Needleless connector valve for UV disinfection

Abstract

To provide various methods and devices for disinfecting intracavity and transdermal access sites using ultraviolet light.SOLUTION: A UV-transmissive needleless connector comprises an outer housing 102 that is at least partially UV-transmissive. The connector is configured to elastically deform to form a fluid pathway through the connector.SELECTED DRAWING: Figure 1A

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit of U.S. Provisional Patent Application No. 62 / 822,658, filed Mar. 22, 2019, and U.S. Provisional Patent Application No. 62 / 911,059, filed Oct. 4, 2019. This application is a national stage application of International Application No. PCT / US2017 / 041556, filed Jul. 11, 2017, and claims the benefit of U.S. Provisional Patent Application No. 62 / 360,922, filed Jul. 11, 2016, which is related to U.S. Application No. 16 / 316,918, filed Jul. 11, 2017.

[0002] (Incorporation by Reference) All publications and patent applications mentioned in this specification are hereby incorporated by reference in their entirety, as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference.

[0003] (Field) Systems and methods related to the use for sterilizing access (insertion) sites generally are described herein. More specifically, various methods and apparatuses for using ultraviolet light to sterilize intracavitary and percutaneous access sites are related.

Background Art

[0004] One of the first treatment procedures performed when a patient is admitted to the hospital is the placement of an intravenous line (IV). This percutaneously placed IV line allows healthcare providers to directly access the patient's bloodstream through a peripheral vein, enabling rapid administration of fluids, medications, or collection of blood samples. In more severe cases where direct supply of high-concentration blood is required, such as chemotherapy, temporary kidney dialysis, or catheter treatment for heart monitoring, a central venous catheter (CVC or central line) is inserted. This line is typically inserted percutaneously into a major branch vessel (usually the subclavian vein), although it can also be inserted into a peripheral vein, and then the distal portion of the catheter is guided into the superior vena cava.

[0005] In both peripheral and central catheter procedures, a lumen, which is an open pathway from the external access site to the bloodstream, is formed. This intravascular access site serves as a point for attaching various therapeutic or diagnostic medical devices, including but not limited to stopcocks, needleless access sites, IV bags, infusion pumps, drug delivery pumps, kidney dialysis devices, thermodilution catheters, etc. Unfortunately, this access site can also be an entry point for bacterial infections. Thus, each time the access site is opened to attach a medical device, there is an opportunity for bacteria to enter the catheter lumen and migrate into the bloodstream.

[0006] In addition to contamination of the catheter lumen via the external access site, bacteria can also enter through the skin puncture or subcutaneous tubing formed by the catheter during the placement of an IV or CVC. The bacteria move along the outer wall of the catheter to the distal end and infect the tubing along the wall of the catheter.

[0007] In conventional IV lines and CVCs, in order to minimize the serious problems identified in the following paragraphs, some plastic fixture with a female - type luer lock or luer slip connector attached to the proximal end is used. These connectors must be closed with a luer cap when not in use to prevent contamination of the access site. This is because the outside of the luer cap is contaminated, and it is almost impossible to prevent the male luer shape, once removed, from touching the contaminated surface. Therefore, in conventional infection control measures, the luer cap was always replaced when accessing the line. This procedure is not only costly but also increases the chance of bacteria entering the lumen of the connector during the removal and replacement process.

[0008] In some cases, the IV access site has been changed to a needleless access valve, which has an elastomeric seal and can be opened via the tip of a male luer connector attached to a syringe or similar device. These needleless access valves are supposed to be cleaned with a cotton swab containing alcohol before the valve is opened by the sterile male luer tip of the syringe. Unfortunately, cleaning with a cotton swab requires a significant amount of time, additional consumables, and appropriate skills of the clinician performing the cleaning, so the cleaning procedure may not be followed.

[0009] There are still challenges in preventing infections in patients with indwelling catheters, and improvements in sterilization and infection prevention are required.

Summary of the Invention

Problems to be Solved by the Invention

[0010] In a first aspect, a needleless connector valve is provided. The valve includes an inlet, an outlet, a body, and a sealed valve core disposed within the body. The valve core includes a notch portion and is configured to flex and deform to allow fluid flow through the body.

[0011] In some embodiments, the valve core includes an opaque material. The valve core can include an opaque material. In some embodiments, the body consists of a top and a bottom. The top of the housing can consist of a thickness of about 0.050 inches.

[0012] In another aspect, a needleless connector valve is provided. The connector valve includes an inlet, an outlet, a body, and a sealed valve core disposed within the body. The valve core includes a first notch portion and a second notch portion, and the valve core is configured to flex and deform to allow fluid flow through the body.

[0013] In some embodiments, the valve includes an electronic element. The electronic element may be a chip. The electronic element may be a resistor. In some embodiments, the electronic element includes an encryption function. The electronic element can be configured to ensure proper use of the connector to the handpiece of the sterilization device. In some embodiments, the electronic element includes a timeout function. The timeout function can be configured so that the connector valve cannot be switched to a different connector valve. In some embodiments, the electronic element is configured to mate with the mating mechanism of the sterilization device. The mating mechanism can include pogo pins. In some embodiments, the valve includes a gentle ramping mechanism around the electronic element to allow the pogo pins to slide over the connector when the connector is placed in the sterilization device. In some embodiments, the body includes the electronic element. In some embodiments, the body includes an indexing mechanism. The connector valve can further include a mechanism configured to ensure proper positioning of the connector valve within the sterilization device. In some embodiments, the mechanism includes a pocket.

[0014] The connector valve can be provided with an indexing mechanism. In some embodiments, the indexing mechanism is configured to interact with a corresponding mechanism on the sterilization device. The corresponding mechanism can include a nested mechanism configured to interact with a protrusion on the connector valve. In some embodiments, the indexing mechanism is disposed near the bottom of the connector valve.

[0015] The body can include a UV-transmissive portion. In some embodiments, the body has a top and a bottom. The top and the bottom may be separate components that are joined. The top of the body can have a partial thread. In some embodiments, the top of the body has a complete thread. The top of the body can include a square cross-section with rounded corners. In some embodiments, the partial thread is located at the rounded corners. The top of the body can include a UV-transmissive material. In some embodiments, the bottom of the body has an outlet. The outlet can be configured to attach to another connector. In some embodiments, the bottom of the body includes a UV-transmissive material.

[0016] The first notch portion and / or the second notch portion of the valve core can have a scallop (scallop shell) shape. In some embodiments, the core can be configured to flex and deform at the first notch portion, and the first notch portion is larger than the second notch portion.

[0017] In some embodiments, the valve core includes a cavity. The valve core can include a beam that connects two sides of the valve core and extends along most of the length of the valve core. In some embodiments, the valve core includes a beam that extends partially along the side of the valve core. The beam can be disposed near the top of the cavity of the valve core. In some embodiments, the connector valve is configured to generate a positive displacement. The connector valve can be configured to generate a negative displacement. In some embodiments, the connector valve is configured to generate a neutral displacement.

[0018] In another aspect, a method of accessing a needleless connector valve is provided. The method includes 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 step flexing the valve core of the connector valve at a first notch and a second notch, the flexing enabling fluid access to an outlet of the connector valve.

[0019] In some embodiments, deflecting the connector valve includes deflecting the first notch and then deflecting the second notch. The first notch can be larger than the second notch. In some embodiments, connecting the connector includes connecting a male luer connector. The method can further include sterilizing the connector valve with a UV sterilization device before connecting the connector. In some embodiments, sterilizing the connector valve with a UV sterilization device includes inserting the connector valve into an opening of the sterilization device. Sterilizing the connector valve with a UV sterilization device can include electrically connecting an electrical element of the connector valve to a corresponding mechanism of the UV sterilization device. In some embodiments, sterilizing the connector valve within the UV sterilization device includes fitting an indexing mechanism of the connector valve to a fitting mechanism of the UV sterilization device.

Brief Description of the Drawings

[0020] The novel features of the present invention are specifically set forth in the appended claims. The features and advantages of the present invention will be better understood from the following detailed description, which illustrates exemplary embodiments utilizing the principles of the present invention, and the accompanying drawings. By referring to the embodiments in which the principles of the present invention are utilized and the accompanying drawings, the features and advantages of the present invention can be better understood.

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DETAILED DESCRIPTION OF THE INVENTION

[0032] Figures 1A and 1B respectively show a perspective view and a front view of an embodiment of a needleless connector valve 100. The valve includes an outer housing 102 and a valve core 104. The housing 102 includes an upper section 106 and a lower section 108. The connector includes an inlet port 110 and an outlet port 112.

[0033] The upper section 106 of the housing and the valve core 104 have a generally square cross-section with rounded corners. This shape can advantageously optimize the shape of the connector for sterilization (e.g., using one or more LEDs in a UV sterilization device). Also, the connector has a very small space (e.g., 80 microliters) between the valve core 104 and the housing 102. Minimizing this space reduces the size of the fluid path and the amount of fluid that needs to be sterilized. Reducing the amount of fluid to be sterilized advantageously makes it possible to minimize the UV energy and processing time required for effective UV sterilization.

[0034] Figure 2A shows a perspective view and a side view of an embodiment of the valve core 104, respectively. The upper surface of the valve core 104 is composed of a substantially flat surface that is located at substantially the same height as the upper surface of the housing 102. The lip 202 near the upper surface can be configured to fit with a corresponding mechanism on the housing 102. In the closed position, the lip 202 is configured to fit with the housing 102 over the entire circumference of the lip 202. When the needleless connector is fitted into the male luer connector, the valve core is designed to flex and deform in a predictable and repeatable manner. The flexural deformation (bending, twisting, buckling) of the valve core moves a part of the lip 202 away from the housing 102, forming a fluid path for the fluid introduced through the male luer connector to flow. The valve core is composed of an upper part 206 and a lower part 208. The upper part 206 of the valve core is provided with a notch (cutout) 204. As shown in FIGS. 2A and 2B, the notch 204 can be configured in a V-shape with a rounded tip. The side view of FIG. 2B shows that the rounded tip portion 210 is disposed near the central longitudinal axis 212 of the valve core. The side portion 214 of the notch 204 extends from the rounded tip portion toward the outer surface 216 of the valve core. Other shapes (e.g., U-shaped, V-shaped, parabolic-shaped, etc.) are also possible. The shape can be optimized to minimize shadow and maximize the transmittance of UV light.

[0035] The upper part 206 of the valve core is configured to flex and deform when the inlet port 110 is fitted into the male luer connector. The shape of the notch 204 can be configured to exhibit predictable and consistent flexural deformation (bending) to form a fluid path for the liquid entering from the inlet port 110.

[0036] Figures 2C and 2D show side and perspective views of another embodiment of the valve core 104. The upper surface of the valve core 104 consists of a substantially flat surface that is substantially at the same height as the upper surface of the housing 102. A lip 202 near the upper surface can be configured to engage a corresponding mechanism on the housing 102. In the closed position, the lip 202 is configured to engage the housing 102 over the entire circumference of the lip 202. When the needleless connector is fitted into the male luer connector, the valve core is designed to flex and deform in a predictable and repeatable manner, and the flexure deformation of the valve core moves a portion of the lip 202 away from the housing 102 to form a fluid path for the fluid introduced through the male luer connector to flow. The valve core is composed of an upper portion 206, a middle portion 208, and a lower portion 210. The middle portion 208 is configured with a larger diameter than the upper portion 206. The lower portion 210 is configured with a larger diameter than the middle and upper portions 206, 208. The cross-section of the middle portion 208 is configured in a substantially square shape with rounded corners. The upper portion 206 of the valve core is provided with a notch 204. As shown in FIGS. 2A and 2B, the notch 204 can be configured in a scallop shape. The side view of FIG. 2B shows that the notch 204 is configured in a substantially arc shape. Other shapes (e.g., U-shaped, V-shaped, parabolic, etc.) are also possible. The shape can be optimized to minimize shadow and maximize the transmittance of UV light.

[0037] The upper portion 206 of the valve core is configured to flex and deform when the inlet port 110 is fitted into the male luer connector. The shape of the notch 204 can be configured to exhibit predictable and consistent flexure deformation (bending) to form a fluid path for the liquid entering from the inlet port 110.

[0038] The valve cores described in this specification can, in some embodiments, include silicone. Other materials are also possible (e.g., styrenic block copolymers, thermoplastic olefin elastomers, thermoplastic polyester elastomers, thermoplastic amide elastomers, and thermoplastic urethane elastomers, etc.). The selection of materials can be used to optimize the UVC treatment. For example, like different silicone materials, the valve core can be composed of optically transparent, translucent, or opaque materials to UVC light. Additives such as colorants that promote the absorption or reflection of UVC light can also be added to the valve material. The valve core material can also be selected or changed to enhance physical properties such as the elasticity and lubricity of the valve. The valve core material can also be selected or changed to have a low or high surface tension. One reason for adjusting the surface tension is to ensure that there are no bubbles of residual liquid at the end of the valve (CIP12) after injecting the liquid. If the surface tension is high, the adhesion force of the bubbles may be insufficient and they may fall off. Conversely, if the surface tension is low, the film of the remaining liquid may become thin.

[0039] The surface of the valve can also be changed according to the performance. For example, the surface of the substantially flat valve may contact the inner surface at the top of the valve when at rest or during flexural deformation. Also, the surface of the valve may contact other surfaces of the valve during flexural deformation. When the valve material has adhesiveness to itself or to the housing, it may be preferable to have a textured surface such as obtained by processing the surface of the mold used to manufacture the valve by bead blasting or the like. By giving texture to the surface, the ability of the valve to flex and not flex during use can be enhanced. The surface finish of the mating surfaces of the syringe tip and the connector can be used to affect the bubbles of liquid on the valve (CIP12) surface.

[0040] Figures 3A and 3B are side and perspective views of the upper section 106 of the housing 102. The opening 302 provided at the top of the housing 102 forms the inlet port 110. The section 106 of the housing constitutes the top 306 near the inlet port. The top 306 gradually increases in diameter towards the middle section 308. The bottom 310 has a larger diameter than the middle section 308 and forms a lip 312 between the middle section 308 and the bottom 310. The top and the middle section 308 are configured with a generally square cross-section having rounded corners. The bottom 310 generally has a rounded or circular cross-section. In other configurations, the bottom is configured with a generally square cross-section having rounded corners. This can be advantageous as an indicator for the mating handpiece.

[0041] In some embodiments, the top of the housing does not have a complete thread for fitting a male Luer connector. Instead, as shown in FIGS. 3A and 3B, the top is configured with a partial thread. The partial thread advantageously requires less material for the UV sterilizing light to pass through compared to a complete thread and also has less shadow than a complete thread, thus minimizing the amount of UV energy and the processing time required for sterilization. The partial thread 304 comprises raised protrusions and can be disposed at the four rounded corners of the top of the housing, as best shown in FIG. 3B. It will be understood that in some embodiments, the top may be configured with a complete thread or another connection means. The thread or partial thread can be configured to connect to a male Luer connector such as those found on syringes or infusion tubing sets.

[0042] At the top 306 and the middle section 306 of the housing, the fluid is configured to flow through the space between the valve core and the housing. The bottom 310 of the housing comprises one or more channels 314 disposed around or circumferentially on the bottom 310. FIG. 3B shows two channels disposed at approximately 90° intervals around the bottom 310. The channels 314 provide a fluid path for the fluid to move towards the outlet port 112.

[0043] The top of the housing is made of a UV-transmissive material such as a cyclic olefin copolymer like Topas® by Advanced Polymers, GmbH, Frankfurt, Germany. Other materials (e.g., polymethylpentene such as TPX® by Mitsui Chemicals America, Inc., Livingston, New York) are also possible.

[0044] Figures 4A and 4B respectively show a front view and a side view of the bottom section of the connector 100, i.e., the base 108. The base has an outlet port 112 on the bottom surface. The thread 402 disposed near the bottom surface portion of the base 108 enables connection to a female Luer connector. The thread 402 can be used to connect the connector to a patient's catheter line (e.g., a CVC line). The connector includes an opening 404 that passes from the top of the base 108 to the bottom of the base 108. These openings 104 allow ambient air to enter and exit the valve. In some configurations, air vents through the thread, while in other configurations, the vent holes may be located anywhere from both sides of the thread region or to an adhesive joint that seals the internal fluid path of the upper and lower connectors. This allows the valve to be freely compressed without compressing the gas inside the valve. Compressed gas affects the rigidity of the valve, making it relatively harder when the valve is compressed. Since compressed gas is less dense than liquid, if the valve is compressed without an opening to the ambient air, there is a possibility of leakage into the fluid path. If there are no holes and the internal gas leaks into the fluid path, a vacuum may occur inside the valve when returning to the uncompressed state. This may prevent it from fully returning to its original uncompressed state. The opening 406 shown in Figure 4B provides a path for the fluid flowing through the channel 314 to flow to the channel outlet tip 112. The base 108 has a small-diameter portion 408. The small diameter forms a channel that communicates with all the channels 314 around the diameter, allowing the channels to communicate with the opening 406 and thus providing a path for the fluid to exit from the tip 112 at the end of the valve.

[0045] The bottom surface of the housing is made of a UV-transmissive material such as a cyclic olefin copolymer like Topas® by Advanced Polymers, GmbH, Frankfurt, Germany. Other materials (e.g., polymethylpentene such as TPX® by Mitsui Chemicals America, Inc., Livonia, New York) are also possible. Alternatively, this part of the connector does not require UV transmissivity and can be made of alternative materials such as acrylic, polycarbonate, polyester, polypropylene, or other suitable materials.

[0046] The base 108 has an outer diameter slightly smaller to fit the inner diameter of the upper section 106. In the assembled state, the valve is compressed between the base housing and the top housing. The fluid flowing through the valve follows a path around the compressed portion via the channel 314. The compressed portion of the valve forms an airtight and fluid-tight seal between the inside and outside of the valve. The rib 410 having a triangular outer shape creates a complete circle on the sealing surface of the base. This rib locally compresses the valve and ensures a complete seal. Although the rib is shown with a triangular outer shape, it can have a radial outer shape, a triangular outer shape with a flat surface, or other outer shapes that help ensure a complete seal.

[0047] To optimize the UVC transmittance of the connector and provide sufficient mechanical strength and performance for use in high-volume production processes such as injection molding, the wall thickness of the top housing is preferably about 0.050 inches (1.27 millimeters). Other thicknesses (e.g., about 0.030 inches (0.762 millimeters) to 0.070 inches (1.778 millimeters)) are also possible.

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

[0049] Figures 5A and 5B are side views of a connector assembly with the valve cores of FIGS. 2C and 2D within housing 102. As shown in FIG. 5B, the upper surface 502 of the lower portion 218 of valve core 104 is pressed against the inner surface 504 of the housing within the lip 312 of the housing. The rib 410 of base 108 presses against the bottom surface 506 of valve core 104. As shown, the local area of the valve is significantly compressed by the force concentrated at the outer shape portion. In this cross-sectional view, it can be seen that the area around the valve is completely sealed, and the eight channels around the base of the top housing provide the only path for liquid to flow around the valve base and through the bottom housing.

[0050] Figures 6A through 6D show the connector 600 described herein connected to a syringe. As shown in FIG. 6A, the syringe tip 602 is present to compress valve core 604. The upper surface of valve core 604 is in the same plane as syringe tip 602. The compression of notch 606 is minimal. The surface on the opposite side of notch 608 is locally pressed against the inner surface of the connector.

[0051] FIG. 6B shows the state where syringe tip 602 further compresses valve core 604. The upper surface of valve core 604 is still in the same plane as the syringe tip. In notch 606, there is significant compression and initial bending deformation. The opposite surface 608 is bent downward and away from notch 608.

[0052] FIG. 6C shows the state where syringe tip 602 further compresses valve core 604. The upper surface 610 of valve core 604 is deflected away from syringe tip 602. Bending deformation has occurred in notch 606. The opposite surface 608 is bent downward and away from the notch. Secondary bending (distortion) 612 of the valve core occurs in the middle portion of the valve core.

[0053] FIG. 6D shows the syringe tip 602 further compressing the valve core 604. The deflection (strain) increases at the notch 606. The opposite side portion 608 is bent downward away from the notch. At the middle portion of the valve core, the secondary deflection (strain) 612 of the valve core increases.

[0054] FIGS. 7A through 7E show various views of one embodiment of a needleless connector valve 700. In the front view of FIG. 7A and the rear view of FIG. 7B, the valve body 702 and the valve core 704 can be seen. The valve core 704 includes two notches 706. The valve body 702 is composed of a top 708 and a bottom 710. The bottom 710 constitutes an outlet that can form a mounting point 712 (for example, the mounting point of a standard female Luer connector). In another configuration, the internal thread mechanism at the bottom may be a separate collar that is adhesively or snap - fitted, or otherwise attached to the connector in the mating groove, which may be advantageous for facilitating the molding of various components. Also, in another configuration, the Luer connection mechanism at the bottom can be nested further into the base and can reach the vent hole. This is advantageous for minimizing the size and weight of the connector.

[0055] FIG. 7C is a perspective view of the connector valve 700. The valve includes an electronic element 720 and an indexing mechanism 722. FIGS. 7C, 8A, and 8B show an embodiment having four separate pieces, and the fourth piece is the electronic element 720, which will be described in more detail below. FIGS. 7D and 7E are views of the connector valve 700 cut in a vertical plane.

[0056] Figures 8A and 8B are detailed views of the electronic element 720 (e.g., chip) of the connector valve 700. The electronic element is fixed with two contact pads 802 exposed (Figure 8A). The chip 720 may be a resistor or other element. This chip 720 can be configured to fit with the electrical connector of the UVC sterilization handpiece. In some embodiments, this chip 720 is used to close the circuit so that the handpiece detects the presence of the connector and executes a sterilization cycle. Optionally, this chip has encryption performance. This performance ensures proper use of the connector with the handpiece. In some embodiments, the chip has a timeout function so that the connector can only be used up to a specified life and cannot be pulled out for use with another connector. The sealing portion may be designed to optimally engage with a fitting mechanism (e.g., a spring-loaded electrical contact "pogo" pin for fitting). In particular, a gentle ramping 804 can be provided around the chip so that the rounded end of the pogo slides easily over the connector (Figure 8A). Also, as shown in Figures 8B and 8C, the design of the pocket 806 formed by the lower and upper portions of the valve housing allows for precise control of the position. This pocket can precisely control the position of the connector three-dimensionally so as to optimally engage with the mating connector on the handpiece.

[0057] In some embodiments, the connector comprises an indexing mechanism 722 (FIG. 7C) such that when the connector is in an ideal position, the chip on the connector engages. This can be implemented using an outer profile 722 that protrudes from the surface of the connector and mates with a nested outer profile on the associated handpiece. In order to sterilize as many connectors as possible, as shown in FIG. 7C, the protrusion may be at or near the end of the bottom of the connector. Then, if the bottom of the connector is made of a UVC-transparent material, there is an advantage that UVC light can be transmitted through the female-threaded luer connector portion of the connector fitting. This will advantageously sterilize any part of the mating connector that is exposed to UVC light, such as the threads, upper end, and upper end portion of the inner surface of the mating connector. In another configuration, the mating nested mechanism on the associated handpiece can be oriented adjacent to the chip. Then, mechanism 722 is directly adjacent to the chip while maintaining the performance mechanism described above, but not adjacent to the end of the bottom of the connector.

[0058] The system can be sterilized in various ways. For example, the described embodiments can be sterilized with UVC light, but can also be sterilized using standard treatment alcohol swabbing techniques, or an alcohol-sterilizing cap.

[0059] Figures 9A-9B respectively show a front view and a top perspective view of an embodiment of the top 902 of a connector valve. Unless otherwise specified, the top 902 of the connector valve can be the same as the top described with respect to the top 306 in FIGS. 3A and 3B. In some embodiments, the top of the housing does not have a complete thread for fitting. Instead, the top has a partial thread. The partial thread advantageously has less material for the UV sterilizing light to pass through, generates less shadow than a complete thread, and can minimize the amount of UV energy and the processing time required for sterilization. The partial thread can be provided with ridge-like protrusions and can be arranged at the four rounded corners of the top of the housing. Also, the partial thread can be composed of one, two, or more partial threads that are not ridge (ridge)-like protrusions provided at the four rounded corners of the top of the housing, and these are oriented to minimize the amount of UV energy and the processing time required for sterilization. It will be understood that in some embodiments, the top can have a complete thread or another connection means. The thread or partial thread can be configured to connect to a male luer connector, such as those found on syringes or infusion tubing sets.

[0060] The top of the housing is composed of a UV-transmissive material such as a cyclic olefin copolymer like Topas (registered trademark) by Advanced Polymers, GmbH, Frankfurt, Germany. Other materials (e.g., polymethylpentene like TPX (registered trademark) by Mitsui Chemicals America, Inc., Livonia, New York) are also possible.

[0061] Figure 10 is a bottom perspective view of the bottom 1002 of the connector valve. The bottom 1002 includes an outlet port 1004 that can function as a mounting point (e.g., a standard female Luer connector). As described above, the bottom 1002 can include a UVC transmissive material and can transmit UVC light for sterilization through the Luer connector. As described above, in some embodiments, the internal thread mechanism of the bottom can be a separate collar attached to the connector by adhesion, snap fit, or other means in the mating groove, which can be advantageous for facilitating the molding of various components. In another configuration, the connection mechanism of the bottom (e.g., the Luer connector mechanism) can be further nested within the base and can extend to the vent hole. This is advantageous for minimizing the size and weight of the connector.

[0062] Figure 11A shows an embodiment of a valve core 1102 having two notches 1104, 1106, both of which form a scallop shape. Both of the two scallops are perpendicular to the neutral axis 1108 and do not intersect. The larger scallop 1106 is on one side of the valve core 1102, and the second smaller scallop 1104 is on the other side of the valve core. The valve core 1102 is arranged to first deflect and deform with the larger scallop 1106. The presence of such a site that is easily deflectable allows the valve surface to separate from the tip of the male Luer with little deviation during insertion. By adding the second scallop 1104, the cross-sectional area of the beam decreases, and as a result, the rigidity decreases, further reducing the resistance to deflection (deformation). The term "beam" can be used to refer to the valve from the perspective of Euler's formula for long columns. Here, the compression of the beam length means the characteristic deflection behavior according to the equation: Cr =(π 2 EI) / (KL) 2 and means the characteristic deflection behavior according to the equation, where P Cr= Critical load for deflection to occur, E = modulus of elasticity, I = minimum moment of inertia of cross-sectional area, L = length of unsupported column, and K = effective length factor of column. For this valve, since E, L, and K are the same, by changing the moment of inertia, the deflection force and direction can be determined. In this case, the moment of inertia of the scalloped portion of the column without scallops is I スカラップ無し = (πd 4 ) / 32, I 中立軸に沿わないスカラップ間 = ((minimum distance between scallops) * d 3 ) / 12, and I 中立軸に沿ったスカラップ間 = (d * (minimum distance between scallops) 3 ) / 12. From this equation, it can be seen that the moment of inertia is overwhelmingly the smallest between the scallops along the neutral axis, and it is easier to deflect there.

[0063] Figure 11B is a top view of the connector. The valve surface 1140 is the top of the portion of the valve that contacts the syringe to be fitted during use. The valve surface that contacts the inside of the valve top 1142 is the surface of the valve body along the square-shaped portion of the valve within the square-shaped fitting portion at the top of the connector.

[0064] Figure 11C is a bottom view of the connector valve. The continuous beam 1116 connects to the inner wall of the valve at two sides 1144 of the internal cavity that is the base of the valve and extends completely (or, in some embodiments, almost) to the length of the valve cavity. As shown, the two sides 1150 of the internal cavity are not connected to the full length of the valve. The orientation of the continuous beam with low rigidity indicated by arrow 1146 reflects an orientation with a low moment of inertia that tends to deflect under a significantly lower force than the orientation of the continuous beam with high rigidity indicated by arrow 1148, which has a relatively high moment of inertia.

[0065] Figure 11D shows a cross-section of the valve core 1102 perpendicular to the neutral axis 1122 and shows additional features of the valve core 1102 to facilitate bending deformation in the preferred orientation. The cross-section shows a short internal beam 1110 (e.g., a thicker portion of the valve core) at one end of the cavity and a longer beam 1112 extending through the cavity (an open volume within the valve core) on the opposing inner side to the remaining portion. When compressed, the thinner portion tends to bend and deform more than the thicker portion. Therefore, most of the valve (e.g., the entire length) has features where deformation points are likely to occur. Further, there is a continuous beam 1116 extending across the entire length of the valve perpendicular to the bending deformation surface 1114. The continuous beam can refer to a continuous solid portion of the valve core running along the neutral axis. In the bending direction, this beam is along the neutral axis 1122 and does not significantly contribute to strain resistance (Figures 11C and 11D). However, in a direction perpendicular to bending, there is a significant difference in rigidity. This makes bending deformation in the preferred orientation even more likely to occur. The substantially square outer shape of the valve body is preferentially arranged to bend and deform along the four faces because the arcs between the faces are substantially more rigid than the faces. Further, internal ribs running along the length of the valve body connect two faces 1118, 1120 perpendicular to the strain (Figures 11C and 11D). The beam 1116 maintains the distance between the faces 1118, 1120 during deformation, while the unsupported faces can freely flex. All of these design features contribute to the mechanical function of the valve. Figure 11E shows a cross-section of the valve core along the neutral axis.

[0066] In some embodiments, the fluid displacement when removing the male lure from the valve is an important feature. In some embodiments, it is preferable to have a substantially neutral (intermediate) displacement of the fluid. In other embodiments, it may be preferable to have a positive or negative displacement. The internal volume of the valve 1130 shown in FIG. 11D facilitates adjustment of the displacement of the system because the displacement volume within the valve is directly correlated with the fluid displacement volume within the connector body. In particular, when the valve is compressed, air is discharged from the valve cavity. When the compression of the valve is reduced, air enters the valve cavity. When the valve is neutral, the air fills a volume corresponding to the volume displaced by the removal of the syringe tip. It displaces more in the case of positive displacement and less in the case of negative displacement. The optimal displacement amount can be adjusted by increasing or decreasing the wall thickness of the beam 1132 extending along the length of the valve. As described above, this design feature has little impact on the operating force and flexural deformation of the valve. Therefore, it can be said to be an ideal function for fine-tuning the displacement with little impact on the functional performance.

[0067] Here, when a feature or element is said to be on top of another feature or element, the feature or element may be directly on top of the other feature or element, or intervening features or elements may also be present. In contrast, when a feature or element is said to be "directly" on top of another feature or element, no intervening features or elements are present. Also, when a feature or element is said to be "connected to", "attached to", or "coupled to" another feature or element, it will be understood that it may 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 said to be "directly connected to", "directly attached to", or "directly coupled to" another feature or element, no intervening features or elements are present. Although described or illustrated with respect to one embodiment, the features and elements so described or illustrated are applicable to other embodiments as well. Also, it will be understood by those skilled in the art that references to structures or features disposed "adjacent" to another feature may have portions that overlap or underlie the adjacent feature.

[0068] The terms used herein are for the purpose of describing particular embodiments and are not intended to limit the invention. For example, the singular forms "a", "an", and "the" used herein are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprising" and / or "comprises" used herein are used to specify the presence of the recited features, steps, operations, elements, and / or components, and it will be further understood that they 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] In this specification, for ease of explanation, spatially relative terms such as "under", "below", "lower", "over", "upper", etc. are used to illustrate the relationship between one element or feature and another element or feature. It will be understood that spatially relative terms are intended to encompass different orientations of the device in use and operation in addition to the orientation depicted in the figures. For example, if the device in the figure is inverted, an element described as "under" or "below" another element or feature will face "above" the other element or feature. Thus, the exemplary term "below" can encompass both the "above" and "below" directions. The device may be in other orientations (rotated 90 degrees or otherwise), and the spatially relative descriptions used here will be interpreted accordingly. Similarly, terms such as "upwardly", "downwardly", "vertical", "horizontal", etc. are used for explanatory purposes only unless otherwise specified.

[0070] In this specification, the terms "first" and "second" are used to describe various functions / elements (including steps), but these functions / elements should not be limited by these terms except where the context indicates otherwise. These terms may be used to distinguish one function / element from another. They can be used to distinguish a feature / element from another feature / element. Thus, the first feature / element described below can be referred to as the second feature / element, and similarly, the second feature / element described below can be referred to as the first feature / element without departing from the teachings of the present invention.

[0071] In this specification and the following claims, unless the context requires otherwise, the word "comprise", and variations such as "comprises" and "comprising", are meant to imply that the various components can be employed jointly in methods and articles (e.g., compositions and apparatuses including devices and methods). For example, the term "comprising" is understood to mean including any recited element or step but not excluding other elements or steps.

[0072] In this specification and the claims, unless specifically specified otherwise, including when used in examples, all numbers can be read as if the term "about" or "approximately" were prefixed to them even if the term does not explicitly appear. The terms "about" or "approximately" may be used to indicate that the described value or position is within a reasonable range that can be expected when describing size or position. For example, a numerical value can have a value of ±0.1% of the recited value (or range of values), ±1% of the recited value (or range of values), ±2% of the recited value (or range of values), ±5% of the recited value (or range of values), ±10% of the recited value (or range of values), etc. Also, the numerical values described herein should be understood to include those before and after the value, unless it is determined otherwise from the context. For example, if the value "10" is disclosed, "about 10" is also disclosed. The numerical ranges described in this specification are intended to include all sub-ranges contained therein. Also, as can be appropriately understood by those skilled in the art, when a value is disclosed, it should be understood that values "less than", "greater than", and the possible ranges between the values are also disclosed. For example, if the value "X" is disclosed, "less than X" and "greater than or equal to X" (e.g., X is a numerical value) are also disclosed. Also, in this application, data is provided in various forms, and it should also be understood that this data represents ranges of endpoints and starting points, and any combination of data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it should be understood that not only between 10 and 15, but also greater than 10, greater than or equal to, less than, less than or equal to, and between 10 and 15 are disclosed. Also, each unit between two specific units is understood to be disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, 14 are also disclosed.

[0073] While the above describes various exemplary embodiments, various changes can be added to the various embodiments without departing from the scope of the invention as recited in the claims. For example, the order in which the various described method steps are executed may often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be executed. One or more method steps may be completely skipped. Optional features of the various device and system embodiments may be included in some embodiments and not in others. Accordingly, the foregoing description is provided primarily for purposes of illustration and should not be construed as limiting the scope of the invention as recited in the claims.

[0074] The examples and figures included herein are illustrative rather than limiting, showing specific embodiments in which the subject matter can be practiced. As noted above, other embodiments can be utilized and derived from them, such that structural and logical substitutions and changes can be made without departing from the scope of the present disclosure. Such embodiments of the subject matter of the present invention are not intended to limit the scope of the present application to any single invention or inventive concept for convenience only, and where multiple are actually disclosed, the term "invention" may be referred to herein individually or collectively. Accordingly, while specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose can be substituted for the specific embodiments shown. The present disclosure is intended to cover any and all adaptations or variations of the various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those skilled in the art upon review of the above description.

Claims

1. The entrance and The exit, The main body, a sealed valve core disposed within the body, the valve core including a cut-out portion, the valve core configured to flex to permit fluid flow through the body; and A needleless connector valve comprising:

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 the body comprises a top and a bottom.

5. 10. The needleless connector valve of claim 1, wherein the top of the housing is approximately 0.050 inches (approximately 1.27 mm) thick.

6. The entrance and The exit, The main body, a sealed valve core disposed within the body, The valve core is A first cutout portion; a second cut-out portion, the valve core configured to flex to permit fluid flow through the body; A needleless connector valve comprising:

7. A connector valve according to claim 1 , wherein the valve comprises electronic elements.

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

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

10. A connector valve according to any one of claims 7 to 9, wherein the electronic element comprises an encryption function.

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

12. A connector valve according to any one of claims 7 to 11, wherein the electronic element comprises a time-out function.

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

14. 14. The connector valve of any one of claims 7 to 13, wherein the electronic element is configured to engage with a mating feature of a sterilisation device.

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

16. 17. The connector valve of claim 16, wherein the valve includes a gentle ramping mechanism around the electronic element to allow the pogo pin to slide over the connector when the connector is placed in the sterilizer.

17. A connector valve according to any one of claims 6 to 16, wherein the body comprises electronic elements.

18. The connector valve of claim 1 , wherein the body comprises an indexing mechanism.

19. 19. The connector valve of any one of claims 1 to 18, further comprising a mechanism configured to ensure proper positioning of the connector valve within a sterilization apparatus.

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

21. The connector valve of claim 1 , wherein the connector valve comprises an indexing mechanism.

22. The connector valve of claim 21 , wherein the indexing mechanism comprises a protrusion on the connector valve.

23. 23. The connector valve of claim 21 or 22, wherein the indexing mechanism is configured to interact with a corresponding mechanism on a sterilization device.

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

25. 25. A connector valve according to any one of claims 21 to 24, wherein the indexing mechanism is located near a bottom of the connector valve.

26. 26. A connector valve according to any one of claims 6 to 25, wherein the body includes a UV transparent portion.

27. 27. The connector valve of any one of claims 6 to 26, wherein the body comprises a top and a bottom.

28. 28. A connector valve as claimed in claim 4 or any one of claims 6 to 27, wherein the top and bottom are separate components which are joined together.

29. 29. A connector valve as claimed in claim 4 or any one of claims 6 to 28, wherein the top of the body is provided with a partial thread.

30. 30. A connector valve as claimed in claim 4 or any one of claims 6 to 29, wherein the top of the body is provided with a full thread.

31. 31. A connector valve as claimed in claim 4 or any one of claims 6 to 30, wherein the top of the body comprises a square cross-section with rounded corners.

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

33. 33. A connector valve as claimed in any one of claims 4 or 6 to 32, wherein the top of the body comprises a UV transparent material.

34. 34. A connector valve as claimed in any one of claims 4 or 6 to 33, wherein a bottom of the body is provided with an outlet.

35. 35. The connector valve of any one of claims 1 to 34, wherein the outlet is configured for attachment to another connector.

36. 36. A connector valve as claimed in any one of claims 4 or 6 to 35, wherein the bottom of the body comprises a UV transparent material.

37. 37. The connector valve of any one of claims 6 to 36, wherein the first cut-out portion and / or the second cut-out portion of the valve core comprises a scalloped shape.

38. 38. The connector valve of claim 6, wherein the core is configured to flex at the first cut-out portion, the first cut-out portion being larger than the second cut-out portion.

39. 39. A connector valve according to any one of claims 1 to 38, wherein the valve core includes a cavity.

40. 40. A connector valve as claimed in any one of claims 1 to 39, wherein the valve core comprises a beam connecting two sides of the valve core and extending along the majority of the length of the valve core.

41. 41. A connector valve according to any one of claims 1 to 40, wherein the valve core comprises a beam extending partially along a side of the valve core.

42. 42. The connector valve of claim 41, wherein the beam is disposed near a top of the cavity in the valve core.

43. 43. The connector valve of any one of claims 1 to 42, wherein the connector valve is configured to generate a positive displacement.

44. 43. The connector valve of any one of claims 1 to 42, wherein the connector valve is configured to generate a negative displacement.

45. 43. The connector valve of any one of claims 1 to 42, wherein the connector valve is configured to generate a neutral displacement.

46. 1. 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 vascular system; and advancing the connector relative to the inlet of the connector valve, the advancing step causing a valve core of the connector valve to flex at a first notch portion and a second notch portion, the flexing deformation allowing fluid access to an outlet of the connector valve.

47. 47. The method of claim 46, wherein flexing the connector valve includes flexing the first cut-out portion followed by flexing the second cut-out portion.

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

49. 49. The method of any one of claims 46 to 48, wherein the step of connecting the connector comprises connecting a male luer connector.

50. 50. The method of any one of claims 46 to 49, further comprising sterilizing the connector bulb with a UV sterilizer prior to connecting the connector.

51. 51. The method of claim 50, wherein the step of sterilizing the connector valve with a UV germicidal device comprises inserting the connector valve into an opening of the germicidal device.

52. 52. The method of claim 50 or 51, wherein the step of sterilizing the connector valve with a UV germicidal device includes electrically connecting an electrical element of the connector valve with a corresponding mechanism of the UV germicidal device.

53. 53. The method of any one of claims 50 to 52, wherein the step of sterilizing the connector valve with a UV germicidal device includes engaging an indexing mechanism of the connector valve with a mating mechanism of the UV germicidal device.

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