WO2018089643A1

WO2018089643A1 - Needleless connector valve

Info

Publication number: WO2018089643A1
Application number: PCT/US2017/060874
Authority: WO
Inventors: Justin A. LANCE; Stephen BOWER; John E. Ashley
Original assignee: Puracath Medical, Inc.
Priority date: 2016-11-10
Filing date: 2017-11-09
Publication date: 2018-05-17

Abstract

Embodiments of needleless connector valves are provided. The valve comprises an inlet, and outlet, and a body between the inlet and outlet. The valve comprises a sealed core segment supporting a septum configured to seal the inlet. Insertion of a connector into the inlet causes the core segment to depress and the septum to fold over on itself, allowing fluid flow around the core segment. Removing the connector causes the core segment to retract and the septum to unfold.

Description

NEEDLELESS CONNECTOR VALVE

INCORPORATION BY REFERENCE

[0001] All publications and patent applications mentioned in this specification are incorporated herein by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

FIELD

[0002] This application relates to needleless connector valves.

BRIEF DESCRIPTION OF THE DRAWINGS

[0003] The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative

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

[0004] Figure l a is a top perspective view of the current invention.

[0005] Figure l b is a bottom perspective view of the device in Figure l a.

[0006] Figure 2a is a side view of another embodiment of the current invention in a closed

configuration.

[0007] Figure 2b is a cross section view of the device in Figure 2a taken through line A-A

[0008] Figure 3a is a side view of the embodiment of Figure 2a but in an open configuration.

[0009] Figure 3b is a cross section view of the device in Figure 2a taken through line B-B

[0010] Figure 4a is a top view of the device of the current invention in a closed configuration.

[0011] Figure 4b is a side view of the embodiment of Figure 4a.

[0012] Figure 4c is a cross section view of the device in Figure 4b taken through line C-C.

DETAILED DESCRIPTION

[0013] Figures l a and lb show needleless connector 10 which is comprised of an inlet port 12 on the top side 1 1 , an outlet port 14 on the bottom side 13, and a body 16 between the top side 1 1 and the bottom side 13. The inlet port 12 is formed by a standard female threaded luer connector 20 that is configured to connect to a male threaded luer connector such as is found on a syringe or an infusion tubing set (not shown). The outlet port 14 is formed by a standard male threaded luer connector 22 that is configured to connect to a female luer connector such as is found on the typical vascular catheter hub (not shown). The needleless connector 10 is therefore configured to be connected to the hub of a vascular catheter to provide quick and easy access without the need for a needle for blunt infusion devices such as a syringe or infusion tubing set. The standard female threaded luer connector 20 comprises one or more male threads 26 that can be continuous or partial (as is shown). The standard male threaded luer connector 22 comprises female threads 24. The needleless connector 10 can also comprise a base section 30 with base ribs 32 near the bottom side 13 to facilitate connecting and disconnecting the needleless connector 10 to the hub of a vascular catheter. The needleless connector also comprises a neck section 28 near the top side 1 1 that is generally of a smaller diameter than the diameter of the body 16.

[0014] The needleless connector's body 16, base 30, and neck 28 are made from an ultraviolet light transmissive moldable polymer material (e.g., a cyclic olefin copolymer such as Topas® Advance Polymers, GmbH, Frankfurt Germany, or polymethylpentene such as TPX© Mitsui Chemicals America, Rye Brook, NY) that allows ultraviolet light with a wavelength from about 250nm-300nm in length to penetrate through the material. Light of this wavelength is disruptive to microbial cell walls and DNA and has been shown to effectively kill bacteria, fungus, and viruses. Current needleless connectors are made from standard moldable polymers which due to their crystalline structure do not allow the short 250nm-300nm wavelength light to propagate through. Current needleless connectors are often associated with microbial infections as the fluid and residual blood trapped inside the connector in between uses can provide a good environment for microbial growth and colonization. By using the UVC transmissive moldable polymer material for the needleless connector body 16, base 30, and neck 28 of the device can allow ultraviolet light to propagate through the outside of the needleless connector 10 in order to disrupt microbes on the inside and prevent microbial infections.

[0015] Figures 2a and 2b are now described to explain the function of the needleless connector 10. The inlet port 12 is sealed with a septum 18 which blocks the ingress of fluids or any contaminates into the needleless connector 10 when the top side 1 1 of the device is in the closed disconnected state. The septum 18 is made of a compliant material such as silicone, rubber, or an aliphatic polyether-based thermoplastic polyurethanes such as Tecoflex® (Lubrizol Advanced Materials, Inc. Cleveland, OH). The septum 18 can be slightly compressed by the wall of the neck 28 of the needleless connector 10 in order to create the seal. The septum 18 can be supported by a core 19 of a stiffer polymer material or a metal so that the overall shape of the septum in the neck 28 is maintained. The core 19 can be attached to the septum 18 by adhesives, thermal welding, or alternately by over-molding the septum onto the core. The core can have raised ribs 34 on the top surface that create fluid pathways as will be described herein. The septum 18 can continue past the neck 10 and past the core 19 into the body 16 section of the needleless connector 10 where it is attached to a chamber body 38 that is positioned inside the body 16. The septum 18 can be attached to the chamber body 38 by adhesive, thermal welding, or alternately by over-molding the septum 18 to the chamber body 38. The septum 18 can be over-molded to the core 19 and the chamber body 38 in sequential molding operations where the septum 18 is partially formed in the first operation and completely formed in the second.

Alternately, the septum 18 can be over-molded onto the core 19 and the chamber body 38 in one operation where it is completely formed. The chamber body 38 is attached to a chamber base 40 by use of adhesives, solvents, thermal welding, ultrasonic welding, or molding. The septum 18, core 19, chamber body 38 and chamber base 40 together form an inner chamber 36 that is sealed from the rest of the needleless connector 10. The inner chamber 36 can contain a spring 44 and a piston 42 which are configured to press against the chamber base 40 and the core 19 to maintain the septum 18 in place in the neck 28 of the needleless connector 10 in the closed disconnected state shown in Figures 2a and 2b.

[0016] Figures 3a and 3b show the needless connector 10 in an open connected state where fluid can flow through the inlet port 12 into the body 16 and around the inner chamber 36 to the outlet port 14. In this state, a male thread luer syringe tip or a male threaded luer infusion line connector is threaded over the female threaded luer connector 20 on neck 28 of the needleless connector 10. The syringe tip (not shown) or infusion line tip (not shown) enters into the inlet port 12 and pushes the septum 18 and core 19 down through the neck 28 to the position shown in Fig 3b. At this position the top edge of the septum 18 is still constrained in the neck portion 28 put fluid can be flow past the septum 18 through the fluid channels 48 that are cut into the inner wall 17 of the junction between the neck 28 and the body 16. The unconstrained septum 50 between the core 19 and the chamber body 38 folds over itself and into the inner chamber 36. The piston 42 at the bottom of the core 19 compresses the spring 44 into the inner chamber 36. Fluid that flows through the fluid channels 48 can pass between the body 16 and the chamber body 38 and underneath the chamber base 40 and through the outlet 14. Likewise, in this position fluid can flow into the outlet 14 and through the needleless connector 10 to the inlet 12. The raised ribs 34 on the top of the core 19 provide a stop on the face of the syringe or infusion line tip around which the fluid can flow from the syringe or infusion line tip around the core 19 and septum 18 and into the fluid channels 48. When the syringe tip of infusion line tip is removed, the spring 44 pushes on the piston 42 which forces the core 19 and attached septum 18 back up through the neck 28 to reseal the needleless connector 10.

[0017] A unique feature of the invention is that as the septum 18 unfolds it decreases the fluid volume inside the connector 10 in near equal proportion to the increase in fluid volume that occurs as the septum 18 and core 19 re-enter the neck 29. This can be important because as the syringe or infusion line tip is withdrawn from the inlet port 12 and the septum 18 and core 19 reenter the neck, if the septum 18 did not unfold, the change in fluid volume would pull fluid into the outlet port 14. This is undesirable as the fluid entering the outlet port would draw fluid all the way along the attached catheter resulting in blood being pulled into the tip of the catheter. Blood drawn into the tip of the catheter and left there until the next time the needleless connector is accessed would tend to coagulate and potentially clog the catheter rendering it unusable. With the septum 18 unfolding to decrease the fluid volume in the needleless connector, no fluid is drawn into the outlet port 14 and no fluid is drawn up into the catheter. The inner chamber 36 is sealed and has an internal low pressure or vacuum when the septum 18 and core 19 are in the sealed position (as shown in Fig 2b) which allows it to fold into the chamber during insertion of the syringe or infusion line tip. If the inner chamber 36 was at ambient pressure in the seal position, the septum 18 would bulge out during insertion of the syringe or infusion line tip and the fluid volume inside the needleless connector 10 would decrease rather than decreasing during retraction. Then retraction of the syringe or infusion line tip would cause fluid to be drawn into the outlet port 14. The low or vacuum pressure in the inner chamber 36 and the folding septum 18 can be important features in the present invention.

[0018] Figure 4a is a top view of the device showing the cross-sectional line B-B that sections the view in Figure 2a and the cross-sectional line C-C that sections the view in Figure 4c. Line C-C is rotated about the center of the needleless connector 10 by 45 degrees relative to line B-B. In Figure 4c chamber body flanges 52 is shown that extends from the chamber body 38. Also shown is chamber base flanges 54 extending from the chamber base 40 and base supports 56 that extend from the base 30. The chamber body flanges 52, chamber base flanges 54 and base supports 56 position the inner chamber 36 relative to the body 16 and the base 30 such that the inner chamber 36 is stationary and the fluid pathways 50 are formed between the inner chamber 36 and the body 16 and base 30. There can be 2, 3, 4, or any number of sets of chamber body flanges 52, chamber base flanges 54 and base supports 56 to properly support the inner chamber 36 and create fluid pathways 50 around the inner chamber 36.

[0019] Variations and modifications of the devices and methods disclosed herein will be readily apparent to persons skilled in the art. As such, it should be understood that the foregoing detailed description and the accompanying illustrations, are made for purposes of clarity and understanding, and are not intended to limit the scope of the invention, which is defined by the claims appended hereto. Any feature described in any one embodiment described herein can be combined with any other feature of any of the other embodiment whether preferred or not.

[0020] It is understood that the examples and embodiments described herein are for illustrative purposes only and that various modifications or changes in light thereof will be suggested to persons skilled in the art and are to be included within the spirit and purview of this application and scope of the appended claims. All publications, patents, and patent applications cited herein are hereby incorporated by reference for all purposes.

Claims

CLAIMS claimed is:

1. A needleless connector valve comprising

an inlet;

an outlet;

a body;

a sealed core positioned within the body; and

a septum supported by the core and positioned proximate the inlet, the septum comprising a relaxed and a depressed state, the septum configured to block flow in its relaxed state and allow flow in its depressed state, wherein the septum folds over itself as it moves from the relaxed to the depressed state.

2. The valve of claim 1 , wherein the body comprises fluid channels at a neck portion of the valve near the inlet.

3. The valve of claim 1, wherein the septum unfolding is configured to decrease fluid volume inside the valve in near equal proportion to an increase in fluid volume caused by the septum and core moving back towards the inlet.

4. The valve of claim 1 , wherein the core comprises a spring element.

5. The valve of claim 1 , wherein the body comprises an ultraviolet light transmissive material.

6. The valve of claim 1 , wherein the body comprises a material configured to allow 250nm-300nm wavelength light to propagate therethrough.

7. The valve of claim 1 , wherein the septum comprises silicone, rubber, or an aliphatic polyether-based thermoplastic polyurethane.

8. The valve of claim 1 , wherein the inlet comprises a standard female threaded luer connector.

9. The valve of claim 1 , wherein the outlet comprises a standard male threaded luer connector.

10. A needleless connector valve comprising

an inlet;

an outlet;

a body configured to allow 250nm-300nm wavelength light to propagate therethrough; and

a sealed core positioned within the body.

1 1. A method for using a needleless connector valve comprising

inserting a connector into an inlet of the valve; and advancing the connector, thereby depressing a sealed core within the valve and allowing fluid flow around the sealed core, the sealed core supporting a septum that folds over itself as the connector is advanced.

12. The method of claim 1 1 , further comprising retracting the connector, thereby retracting the sealed core and unfolding the septum.

13. The method of claim 12, wherein unfolding the septum decreases fluid volume inside the valve near equal proportion to an increase in fluid volume occurring as the core retracts.

14. The method of claim 11 , wherein the valve comprises an ultraviolet transmissive material configured to transmit ultraviolet light with a wavelength of about 250nm-

300nm.

15. The method of claim 1 1, wherein inserting a connector comprises inserting a syringe tip or infusion line.