CN113853233A

CN113853233A - Needleless connector valve for UV disinfection

Info

Publication number: CN113853233A
Application number: CN202080035073.8A
Authority: CN
Inventors: J·A·拉苏尔利; T·J·莫斯勒; J·芬特雷斯; J·V·拉纳莱塔; J·C·齐内戈; M·G·福尔卡斯; E·A·高见
Original assignee: Puracath Medical Inc
Current assignee: Puracath Medical Inc
Priority date: 2019-03-22
Filing date: 2020-03-20
Publication date: 2021-12-28
Also published as: CA3133307A1; EP3941563A1; WO2020198042A1; EP3941563A4; JP2022527246A; JP2025087900A

Abstract

Embodiments of an ultraviolet transmissive needleless connector are provided. The connector includes an at least partially ultraviolet transmissive housing. The connector includes a spool configured to twist to form a fluid path through the connector.

Description

Needleless connector valve for ultraviolet disinfection

Cross Reference to Related Applications

This application claims the benefit of united states provisional patent application No. 62/822,658 filed on 3, 22, 2019 and united states provisional patent application No. 62/911,059 filed on 10, 4, 2019. This application may be related to U.S. application No. 16/316,918 filed on 11/7/2017, which is a national phase application of international application No. PCT/US2017/041556 filed on 11/7/2017, which claims the benefit of U.S. provisional patent application No. 62/360,922 filed on 11/7/2016.

Is incorporated by reference

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

Technical Field

Systems and methods generally related to use for disinfecting an access site are described. More particularly, various methods and devices for disinfecting intraluminal and percutaneous access sites using ultraviolet radiation.

Background

One of the first interventions that occur when a patient is admitted is the placement of an Intravenous (IV) tube. Such percutaneously placed IV tubing provides a caregiver with a direct path to the patient's bloodstream through a peripheral vein for rapid infusion of fluids, medications, or blood sample withdrawal. In more severe cases, a high blood flow supply needs to be obtained directly, for example in chemotherapy, temporary kidney dialysis or cardiac monitoring catheterization, requiring the insertion of a central venous catheter (CVC or central catheter). This tube is typically inserted percutaneously into a major branch vessel, typically the subclavian vein (but may also be placed in the peripheral vein), and the distal portion of the catheter is then guided to the superior vena cava.

Both peripheral and central catheterization create an open channel or lumen into the blood stream from an external access site. The intraluminal access site provides an attachment point for various therapeutic or diagnostic medical devices, including, but not limited to, stopcocks, needleless access sites, IV bags, infusion pumps, drug delivery pumps, kidney dialysis equipment, thermodilution catheters, and the like. Unfortunately, this access site also provides an entry point for bacterial infections. Thus, each time the access site is opened to accommodate the attachment of a medical device, bacteria have an opportunity to enter the catheter lumen and migrate into the bloodstream.

In addition to contaminating the catheter lumen through an external access site, bacteria may also enter through the skin puncture and subcutaneous tunnel formed by the catheter when placing an IV or CVC. Bacteria can then travel down the outer wall of the catheter to its distal end, infecting the tract along the wall of the catheter as they migrate.

To alleviate the serious problems noted in the preceding paragraph, conventional IV tubing and CVCs use some type of molded plastic fitting at their proximal end, terminating in a female luer lock or luer slip connector. These connectors must be closed with a luer cap when not in use to prevent contamination of the access site. The luer cap must be removed and discarded each time the tube is accessed, since it must be assumed that the exterior of the luer cap is contaminated and once removed, it is almost impossible to prevent the male luer structure from contacting the contaminated surface. Thus, traditional infection control practices are to always replace the luer cap each time the tube is accessed. Not only is this process costly, but the removal and replacement process provides additional opportunities for bacteria to enter the connector lumen.

In some instances, IV access sites have been converted to needleless access valves that incorporate a resilient seal that can be opened by the tip of a male luer connector mounted on a syringe or similar device. These needleless access valves require cleaning with alcohol saturated cotton swabs before being opened by the sterile male luer tip of the syringe. Unfortunately, compliance with the wiping procedure can be sporadic because it requires a significant amount of time, additional supplies, and the proper skill of the clinician performing the wiping procedure.

Due to the continuing challenges associated with preventing infection in indwelling catheter patients, improvements in disinfection and prevention of infection are needed.

Disclosure of Invention

In a first aspect, a needleless connector valve is provided. The valve includes an inlet; an outlet; a body; and a sealed spool within the body, the spool including a cut-out portion, the spool configured to twist to allow fluid flow through the body.

In some embodiments, the valve core comprises an opaque material. The valve core may comprise an opaque material. In some embodiments, the body includes a top and a bottom. The top of the housing comprises a thickness of about 0.050 ".

In another aspect, a needleless connector valve is provided. The connector valve includes an inlet; an outlet; a body; and a sealed spool within the body, the spool including a first cutout portion and a second cutout portion, the spool configured to twist to allow fluid flow through the body.

In some embodiments, the valve includes electronics. The electronic component may be a chip. The electronic component may be a resistor. In some embodiments, the electronic component includes encryption capabilities. The electronic component may be configured to ensure proper use of the connector with a handpiece of a disinfection unit. In some embodiments, the electronic component includes a timeout feature. The timeout feature is configured to ensure that the connector valve is not closed by a different connector valve. In some embodiments, the electronic component is configured to engage with a mating feature of a disinfecting unit. The mating feature may comprise a pogo pin. In some embodiments, the valve includes a gentle ramp feature around the electronics to enable the pogo pin to slide over the connector when the connector is placed into the sterilization unit. In some embodiments, the body includes an electronic component. In some embodiments, the body includes an indexing feature. The connector valve may also include features configured to ensure proper positioning of the connector valve within the sterilization unit. In some embodiments, the feature comprises a groove.

The connector valve includes an indexing feature. In some embodiments, the indexing feature is configured to interact with a corresponding feature on the disinfecting unit. The corresponding feature comprises a nesting feature configured to interact with a protrusion on the connector valve. In some embodiments, the indexing feature is located near a bottom of the connector valve.

The body includes a UV transparent portion. In some embodiments, the body includes a top and a bottom. The top and bottom are separate components that are joined together. The top of the body includes partial threads. In some embodiments, the top of the body comprises full threads. The top of the body includes a square cross-section with rounded corners. In some embodiments, the partial threads are located at a fillet. The top of the body includes a UV transmissive material. In some embodiments, the bottom of the body includes the outlet. The outlet may be configured to attach to other connectors. In some embodiments, the bottom of the body comprises a UV transmissive material.

The first cutout and/or the second cutout of the valve cartridge may include a scallop shape. In some embodiments, the spool is configured to first twist at the first notch, which is larger than the second notch.

In some embodiments, the valve cartridge includes a cavity. The spool may include a beam connecting the two sides of the spool and extending along a majority of the length of the spool. In some embodiments, the spool includes a beam extending partially along one side of the spool. The beam may be located near the top of the cavity of the spool. In some embodiments, the connector valve is configured to cause a positive displacement. The connector valve may be configured to cause a negative displacement. In some embodiments, the connector valve is configured to cause a neutral displacement.

In another aspect, a method of accessing a needleless connector valve is provided. The connector valve includes an inlet port connecting a connector to 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 the spool of the connector valve to twist at the first and second notches, the twisting allowing fluid to enter the outlet of the connector valve.

In some embodiments, twisting the connector valve includes twisting the first cut and then twisting the second cut. The first cut is larger than the second cut. In some embodiments, connecting the connector includes connecting a male luer connector. The method further includes sterilizing the connector valve in a UV sterilization unit prior to connecting the connector. In some embodiments, sterilizing the connector valve in the UV sterilization unit includes inserting the connector valve into an opening of the sterilization unit. Sterilizing the connector valve in the UV sterilization unit includes electrically connecting an electrical element of the connector valve with a corresponding feature in the UV sterilization unit. In some embodiments, sterilizing the connector valve in a UV sterilization unit includes engaging an indexing feature of the connector valve with a mating feature in the UV sterilization unit.

Drawings

The novel features of the invention are set forth with particularity in the appended claims. 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:

fig. 1A and 1B show various views of an assembled needleless connector valve.

Fig. 2A-2D depict various views of a valve cartridge for use with the needleless connector valve of fig. 1A and 1B.

Fig. 3A and 3B show various views of the housing top of the needleless connector valve of fig. 1A and 1B.

Fig. 4A and 4B show various views of the housing bottom of the needleless connector valve of fig. 1A and 1B.

Fig. 5A and 5B show side views of an embodiment of a needleless connector valve.

Fig. 6A-6D illustrate a syringe connected to a needleless connector valve in accordance with the present invention.

Figures 7A-7E illustrate various views of an embodiment of a needleless connector valve.

Fig. 8A, 8B, and 8C illustrate various views of an embodiment of an identification chip assembly.

Fig. 9A and 9B illustrate various views of an embodiment of a top portion of a needleless connector.

Fig. 10 shows a view of an embodiment of a bottom of a needleless connector.

11A-11E illustrate various views of an embodiment of a needleless connector valve.

Detailed Description

Fig. 1A and 1B show a perspective view and a front view, respectively, of an embodiment of a needleless connector valve 100. The valve includes a housing 102 and a valve spool 104. The housing 102 includes an upper portion 106 and a lower portion 108. The connector includes an inlet 110 and an outlet 112.

The upper portion 106 of the housing and the spool 104 include a generally square cross-section with rounded corners. Such a shape may advantageously optimize the connector shape for sterilization (e.g., one or more LEDs used in a uv sterilization device). The connector also has very little space (e.g., 80 microliters) between the spool 104 and the housing 102. Minimizing this space reduces the size of the fluid path, reducing the amount of fluid that needs to be sterilized. Reducing the amount of fluid to be disinfected may advantageously minimize the UV energy and treatment time required for effective US disinfection.

Fig. 2A shows a perspective view and a side view, respectively, of an embodiment of the spool 104. The top surface of the spool 104 includes a substantially flat surface that is substantially flush with the top of the housing 102. The lip 202 near the top surface may be configured to engage a corresponding feature on the housing 102. In the closed position, the lip 202 is configured to engage the housing 102 around the entire circumference of the lip 202. When the needleless connector is mated with the male luer connector, the valve cartridge is designed to twist in a predictable and repeatable manner, which causes a portion of lip 202 to move away from housing 102, thereby creating a fluid path for fluid introduced via the male luer connector to flow. The valve cartridge includes an upper portion 206 and a lower portion 208. The upper portion 206 of the valve cartridge includes a cutout 204 portion. As shown in fig. 2A and 2B, the notch 204 may include a V-shape with a rounded tip. The side view of fig. 2B shows that the rounded tip portion 210 is located near the central longitudinal axis 212 of the valve cartridge. The sides 214 of the notch 204 extend from the rounded tip to the outer surface 216 of the poppet. 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.

The upper portion 206 of the valve cartridge is configured to twist when the inlet 110 is engaged with a male luer connector. The shape of the cutout 204 may be configured to exhibit a predictable and consistent distortion, thereby creating a fluid path for liquid entering through the inlet 110.

Fig. 2C and 2D show side and perspective views of another embodiment of the spool 104. The top surface of the spool 104 includes a substantially flat surface that is substantially flush with the top of the housing 102. The lip 202 near the top surface may be configured to engage a corresponding feature on the housing 102. In the closed position, the lip 202 is configured to engage the housing 102 around the entire circumference of the lip 202. When the needleless connector is mated with the male luer connector, the valve cartridge is designed to twist in a predictable and repeatable manner, which causes a portion of lip 202 to move away from housing 102, thereby creating a fluid path for fluid introduced via the male luer connector to flow. The valve cartridge includes an upper portion 206, a middle portion 208, and a lower portion 210. The middle portion 208 includes a larger diameter than the upper portion 206. Lower portion 210 includes a larger diameter than intermediate portion 208 and upper portion 206. The cross-section of the middle portion 208 comprises a generally square shape with rounded corners. The upper portion 206 of the valve cartridge includes a cutout 204 portion. As shown in fig. 2A and 2B, the cutout 204 may include a fan shape. The side view of fig. 2B shows that the cut-out 204 generally comprises an arc. 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.

In some embodiments, the valve cartridge of the present invention may comprise silicone. Other materials are also possible (e.g., styrene block copolymers, thermoplastic olefin elastomers, thermoplastic polyester elastomers, thermoplastic amide elastomers, and thermoplastic polyurethane elastomers). Material selection can be used to optimize UVC treatment. For example, the valve core may be composed of a material that is optically transparent, translucent, or opaque to UVC light, such as a different silicone material. In addition, additives such as colorants may be added to the valve material to enhance absorption or reflection of UVC light. The valve core material may also be selected or modified to enhance physical properties, such as the elasticity or lubricity of the valve. The spool material may also be selected or modified to have a low or high surface tension. One reason that surface tension may need to be adjusted is that there are no residual liquid beads at the end of the valve (CIP12) after the liquid is injected. High surface tension may result in insufficient adhesion of the liquid beads, leading to their falling off, and low surface tension may result in residual liquid forming a thin film.

The surface of the valve may also be modified according to performance. For example, a substantially flat surface of the valve may contact an inner surface of the valve top at rest or during twisting. The surface of the valve may also contact other surfaces of the valve during twisting. If the valve material adheres to itself or to the housing, it preferably has a textured surface, such as may be produced by bead blasting or otherwise treating the surface of a mold used to make the valve. The surface texture may enhance the ability of the valve to twist and loosen during use. The surface finish of the mating surfaces of the connector and syringe tip can be used to affect the ability of the liquid to bead up on the valve surface (CIP 12).

Fig. 3A and 3B show side and perspective views of the upper portion 106 of the housing 102. An opening 302 in the top of the housing 102 forms the inlet 110. The housing portion 106 includes a top 306 near the inlet. The diameter of the top portion 306 gradually increases to a middle portion 308. The bottom portion 310 includes a larger diameter than the middle portion 308, forming a lip 312 between the middle portion 308 and the bottom portion 310. The top and middle portions 308 comprise a generally square cross-section with rounded corners. The base 310 includes a generally circular cross-section. In other constructions, the base includes a generally square cross-section with rounded corners. This may be advantageous for indexing to the mating head.

In some embodiments, the top of the housing does not include full threads for mating with a male luer connector. Instead, the top portion includes partial threads, as shown in fig. 3A and 3B. Partial threads may advantageously provide less penetration of material and less shadowing by UV disinfection light than full threads, thereby minimizing UV energy and processing time required for disinfection. The partial threads 304 may include ridges and are located at the four corners of the top of the housing as best shown in fig. 3B. It should be understood that in some embodiments, the top portion includes full threads or other means of attachment. The threads or partial threads may be configured to connect to a male threaded luer connector, such as found on a syringe or infusion set.

In the top and

middle portions

306, 308 of the housing, fluid is configured to flow in the space between the spool and the housing. The bottom 310 of the housing includes one or more channels 314 disposed around the perimeter or circumference of the bottom 310. Fig. 3B shows 2 channels positioned at approximately 90 increments around the perimeter of the base 310. The channel 314 provides a fluid path for fluid to move toward the outlet 112.

The top of the housing comprises a UV transmissive material, for example from Frankfurt, Germany "

Cycloolefin copolymers from advanced Polymers ", Inc. Other materials (e.g., from Leiyxi, N.Y.) "

Polymethylpentene from Mitsui chemical america "corporation) is also possible.

Fig. 4A and 4B show front and side views, respectively, of the bottom or base 108 of the connector 100. The base includes an outlet 112 at the bottom surface. Threads 402 located near the bottom of base 108 allow connection to a female luer fitting. The threads 402 may be used to connect the connector to a conduit line (e.g., a CVC tube) on a patient. The connector includes an opening 404 from the top of the base 108 through the bottom of the base 108. These openings 104 allow ambient air to enter and exit the valve. In some configurations, the vent holes are threaded, in other configurations, the vent holes may pass through the sides in the threaded region or anywhere up to the bonded joint that seals the internal fluid paths of the top and bottom connectors. This allows the valve to compress without compressing the gas in the valve, allowing the valve to compress freely without compressing the gas inside the valve. The compressed gas affects the stiffness of the valve, making it relatively stiff when the valve is compressed. The compressed gas is less dense than the liquid and may leak into the fluid path when the valve is compressed without an opening to the ambient air. Without the hole and the internal gas does escape to the fluid passage, a vacuum may be created inside the valve when returning to the uncompressed state. This may prevent a complete return to the original uncompressed state. The opening 406 shown in fig. 4B provides a path for fluid flowing through the channel 314 to exit the tip 112 through the channel. The base 108 has a reduced diameter portion 408. 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, exiting the end of the valve at the tip 112.

The base of the housing may comprise a UV transmissive material, for example from Frankfurt, Germany "

Polymethylpentene from mitsui chemicals America "company) is also possible. Alternatively, this portion of the connector may not require UV transmittance and may be made of alternative materials, such as acrylic, polycarbonate, polyester, polypropylene, or other suitable materials.

The base portion 108 has a slightly smaller outer diameter portion that matches the inner diameter of the top portion 106. In the assembled configuration, the valve is compressed between the base and the top housing. Fluid flowing through the valve follows a path around the compression point through the passage 314. The compressed portion of the valve forms an air-tight and fluid-tight seal between the interior of the valve and the exterior of the valve. The rib 410 having a triangular profile forms a complete circle on the sealing surface of the base. The ribs concentrate the compression of the valve, ensuring a complete seal. The ribs are shown as having a triangular profile, but may have other profiles, such as a radial profile, or have a flat triangular profile, or other profile for ensuring a complete seal.

To optimize the UVC transmittance of the connector, as well as to provide sufficient mechanical strength and the ability to use a batch manufacturing process such as injection molding, the wall thickness of the top housing is preferably about 0.050 ". Other thicknesses (e.g., about 0.030 "to 0.070") are also possible.

In some embodiments, the connector is molded as three separate pieces that are connected together, as shown in fig. 1-4B. Other configurations are possible (e.g., 2-piece, 4-piece, 5-piece, etc.), as described with reference to fig. 7C and 8A-B.

Fig. 5A and 5B show side views of the connector assembly with the valve cartridge 104 of fig. 2C and 2D within the housing 102. As shown in fig. 5B, an upper surface 502 of the lower portion 218 of the valve spool 104 presses against an inner housing surface 504 within the housing lip 312. Rib 410 of base 108 presses against bottom surface 506 of valve spool 104. As shown, the valve is locally compressed significantly due to the concentrated forces at the contour. In this cross-sectional view you can see the complete seal around the valve, the 8 channels around the base of the top housing provide the only paths that allow liquid to flow around the valve base and through the bottom housing.

Fig. 6A-6D illustrate a connector 600 connected to a syringe according to the present invention. As shown in fig. 6A, syringe tip 602 is used to compress valve element 604. The top surface of the poppet 604 is flush with the syringe tip 602. The compression of the slit 606 is minimal. The opposite side of the cutout 608 is partially pressed against the inner surface of the connector.

Fig. 6B shows the syringe tip 602 further compressing the poppet 604. The top surface of the poppet 604 remains flush with the syringe tip. There is significant compression and initial distortion at the notch 606. The opposite side 608 is deflected downward and away from the cutout 608.

Fig. 6C shows the syringe tip 602 further compressing the poppet 604. The top surface 610 of the poppet 604 is deflected from the syringe tip 602. There is a twist at the notch 606. The opposite side 608 is deflected downward and away from the incision. There is a second twist 612 of the spool in the middle portion of the spool.

Fig. 6D shows the syringe tip 602 further compressing the poppet 604. The twist at the notch 606 increases. The opposite side 608 is deflected downward and away from the incision. A second twist 612 of the spool is added in the middle portion of the spool.

Fig. 7A-7E illustrate various views of an embodiment of a needleless connector valve 700. The valve body 702 and the valve spool 704 are visible in the front and back views of fig. 7A and 7B, respectively. The spool 704 includes two cutouts 706. Valve body 702 includes a top 708 and a bottom 710. The bottom 710 includes an outlet that may include an attachment point 712 (e.g., a standard female luer connector attachment point). In alternative arrangements, the internal threaded feature of the base may be a separate collar that is bonded, snapped into a mating groove, or otherwise attached to the connector; this facilitates molding of various parts. In another alternative configuration, the bottom luer connection feature may be further nested in the base, possibly as far as the vent; this is advantageous to minimize the size and weight of the connector.

Fig. 7C shows a perspective view of the connector valve 700. The valve includes electronics 720 and an indexing feature 722. Fig. 7C, 8A and 8B show an embodiment with 4 separate components, wherein the fourth component is an electronic component 720, which will be described in more detail below. Fig. 7D and 7E show views of the connector valve 700 through a vertical plane.

Fig. 8A and 8B show detailed views of the electronics 720 (e.g., chip) of the connector valve 700. The electronic component is held in place, exposing two contact pads 802 (fig. 8A). Chip 720 may be a resistor or other component. The chip 720 may be configured to mate with an electrical connector in a UVC disinfection handpiece. In some embodiments, this chip 720 is used to close the circuit so that the handpiece detects the presence of the connector and performs the sterilization cycle. Optionally, the chip has encryption capabilities. This ability will ensure proper use of the header connector. In some embodiments, the chip has a timeout feature such that a connector is only used for its specified lifetime and it cannot be extracted for use with another connector. The package may be designed for optimal engagement with mating features (e.g., mating spring-loaded electrical contact "spring" pins). In particular, there may be a gentle slope 804 around the chip so that the rounded end of the spring easily slides over the connector (fig. 8A). As shown in fig. 8B and 8C, this position can be tightly controlled by the design of the recesses 806 formed by the lower and upper portions of the valve housing. This groove allows tight control of the position of the connector in three dimensions for optimal engagement with a mating connector on the handpiece.

In some embodiments, the connector includes an indexing feature 722 (fig. 7C) so that when the connector is in a desired position, the chips on the connector engage. This can be achieved by a feature 722 protruding from the connector surface that mates with a nesting feature on the associated handpiece. To sterilize the connector as much as possible, the protrusion may be located at or near the end of the bottom of the connector, as shown in FIG. 7C. Making the bottom of the connector from a UVC transparent material would have the advantage of being able to transmit UVC light to the female threaded luer on the mating part of the connector. This will advantageously sterilize any portion of the mating connector that is exposed to UVC light, such as the threads, top edges and tops of the inner surface of the mating connector. In another configuration, mating nesting features on the associated handpiece can be positioned adjacent the chip. Feature 722 would then be immediately adjacent the chip, rather than at the bottom end of the connector, while maintaining the performance characteristics described above.

The system may be sterilized using a variety of methods. For example, the embodiments described may be sterilized with UVC light, but may also be sterilized with standard alcohol wiping techniques or alcohol sterilization caps.

Fig. 9A-9B illustrate front and top perspective views, respectively, of an embodiment of a top portion 902 of a connector valve. Unless otherwise described, the top 902 of the connector valve may be similar to the top described with respect to the top 306 described with respect to fig. 3A and 3B. In some embodiments, the top of the housing does not include full threads for mating. Instead, the top portion includes partial threads. Partial threads may advantageously provide less penetration of material and less shadowing by UV disinfection light than full threads, thereby minimizing UV energy and processing time required for disinfection. The partial threads may include ridges and are located at the four corners of the top of the housing. The partial thread may also consist of one, two or more partial threads, which are not rigid protrusions at the four corners of the top of the housing; these can be oriented to minimize the UV energy and treatment time required for disinfection. It should be understood that in some embodiments, the top portion includes full threads or another means of attachment. The threads or partial threads may be configured to connect to a male threaded luer connector, such as those found on syringes or infusion tubing sets.

Polymethylpentene from Mitsui chemical america "corporation) is also possible.

Fig. 10 shows a bottom perspective view of the bottom 1002 of the connector valve. The bottom 1002 includes an outlet 1004, which outlet 1004 may be used as an attachment point (e.g., a standard female luer connector). As described above, the base 1002 may include a UVC transparent material, allowing the transmission of sterile UVC light to the luer connector. As noted above, in some embodiments, the internal threaded feature of the base may be a separate collar that is bonded, snapped into a mating groove, or otherwise attached to the connector; this facilitates molding of various parts. In another alternative configuration, the bottom connection feature (e.g., luer connection feature) may be further nested in the base, possibly up to the vent. This is advantageous to minimize the size and weight of the connector.

Fig. 11A shows an embodiment of a valve core 1102 having two

cutouts

1104, 1106, both of which include scallops. Both sectors are perpendicular to the neutral axis 1108 and do not intersect the neutral axis 1108. The larger sector 1106 is located on one side of the spool 1102 and the smaller second sector 1104 is located on the other side of the spool. The poppet 1102 is configured to twist first at the larger sector 1106. This pre-set twist allows the valve face to deflect away from the tip of the male luer connector with very little displacement upon insertion. The addition of the second sector 1104 further reduces the resistance to deflection by reducing the cross-sectional area of the beam and thus its stiffness. The term "beam" may be used to refer to a valve in the form of an euler cylinder. Wherein the compression of the beam length is by equation P_Cf＝(π²EI)/(KL)²Derived characteristic twisting behavior, wherein P_CfThe critical load at which twisting occurs, E, the modulus of elasticity, and I, the minimum cross-sectional moment of inertia. L is the unsupported column length and K is the column effective length factor. With respect to this valve, since E, L and K are the same, by modifying the moment of inertia, we can determine the twisting force and direction. In this case, the sector of the column without sectors has a moment of inertia I_{Without fan shape}＝(πd⁴)/32，I_{Non-neutral axis between sectors}(minimum distance between sectors) d³) /12, and I_{Between sectors-along the neutral axis}═ d (minimum distance between sectors)³)/12. As can be seen from the equations, the moment of inertia is minimal between the sectors along the neutral axis and tends to twist there.

Fig. 11B shows a top view of the connector. The valve face 1140 is the top of the valve portion that contacts the mating syringe during use. The valve surface that contacts the interior of the valve top 1142 is the face of the valve body in the portion along the square section of the valve that is within the mating square section of the connector top.

Fig. 11C shows a bottom view of the connector valve. The continuous beam 1116 connects to the inner wall of the valve at both sides 1144 of the internal cavity of the valve base and extends completely (or in some embodiments, mostly) up the length of the valve cavity. As shown in fig. 11C, the sides 1150 of the lumen do not connect the length of the valve up. The low stiffness continuous beam direction shown by arrow 1146 reflects a low moment of inertia direction that tends to twist with a much lower force than the high stiffness continuous beam direction (with a relatively high moment of inertia) shown by arrow 1148.

Fig. 11D shows a cross-section of the spool 1102 perpendicular to the neutral axis 1122, illustrating additional features of the spool 1102 to facilitate twisting in a preferential direction. This cross-section shows a shorter internal beam 1110 at one end of the chamber (e.g., the thicker portion of the poppet) and a longer beam 1112 extending through the rest of the chamber (the open volume within the poppet) on the opposite, inner side. Upon compression, the thinner portions tend to distort relative to the thicker portions. Thus, a large portion (e.g., the entire length) of the valve is characterized by a susceptibility to kink points. Further, perpendicular to the twisted plane 1114, there is a continuous beam 1116 that extends the entire length of the valve. A continuous beam may refer to a continuous solid cross-section of the spool extending along the neutral axis. In the twist direction, the beam is along the neutral axis 1122 and does not significantly increase the twist resistance (fig. 11C and 11D). However, there is a large difference in stiffness in the direction perpendicular to the bending. This further tends to twist in the preferential orientation. The generally square profile of the valve body is preferably arranged to twist along four faces because the arcs between the faces are stiffer than the faces. In addition, internal ribs running along the length of the valve body bridge the two

faces

1118, 1120 that are perpendicular to the twist (fig. 11C and 11D). Beam 1116 maintains the distance between

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. 11E shows a cross-section of the spool along the neutral axis.

A key feature of some embodiments is the fluid displacement when the male luer is removed from the valve. In some embodiments, it is preferred to have a substantially neutral fluid displacement. In other embodiments, it may be preferable to have a positive or negative displacement. As shown in FIG. 11D, the internal volume of the valve 1130 facilitates regulating the displacement of the system, as the displacement in the valve is directly related to the displacement in the connector body. In particular, when the valve is compressed, air is exhausted from the valve chamber. As the valve depressurizes, air enters the valve cavity. For a neutral valve, the volume filled with air corresponds to the volume displaced by removal of the syringe tip. For positive displacements it displaces more and for negative displacements it displaces less. Optimal displacement may be achieved by increasing or decreasing the wall thickness of the beam 1132 extending the length of the valve. As previously mentioned, this design feature has little effect on valve actuation force and distortion. It is therefore an ideal property for fine tuning the displacement, with negligible impact on functional performance.

When a feature or element is referred to herein 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 one 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 illustrated with respect to one embodiment, features and elements so described or illustrated may be applied to other embodiments. Those skilled in the art will also appreciate that references to a structure or feature disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.

The 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" 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 "/".

Spatially relative terms, such as "below … …", "below", "above … …", "above", and the like, may be used herein for ease of description to describe one element or feature's relationship to another element or feature 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 the device in the figures is turned over, elements described as below other elements or features would then be oriented above the other elements or features. Thus, the exemplary term "below … …" may include orientations of "above … …" and "below … …". The device may be otherwise oriented (rotated 90 degrees or in other directions) and the spatially relative descriptors used in the present invention interpreted accordingly. Similarly, the terms "upward," "downward," "vertical," "horizontal," and the like are used herein for the purpose of explanation only, unless explicitly indicated otherwise.

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.

Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" and "comprising", will be understood to imply the use of various components (e.g., compositions and apparatus, including devices and methods) in methods and articles of manufacture. 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.

As used in the specification and claims, including as used in the examples, 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. When values and/or locations are described, the phrase "about" or "approximately" may be used to indicate that the described values and/or locations are within a reasonable expected range of values and/or locations. For example, a numerical value may have +/-0.1% of a specified value (or range of values), +/-1% of a specified value (or range of values), +/-2% of a specified value (or range of values), +/-5% of a specified value (or range of values), +/-10% of a specified value (or range of values), and the like. Unless the context indicates otherwise, any numerical value given herein is also to be understood as encompassing or approximating that value. 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, the values "less than or equal to," greater than or equal to, "and possible ranges between values are also disclosed, as is well understood by those of skill in the art. For example, if the value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" (e.g., where X is a numerical value) are also disclosed. It should also be understood that throughout this application, data is provided in a number of different formats, and that the data represents endpoints and starting points, and ranges for any combination of data points. For example, if a particular data point "10" and a particular data point "15" are disclosed, it should be understood that greater than, greater than or equal to, less than or equal to, and equal to 10 and 15 and between 10 and 15 are considered disclosed. It is also understood that each unit between two particular units is also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

While various illustrative embodiments have been described above, any of numerous variations may be made thereto without departing from the scope of the invention as described in the claims. For example, in alternative embodiments, the order in which the various described method steps are performed may generally be varied, 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. Accordingly, the foregoing description is provided primarily for the purpose of illustration and should not be construed as limiting the scope of the invention as set forth in the claims.

The examples and illustrations included herein show, by way of illustration and not limitation, specific embodiments in which the subject matter may be practiced. As described above, other embodiments may be utilized and derived therefrom, 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 of the invention not specifically described, will be apparent to those of skill in the art upon reviewing the above description.

Claims

1. A needleless connector valve comprising:

an inlet;

an outlet;

a body; and

a sealed spool within the body, the spool including a cut-out portion, the spool configured to twist 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 spool comprises an opaque material.

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

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 spool within the body, the spool including a first cutout portion and a second cutout portion, the spool configured to twist to allow fluid flow through the body.

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

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

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

10. The connector valve of any of claims 7-9, wherein the electronic component includes encryption capability.

11. The connector valve according to any of claims 7-10, wherein the electronics are configured to ensure 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 component includes a timeout feature.

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

14. The connector valve of any of claims 7-13, wherein the electronics are configured to engage with a mating feature of a sterilization unit.

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

16. The connector valve of claim 16, wherein the valve includes a gradual ramp feature around the electronic component to enable the pogo pin to slide over the connector when the connector is placed into the sterilization unit.

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

18. A connector valve according to any of claims 1-17, wherein the body includes 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 the sterilization unit.

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

21. The connector valve according to any one of claims 1-20, wherein the connector valve comprises an indexing feature.

22. The connector valve according to claim 21, wherein the indexing feature comprises a protrusion on the connector valve.

23. The connector valve according to claim 21 or 22, wherein the indexing feature is configured to interact with a corresponding feature on a disinfecting unit.

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

25. The connector valve according to any of claims 21-24, wherein the indexing feature is located near a bottom of the connector valve.

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

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

28. A connector valve according to any of claims 4 or 6 to 27, wherein the top and bottom parts are separate parts connected together.

29. A connector valve according to any of claims 4 or 6 to 28, wherein the top of the body comprises partial threads.

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

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

32. A connector valve according to claim 31, wherein the partial threads are located at a rounded corner.

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

34. A connector valve according to any of claims 4 and 6 to 33, wherein the bottom 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 of the body comprises a UV transmissive material.

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

38. The connector valve of any of claims 6-37 wherein the spool is configured to initially twist at the first notch, the first notch being larger than the second notch.

39. The connector valve of any of claims 1-38 wherein the valve spool includes a cavity.

40. The connector valve according to any of claims 1-39 wherein the spool includes a beam connecting two sides of the spool and extending along a majority of the length of the spool.

41. The connector valve according to any of claims 1-40 wherein the valve spool comprises a beam extending partially along one side of the valve spool.

42. The connector valve of claim 41 wherein the beam is located near a top of the cavity of the spool.

43. A connector valve according to any one of claims 1 to 42, wherein the connector valve is configured to cause a positive displacement.

44. A connector valve according to any one of claims 1 to 42, wherein the connector valve is configured to cause a negative displacement.

45. A connector valve according to any one of claims 1 to 42, wherein the connector valve is configured to cause a 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 the spool of the connector valve to twist at the first and second notches, the twisting allowing fluid to enter the outlet of the connector valve.

47. The method of claim 46, wherein twisting the connector valve comprises twisting the first cut and then twisting the second cut.

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

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 sterilizing the connector valve in a UV sterilization unit prior to connecting the connector.

51. The method of claim 50, wherein sterilizing the connector valve in a UV sterilization unit includes inserting the connector valve into an opening of a sterilization unit.

52. The method of any one of claims 50 and 51, wherein sterilizing the connector valve in a UV sterilization unit includes electrically connecting an electrical element of the connector valve with a corresponding feature in a UV sterilization unit.

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