JP2022527246A - Needleless connector bulb for UV sterilization - Google Patents

Abstract

An embodiment of a UV permeable needleless connector is provided. The connector comprises an outer housing that is at least partially UV permeable. The connector is configured to flex and deform to form a fluid path through the connector. [Selection diagram] FIG. 1A

Description

(Mutual reference of related applications)
This application benefits from US Provisional Patent Application No. 62 / 822,658 filed March 22, 2019 and US Provisional Patent Application No. 62/911,059 filed October 4, 2019. It is an assertion. This application relates to US Application Nos. 16/316, 918 filed July 11, 2017, which is a national stage application of International Application No. PCT / US2017 / 041556 filed on July 11, 2017, 2016. It claims the benefit of US Provisional Patent Application No. 62 / 360,922 filed on July 11, 2014.

(Used by reference)
All publications and patent applications referred to herein are herein by reference, just as it is indicated that each individual publication or patent application is specifically and individually incorporated by reference. The whole is used here.

(Field)
Systems and methods related to their use for sterilizing access (insertion) sites in general are described herein. More specifically, it relates to various methods and devices for sterilizing intracavitary and percutaneous access sites using ultraviolet light.

One of the first treatments performed when a patient is admitted to the hospital is the placement of a venous line (IV). This percutaneously indwelling IV line gives healthcare professionals direct access to the patient's blood flow via peripheral veins, allowing rapid infusions and dosing, and blood sample collection. can. Central venous catheters (CVC or central line) are inserted in more severe cases where high concentrations of blood need to be supplied directly, such as chemotherapy, temporary kidney dialysis, or cardiac monitor catheterization. This line is usually percutaneously inserted into the major bifurcated vessel (mostly the subclavian vein) (although it can also be inserted into the peripheral vein) and then guides the distal portion of the catheter to the superior vena cava. ..

Peripheral and central catheterization form an open pathway or lumen to the bloodstream from an external access site. This intraluminal access site includes, but is not limited to, stopcocks, needleless access sites, IV bags, infusion pumps, drug delivery pumps, kidney dialysis machines, thermodilution catheters, and a variety of therapeutic or diagnostic medical devices. It will be a point to install the equipment. Unfortunately, this access site is also the gateway to bacterial infections. Therefore, each time the access site is opened to attach a medical device, there is an opportunity for bacteria to enter the lumen of the catheter and transfer to the bloodstream.

In addition to contamination of the catheter lumen through external access sites, bacteria also invade through skin punctures and subcutaneous ducts formed by the catheter when placing IVs and CVCs. Bacteria travel along the outer wall of the catheter to the distal end and infect the ducts along the wall of the catheter.

Traditional IV lines and CVCs use some plastic fixture with a female luer lock or lure slip connector at the proximal end to minimize the serious problems identified in the following paragraphs. is doing. These connectors must be closed with luer caps when not in use to prevent contamination of access sites. This is because the outside of the lure cap is contaminated and it is almost impossible to prevent the male lure shape once removed from touching the contaminated surface. Therefore, in conventional infection control, the lure cap was always replaced when accessing the line. Not only is this procedure costly, but the process of removal and replacement increases the chances of bacteria invading the lumen of the connector.

In some cases, the IV access site has been changed to a needleless access valve, which has an elastomeric seal and is via the tip of a male luer connector attached to a syringe or similar device. Can be opened. These needleless access valves are 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 great deal of time, additional consumables, and the appropriate skill of the clinician to perform the cleaning, which may result in non-compliance with the cleaning procedure.

There are still issues regarding the prevention of infection in patients wearing indwelling catheters, and improvements in sterilization and infection prevention are required.

In a first aspect, a needleless connector valve is provided. The valve comprises an inlet, an outlet, a body, and a sealed valve core located within the body, the valve core having a notch, and the valve core allowing the flow of fluid through the body. It is configured to bend and deform.

In some embodiments, the valve core comprises an opaque material. The valve core can contain an opaque material. In some embodiments, the body consists of a top and a bottom. The top of the housing can be about 0.050 inches thick.

In another embodiment, a needleless connector valve is provided. The connector valve comprises an inlet, an outlet, a body, and a sealed valve core disposed within the body, the valve core comprising a first notch portion and a second notch portion, and the valve core is: It is configured to bend and deform to allow the flow of fluid through the body.

In some embodiments, the valve comprises an electronic element. The electronic element may be a chip. The electronic element may be a resistor. In some embodiments, the electronic element comprises an encryption function. The electronic element can be configured to ensure (guarantee) proper use of the connector with the handpiece of the sterilizer. In some embodiments, the electronic element comprises a time-out function. The timeout function can be configured to prevent the connector valve from switching to a different connector valve. In some embodiments, the electronic element is configured to fit with the fitting mechanism of the sterilizer. The fitting mechanism can include a pogo pin. In some embodiments, the valve comprises 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. In some embodiments, the body comprises an electronic element. In some embodiments, the body comprises an index mechanism. The connector valve may further comprise a mechanism configured to ensure proper positioning of the connector valve within the sterilizer. In some embodiments, the mechanism comprises a pocket.

The connector valve can be equipped with an index mechanism. In some embodiments, the indexing mechanism is configured to interact with the corresponding mechanism on the sterilizer. The corresponding mechanism can include a nested mechanism configured to interact with a protrusion on the connector valve. In some embodiments, the index mechanism is located near the bottom of the connector valve.

The body can include a UV transmissive portion. In some embodiments, the body comprises a top and a bottom. The top and bottom may be separate components to be joined. The top of the body can be provided with a partial thread. In some embodiments, the top of the body is fully threaded. The top of the body can include a square cross section with rounded corners. In some embodiments, the partial threads are located at the rounded corners. The top of the body can include a UV permeable material. In some embodiments, the bottom of the body comprises an outlet. The outlet can be configured to attach to another connector. In some embodiments, the bottom of the body comprises a UV permeable material.

The first notch and / or the second notch of the valve core can be provided with a scallop shape. In some embodiments, the core can be configured to flex and deform at the first notch, the first notch being larger than the second notch.

In some embodiments, the valve core comprises a cavity. The valve core can connect the two sides of the valve core and include a beam extending along most of the length of the valve core. In some embodiments, the valve core comprises a beam that partially extends along the sides of the valve core. The beam can be placed near the top of the valve core cavity. 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.

In another aspect, a method of accessing the needleless connector valve is provided. The connector valve comprises connecting the connector to the inlet of the connector valve, the connector valve providing access to the patient's vasculature, and advancing the connector to the inlet of the connector valve. The step of bending and deforming the valve core of the connector valve at the first notch and the second notch, and this bending deformation allows fluid access to the outlet of the connector valve.

In some embodiments, bending and deforming the connector valve involves bending and deforming the first notch and then bending and deforming the second notch. The first notch can be made larger than the second notch. In some embodiments, connecting the connector involves connecting a male luer connector. The method can further include sterilizing the connector valve with a UV sterilizer prior to connecting the connector. In some embodiments, sterilizing the connector bulb with a UV sterilizer comprises inserting the connector bulb into the opening of the sterilizer. Sterilizing a connector valve with a UV sterilizer can include electrically connecting the electrical elements of the connector valve to the corresponding mechanism of the UV sterilizer. In some embodiments, sterilizing a connector valve in a UV sterilizer comprises fitting the index mechanism of the connector valve to the fitting mechanism of the UV sterilizer.

The novel features of the present invention are specifically described in the subsequent claims. The features and advantages of the invention will be better understood with reference to the following detailed description showing exemplary embodiments utilizing the principles of the invention and the accompanying drawings. The features and advantages of the invention can be better understood by reference to embodiments in which the principles of the invention are utilized and the accompanying drawings thereof.

FIG. 1A is a diagram of an assembled needleless connector valve. FIG. 1B is a diagram of an assembled needleless connector valve.

FIG. 2A is a diagram of a valve core for use with the needleless connector valves of FIGS. 1A and 1B. 2B is a diagram of a valve core for use with the needleless connector valves of FIGS. 1A and 1B. 2C is a diagram of a valve core for use with the needleless connector valves of FIGS. 1A and 1B. FIG. 2D is a diagram of a valve core for use with the needleless connector valves of FIGS. 1A and 1B.

3A is a view of the top of the housing of the needleless connector valve of FIGS. 1A and 1B. 3B is a view of the top of the housing of the needleless connector valve of FIGS. 1A and 1B.

4A is a view of the bottom of the housing of the needleless connector valve of FIGS. 1A and 1B. 4B is a view of the bottom of the housing of the needleless connector valve of FIGS. 1A and 1B.

FIG. 5A is a side view of an embodiment of a needleless connector valve. FIG. 5B is a side view of an embodiment of a needleless connector valve.

FIG. 6A shows a syringe connected to a needleless connector valve as described herein. FIG. 6B shows a syringe connected to a needleless connector valve as described herein. FIG. 6C shows a syringe connected to a needleless connector valve as described herein. FIG. 6D shows a syringe connected to a needleless connector valve as described herein.

FIG. 7A shows an embodiment of a needleless connector valve. FIG. 7B shows an embodiment of a needleless connector valve. FIG. 7C shows an embodiment of a needleless connector valve. FIG. 7D shows an embodiment of a needleless connector valve. FIG. 7E shows an embodiment of a needleless connector valve.

FIG. 8A is a diagram of an embodiment of the identification chip assembly. FIG. 8B is a diagram of an embodiment of the identification chip assembly. FIG. 8C is a diagram of an embodiment of the identification chip assembly.

FIG. 9A is a diagram of an embodiment of the top of a needleless connector. FIG. 9B is a diagram of an embodiment of the top of the needleless connector.

FIG. 10 is a diagram of an embodiment of the bottom of the needleless connector.

FIG. 11A is a diagram of an embodiment of a needleless connector valve. FIG. 11B is a diagram of an embodiment of a needleless connector valve. FIG. 11C is a diagram of an embodiment of a needleless connector valve. FIG. 11D is a diagram of an embodiment of a needleless connector valve. FIG. 11E is a diagram of an embodiment of a needleless connector valve.

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

The upper section 106 of the housing and the valve core 104 have a substantially square cross section with rounded corners. This shape can advantageously optimize the shape of the connector for sterilization (eg, using one or more LEDs in a UV sterilizer). Also, the connector has a very small space (eg, 80 microliters) between the valve core 104 and the housing 102. Minimizing this space reduces the size of the fluid path and reduces 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.

FIG. 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 located at substantially the same height as the upper surface of the housing 102. The lip 202 near the top surface can be configured to fit into the corresponding mechanism on the housing 102. In the closed position, the lip 202 is configured to fit into the housing 102 over the entire circumference of the lip 202. When the needleless connector is fitted to the male luer connector, the valve core is designed to flex and deform in a predictable and repeatable manner, and the flex deformation (distortion, twisting, bending, buckling) of the valve core is , A portion of the lip 202 is moved 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 and a lower portion 208. The upper portion 206 of the valve core comprises a notch (cutout) 204. As shown in FIGS. 2A and 2B, the cutout portion 204 can be formed in a V-shape having 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 core. The side portion 214 of the notch portion 204 extends from the rounded tip portion toward the outer surface 216 of the valve core. Other shapes (eg, 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 core is configured to flex and deform when the inlet port 110 is fitted to the male luer connector. The shape of the notch 204 can be configured to exhibit a predictable and consistent deflection deformation (distortion) so as to form a fluid path for the liquid entering through the inlet port 110.

2C and 2D show side views 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 the same height as the upper surface of the housing 102. The lip 202 near the top surface can be configured to engage the 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 to the male luer connector, the valve core is designed to flex and deform in a predictable and repeatable manner, and the flex deformation of the valve core causes a portion of the lip 202 to house 102. It forms a fluid path for the fluid introduced through the male luer connector to flow away from it. The valve core is composed of an upper portion 206, an intermediate 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 composed of a diameter larger than that of the middle portion and the upper portions 206 and 208. The cross section of the intermediate portion 208 is composed of a substantially square shape with rounded corners. The upper portion 206 of the valve core comprises a notch 204. As shown in FIGS. 2A and 2B, the notch 204 can form a scalloped shape. The side view of FIG. 2B shows that the notch 204 is formed in a substantially arc shape. Other shapes (eg, 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 core is configured to flex and deform when the inlet port 110 is fitted to the male luer connector. The shape of the notch 204 can be configured to exhibit a predictable and consistent deflection deformation (distortion) so as to form a fluid path for the liquid entering through the inlet port 110.

The valve cores described herein can include silicone in some embodiments. Other materials are also possible (eg, styrene-based block copolymers, thermoplastic olefin-based elastomers, thermoplastic polyester-based elastomers, thermoplastic amide-based elastomers, and thermoplastic urethane-based elastomers). Material selection can be used to optimize UVC treatment. The valve core can be constructed of a material that is optically transparent, translucent or opaque to UVC light, such as different silicone materials. Further, additives such as a colorant that promotes absorption and reflection of UVC light may be added to the bulb material. The valve core material can also be selected or modified to enhance physical properties such as elasticity and lubricity of the valve. The valve core material can also be selected or modified to have low or high surface tension. One of the reasons why the adjustment of surface tension is desirable is to prevent the presence of residual liquid bubbles at the end of the valve (CIP12) after injecting the liquid. If the surface tension is high, the adhesive force of the bubbles may be insufficient and the bubbles may fall off, while if the surface tension is low, the residual liquid film may become thin.

The surface of the valve can also be changed according to the performance. For example, the surface of a substantially flat valve may come into contact with the inner surface of the top of the valve when stationary or flexing and deforming. Further, the surface of the valve may come into contact with another surface of the valve when it is flexed and deformed. As obtained by processing the surface of the mold used to manufacture the valve, such as by bead blasting, if the valve material is sticky to itself or to the housing. It may be preferable to have a textured surface. By giving the surface a texture, it is possible to enhance the ability of the valve to be flexed and deformed during use. The surface finish of the fitting surface of the syringe tip and connector can be used to affect the liquid foam on the valve (CIP12) surface.

3A and 3B are side views 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. Section 106 of the housing constitutes a top 306 near the inlet port. The top 306 gradually increases in diameter toward the middle 308. The bottom 310 has a larger diameter than the middle 308 and forms a lip 312 between the middle 308 and the bottom 310. The top and middle 308 are composed of a substantially square cross section with rounded corners. The bottom 310 generally has a rounded or circular cross section. In other configurations, the bottom is composed of a substantially square cross section with rounded corners. This can be an advantageous indicator for the handpiece to be fitted.

In some embodiments, the top of the housing is not fully threaded to fit the male luer connector. Instead, as shown in FIGS. 3A and 3B, the top is made up of partial threads. Partial threads have the advantage of requiring less UV sterilizing light transmission material and less shadows than full threads, thus requiring UV energy for sterilization. The amount and processing time can be minimized. The partial thread 304 has a raised protrusion and can be placed at the four rounded corners of the top of the housing, as best shown in FIG. 3B. In some embodiments, it will be appreciated that the top is composed of a complete thread or another connecting means. Threads or partial threads can be configured to connect to male threaded luer connectors such as those found on syringes and infusion tube sets.

At the top 306 and middle 306 of the housing, the fluid is configured to flow in the space between the valve core and the housing. The bottom 310 of the housing comprises one or more channels 314 arranged around or on the circumference of the bottom 310. FIG. 3B shows two channels spaced about 90 ° around the bottom 310. Channel 314 provides a fluid path for the fluid to travel towards the outlet port 112.

The top of the housing is composed of a UV permeable material such as a cyclic olefin copolymer such as Torpas® by G.M. Beher, Advanced Polymers, Frankfurt, Germany. Other materials (eg, polymethylpentene such as TPX® by Rye Brook's Mitsui Chemicals America, NY) are also possible.

4A and 4B show a front view and a side view of the bottom section of the connector 100, ie, the base 108, respectively. The base is provided with an outlet port 112 on the bottom surface. A thread 402 located near the bottom portion of the base 108 allows connection to a female luer connector. The thread 402 can be used to connect the connector to the patient's catheter line (eg, the CVC line). The connector comprises 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 is ventilated across the thread, while in other configurations the vents pass on both sides of the thread area or are glued joints that seal the internal fluid path of the upper and lower connectors. May exist somewhere up to. This allows the valve to be freely compressed without compressing the gas inside the valve. The compressed gas affects the rigidity of the valve and becomes relatively hard when the valve is compressed. Because compressed gas is less dense than liquid, it can leak into the fluid path if the valve is compressed without an opening to the surrounding air. If there are no holes and the gas inside leaks into the fluid path, a vacuum can be created inside the valve when returning to the uncompressed state. This may make it impossible to completely return to the original uncompressed state. The opening 406 shown in FIG. 4B provides a path for 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 channels 314 around the diameter, providing a path for the channel to communicate with the opening 406 and thus exit the tip 112 of the valve end.

The bottom of the housing is composed of a UV permeable material such as a cyclic olefin copolymer such as Torpas® by G.M. Beher, Advanced Polymers, Frankfurt, Germany. Other materials (eg, polymethylpentene such as TPX® by Rye Brook's Mitsui Chemicals America, NY) are also possible. Alternatively, this portion of the connector does not require UV permeability and can be made of an alternative material such as acrylic, polycarbonate, polyester, polypropylene, or any other suitable material.

The base 108 has a slightly smaller outer diameter 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, which has a triangular outer shape, creates a perfect circle on the sealing surface of the base. This rib locally compresses the valve to ensure a perfect seal. The ribs are shown with a triangular outline, but can have a radial outline, a triangular outline with a flat surface, or any other outline that helps ensure a perfect seal.

In order to optimize the UVC transmission of the connector and provide sufficient mechanical strength and performance to use mass production processes such as injection molding, the wall thickness of the top housing is preferably about 0. It is 050 inches (1.27 mm). Other thicknesses (eg, about 0.030 inches (0.762 mm) to 0.070 inches (1.778 mm)) are also possible.

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

5A and 5B are side views of a connector assembly with the valve core 104 of FIGS. 2C and 2D inside the housing 102. As shown in FIG. 5B, the top surface 502 of the lower portion 218 of the valve core 104 is pressed against the inner surface 504 of the housing within the housing lip 312. The rib 410 of the base 108 presses the bottom surface 506 of the valve core 104. As shown, the local area of the valve is significantly compressed by the force concentrated in the outer shape. In this cross section, the perimeter of the valve is completely sealed and the eight channels around the base of the top housing provide the only path that allows liquid to flow around the base of the valve and through the bottom housing. You can see that it is doing.

6A-6D show a state in which the connector 600 described herein is connected to a syringe. As shown in FIG. 6A, the syringe tip 602 is present to compress the valve core 604. The upper surface of the valve core 604 is flush with the tip of the syringe 602. The compression of the notch 606 is minimal. The opposite surface of the notch 608 is locally pressed against the inner surface of the connector.

FIG. 6B shows a state in which the syringe tip 602 further compresses the valve core 604. The upper surface of the valve core 604 is still flush with the tip of the syringe. At the notch 606 there is significant compression and initial deflection deformation. The opposite surface 608 bends and deforms downward and is separated from the notch 608.

FIG. 6C shows a state in which the syringe tip 602 further compresses the valve core 604. The upper surface 610 of the valve core 604 is bent away from the syringe tip 602. The cutout portion 606 is bent and deformed. The opposite surface 608 bends and deforms downward and is separated from the notch. A secondary deflection (strain) 612 of the valve core occurs in the middle portion of the valve core.

FIG. 6D shows how the syringe tip 602 further compresses the valve core 604. Deflection (distortion) is increased at the notch 606. The opposite side portion 608 bends downward away from the notch. In the middle part of the valve core, the secondary deflection (strain) 612 of the valve core is increased.

7A-7E show various diagrams of one embodiment of the 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 portion 708 and a bottom portion 710. The bottom 710 constitutes an outlet that can form a mounting point 712 (eg, a mounting point for a standard female luer connector). In another configuration, the bottom internal thread mechanism may be a separate collar that is glued or snapped into the fitting groove, or otherwise attached to the connector, which allows the molding of various components. It may be advantageous to facilitate. In another configuration, the lure connection mechanism at the bottom can be further nested at the base, and even a ventilation hole can be inserted. This is advantageous in minimizing the size and weight of the connector.

FIG. 7C is a perspective view of the connector valve 700. The valve comprises an electronic element 720 and an index mechanism 722. 7C, 8A and 8B show an embodiment having four separate pieces, the fourth piece being the electronic element 720, which is described in more detail below. 7D and 7E are views of the connector valve 700 cut out in a vertical plane.

8A and 8B are detailed views of the electronic element 720 (eg, chip) of the connector valve 700. The electronic element is fixed with the two contact pads 802 exposed (FIG. 8A). The chip 720 may be a resistor or other element. The chip 720 can be configured to fit into the electrical connector of the UVC sterilization handpiece. In some embodiments, the chip 720 is used to close the circuit so that the handpiece detects the presence of the connector and performs a sterilization cycle. Optionally, this chip has cryptographic performance. This performance ensures proper use of the connector in the handpiece. In some embodiments, the chip has a timeout feature so that the connector is used only for the specified life and cannot be pulled out for use with another connector. The encapsulation may be designed to optimally engage a fitting mechanism (eg, a spring-loaded electrical contact "pogo" pin to be fitted). In particular, a loose ramping 804 can be provided around the tip so that the rounded end of the pogo easily slides over the connector (FIG. 8A). Also, as shown in FIGS. 8B and 8C, the design of the pocket 806 formed by the lower and upper portions of the valve housing allows precise position control. This pocket can precisely control the position of the connector in three dimensions so that it optimally engages with the mating connector on the handpiece.

In some embodiments, the connector comprises an index mechanism 722 (FIG. 7C) such that the tip on the connector engages when the connector is in the ideal position. This can be done with an outer shape 722 protruding from the surface of the connector that fits into the nested outer shape on the associated handpiece. To sterilize as many connectors as possible, the protrusions may be at or near the bottom end of the connector, as shown in FIG. 7C. Next, if the bottom of the connector is manufactured of a UVC transparent material, there is an advantage that UVC light can be transmitted to the female thread luer connector portion of the connector fitting portion. This will advantageously sterilize any part of the mating connector exposed to UVC light, such as the thread, top edge, and top edge portion of the inner surface of the mating connector. In another configuration, a mating nested mechanism on the associated handpiece can be oriented adjacent to the chip. The mechanism 722 is then directly adjacent to the chip, but not to the end of the bottom of the connector, while maintaining the performance mechanism described above.

The system can be sterilized in a variety of ways. For example, the embodiments described can be sterilized with UVC light, but can also be sterilized using standard therapeutic alcohol wipe techniques or alcohol sterilization caps.

9A-9B show a front view and a top perspective view of an embodiment of the top 902 of the connector valve, respectively. Unless otherwise stated, the top 902 of the connector valve can be similar to the top described with respect to the top 306 in FIGS. 3A and 3B. In some embodiments, the top of the housing is not fully threaded for fitting. Instead, the top has a partial thread. Partial threads have the advantage of producing less material for UV sterilization light to pass through, producing less shadows than full threads, minimizing the amount of UV energy and processing time required for sterilization. can do. The partial threads are provided with ridge-shaped protrusions and can be placed at the four rounded corners of the top of the housing. Also, the partial threads are not ridge-like protrusions on the four rounded corners of the top of the housing, but one, two, or more partial threads. It can also be composed of mountains, which are oriented to minimize the amount of UV energy and processing time required for sterilization. In some embodiments, it will be appreciated that the top is provided with a complete thread or another connecting means. Threads or partial threads can be configured to connect to male threaded luer connectors, such as those found on syringes and infusion tube sets.

The top of the housing is composed of UV-permeable materials such as Torpas (Cyclic olefin copolymers such as registered trademarks) by Gaembeher, Advanced Polymers, Frankfurt, Germany. Other materials (eg, Mitsui Chemicals, Livelook, New York). Polymethylpentene, such as TPX® by the United States) is also possible.

FIG. 10 is a perspective view of the bottom of the bottom 1002 of the connector valve. The bottom 1002 comprises an outlet port 1004 that can serve as a mounting point (eg, a standard female luer connector). As mentioned above, the bottom 1002 can contain a UVC transmissive material and can transmit sterilizing UVC light through the luer connector. As mentioned above, in some embodiments, the inner thread mechanism at the bottom can be a separate collar that is glued, snapped, or otherwise attached to the connector in the fitting groove. It can be advantageous to facilitate the molding of various components. In another configuration, the bottom connection mechanism (eg, luer connector mechanism) can be further nested in the base and even into the vents. This is advantageous in minimizing the size and weight of the connector.

FIG. 11A shows an embodiment of a valve core 1102 having two notches 1104 and 1106, both of which form a scalloped shape. Both 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 flex and deform first with the larger scallop 1106. Since there is a portion that is easily bent and deformed in this way, the valve surface can be separated from the tip of the male lure with almost no deviation at the time of insertion. The addition of the second scallop 1104 reduces the cross-sectional area of the beam, resulting in lower stiffness, which further reduces resistance to deflection deformation (distortion). The term "beam" can be used to refer to a valve from the official point of view of Euler's long pillar. Here, the compression of the beam length means the characteristic deflection deformation behavior according to the equation P _Cr = (π ² EI) / (KL) ² , and P _Cr = the critical load for generating strain, E. = Elastic modulus, I = Minimum moment of inertia of cross-sectional area, L = Length of unsupported column, and K = Effective length coefficient of column. Since E, L, and K are the same for this valve, the strain force and direction can be determined by changing the moment of inertia. In this case, the moment of inertia of the scalloped portion of the column without scallops is I _{no scallops} = (πd ⁴ ) / 32, I _{scallops not along the neutral axis} = ((minimum distance between scallops) * d ³ ) / 12, And, the distance between _{scallops along the I neutral axis} = (d * (minimum distance between scallops) ³ ) / 12. From this equation, it can be seen that the moment of inertia is overwhelmingly minimized between the scallops along the neutral axis, where it tends to bend and deform.

FIG. 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 in contact with the inside of the valve top 1142 is the surface of the valve body along the square portion of the valve within the mating square portion of the connector top.

FIG. 11C is a bottom view of the connector valve. The continuous beam 1116 connects to the inner wall of the bulb at the two sides 1144 of the inner cavity that is the base of the bulb and extends completely (or most in some embodiments) to the length of the bulb cavity. ing. As shown, the two side portions 1150 of the internal cavity are not connected to the length of the valve. The orientation of the low-rigidity continuous beam indicated by arrow 1146 tends to flex and deform with significantly lower force than the orientation of the high-rigidity continuous beam indicated by arrow 1148, which has a relatively high moment of inertia. It reflects the orientation of the moment.

FIG. 11D shows a cross section of the valve core 1102 perpendicular to the neutral axis 1122, showing additional features of the valve core 1102 to facilitate deflection deformation in the preferred orientation. The cross section is longer, extending through the short internal beam 1110 at one end of the cavity (eg, the thicker part of the valve core) and the opposite internal cavity (open volume in the valve core) to the rest. The beam is 1112. When compressed, thinner parts tend to bend and deform more than thicker parts. Therefore, most of the valves (for example, the total length) have a characteristic that deformation points are likely to occur. Further, there is a continuous beam 1116 extending over the entire length of the bulb perpendicular to the deflection deformation surface 1114. A continuous beam can refer to a continuous solid portion of the valve core that runs along a neutral axis. In the bending direction, this beam is along the neutral axis 1122 and does not contribute significantly to strain resistance (FIGS. 11C and 11D). However, there is a significant difference in stiffness in the direction perpendicular to the bend. As a result, bending deformation in the preferential orientation is more likely to occur. The substantially square outer shape of the valve body is preferentially arranged to flex and deform along the four surfaces because the arc between the surfaces is substantially stiffer than the surface. Further, an internal rib traveling along the length of the valve body connects the two surfaces 1118 and 1120 perpendicular to the strain (FIGS. 11C and 11D). The beam 1116 maintains the distance between the surfaces 1118, 1120 during deformation, while the unsupported surface is free to flex. All of these design features contribute to the mechanical functioning of the valve. FIG. 1IE shows a cross section of a valve core along a neutral axis.

In some embodiments, fluid displacement when removing the male lure from the valve is an important feature. In some embodiments, it is preferred 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 system displacement because the displacement volume in the valve directly correlates with the fluid displacement volume in the connector body. In particular, when the valve is compressed, air is expelled from the valve cavity. When the valve compression is reduced, air enters the valve cavity. When the valve is neutral, the air fills the volume corresponding to the volume displaced by the removal of the syringe tip. Positive displacements cause more displacement, negative displacements cause less displacement. The optimum amount of displacement can be adjusted by increasing or decreasing the wall thickness of the beam 1132 extending along the length of the bulb. As mentioned above, this design feature has little effect on valve operating force and deflection deformation. Therefore, it can be said that it is an ideal function for finely adjusting the displacement without affecting the functional performance.

Here, when it is said that a feature or element is on top of another feature or element, the feature or element may be directly on top of the other feature or element, and there are also intervening features or elements. You may. In contrast, when a feature or element is said to be "directly" on top of another feature or element, there are no intervening features or elements. Also, when a feature or element is referred to as being "connected," "attached," or "bonded" to another feature or element, it is directly connected, attached, or combined to another feature or element. It will be understood that there may be features or elements that are or intervene. In contrast, if a feature or element is referred to as "directly connected," "directly attached," or "directly coupled" to another feature or element, there are no intervening features or elements. .. Although described or illustrated with respect to one embodiment, the features and elements so described or illustrated are also applicable to other embodiments. It is also to those skilled in the art that references to structures or features that are "adjacent" to another feature may have parts that overlap or underlie the adjacent features. Will be understood.

The terms used herein are intended to describe a particular embodiment 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, unless the context clearly indicates otherwise. .. As used herein, the terms "configuration" and / or "comprising" identify the presence of the described features, steps, operations, elements, and / or components, one or more. It will be further understood that it does not preclude the existence or addition of 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 related listed items and may be abbreviated as "/".

In the present specification, for ease of explanation, "under (above)", "below (below)", "lower (below)", "over (beyond)", "upper (upper). Spatial relative terms such as "above)" are used to illustrate the relationship between one element or feature and another. It will be appreciated that spatially relative terms are intended to include different orientations of the device during use and operation, in addition to the orientations depicted in the figure. For example, if the device in the figure is inverted, the elements described "below" or "below" the other elements or features are facing "up" to the other elements or features. .. Thus, the exemplary term "bottom" can include both "top" and "bottom" directions. The device may be in the other orientation (rotated 90 degrees or in the other orientation), and the spatially relative description used herein is interpreted accordingly. Similarly, terms such as "upwardly", "downwardly", "vertical", and "horizontal" are for illustration purposes only, unless otherwise noted. Is used for.

The terms "first" and "second" are used herein to describe various functions / elements (including steps), except as the context indicates. Should not be limited by these terms. These terms may be used to distinguish one function / element from another. It can be used to distinguish a feature / element from another feature / element. Therefore, the first feature / element described below can be referred to as a second feature / element, and similarly, the second feature / element described below does not deviate from the teachings of the present invention. , Can be referred to as the first feature / element.

In the specification and subsequent claims, the term "comprise" and variations such as "comprises" and "comprising" are subject to various components, unless otherwise required by the context. It means that it can be jointly adopted in a method and an article (eg, a device and a composition and a device including the method). For example, the term "constituting" is understood to mean including any described element or step, but not excluding other elements or steps.

In the specification and claims, all numbers, even when the term does not explicitly appear, "about," unless expressly specified, including those used in the examples. Can be read as if it were preceded by the word "or". The word "about" or "approximately" is sometimes used in describing size or position to indicate that the described value or position is within the expected reasonable range. For example, a number is ± 0.1% of the stated value (or range of values), ± 1% of the stated value (or range of values), ± of the stated value (or range of values). It can have values such as 2%, ± 5% of the stated value (or range of values), ± 10% of the stated value (or range of values), and so on. In addition, the numerical values given here should be understood to include before and after the values, unless it is judged that the numerical values are not the same in the context. For example, when the value "10" is disclosed, "about 10" is also disclosed. The numerical ranges described herein are intended to include all partial ranges contained therein. It should also be understood that when a value is disclosed, the possible range between "less than", "greater than", and the value is also disclosed, for those skilled in the art to be adequately understood. .. For example, when the value "X" is disclosed, "X or less" and "X or more" (for example, X is a numerical value) are also disclosed. It should also be understood that this application provides data in various formats, which represent a range of end and start points and any combination of data points. For example, if a particular data point "10" and a particular data point "15" are disclosed, not only between 10 and 15, but also greater than, greater than or equal to, less than, less than or equal to, and 10 and so on. It should be understood that it is believed to have been disclosed for as long as fifteen. It is also understood that each unit between the two specific units is also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, 14 are also disclosed.

Although various exemplary embodiments have been described above, any of a number of modifications can be made to the various embodiments without departing from the scope of the invention described in the claims. For example, the order in which the various method steps described may be performed may often change in alternative embodiments, and one or more method steps may be performed in other alternative embodiments. You may skip one or more method steps altogether. Optional features of various device and system embodiments may be included in some embodiments and not in other embodiments. Therefore, the above description is provided primarily for purposes of illustration and should not be construed as limiting the scope of the invention described in the claims.

The examples and figures contained herein show, but are not limited to, specific embodiments in which the subject may be practiced. As mentioned above, other embodiments may be utilized or derived so that structural and logical substitutions and modifications 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 concept of invention for convenience only, if a plurality of inventions are in fact disclosed. May be referred to herein individually or collectively by the term "invention." Accordingly, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same objective can be substituted for the specific embodiments illustrated. The present disclosure is intended to cover any and all indications or variations of various embodiments. Combinations of the above embodiments, as well as other embodiments not specifically described herein, will be apparent to those of skill in the art upon consideration of the above description.

Claims (53)

At the entrance,
With the exit
With the main body
A sealed valve core disposed within the body, the valve core comprising a notch, the valve core being configured to flex and deform to allow fluid flow through the body. There is a valve core and
Equipped with a needleless connector valve. The needleless connector valve according to claim 1, wherein the main body contains a UV permeable material. The needleless connector valve according to claim 1, wherein the valve core contains an opaque material. The needleless connector valve according to claim 1, wherein the main body includes a top and a bottom. The needleless connector valve of claim 1, wherein the top of the housing is about 0.050 inches (about 1.27 millimeters) thick. At the entrance,
With the exit
With the main body
A sealed valve core disposed within the body, the valve core comprising a first notch portion and a second notch portion, the valve core allowing fluid to flow through the body. With a valve core, which is configured to flex and deform like
Equipped with a needleless connector valve. The connector valve according to any one of claims 1 to 6, wherein the valve comprises an electronic element. The connector valve according to claim 7, wherein the electronic element is a chip. The connector valve according to claim 7 or 8, wherein the electronic element is a resistor. The connector valve according to any one of claims 7 to 9, wherein the electronic element has an encryption function. The connector valve according to any one of claims 7 to 10, wherein the electronic element is configured to ensure proper use of the connector with the handpiece of the sterilizer. The connector valve according to any one of claims 7 to 11, wherein the electronic element has a time-out function. 12. The connector valve of claim 12, wherein the time-out function is configured to ensure that the connector valve cannot be switched to a different connector valve. The connector valve according to any one of claims 7 to 13, wherein the electronic element is configured to engage with a fitting mechanism of a sterilizer. The connector valve according to claim 14, wherein the fitting mechanism includes a pogo pin. 16. The valve comprises a loose ramping mechanism around the electronic element to allow the pogo pin to slide over the connector when the connector is placed in the sterilizer. Described connector valve. The connector valve according to any one of claims 6 to 16, wherein the main body comprises an electronic element. The connector valve according to any one of claims 1 to 17, wherein the main body includes an index mechanism. The connector valve according to any one of claims 1 to 18, further comprising a mechanism configured to ensure proper positioning of the connector valve within the sterilizer. 19. The connector valve of claim 19, wherein the mechanism comprises a pocket. The connector valve according to any one of claims 1 to 20, wherein the connector valve includes an index mechanism. 21. The connector valve according to claim 21, wherein the index mechanism includes a protrusion on the connector valve. 22. The connector valve of claim 21 or 22, wherein the index mechanism is configured to interact with a corresponding mechanism on the sterilizer. 23. The connector valve of claim 23, wherein the corresponding mechanism comprises a nested mechanism configured to interact with the protrusion on the connector valve. The connector valve according to any one of claims 21 to 24, wherein the index mechanism is arranged near the bottom of the connector valve. The connector valve according to any one of claims 6 to 25, wherein the main body includes a UV transmissive portion. The connector valve according to any one of claims 6 to 26, wherein the main body includes a top and a bottom. The connector valve according to any one of claims 4 or 6 to 27, wherein the top and the bottom are separate components to be coupled. The connector valve according to any one of claims 4 or 6 to 28, wherein the top of the main body is provided with a partial thread. The connector valve according to any one of claims 4 or 6 to 29, wherein the top of the body is fully threaded. The connector valve according to any one of claims 4 or 6 to 30, wherein the top of the body comprises a square cross section having rounded corners. 31. The connector valve of claim 31, wherein the partial thread is located at the rounded corner. The connector valve according to any one of claims 4 or 6 to 32, wherein the top of the body comprises a UV transmissive material. The connector valve according to any one of claims 4 or 6 to 33, wherein the bottom of the main body is provided with an outlet. The connector valve according to any one of claims 1 to 34, wherein the outlet is configured to be attached to another connector. The connector valve according to any one of claims 4 or 6 to 35, wherein the bottom of the main body contains a UV transmissive material. The connector valve according to any one of claims 6 to 36, wherein the first notch portion and / or the second notch portion of the valve core has a scalloped shape. The core is configured to bend and deform at the first notch portion, and the first notch portion is larger than the second notch portion, according to any one of claims 6 to 37. Described connector valve. The connector valve according to any one of claims 1 to 38, wherein the valve core includes a cavity. The connector valve according to any one of claims 1 to 39, wherein the valve core connects two sides of the valve core and comprises a beam extending along most of the length of the valve core. The connector valve according to any one of claims 1 to 40, wherein the valve core comprises a beam partially extending along a side portion of the valve core. 41. The connector valve of claim 41, wherein the beam is located near the top of the cavity of the valve core. The connector valve according to any one of claims 1 to 42, wherein the connector valve is configured to generate a positive displacement. The connector valve according to any one of claims 1 to 42, wherein the connector valve is configured to generate a negative displacement. The connector valve according to any one of claims 1 to 42, wherein the connector valve is configured to generate a neutral displacement. How to access the needleless connector valve
A step of connecting a connector to the inlet of the connector valve, wherein the connector valve provides access to the patient's vascular system.
The step of advancing the connector with respect to the inlet of the connector valve, in which the step of advancing the connector, causes the valve core of the connector valve to bend and deform at the first notch and the second notch, resulting in bending. A method comprising a step, which allows fluid access to the outlet of the connector valve by deformation. 46. The method of claim 46, wherein bending and deforming the connector valve includes bending and deforming the first notch and then bending and deforming the second notch. The method of claim 46 or 47, wherein the first notch is larger than the second notch. The method of any one of claims 46-48, wherein the step of connecting the connector comprises connecting a male luer connector. The method of any one of claims 46-49, further comprising a step of sterilizing the connector bulb with a UV sterilizer prior to the step of connecting the connector. The method of claim 50, wherein the step of sterilizing the connector valve with the UV sterilizer comprises inserting the connector valve into an opening of the sterilizer. The method of claim 50 or 51, wherein the step of sterilizing the connector valve with the UV sterilizer comprises electrically connecting the electrical element of the connector valve to the corresponding mechanism of the UV sterilizer. The step according to any one of claims 50 to 52, wherein the step of sterilizing the connector valve with the UV sterilizer comprises engaging the index mechanism of the connector valve with the fitting mechanism of the UV sterilizer. Method.

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