments around the perimeter of the bottom portion 310. The channels 314 provide a fluid path for the fluid to move towards the outlet port 112.

[0043] The top portion of the housing comprises a UV transmissive material, such as cyclic olefin copolymer such as Topas® Advance Polymers, GmbH, Frankfurt Germany. Other materials (e.g., polymethylpentene such as TPX® Mitsui Chemicals America, Rye Brook, NY) are also possible.

[0044] FIGS. 4A and 4B illustrate front and side views, respectively of the bottom section or base 108 of the connector 100. The base comprises the outlet port 112 at the bottom surface. Threads 402 positioned near a bottom portion of the base 108 allow connection to a female luer connection. The threads 402 can be used to connect the connector to a catheter line on a patient (e.g., a CVC line). The connector comprises openings 404 that pass from a top portion of the base 108 through the bottom of the base 108. These openings 104 allow ambient air into and out of the valve. In some configurations the air vents past the threads, in other configurations vent holes could be through the sides in the region of the threads or anywhere up to the bond joint that hermetically seals the top and bottom connector internal fluid path. This allows the valve to compress without compressing gas in the valve, allowing the valve to freely compress without compressing gas within the interior of the valve. Compressed gas could affect the stiffness of the valve making it relatively stiffer as the valve compressed. Compressed gas being less dense than liquid, could potentially leak into the fluid path when the valve was compressed without the openings to ambient air. In the case that there were no holes, and internal gas did escape into the fluid channel, there could be a vacuum generated in the interior of the valve when returning to the uncompressed state. This could prevent a full return to the original uncompressed state. Opening 406, shown in FIG. 4B, provides a path for the fluid flowing through channels 314 to flow through to the channel exiting tip 112. There is a reduced diameter portion 408 of the base 108. The reduced diameter forms a channel that communicates around the diameter with all of the channels 314 and provides a path for the channels to communicate with the opening 406 and therefore out of the end of the valve at tip 112.

[0045] The base of the housing can comprise UV transmissive material, such as cyclic olefin copolymer such as Topas® Advance Polymers, GmbH, Frankfurt Germany. Other materials (e.g., polymethylpentene such as TPX® Mitsui Chemicals America, Rye Brook, NY) are also possible. Alternatively, this portion of the connector may not require UV transmissivity, and could be made out of an alternate material such as acrylic, polycarbonate, polyester,

polypropylene, or other suitable material.

[0046] The base 108 has a slightly smaller outer diameter portion that fits with in the inner diameter of the top 106. In the assembled configuration the valve is compressed between the base and top housings. The fluid flowing through the valve follows the path around the compressed points though channels 314. The compressed portion of the valve creates an air and fluid tight seal between the inside of the valve and the outside of the valve. A rib 410 with a triangular profile creates a complete circle on the sealing surface of the base. This rib focally compresses the valve ensuring a complete seal. The rib is shown with a triangular profile, but could have other profiles such as a radial profile, or a triangular profile with a flat, or other profile that serves to ensure a complete seal.

[0047] In order to optimize the UVC transmissivity of the connector as well as to provide sufficient mechanical strength and ability to use a volume manufacturing process such as injection molding, the wall thickness of the top housing is preferably about .050”. Other thicknesses (e.g., about 0.030” to 0.070”) are also possible

[0048] In some embodiments, the connector is molded as three separate pieces that are joined together, as shown in FIGS. 1-4B. Other configurations are also possible (e.g., 2 pieces, 4 pieces, 5 pieces, etc.), as described with respect to FIGS. 7C and 8A-B.

[0049] FIGS. 5A and 5B show side views of the connector assembly with the valve core 104 of FIGS. 2C and 2D within the housing 102. As shown in FIG. 5B, the upper surface 502 of the lower portion 218 of the valve core 104 presses against the inside surface 504 of the housing within the lip 312 of the housing. The rib 410 of the base 108 presses against the bottom surface 506 of the valve core 104. As shown, the valve local compresses significantly due to concentrated force at the profile. In this sectional view you can see a complete seal around the valve, the 8 channels around the base of the top housing providing the only path allowing liquid to flow around the valve base and through the bottom housing.

[0050] FIGS. 6A-6D show a connector 600 as described herein being connected to a syringe. As shown in FIG. 6A, the syringe tip 602 beings to compress the valve core 604. The top face of the valve core 604 is flush with the syringe tip 602. There is minimal compression of the cutout 606. The opposite side of the cutout 608 presses against an inside surface of the connector locally.

[0051] FIG. 6B shows the syringe tip 602 further compressing the valve core 604. The top face of the valve core 604 is still flush with the syringe tip. There is noticeable compression and initial buckling at the cutout 606. The opposite side 608 is deflecting down and away from the cutout 608.

[0052] FIG. 6C shows the syringe tip 602 further compressing the valve core 604. The top face 610 of the valve core 604 is deflected from the syringe tip 602. There is buckling at the cutout 606. The opposite side 608 is deflecting down and away from the cutout. There is secondary buckling 612 of the valve core in an intermediate portion of the valve core.

[0053] FIG. 6D shows the syringe tip 602 further compressing the valve core 604. There is increased buckling at the cutout 606. The opposite side 608 is deflecting down and away from the cutout. There is increased secondary buckling 612 of the valve core in an intermediate portion of the valve core.

[0054] FIGS. 7A-7E show various views of an embodiment of a needleless connector valve 700. In the front and back views, respectively of FIGS. 7 A and 7B, the valve body 702 and valve core 704 are visible. The valve core 704 comprises two cutouts 706. The valve body 702 comprises a top portion 708 and a bottom portion 710. The bottom portion 710 comprises an outlet that can comprise an attachment point 712 (e.g., a standard female Luer connector attachment point). In an alternative configuration, the internal threaded feature of the bottom portion can be a separate collar that is bonded, snapped into a mating groove or otherwise attached to the connector; this could be advantageous to facilitate molding the various components. In another alternative configuration, the bottom portion Luer connecting feature can be nested further into the base, potentially as far up as the vent holes; This could be

advantageous to minimize the connector size and weight.

[0055] FIG. 7C shows a perspective view of the connector valve 700. The valve comprises an electronic element 720 and an indexing feature 722. FIGS. 7C, 8 A and 8B illustrate an embodiment with 4 separate pieces, with the fourth piece being an electronic element 720, described in more detail below. FIG. 7D and 7E show views of the connector valve 700 taken across perpendicular planes. [0056] FIGS. 8 A and 8B show detailed views of the electronic element 720 (e.g., a chip) of the connector valve 700. The electronic element is secured in place with 2 contact pads 802 exposed (FIG. 8A). The chip 720 could be a resistor or other element. This chip 720 can be configured to mate with electrical connectors in a UVC disinfection handpiece. In some embodiments, this chip 720 is used to close a circuit so that the handpiece detects the presence of the connector and executes a disinfection cycle. Optionally, the chip has encryption capability. This capability would ensure the proper use of the connector with the handpiece. In some embodiments, the chip has a timeout feature so that the connector was only used for its proscribed life and so that it could not be extracted for use with another connector. The encapsulation may be designed for optimal engagement with a mating feature (e.g., mating spring loaded electrical contact“pogo” pins). In particular, there may be gentle ramping 804 around the chip so that the rounded end of the pogo easily slides over the connector (FIG. 8A). The position can be tightly controlled via the design of a pocket 806 formed by the lower and upper portions of the valve housing, shown in FIG. 8B and 8C. This pocket can tightly control the location of the connector in three dimensions so that it optimally engages the mating connectors on the handpiece.

[0057] In some embodiments, the connector comprises an indexing feature 722 (FIG. 7C) so that the chip on the connector engages when the connector is ideally positioned. This can be achieved with a feature 722 that protrudes from the surface of the connector that mates with a nest feature on the associated handpiece. In order to disinfect as much of the connector as possible, the protrusion can be at or near the end of the bottom portion of the connector, as shown in FIG. 7C. Manufacturing the bottom portion of the connector from a UVC transparent material would then have the advantage of being able to transmit UVC light to the female threaded luer connection on the connector mating part. This would advantageously disinfect any portion of the mating connector exposed to UVC light such as the threads, top edge, and top portion of the inner surface of the mating connector. In alternate configurations, the mating nest feather on the associated handpiece could be oriented adjacent to the chip. The feature 722 then would be immediately adjacent to the chip and not at the end of the bottom portion of the connector while maintaining the performance features described above.

[0058] The system can be disinfected using a variety of methods. For example, the embodiment described can be disinfected with UVC light, but, can also be disinfected using standard of care alcohol wiping techniques, or alcohol disinfection caps.

[0059] FIGS. 9A-9B show front and top perspective views, respectively, of an embodiment of a top portion 902 of a connector valve. Unless otherwise described, the top portion 902 of the connector valve can be similar to the top portion described with respect to top portion 306 described with respect to FIGS. 3 A and 3B. In some embodiments, the top portion of the housing does not comprise full threads for mating. Instead, the top portion comprises partial threads. Partial threads can advantageously provide less material for the UV disinfection light to penetrate and produce fewer shadows than full threads, minimizing the amount of UV energy and treatment time required for disinfection. The partial threads can comprise ridged protrusions and be positioned at the four rounded comers of the top portion of the housing. The partial threads could also consist of one, two or more partial threads that are not rigid protrusions at the four rounded corners of the top portion of the housing; these could be oriented to minimize the amount of UV energy and treatment time required for disinfection. It will be appreciated that, in some embodiments, the top portion comprises full threads or another means of connection. The threads or partial threads can be configured to connect to a male threaded luer connector such as that found on a syringe or infusion tubing set.

[0060] The top portion of the housing comprises a UV transmissive material, such as cyclic olefin copolymer such as Topas® Advance Polymers, GmbH, Frankfurt Germany. Other materials (e.g., polymethylpentene such as TPX® Mitsui Chemicals America, Rye Brook, NY) are also possible.

[0061] FIG. 10 shows a bottom perspective view of a bottom portion 1002 of a connector valve. The bottom portion 1002 comprises an outlet port 1004 that can serve as an attachment point (e.g., Standard female Luer connector). As noted above, the bottom portion 1002 can comprise a UVC transparent material, allowing disinfecting UVC light to be transmitted to the Luer connector. As noted above, in some embodiments, the internal threaded feature of the bottom portion can be a separate collar that is bonded, snapped into a mating groove or otherwise attached to the connector; this could be advantageous to facilitate molding the various components. In another alternative configuration, the bottom portion connecting feature (e.g., Luer connecting feature) can be nested further into the base, potentially as far up as the vent holes. This could be advantageous to minimize the connector size and weight.

[0062] FIG. 11 A shows an embodiment of a valve core 1102 with 2 cutouts 1104, 1106, both of which comprise a scalloped shape. Both of the 2 scallops are perpendicular to, and do not cross, the neutral axis 1108. A larger scallop 1106 is on one side of the valve core 1102 and a second, smaller scallop 1104 is one another side of the valve core. The valve core 1102 is disposed to buckle first at the larger scallop 1106. This predisposed buckling site allows the valve face to deflect away from the tip of the male luer upon insertion with very little

displacement. The addition of a second scallop 1104 further reduces the resistance to deflection by reducing the cross sectional area of the beam and therefore its stiffness. The term‘beam’ can be used to refer to the valve in terms of a Euler Column. Where compression of the beam length refers to characteristic buckling behavior by the equation P_Cf=( ²EI)/(KL)² where P_CT=critical load for buckling to occur, E = modulus of elastic, I = minimum cross sectional moment of interia. L = unsupported column length, and K = column effective length factor. Since E, L, and K are the same with respect to this valve, by modifying the moment of inertia we can determine the buckling force and orientation. In this case the scalloped portion of the column without scallops has a moment of inertia scaiiop =( d⁴)/32, Ibetween scaiiops-non-neutrai-axis = ((smallest distance between scallops)*d³)/12, and Ibetween scaiiops-aiong-neutrai-axis = (d*(smallest distance between scallops)³)/12. It can be seen from the equations that the moment of inertia is by far the smallest between the scallops along the neutral axis and will predispose to buckle there.

[0063] FIG. 1 IB shows a top view of the connector. The valve face 1140 is the top of the portion of the valve that contacts the mating syringe during use. The valve surfaces contacting inside of valve top 1142 are the faces of the valve body in the portion along the square-shaped portion of the valve that are within the mating, square shaped portion of the connector Top.

[0064] FIG. 11C shows a bottom view of the connector valve. A continuous beam 1116 connects to the internal wall of the valve at two sides 1144 of the internal cavity the base of the valve and extends fully (or, in some embodiments, mostly) up the length of the valve cavity.

Two sides 1150 of the internal cavity are not connected up the length of the valve as indicated. The continuous beam orientation of Low Stiffness, indicated by arrow 1146, reflects the orientation of low inertial moment that is predisposed to buckle at a significantly lower force than the Continuous Beam Orientation of High Stiffness, indicated by arrow 1148, with its relatively high inertial moment.

[0065] FIG 1 ID shows a cross section of a valve core 1102 perpendicular to the neutral axis 1122, showing additional features of the valve core 1102 to facilitate buckling in a preferential orientation. The cross section shows a shorter internal beam 1110 (e.g., a thicker portion of the valve core) at one end of the cavity and a longer beam 1112 that extends the rest of the way through the cavity (open volume within the valve core) on the opposing internal side. Upon compression, the thinner portions are predisposed to buckle relative to the thicker sections. Therefore, a large portion (e.g., the entire length) of the valve has features that predispose buckling points. In addition, perpendicular to the buckling plane 1114, there is a continuous beam 1116 that extends the entire length of the valve. The continuous beam can refer to a continuous, solid section of the valve core running along the neutral axis. In the bending orientation this beam is along the neutral axis 1122 and does not significantly contribute to buckling resistance (FIGS. 11C and 1 ID). However, in the direction perpendicular to bending there is a substantial difference in stiffness. This further predisposes buckling in a preferential orientation. The substantially square profile of the body of the valve is preferentially disposed to buckle along the four faces, as the arcs between the faces are substantially stiffer than the faces. Further, the internal rib that runs the length of the body of the valve bridges the two faces 1118, 1120 perpendicular to buckling (FIGS. 11C and 1 ID). The beam 1116 retains the distance between the faces 1118, 1120 during deformation, while the unsupported faces are free to deflect. All of these design features contribute to the mechanical function of the valve. FIG. 1 IE shows a cross-section of the valve core along the neutral axis.

[0066] A key feature of some embodiments is the fluid displacement when removing the male luer from the valve. In some embodiments, it is preferred to have substantially neutral displacement of fluid. In other embodiments it may be preferential to have positive or negative displacement. The interior volume of the valve 1130, shown in FIG. 1 ID facilitates tuning the displacement of the system as the displaced volume in the valve is directly correlated to the displaced volume in the connector body. In particular, as valve compresses, air is displaced from the valve cavity. As the valve decompresses, air enters the valve cavity. For a neutral valve, the air fills the volume equivalent to the volume displace by the syringe tip removal. For positive displacement it displaces more and for negative displacement less. The optimal displacement can be dialed in by increasing or decreasing the wall thickness of the beam 1132 that extends the length of the valve. As noted previously, this design feature has little impact on the valve actuation force and buckling. Therefore it is an ideal feature for fine tuning displacement with negligible impact on functional performance.

[0067] When a feature or element is herein referred to as being“on” another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also be present. In contrast, when a feature or element is referred to as being“directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being“connected”,“attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being“directly connected”,“directly attached” or“directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed“adjacent” another feature may have portions that overlap or underlie the adjacent feature.

[0068] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms“a”,“an” and“the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms“comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term“and/or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as“/”.

[0069] Spatially relative terms, such as“under”,“below”,“lower”,“over”,“upper” and the like, may be used herein for ease of description to describe one element or feature’s relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as“under” or“beneath” other elements or features would then be oriented“over” the other elements or features. Thus, the exemplary term“under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms“upwardly”,“downwardly”,“vertical”,“horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

[0070] Although the terms“first” and“second” may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one

feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.

[0071] Throughout this specification and the claims which follow, unless the context requires otherwise, the word“comprise”, and variations such as“comprises” and“comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term

“comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0072] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word“about” or“approximately,” even if the term does not expressly appear. The phrase“about” or “approximately” may be used when describing magnitude and/or position to indicate that the value and/or position described is within a reasonable expected range of values and/or positions. For example, a numeric value may have a value that is +/- 0.1% of the stated value (or range of values), +/- 1% of the stated value (or range of values), +/- 2% of the stated value (or range of values), +/- 5% of the stated value (or range of values), +/- 10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value“10” is disclosed, then“about 10” is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that “less than or equal to” the value,“greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value“X” is disclosed the“less than or equal to X” as well as“greater than or equal to X” (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point“10” and a particular data point“15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0073] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative

embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others.

Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.

[0074] The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure.

Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term“invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

Claims

CLAIMS What is claimed is:

1. A needleless connector valve comprising

an inlet;

an outlet;

a body; and

a sealed valve core positioned within the body, the valve core comprising a cut out portion, the valve core configured to buckle to allow fluid flow through the body.

2. The needleless connector valve of claim 1, wherein the body comprises a UV- transmissive material.

3. The needleless connector valve of claim 1, wherein the valve core comprises an opaque material.

4. The needleless connector valve of claim 1, wherein body comprises a top portion and a bottom portion.

5. The needleless connector valve of claim 1, wherein the top portion of the housing comprises a thickness of about 0.050”.

6. A needleless connector valve comprising

an inlet;

an outlet;

a body; and

a sealed valve core positioned within the body, the valve core comprising a first cut out portion and a second cut our portion, the valve core configured to buckle to allow fluid flow through the body.

7. The connector valve of any of claims 1-6, wherein the valve comprises an

electronic element.

8. the connector valve of claim 7, wherein the electronic element is a chip.

9. The connector valve of claims 7 or 8, wherein the electronic element is a resistor.

10. The connector valve of any of claims 7-9, wherein the electronic element

comprises encryption capability.

11. The connector valve of any of claims 7-10, wherein the electronic element is configured to ensure the proper use of the connector with a handpiece of a disinfection unit.

12. The connector valve of any of claims 7-11, wherein the electronic element comprises a timeout feature.

13. The connector valve of claim 12, wherein timeout feature is configured to ensure the connector valve is not switched out for a different connector valve.

14. The connector valve of any of claims 7-13, wherein the electronic element is

configured to engage with a mating feature of a disinfection unit.

15. The connector valve of claim 14, wherein the mating feature comprises pogo pins.

16. The connector valve of claim 16, wherein the valve comprises gentle ramping feature around the electronic element to enable the pogo pins to slide over the connector when the connector is placed into the disinfection unit.

17. The connector valve of any of claims 6-16, wherein the body comprises an

electronic element.

18. The connector valve of any of claims 1-17, wherein the body comprises an

indexing feature.

19. The connector valve of any of claims 1-18, further comprising a feature

configured to ensure proper positioning of the connector valve within a disinfection unit.

20. The connector valve of claim 19, wherein the feature comprises a pocket.

21. The connector valve of any of claims 1-20, wherein the connector valve

comprises an indexing feature.

22. The connector valve of claim 21, wherein the indexing feature comprises a

protrusion on the connector valve.

23. The connector valve of claims 21 or 22, wherein the indexing feature is

configured to interact with a corresponding feature on a disinfection unit.

24. The connector valve of claim 23, wherein the corresponding feature comprising a nesting feature configured to interact with a protrusion on the connector valve.

25. The connector valve of any of claims 21-24, wherein the indexing feature is

positioned near a bottom portion of the connector valve.

26. The connector valve of any of claims 6-25, wherein the body comprises a UV transparent portion.

27. The connector valve of any of claims 6-26, the body comprising a top portion and a bottom portion.

28. The connector valve of any of claims 4 or 6-27, wherein the top portion and the bottom portion are separate components that are joined.

29. The connector valve of any of claims 4 or 6-28, wherein a top portion of the body comprises partial threads.

30. The connector valve of any of claims 4 or 6-29, wherein a top portion of the body comprises full threads.

31. The connector valve of any of claims 4 or 6-30, wherein a top portion of the body comprises a cross section of a square shape with rounded comers.

32. The connector valve of claim 31, wherein partial threads are positioned at the rounded corners.

33. The connector valve of any of claims 4 or 6-32, wherein a top portion of the body comprises a UV transmissive material.

34. The connector valve of any of claims 4 and 6-33, wherein a bottom portion of the body comprises the outlet.

35. The connector valve of any of claims 1-34, wherein the outlet is configured to attach to other connectors.

36. The connector valve of any of claims 4 and 6-35, wherein a bottom portion of the body comprises a UV transmissive material.

37. The connector valve of any of claims 6-36, wherein the first cutout and/or the second cutout of the valve core comprises a scallop shape.

38. The connector valve of any of claims 6-37, wherein the core is configured to buckle at the first cutout first, the first cutout larger than the second cutout.

39. The connector valve of any of claims 1-38, wherein the valve core comprises a cavity.

40. The connector valve of any of claims 1-39, wherein the valve core comprises a beam connecting two sides of the valve core and extending along most of a length of the valve core.

41. The connector valve of any of claims 1-40, wherein the valve core comprises a beam extending partially along a side of the valve core.

42. The connector valve of claim 41, wherein the beam is positioned near a top

portion of a cavity of the valve core.

43. The connector valve of any of claims 1-42, wherein the connector valve is

configured to cause positive displacement.

44. The connector valve of any of claims 1-42, wherein the connector valve is

configured to cause negative displacement.

45. The connector valve of any of claims 1-42, wherein the connector valve is

configured to cause neutral displacement.

46. A method of accessing a needleless connector valve comprising

connecting a connector to an inlet of the connector valve, the connector valve providing access to a patient’s vasculature; and

advancing the connector relative to the inlet of the connector valve, the advancing causing a valve core of the connector valve to buckle at a first cutout and a second cutout, the buckling allowing fluid access to an outlet of the connector valve.

47. The method of claim 46, wherein causing the connector valve to buckle comprises causing the first cutout to buckle and then causing the second cutout to buckle.

48. The method of claims 46 or 47, wherein the first cutout is larger than the second cutout.

49. The method of any of claims 46-48, wherein connecting a connector comprises connecting a male luer connector.

50. The method of any of claims 46-49, further comprising disinfecting the connector valve in a UV disinfection unit prior to connecting the connector.

51. The method claim 50, wherein disinfecting the connector valve in a UV

disinfection unit comprises inserting the connector valve into an opening of the disinfection unit.

52. The method of any of claims 50 and 51, wherein disinfecting the connector valve in a UV disinfection unit comprises electrically connecting an electrical element of the connector valve with a corresponding feature in the UV disinfection unit.

53. The method of any of claims 50-52, wherein disinfecting the connector valve in a UV disinfection unit comprises engaging an indexing feature of the connector valve with a mating feature in the UV disinfection unit.