HK1200745B

HK1200745B - Medical connectors and methods of use

Info

Publication number: HK1200745B
Application number: HK15101115.1A
Authority: HK
Inventors: 托马斯．F．范格罗二世
Original assignee: Icu医学有限公司
Priority date: 2009-03-25
Filing date: 2015-02-02
Publication date: 2017-12-01

Abstract

Some embodiments disclosed herein relate to a medical connector having a backflow resistance module configured to prevent fluid from being drawn into the connector when a backflow inducing event occurs. In some embodiments, the backflow resistance module can include a variable-volume chamber configured to change in volume in response to a backflow-inducing event and a check valve configured to resist backflow. In some embodiments, the medical connector can include a fluid diverter configured to direct fluid flowing through the medical connector into the variable volume chamber to prevent fluid stagnation therein. In some embodiments, the medical connector includes a body member, a base member, a seal member, a support member, and a valve member.

Description

Medical connector and method of use

RELATED APPLICATIONS

According to 35u.s.c. § 119(e), the present invention claims the benefit of the following patent applications: U.S. provisional patent application having application date of 3 and 25 months 2009, application number 61/163,367, entitled "medical connector and method of use thereof"; and U.S. provisional patent application having application date of 2009, 10/13, application No. 61/251,232, entitled "medical connector and method of use thereof". The entire contents of both of the above-mentioned patent applications are hereby incorporated by reference, and the entire disclosures thereof are made part of this specification.

Technical Field

Embodiments of the present invention relate generally to medical connectors through which fluids flow, and more particularly to self-sealing medical connectors.

Background

Closable medical connectors or valves are useful in fluid administration in hospitals and medical facilities. The closeable medical connector is repeatably connectable to a variety of other medical implements and is automatically closeable upon disconnection from the other medical implements.

Disclosure of Invention

Some embodiments disclosed herein relate to a closed patient access system (patient access system) that automatically reseals after administration of a fluid, medicament, or other suitable substance (hereinafter collectively referred to as a "fluid") using a medical implement connected or in communication with the system. A two-way valve can be used, with its repeatability the tightness of the opening and the reusability. The two-way valve can assist in the transfer of fluids, particularly liquids, while maintaining sterility. After use, the valve is wiped in a conventional manner with a suitable substance to maintain its sterility.

Some embodiments disclosed herein relate to a medical connector having a backflow barrier module for preventing fluid from being drawn into the connector upon a backflow-inducing event (e.g., syringe bounce, syringe disconnect, etc.). In some embodiments, the backflow prevention module may include a variable volume chamber for changing volume in response to a backflow inducing event, and a check valve for preventing backflow. In some embodiments, the medical connector may include a fluid diverter for directing fluid flowing through the medical connector into the variable volume chamber to prevent fluid from being trapped therein. In some embodiments, a medical connector includes a body member, a base member, a sealing member, a support member, and a valve member.

Drawings

Specific embodiments of the present invention will be discussed below in conjunction with the following figures. These drawings are for illustrative purposes only and the present invention is not limited by what is shown in the drawings.

FIG. 1 is a schematic view of certain components of some embodiments of a medical connector;

FIG. 2A is a proximal perspective view of one embodiment of a valve or needle-free connector;

FIG. 2B is a distal perspective view of the connector embodiment shown in FIG. 2A;

FIG. 3 is a proximal end exploded view of the connector embodiment shown in FIG. 2A;

FIG. 4 is a distal exploded view of the connector embodiment shown in FIG. 2A;

FIG. 4A is an exploded cross-sectional view of the connector embodiment shown in FIG. 2A along its axial centerline;

FIG. 5 is a perspective view of an embodiment of a sealing member of the connector embodiment shown in FIG. 2A;

FIG. 6 is another perspective view of the embodiment of the sealing member shown in FIG. 5;

FIG. 7 is a proximal perspective view of a support member embodiment of the connector embodiment shown in FIG. 2A;

FIG. 8 is a distal perspective view of the support member embodiment shown in FIG. 7;

FIG. 9 is a cross-sectional view of the support member embodiment shown in FIG. 7 along an axial centerline thereof;

FIG. 10 is a proximal perspective view of an adjuster embodiment of the connector embodiment shown in FIG. 2A;

FIG. 11 is a distal perspective view of the regulator embodiment shown in FIG. 10;

FIG. 12 is a cross-sectional view of the embodiment of the regulator shown in FIG. 10 taken along an axial centerline thereof;

FIG. 13 is a cross-sectional view of the connector embodiment shown in FIG. 2A, illustrating the sealing member in a first or closed position prior to the sealing member being contacted and opened by a medical implement (such as the illustrated example of a syringe);

FIG. 14 is a cross-sectional view of the connector embodiment shown in FIG. 2A, illustrating the sealing member in a second or open position after the sealing member is contacted and opened by a syringe;

FIG. 15 is a schematic view of the embodiment of the connector shown in FIG. 2A for injecting fluid into a blood stream of a patient's arm;

FIG. 16 is a cross-sectional view of the connector embodiment shown in FIG. 2A, showing the sealing member in an open position, and the piston advanced to the bottom surface of the syringe;

FIG. 17 is a cross-sectional view of the connector embodiment shown in FIG. 2A, showing the sealing member in an open position and the syringe after the plunger of the syringe has bounced off the bottom surface of the syringe;

FIG. 17A is a cross-sectional view of the connector embodiment shown in FIG. 2A, showing the sealing member in a first position after the syringe is removed from the connector;

FIG. 18 is a proximal perspective view of another embodiment of a support member that may be used with the connector shown in FIG. 2A or any other connector disclosed herein;

FIG. 19 is a distal perspective view of the support member embodiment shown in FIG. 18;

FIG. 20 is a cross-sectional view of the support member embodiment shown in FIG. 18 along an axial centerline thereof;

FIG. 21 is a proximal perspective view of another embodiment of a sealing member that may be used with the connector shown in FIG. 2A or any other connector disclosed herein;

FIG. 22 is a distal perspective view of the embodiment of the sealing member shown in FIG. 21;

FIG. 23 is a proximal perspective view of another embodiment of a sealing member that may be used with the connector shown in FIG. 2A or any other connector disclosed herein;

FIG. 24 is a distal perspective view of the embodiment of the sealing member shown in FIG. 23;

FIG. 25A is a proximal perspective view of another embodiment of a sealing member that may be used with the connector shown in FIG. 2A or any other connector disclosed herein;

FIG. 25B is a distal perspective view of the embodiment of the sealing member shown in FIG. 25A;

FIG. 26A is a perspective view of another embodiment of a support member that may be used with the connector shown in FIG. 2A or any other connector disclosed herein;

FIG. 26B is a cross-sectional view of the support member embodiment shown in FIG. 26A;

FIG. 26C is a cross-sectional view of a connector including the support member embodiment shown in FIG. 26A;

FIG. 26D is a cross-sectional view of another embodiment of a support member that may be used with the connector shown in FIG. 2A or any other connector disclosed herein;

FIG. 27 is a proximal perspective view of another embodiment of a valve or needle-free connector;

FIG. 28 is a distal perspective view of the connector embodiment shown in FIG. 27;

FIG. 29 is a proximal end exploded view of the connector embodiment shown in FIG. 27;

FIG. 30 is a distal end exploded view of the connector embodiment shown in FIG. 27;

FIG. 31 is a cross-sectional view of the connector embodiment of FIG. 27 showing the sealing member in a first or closed position prior to the sealing member being contacted and opened by a syringe;

FIG. 32 is a cross-sectional view of the connector embodiment of FIG. 27 showing the sealing member in a first or open position after the sealing member has been contacted and opened by a syringe;

FIG. 33 is a distal exploded perspective view of another embodiment of a connector;

FIG. 34 is an exploded cross-sectional view of the connector embodiment of FIG. 33 along its axial centerline;

FIG. 35 is a cross-sectional view of the seal member of the connector embodiment shown in FIG. 33 along an axial centerline thereof, with the seal member in a second or open position;

FIG. 36 is a proximal perspective view of another embodiment of a valve or needle-free connector;

FIG. 37 is a distal perspective view of the connector shown in FIG. 36;

FIG. 38 is a proximal exploded perspective view of the connector shown in FIG. 36;

FIG. 39 is a distal exploded perspective view of the connector shown in FIG. 36;

FIG. 40 is an exploded cross-sectional view of the connector of FIG. 36 along its axial centerline;

FIG. 41 is a cross-sectional view of the connector shown in FIG. 36 and an additional needle-free connector in an unengaged configuration;

FIG. 42 is a cross-sectional view of the connector of FIG. 36 and the additional connector of FIG. 41 in an engaged configuration;

FIG. 43 is a distal cross-sectional view of an embodiment of a dynamic volume adjuster;

FIG. 44 is a cross-sectional view of the dynamic volume adjuster of FIG. 43 taken along its axial centerline;

FIG. 45 is a cross-sectional view of a valve or needle-free connector including the dynamic volume adjuster of FIG. 43;

FIG. 46 is a distal perspective view of an embodiment of a valve member;

FIG. 47 is a cross-sectional view of the valve member shown in FIG. 45 taken along an axial centerline thereof;

FIG. 48 is a cross-sectional view of a valve or needle-free connector including the dynamic volume adjuster of FIG. 46;

FIG. 49 is a cross-sectional view of a valve or needleless connector including both the dynamic volume adjuster of FIG. 43 and the valve member of FIG. 46;

FIG. 50A is a cross-sectional view of an embodiment of a base member;

FIG. 50B is a cross-sectional view of a valve or needle-free connector including the base member shown in FIG. 50A;

FIG. 51 is a distal perspective view of an embodiment of the regulator having a single slit;

FIG. 52 is a distal perspective view of an embodiment of the regulator having five slots;

FIG. 53 is a distal perspective view of another embodiment of a regulator;

FIG. 54 is a cross-sectional view of the regulator of FIG. 53 taken along an axial centerline thereof in a first direction;

FIG. 55 is a cross-sectional view of the regulator of FIG. 53 in a second direction along an axial centerline thereof;

FIG. 56 is a distal perspective view of another embodiment of a valve member;

FIG. 57 is a cross-sectional view of a valve or medical connector in a closed configuration including the valve member shown in FIG. 56;

FIG. 58 is another cross-sectional view of the connector shown in FIG. 57, with the valve member in an open configuration;

FIG. 59 is a distal perspective view of another embodiment of a regulator;

FIG. 60 is a cross-sectional view of the adjuster of FIG. 59 along its axial centerline;

FIG. 61 is a cross-sectional view of a valve or needle-free connector in a closed configuration including the regulator shown in FIG. 59;

FIG. 62 is another cross-sectional view of the connector shown in FIG. 61, with the regulator in an open configuration;

FIG. 63 is a proximal perspective view of another embodiment of an adjuster;

FIG. 64 is a cross-sectional view of a valve or needle-free connector in a closed configuration including the regulator shown in FIG. 63;

FIG. 65 is another cross-sectional view of the connector shown in FIG. 64, with the regulator in a first open configuration;

FIG. 66 is another cross-sectional view of the connector shown in FIG. 64, with the actuator in a second open configuration;

FIG. 67 is a distal perspective view of another embodiment of a regulator;

FIG. 68 is a cross-sectional view of the adjuster of FIG. 67 taken along its axial centerline;

FIG. 69 is a valve or needle-free connector in a closed configuration including the regulator shown in FIG. 67;

FIG. 70 is a partial cross-sectional view of the connector shown in FIG. 69 with the regulator in a first open configuration;

FIG. 71 is another partial cross-sectional view of the connector shown in FIG. 69, with the regulator in a second open configuration;

FIG. 72 is a cross-sectional view of another embodiment of a valve or needle-free connector support member;

FIG. 73 is a proximal perspective view of another embodiment of a support member;

FIG. 74 is a cross-sectional view of a valve or needle-free connector including the support member shown in FIG. 73;

FIG. 75 is a cross-sectional view of another embodiment of a support member including a pouch-like member;

fig. 76 is a partial cross-sectional view of the support member of fig. 75 with the pouch member in an approximately collapsed configuration;

FIG. 77 is another partial cross-sectional view of the support member of FIG. 75 with the pouch member in an expanded configuration;

FIG. 78 is a side view of another embodiment of a valve or needle-free connector;

FIG. 79 is a cross-sectional view of the connector of FIG. 78 along an axial centerline thereof;

FIG. 80 is a side view of another embodiment of a valve or needle-free connector;

FIG. 81 is a cross-sectional view of the connector of FIG. 80 taken along an axial centerline thereof;

FIG. 82 is a side view of another embodiment of a valve or needle-free connector;

FIG. 83 is a cross-sectional view of the connector of FIG. 82 along an axial centerline thereof;

FIG. 84 is a side view of another embodiment of a valve or needle-free connector;

FIG. 85 is a cross-sectional view of the connector of FIG. 84 along an axial centerline thereof;

FIG. 86A is a side view of another embodiment of a valve or needle-free connector;

FIG. 86B is a cross-sectional view of the connector of FIG. 86A taken along an axial centerline thereof;

FIG. 87A is a side view of another embodiment of a valve or needle-free connector;

FIG. 87B is a cross-sectional view of the connector of FIG. 87A taken along an axial centerline thereof;

FIG. 88A is a side view of another embodiment of a valve or needle-free connector;

FIG. 88B is a cross-sectional view of the connector shown in FIG. 88A taken along an axial centerline thereof;

FIG. 89A is a side view of another embodiment of a valve or needle-free connector;

FIG. 89B is a cross-sectional view of the connector of FIG. 89A taken along an axial centerline thereof;

FIG. 90A is a side view of another embodiment of a valve or needle-free connector;

FIG. 90B is a cross-sectional view of the connector shown in FIG. 90A along an axial centerline thereof;

FIG. 91A is a side view of another embodiment of a valve or needle-free connector;

fig. 91B is a cross-sectional view of the connector shown in fig. 91A along its axial centerline.

Detailed Description

The following detailed description is directed to specific embodiments of the disclosure. In the description, like reference numerals refer to like parts throughout the specification and drawings.

In some aspects of the described embodiments, various means for closing one or more ends of a connector are described. These closure mechanisms may be used to substantially prevent and/or substantially block fluid flow through the end of the connector when the closure mechanism or valve is in the closed position. When the closure mechanism is in an open position, such as when the connector is engaged with a needle-free syringe or other medical connector, fluid is allowed to flow through one or more ends of the connector. As used herein, terms such as "closed" or "sealed" and variations thereof are understood to refer to an obstruction or resistance to fluid flow. These terms should not be construed as requiring a particular structure or morphology to achieve complete fluid containment in all cases.

In some aspects of the disclosed embodiments, various means for controlling fluid flow within a connector are presented. These fluid control valves or mechanisms can assist in controlling potential, undesirable fluid movement into or out of the connector. For example, it may be desirable to prevent, impede, or reduce negative flow or fluid into the connector. As used herein, negative flow, retrograde flow, reflux flow, inflow flow and related terms are consistent with their ordinary meaning in the medical connector arts. In some cases, these terms refer to the flow of fluid into the connector caused by: due to an increase or effective increase in the internal volume of the fluid space within the connector, or due to fluid being sucked or removed from the outside (e.g., by withdrawing a portion of the medical implement that was previously inserted into the connector), or due to external forces of fluid pressure in a generally retrograde direction, e.g., due to patient coughing, increased patient blood pressure, or instability of the fluid source (e.g., a decrease or "dry out" of the fluid volume of the infusion bag), etc. The negative flow is typically generated in a direction generally opposite or opposite to the intended fluid flow.

As used herein, the terms "neutral", "neutral displacement", "neutral flow" and other related terms are consistent with their customary meaning in the medical connector art. In some cases, these terms refer to medical connectors or valves that: these medical connectors or valves typically do not produce negative flow in most clinical conditions that require the use of a particular connector or valve, or produce a very low level of negative flow in most clinical conditions that require the use of a particular connector or valve, thereby making the risk of harm to the patient or the likelihood of the need to replace the connector, valve or catheter due to negative flow very low. In addition, a neutral connector or valve generally does not produce clinically significant fluid flow from the distal end of the connector or valve to the proximal end of the connector or valve that is automatically produced upon connection or disconnection of another medical implement to the distal end of the connector or valve. In some disclosed embodiments, the connector or valve may be neutral, or neutral flow may be obtained.

Negative flow has a number of sources, including negative flow that is generated when a medical implement, such as a syringe, is removed from the proximal end of the connector (referred to herein as the first or female end of the connector). With the syringe removed, the fluid holding space within the connector may increase. When this fluid space is in communication with the patient's fluid line conduit, the increase in fluid space within the connector may draw fluid back into the connector from the conduit from the distal end, referred to herein as the second or male end. This may be disadvantageous because such negative flow may thus draw blood from the patient's body into the opposite end of the catheter. Such blood in the fluid line may clot or otherwise foul the fluid line, possibly requiring premature replacement and reinsertion of the catheter line, connector, and other medical implements.

Negative flow may also originate from an instrument connected to the proximal end of the connector. An example of this type of negative flow is that caused by a pump or a manual injector. For example, when the medical implement connected to the connector is a syringe, it typically includes a resilient piston head of the connector piston for depression by a user or machine. When the fluid in the syringe is discharged, the piston may be compressed toward the end of the syringe chamber. Upon release of pressure on the piston wall, the compression piston head will typically rebound or expand slightly in the proximal direction away from the end of the connector lumen. A small vacuum may thus be formed between the end of the cavity and the distal surface of the piston head. Since the syringe and the patient-connected catheter are still in fluid communication, the vacuum may be filled with fluid from the connector, which in turn pulls fluid from the catheter into the connector. This back-out of fluid can cause clotting or fouling of the guidewire.

In use, the negative flow may be generated in other ways, for example when an infusion bag used for infusing fluid through the catheter dries out, the patient's blood pressure changes or the patient's body moves, etc. Negative flow may also be generated by the momentum of the fluid flow. A syringe or machine may inject fluid into the connector. The user or machine typically pushes as much fluid as possible into the connector, for example by pressing the piston head to the end of the syringe lumen. Some negative flow may occur within the connector even before the pressure on the piston is released. Fluid molecules are connected by intermolecular forces and have momentum. As the final amount of fluid leaves the fluid source, the fluid is pushed out of the connector and out of the catheter. With the force pushing the fluid in the distal direction ending, the fluid at the end of the catheter continues to flow out of the catheter, while further fluid from the end of the catheter remains in the catheter. The vacuum between the end of the catheter and the end of the fluid column within the catheter can be filled with blood, which will result in a clot.

Some embodiments of the invention may substantially eliminate, reduce, minimize, or control the effects of some or all of the negative flow sources. Although the operation of some embodiments disclosed herein is discussed in connection with a single negative flow source (e.g., injector bounce), it should be understood that many negative flow sources may be eliminated, reduced, minimized, or controlled in a similar or identical manner.

Fig. 1 illustrates various components and configurations that may be included in some embodiments of the needle-free connectors disclosed herein. Fig. 1 should not be interpreted as illustrating all possible combinations and/or components that can be used. Some embodiments may include a proximal end, a proximal closure system, an internal closure system, and a distal end, which are arranged in connection with each other, as shown by the first series of boxes located on the left side of fig. 1. Some embodiments may include a proximal end, a proximal closure system, a volume adjuster, an internal closure system, and a distal end, which are arranged in connection with each other, as shown by the second series of boxes in fig. 1. Some embodiments may include a proximal end, a proximal closure system, an internal closure system, a volume adjuster, and a distal end, which are arranged in connection with each other, as shown in the third series of blocks in fig. 1. Some embodiments may include a proximal end, a proximal closure system, a volume adjuster, and a distal end, which are arranged in connection with each other, as shown by the fourth series of boxes in fig. 1. Some embodiments may include a proximal end, a proximal closure system, a combined internal closure system and volume adjuster, and a distal end, which are arranged in connection with each other, as shown in the fifth series of blocks in fig. 1. Any of these components may be omitted in certain embodiments and additional components may be included between the illustrated components that are disposed in connection with each other.

Many other combinations and other types of components may be used instead of or in addition to the configuration shown in fig. 1. For example, some embodiments may include a proximal end, a combined proximal closure system and volume adjuster and/or a combined proximal closure system and internal closure system, and a distal end. In some embodiments, there may be multiple sets of components shown in FIG. 1. For example, a pair of volume adjusters may be provided on either side of the internal closure system. In some embodiments, the distal end may comprise a closed system. Any components, features, or steps illustrated or described herein may be omitted in some embodiments. No single element, feature or step is essential or critical.

Several embodiments of a proximal closure system are illustrated, including a sealing member 26 and a support member 28 (see, e.g., fig. 3), a sealing member 26' (see, e.g., fig. 21), a sealing member 26 "(see, e.g., fig. 23), a sealing member 326 (see, e.g., fig. 34), a cap 491 (see, e.g., fig. 38), and sealing members 2126, 2226, 2326, 2426, 2526, 2626, 2726, 2826, 2926, and 3026 (see, e.g., fig. 79, 81, 83, 85, 86B, 87B, 88B, 89B, 90B, and 91B). Other types of proximal closure systems may also be used. The proximal closure system of each embodiment may be interchanged (if desired) with the proximal closure system of the other embodiments appropriately modified. The proximal closure system may also be omitted in some embodiments.

Several embodiments of volume adjusters are illustrated, including volume adjusters 30, 330, 630, 1030, 1130, 1230, 1430, 1530, 1730, 1930, 2130, 2230, 2330, 2430, 2530, 2630, 2730, 2830, 2930, and 3030 (see, e.g., fig. 10-12, 34, 43-44, 51-53, 59-60, 63, 67-68, 74, 79, 81, 83, 85, 86B, 87B, 88B, 89B, 90B, and 91B), a balloon member 1830 (see, e.g., fig. 72), and a pouch 2030 (see, e.g., fig. 75-77). Other types of volume adjusters may also be used, including other volume adjusters as shown and/or described herein. The volume adjuster of each embodiment may be interchanged (if desired) with the volume adjuster of the other embodiment appropriately modified. The volume adjuster may also be omitted in some embodiments.

Several embodiments of internal closure systems are illustrated, including valve members 108, 308, 408, 730, 1008, 1108, 1208, 1330, 1408, 1508, and 1708 (see, e.g., FIGS. 10-12, 34, 40, 46-47, 51-53, 57, 59-60, 63, and 67-68), as well as similar valve members shown in FIGS. 79, 81, 83, 85, 86B, 87B, 88B, 89B, 90B, and 91B. Other types of internal closure systems may also be used, including other internal closure systems shown and/or described herein. The internal closure system of each embodiment may be interchanged (if desired) with those of the other embodiments appropriately modified. The internal closure system may also be omitted in some embodiments.

Fig. 2A and 2B are perspective views of one embodiment of a valve or needle-free connector 20, respectively. Fig. 3 and 4 are exploded views of the embodiment of the connector 20 shown in fig. 2A. Fig. 4A is an exploded cross-sectional view of the connector 20 shown in fig. 2A. Referring to fig. 2A-4A, some embodiments of the needle-free connector 20 may include, inter alia, a body member 22, a base member 24, a sealing member 26, a support member 28, and an adjuster 30.

In the illustrated embodiment, the body member 22 and the base member 24 may be assembled together to form a housing that substantially encloses a sealing member 26 (hereinafter first valve member), a support member 28, and a regulator 30. Body member 22 and base member 24 may be joined together using adhesives, plastic or sonic welding, a bayonet mechanism, interference mechanism, or snap mechanism, or by using any other suitable feature or method. In some embodiments, the body member 22 and the base member 24 may be joined together using sonic welding in a generally triangular shape, although other shapes are suitable.

Body member 22, base member 24, support member 28, and any other portion or feature of connector 20 may be made from any of a number of suitable materials. For example, the body member 22, the base member 24, the support member 28, and any other portion or feature of the connector 20 may be made of a relatively rigid material, such as polycarbonate, glass-filled GE Valox420, polypropylene, or other polymeric material. Body member 22, base member 24, support member 28, and any other portion or feature of connector 20 may also be made of a hydrophobic material, such as Bayer Makrolon or any other similar or suitable material. One or more components of the connector 20 and other connectors disclosed herein may include any suitable form of suitable antimicrobial factor, such as a component coating as part of a component matrix, or other suitable form. In some embodiments, the antimicrobial factor is separated from one or more components in use or over time. In some embodiments, the antimicrobial agent may comprise silver ions.

As described above, the support member 28 may be formed from the same type of rigid material that forms the body member 22 or the base member 24. In some embodiments, for example, support member 28 may be formed from a material that is semi-rigid or even softer than the material used for body member 22, base member 24, or other components of connector 20. In some embodiments, the support member 28 (and any other embodiments of support members for any other connectors disclosed herein) may be integrally formed with the base member 24 (and any other embodiments of base members for any other connectors disclosed herein), or may be formed separately and engaged with the base member.

In some embodiments, the body member 22 may include one or more recesses or grooves 41 extending generally in the longitudinal direction of the connector 20 to assist in the movement of the sealing member 26. The groove 41 may provide an area for collapsing the sealing member 26 into and may reduce the surface area that the sealing member 26 contacts as the sealing member 26 moves within the housing.

Fig. 5 and 6 are perspective views of an embodiment of the sealing member 26 in the connector 20 shown in fig. 2A. Referring to fig. 1-6, the sealing member 26 may be configured such that the proximal end portion 34 of the sealing member 26 is sealingly received by the opening 36 of the proximal end 162 of the body member 22. In some embodiments, as in the illustrated embodiment, the proximal end portion 34 of the sealing member 26 may have a lip portion 38 formed thereon (the lip portion 38 being an annular projection) for contacting the opening 36 of the body member 22 to effect a seal. The distal end 53 of the sealing member 26 may include an opening 54. In some embodiments, the support member 28 may be received within the opening 54. In some embodiments, distal end 53 further includes an outwardly extending flange 56, with flange 56 extending around or substantially around sealing member 26. In some embodiments, the flange 56 may assist in positioning the sealing member 26 within the interior cavity of the body member 22.

The term "proximal" as used herein refers to the end of the connector 20 at or near the end of the body member 22. The term "distal end" refers herein to the opposite end of the connector, i.e., the end of the connector 20 at or near the end of the base member 24. In the illustrated embodiment, the proximal end is configured as a female end and the distal end is configured as a male end. Any end, arrangement or aspect of the connector 20 may be configured to accommodate any standard medical connector or instrument and is configured to comply with ANSI (American National Standards Institute, Washington, d.c.) or other applicable Standards. The term "medical instrument" herein refers to any medical device commonly used in the medical field that can be connected or engaged with any of the embodiments of the connector disclosed herein. Examples of medical implements contemplated include, but are not limited to, tubing, luer fittings, catheters, syringes, intravenous devices (peripheral and central), closeable male luer connectors (either integrally formed with the syringe or as a separate connector), pumps, piggyback lines, and other components that may be used to connect medical valves or connectors.

The seal member 26, the proximal end portion 34 of the seal member 26, and the lip portion 38 may be integrally formed, or may be separately formed and then joined together by an adhesive or other suitable material or method. In some embodiments, the seal member 26 or seal, any other embodiments of seal members, and components or features thereof disclosed herein may be made of many different suitable materials, including silicon-based deformable materials, rubber, or other suitable materials. Silicon-based deformable materials form a fluid-tight enclosure with plastics and other rigid composites.

The sealing member 26, or any other sealing member disclosed herein, may be formed from one, two, or more different materials. In some embodiments, different portions of the sealing member 26 may be formed of different materials. For example, the sealing member 26 may have a spring (not shown) to provide some or all of the restoring force required to bias the sealing member 26 to the closed position. The spring may be formed of metal (e.g., steel), plastic, or any other suitable rigid or flexible material, and may form the core of the sealing member 26 such that the silicone rubber or other flexible sealing material encapsulates the spring therein. In some embodiments, the sealing member 26 may be made solely of a resilient or elastic material. Also, by way of example, the sealing member 26 may include an elastomeric body portion and a separately formed elastomeric proximal end portion. These separate pieces may be engaged with each other, for example by being connected to a guide member having a first end for connection to the proximal portion and a second end for connection to the body portion. The guide member may be made of a material that is harder than the material of the body portion and/or the proximal portion.

The seal member 26 may have a tapered elastomeric body portion 50, the elastomeric body portion 50 having a generally pleated, generally wave-shaped, generally staggered, or generally wave-shaped profile to facilitate elastic compression and expansion of the seal member 26 upon application and removal of axial forces. In some embodiments, the body portion 50 may include a series of integrally formed or separately formed, re-joined together, generally circular or O-shaped structures, or one or more slot structures generally transverse to the direction of compression and expansion. The diameter or cross-sectional shape and/or size of these structures and shapes may vary. In some embodiments, the structures and shapes may extend generally alternately inward and outward in a direction approximately perpendicular to a longitudinal axis of the sealing member 26 (e.g., as shown in fig. 3-6). These structures and shapes may be in a variety of forms, such as a helical form.

In some embodiments, the inner surface of the body portion 50 may substantially match the outer surface of the body portion 50, such that the inner surface of the body portion 50 may also have the structure or profile described elsewhere herein. In some embodiments, the inner surface of the body portion 50 may extend generally radially inward while a corresponding portion of the outer surface of the body portion 50 extends radially outward; the inner surface of the body portion 50 may extend generally radially outward while a corresponding portion of the outer surface of the body portion 50 extends radially inward. Thus, the body portion 50 may include a series of protrusions, wherein the thickness of the walls of the body portion 50 alternates between thick sections and thin sections, such as shown in fig. 4A. In some embodiments, the inner surface of the body portion 50 may extend generally radially inward while a corresponding portion of the outer surface of the body portion 50 extends generally radially inward; the inner surface of the body portion 50 may extend generally radially outward while a corresponding portion of the outer surface of the body portion 50 extends radially outward. Thus, the body portion 50 may include a series of curved sections, wherein the walls of the body portion 50 have a more uniform thickness. In some embodiments, the inner surface of the body portion 50 may have a relatively smooth or flat surface shape.

The body portion 50 may have a substantially uniform cross-sectional shape or size along its length, or the cross-sectional shape or size of the body portion 50 may vary along at least a portion of its length. In some embodiments, the shape of the interior of the body portion 50 may approximately match the outer surface of the elongated portion 62 of the support member 28. In some embodiments, the body portion 50 includes a generally conical lower portion 50a, and a generally cylindrical upper portion 50 b. Many variations are possible.

The sealing member 26 may be configured to bias the body portion 50 toward an initial or expanded position, as shown in FIG. 5. When an axial force is applied to the sealing member 26, the proximal portion 34 and/or the body portion 50 may be caused to be compressed to the second position and thereby axially retracted to shorten the overall length of the sealing member 26. When the axial force is removed from the sealing member 26, the proximal portion 34 and/or the body portion 50 may be biased to re-extend to return the sealing member 26 to its relaxed state in the first or closed position, in which state the sealing member 26 may remain somewhat compressed such that, for example, the lip 38 of the proximal portion 34 engages the inner surface or surfaces of the body member 22 under a certain degree of axial tension.

The sealing member 26 may be configured such that the proximal end portion 34 of the sealing member 26 is received in the opening 36 in the body member 22. In some embodiments, such as the illustrated embodiment, the proximal portion 34 of the seal member 26 may have a lip portion 38 (the lip portion 38 may be an annular protrusion), the lip portion 38 being configured to contact the inner surface of the opening 36 of the body member 22 to provide a seal that substantially prevents particulate or fluid from entering the connector.

Additionally, as shown in FIG. 5, a slit or opening 52 may be formed in the proximal end portion 34 of the sealing member 26. The slit 52 of the sealing member 26 may be biased to a closed position to substantially prevent or impede fluid flow through the slit 52 in the sealing member 26. Additionally, in some embodiments, as will be described in greater detail below, the slit 52 may be opened by retracting the sealing member 26 distally past the support member 28, such that at least a portion of the proximal portion of the support member 28 pierces and passes through the slit 52. In some embodiments, the slit 52 may be configured to be open without piercing through the support member 28.

Fig. 7 and 8 are perspective views of an embodiment of the support member 28 in the embodiment of the connector 20 shown in fig. 2A. Fig. 9 is a cross-sectional view of the embodiment of the support member 28 shown in fig. 7 along an axial centerline thereof. Referring to fig. 7-9, in some but not all embodiments, support member 28 may include a base portion 60, an elongated portion 62 protruding from base portion 60 in a proximal direction, and a distal end 64 protruding from base portion 60 in a distal direction. In some embodiments, one or more components of the illustrated support member 28 may be omitted, or replaced with different components. For example, the support member need not include an elongated portion 62. In some embodiments, the support member may be substantially shorter so as not to extend into, through, and/or near the proximal end of the sealing member. In some embodiments of the connector 20, there is no support member at all. The sealing member may be arranged to be opened without piercing the support member, or without the support member at all, for example when the sealing member is in a natural open position in which it can be forced closed by a smaller diameter housing, or when the sealing member is connected to the proximal end region of the housing, etc. The regulator may also be fixed or positioned within the housing, and the regulator may operate without a support member. For example, in some embodiments, the regulator 30 may be connected to a sealing member and/or may be suspended separately from another structure, or the regulator 30 may be unconnected, free floating, without the distal end 64 or internal support shown in fig. 13.

In some embodiments, one or more components of the illustrated support member 28 may be formed separately and then attached to each other by adhesive, sonic welding, snap-fit, or other means. For example, the elongate portion 62 and the base portion 60 may be formed separately and joined together, for example, by sonic welding. In some embodiments, the entire support member 28 may be integrally formed as a single piece unit. In some embodiments, fluid may flow through one or more apertures within the lumen of the connector 20, such as apertures at or near the distal end of the lumen, either internal or external to the sealing member or other fluid barrier. Although illustrated as a single member, in some embodiments, the components of the support member 28 may be formed separately. For example, the elongate portion 62 and/or any other component may be arranged to move within the connector in use.

In some embodiments, distal end 64 may include a generally cylindrical outer surface 64 a. The longitudinal length of distal end 64 may be substantially less than the longitudinal length of elongate portion 62, as shown. The distance generally across the transverse cross-section of the distal end 64 may be less than the distance generally across the transverse cross-section of the adjuster 30 (see, e.g., fig. 12). Additionally, in some embodiments, the opening 66 may pass axially through at least a portion of the support member 28. In the illustrated embodiment, the opening 66 may be in fluid communication with a fluid passageway 69 that extends generally axially through the support member 28. The fluid passageway may extend through the distal end 64, the base portion 60, and a majority of the elongate portion 62 such that one or more transverse or radial openings 68 formed at the proximal end of the elongate portion 62 communicate with the opening 66.

As shown in fig. 7-9, the elongated portion 62 may have a tapered outer surface 70 and a proximal tip portion 72. The proximal tip section 72 may have a generally tapered (or generally conical) outer surface, or may be generally cylindrical. The elongated portion 62 may be configured such that the proximal tip portion includes a cross-sectional area that is substantially smaller than a cross-sectional area of the base portion 60 of the support member 28. In some embodiments, the proximal tip portion 72 may be configured to enable the proximal end portion 34 of the sealing member 26 to be retracted (e.g., from a compressed position to an expanded or initial position) relative to the proximal tip portion 72 of the support member 28 without significant pulling or snagging from the support member 28. In some embodiments, the proximal tip portion 72 has a sharp or rounded tip 74 to pierce the slit 52 formed on the sealing member 26. In some embodiments, tip 74 is integrally formed with tip portion 72 and the remainder of elongate portion 62. In some embodiments, the proximal end of the elongate portion 62 includes a hole at its proximal tip and a passageway 69, which passageway 69 may extend from the opening 66 to the opening of the tip.

The base portion 60 may have an outer annular wall 78, the outer annular wall 78 forming an annular channel 82 with the distal end of the support member 28. The channel 82 may be used to receive a portion of the distal end portion 56 of the sealing member 26. In some embodiments, the base portion 60 may be used to secure the distal end portion 56 relative to the base portion 60 of the support member 28 to prevent the distal end portion 56 from moving in a distal axial direction relative to the base portion 60. In addition, the channel 82 may serve to secure the distal end portion 56 relative to the base portion 60 of the support member 28 to prevent the distal end portion 56 from moving in a radial direction relative to the base portion 60. The sealing member 26 may be assembled with the support member 28, and the distal end portion 56 of the sealing member 26 may or may not be secured to the base portion 60 of the support member 28. Indeed, in some embodiments, the distal end of the sealing member 26 may "float" within the lumen of the body member 22 and may move axially as the sealing member 26 moves from the closed position to the open position.

The distal portion 64 of the support member 28 may have one or more transverse or radial openings 86 through the distal end 64. In the illustrated embodiment, the distal end 64 has two openings 86 formed therein and is configured as a generally rectangular slot with a major axis extending generally along the axis of the connector. However, in some embodiments, one, three, four, or more openings can be formed in the distal end 64, and these openings can be slots or other shaped apertures. In some embodiments, one or more openings 86 may extend along at least a majority of the longitudinal length of distal end 64, as shown. The one or more openings 86 may be formed to communicate with the axial openings 66 formed in the support member 28.

A generally annular cavity or chamber 88 may be located on the distal end 64 of the support member 28. The annular cavity 88 may be located between two annular protrusions 90 and 92, with the two annular protrusions 90 and 92 located on the distal end 64. As will be described in greater detail below, the cavity 88 may be filled with a fluid that flows through the openings 66 and 86 located on the support member 28. An annular projection 94 may also be located at the distal portion of the support member 28 such that a channel 96 is formed between the annular projections 90 and 94.

Fig. 10 and 11 are perspective views of embodiments of the regulator 30 of the connector shown in fig. 2A, respectively. Fig. 12 is a cross-sectional view of the embodiment of the regulator 30 shown in fig. 10, taken along an axial centerline of the regulator 30. As shown in fig. 10-12, the regulator 30 may have a body portion 100 and a proximal end portion 102. In some embodiments, as in the illustrated embodiment, the body 100 may be approximately cylindrical, while the proximal portion 102 may have an annular raised portion or lip 103 and an opening 104 therethrough. In some embodiments, as shown, the connector includes a plurality of valve structures, such as a sealing member 26 and a regulator 30, to control fluid flow through and/or within the connector 20.

Any of the other embodiments of the regulator 30 or regulator, valve or valve member disclosed herein, as well as any of its components or features, may be made of a variety of different materials, including silicon-based deformable materials, rubber or other suitable materials. Silicon-based deformable materials are among those that can form a fluid-tight closure with plastic and other rigid composite or metallic materials. In some embodiments, the regulator 30 may be resilient, elastic, and/or returnable. In some embodiments, the regulator 30 may be made of the same material as the sealing member 26. As shown in the illustrated embodiment, the variable volume or dynamic regulator portion of the regulator 30 may have very thin, extremely resilient and/or compliant side wall or walls, which in some embodiments are even thinner than at least a portion or all of the side walls of the sealing member 26, such that the regulator 30 is highly sensitive to changes in hydraulic pressure.

Additionally, the regulator 30 may include a valve member at the distal portion 108 having one or more apertures or slits 110 formed therein, two slits 110 in the illustrated embodiment. In some embodiments, as shown in the illustrated embodiment, the end 108 may include a valve member having an approximately arcuate, approximately dome-shaped, or approximately spherical shape. The distal portion 108 may be configured such that the distal portion 108 is biased toward a closed position (e.g., the slit 110 is biased toward a closed configuration). Thus, in some embodiments, the distal portion 108 may be configured to be substantially closed when the magnitude of the pressure differential between the fluid within the regulator 30 and the fluid acting on the outer surface of the regulator 30 is below a predetermined level (e.g., when the difference between the pressure acting on the inner surface 108a of the end 108 and the pressure acting on the outer surface 108b of the end 108 is below a predetermined level).

As shown, the shape of the valve member on the distal portion 108 may cause the valve member to close more tightly as the fluid pressure distal to the valve member rises to a particular level. Beyond this level of fluid pressure resistance, then the valve member may flex or move inwardly (e.g., in a proximal direction) to allow retrograde flow therethrough. The valve member may be configured (e.g., by selecting an appropriate shape, location, and materials used) such that the level of fluid resistance is greater than the pressure differential typically created by syringe bounce, removal of the proximal luer fitting, and/or externally induced negative flow (e.g., patient coughing, sneezing, movement, and increased blood pressure or decreased infusion bag fluid), but less than the pressure differential typically created by intentional removal of fluid from the proximal end of the connector 20. In some embodiments, as shown, the valve member may substantially retain its original shape as the pressure differential increases or builds up toward its cracking pressure to avoid or reduce communication of negative flow forces through the valve member at pressure differentials below the cracking pressure.

In some embodiments, retrograde flow or negative flow may be caused by external effects (sometimes from upstream of the connector 20), such as a decrease in fluid level within the infusion bag, and/or fluctuations or other movement of the fluid line caused by the patient or caregiver. When the fluid in the bag falls to a low level or is about to dry out (or the position of the bag is too low relative to the patient), the previous head pressure of the bag is also reduced. In some embodiments, this drop in head pressure may make the fluid line susceptible to "sloshing" or changing movement of the liquid column upstream and downstream of the connector due to the patient moving around, creating a periodic negative flow. In some embodiments, an internal or distal valve member, such as a valve member located at the distal end 108 of the regulator, may be set closed when the upstream head pressure from the progressively decreasing fluid level in the infusion bag falls below a threshold at which point sloshing or changing fluid movement may begin.

In some embodiments, the valve member may be a bistable valve configured to open in a first direction (e.g., in a proximal to distal direction) under a fluid force above a particular threshold, the fluid force acting in the first direction and remaining open to fluid flow in that direction until a fluid force above a desired threshold acts in a second direction (e.g., in a distal to proximal direction), the force causing the valve to open and remaining open to fluid in the second direction. The bistable valve can be switched back to the first direction again from a flow in the second direction by a force in the first direction which is above the threshold value.

In some embodiments, the width of the one or more slits 110 (represented by "WS" in fig. 12) may be approximately equal to the width of the opening 104 (represented by "WO" in fig. 12). In some embodiments, as illustrated, the width WS of one or more slits 110 may be less than the width of the opening 104. In some embodiments, as shown, the width WS, or the width across the transverse cross-sectional distance of the variable volume chamber, may be substantially less than the longitudinal length of the variable volume chamber, or substantially less than the longitudinal length of the entire regulator 30. In some embodiments, as shown, the thickness of the wall of the regulator 30 at the distal portion 108 in at least a portion of the valve member region may be substantially greater than the thickness of the regulator 30 in the variable volume chamber or body portion 100 to enhance the resiliency, compliance of the body 100 and resistance to backflow caused by the valve member. In some embodiments, as shown, the longitudinal length of the valve member at the distal end portion 108 may be substantially less than the longitudinal length of the variable volume chamber located in the body portion 100 of the regulator 30 (in both embodiments, the portions are connected or disconnected).

In some embodiments, the regulator 30 may be configured such that the distal portion 108 of the regulator 30 opens to allow fluid to flow through the regulator 30 in a first direction when the pressure differential inside and outside the regulator 30 reaches a first magnitude (e.g., in a direction from the proximal end 102 to the closed end or distal end 108, as indicated by arrow a1 in fig. 10). Similarly, the regulator 30 may be configured such that the distal portion 108 of the regulator 30 opens to allow fluid to flow through the regulator 30 in a second direction when the pressure differential inside and outside the regulator 30 reaches a second magnitude (e.g., in a direction from the closed end or distal end 108 to the proximal end 102, as indicated by arrow a2 in fig. 10).

The valve member of the internal or distal closure system may have many different shapes and arrangements. For example, in some embodiments, the valve member and associated attachments and positioning structures may be the same as or similar to the valves 2200 and 2250 illustrated in paragraphs 309 through 325, and fig. 50 through 56 of U.S. patent application publication No. 2010/0049157a1, the disclosure of which is incorporated herein in its entirety (including the references).

In some embodiments, the first magnitude of the pressure difference may be approximately equal to the second magnitude of the pressure difference. In some embodiments, as illustrated, the first magnitude of the pressure differential may be less than the second magnitude of the pressure differential, such that the regulator 30 is more resistive to fluid flow in the second direction a2 than in the first direction a 1. In other words, the end 108 of the regulator 30 may be disposed biased to allow fluid to pass through the end 108 in the first direction a1 at a lower magnitude of pressure differential than in the second, reverse direction a 2. With this arrangement, the regulator 30 may inhibit backflow (e.g., fluid flow in the second direction a 2) from downstream of the regulator 30 until the magnitude of the pressure differential exceeds a threshold required to open the slit 110.

For example, and without limitation, in the embodiment of the regulator 30 shown in fig. 10-12, the spherical shape of the distal portion 108 of the regulator 30 causes the end 108 to have a lower durometer in a first direction (indicated by arrow a 1) than in a second direction (indicated by arrow a 2). In this arrangement, the force required to deflect the closed or distal end portion 108 of the actuator in the A2 direction to open the opening 110 in the A2 direction is greater than the force required to deflect the distal end portion 108 of the actuator in the A1 direction to open the opening 110 in the A1 direction.

In some embodiments, the fluid (liquid or gas) pressure acting on the inner surface 108a of the regulator 30 may be about 0.5 atmospheres greater than the fluid (liquid or gas) pressure acting on the outer surface 108b of the regulator 30, such that the distal end portion 108 of the regulator 30 opens in the direction of a 1. In some embodiments, the pressure of the fluid acting on the inner surface 108a of the regulator 30 may be about 0.1 atmosphere to about 1.0 atmosphere, or about 0.2 atmosphere to about 0.8 atmosphere, or about 0.4 atmosphere to about 0.6 atmosphere, greater than the pressure of the fluid acting on the outer surface 108b of the regulator 30, such that the closed end or distal portion 108 of the regulator 30 opens in the a1 direction, allowing fluid flow in the a1 direction.

In some embodiments, the fluid pressure acting on the outer surface 108b of the regulator 30 may be approximately 1 atmosphere greater than the fluid pressure acting on the inner surface 108a of the regulator 30, such that the distal end portion 108 of the regulator 30 opens in the direction of a 2. In some embodiments, the fluid pressure acting on the outer surface 108b of the regulator 30 may be about 0.5 atmospheres to about 1.5 atmospheres, or about 0.7 atmospheres to about 1.3 atmospheres, or about 0.9 atmospheres to about 1.1 atmospheres, greater than the fluid pressure acting on the inner surface 108a of the regulator 30, such that the distal end portion 108 of the regulator 30 opens in the a2 direction, allowing fluid flow in the a2 direction.

In some embodiments, the magnitude of the pressure differential required to open the distal portion 108 of the regulator 30 in the A2 direction is approximately twice the pressure required to open the distal portion 108 of the regulator 30 in the A1 direction. In some embodiments, the magnitude of the pressure differential required to open the distal portion 108 of the regulator 30 in the A2 direction is substantially greater than the pressure required to open the distal portion 108 of the regulator 30 in the A1 direction, e.g., at least about 40% greater than the pressure required to open the distal portion 108 of the regulator 30 in the A1 direction. In some embodiments, including some of the embodiments illustrated herein, the magnitude of the pressure differential required to open the distal portion 108 of the regulator 30 in the A2 direction is about two to three times less than the pressure required to open the distal portion 108 of the regulator 30 in the A1 direction. In some embodiments, when a standard syringe 15 is connected to the proximal end of the connector and the syringe handle is advanced with the normally applied force for fluid transfer, the regulator 30 will allow fluid flow in the A1 direction, while when a substantially greater retraction force is applied to the syringe handle, the regulator 30 will allow fluid flow in the A2 direction.

In some embodiments, at least a portion of the distal end 108 of the adjuster 30 may be generally flat, rather than generally spherical. In some embodiments, the magnitude of the pressure differential required to open the regulator 30 in the A1 direction is approximately equal to or approximately equal to the magnitude of the pressure differential required to open the regulator 30 in the A2 direction. In some embodiments, a fluid impeding portion of the regulator 30, such as the distal portion 108, may include a portion or recess of increased thickness on the proximal or distal surface of the distal portion 108 that may, depending on the particular orientation, raise or lower the magnitude of the pressure differential required to open the regulator 30 in the a1 or a2 directions. Thus, in some embodiments, regulator 30 may produce a greater resistance to fluid flow in one direction than in another direction, such as a greater resistance in the A2 direction than in the A1 direction, even though the distal portion is approximately flat rather than spherical.

In some embodiments, the distal portion 108 of the regulator 30 may flex inwardly in the proximal direction before the slit 110 opens to allow fluid flow in the a2 (proximal) direction. In some cases, this pre-opening movement may result in some backflow into the distal end of connector 20, and therefore, it may be advantageous to mitigate or eliminate this pre-opening movement of regulator 30. In some embodiments, the spherical distal portion 108 of the regulator may reduce or minimize movement of the regulator 30 prior to opening to fluid flow in the direction of A2. In some embodiments, only a small portion of the volume, e.g., less than or equal to 0.1ml, of fluid is displaced before the regulator 30 is opened to allow fluid to flow therethrough.

In addition, referring to fig. 12, the adjuster 30 may further include an inner annular protrusion 112 formed on the inner surface 100a of the body portion 100. In some embodiments, the inner annular protrusion 112 may be received within the channel 96, the channel 96 being formed between the annular protrusions 90 and 94 of the support member 28. In this arrangement, the inner annular protrusion 112 may be used to secure or support the adjuster 30 in a desired axial position relative to the support member 28 to prevent or inhibit axial movement of the adjuster 30 relative to the support member 28. In some embodiments, the adjustor 30 is disposed within a lumen in the distal end region of the connector 20 and substantially or completely surrounds the distal end 64 of the internal component, such as the support member 28.

Referring to fig. 12, in some embodiments, the width of the annular protrusion 112 (represented by "WP" in fig. 12) may be less than (e.g., half of) the width WO of the opening 104. As shown, the interior of the regulator 30 may include a first cross-sectional area (e.g., at the proximal region), a second cross-sectional area (e.g., at the intermediate region), and a third cross-sectional area (e.g., at the distal region), wherein the second cross-sectional area is smaller than the first cross-sectional area and the third cross-sectional area. Additionally, the internal volume of the first or proximal region may be substantially greater than the internal volume of the second or distal region. In some embodiments, as in the illustrated embodiment, the width WP can be defined by the protrusion 112, which can be a quarter or half of the width WO of the opening 104. Other features relating to the regulator 30 will be described in connection with figures 13 to 16.

Fig. 13 is a cross-sectional view of the embodiment of connector 20 shown in fig. 2A, illustrating sealing member 26 in a first or closed position (e.g., prior to sealing member 26 being accessed and opened by insertion of a luer, such as on syringe 120). Fig. 14 is a cross-sectional view of the embodiment of connector 20 shown in fig. 2A, illustrating sealing member 26 in a second or open position (e.g., after sealing member 26 is contacted and opened by insertion of a luer, such as on syringe 120). The sealing member 26 is movable when traveling between the closed and open positions. In some embodiments, as shown, the sealing member 26 may compress in the open position and expand or return to its original position in the closed position. In some embodiments, the longitudinal length of the sealing member 26 in the open position is less than its longitudinal length in the closed position. Many other types of sealing members may also be used to open or close fluid passages within the connector in various ways. The sealing member 26 may be placed within the connector 20 such that the proximal surface 46 of the sealing member 26 is generally aligned or flush with the proximal opening of the connector 20, thereby enabling effective sterile wiping across the proximal surface 46.

The syringe 120 shown in fig. 13 through 16 (and elsewhere in this disclosure) is of the type of medical implement that may be used with the connector 20. Of course, the connector 20 is configured for use with a variety of medical implements and is not limited to the syringe 120 illustrated. The syringe 120 may be any medical syringe suitable or commonly used in the medical field. As shown, the syringe 120 may have a cylindrical body portion 122, the body portion 122 having an opening 124, a hollow sleeve 126 projecting from the body portion 122, and a piston 128, the piston 128 adapted to be received within the opening 124 of the body portion 122 and to move within the opening 124. The piston 128 may have a packing 129 made of an elastic material or rubber fixed to an end thereof. Typically such medical injectors are operated by: fluid is expelled from the syringe 120 by pushing the piston 128 toward the bottom surface 130 of the body portion 122, causing the fluid to be expelled through the hollow sleeve 126. In this manner, the fluid is generally not completely expelled from the syringe 120 until the rubber seal 129 of the piston contacts the bottom surface 130 of the syringe 120.

Fig. 15 illustrates the embodiment of the connector 20 shown in fig. 2A being used to inject fluid into the bloodstream of a patient's arm. The connector 20 (or any other embodiment of the connector disclosed herein) may be adapted for a variety of medical applications and is not limited to the application shown in fig. 15. As shown in FIG. 15, the connector 20 may be connected to a catheter 132, with the other end of the catheter 132 in communication with the patient's bloodstream. In this arrangement, a syringe 120 may be inserted into the connector 20 to open the sealing member 26 of the connector 20. When the sealing member 26 is in the open position shown in fig. 14, fluid from the syringe 120 may be delivered through the connector 20 and the catheter 132 and into the vasculature of a patient.

To inject all or substantially all of the fluid in the syringe 120 into the patient's vasculature, the plunger 128 or other mechanism of the syringe 120 is pressed by a caregiver or automated machine all the way into the body member 122 until the plunger 128 or rubber seal 129 bottoms out against the bottom surface 130 of the syringe 120, which causes the resilient rubber seal 129 to be compressed between the substantially rigid plunger 128 and the bottom surface of the syringe. At this point, the seal 129, which is typically made of rubber or other resilient material, at the end of the piston 128 may rebound when the caregiver's force on the piston 128 is removed.

In conventional systems (e.g., in systems without the connector 20 to counteract the effects of syringe bounce), a vacuum or suction source may be created within the syringe 120 when the piston 128 and the gasket 129 bounce off the bottom surface of the syringe 120. Sometimes, the spring back effect of the plunger 128 within the syringe 120 may be large enough to draw fluid out of the catheter 132, even from the patient's own vasculature, toward the syringe 120. For example, the syringe bounce can create a vacuum that reduces the pressure within the syringe and connector to 1 atmosphere. Additionally, in some instances, removal of the syringe or other medical implement from the connector may create a vacuum or suction source within the connector. The term "flashback" is used interchangeably with "negative flow" in some instances to describe an unintentional or adverse flow of blood and/or other fluids from the patient's vasculature to the conduit 132 and/or other components in fluid communication with the catheter 132.

The connector 20 may include a backflow barrier module for preventing, substantially preventing, reducing, or impeding backflow, retrograde flow, negative flow, inflow, or other pressure differentials caused by many different types of sources, such as a rebound effect of the syringe 120, removal of at least a portion of the medical implement (e.g., a luer of the syringe 120) from the connector, drying of the infusion bag, and the like. In some embodiments, backflow phenomena may be prevented, substantially prevented, reduced, or impeded by providing a regulator, such as a variable volume internal chamber, a volume adjuster, a dynamic volume adjuster, or a dynamic regulator, for reducing volume by collapsing or moving to counteract vacuum effects or various other effects due to syringe bounce, and/or a valve member for preventing fluid flow in at least one direction until a particular pressure differential threshold is exceeded, to the backflow prevention module of the connector 20. In some embodiments, as shown, the regulator may be configured to expand or move to increase the volume to counteract the pressure differential. In some embodiments, for example, the regulator 30 may perform a diaphragm-like function. In particular, regulator 30 may include a resilient or flexible wall having an interior surface that is in fluid communication with the fluid passageway within connector 20, and such wall may also flex or contract inwardly under suction or other fluid forces to reduce or change the volume of space within regulator 30 and ultimately cause all or a portion of the gas, liquid, or other fluid contained within regulator 30 to flow into or out of syringe 120 or other medical implement to counteract the vacuum effect. As shown, the regulator 30 may form a portion of the fluid pathway through a valve (e.g., fluid may enter from a first end of the regulator 30 and exit from a second end of the regulator 30). The movable wall of the regulator 30 may have a variety of different arrangements. For example, the walls may be elastic (as shown) or rigid, and/or may flex or bend (as shown), or may slide, rotate, etc. In some embodiments, a desired dynamic change in volume may be achieved by inserting a substantially rigid and/or substantially tubular structure having varying internal volumes into the fluid path. For example, such structures may be arranged to slide relative to one another in a substantially coaxial telescopic movement to effect a change in fluid volume.

In some embodiments, the backflow prevention module may further comprise a valve for preventing fluid flow in the proximal direction. The valve may be a check valve or a one-way valve to reduce or almost completely block fluid flow in the proximal direction; thus, connector 20 is a one-way connector under most of the fluid pressures typical of medical valves. In some embodiments, the valve may be configured to allow fluid flow in the proximal direction under sufficient force so that the connector 20 becomes a bi-directional connector. In some embodiments, for example, the distal portion of the regulator 30 and one or more slits 110 formed therein may be configured to block fluid flow in a proximal direction, as described in more detail elsewhere in this specification.

In some embodiments, the valve may be configured to: such that the force required to open the valve to allow fluid flow in the proximal direction is greater than the force required to reduce the variable volume chamber from the first volume to the second volume. For example, if a pressure differential is inadvertently created (e.g., due to the rebound effect of the syringe), the variable volume chamber may contract to counteract the pressure differential while the valve may remain closed. Thus, in some embodiments, pressure differentials caused by syringe bounce or other effects do not transfer or propagate to the fluid on the distal side of the valve or on the distal side of the connector 20, and backflow of fluid is also prevented.

In some embodiments, the force required to further reduce the volume of the variable volume chamber below the second volume is greater than the force required to open the valve to allow fluid flow in the proximal direction. Thus, if the pressure differential is intentionally created (e.g., a physician retracts the syringe plunger 128 to draw fluid into the syringe 120), the variable volume chamber may be collapsed to a second volume and then the valve may be opened to allow fluid to flow in a proximal direction. Thus, in some embodiments, the backflow barrier module may be ignored if a sufficiently large force is applied.

In the illustrated embodiment, the backflow barrier module may include various components of the connector 20, such as, but not limited to: the adjuster 30, the distal end portion 64 of the support member 28, the inner surface of the base member 24, and one or more openings 140 formed in the base member. Many other variations are possible. For example, in some embodiments, the regulator 30 itself or the separate fluid obstruction 108 itself may function as a backflow prevention module.

Referring to fig. 13, the adjuster 30 may be positioned over the distal end portion 64 of the support member 28 to seal the annular cavity 88 formed between the two annular projections 90 and 92. In this arrangement, the annular projections 90 and 92, the outer surface 64a of the distal end portion 64 of the support member 28, and the inner surface 100a of the volume adjuster or body portion 100 of the regulator 30 sealingly bound the annular cavity 88. As will be described in greater detail below, when a portion of the gas or fluid within the chamber 88 is drawn into the syringe 120, the volume adjuster or body portion 100 of the regulator 30 may flex, contract, deform or move inwardly in response to the rebound of the piston 128 within the syringe 120, or in response to a number of other effects that may cause an undesirable level of negative pressure. The regulator or volume adjuster may have a variety of placement and/or positioning within the connector. For example, in some embodiments, the regulator or volume adjuster may be disposed inside the elongated portion 62 of the support member 28, or integrated with the elongated portion 62. In some embodiments, at least a portion of the sides of the elongated portion 62 may be resilient or movable to change the volume within the connector. In this manner, the overall length of the connector may be reduced relative to some embodiments shown herein.

One or more openings 86 may be formed through the distal end portion 64 of the support member 28 to allow fluid to pass between the cavity 88 of the support member 28 and the openings 66. In the illustrated embodiment, two openings 86 are formed through the distal end portion 64 of the support member 28. Any suitable or desired number of openings may be formed in the distal end portion 64 of the support member 28 to allow fluid to pass between the cavity 88 of the support member 28 and the openings 66. In the illustrated embodiment, the opening 86 is generally slot-shaped, but in other embodiments, the opening 86 may have any suitable cross-sectional shape and/or size. For example, in some embodiments, the opening may have a substantially circular cross-section.

Additionally, referring to fig. 3, 4, and 13, the connector 20 may be configured to position the regulator 30 in a second cavity of the connector 20, such as the cavity 138 of the base member 24. In some embodiments, the regulator 30 in the initial position may be securely received in the cavity 138 in the base member 24 such that little air space exists between the outer surface 100b of the body portion 100 of the regulator 30 and the inner surface 138a of the cavity 138.

As shown in fig. 3 and 13, one or more openings 140 may be formed through the base member 24 to form an air passageway between the outer surface 100b of the body portion 100 of the regulator 30 and the ambient environment. The connector 20 may be positioned such that the body member 22 does not significantly restrict air flow through the one or more openings 140. Although only one opening 140 is illustrated, any suitable number of openings 140 may be formed in base member 24. As will be described in detail below, the one or more openings 140 may allow air to flow generally freely into the space between the outer surface 100b of the regulator 30 and the inner surface 138b of the cavity 138. In some embodiments, air may move within at least a portion of the interface between body member 22 and base member 24 (e.g., the interface portion below annular protrusion 182 and annular channel 180) to reach aperture 140. In some embodiments, body member 22 may include apertures (not shown) that allow air to reach apertures 140 on base member 24. In some embodiments, the aperture 140 in the base member may be open at a location that is not covered by the body member 22, but rather opens directly to the exterior of the connector 20. In some embodiments, air is filtered through at least a portion of body member 22 to aperture 140. In some embodiments, the base member 24 may not have the aperture 140, but may allow air to filter through at least a portion of the body member 22 to the space between the outer surface 100b of the regulator 30 and the inner surface 138b of the cavity 138.

The regulator 30 and/or the base member 24 may seal the connector 20 such that air flowing through the opening 140 cannot flow around the outer surface 100b of the regulator 30 and cannot enter the cavity 138 formed in the base member 24. For example, the protrusion 90 may form an airtight seal with the resilient wall of the regulator 30 and the inner wall 138a of the cavity 138, such that air entering the connector 20 through the aperture 140 is effectively held between the inner wall surface 138a and the outer surface 100 intermediate the two protrusions 90 and 92. As will be described in detail below, the openings 140 may allow air to flow toward the outer surface 100b of the body portion 100 of the regulator 30, and thus the regulator 30 may be substantially free to deform inwardly in response to the syringe bounce effect or other effects described herein that result in retrograde flow.

Other features of the body member 22 and the base member 24 are described in connection with fig. 3, 4, and 13. In the assembled configuration, the sealing member 26 may be supported by the support member 28 to receive the elongated portion 62 within the opening 54 formed in the sealing member 26. Additionally, the adjuster 30 may be supported by the support member 28 such that the distal end portion 64 of the support member 28 is received within an opening 104 formed in the adjuster 30. The sealing member 26, support member 28, and adjuster 30 may then be ganged together and secured within the body member 22 and base member 24. The body member 22 and the base member 24 may be joined together to form a rigid housing that encloses the sealing member 26, the support member 28, and the regulator 30 within the internal cavity 61.

The base member 24 may have a male end projection 142 projecting therefrom, the male end projection 142 forming an opening 144 therethrough, the opening 144 being in fluid communication with the chamber 138 formed in the base portion 24. In some embodiments, as shown, the male tip projection 142 is substantially open to fluid flow in both the open and closed positions of the valve. Additionally, the cover piece 146 may include protrusions or other features (not shown) to enhance the grip of the connector 20, as well as internal threads 150 formed on the inner surface 146a of the cover piece 146. Base member 24 may include a circumferential groove 145 that extends around or substantially around base member 24 to provide a friction area for gripping by an operator. Such grooves also provide a uniform wall thickness in the region of the base member 24 to improve production efficiency. Base member 24 may meet ANSI standards for medical connectors.

Body member 22 may have an annular ridge or protrusion 160 formed around outer surface 22a of body member 22 adjacent a proximal end portion 162 of body member 22. Proximal portion 162 may be smooth, generally cylindrical, or may have external threads or thread features 163 to enable connector 20 to be threadably connected with an appropriate medical implement. The projections 160 may be threaded into a threaded collar or casing (not shown) provided with a luer lock type syringe to prevent or hinder insertion of the syringe into the connector. Additionally, referring to fig. 14, the inner surface 22b of the body member 22 may be substantially smooth (as shown in fig. 13 and 14). In some embodiments, the inner surface 22b of the body member 22 may include linearly disposed ridges or channels, or other features. When the sealing member 26 is opened, the channels or recesses formed by the ridges may be used to receive portions of the sealing member 26 as the sealing member 26 is compressed and expands outwardly against such ridges or channels. Additionally, such ridges may reduce the area of the surface area in contact with the sealing member as the sealing member moves within the connector housing.

As shown in fig. 3 and 4, base member 24 can include a proximal end portion 170 having one or more protrusions 172 distributed about an outer surface of proximal end portion 170 of base member 24. In addition, the body member 22 can include a distal portion 174, the distal portion 174 having an opening 176 extending through the entire body member 22 and one or more recesses 178 formed in the distal portion 174. The one or more recesses 178 may be used to receive one or more protrusions 172 on the proximal end portion 170 of the base member 24. The protrusion 172 and recess 178 may serve to substantially prevent rotation of the body member 22 relative to the base member 24, thereby providing a more secure connection between the body member 22 and the base member 24.

Additionally, body member 22 can include an annular channel 180 formed within distal end 174, which annular channel 180 is configured to receive an annular projection 182 on proximal portion 170 of base member 24. Annular channel 180 and annular protrusion 182 may provide a bayonet-fit type connection between body member 22 and base member 24. With this arrangement, when body member 22 is coupled to base member 24 (as shown in FIG. 13), annular channel 180 and annular projection 182 substantially prevent body member 22 from being disconnected from base member 24. Many other configurations and methods of component attachment may be used.

The operation of one embodiment of the connector 20 is discussed below. Fig. 13 illustrates the positions of the components that make up the connector 20 when the sealing member 26 is in the closed position (e.g., prior to connection of a syringe or other medical implement to the connector 20). With this arrangement, the sealing member 26 may be biased toward the closed position, as shown in FIG. 13. Additionally, the slit 110 on the actuator 30 may be biased toward the closed position, as shown in FIG. 13.

Fig. 14 illustrates the sealing member 26 in an open position after insertion of a syringe 120 connected to the connector 20. As shown in fig. 14, the syringe 120 or other medical implement luer fitting or cannula 126 is pushed toward the sealing member 26 with sufficient force to overcome the biasing force of the sealing member 25, in the direction of arrow a4 in fig. 14, to compress or otherwise move the sealing member 26 within the body member 22. When the seal member 26 is compressed within the body member 22 to a sufficient distance such that the end surface 46 of the seal member 26 passes through the opening 68 of the support member 28, the opening 66 and/or the passageway 69 are fluidly connected with the interior of the syringe 120. The force exerted by the sleeve 126 against the end surface 46 of the sealing member 26 may be sufficient to cause a substantially fluid tight seal between the sleeve 126 and the end surface 46 of the sealing member 26, such that when the syringe 120 is connected to the connector 20 in this manner, all or substantially all of the fluid within the syringe 120 flows into the opening 68.

Thus, as shown in fig. 14, when the sealing member 26 is in the open position, the piston 128 of the syringe 120 may be depressed to force fluid into the connector 20. As shown by the flow arrows of fig. 14, in some embodiments, after forcing fluid out of syringe 120, the fluid may flow into one or more openings 68 formed in support member 28 and through passage 69 and opening 66 in support member 28. In some embodiments, a portion of the fluid may flow through an opening 86 in the support member 28 into a chamber 88 between the support member 28 and the regulator 30. Additionally, if the pressure on the piston 128 within the syringe 120 is great enough to exceed the threshold pressure differential required to open the one or more slits 110 in the regulator 30, fluid will also flow through the opening 144 in the base component 24 and into another medical implement coupled to the base component 24. As shown, the capacity within the regulator 30 at the stage shown in FIG. 14 may be substantially the same as in the stage shown in FIG. 13. As described herein, the connector 20 may enable the sealing member 26 to return to the closed position under the influence of its internal biasing force when the syringe 120 or other medical implement is removed from the connector 20.

Fig. 16 is a cross-sectional view of the embodiment of the connector 20 shown in fig. 2A, showing the sealing member 26 in an open position and the piston 128 pressing against the bottom surface 130 of the syringe 120. As shown in fig. 16, the physician or caregiver administering the fluid in the syringe 120 to the patient typically presses the piston 128 against the bottom surface 130 of the piston to squeeze the fluid from the syringe substantially entirely into the connector, causing the resilient seal 129 at the end of the piston to be compressed between the substantially rigid piston 128 and the substantially rigid bottom surface 130 of the piston. As shown, the capacity within the regulator 30 at the stage shown in fig. 16 may be substantially the same as at the stages shown in fig. 13 and 14.

In this position, when the piston 128 has been fully compressed relative to the syringe 120 and no more fluid is expressed from the syringe 120, the flow of fluid in the syringe 120 and connector 20 stops. When no more fluid flows through the connector 20, the pressure differential between the fluid within the connector 20 and the fluid outside the connector 20 (e.g., within a conduit in fluid communication with the distal end of the connector) falls below a threshold value required to open or maintain the one or more slits 110 of the regulator 30 in an open state; until the opposing pressure differential exceeds the threshold required to open the one or more slits 110, the one or more slits 110 close and no more fluid passes through the regulator 30.

Fig. 17 is a cross-sectional view of the connector embodiment shown in fig. 2A, showing the sealing member 26 and syringe 120 in an open position, wherein the plunger 128 of the syringe 120 has bounced off the bottom surface 130 of the syringe 120. When the rubber seal 129 at the end of the plunger 128 has pressed against the bottom surface 130 of the syringe 120 to expel substantially all of the fluid from the syringe 120, and the caregiver releases the plunger 128, the resilient seal 129 at the end of the plunger 128 will typically cause the plunger 128 to bounce off the bottom surface 130 of the syringe (as shown) or to expand upward from the bottom surface 130 of the syringe. When this occurs, a space is formed between the gasket 129 and the bottom surface 130 of the syringe 120, thereby creating a vacuum in the syringe 120.

See fig. 17, where connector 20 may be used to compensate for syringe bounce effects such that the pressure differential of the fluid within connector 20 relative to the fluid outside connector 20 may be less than the threshold pressure differential required to open one or more slits 110 on regulator 30.

For example, connector 20 may compensate for a vacuum formed within syringe 120 when plunger 128 is removed from bottom surface 130 of syringe 120 or expanded in the direction indicated by arrow A5 (e.g., when plunger 128 bounces). As shown in FIG. 17, regulator 30 may be configured such that a volume adjuster or body portion 100 of regulator 30 is capable of deflecting into one or more chambers 88 in response to a vacuum formed within syringe 120 to reduce the volume of chamber 88 and, thus, the volume of space within connector 20. As shown, the volume within the regulator 30 at the stage shown in fig. 17 may be less than the volume within the regulator 30 at the stage shown in fig. 13, 14, and 16 (e.g., by an amount that is about the amount of fluid that reenters the syringe 120 due to rebound of the piston 128).

In some embodiments, as shown, a regulator, such as a dynamic regulator, variable volume chamber, or volume adjuster, may be moved to reduce, substantially eliminate, or substantially cancel out a vacuum or pressure differential by causing a corresponding or opposite change in volume that is of substantially equal magnitude or magnitude to the pressure differential or vacuum that creates the negative or retrograde flow and/or that is created simultaneously with the pressure differential or vacuum that creates the negative or retrograde flow. In some embodiments, as shown, the regulator 30 may provide a plurality of different volume regulators (e.g., continuously variable volume regulators within a cylindrically related range) to enable the regulator to respond to a variety of different effects that may cause different amounts of vacuum or pressure differentials that may cause negative or retrograde flow. The volume adjustment of the regulator 30 may be enabled or configured to be automated and independent of the movement of other components of the valve. For example, as shown, the change in volume of the regulator 30 between the stages shown in fig. 16 and 17 need not necessarily be dependent on or require the connector 20 to move between the closed and open positions; conversely, the location of the proximal closure system (e.g., the seal 26 associated with the support member 28) may be substantially the same as in these stages. As shown, in some embodiments, the sealing member 26 may be spaced apart and disconnected from the regulator 30 in the open and/or closed positions.

As regulator 30 changes its volume, displaced fluid (gas or liquid) within chamber 88 due to the change in volume of chamber 88 may flow into syringe 120 or other medical implement connected to connector 20. In some embodiments, the closed end portion 108 of the regulator 30 may remain closed while the regulator 30 regulates the volume of fluid within the connector 20. In some embodiments, the body portion 100 of the regulator 30 is movable independently of the movement of the sealing member 26. As shown, in fig. 16 and 17, the body portion 100 of the regulator 30 may be deflected inwardly while the sealing member 26 remains substantially stationary in the collapsed configuration. In some embodiments, the sealing member 26 and the regulator 30 may be combined into an integrated or unitary assembly, and/or the sealing member 26 may be proximately arranged to include some or all of the features of the regulator 30.

In some embodiments, as shown, the regulator 30 may initially expand and contract or move in a direction generally perpendicular to the axis of flow of the fluid through the connector 20 without significant expansion or contraction (or no expansion or contraction at all) in a direction generally parallel to the axis of flow of the fluid through the connector 20. In some embodiments, as shown, the diameter and/or cross-sectional area of the variable volume portion or body portion 100 of the regulator 30 is substantially constant between the proximal and distal ends in the initial position.

Thus, the connector 20, in particular the regulator 30, may be arranged: when the syringe 120 rebounds, the vacuum suction or retrograde flow within the syringe is reduced by reducing the volume within the connector 20 immediately prior to the closure of the sealing member 26, such that the pressure differential between the fluid within the connector 20 and the fluid external to the connector 20 is dynamically maintained below the pressure differential threshold required to open the one or more slits 110 on the regulator 30. Additionally, in some embodiments, the end 108 of the regulator 30 may deflect slightly inward to assume the vacuum created by the syringe bounce without causing the one or more slits 110 to open.

In some embodiments, connector 20 and regulator 30 may compensate for a vacuum of at least about 1 atmosphere within syringe 120 without opening regulator 30. In some embodiments, connector 20 and regulator 30 may compensate for a vacuum within syringe 120 of between approximately 0.5 atmospheres and approximately 3 atmospheres, or between approximately 1 atmosphere and approximately 2 atmospheres, without opening regulator 30.

When a desired amount of fluid has been dispensed from the syringe 120 or other medical implement, the syringe 120 or other medical implement may be removed from the connector 20. When the syringe 120 or other medical implement is removed from the connector 20, the connector 20 may return the sealing member 26 to the initial position under the biasing force within the sealing member 26. This reversibility of the sealing member 26 makes the connector 20 particularly suitable as a connection valve for fluid communication between two fluid lines. Because the connector 20 is sealably closed and sterilized, a variety of syringes or medical implements can be easily connected to the connector 20 multiple times without disconnecting the connector 20 from the patient's vasculature.

Removal of a luer fitting of a medical implement, such as syringe 120, may also cause backflow or negative flow into connector 20. As shown in fig. 17A, the regulator 30 may also be configured to impede or prevent such negative flow. As shown, the regulator 30 can be sized to accommodate additional inward bending or other movement after the syringe bounce effect shown in FIG. 17. Thus, as the syringe 120 is removed from the connector 20 such that the pressure differential remains less than the cracking pressure required to open the slit 110 and the regulator 30, the sidewall 100 of the regulator 30 continues to collapse inwardly. As shown, the capacity within the regulator 30 at the stage shown in fig. 17 may be less than the capacity within the regulator 30 at the stages shown in fig. 13, 14, 16, and 17. Because regulator 30 remains closed, substantially no fluid is drawn into the distal end of connector 20, and substantially no fluid is drawn into a catheter or other medical implement connected to the distal end of the connector, and therefore, substantially no negative flow is created. In some embodiments, the variable volume within the regulator 30 may produce a variation of at least about 0.01ml and/or less than or equal to 0.1 ml; of course, in many embodiments, the volume may vary beyond this range depending on the particular arrangement within the connector (e.g., the amount of dead space). In some embodiments, the variable volume of the variable volume chamber is at least about 0.02cc and/or less than or equal to about 0.06 cc. In some embodiments, the variable volume of the variable volume chamber is about 0.04 cc.

In some embodiments, as shown in FIGS. 17 and 17A, some fluid may remain within the regulator 30, including within the fluid chamber 88 between the outer surface of the distal end portion 64 of the support member 28 and the inner surface of the volume adjuster of the body portion 100 of the regulator, even after the regulator 30 has moved to compensate for or respond to changes in pressure or fluid volume.

In some embodiments, as shown in FIG. 17, the volume adjustment of the regulator 30 may be independent of the movement of other components of the valve (e.g., the proximal closure system). For example, the change in volume of the regulator 30 between the stages shown in fig. 17 and 17A need not necessarily be dependent upon or require the connector 20 to move between the closed position and the open position; conversely, the volume of the regulator 30 may change in response to the regulator 30 automatically responding to the pressure differential communicated through the fluid, but need not necessarily change because the regulator is mechanically or directly connected to other components within the connector 20. In some embodiments, the regulator 30 may be in direct or mechanical communication with other components, including the proximal closure system.

In some embodiments (not shown), the regulator 30 may be configured to include a rigid chamber rather than the soft, resilient body portion 100 described elsewhere herein. For example, the regulator 30 may be configured with a resilient end portion that forms one or more slits or openings at the distal end, similar to the regulator 30, but having a body portion that does not flex or deflect inwardly in response to syringe bounce or other retrograde flow inducing events. Conversely, in some embodiments, an adjuster (not shown) may slide axially within a chamber 138 on the base member 24, but is biased away from the support member by a spring member. In these and other embodiments, the support member may be devoid of the distal portion 64. In this arrangement, when a vacuum is formed within the syringe, the regulator may be arranged to slide towards the syringe against the biasing force to reduce the volume within the connector and prevent the one or more slits in the regulator from opening. In some embodiments, the variable volume or dynamic volume adjuster of regulator 30 may comprise a flexible bag or other flexible container for fluid that is substantially inelastic and is not collapsible. The container may be made of very soft polyethylene or other material and may be configured to selectively admit fluid by filling, but not causing the container walls to collapse.

In some embodiments (not shown), the adjuster may be positioned adjacent the inner surface of the opening 66 on the distal end portion 64 of the support member 28 to align with, or be located substantially within, a portion of the inner surface of the opening 66, and within a passageway 69 extending within the distal end portion 64 of the support member 28, or in an inner surface having another internal opening in fluid communication with the opening 66. For example, in some embodiments, the regulator may cover a portion of the inner surface of a hollow cylindrical member, with an opening through the cylindrical member communicating with the opening 66. In some embodiments, at least a portion of the regulator (e.g., the intermediate portion) may be unconstrained so as to flex or move inwardly in response to a vacuum within the syringe, disconnection of the syringe or other medical implement from the connector, or the like. The opening 66 formed in the distal end portion 64 of the support member 28 may be increased in size or diameter to accommodate the adjuster abutting the inner surface. As described above, in some embodiments (not shown), the regulator may include a cylindrical sidewall configured to flex inwardly to reduce the internal volume and internal pressure within the connector, thereby compensating for the vacuum created by syringe bounce or disconnection of the medical implement. As with other embodiments described herein, the connector may have a gas port that is sealed from the opening 66 and the fluid flowing through the connector, but which allows the regulator to freely slide axially, or flex or collapse inwardly. After introduction of the fluid, the volume of fluid within the connector 20 may again change when a medical implement, such as the luer tip 126 of the syringe 120, is reinserted into the proximal end of the connector 20 in a closed state (e.g., the stage shown in fig. 17A). In this case, the volume of fluid within the connector 20 may increase to expand or move the sidewalls outwardly to increase the variable volume within the regulator 30. Because the regulator 30 may thus absorb the volume differential, the valve member 138 may remain closed upon reinsertion, while fluid flow toward the patient may be substantially or completely eliminated upon reinsertion of the luer fitting tip 126. In some cases, positive flow, which may be caused by reinsertion of medical instruments, is undesirable and can be avoided, especially for patients with relatively small blood volumes, such as neonates. Upon reinsertion of the medical implement, the connector 20 progresses to one or more states, e.g., similar to the states shown in fig. 16 and 17, having a variable internal volume that is different from the volume shown in fig. 17A.

In some embodiments, as shown in fig. 13-17A, a valve member located on the distal portion 108 of the regulator 30 may substantially prevent the entry of many forms of internally or externally generated negative flow or fluid. The dynamically adjusted volume of the body 100 of the regulator 30 may keep the valve member on the distal portion 108 closed even when the fluid volume is being withdrawn or changed, and may allow the use of a valve member on the distal portion 108 that has a lower threshold for fluid flow in the proximal direction. In some embodiments, as shown, the pressure differential required to open the valve member to flow fluid in the reverse direction from the proximal end to the distal end is substantially lower than the pressure differential required to open the valve member to flow fluid in the distal direction to the proximal end. Additionally, the valve member on the distal portion 108 may substantially prevent negative or retrograde flow caused by an external source on the distal side of the connector 20.

Fig. 18 and 19 are perspective views of another embodiment support member 28 ', which support member 28' may be used with the connector 20 shown in fig. 2A or any of the other connectors disclosed herein. Fig. 20 is a cross-sectional view of the embodiment of the support member 28 'shown in fig. 18, taken along an axial centerline of the support member 28'. In some embodiments, the support member 28' may have any of the features or other details and arrangements of the support member 28. Additionally, the support member 28' may operate with the body member 22, the base member 24, the sealing member 26, or the regulator 30. Thus, in some embodiments, the support member 28' may be used in place of the support member 28. Many of the features of the support member 28' shown in fig. 18 to 20 may be the same as or similar to the corresponding features of the support member 28.

As shown in fig. 18-20, the distal portion 64 'of the support member 28' may have one or more openings 86 'extending transversely or radially through the distal portion 64'. In the illustrated embodiment, two openings 86 'are formed in the distal portion 64'. However, in some embodiments, only one opening may be formed on distal portion 64', or three, four, or more openings may be formed. The opening 86 'may communicate with the axial opening 66' and the fluid passage 69 'formed on the support member 28'. Similar to the support member 28, the openings 66 ' may communicate with one or more openings 68 ' formed in the proximal end portion 62 ' of the support member 28.

Additionally, the support member 28 'may have one or more recesses 87' formed on the distal portion 64 'of the support member 28' that are in fluid communication with one or more openings 86 'formed on the distal portion 64'. The one or more smoothly contoured recesses 87 'may include one or more generally circular, parabolic cavities 88', which cavities 88 'may be filled with fluid flowing through the openings of the openings 66' and 68 'of the support member 28' in a manner similar to the cavities 88 of the support member 28. Similar to support member 28, distal portion 64 'of support member 28' may be configured to be received in opening 104 on regulator 30 to support regulator 30 in a manner similar to connector 20.

The support member 28' may operate in the same similar manner as the support member 28. In particular, when a vacuum is created within the syringe due to syringe bounce or other forces, the body portion 100 of the regulator 30 may deflect inwardly due to the vacuum created within the syringe 120 to form the cavity 88'. This may reduce the volume of chamber 88', thereby reducing the volume within connector 20. At the same time, fluid (gas or liquid) within one or more chambers 88 ', displaced by the change in volume of one or more chambers 88', may flow into syringe 120, thereby mitigating the vacuum effect within the syringe described above.

Fig. 21 and 22 are perspective views of another embodiment of a sealing member 26 ', which sealing member 26' may be used with the connector 20 shown in fig. 2A or any other connector disclosed herein. In some embodiments, the sealing member 26' may have any features or other details of the sealing member 26 or any other sealing member described herein. The sealing member 26' is operable with the body member 22, the base member 24, the support member 28, or the adjuster 30. Thus, in some embodiments, the sealing member 26' may be used interchangeably with the sealing member 26. In some embodiments, the internal wall structure of the body member 22 (including but not limited to the internal abutment surface 164) may be slightly modified to accommodate different configurations of the sealing member 26'. For example, the internal abutment surface 264 of the body member shown in fig. 27-32 may have a shallow angle (e.g., less than about 45 °) from horizontal.

The sealing member 26 ' may include an annular collar portion 42 ' having a proximal end face 44 '. In some embodiments, as will be described in detail below, the collar portion 42 ' may interact with an inner surface of the body member 22 (which may have an annular protrusion, one or more lugs, or other protruding features) to limit axial movement of the proximal end portion 34 ' of the sealing member 26 ' in the proximal direction. In some embodiments, the body member 22 and the sealing member 26' may be provided as: an end surface 46 '(which end surface 46' may be planar) of the seal member 26 'abuts an end surface 48 of the body member 22 or is coplanar with the end surface 48 of the body member 22 when the seal member 26' is in the closed position. Fig. 2A illustrates a first or closed position of the sealing member 26' relative to the body member 22. The proximal surfaces are generally aligned to facilitate cleaning and sterilization of the sealing member and other components of the connector 20. The sealing member 26' and the body member 22 may be configured to: the end surface 46 'may be substantially continuously aligned with the end surface 48 of the body member 22 when the sealing member 26' is in the closed position.

Like the sealing member 26, the sealing member 26 'may have an elastomeric body portion 50', the elastomeric body portion 50 'being shaped as previously described to enable the sealing member 26' to elastically compress and expand as axial force is applied and removed at the proximal portion 34 'of the sealing member 26'. In some embodiments, the body portion 50' may comprise a series of integrally formed, or separately formed, O-ring structures that are then joined together. These "O" rings may have different diameters or cross-sectional shapes and/or sizes.

In some embodiments, the inner surface of the body portion 50 'may approximately match the outer surface of the body portion 50'. In some embodiments, the inner surface of the body portion 50' may have a relatively smooth or flat surface profile. The body portion 50 'may have a substantially continuous cross-sectional shape or size along its length, or the cross-sectional shape or size of the body portion 50' may vary along at least a portion of its length. In some embodiments, the interior shape of the body portion 50' may substantially match the exterior surface of the elongated portion 62 of the support member 28. The sealing member 26' may be moved from the first position to the second position in a similar manner as the sealing member 26. In the closed position, the sealing member 26 ' may be held under some additional level of compression, e.g., with the proximal face 44 ' of the collar portion 42 ' engaged with one or more interior surfaces of the body member 22.

The body member 22 may include an internal abutment surface 164 that may interact with a corresponding annular collar portion 42 'on the sealing member 26'. The internal abutment surface 164 on the body member 22 and the annular collar portion 42 ' on the sealing member 26 ', respectively, may limit movement of the sealing member 26 ' relative to the body member 22 in a proximal direction (e.g., the direction shown by arrow a3 in fig. 14). In some embodiments, the internal abutment surface 164 on the body member 22 and the annular collar portion 42 ' on the sealing member 26 ', respectively, may stop the sealing member 26 ' at a position where the end surface 46 ' of the sealing member 26 ' may abut or be substantially coplanar with the end surface 48 of the body member 22. Thus, the end surface 46 'of the sealing member 26' may be prevented from protruding beyond the end surface 48 of the body member 22, or protruding beyond the end surface 48 in a constant manner, e.g., a constant distance to the end surface 48 upon activation of different valves.

The proximal end portion 34 'of the sealing member 26' is sealably received in an opening 36 in the body member 22. In some embodiments, as shown in the illustrated embodiment, the proximal portion 34 'of the sealing member 26' may have a lip portion 38 '(which lip portion 38' may be an annular projection) for contacting an inner surface of the opening 36 of the body member 22 to effect a seal.

The seal member 26 ', the proximal portion 34' of the seal member 26 ', and the lip portion 38' may be integrally formed, or may be separately formed and joined together with an adhesive or any other suitable material or method. In some embodiments, the sealing member 26' or any other embodiment of a seal or sealing member disclosed herein may be made of a variety of different suitable materials, including silicon-based deformable materials, rubber, or other suitable materials. The silicon-based deformable material can form a fluid-tight enclosure with plastic or other rigid polymeric material.

Similar to the sealing member 26, the body portion 50 'of the sealing member 26' may be biased toward an expanded or initial position. When an axial force is applied to the seal member 26 ', the body portion 50 ' may be compressed, thereby axially contracting to shorten the overall length of the seal member 26 '. When the axial force is removed from the sealing member 26 ', the body portion 50 ' may expand due to the bias to return the sealing member 26 ' to its original or relaxed state.

Additionally, as shown in FIG. 21, the proximal portion 34 ' of the sealing member 26 ' may have a slit or opening 52 ' therein. The slit 52 ' of the sealing member 26 ' may be biased to a closed position to substantially prevent or impede liquid flow through the slit 52 ' or opening 54 ' on the sealing member 26 '. Additionally, as will be described in detail below, in some embodiments, the slit 52 ' may be opened by retracting the sealing member 26 ' in a distal direction beyond the support member 28, thereby causing at least a portion of the proximal portion of the support member 28 to penetrate through the slit 52 '.

Fig. 23 and 24 are perspective views of another embodiment sealing member 26 ", which sealing member 26" may be used with the connector 20 shown in fig. 2A or any other connector disclosed herein. In some embodiments, the sealing member 26 "may have any feature, detail, or configuration of the sealing member 26 or the sealing member 26'. The sealing member 26 "may be used with the body member 22, the base member 24, the support member 28, or the adjuster 30. Additionally, the seal member 26 "may be used with the body member 22, the base member 24, one embodiment of the support member 28 without the elongated portion 62 (not shown), and the regulator 30. In particular, because the sealing member 26 "may be opened and closed without the elongated portion 62 of the support member 28, in some embodiments of the connector 20 (not shown), the sealing member 26" may operate without the elongated portion 62.

Thus, in some embodiments, the sealing member 26 "may be used instead of the sealing member 26 or the sealing member 26'. In some embodiments, the internal wall structure of the body member 22, including but not limited to the internal abutment surface 164, need not be slightly modified to accommodate the different configurations of the sealing member 26 ". Many of the features of the sealing member 26 "shown in fig. 23 may be the same as or similar to the corresponding features of the sealing member 26.

As shown in FIG. 23, the proximal end portion 34 "of the sealing member 26" is sealably received in the opening 36 in the body member 22. The proximal portion 34 "and/or the end surface 46" of the sealing member 26 "may be generally oval or elliptical. In some embodiments, the end surface 46 "of the sealing member 26" may have a first length or dimension (represented by length D1 in fig. 23) and a second length or dimension (represented by length D2 in fig. 23), wherein the second length D2 is less than the first length D1. In some embodiments, length D1 may be at least about one-quarter or at least about one-third greater than length D2. In some embodiments, the cross-sectional shape of the proximal end portion 34 "may be similar to the shape of the end surface 46" of the sealing member 26 ".

In addition, as shown in FIG. 23, a slit or opening 52 "may be formed in the proximal portion 34" of the sealing member 26 ". When the sealing member 26 "is in a relaxed state, the opening 52" of the sealing member 26 "is biased to an open position (as shown) to allow liquid to flow through the opening 52" and the opening 54 "in the sealing member 26'. When opposing forces, such as, but not limited to, forces F1 and F2 shown in FIG. 23, are applied to the proximal portion 34 "of the sealing member 26", the opening 52 "will seal closed to substantially impede or prevent any fluid flow therethrough.

Accordingly, the opening 36 in the body member 22 may have a generally circular cross-section such that when the proximal end portion 34 "of the sealing member 26" is inserted into the opening 26 in the body member 22, the generally rigid circular opening 36 applies a force to the proximal end portion 34 "of the sealing member 26" that closes the opening 52 "to generally block fluid flow through the opening 52". As the proximal portion 34 "of the seal member 26" is compressed and retracted from the opening 36 (e.g., by inserting a syringe or other medical implement), the proximal portion 34 "of the seal member 26" will no longer be restricted by the opening 36 of the body member 22, and thus, the bias of the proximal portion 34 "will open the opening 52" and allow fluid flow therethrough.

Thus, in this arrangement, the connector operates in a desired manner without the use of the elongate portion 62 of the support member 28. However, in some embodiments, the sealing member 26 "may be used with a support member 28 having an elongated portion 62, wherein the slit or opening 52" may also be opened by retracting the sealing member 26 "distally past the support member 28 such that at least a portion of the proximal end portion of the support member 28 penetrates the slit 52". In some embodiments, as with other embodiments of the seal member, the proximal portion 34 "of the seal member 26 may have a lip portion 38" (the lip portion 38 "may be an annular protrusion) for contacting the inner surface of the opening 36 of the body member 22 to effect a seal.

The seal member 26 ", the proximal portion 34" of the seal member 26 ", and the lip portion 38" may be integrally formed, or may be separately formed and joined together with an adhesive or any other suitable material or method. In some embodiments, the sealing member 26 "or any other embodiment of the seal or sealing member disclosed herein may be made of a variety of different suitable materials, including silicon-based deformable materials, rubber, or other suitable materials. The silicon-based deformable material can form a fluid-tight enclosure with plastic or other rigid polymeric material.

The sealing member 26 "may have an elastomeric body portion 50" with a plurality of accordion-like structures that allow the sealing member 26 "to elastically compress and expand under an axial force applied to the proximal portion 34" of the sealing member 26 ". The body portion 50 "may have a generally uniform cross-sectional shape throughout its length (as shown), or the cross-section of the body portion 50" may vary along a portion of its length (not shown), similar to the sealing member 26'. In some embodiments, the interior shape of the body portion 50 "may substantially match the exterior surface of the elongated portion 62 of the support member 28 (when such an elongated portion 62 is present).

Similar to the sealing member 26, the body portion 50 "of the sealing member 26" may be biased toward the expanded or initial position. When an axial force is applied to the sealing member 26 ", the body portion 50" may be compressed and then axially retracted to shorten the overall length of the sealing member 26 ". When the axial force is removed from the sealing member 26 ", the body portion 50" may return the sealing member 26 "to a relaxed state due to the biasing force.

Fig. 25A and 25B are perspective views of another embodiment sealing member 26 "' that may be used with the connector shown in fig. 2A or any of the other embodiments disclosed herein. In some embodiments, the sealing member 26 "' may have any features or other details of the sealing member 26 or any other sealing member described herein. The sealing member 26 "" may operate with the body member 22, the base member 24, the support member 28, or the regulator 30. Thus, in some embodiments, the sealing member 26 "' may be used interchangeably with the sealing member 26. Many of the features of the sealing member 26 "' shown in fig. 25A and 25B may be the same as or similar to the corresponding features of the sealing member 26.

The proximal end portion 34 "'of the sealing member 26"' is sealably received in an opening 36 on the body member 22. The proximal portion 34 "' may be generally cylindrical and have a generally smooth sidewall. In some embodiments, as shown, the proximal end portion 34 "' of the sealing member 26 may have a lip portion 38" ' (which lip portion 38 "' may be an annular projection) for contacting an inner surface of the opening 36 of the body member 22 to effect a seal.

The sealing member 26 may also include an annular collar protrusion 42 "'having a proximal face 44"'. In some embodiments, the collar protrusion 42 "' may contact an inner surface of the body member 22 (which may be an annular protrusion, or one or more lugs or other protruding features) to limit axial movement of the proximal portion 34" ' of the sealing member 26 "' in the proximal direction. In some embodiments, the body member 22 "'and the sealing member 26"' may be configured to: an end surface 46 "'of the seal member 26"' (which end surface 46 "'may be planar) may abut an end surface 48"' of the body member 22 or be coplanar with the end surface 48 "'when the seal member 26"' is in the closed position. This general alignment may allow for easy cleaning and sterilization of the sealing members and other components of the connector 20. The sealing member 26 "' and the body member 22 may be configured to: when the sealing member 26 "'is in the closed position, the end surface 46"' may be substantially continuously aligned with the end surface 48 of the body member 22.

The seal member 26 "', the proximal portion 34"' of the seal member 26 "'and the lip portion 38"' may be integrally formed or may be formed separately and joined together with an adhesive or any other suitable material or method. In some embodiments, the sealing member 26 "' or any other embodiment of a seal or sealing member disclosed herein may be made of a variety of different suitable materials, including silicon-based deformable materials, rubber, or other suitable materials. The silicon-based deformable material can form a liquid-tight closure with plastic or other rigid polymeric material.

The sealing member 26 "' may have a resilient body portion 50" ', which resilient body portion 50 "' has a profile as described for other seal embodiments such that the sealing member 26" ' resiliently compresses and expands under the axial force acting on the proximal portion 34 of the sealing member 26 "'. In some embodiments, the inner surface of the body portion 50 "'may substantially match the outer surface of the body portion 50"'. In some embodiments, the inner surface of the body portion 50 "' may have a relatively smooth or flat surface profile. In some embodiments, the body portion 50 "' may have a substantially uniform cross-sectional shape along its entire length, or the cross-sectional shape or size of the body portion 50" may vary along at least a portion of its length. In some embodiments, the interior shape of the body portion 50 "' may substantially match the exterior surface of the elongated portion 62 of the support member 28.

Similar to the sealing member 26, the body portion 50 "'of the sealing member 26"' may be biased toward the expanded or initial position. When an axial force acts on the sealing member 26 "', the body portion 50" ' may be compressed and axially retracted to shorten the overall length of the sealing member 26 "'. When the axial force is removed from the sealing member 26 "', the body portion 50" ' may return the sealing member 26 "' to a relaxed state due to the biasing force.

Additionally, as shown in fig. 25A, there may be a slit or opening 52 "' on the proximal portion 34" ' of the sealing member 26 "'. The slit 52 "' of the sealing member 26" ' may be biased to a closed position to substantially prevent or impede liquid flow through the slit 52 "' or opening 54" ' on the sealing member 26 "'. Additionally, as will be described in detail below, in some embodiments, the slit 52 "' may be opened by retracting the sealing member 26" ' in a distal direction beyond the support member 28 such that at least a portion of the proximal portion of the support member 28 penetrates and passes through the slit 52 "'.

Fig. 26A is a perspective view of another embodiment, a support member 28 "", which support member 28 "" may be used with the connector 20 shown in fig. 2A or any other connector disclosed herein. Fig. 26B is a cross-sectional view of the support member 28 "" shown in fig. 26A along an axial centerline thereof. Fig. 26C is a cross-sectional view of the connector 20 including the support member 28'. In some embodiments, the support member 28 "" may have any feature, detail, or arrangement of the support member 28. Additionally, the support member 28 "" is operable with the body member 22, the base member 24, the sealing member 26, the regulator 30, and the assemblies thereof described herein. Thus, in some embodiments, the support member 28 "" may be used interchangeably with the support member 28. Many of the features of the support member 28 "" shown in fig. 26A and 26B may be the same as or similar to the corresponding features of the support member 28.

As shown in fig. 26A-26C, the support member 28 "" may include a fluid diverter 65 '"for separating at least a portion of the fluid from the fluid passageway 69'" through an opening 86 "" of the support member 28 "" distal portion 64 "" into one or more chambers 88 "" between the support member 28 "" and the body portion 100 of the regulator 30.

In some embodiments, the fluid diverter may be a ball 65 "". The ball 65 "" may be made of a substantially rigid material, such as nylon, or may be made of a semi-rigid material or a flexible material. In some embodiments, ball 65 "" may be received in fluid passageway 69 "" at a location such that a portion of opening 86 "" is proximal to ball 65 "" and another portion of opening 86 "" is distal to ball 65 "" as shown in fig. 26B. In some embodiments, the ball 65 "" may be formed separately from the remainder of the support member 28 "" as shown in fig. 26A, and may be inserted into the fluid pathway through, for example, the opening 66 "". In some embodiments, the material of ball 65 "" may be more rigid than the material of distal portion 64 "" of support member 28 "" such that upon insertion of ball 65 "" the walls of opening 66 "" and the walls of fluid passageway 69 "" can temporarily flex a small amount outwardly. In some embodiments, the material of ball 65 "" may be less rigid than the material of distal portion 64 "" of support member 28 "" such that ball 65 "" is capable of being compressed and deformed upon insertion into fluid passage 69 "" through opening 66 "" therein. In some embodiments, upon insertion, the walls of the opening 66 "" and the walls of the fluid passageway 69 "" may expand, while the ball is temporarily compressed and deformed. In some embodiments, ball 65 "" may be made of the same material (e.g., polycarbonate) as the rest of support member 28 "".

In some embodiments, the diameter of ball 65 "" may be greater than the diameter of fluid passageway 69 "", so that frictional forces generated by fluid passageway 69 "" squeezing ball 65 "" secure ball 65 "" in place during operation. Depending on the material selected, the walls of ball 65 "" and/or fluid passage 69 "" may be compressed or otherwise bent to continuously create frictional forces that hold ball 65 "" in place. In some embodiments, fluid passage 69 "" may include a groove 67 "" for receiving ball 65 "". Groove 67 "" may be shaped like at least a portion of the surface of ball 65 "" and may have a diameter equal to or slightly less than the diameter of ball 65 "". Once ball 65 "" is inserted at a point in groove 67 "" into which it "snaps," ball 65 "" may remain substantially at that point. The fluid diverter 65 "" may have a smooth, rounded, curved, and/or gradually changing shape to substantially avoid or reduce abrupt angular changes in fluid flow and the consequent rush and/or damage to the fluid being transported, particularly blood cells.

As seen in fig. 26C, in operation, fluid may flow from a syringe or other medical implement connected to the proximal end 162 of the body portion 22 of the connector 20 into the fluid passageway 69 "" of the support member 28 "" through one or more openings 68 "" in the elongate portion 62 "" and into the fluid passageway. Fluid may flow distally through fluid passageway 69 "", until it reaches a fluid diverter (e.g., ball 65 ""). The fluid diverter may cause fluid to flow out of the fluid pathway 69 "" through the opening 86 "" into one or more chambers 88 "". Fluid may re-flow into the fluid passageway 69 "" through the opening 86 "" at the distal end of the fluid shunt. Fluid may then flow out of support member 28 "" via opening 66 "" and through slit 110 of regulator 30 out of the distal end of base member 24. Thus, the fluid diverter can interrupt a generally linear or laminar fluid path between the proximal end and the distal end, yet be generated within the support member 28 "" and can increase the lateral fluid flow through the one or more chambers 88 "" thereby preventing or reducing fluid retention within the one or more chambers 88 "". In some embodiments, the increased fluid flow through one or more chambers 88 "" may prevent or reduce clotting, bacterial growth, or other undesirable effects within connector 20 due to fluid retention. It should be understood that although the operation of connector 20 and support member 28 "" are described in connection with fluid flowing from the proximal end to the distal end of connector 20, if fluid is drawn into the proximal end of connector 20 from the distal end of connector 20 (e.g., when blood is drawn from a patient into syringe 120), the fluid diverter may also divert fluid into one or more chambers 88 "" to increase the fluid flow therein. The fluid diverter may also be used independently of the support member, for example when no support member is present, embodiments may still include a diverter connected to or movable within the housing or another structure.

It should be appreciated that although the fluid diverter of the 65 "" form shown in fig. 26A through 26C has a generally spherical shape, many other shaped fluid diverters may be inserted into the fluid passageway 69 "" to introduce fluid into the one or more chambers 88 "", such as generally flat plates, pyramids, diamonds, or teardrops, for example. Many variations are possible.

Fig. 26D is a sectional view of a support member 28 ""' as another embodiment. In some embodiments, the support member 28 ""' may have any feature, detail, or configuration of the support member 28. Additionally, the support member 28 ""' is operable with the body member 22, the base member 24, the sealing member 26, the regulator 30, without or with only slight modifications to these components. Thus, in some embodiments, the support member 28 ""' may be used interchangeably with the support member 28 without or with only slight modifications to other components comprising the connector 20. Many of the features of the support member 28 ""' shown in fig. 26D may be the same as or similar to the corresponding features of the support member 28.

In some embodiments, the support member 28 "" 'may include a fluid diverter 65 "" integrally formed with the support member 28 ""'. In some embodiments, the fluid diverter 65 "" ' may be injection molded as part of the distal portion 64 "" ' of the support member 28 "" '. The fluid diverter 65 "" 'may be positioned in the fluid passageway 69 ""' such that a portion of the opening 86 "" 'is proximate to the fluid diverter 65 "", and another portion of the opening 86 ""' is distal to the fluid diverter 65 "". Thus, the fluid diverter 65 "" 'may operate in a manner similar to a ball "", directing fluid out of the fluid passageway 69 ""', into one or more chambers 88 "" ', and then from the one or more chambers 88 ""', into the fluid passageway 69 "" 'through the opening 86 ""'. In some embodiments, as shown, the proximal and/or distal ends of the fluid shunt (where the fluid shunt first contacts the fluid flow, depending on the direction of the fluid) may be narrower than the middle portion thereof, such that at least a portion of the fluid flow more gradually tapers from a generally vertical direction to a lateral direction. The increased flow of fluid through the one or more chambers 88 "" caused by the fluid diverter 65 "" may prevent stagnation of fluid in the one or more chambers 88 "" from occurring. In some embodiments, the flow diverter 65 ""' may be generally diamond shaped with rounded corners to divert the flow without sharp turns in the flow.

Fig. 27 and 28 are perspective views of another embodiment of a valve or needle-free connector 220. Fig. 29 and 30 are exploded views of the embodiment of the connector 220 shown in fig. 27. In some embodiments, connector 220 may have the features, details, or configurations of any other connector described herein, including but not limited to connector 20.

There may be a small dead volume within the connector 220 in some embodiments, as compared to the volume of fluid bolus typically administered to a target patient population. Thus, the amount of fluid entering the connector 220 may be approximately equal to the amount of fluid exiting the connector 220. Additionally, the overall equivalent fluid volume of the connector 220 may be very small, such that the volume of fluid flowing through the system to replace a valve fluidly connected to a medical implement (e.g., a syringe) may be very close to or equal to zero. Even in embodiments that include an internal valve mechanism, such as the embodiments shown in fig. 1-6, the valve mechanism may achieve a vortical flow compensation effect while reducing dead band.

As will be described below, the body member 222 and the base member 224 may be joined together to form a rigid housing to substantially enclose the sealing member 226. Body member 222 and base member 224 may be joined together using any suitable method or feature, including but not limited to features described elsewhere herein for joining body member 222 and base member 224.

Referring to fig. 27 to 30, in some embodiments, the connector 220 may include a body member 222, a base member 224, and a sealing member 226. In some embodiments, the body member 222 and the sealing member 226 may be the same as or similar to any other body member or sealing member of the embodiments of the body member 22 and the sealing member 26 or described again. As shown, the proximal end portion 234 of the sealing member 226 is sealably received in an opening 236 formed in the body member 222. In some embodiments, as shown, the proximal end portion 234 of the seal member 226 may have a lip portion 238 (the lip portion 238 may be an annular protrusion) for contacting an inner surface of an opening 236 of the body member 222 to form a seal.

The seal member 226 may also include an annular collar portion 242, similar to the collar portion 42 'of the seal member 26'. In some embodiments, collar portion 242 may interact with an inner surface of body portion 222 (which may have an annular protrusion, one or more lugs, or other protruding features) to limit axial movement of proximal portion 234 of sealing member 226 in the proximal direction. In some embodiments, the body member 222 and the seal member 226 may be provided as: an end surface 246 of the seal member 226 (which end surface 246 may be planar) abuts an end surface 248 of the body member 222 or is coplanar with the end surface 248 of the body member 222 when the seal member 226 is in the closed position. Fig. 27 illustrates the closed position of the sealing member 226. The seal member 226 and the body member 222 may be provided as: when the seal member 226 is in the closed position as described in other embodiments, the end surface 246 may be generally aligned with the end surface 248 of the body member 222.

The seal member 226 may have a resilient body portion 250, the resilient body portion 250 having a plurality of accordion-like structures that allow the seal member 226 to resiliently compress and expand under an axial force acting on the proximal portion 234 of the seal member 226. The body portion 250 may have a generally uniform cross-sectional shape throughout its length (as shown), or the cross-section of the body portion 250 may vary along a portion of its length (not shown), similar to the body portion 50 'of the seal member 26'. The seal member 226 may have any of the other seal member features, dimensions, or other configuration details disclosed herein.

Additionally, as shown in fig. 29, there may be a slit or opening 252 on the proximal end portion 234 of the sealing member 226. The slit 252 of the sealing member 226 may be biased to a closed position to substantially prevent or impede fluid flow through the slit 252 or opening 254 in the sealing member 226. An elongated portion 262 may be received in the opening 254. Additionally, as will be described in detail below, the slit 252 may be opened by retracting the sealing member 226 in a distal direction beyond the elongate portion 262, causing at least a portion of a proximal portion of the elongate portion 262 to penetrate through the slit 252.

Referring to fig. 29, the elongated portion 262 may protrude from the base member 224. In some embodiments, the elongate portion 262 may have any other elongate portion feature or configuration described herein, including but not limited to the elongate portion 62. As shown, the elongate portion 262 may have one or more openings 268. In addition, the elongate portion 262 may have a tapered (or cylindrical) outer surface 270 and a proximal tip portion 272. The proximal tip portion 272 may have a tapered outer surface, which may also be cylindrical.

The proximal tip portion 272 may be configured such that the proximal portion 234 of the sealing member 226 in some embodiments may be retracted relative to the proximal tip portion 272 of the elongate portion 262 without significant tugging or snagging from the support member 28. In some embodiments, the proximal tip portion 272 may have a sharp or rounded tip 274 to pierce the slit 252 formed on the sealing member 226.

The base member 224 may have a male end projection 241, the male end projection 241 forming an opening 237 therethrough, the opening 237 may be in fluid communication with a passageway 269 extending axially through the elongate portion 262 and one or more openings 268 in the elongate portion 262. Additionally, the casing 243 has protrusions 245 or other features for enhancing the gripping of the connector 220, as well as internal threads 247 formed on the inner surface of the casing 243. Base member 224 may meet ANSI standards for medical connectors.

Fig. 31 is a cross-sectional view of the embodiment of connector 220 shown in fig. 27, illustrating sealing member 226 in a first or closed position prior to syringe 120 contacting and opening sealing member 226. Fig. 32 is a cross-sectional view of the embodiment of connector 220 shown in fig. 27, illustrating sealing member 226 in a second or open position after syringe 120 contacts and opens sealing member 226.

The syringe 120 shown in fig. 31 and 32 (and elsewhere in this disclosure) is an example of one type of medical implement that may be used with the connector 220. Of course, the connector 220 may be used with a variety of medical implements and is not limited to syringes 120. The syringe 120 may be any suitable or conventional syringe used in the medical field.

Referring to fig. 31, body member 222 can have an annular ridge or protrusion 260 formed around outer surface 222a of body member 222, adjacent proximal portion 263 of body member 222. Proximal portion 263 may be smooth, generally cylindrical, or may have external threads or threaded features 163 so that connector 220 may be threadably connected with an appropriate medical implement. The inner surface 222b of the body member 222 may be substantially smooth (as shown in fig. 31 and 32). In some embodiments, the inner surface 222b of the body member 222 may include generally axially-distributed, generally linearly-disposed ridges or channels, or other such features, for receiving portions of the sealing member 226 as the sealing member 226 is compressed and expands outwardly against such ridges or channels when the sealing member 226 is opened.

Additionally, the body member 222 may include an internal abutment surface 264 that may interact with a corresponding annular collar portion 242 on the seal member 226. Internal abutment surfaces 264 on the body member 222 and the annular collar portion 242 on the sealing member 226, respectively, may be used to limit movement of the sealing member 226 in a proximal direction relative to the body member 222 (e.g., the direction shown by arrow a6 in fig. 32). In some embodiments, the internal abutment surface 264 on the body member 222 and the annular collar portion 242 on the seal member 226, respectively, may serve to stop the seal member 226 at a location at which the end surface 246 of the seal member 226 may abut or be substantially coplanar with the end surface 248 of the body member 222, thereby preventing the end surface 246 of the seal member 226 from protruding beyond a certain point, such as a region at or near the end surface 248 of the body member 222.

Similar to base member 24, as shown in fig. 29 and 30, base member 224 can include a proximal portion 267 having one or more projections 271 distributed about an outer surface of the proximal portion 267 of base member 224. In addition, the body member 222 may include a distal end portion 275, the distal end portion 275 being formed with an opening 277 extending through the entire body member 222, and one or more channels or grooves 279 formed in the distal end portion 275 of the body member 222. The one or more grooves 279 can be used to receive one or more protrusions 271 on the proximal portion 267 of the base member 224. The protrusions 271 and recesses 275 can serve to substantially prevent rotation of the body member 222 relative to the base member 224, thereby providing a more secure connection between the body member 222 and the base member 224.

As shown in fig. 31 and 32, the body portion 250 of the sealing member 226 may extend into the base member 224. The force with which the resilient sealing member is caused to rebound to the first or closed position depends on a number of factors including the resilience of the material, the shape of the sealing member wall and the length of the sealing member. In some embodiments, the increased length of the body portion 250 of the seal member 226 compared to other seal members disclosed herein may reduce the force to return the seal member 226 to the first position after the syringe or other medical implement is withdrawn, thereby making it easier for the seal member 226 to be disconnected or connected to the syringe or other medical implement. In some embodiments, the length of the body portion 250 in the relaxed state is about 1 to 4 times the length of the proximal portion 234 (including any annular protrusion) of the sealing member 226. In some embodiments, the length of the body portion 250 is about 1.5 to 3 times the length of the proximal portion 234 of the sealing member 226. In some embodiments, the body portion 250 is about at least 2.5 times the length of the proximal portion 234 of the sealing member 226.

The operation of the connector 220 will be described below. Fig. 31 illustrates the position of the assembly including the connector 220 when the sealing member 226 is in a closed position (e.g., when a syringe or other medical implement is connected to the connector 220). In this configuration, the sealing member 226 may be biased toward the closed position, as shown in fig. 31.

Fig. 32 shows the sealing member 226 in an open position after insertion of the syringe 120 connected to the connector 220. As shown in fig. 32, the sleeve 126 of the syringe 120 is pushed against the sealing member 226 with sufficient force to overcome the biasing force of the sealing member 25, in the direction of arrow a7 in fig. 32, to compress the sealing member 226 within the body member 222. When seal member 226 is compressed within body member 222 to a sufficient distance such that end surface 246 of seal member 226 passes through opening 268 in support member 228, passageway 269 is in fluid connection with the interior of syringe 120. When syringe 120 and connector 20 are connected in this manner, sleeve 126 may exert a sufficient force against end surface 246 of sealing member 226 to substantially fluidly seal between sleeve 126 and end surface 246 of sealing member 226 such that all or substantially all of the fluid within syringe 120 and/or exiting syringe 120 flows into passageway 269.

Thus, when the sealing member 226 is in the open position, as shown in fig. 32, the piston 128 of the syringe 120 may be compressed to force fluid into the connection 220. The arrows of fig. 32 illustrate that as fluid is forced out of the syringe 120, fluid may flow into the one or more openings 268 in the support member 228 and through the passageway 269 in the support member 228 and the opening 237 in the base member 224 into any other medical implement connected to the base member 224. When the syringe 120 or other medical implement is removed from the connector 220, the connector 220 may cause the seal member 226 to return to the closed position under the biasing force within the seal member 226.

In the illustrated embodiment, the connector 220 does not include a backflow prevention module, but the connector 220 may include a backflow blocking module, the same as or similar to the backflow blocking module of the connector 20. For example, the connector 220 may include a variable volume chamber and a valve for blocking the back flow of the fluid stream. In some embodiments, the backflow prevention module may include a regulator similar to regulator 30.

Fig. 33 is a distal exploded view of a valve or needle-free connector 320. Fig. 34 is an exploded cross-sectional view of the connector 320 of fig. 33 along its axial centerline. In some embodiments, connector 320 may have any of the features, or details or morphology of any other connector described herein, including but not limited to connector 20.

Referring to fig. 33 and 34, in some embodiments, connector 320 may include a body member 322, a base member 324, a sealing member 326, a support member 328, and a regulator 330, which may be the same as or similar to body member 22, base member 24, sealing member 26, support member 28, and regulator 30 or any other such member described herein. The body member 322 and the base member 324 may be coupled together to form a rigid housing that generally encloses the sealing member 326, the support member 328, and the regulator 330 therein. The body member 322 and the base member 324 may be connected by adhesive, snap fit, sonic welding, or by other suitable means of features, including but not limited to those described herein.

In the illustrated embodiment, the seal member 326 may be configured such that its proximal end region 334 is received within an opening 336 formed in the body member 322. The cooperation of proximal region 334 and opening 336 may form a substantially fluid-tight seal. In some embodiments, the proximal end portion 334 of the seal member 326 may have a lip portion 338 (the lip portion 338 may be an annular protrusion), the lip portion 338 being configured to contact an inner surface of the opening 336 of the body member 322 to provide a removable seal.

The sealing member 326 may also have an annular collar portion 342, which annular collar portion 342 may be similar to the collar portion 42 'of the sealing member 26'. In some embodiments, the collar portion 342 may be spaced distally from the proximal end portion 334 and may have a larger diameter than any other portion of the proximal end portion 334 or than any other portion of the sealing member 326. Collar portion 342 may be disposed such that it contacts an inner surface (which may be an annular protrusion, one or more protrusions, or other protruding feature) of body member 322, thereby limiting axial movement of proximal portion 334 of sealing member 326 in the proximal direction. In some embodiments, the vertical thickness of collar portion 342 may be at least equal to or substantially greater than the wall thickness of sealing member 326, as shown, at other adjacent or adjacent regions, thereby reducing bending or twisting of collar portion 342. In some embodiments, the body member 322 and the sealing member 326 may be arranged such that an end surface 346 (which may be planar) of the sealing member 326 is adjacent to or approximately co-planar with an end surface 348 of the body member 322 when the sealing member 326 is in the closed position. The sealing member 326 and the body member 322 may then be arranged such that the end surface 346 is always aligned with the end surface 348 of the body member 322 when the sealing member 326 is in the closed position.

The seal member 326 may have a resilient body portion 350 having a plurality of rigid segments, regions or O-rings 351 separated by one or more resiliently foldable portions 349 and configured to resiliently compress and expand the seal member 326 when an axial force is applied to the proximal portion 334 of the seal member 326. The body portion 350 may have a substantially uniform cross-sectional shape along its length, or the cross-section of the body portion 350 may vary along at least a portion of its length (as shown). In some embodiments, as shown, the proximal region of the seal member 326 may include a proximal region 334 and a distal region of the seal member 326, the proximal region 334 tapering generally radially inward in a downward or distal direction, and the distal region may taper generally radially outward in a downward or distal direction. The sealing member 326 may have other features, dimensions, or other morphological details of any other sealing member disclosed herein.

Fig. 35 illustrates the sealing member 326 in an open (e.g., compressed) position. In the open and/or closed state, the sealing member 326 may have a foldable area with a wall thickness less than one third or one quarter of the thickness of the wall of the adjacent rigid area. When the sealing member 326 is compressed, the foldable portion 349 may be configured to bend radially outward away from the elongate portion 362 of the support member 328. Foldable portions 349 may be horizontally spaced apart from elongate portion 362 and/or generally disposed such that they do not slidingly contact elongate portion 362 when sealing member 326 is in a collapsed or open state and/or when sealing member 326 is advanced from a closed state to an open state. In some embodiments, at least one, some, or all of the rigid regions, segments, or O-rings 351 are disposed such that they are in contact with the elongated portion 362 as the seal member 326 is slid axially therealong. In some embodiments, substantially less than half of the surface area of the inner surface of the sealing member 326 is in contact with the elongate portion 362 when the sealing member 326 is in the open or compressed state, and/or when the sealing member 326 is progressing from the closed state to the open state. In some embodiments, an inner surface of collar portion 342 (e.g., an inner portion of the sealing member) may be configured to flex radially outward when sealing member 326 is compressed. In some embodiments, the proximal portion 334 of the sealing member 326 may also include one or more O-rings 351 and/or one or more foldable portions 349. In some embodiments, O-ring 351 may protrude radially inward such that when sealing member 326 is in the closed state, foldable portion 349 and/or the inner surface of collar portion 342 do not contact elongate portion 362. As shown in fig. 34, the closed state of the sealing member 326 is illustrated.

In the open position, as depicted in fig. 35, seal member 326 may include at least one radially outwardly extending portion 349 (e.g., between collar portion 342, if present, and proximal end surface 346) at a proximal end thereof, the radially outwardly extending portion 349 having a cross-sectional area (e.g., defined by an outer perimeter) greater than a surface area of proximal end portion 346. The seal member 326 may include at least a first radially outwardly extending portion 353 at its distal end (e.g., between the collar portion 342, if present, and the distal end portion), the radially outwardly extending portion 353 having a cross-sectional area greater than a surface area of the collar 342 and/or the proximal end portion 346. The seal member 326 may include at least a second radially outwardly extending portion 355 at its distal end, the second radially outwardly extending portion 355 having a cross-sectional area that is greater than a cross-sectional area of a portion of the collapsible wall of the seal member 326 adjacent or proximate to, and less than a cross-sectional area of the first radially outwardly extending portion 353 at the distal end. In some embodiments, the sealing member 326 may be free to slide axially on the elongated support member with relatively little frictional resistance because a majority of the inner surface of the sealing member 326 is not in contact with the elongated portion 362. Accordingly, the sealing member 326 may be configured to reduce the likelihood that the sealing member 326 will become inactive or slow when moved away from an open (e.g., compressed) state.

The sealing member 326 may be provided in various other ways. For example, in the illustrated embodiment, sealing member 326 includes a plurality (e.g., 4) of rigid regions or segments, such as O-rings, including a plurality (e.g., 3) of foldable portions 349, although other numbers of rigid regions, rigid segments, or O-rings 351 and/or foldable portions 349 may be used. Also, in some embodiments, foldable portion 349 may be configured to collapse radially inward such that a portion of foldable portion 349 is in contact with elongate portion 362 while other portions of the inner surface of seal member 326 remain out of contact with elongate portion 362.

A slit or opening 352 may be formed on the proximal end portion 334 of the sealing member 326. The sealing member 326 may be configured to bias the slit 352 toward a closed position to substantially prevent or inhibit fluid flow through the slit 352 or opening 354 formed in the sealing member 326. The opening 354 may be configured to be received by the elongated portion 362. The slit 352 may be opened by retracting the sealing member 326 in a distal direction beyond the elongate portion 362, thereby causing at least a portion of the proximal portion of the elongate portion 362 to penetrate into and through the slit 352.

Support member 328 may be the same as or similar to support member 28 and may include, for example, an elongated portion 362 protruding from base portion 360 in a proximal direction and a distal portion 364 protruding from base portion 360 in a distal direction. Distal portion 364 may include an opening 366, which opening 366 may be in fluid communication with a fluid passageway 369 extending axially through distal portion 364, base portion 360, and at least a portion of elongate portion 362. The elongate portion 362 may include one or more openings 368 and an opening 366, the opening 368 being in fluid communication with the fluid passageway 369. Distal portion 364 may include one or more openings 386 in fluid communication with fluid passageway 369. The support member 328 may have any other features, dimensions, or other morphological details of any other support member disclosed herein.

The regulator 330 may be the same as or similar to the regulator 30 and may include, for example, a cylindrical body portion 300, an annular raised proximal portion 302, and a distal portion 308. Distal portion 308 is substantially dome-shaped or hemispherical. The distal portion 308 may have one or more slits 310 formed therein. In some embodiments, the slit 310 may be biased toward a closed state, but may open if a sufficient pressure differential is applied, allowing fluid to flow through the regulator 330, as described elsewhere herein.

The base member 324 may have a male end projection 341 projecting therefrom, the male end projection 341 defining an opening 337 therethrough, the opening 337 may be in fluid communication with a passageway 369 extending axially through the support member 328 and one or more openings 368 in the elongated portion 362. The base member 324 may also include a cover 343, the cover 343 having internal threads formed on an inner surface thereof. The base member may include one or more protrusions 371 located around the outer surface of the proximal portion 367 of the base member 324. In addition, the body member 322 may include one or more channels or grooves 377 formed on the distal end portion 375 thereof. The one or more channels or recesses 377 may be configured to receive the one or more protrusions 371 to substantially prevent rotation of the body member 322 relative to the base member 324. In addition, body member 322 can include an annular channel 383 configured to receive an annular projection 381 formed on a proximal portion 367 of base member 324 to provide a snap-fit connection between body member 322 and base member 324.

The body member 322 may have an annular ridge or projection 359 formed around the outer surface of the body member 322 adjacent the proximal end portion 363 of the body member 322. The proximal portion 363 may be smooth and generally cylindrical, or may have external threads or threaded features such that the connector 320 may be threadably connected with other suitable medical implements. In addition, body member 322 may include an internal abutment surface 365, and the abutment surface 365 may interact with an annular collar portion 342 formed on seal member 326. Abutment surfaces 36 and annular collar portion 34 formed on body member 322 and sealing member 326, respectively, may be used to limit movement of sealing member 326 in a proximal direction relative to body member 322. In some embodiments, abutment surface 364 and annular collar portion 342 formed on body member 322 and sealing member 326, respectively, serve to stop sealing member 326 at a location at which end surface 346 of sealing member 326 may be substantially adjacent to or substantially coplanar with end surface 348 of body member 322, thereby preventing end surface 346 of sealing member 326 from protruding beyond a certain point, such as an area at or adjacent to end surface 348 of body member 322, or preventing end surface 346 of sealing member 326 from protruding more than a predetermined amount (e.g., at least about 1mm) beyond end surface 348 of body member 322.

Fig. 36 and 37 are perspective views of an embodiment of a valve or needle-free connector 420. Fig. 38 and 39 are exploded perspective views of the connector 420. Fig. 40 is an exploded cross-sectional view of the connector 420. In some embodiments, connector 420 may have any of the features or other details or forms of any other connector disclosed herein, including but not limited to connector 20. Connector 420 is particularly well suited for use as an intermediate connector in a fluid flow path between two portions of a patient fluid line or conduit, but may be used for other purposes as shown herein.

Referring to fig. 36-40, in the illustrated embodiment, the connector 420 can include a body member 422, a base member 424, a support member 428, and an adjuster 430, which can be the same as or similar to the body member 22, the base member 24, the support member 28, and the adjuster 30 of the connector 20. In some embodiments, the connector 420 may include a backflow blocking module, while some other features of the connector 20 are omitted. Clearly, the illustrated embodiment may not include a sealing member. As will be described in detail below, in some embodiments, the connector 420 may be connected to a connector that does not include backflow prevention (such as the embodiment shown for connector 220), thereby enabling the connector to add backflow prevention functionality. In some embodiments, the connector 420 may be used directly with a medical implement (e.g., the syringe 120).

The body member 422 may be coupled to the base member 424 to form a housing that may generally enclose the support member 428 and the regulator 430 therein. The body member 422 and the base member 424 may be connected by adhesive, snap fit, sonic welding, or by other suitable means of features, including but not limited to those described herein.

The support member 428 may be the same as or similar to any of the support members disclosed herein, and the support member 428 may include, for example, a base portion 460 and a distal portion 464 protruding in a distal direction from the base portion 460. Distal portion 464 may include an opening 466, and opening 466 may be in fluid communication with a fluid passageway 469 extending axially through distal portion 364 and base portion 460. Base portion 460 may include an opening 468, the opening 468 in fluid communication with fluid passage 469 and opening 466. The distal portion 464 may include one or more openings 486, the openings 486 being in fluid communication with the fluid passage 469. In some embodiments, as shown, the support member 428 may not include an elongated portion.

The regulator 430 may be the same as or similar to any other regulator, valve, or valve member or component disclosed herein. The adjustor 430 may include, for example, a cylindrical body portion 400, an annular raised proximal portion 402, and a distal portion 408. Distal portion 408 may be substantially dome-shaped or hemispherical. The distal portion 408 may have one or more slits 410 formed therein. In some embodiments, the slit 410 may be biased toward a closed state, but may open to allow fluid flow through the regulator 430 if a sufficient pressure differential is applied.

The base member 424 may have a male end projection 441 protruding therefrom, the male end projection 441 defining an opening 437 therethrough, the opening 437 being fluidly communicable with a passage 469 extending axially through the support member 428. The base member 424 may also include a cover 443 having internal threads formed on an inner surface thereof. The base member 424 may include one or more protrusions 471 positioned about an outer surface of the proximal portion 467 of the base member 424. In addition, the body member 422 may include one or more channels or grooves 477 formed in the distal end portion 475 thereof. The one or more channels or grooves 477 may be configured to receive the one or more protrusions 471 so as to substantially prevent rotation of the body member 422 relative to the base member 424. In addition, the body member 422 may include an annular passage 483, the annular passage 483 being configured to receive an annular projection 481 formed on a proximal end portion 467 of the base member 424 to provide a snap-fit connection between the body member 422 and the base member 424.

Body member 422 may have a proximal end portion 463 that may be smooth and generally cylindrical, or may have external threads or threaded features such that connector 420 may be threadably connected with other suitable medical implements, such as connectors lacking a backflow prevention function (as in the embodiment shown for connector 220). An opening 436 may be formed in the proximal end portion 463 of the body member 422. In some embodiments, the connector 420 may not include a sealing member disposed proximate the opening 436.

In some embodiments, the connector 420 may also include a cap 491. The cap may include a closed male protrusion 493 and a shroud 495 surrounding the closed male protrusion 493. The cap 495 may have internal threads formed on an inner surface thereof that are configured to threadably mate with external threads on the proximal end portion 463 of the body member 422. The cap 491 may include gripping features 497 formed on the outer surface of the enclosure 495 to assist in securing or removing the cap 491. Various modifications may also be made. For example, in some embodiments, the cap 491 may not include a closed male protrusion 493.

Fig. 41 is a cross-sectional view of the unmated configuration of the connector 420 and the connector 520 without the backflow prevention function. Fig. 42 is a cross-sectional view of connector 420 and connector 520 in an engaged configuration. Referring now to fig. 41 and 42, the cap 491 can be configured to seal the opening 436 when secured to the proximal end 463 of the body member 422, as shown in fig. 41. In some embodiments, certain portions of the cap (e.g., closed male protrusion 493, annular surface 499 around the base of closed male protrusion 493) may include a sealing gasket (e.g., an O-ring) configured to seal against end surface 448 or other portions of body member 422. In some embodiments, closed male protrusions 493 may extend to openings 436 and may be provided to seal against the inner surface of body member 422.

Connector 520 may be, for example, manufactured by ICU pharmaceuticals of san Clintonia, CalifA connector is provided. Various embodiments of this type of connector are described in U.S. patent 5,685,866, the entire contents of which are incorporated herein by reference. The connector 520 may include, for example, a body member 522, a base member 524, and a sealing member 526. The body member 522 may be connected to the base member 524 to form a housing. The base member 524 may include a male end protrusion 541 and an elongated portion 562. The fluid pathway 569 may extend through the male end protrusion 541 and at least a portion of the elongate portion 562 to one or more apertures 568 formed near the proximal end of the elongate portion 562. The body member 522 may include a cover 543, the cover 543 being arranged such that when the body member 522 and the base member 524 are coupled to each otherWhen attached, around the male end protrusion. The boot may have internal threads formed on an inner surface thereof that are configured to closely mate with external threads formed on the proximal portion 463 of the connector 420. Body member 522 may also include a proximal end 563 having external threads such that connector 520 may be threadably coupled to other suitable medical implements (e.g., syringes).

The sealing member 526 may be positioned such that it surrounds at least a portion of the elongate portion 562. The sealing member 526 may be the same as or similar to the sealing member 26 or any other sealing member disclosed herein. In some embodiments, the sealing member 562 may be configured to resiliently compress when a medical implement is coupled to the proximal end 563 of the connector 520, thereby exposing one or more apertures 568 in the elongate portion 562 to open a fluid connection between the fluid pathway 569 and the medical implement.

In some embodiments, the connector 520 does not have a backflow prevention function, such that if the connector 520 is not connected to the connector 420, the connector 520 may experience a degree of fluid backflow upon syringe bounce, medical implement disconnection, or other backflow-inducing event. The connector 420 may include a backflow prevention module that may be formed by various components of the connector 420, such as the regulator 430, the support member 428, and the like. In some cases, connector 420 may be connected to connector 520 (as shown in fig. 42) to add a backflow prevention function to connector 520. Thus, when the connector 520 is connected to the connector 420, the backflow prevention module may function substantially as described elsewhere herein, preventing fluid from flowing back out of the connector 520 in the event of a syringe bounce, or other backflow-inducing event. It is understood that the connector 520 may be any of a variety of other connector types. Thus, the connector 420 may be used to add backflow prevention functionality to a variety of connector types that may provide a variety of different features.

In some cases, connector 420 may remain connected to connector 520 throughout the period of use of connector 520, such that connectors 420 and 520 may be considered a single connector once connected. In some embodiments, connector 420 may be connected to connector 520 prior to packaging or sale to a user. In some embodiments, connector 420 may be permanently connected to connector 520 (e.g., using plastic welding or the like) prior to packaging or sale to a user. In some embodiments, the connector 420 may lack the cap 491. For example, if connector 420 is sold pre-connected to connector 520, cap 491 is absent. Likewise, the connector 420 without the cap 491 may be packaged in sterile packaging designed to be opened directly prior to connection of the connector 420 to the connector 520.

In some cases, a medical implement, such as a syringe, may be connected directly to proximal portion 463 of connector 420 without connector 520 therebetween. However, in some embodiments, the connector 420 does not include a resilient sealing member (e.g., sealing member 526) to reseal the opening 436 after each removal of the medical implement. In this way, using a connector 420 without a connection connector 520 may have advantages, for example, when connecting a medical implement to the connector 420 only once or a relatively small number of times. In some embodiments, the cap 491 may be used to seal the proximal end portion 463 after removal of the medical implement. In some embodiments, a new, sterile cap may be used.

Fig. 43 is a perspective view of the regulator 630. Fig. 44 is a sectional view of the regulator 630 shown in fig. 43 taken along the axial center thereof. The adjuster 630 may include a body portion 600, and the body portion 600 may be, for example, substantially cylindrical. The proximal portion 602 of the adjustor 630 can include an annular raised lip 603 and an opening 604 therethrough. The distal portion 608 may include an inner annular protrusion 612 and an opening therethrough. In some embodiments, as shown, the regulator 630 does not include a closure portion (e.g., the distal portion 108 of the regulator 30 and the slit 110). Thus, in some embodiments, the fluid path through regulator 630 is always open.

Fig. 45 is a cross-sectional view of a valve or needle-free connector 620 configured for use with the regulator 630 shown in fig. 43. In some embodiments, connector 620 may have any of the features or other details or forms of any of the other connectors disclosed herein. In some embodiments, the connector 620 may include a body member 622, a base member 624, a sealing member 626, a support member 628, and a regulator 630, which may be the same as or similar to, for example, the body member 22, the base member 24, the sealing member 26, the support member 28, and the regulator 30 of the connector 20.

The regulator 630, or at least a portion thereof, may be constructed of one or a combination of various suitable materials, including but not limited to rubber, silicon-based deformable materials, etc., such that the body portion 600 of the regulator 630 may deflect inwardly, reducing the volume of the annular cavity 688 to counteract syringe bounce or other back flow inducing events. In some embodiments, the regulator 630 may be configured such that it requires less force to deflect the body portion 600 of the regulator 630 inwardly, thereby reducing the volume of the annular cavity 688, as compared to the force required to draw a similar volume of fluid from the patient to the connector 620. In this manner, if a syringe bounce or other reflux inducing event occurs, the body portion of the regulator 630 may collapse, reducing the volume of the annular cavity 688, expelling fluid to counteract the vacuum, thereby preventing or delaying reflux.

Fig. 46 is a perspective view of an embodiment of a valve member 730. Fig. 47 is a cross-sectional view of the valve member 730 shown in fig. 46. The valve member 730 may include a proximal portion 702, the proximal portion 702 including an inner annular protrusion 712 and an opening 704 therethrough. The valve member 730 may also include a distal portion 708, which distal portion 708 may be substantially dome-shaped or hemispherical, and may include one or more slits 710. Similar to the regulator 30, the valve member 730 may be configured to remain closed and prevent fluid flow until a pressure threshold is reached at which the slit 710 in the valve member 730 may open to allow fluid flow. In some embodiments, the valve member 730 may be configured to require a greater force to open the valve member 730 in a first direction (e.g., in the a2 direction) than in a second direction (e.g., in the a1 direction).

Fig. 48 is a cross-sectional view of a valve or needleless connector 720 configured for use with the valve member 730 of fig. 46. In some embodiments, the connector 720 may have any of the features or other details or forms of any of the other connectors disclosed herein. In some embodiments, the connector 720 may include a body member 722, a base member 724, a sealing member 726, a support member 728, and a valve member 730, which may be the same or similar to the body member 22, the base member 24, the sealing member 26, the support member 28, and the regulator 30 of the connector 20.

The valve member 730 may be placed on the distal portion 764 of the support member 728 such that the inner annular protrusion 712 is received within the channel 796 formed between the annular protrusions 790 and 794 to secure the valve member 730 to the support member 728.

In some embodiments as shown, the connector 720 may not include a variable volume chamber (e.g., annular chamber 88). In these embodiments, the valve member 730 can be configured to more strictly prevent backflow because there is no variable volume chamber to relieve pressure due to syringe bounce or other backflow-inducing events. For example, in some embodiments, the fluid pressure acting on the outer surface 708b of the valve member 730 may be between about 1.0 atmosphere and 2.0 atmospheres greater than the fluid pressure acting on the inner surface 708a of the valve member 730 for opening the valve member 730 in the a2 direction, which allows fluid flow. The valve member 730 may be modified in different ways to increase the threshold pressure required to open the valve member for fluid flow in the a2 direction. For example, the curvature, thickness, or material of the dome-shaped distal portion 708 may be altered to adjust the reflux threshold pressure. Likewise, the number or direction of the slits 710 may also be altered to adjust the reflow threshold pressure.

Fig. 49 illustrates a cross-sectional view of a valve or needleless connector 820 configured for use with the regulator 630 of fig. 43 and the valve member 730 of fig. 46. In some embodiments, the connector 820 may have any of the features or other details or forms of any other connector disclosed herein. In some embodiments, connector 820 may include a body member 822, a base member 824, a seal member 826, a support member 828, a regulator 630, and a valve member 730, which may be the same as or similar to, for example, body member 22, base member 24, seal member 26, support member 28, and regulator 30 of connector 20.

In some embodiments, support member 828 may include a first channel 896a formed between annular protrusions 890 and 894a, and a second channel 896b formed between annular protrusions 894a and 894 b. When assembled, the regulator 630 and valve member 730 can be placed on the distal portion 864 of the support member 828. The inner annular projection 612 of the regulator 630 may be received within the passage 896a and the inner annular projection of the valve member 730 may be received within the passage 896b, thereby preventing axial movement of the regulator 630 and the valve member 730 relative to the support member 828. In some embodiments, connector 820 functions similarly to connector 20 except for the variable volume chamber and backflow prevention valve provided by regulator 630 and valve member 730, respectively.

Fig. 50A is a cross-sectional view of base member 924. Base member 924 is similar in some respects to base member 24. The base member 924 may include a male end projection 941 that includes an opening 937 therethrough in fluid communication with the cavity 921 formed in the base member 924. The cavity 921 may have an annular recess 923 located between the annular step 925 and the annular projection 927. Holes 929 extending through the wall of the base member 924 can provide access to the annular recess 923 so that air can flow into or out of the annular recess 923 from outside of the base member 924 through the holes 929.

Fig. 50B illustrates a cross-sectional view of an embodiment of a valve or needle-free connector 920 using the base member 924 shown in fig. 50A. In some embodiments, the connector 920 may have any of the features or other details or forms of any other connector disclosed herein. In some embodiments, the connector 920 may include a body member 922, a base member 924, a sealing member 926, a support member 928, and an adjuster 930, which may be the same or similar to, for example, the body member 22, the base member 24, the sealing member 26, the support member 28, and the adjuster 30 of the connector 20.

In some embodiments of connector 920, the variable volume chamber may be configured to expand when fluid is injected into connector 920 from a medical implement (e.g., a syringe). The variable volume chamber may be configured to return to its natural, unexpanded volume, or to a volume less than its natural volume to counteract syringe bounce or other reflux inducing events and prevent reflux.

The adjuster 930 may be disposed on the distal end portion 964 of the support member 928, defining an annular cavity 988 between the two annular projections 990 and 992 of the support member 928. The inner annular protrusion 912 of the adjuster 930 may be received within a channel 996 formed between the annular protrusions 990 and 994 to secure the adjuster 930 to the support member 928. The annular raised portion 903 of the adjuster 930 may be secured between the base portion 960 of the support member 928 and the upper surface of the annular projection 927 of the base member 924, sealing the top of the annular recess 923. In some embodiments, the annular protrusion 90 may press the wall of the regulator 930 against the inner wall of the cavity 921 below the annular step 925 to form an air seal. In this way, air entering the annular recess 923 through the holes 929 is prevented from entering other components of the connector 920 or entering the fluid stream as bubbles (which can create a serious health risk to the patient).

In some embodiments, when pressure is applied to the inner surface of the body member 900, such as when injecting fluid from a medical implement (e.g., a syringe) into the connector 920, the body portion 900 of the regulator 930 may be configured to flex outwardly into the annular recess 923, thereby increasing the volume of the annular cavity 988. In some embodiments, the force required to expand the volume of the toroidal cavity 988 is less than the force required to open the slit 910 on the regulator 930 to allow fluid flow in the distal direction. Thus, as fluid is injected into the connector 920 from a medical implement (e.g., a syringe), the annular cavity 988 expands until the force required to further expand the annular cavity 988 is greater than the force required to open the regulator 930 for fluid flow in the distal direction, at which point the regulator 930 opens and fluid is pushed into the distal end of the connector 920. When a syringe bounce, or other reflux inducing event, occurs, the body portion 900 of the regulator 930 can return to its unexpanded position, reducing the volume of the annular cavity 988, counteracting the vacuum, and preventing reflux from occurring. In some cases, the volume of the annular cavity 988 may be reduced beyond its natural, unexpanded volume by bending the body portion 900 of the regulator 930 inwardly into the annular cavity 988, thereby providing additional vacuum cancellation. In some embodiments, the main body portion 900 of the regulator 930 is expandable upon expansion such that the main body portion 900 contains an amount of potential energy in its expanded state. In some embodiments, this potential energy is insufficient to cause side effects, such as raising the plunger of the syringe, or opening the slit of the regulator 930.

In some embodiments, the connector 920 may be configured such that when the body portion 900 is in the unexpanded state, the body portion 900 of the valve body 930 is disposed substantially against the distal end portion 964 of the support member 928. In this embodiment, when body portion 900 is in an unexpanded state, annular cavity 988 is not present. As fluid is injected into the connector 920, the main body portion 900 may expand outward into the annular recess 923. To prevent backflow, the body portion 900 may return to its unexpanded state, but may not flex inward to further reduce the volume of the connector 920. In some embodiments, the distal end portion 964 of the support member 928 may be thicker than shown in fig. 50B, such that the annular cavity 988 is not formed between the annular protrusions 990 and 992, and the body portion 900 of the adjuster 930 may abut against the distal end portion 996 of the support member 928.

In some embodiments, the base member 924 may not include the hole 929, and the annular recess 923 may be filled with a compressible fluid, such as air or other gas. In this way, when the body portion 900 is flexed, the compressible fluid can expand or compress as desired, thereby increasing or decreasing the volume of the annular recess 923.

Fig. 51 is a perspective view of an embodiment of regulator 1030. Regulator 1030 may be similar in some respects to regulator 30 or any other regulator or valve member disclosed herein. In some embodiments, adjuster 1030 includes body portion 1000, proximal portion 1002, and distal portion 1008. The proximal portion 1002 may include an annular raised lip 1003 and an opening 1004 therethrough. The distal portion 1008 may be substantially dome-shaped or semi-spherical and may include a single slit 1010 therethrough. The single slot 1010 may be formed in a variety of different sizes. In some embodiments, the width of the single slot 1010 may be equal to or less than the width of the opening 1004. Slit 1010 may be formed symmetrically or asymmetrically on distal portion 1008 of adjuster 1030.

Figure 52 is a perspective view of an embodiment of an adjuster 1130. The regulator 1130 may be similar in some respects to the regulator 30 or any other regulator or valve member disclosed herein. In some embodiments, the adjustor 1130 comprises a body portion 1100, a proximal portion 1102, and a distal portion 1108. The proximal portion 1102 can include an annular raised lip 1103 and an opening 1104 therethrough. In some embodiments, the distal portion 1108 may be substantially dome-shaped or hemispherical, and may include a plurality of slits 1110 (e.g., 5, as shown). Each slit 1110 may meet at a central point of the distal portion 1108 of the adjuster 1130 and extend radially outward along the distal portion 1108. In some embodiments, a different number of slits may be used, such as, but not limited to, 3 slits, 6 slits, 7 slits, and the like. The number of slots may be selected based on the desired cracking pressure of the regulator 1130. Generally, a greater number of slits will produce a lower cracking pressure, which makes it easier to open the regulator 1130 for fluid to flow through.

Fig. 53 is a perspective view of an embodiment of an adjuster 1230. Fig. 54 is a cross-sectional view of the adjuster 1230 along its axial centerline in a first plane. Fig. 55 is a cross-sectional view of adjuster 1230 along its axial centerline in a second plane orthogonal to the first plane. Regulator 1230 may be similar in some respects to regulator 30 or any other regulator or valve member disclosed herein. In some embodiments, the adjuster 1230 includes a body portion 1200, a proximal portion 1202, and a distal portion 1208. The proximal portion 1202 may include an annular raised lip 1203 and an opening 1204 therethrough. In some embodiments, distal portion 1208 may be substantially dome-shaped or hemispherical and may include a slit 1210. In some embodiments, a beam 1209 (shown in phantom in FIG. 53) is formed on each side of the slot 1209 through which the slot 1209 passes. The beam 1209 can serve to increase the wall thickness of the regulator over at least a portion of the width of the slot 1210, thereby increasing the cracking pressure required to open the regulator 1230.

In some embodiments, the beam 1209 may be centered on the axial centerline of the adjuster 1230. Referring to fig. 54, in some embodiments, the width of the beam 1209 (represented by "WB" in fig. 54) may be smaller than the width defined by the slot 1210 (represented by "WS" in fig. 54). In some embodiments, the width WB of the beam may extend the entire length of the width WS of the slot 1210, or beyond the width WS of the slot 1210. In some embodiments, multiple beams may be used to achieve the desired opening pressure for regulator 1230.

Fig. 56 is a perspective view of check valve member 1330. In some embodiments, valve member 1330 may be generally disk-shaped and include a channel 1301 formed in one side thereof. The passage 1301 may pass through the center of the valve member 1330. Valve member 1330 may be constructed of a deformable, resilient material, such as a silicon-based deformable material, rubber, or the like. The valve member 1330 may be constructed of a material capable of forming a fluid tight seal with a plastic or other rigid material.

Fig. 57 is a cross-sectional view of a valve or needleless connector 1320 configured for use with the valve member 1330 shown in fig. 56. In some embodiments, connector 1320 may have any of the features or other details or forms of any other connector disclosed herein. In some embodiments, connector 1320 may include body member 1322, base member 1324, sealing member 1326, support member 1328, regulator 630, and valve member 1330, which may be the same as or similar to, for example, body member 22, base member 24, sealing member 26, support member 28, and regulator 30 of connector 20.

Base member 1324 may include a cavity 1329 and a beam 1319, with beam 1319 extending over at least a portion of cavity 1329. Valve member 1330 can be placed on beam 1319 such that beam 1319 can be received in channel 1301 on valve member 1330. The support member 1328 can be positioned with the distal surface of the annular protrusion 1394 in contact with the proximal surface of the valve member 1330. In some embodiments, the support member 1328 can force the valve member 1330 to bend slightly so that the resilient force of the valve member 1330 forms an annular seal against the distal surface of the annular protrusion 1394.

Fig. 58 illustrates a cross-sectional view of the connector 1320 shown in fig. 57, with the valve member 1330 in the open configuration and fluid injected through the connector 1320. Fluid may be injected into connector 1320 from syringe 120 or other medical implement. Fluid may enter the valve member 1330 through a fluid passage 1369 in the support member 1328. When the pressure in fluid passage 1369 is sufficiently greater than the pressure in chamber 1321, valve member 1330 will flex away from support member 1328, breaking the seal, allowing fluid to flow into chamber 1321 and out of connector 1320 through male end protrusion 1341. When the pressure drops (e.g., when fluid is no longer being injected), the valve member 1330 resiliently returns to its closed position (as shown in FIG. 57), forming a seal against the support member 1328.

In the event of a syringe bounce or other backflow-inducing event, the pressure differential may cause the valve member 1330 to press more tightly against the support member 1328, thereby preventing backflow. In some embodiments, connector 1320 may include an adjuster 630 (as discussed in fig. 43-45). The regulator 630 may be configured to flex inwardly to reduce the volume of the annular cavity 1388 to mitigate pressure differentials due to syringe bounce or other backflow inducing events. In some embodiments, the valve member 1330 may be a check valve or one-way valve that may substantially prevent fluid flow in the proximal direction. Thus, in some embodiments, the regulator 630 to provide a variable volume chamber is not required to prevent backflow. However, in some embodiments, such as the embodiment shown in fig. 57 and 58, a regulator 630 may be included so that the variable volume chamber may reduce volume to relieve pressure due to syringe bounce or other back flow inducing events.

Various other types of check valves may also be used to prevent backflow. For example, fig. 59 is a perspective view of a regulator 1430 including a generally flat, tapered, closed valve, such as a duckbill check valve 1405. Fig. 60 is a cross-sectional view of the regulator of fig. 59. Regulator 1430 may be similar to regulator 30 or any other regulator or valve member disclosed herein. In some embodiments, the adjuster 1430 may include a body portion 1400, a proximal portion 1402, and a distal portion 1408. Proximal portion 1402 may include an annular raised lip 1403 and an opening 1404 therethrough. The distal portion 1408 may include a duckbill check valve 1405 formed by two resilient, generally flat, tapered surfaces or mouths 1407a, 1407b, the two surfaces 1407a and 1407b meeting to form an elongated slit 1410, the elongated slit 1410 extending in a generally transverse direction, entirely or approximately entirely distally. The adjuster 1430 may also include an inner annular protrusion 1412. Many variations are possible. For example, in some embodiments, the check valve 1405 and the body portion 1400 of the regulator may be formed separately.

Fig. 61 is a cross-sectional view of a valve or needle-free connector 1420, the connector 1420 including an adjuster 1430 in a closed configuration. Fig. 62 is a cross-sectional view of the connector 1420 with the regulator 1430 in the open configuration and fluid injected through the connector 1420. In some embodiments, connector 1420 may have any feature or other detail or form of any other connector disclosed herein. In some embodiments, the connector 1420 may include a body member 1422, a base member 1424, a seal member 1426, a support member 1428, an adjuster 1430, which may be the same or similar to, for example, the body member 22, the base member 24, the seal member 26, the support member 28, and the adjuster 30 of the connector 20. Like the adjustor 30, the adjustor 1430 can be disposed on a distal portion 1464 of the support member 1428.

When fluid is injected into connector 1420 from a medical implement (e.g., syringe 120), the fluid may flow into duckbill check valve 1405 through fluid passageway 1469. The pressure differential due to the inflow of fluid separates the mouths 1407a and 1407b on the duckbill check valve 1405, thereby opening the slit 1410 and allowing fluid to flow through the duckbill check valve 1405 and out of the connector 1420 via the male end protrusion 1441.

In the event of an injector bounce or other back flow inducing event, the resulting pressure differential may cause the mouths 1407a, 1407b of duckbill check valve 1405 to squeeze tightly against one another, preventing back flow of fluid. In some embodiments, the body portion 1400 of the regulator 1430 may be bent inward to reduce the volume of the connector, thereby relieving some of the pressure caused by syringe bounce or other retrograde inducing events. In some embodiments, a duckbill check valve 1405 may be disposed to substantially prevent the flow of fluid in a distal direction. Thus, in some embodiments, connector 1420 may include a duckbill check valve 1405, but omitting the body portion 1400 that may provide the variable volume chamber.

In some embodiments, the backflow prevention valve is not a check valve or one-way valve that substantially prevents backflow. Rather, the backflow prevention valve may not prevent backflow until a certain threshold pressure differential is reached, at which the backflow prevention valve opens to allow backflow to occur. In some embodiments, the backflow prevention valve may be configured such that the threshold pressure differential is sufficiently high to prevent unintended backflow, such as caused by syringe bounce or withdrawal of a medical implement; but is made low enough to allow intentional flashback, such as flashback caused when a fluid (e.g., blood) is drawn into the syringe through the connector. In some embodiments, the regulator 30 may provide a two-way backflow prevention valve, as described in detail elsewhere herein. Other two-way backflow prevention valves may also be used.

FIG. 63 is a perspective view of an embodiment of a regulator 1530 that can function to control fluid flow and/or mitigate the effects of pressure differentials using moving wall portions. In some embodiments, the moving wall portion may be generally flat, generally horizontal as shown. In some embodiments, regulator 1530 may function as a two-way back flow check valve, as described in more detail below. Regulator 1530 may include a resilient body portion 1500, a proximal moving wall or plug portion 1508, and a distal connector portion 1502. The distal connector portion 1502 may include a hole 1504 therethrough. The proximal end wall or plug portion 1508 may be generally disc-shaped and may include an annular tapered or circular edge 1510 extending around the circumference of the plug portion 1508. In some embodiments, the wall or plug portion 1508 may be made of a resilient material, as shown, and in some embodiments, the wall or plug portion 1508 may be rigid or substantially rigid. Resilient body portion 1500 may connect plug portion 1508 to connector portion 1502. In some embodiments, the resilient body portion 1500 may include one or more generally transverse, generally horizontal grooves, such as made from a series of stacked O-rings, to assist in compression. In some embodiments, the elastic body portion 1500 may include a spring or other member that returns the elastic body portion 1500 to its original state after being stretched or compressed. Regulator 1530 may be constructed from a variety of different suitable materials including silicon-based deformable materials, rubber, or other suitable materials. In some embodiments, regulator 1530, or other portion thereof, may be constructed of a material capable of forming a fluid tight seal with a plastic or other rigid material.

Fig. 64 is a cross-sectional view of a valve or needle-free connector 1520 that includes connector 1530 in a relaxed position. In some embodiments, connector 1520 may have any feature or other detail or form of any other connector disclosed herein. In some embodiments, connector 1520 may include a body member 1522, a base member 1524, a sealing member 1526, a support member 1528, a regulator 630, and a regulator 1530, which may be the same as or similar to, for example, body member 22, base member 24, sealing member 26, support member 28, and regulator 30 of connector 20.

In some embodiments, the base member 1524 includes a cavity 1521 therein, and a support beam 1519 extending within the cavity 1521 or through the cavity 1521. The connector portion 1502 may be configured to secure the regulator 1530 to the support beam 1519, wherein the support beam 1519 extends through the opening 1504 within the connector portion 1502. For example, in some embodiments, the base member 1524 may be constructed from two pieces that are separated along its axial centerline. Regulator 1530 may be attached to one piece of base member 1524 and then the two pieces of base member may be attached to each other by snap-fitting, plastic welding, sonic welding, etc. to form base member 1524 with regulator 1530 secured thereto. The regulator 1530 may also be secured to the connector in various other ways. For example, in some embodiments, a portion of regulator 1530 may be disposed between two other components of connector 1520 (e.g., base member 1524 and support member 1528), thereby providing a friction or pressure fit that secures regulator 1530 in place.

The cavity 1521 may include an annular ridge 1523, the ridge 1523 having a lower tapered surface 1525 and an upper tapered surface 1527. In some embodiments, the surface between the upper tapered surface 1527 and the lower tapered surface 1525 may be substantially cylindrical. The plug portion 1508 of the regulator 1530 may be located opposite the annular ridge 1523 when the resilient body portion 1500 is in a relaxed or initial state. In some embodiments, the annular ridge 1523 tightly compresses the annular tapered edge of the plug portion 1508, thereby forming a substantially liquid-tight annular seal between the plug portion 1508 and the ridge 1523.

FIG. 65 is a cross-sectional view of connector 1520 with regulator 1530 in the open position and fluid injected through connector 1520 in the distal direction. As fluid is injected into the connector 1520 from a medical implement (e.g., syringe 120), the fluid may enter the upper portion of the cavity 1521 through the fluid passageway 1569 formed in the support member 1528 until the fluid contacts the upper surface of the plug portion 1508 of the regulator 1530. The pressure differential may cause the resilient body portion 1500 to compress, lowering the plug portion 1508 until it disengages the annular ridge 1523, thereby breaking the annular seal, allowing fluid to flow around the regulator 1530 and out the male end projection 1541 of the connector 1520. When the pressure drops (e.g., when fluid is no longer being injected into the connector 1520), the resilient body portion 1500 of the regulator 1530 may return to its relaxed state (shown in fig. 64), re-engaging the annular seal between the plug portion 1508 and the annular ridge 1523.

Fig. 66 is a cross-sectional view of connector 1520 with regulator 630 in an open position and fluid drawn in a proximal direction through connector 1520. In the event of a syringe bounce or other reflux inducing event, the resulting pressure differential may collapse the regulator 630 (as shown in fig. 66), thereby reducing the volume of the variable volume chamber and relieving the pressure due to the reflux inducing event. In some embodiments, regulator 1530 may be empty or sufficiently resilient to provide both a valve function and a pressure-counteracting function by changing its volume in response to pressure changes. In some embodiments, the force required to fold regulator 630 is less than the force required to stretch elastic body member 1500 of regulator 1530. As such, when regulator 630 is folded, plug portion 1508 of regulator 1530 may remain substantially undeformed, such that fluid at the distal end of plug portion 1508 is substantially unaffected by the vacuum due to the backflow-inducing event, thereby generally completely preventing backflow of fluid.

In some embodiments, additional pressure may be applied after regulator 630 has collapsed (e.g., intentionally removing the piston of syringe 120). The additional pressure may expand the resilient body portion 1500 of the regulator 1530 such that the plug portion 1508 slides axially over the annular ridge 1523. If sufficient pressure is applied, the plug portion 1508 may disengage from the annular ridge 1523 and allow fluid to flow in a proximal direction through the connector 1520, as shown in FIG. 66. In some embodiments, the regulator 1530 may be configured such that the force required to stretch the elastic body portion 1500 such that it is sufficient to open the regulator 1530 for fluid flow in the proximal direction is greater than the force required to compress the elastic body portion 1500 such that it is sufficient to open the regulator 1530 for fluid flow in the distal direction. In some embodiments, when the resilient body portion 1500 is in a relaxed state, the plug portion 1508 is located closer to the lower tapered surface 1525 than the upper tapered surface 1527.

In some embodiments, the thickness (e.g., in the vertical direction) of the annular ridge 1523 may be substantially greater than in the illustrated embodiment, thereby allowing the plug portion or wall 1508 to move a greater distance in each direction before opening the valve that allows fluid flow. For example, in some embodiments, the thickness of the annular ridge 1523 or other connecting structure may be at least about 2 to 3 times the thickness of the plug portion or wall 1508 that moves therealong. The annular ridge 1523 or other connecting structure may include a protrusion, catch or other interference structure (not shown) to limit movement of the wall or plug portion on the distal and/or proximal ends. In some embodiments, this arrangement may form a one-way valve.

Fig. 67 is a perspective view of the adjuster 1730. Fig. 68 is a cross-sectional view of the adjuster 1730 shown in fig. 67, taken along its axial centerline. Referring to fig. 67 and 68, the adjuster 1730 may include a body portion 1700, a proximal portion 1702, and a distal portion 1708. The proximal portion may include an annular raised lip 1703 and an opening 1704 therethrough. The distal portion 1708 may include a concave central portion 1705 and a tapered annular wall 1706. One or more apertures 1710 may be formed through the tapered annular wall 1706. The adjuster 1730 may also include an inner annular protrusion 1712. The adjuster 1730 may be constructed of many different suitable materials including silicon-based deformable materials, rubber, or other suitable materials. In some embodiments, the regulator 1730, or other portion thereof, may be constructed of a material capable of forming a fluid-tight seal with a plastic or other rigid material.

Fig. 69 is a cross-sectional view of a valve or needle-free connector 1720 that includes a valve 1730 as shown in fig. 67 and 68. Fig. 69 illustrates regulator 1730 in an initial or relaxed (closed) state. In some embodiments, connector 1720 may have any feature or other detail or form of any other connector disclosed herein. In some embodiments, connector 1720 may include a body member 1722, a base member 1724, a sealing member 1726, a support member 1728, and an adjuster 1730, which may be the same or similar to, for example, body member 22, base member 24, sealing member 26, support member 28, and adjuster 30 of connector 20.

The adjuster 1730 may be disposed on the distal portion 1764 of the support member 1728 defining an annular cavity 1788 between the two annular protrusions 1790 and 1792 of the support member 1728. The inner annular protrusion 1712 of the adjuster 1730 can be received within the channel 1796 formed between the annular protrusions 1790 and 1794 to secure the adjuster 1730 to the support member 1728. In some embodiments, the distal portion 1764 of the support member 1728 may be configured to receive the distal portion 1708 of the adjuster 1730. The support member 1728 can include a tapered inner surface 1765 located adjacent a distal opening 1766, the distal opening 1766 configured to receive the tapered annular wall 1706 to form a fluid-tight seal when the distal portion 1708 of the adjuster 1730 is in the relaxed position. When the adjuster 1730 is in the relaxed position shown in fig. 69, the aperture 1710 formed in the tapered annular wall 1706 may be covered by a tapered inner surface 1765 of the support member 1728 such that fluid cannot flow in through the aperture 1765.

Fig. 70 is a partial cross-sectional view of connector 1720 with regulator 1730 in an open position and fluid injected in a distal direction through connector 1720. As fluid is injected into the connector 1720 from a medical implement (e.g., a syringe), the fluid may pass through the fluid passageway 1769 formed within the support member 1728 until the fluid contacts the surface of the recessed central portion 1705 of the regulator 1730. The pressure differential may cause the distal portion 1708 of the adjuster 1730 to bend distally away from the support member 1728 until the tapered annular wall 1706 of the adjuster 1730 disengages from the inner tapered wall 1765 of the support member 1728, thereby breaking the annular seal and allowing fluid to flow through the aperture 1710 in the adjuster 1730 and out the male end protrusion 1741 of the connector 1720. When the pressure drops (e.g., when fluid is no longer being injected into the connector 1720), the resilient distal portion 1708 of the adjuster 1730 can return to its initial or relaxed state (as shown in fig. 69), such that the tapered annular wall 1706 re-engages and seals against the inner tapered surface 1765 of the support member 1728.

Fig. 71 is a partial cross-sectional view of connector 1720 with actuator 1730 in an open position and fluid drawn through connector 1720 in a proximal direction. In the event of a backflow-inducing event, the resulting pressure differential may collapse the body portion 1700 of the regulator 1730 (as shown in fig. 71), thereby reducing the volume of the annular chamber 1788 and relieving the pressure due to syringe bounce or other backflow-inducing events. In some embodiments, the force required to collapse the body portion 1700 of the adjuster 1730 is less than the force required to stretch the annular tapered wall 1706 of the adjuster 1730. In this manner, the recessed central portion 1705 of the regulator 1730 may remain substantially unaffected as the body portion 1700 of the regulator 1730 collapses or changes volume, such that fluid at the distal end of the regulator 1730 is substantially unaffected by the vacuum due to syringe bounce or other retrograde inducing events, thereby preventing fluid backflow.

In some embodiments, additional pressure may be applied after the body portion 1700 of the regulator 1730 has been collapsed (e.g., by intentionally withdrawing the plunger of the syringe). The additional pressure differential may cause the concave central portion 1705 to be drawn proximally into the fluid passageways 1769 of the support member 1728, thereby stretching the tapered annular wall 1706. If sufficient pressure is applied, the aperture 1710 formed in the tapered annular wall 1706 may be exposed to fluid flow in a proximal direction through the aperture 1710 in the regulator 1730, as shown in FIG. 71. In some embodiments, the adjuster 1730 may be configured to stretch the tapered annular wall 1706 such that it is sufficient to expose the aperture 1710 for fluid flow in a proximal direction, more than the force required to disengage the tapered annular wall 1706 from the inner tapered wall 1765 of the support member 1728 for fluid flow in a distal direction.

Fig. 72 is a cross-sectional view of a valve or needle-free connector 1820. In some embodiments, the connector 1820 may have any of the features or other details or forms of any of the other connectors disclosed herein. In some embodiments, connector 1820 may include a body member 1822, a base member 1824, a sealing member 1826, a support member 1828, a valve member 730, and a balloon member 1830, which may be the same as or similar to body member 22, base member 24, sealing member 26, support member 28, and regulator 30 of connector 20.

In some embodiments, the distal portion 1864 of the support member 1828 may include a lumen 1865 in fluid communication with the distal opening 1866, a fluid passageway 1869, and one or more apertures 1868 formed on the elongate portion 1862. In some embodiments, the support member 1828 may not include one or more holes extending transversely or radially through the distal portion. In some embodiments, the support member 1865 may include variable volume chambers within the interior cavity 1865 rather than an annular channel formed outside of the support member. In some embodiments, a variable volume chamber 1830, such as a balloon member 1830, may be contained within the lumen 1865 of the support member 1828. The balloon member 1830 may be secured to the support member 1828 in a number of ways, such as by one or more tethers 1801, adhesives, and so forth. The variable volume chamber 1830 may have many shapes and may be placed in many different locations. In some embodiments, the variable volume chamber 1830 is positioned in contact with or adjacent to (e.g., at a corner of) one or more interior surfaces of the interior cavity 1865. The balloon member 1830 may be filled with a compressible/expandable fluid, such as air or other gas. As the volume of fluid contained in the lumen 1865 decreases, the balloon member 1830 may expand, thereby relieving the pressure differential due to the backflow-inducing event.

In some embodiments, the valve member 730 may be placed on the distal portion 1864 of the support member 1828 in a manner similar to that shown in fig. 48. In some embodiments, as the balloon member 1830 expands, the force required to further expand the balloon member 1830 increases. Thus, if sufficient pressure is applied (e.g., when fluid is intentionally drawn into the syringe), the force required to further expand the balloon member 1830 at a certain time is greater than the force required to open the valve member 730 for fluid flow in the proximal direction. When this threshold pressure is reached, one or more slits 710 on the valve member 730 will open to allow fluid to flow through the valve member 730 in the proximal direction. In some embodiments, the balloon member 1830 may be configured such that its expanded volume at a threshold pressure is insufficient to impede the flow of fluid (e.g., to seal an opening into the cavity 1865 or to fill a portion of the cavity 1865). In some embodiments, one or more tethers 1801 may be provided to maintain the balloon member 1830 in a position that does not impede fluid flow even when the balloon member 1830 is in an expanded state. In some embodiments, one or more supporting structures, such as beams or walls (not shown), may prevent interference with the flow of fluid when the balloon member 1830 is in the expanded state.

Fig. 73 is a perspective view of a support member 1928. Fig. 74 is a cross-sectional view of a valve or needle-free connector 1920 including a support member 1928. In some embodiments, connector 1920 may have any of the features or other details or morphology of any of the other connectors disclosed herein. In some embodiments, connector 1920 can include a body member 1922, a base member 1924, a seal member 1926, a support member 1928, and an adjuster 1930, which can be the same or similar to body member 22, base member 24, seal member 26, support member 28, and adjuster 30 of connector 20, for example.

In some embodiments, the distal portion 1964 of the support member 1928 may include a lumen 1965 in fluid communication with the distal opening 1966, a fluid pathway 1969, and one or more apertures 1968 formed in the elongate portion 1962. The support member 1928 may include one or more openings 1986 extending transversely or radially through the distal portion 1964.

In some embodiments, the adjuster 1930 can be placed on the distal end portion 1964 of the support member 1928 in a manner similar to that described in connection with connector 20. In some embodiments, at least a portion of the main body portion 1900 may be configured to stretch or expand, or move, through an opening 1968 formed in a distal portion 1964 of a support member 1928 into a lumen 1965. In the event of a reflux-inducing event, air outside of connector 1920 can pass through apertures 1929, expanding main body portion 1900 of regulator 1930 into lumen 1965, thereby reducing the volume of fluid in lumen 1965 and mitigating pressure differentials caused by syringe bounce, withdrawal of a medical implement, or other reflux-inducing events. In some embodiments, the force required to expand the body portion 1900 into the lumen 1965 is less than the force required to open the one or more slits 1910 on the regulator for fluid flow in the proximal direction. In some embodiments, if additional pressure is applied, such as when fluid is intentionally drawn into the syringe from connector 1920, slit 1910 on regulator 1930 may open to allow fluid flow in the proximal direction.

In some embodiments, support member 1928 may include protrusions 1927 or other features that may be received within recesses (not shown) on base member 1924, thereby aligning openings 1986 on distal end portions 1964 of support member 1928 with apertures 1929 on base member 1924. In some embodiments, base component 1924 may include an annular air channel (not shown) in communication with bore 1929 that allows air to reach the area of main body portion 1900 of regulator 1930, even when opening 1986 is misaligned with bore 1929, and main body portion 1900 expands through opening 1986. In some embodiments, support member 1928 can include a plurality of openings 1986 such that main body portion 1900 of adjuster 1930 can expand into lumen 1965 from a plurality of directions. An annular air passage may allow air to reach each expanded position from a single air hole 1929, or multiple air holes 1929 may be formed in base member 1924.

Fig. 75 is a sectional view of the support member 2028. Fig. 76 is a partial cross-sectional view of a portion of the support member 2028. Referring to fig. 75 and 76, in some embodiments, the distal portion 2064 of the support member 2028 may include an inner lumen 2065 in fluid communication with the distal opening 2066, a fluid passageway 2069, one or more apertures 2068 formed in the elongate portion 2062. Support member 2028 can include an opening 2086 extending transversely or radially through distal portion 2064. In some embodiments, an inflatable member, such as the pouch member 2030, may be positioned at the opening 2086. The pouch member 2030 may include a generally circular connection region 2002, the connection region 2002 forming an air seal with the wall of the opening 2086 at the location where it is formed, such that air cannot pass through the connection region 2002 unless air enters the interior volume 2006 of the pouch member 2030. The connection region 2002 may be secured to a wall of the opening 2086 at an outer surface and/or an inner surface of the support member 2028. The pouch member 2030 may be folded, compressed, flattened, or made smaller in its initial position before the fluid pressure differential changes its shape or volume.

Fig. 76 is a partial cross-sectional view of the support member 2028, showing the pouch member in a reduced volume state. In the event of a reflux-inducing event, the pouch member 2030 may inflate, expand, or move to increase its effective volume within the internal cavity 2065, while the internal volume 2006 is filled with air entering from the outside. As the internal volume 2006 of the pouch member 2030 increases in volume, the remaining volume of fluid in the internal cavity 2065 of the support member 2028 decreases, thereby mitigating pressure differences due to backflow events. In some embodiments, a backflow prevention valve (e.g., valve member 730) may be connected to the distal end of the support member 2028 to cooperate with the variable volume chamber formed on the pouch member 2030 to prevent backflow in a manner similar to that discussed herein.

In some embodiments, the pouch member 2030 may be constructed of a soft material (e.g., polyethylene) such that it does not expand or stretch much (or, in some cases, not appreciably) upon inflation, or the pouch member 2030 may be constructed of an elastic material (e.g., rubber or silicone) that expands and contracts the pouch member 2030. In some embodiments, the pouch member 2030 may be constructed of a relatively non-distensible material, but is flexible enough to allow the pouch member 2030 to fold. In some embodiments, the pouch member 2030 may be secured to an inner or outer surface of the support member 2028, rather than inside the opening 2086 itself.

In some embodiments, the support member 2028 can include protrusions or other features that can be received within a groove of another member (e.g., a base member) to align the opening 2086 with the air vent. In some embodiments, the annular air passage may provide fluid communication between the opening 2086 and the air vent in a manner similar to that described in connector 1920.

Many types of needleless connectors can include a backflow barrier module, such as any of those disclosed herein. For example, fig. 78 is a side view of a valve or needle-free connector 2120, which valve or needle-free connector 2120 may have features or characteristics somewhat similar to the 2452040xx Swabable valve of Halkey-Roberts corporation of florida, st. Fig. 79 is a cross-sectional view of the connector 2120 shown in fig. 78. Some of the features and characteristics of the connector 2120 are described in U.S. patent 6,651,956, the entire disclosure of which is incorporated herein by reference. In some embodiments, the connector 2120 may include a body member 2122, a base member 2124, a sealing member 2126, a support member 2128, and an adjuster 2130. In some embodiments, support member 2128 may not include an elongate portion. The regulator 2130 and support member 2128, as well as other components of the connector 2120, may provide a backflow prevention module that includes a variable volume chamber and/or a backflow prevention valve. The backflow prevention module in the embodiment shown in connector 2120 may function in a manner similar to that disclosed in connector 20 to prevent backflow. In some embodiments, the connector 2120 may include any other backflow blocking module, such as a backflow blocking module similar to the other backflow blocking modules disclosed herein.

Fig. 80 is a side view of a valve or needle-free connector 2220, which valve or needle-free connector 2220 may have some features or characteristics that are somewhat similar to the SafeSite connector of b.branch Medical, inc. Fig. 81 is a cross-sectional view of the connector 2220. Some of the features and characteristics of connector 2220 are described in U.S. patent 4,683,916, the entire disclosure of which is incorporated herein by reference. In some embodiments, the connector 2220 can include a body member 2222, a base member 2224, a disc valve 2225, a brake 2226 for opening the disc valve when the medical implement is connected to the connector 2220, a support member 2228, and an adjuster 2230. In some embodiments, the support member 2228 may not include an elongate portion. The regulator 2230 and the support member 2228, as well as other components of the connector 2220, may provide a backflow prevention module that includes a variable volume chamber and/or a backflow prevention valve. The backflow prevention module of the embodiment shown in connector 2220 may prevent backflow in a manner similar to that described for connector 20. In some embodiments, the connector 2220 may include any other backflow prevention module, such as a backflow prevention module similar to the other backflow prevention modules disclosed herein.

Although the connector disc valve 2225 may be configured to seal the connector against fluid flow in the proximal direction when the medical implement is removed from the connector 2220, a small amount of backflow may still occur when the medical implement is withdrawn before the disc valve 2225 is closed. Also, when the connector 2220 is connected to a medical implement, the disc valve 2225 is open, some source of reflux, such as syringe bounce, can occur. The backflow prevention module of connector 2220 may be configured to eliminate or reduce the effects of these backflow-inducing events.

Fig. 82 is a side view of a valve or needle-free connector 2320, which valve or needle-free connector 2320 may have features or characteristics somewhat similar to MaxPlus connectors of Medegen corporation, california, ontario. Fig. 83 is a cross-sectional view of the connector 2320. Some of the features and characteristics of connector 2320 are described in U.S. patent 5,782,816 and U.S. patent application publication No. 2005/0059952, the entire disclosure of which is incorporated herein by reference. In some embodiments, the connector 2320 may include a body member 2322, a base member 2324, a resilient plug seal 2326, a support member 2328 and an adjuster 2330. The regulator 2330 and support member 2328, as well as other components of the connector 2320, may provide a backflow prevention module that includes a variable volume chamber and a backflow prevention valve. The backflow prevention module in the embodiment shown in connector 2320 may prevent backflow in a manner similar to that described in connector 20. In some embodiments, connector 2320 may include any other backflow blocking module, such as a backflow blocking module similar to the other backflow blocking modules disclosed herein.

In some embodiments, the connector 2320 produces a positive flow of fluid in the distal direction when the medical implement is disconnected from the connector 2320. For example, when a medical implement is connected to the connector 2320, the elastomeric plug seal 2326 may collapse to increase the volume of fluid inside the connector 2320. Then, when the medical implement is subsequently removed, the elastomeric plug seal 2326 may expand, reducing the volume of fluid within the connector 2320 and relieving the pressure created by the removal of the medical implement. However, some source of reflux, such as syringe bounce, may occur when the connector 2320 is connected to a medical implement with the elastomeric plug member 2326 held in a compressed state. The backflow prevention module of the connector 2320 may be configured to eliminate or reduce the effects of these backflow inducing events that are not addressed by the elastomeric plug seal 2326. In some embodiments, the variable volume chamber formed at least in part by regulator 2330 may change volume independent of the movement of elastomeric plug seal 2326. In some embodiments, when a medical implement is connected to the connector, the variable volume chamber formed at least in part by regulator 2330 can reduce the volume as fluid flows into the volume that increases around elastomeric plug seal 2326, preventing or inhibiting backflow of fluid that would otherwise be drawn into the distal end of connector 2320 (e.g., from a catheter). As fluid is injected distally through connector 2320, the variable volume chamber formed at least in part by regulator 2330 increases in volume so that the backflow blocking module may be ready to handle the next backflow-inducing event.

Fig. 84 is a side view of a valve or needle-free connector 2420 that may have some features or characteristics somewhat similar to the CLEARLINK connector of Baxter international corporation of illinois, dielfield. Fig. 85 is a cross-sectional view of the connector 2420. Some of the features and characteristics of connector 2420 are described in U.S. patent 6,585,229, the entire disclosure of which is incorporated herein by reference. In some embodiments, connector 2420 can comprise a body member 2422, a base member 2424, a seal member 2426, a plug member 2425 slidingly received within seal member 2426, a support member 2428, and a regulator 2430. The regulator 2430 and support member 2428, as well as other components of the connector 2420, may provide a backflow prevention module that includes a variable volume chamber and/or a backflow prevention valve. The backflow prevention module in the embodiment shown in connector 2420 may prevent backflow in a manner similar to that described in connector 20. In some embodiments, the connector 2420 may comprise any other backflow prevention module, such as a backflow prevention module similar to the other backflow prevention modules disclosed herein.

Fig. 86A is a side view of a valve or needle-free connector 2520 that may have some features or characteristics that are somewhat similar to SmartSite connectors of Cardinal Health, dublin, ohio. Fig. 86B is a sectional view of connector 2520. Some of the features and characteristics of connector 2520 are described in U.S. Pat. No. 5,676,346, the entire disclosure of which is incorporated herein by reference. In some embodiments, connector 2520 may include a body member 2522, a base member 2524, a sealing member 2526, a support member 2528, and a regulator 2530. In some embodiments, the support member 2528 may not include an elongated portion, but rather includes a proximally extending projection 2562, which projection 2562 may be substantially shortened and not extend through the proximal end of the sealing member 2526. The regulator 2530 and support member 2528, as well as other components of the connector 2520, may provide a backflow prevention module that includes a variable volume chamber and/or a backflow prevention valve. The backflow prevention module in the embodiment shown in connector 2520 may prevent backflow in a manner similar to that described in connector 20. In some embodiments, the connector 2520 may include any other backflow blocking module, such as a backflow blocking module similar to the other backflow blocking modules disclosed herein.

Fig. 87A is a side view of a valve or needle-free connector 2620, which 2620 may have features or characteristics somewhat similar to those of the UltraSite connector of b.braun Medical. Fig. 87B is a cross-sectional view of the connector 2620. Some of the features and characteristics of connector 2620 are described in U.S. patent 5,439,451, the entire disclosure of which is incorporated herein by reference. In some embodiments, the connector 2620 may include a body member 2622, a base member 2624, a plug member 2625, a resilient sealing member 2626, a support member 2628, and a regulator 2630. The regulator 2630 and support member 2628, as well as other components of the connector 2620, may provide a backflow prevention module that includes a variable volume chamber and a backflow prevention valve. The backflow prevention module in the embodiment shown in connector 2620 may prevent backflow in a manner similar to that described in connector 20. In some embodiments, the connector 2620 may include any other backflow blocking module, such as a backflow blocking module similar to the other backflow blocking modules disclosed herein.

Fig. 88A is a side view of a valve or needle-free connector 2720 that may have some features or characteristics that are somewhat similar to the Q-Syte connector of Becton, Dickinson and Company of franklin, nj. Fig. 88B is a sectional view of the connector 2720. Some of the features and characteristics of connector 2720 are described in U.S. patent 6,908,459, the entire disclosure of which is incorporated herein by reference. In some embodiments, connector 2720 may include a body member 2722, a base member 2724, a sealing member 2726, a support member 2728, and an adjuster 2730. The regulator 2730 and support member 2728, as well as other components of the connector 2720, may provide a backflow prevention module that includes a variable volume chamber and/or a backflow prevention valve. The backflow prevention module in the embodiment shown in connector 2720 may prevent backflow in a manner similar to that described in connector 20. In some embodiments, the connector 2720 may include any other backflow blocking module, such as a backflow blocking module similar to the other backflow blocking modules disclosed herein.

Fig. 89A is a side view of a valve or needle-free connector 2820 that may have some features or characteristics that are somewhat similar to the Posiflow connector of Becton, Dickinson and Company of franklin, nj. Fig. 89B is a cross-sectional view of the connector 2820. Some of the features and characteristics of connector 2820 are described in U.S. patent 6,152,900, the entire disclosure of which is incorporated herein by reference. In some embodiments, the connector 2820 may include a body member 2822, a base member 2824, a seal member 2826, a resilient member 2825, a support member 2828, and an adjuster 2830. The regulator 2830 and the support member 2828, as well as other components of the connector 2820, may provide a backflow prevention module that includes a variable volume chamber and/or a backflow prevention valve. The backflow prevention module in the embodiment shown in connector 2820 may prevent backflow in a manner similar to that described in connector 20. In some embodiments, the connector 2820 may include any other backflow blocking module, such as a backflow blocking module similar to the other backflow blocking modules disclosed herein.

In some embodiments, the connector 2820 may be configured to create a positive flow of fluid in the distal direction when the medical implement is disconnected from the connector 2820 to relieve pressure created by removing the medical implement. However, some source of reflux, such as syringe bounce, may occur when the connector 2820 is connected to a medical implement. The backflow blocking module of the connector 2820 may be configured to eliminate or reduce the effects of these unresolved backflow-inducing events. In some embodiments, the variable volume chamber formed at least in part by the regulator 2830 may change volume independent of movement of the sealing member 2826 and the resilient member 2825 due to connection or removal of a medical implement. In some embodiments, when a medical implement is connected to the connector 2820, as fluid flows into the increased volume within the sealing member 2826, the variable volume chamber formed at least in part by the regulator 2830 may decrease the volume, preventing backflow of fluid that would otherwise be drawn into the distal end of the connector 2820 (e.g., from a catheter). When fluid is injected distally through the connector 2820, the variable volume chamber formed at least in part by the regulator 2830 increases in volume, thereby making the backflow blocking module ready to handle the next backflow-inducing event.

Fig. 90A is a side view of a valve or needle-free connector 2920, which valve or needle-free connector 2920 may have some features or characteristics that are somewhat similar to the CLC2000 connector of ICU Medical, inc. FIG. 90B is a cross-sectional view of the connector 2920. Some of the features and characteristics of connector 2920 are described in U.S. patent 6,245,048, the entire disclosure of which is incorporated herein by reference. In some embodiments, the connector 2920 can include a body member 2922, a base member 2924, a piston 2926 slidingly disposed on the body member 2922, a support member 2928, and an adjuster 2930. The regulator 2930 and support member 2928, as well as other components of the connector 2920, may provide a backflow blocking module that includes a variable volume chamber and/or a backflow prevention valve. The backflow prevention module in the embodiment shown in connector 2920 may prevent backflow in a manner similar to that described in connector 20. In some embodiments, the connector 2920 may include any other backflow blocking module, such as a backflow blocking module similar to the other backflow blocking modules disclosed herein.

In some embodiments, the connector 2920 can be configured to produce a positive flow of fluid in the distal direction when the medical implement is disconnected from the connector 2920. For example, the piston 1926 can be configured to slide down the body portion 1922 of the connector 2920 when a medical implement is attached, thereby increasing the volume of fluid surrounding the plug 1926. Then, when the medical implement is removed, the piston 2926 can slide up the body portion 1922, reducing the volume of fluid surrounding the piston 2926 and relieving pressure caused by removing the medical implement. However, some source of reflux, such as syringe bounce, may occur when the connector 2920 is connected to a medical implement. The backflow prevention module of the connector 2920 may be configured to eliminate or reduce the effects of these backflow-inducing events that are not addressed by the piston 2926. In some embodiments, the variable volume chamber formed at least in part by the regulator 2930 may change volume independent of movement of the piston 2926 due to the connection or removal of a medical implement. In some embodiments, when the medical implement is connected to the connector 2920, as fluid flows into the increasing volume around the piston 2926, the variable volume chamber at least partially formed by the regulator 2930 may decrease the volume, preventing backflow of fluid that would otherwise be drawn into the distal end of the connector 2920 (e.g., from a catheter). As fluid is injected distally through the connector 2920, the variable volume chamber formed at least in part by the regulator 2930 increases in volume, thereby making the backflow blocking module ready to handle the next backflow inducing event.

Fig. 91A is a side view of a valve or needle-free connector 3020, which valve or needle-free connector 3020 may have features or characteristics somewhat similar to the InVision-Plus connector of RyMed Technologies, franklin, tennessee. Fig. 91B is a sectional view of the connector 3020. Some of the features and characteristics of connector 3020 are described in U.S. patent 6,994,315, the entire disclosure of which is incorporated herein by reference. In some embodiments, the connector 3020 may include a body member 3022, a base member 3024, a sealing member 3026, a guide member 3025, a diaphragm member 3027, a support member 3028, and a regulator 3030. The regulator 3030 and the support member 3028, as well as other components of the connector 3020, may provide a backflow barrier module that includes a variable volume chamber and/or a backflow barrier valve. The backflow prevention module in the embodiment shown in connector 3020 may prevent backflow in a manner similar to that described in connector 20. In some embodiments, the connector 3020 may include any other backflow prevention module, such as a backflow prevention module similar to the other backflow prevention modules disclosed herein.

In some embodiments, sealing member 3026 may include a series of O-rings, arcuate segments, or other structures to facilitate resilient return of valve member 3026 to its uncompressed position after compression. In some embodiments, O-rings, arcuate segments, or other structures may be connected end-to-end to generally form a spiral pattern along the body of the sealing member 3026, as shown in fig. 91B.

Although the embodiment shown in fig. 78-91B illustrates a support member or regulator that is somewhat similar to support member 28 and regulator 30 with a backflow barrier module, it is understood that any other backflow barrier module, including the backflow barrier modules disclosed herein, may be incorporated into the connector shown in fig. 78-91B.

Although specific examples have been provided herein, it should be understood that the backflow barrier module may be incorporated into many other types of connectors, not just the connectors specifically disclosed herein. For example, the backflow prevention module may be incorporated into a three-way (y-site) connector, or may be incorporated into a connector that provides access to infusion bags and other medical containers, or into a conduit line.

Any features of the embodiments shown and/or described in the drawings, such as distances, proportions of parts, etc., which are not explicitly described herein, are part of the present disclosure. Furthermore, although the present invention has been disclosed in terms of various embodiments, features, aspects and examples, it will be understood by those of ordinary skill in the art that the scope of the present invention extends beyond the specifically disclosed embodiments to alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. Thus, it should be understood that various features and aspects of the embodiments disclosed herein can be combined with or substituted for one another in order to achieve different modes of the disclosed invention. Therefore, the scope of the invention disclosed herein should not be limited by the particular embodiments described.

While the invention has been disclosed in terms of certain preferred embodiments and examples, it will be understood by those skilled in the art that the scope of the invention extends beyond the specifically disclosed embodiments to alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. In addition, while a number of variations of the invention have been shown and described in detail, other variations, which are within the scope of this invention, will be readily apparent to those of skill in the art. It is also contemplated that various combinations and subcombinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the invention. Thus, it should be understood that various features and aspects of the embodiments disclosed herein can be combined with or substituted for one another in order to achieve different modes of the disclosed invention. Therefore, the scope of the invention disclosed herein should not be limited by the particular embodiments described.

Claims

1. A medical luer connector for connection between a medical implement and a catheter, the medical luer connector comprising:

a body member including a proximal female end for receiving a male luer connector of a medical implement, the body member being connected to a base member including a distal male end, the body member and the base member forming an internal cavity;

a proximal closure system disposed in a proximal region of the lumen, the proximal closure system for moving between a closed position wherein a proximal surface of the proximal closure system is substantially aligned or flush with the proximal opening of the connector and an open position wherein the proximal closure system is compressed and has a smaller longitudinal length;

a support member having a channel formed between the annular protrusions;

an internal closure system comprising a valve member located at a distal region of the connector, wherein the valve member comprises a proximal portion comprising an internal annular protrusion and an opening therethrough, and a distal portion that is substantially dome-shaped and comprises one or more slits;

wherein the valve member is arranged such that the inner annular projections are received within the channels formed between the annular projections to secure the valve member to the support member.

2. The connector of claim 1, wherein: the proximal closure system includes a sealing member.

3. The connector of claim 2, wherein: the sealing member is deformable.

4. The connector of claim 3, wherein: the support member has a sharp or rounded tip.

5. The connector of claim 3, wherein: the support member is adapted to penetrate the sealing member of the connector.

6. The connector of claim 1, wherein: the body member and the base member are joined together by an adhesive.

7. The connector of claim 1, wherein: the body member and the base member are connected together by a bayonet mechanism, an interference mechanism or a press-and-snap mechanism.

8. The connector of claim 1, wherein: the body member and the base member are joined together by sonic welding.

9. A neutral flow medical luer connector for connection between a medical implement and a catheter, the medical luer connector comprising:

a variable volume chamber for varying a volume within the connector;

an internal closure system located at the distal end region of the connector;

wherein the variable volume chamber is to provide a volume change to relieve a pressure differential in the connector such that the connector has a neutral flow when a luer fitting of the medical implement is removed from the connector.

10. The connector of claim 9, wherein: the proximal closure system, the variable volume chamber and the internal closure system are arranged in connection with each other in the connector.

11. The connector of claim 9, wherein: the proximal closure system includes a sealing member.

12. The connector of claim 11, wherein: the sealing member is deformable.

13. The connector of claim 12, wherein: the connector also includes a rigid support member.

14. The connector of claim 13, wherein: the support member has a sharp or rounded tip.

15. The connector of claim 13, wherein: the support member is adapted to penetrate the sealing member of the connector.

16. The connector of claim 9, wherein: the variable volume chamber is used to provide a volume change while the pressure differential is created, which would otherwise create a negative or retrograde flow.

17. The connector of claim 16, wherein: the variable volume chamber is used to provide a volume change having the same magnitude or magnitude as the pressure differential that would otherwise produce a negative or retrograde flow.

18. The connector of claim 17, wherein: the variable volume chamber is configured to expand when fluid is injected from a medical implement into the connector.

19. The connector of claim 18, wherein: the variable volume chamber forms part of a regulator and the regulator further comprises the internal closure system.

20. The connector of claim 19, wherein: the variable volume chamber includes a valve member.

21. The connector of claim 12, wherein: the sealing member is connected to a regulator that includes the variable volume chamber and the internal closure system.

22. The connector of claim 19, wherein: the regulator is flexible.

23. The connector of claim 9, wherein: the body member and the base member are joined together by an adhesive.

24. The connector of claim 9, wherein: the body member and the base member are connected together by a bayonet mechanism, an interference mechanism or a press-and-snap mechanism.

25. The connector of claim 9, wherein: the body member and the base member are joined together by sonic welding.