HK1115074B - Medical connector having high flow rate characteristics - Google Patents

Description

Medical connector with high flow rate features

Cross Reference to Related Applications

The benefit of U.S. provisional application No. 60/625,644 filed on 5.11.2004 and U.S. provisional application No. 60/654,250 filed on 18.2.2005, the entire contents of which are incorporated herein by reference.

Background

Technical Field

The invention disclosed herein relates generally to the field of medical connectors and, in particular, to needleless medical connectors.

Background

Fluid handling for parenteral administration in hospitals and medical facilities typically involves the use of connectors to selectively assist in the movement of fluid to and from a patient. For example, one connector may be attached to a catheter leading to a tip location in a patient, and a different connector may be attached to one or more tubes and medical implements to control fluid flow to or from the patient.

Needleless connectors are generally configured to allow a needleless medical device to be selectively connected to such needleless connectors to permit fluid flow between a patient and a fluid source or fluid reservoir. When the medical implement is removed, the connector closes, effectively sealing the catheter attached to the patient, eliminating the need for multiple injections into the patient and placing medical personnel in danger of inadvertent needlestick injuries. Medical instruments using such connectors may be tubing or other medical devices such as catheters, syringes, Intravenous (IV) sets (both peripheral and central lines), piggyback lines, or similar components adapted for connection to medical valves.

Many existing medical connectors may be relatively difficult to grasp during use by a medical professional. In most applications, medical connectors are designed to be relatively small to reduce the cost of manufacture and to reduce the number of fluid "dead spots" within the connector. Moreover, most medical connectors include a housing with a hard, smooth outer surface. Therefore, it is sometimes uncomfortable for medical practitioners to repeatedly pinch the connectors tightly around with their fingers and firmly grasp them during medical procedures. Because medical personnel use these connectors very frequently in patient care, enhancing their ability to effectively grasp these connectors would result in a significant improvement in the time and labor involved in using these connectors. Furthermore, the hard surfaces of existing medical connectors are not comfortable on the patient's skin. These discomfort can become particularly pronounced when patients require frequent medical attention, such as hemodialysis, using these medical connectors.

In addition, many existing medical connectors at least partially obstruct fluid flow with complex flow paths that include various turns, bends, and corners. These obstructions can cause very low flow rates. These obstructions can also damage platelets.

Moreover, many existing medical connectors allow a degree of fluid backflow upon disconnection of the medical devices from the valve. These connectors typically include an interior space through which fluid can flow from the medical implement to the conduit connected to the connector. When a medical implement is attached to a connector, it typically occupies a portion of the internal valve space, displacing a certain amount of fluid in the connector. When the medical implement is disconnected, a vacuum is created by removing a portion of the medical implement from the interior space of the connector, which tends to draw fluid through the patient's tubing toward the connector to fill the space created by the removed implement.

The backflow of fluid has some disadvantages. When the connector is connected to a fluid line leading to a patient, the back flow movement of fluid through the line towards the space in the connector results in a small amount of blood being drawn from the patient in the direction of the connector. This blood being drawn into the catheter over time can create an occlusion in the catheter near the tip of the catheter, limiting the efficacy of the catheter tip.

When the inner diameter of the catheter is small, the possibility of blood clogging the tip of the catheter increases. In parenteral administration applications, such smaller diameter catheters are often used because of their many advantages. For example, smaller catheters reduce the trauma and discomfort associated with inserting them into a patient. Because these conduits have small chambers, even a small suction force can pull fluid back a relatively large distance through the conduit toward the connector.

Also, in some existing medical connectors, there is a gap between the inner sealing member and the outer housing of the connector. These gaps allow bacteria, debris, or disinfectant to pass through the openings into the interior of the connector and possibly into the fluid flowing to or from the patient.

Disclosure of Invention

Certain embodiments of the present invention provide a soft clip medical connector that includes a housing having an upstream end, a downstream end, a chamber extending through a central portion of the housing, and a flexible member. In some embodiments, the flexible member has a valve portion integrally formed with a clamp portion. The valve portion is positioned within a portion of the housing. The valve portion is for controlling the flow of fluid through the housing chamber. The clamping portion covers at least a portion of an outer surface of the housing.

In some embodiments, a medical fluid connector includes a cylindrical body, a valve portion, and a cannula portion. The cylindrical body has an outer wall with a plurality of flanges extending radially therefrom and a chamber extending through a portion thereof. The valve portion provides an openable and closable seal between the first and second ends of the cylindrical body. The sleeve portion may form a unit with the valve portion and may surround a majority of the outer surface of the cylindrical body.

The present invention also provides methods of forming a clamping portion and/or a sealing portion of a medical device. In some embodiments, a method includes pouring an uncured material into a mold, thereby molding a first preform from a substantially flexible material. The preform is removed from the preform mold and a second preform is molded (but not necessarily the same mold as the first molded article). Inserting the first and second preforms into a final mold, infusing an uncured material into the final mold to over-mold the first and second preforms to form a final structure having a valve member and a sleeve portion extending from the valve member.

The present invention also provides methods of making medical fluid connectors. In some embodiments, the methods comprise the steps of: forming a valve member having a sleeve extending therefrom, the valve and sleeve being formed as a unitary body from a substantially flexible material; and forms a relatively rigid housing. Inserting a portion of the valve member into a cavity of the housing such that the sleeve protrudes from the housing member. The sleeve is then inverted to cover or surround at least a portion of the outer surface of the housing member.

In the following embodiment of the method utilizing a soft clip connector, the downstream end is connected to a first medical implement, such as a catheter. A second medical implement is inserted into an opening in the upstream end of the connector. When the second medical implement is introduced into the connector, in some embodiments, the valve member expands, creating a larger internal volume. Fluid flowing from the second medical implement may be allowed to flow into the valve member. In some embodiments, such introduced fluid may cause the internal volume of the valve member to further expand and contract when fluid flow is reduced or stopped.

The internal volume of the valve member also decreases when the second medical implement is removed from the connector. In some embodiments, the valve member may snap back to its initial state (i.e., the state prior to insertion of the second medical implement). The valve member has an interior region closer to the upstream end that is narrower than a region closer to the downstream end to impede fluid flow in the direction of the upstream end and to encourage fluid flow in the direction of the downstream end. Thus, fluid within the connector is forced toward the patient toward the downstream end of the connector, creating a positive flow effect and minimizing backflow of fluid into the valve. Several different configurations of forward valves are disclosed in U.S. patent No. 6,695,817 and U.S. patent application publication No. 2004/0006330 owned by ICU medical limited, and these documents are incorporated by reference herein and the entire contents of their disclosures will form part of this specification.

In many embodiments, the connector is small and easy to grip. The outer sleeve may be made of, for example, silicone rubber, which may provide a desired degree of non-slip friction to standard rubber gloves worn by medical personnel. In some embodiments, the connector is generally smooth and seamless in profile in the region proximate the upstream end due to the unitary configuration of the flexible outer sleeve and valve member. In this configuration, bacteria or other debris are less likely to collect in the areas through which fluid flows to the patient, and it is easier and more effective to wipe these areas with antiseptic. The overall configuration of the valve member and the outer sleeve is also simplified and increases the cost-effectiveness of the manufacturing process.

Drawings

Having thus summarized the general features of the present invention, certain preferred embodiments of the invention and modifications thereof will become apparent to those skilled in the art from the detailed description herein below with respect to the drawings in which:

FIG. 1 is a perspective view of one embodiment of a soft clip medical connector including an outer sleeve surrounding a housing member;

FIG. 2 is a perspective view of one embodiment of a housing member of the soft clip medical connector;

FIG. 3 is a top view of the housing member shown in FIG. 2;

FIG. 4 is a bottom view of the housing member shown in FIG. 2;

FIG. 5 is a transverse cross-sectional view of the housing member shown in FIG. 2, taken along line 5-5 (shown in FIG. 3);

FIG. 6 is a transverse cross-sectional view of the housing member shown in FIG. 2, taken along line 6-6 (shown in FIG. 3);

fig. 7 is an exploded view of another embodiment of a housing member of the soft clip medical connector;

FIG. 8A is a perspective view of a housing member of the first housing portion of the housing member shown in FIG. 7;

FIG. 8B is a perspective view of the first housing portion shown in FIG. 8A from an opposite angle;

FIG. 9A is a perspective view of the second housing portion shown in FIG. 7;

FIG. 9B is a perspective view of the second housing portion shown in FIG. 9A from an opposite angle;

FIG. 10 is a transverse cross-sectional view of the housing member shown in FIG. 7, taken along line 10-10;

FIG. 11 is a transverse cross-sectional view of the housing member shown in FIG. 7, taken along line 11-11;

FIG. 12 is a perspective view of a flexible member including a valve member and a sleeve connected to the valve member;

FIG. 13 is a cross-sectional view of the connector shown in FIG. 12 taken along line 13-13;

FIG. 14 is a cross-sectional view of the flexible member shown in FIG. 12, taken along line 14-14;

FIG. 15 is a perspective view of one embodiment of a preform for use in fabricating some embodiments of a flexible member;

FIG. 16 is a perspective view of another embodiment of a flexible member including a valve member and a sleeve connected to the valve member;

FIG. 17 is a cross-sectional view of the flexible member shown in FIG. 16, taken along line 17-17;

FIG. 18 is a cross-sectional view of the flexible member shown in FIG. 16, taken along line 18-18;

FIG. 19 is a perspective view of a third embodiment of a flexible member having a valve member and a sleeve connected to the valve member;

FIG. 20 is a cross-sectional view of the flexible member shown in FIG. 19, taken along line 20-20;

FIG. 21 is a cross-sectional view of the flexible member shown in FIG. 19, taken along line 21-21;

FIG. 22 illustrates a perspective view of the assembly of the flexible member and the housing member;

FIG. 23 illustrates a perspective view of the sleeve of the flexible member abutting the housing member and the valve member of the flexible member being inserted into the housing member;

fig. 24 is a cross-sectional view of an assembled soft clip medical connector;

fig. 25 is a cross-sectional view of the soft clip medical connector rotated 90 deg. relative to the cross-section shown in fig. 24;

FIG. 26 is a cross-sectional view of the connector shown in FIG. 24 with a syringe connected thereto;

fig. 27 is a cross-sectional view of the connector shown in fig. 24 rotated 90 deg. relative to the cross-section of fig. 26.

Detailed Description

Certain embodiments and examples of soft clip medical connectors will be described with reference to the accompanying drawings. While certain embodiments and examples of soft clip medical connectors are shown and described as including a forward flow valve, certain aspects and advantages of the systems and methods described herein may also be readily applied to many other fluid connector designs that do not include a forward flow feature.

Referring now to fig. 1, the illustrated embodiment of the medical connector 10 includes a substantially rigid housing 12 having a flexible member 80 that is stretched over the outer surface of the housing 12 to provide a soft, grippable outer surface 22. A slit opening 100 is formed in the upstream end 16 of the flexible member 80. The upstream end of the flexible member 80 surrounds the housing 12 to provide an easy-to-clean surface and substantially avoids cavities or pockets in which contaminants collect. Although the upstream end of the flexible member 80 surrounds the entire circumference of the housing 12 as shown, in other embodiments, the upstream end of the flexible member may surround substantially all of the circumference of the housing 12, or may surround a portion of the circumference of the housing 12, such as about three-quarters, about one-half, or less. In other embodiments, the flexible member 80 may be segmented to enclose portions of the housing 12. For example, the flexible member 80 may have one or more openings or perforations that expose a portion of the housing 12 that is located below the flexible member 80, and/or the portion of the flexible member 80 that is located outside of the housing 12 may be made of a strip or band that contacts the housing 12. The outer surface of the flexible member 80 can cover the interior of the flexible member 80, such as the lateral extensions 84 (discussed in further detail below), to prevent interference with those portions during use, thereby making the function of the flexible member 80 more reliable.

Referring now to fig. 2-11, an embodiment of the housing 12 is depicted. Fig. 2-6 illustrate one embodiment of a housing 12 for a soft clip medical connector. Fig. 7-11 depict another embodiment of a housing 12 for a soft clip medical connector. Many other embodiments can be made by utilizing or combining features of one or more of the disclosed embodiments.

2-6, the housing 12 includes an upper cavity 42 for receiving a flexible member 80, and interfaces 16, 30 for connecting the connector to various medical devices. The upper housing 40 generally includes a cylindrical wall 44 having longitudinal slots 46 on opposite sides, e.g., sides oriented approximately 180 ° with respect to each other. The upper housing 40 is connected at a lower end to a base member 48 which includes a lower luer connector 30 (shown in fig. 5 and 6). During storage and transport of the sterile connector 10, a protective cap (not shown) may be used to connect to the lower luer connector 30 to maintain sterility prior to use. The protective cap is typically removed by a medical professional immediately prior to connecting the lower luer connector 30 to a medical implement.

As shown, embodiments of the housing member 12 may also include a plurality of collars 60 that extend radially outward from the outer surface of the cylindrical wall 44 of the upper housing 40. In some embodiments, the ring portion 60 tapers in diameter from the top ring 60a to the bottom ring 60 c. In these embodiments, the number, size and configuration of the ring portions 60 can be modified in many other ways.

A flange 62 may also be provided at the intersection between the ring 60 and the slot 46. The flange 62 prevents the lateral extensions 84 (shown in fig. 23) of the flexible member 80 from catching or catching on the edges of the loop 60 when inserted into the upper housing 40, where the loop 60 is bisected by the longitudinal slit 46. The collar 60 and the flange 62 are generally designed to retain portions of the sleeve 20 on the flexible member 80 in a configuration that will be discussed in further detail below.

As shown in fig. 1, 5 and 6, the tapered ring portion 60 plus a frustoconical skirt 52 generally creates an "hourglass" shaped shell. This is advantageous in providing an easily clamped housing. The reduced diameter region near the lower end of the upper housing 40 may be grasped by a medical practitioner's thumb and forefinger. In the region of the ring portion 60, the upper region of gradually increasing diameter and the lower region of gradually decreasing diameter, the grip of the human hand is less likely to slide along the outer surface of the connector 10 when other medical instruments are attached to or detached from the connector 10. In addition, other gripping surfaces such as bumps, ridges, and other types of indentations or protrusions may be provided on the outer surface of the cannula 20 in the area where the medical professional will grasp the connector 10.

The housing 12 is preferably sized to conform to a compression connector. The compression connector is advantageous for achieving relatively low costs because it requires a relatively small amount of material to manufacture. Furthermore, the compression type is generally a lightweight connector, thus reducing irritation to the patient when the connector is resting or suspended on the patient for extended use. For example, in some embodiments, the housing 12 has a height from the upstream end 16 to the downstream end of a luer cannula 32 of between about 0.400 "and 1.200". In other embodiments, the height of the housing 12 may be between about 0.500 "and 1.000". In other embodiments, the height is also less than 1.000 ". The height of the upper housing 40 from the upstream end 16 to the lower luer connector 30 is between about 0.500 "and 0.750". The upper housing 40 preferably comprises about three-quarters to four-fifths of the total height of the housing 12. The height of the luer cavity 74 extends from the lower end 36 of the housing 12 to the lower surface of the base member 48. In certain embodiments, the luer cavity has a height of between about 0.150 "and 0.350". In other embodiments, the luer cavity has a height of less than about 0.400 ". In one particular embodiment, the height of the luer cavity is about 0.220 ". The height of the luer cavity 74 preferably corresponds to the length of the luer connector to be inserted into the luer cavity 74 so that the luer connector can be inserted flush into the luer cavity 74. The height of the luer cavity 74 is preferably comprised between about one-eighth and about one-third of the height of the housing 12. In some embodiments, the luer cannula 32 extends approximately.050 "to 0.150" beyond the lower end 36 of the housing 12. In other embodiments, the luer cannula 32 extends approximately 0.80 "to 0.120" beyond the lower end 36. In one particular embodiment, the luer cannula 32 extends approximately 0.093 "beyond the lower end 36. The luer cannula is preferably sized and configured for connection to a luer connector to be inserted into the luer cavity 74.

The dimensions of the collar 60 and other housing features corresponding to the features of the sleeve 20 will be further described below. For example, in some embodiments, the cylindrical wall 44 has an outer diameter of between about 0.200 "and about 0.300", preferably between about 0.250 and about 0.275, and in one particular embodiment, an outer diameter of about 0.265. In these embodiments, the height 'h' (i.e., the difference between the outer diameter of the ring and the outer diameter of the upper housing cylinder) of the upper ring 60a is about 0.110 "(±. 0.02"), the height of the middle ring 60b is about 0.093 "(±. 0.02"), and the height of the lower ring 60c is about 0.073 "(±. 0.02"). Thus, in certain embodiments, the housing 12 comprises a generally hourglass-shaped body defined by the cylindrical wall 44 and the ring portions 60a, 60b, 60c and a maximum diameter of between about 0.310 "and 0.410", preferably between about 0.360 "and 0.385", and in one particular embodiment, about 0.375 ". Other dimensions within and outside of the above-described ranges may also be used depending on the particular application.

For example, as shown in FIGS. 1, 2 and 5, the housing 12 may also include projections 70, such as ears, for receiving a luer connector of a threaded medical connector, such as a medical device (e.g., a syringe). In the illustrated embodiment, the ears of the tabs 70 are generally rectangular. The ears may also have substantially rounded or beveled edges to prevent damage to the sleeve 20 of the flexible member 80 when the flexible member 80 is spread over the outer surface of the housing 12, as will be described in more detail below.

The sleeve 20 may be configured with windows 126 to allow the tabs 70 to extend from the flexible member 80 while better tightly engaging the periphery of the tabs 70 when the sleeve 20 is inverted (described in more detail below). In other embodiments, the tabs 70 may comprise other shapes and configurations as desired. In some embodiments without the window 126, the size of the protuberance 70 and the thickness of the cannula are adapted so that the bump 70 forms a bump in the cannula that sufficiently engages the internal threads of a luer connector to be attached to the upstream end 16 of the connector 10.

In some embodiments, the lower housing interface includes a luer connector 30 to facilitate connection of the connector 10 to a medical device with a female luer connector. The luer connector 30 of the housing 12 may include a hard cannula 32 extending downwardly from a lower end 36 of the housing 12 to provide a connection to other medical devices, such as a catheter hub. Other interfaces and connections may be used in place of the luer connector 30, such as luer slip connections, barbed hose connections, and the like.

As shown in fig. 5 and 6, the housing also includes an inner cannula 50 extending into the upper housing cavity 42. Said inner cannula 50 includes a chamber 45 extending through said base member 48 and said luer cannula 32 of said lower luer connector 30. The lower luer connector 30 also includes a skirt 52 that extends downwardly from the base member 48 and generally includes internal threads 56 or other features for securing the connector 10 to another medical device. The skirt 52 tapers from a narrower upper portion thereof to a larger diameter lower portion. In some embodiments, the skirt 52 also includes an annular groove 54 inscribed in its lower portion around the periphery of the skirt 52. This annular groove 54 may be used to retain a portion of the sleeve, as will be described in further detail below.

In some embodiments, it may be desirable to provide a vent 72 (shown in FIG. 4) between the upper housing cavity 42 and a cavity 74 formed by the lower luer skirt 52. Because the outer surface of the housing 12 generally interfaces with the sleeve 20 during final assembly (and, as discussed below with respect to assembly of the medical connector 10, in some embodiments, the sleeve 20 may cover the entire outer surface of the housing 12, or nearly the entire outer surface), such venting between the upper housing 40 and the cavity 74 is beneficial to allow air, gaseous sterilant, or other gases to freely flow into and/or out of the upper housing cavity. This venting is particularly helpful when the volume is reduced when a medical instrument is inserted into the slit opening 100 of the connector 10 and the flexible member 80 expands between the outer surface of the flexible member 80 and the inner wall of the upper housing 40. The vent 72 may also allow moisture and other liquids to freely flow into and/or out of the upper housing cavity, thereby reducing the risk that large amounts of liquid may remain in the upper housing 40 and limit expansion of the flexible member 80, provide a suitable environment for growth of harmful bacteria, or otherwise adversely affect the operation of the medical connector 10. Without the vent, the medical implement so inserted may encounter resistance, creating undue wear on the flexible member 80 and requiring additional effort to use the connector 10. Similarly, a recessed vent 76 may be provided in the lower end 36 of the luer skirt 52 to allow air or other gas to escape from the interior of the luer cavity 74 when the connector 10 is attached to another medical device. In addition, the recessed vent 76 allows air or other ambient gases to enter the luer cavity 74 when the other medical device is removed from the medical connector 10 so that the medical device does not become vacuumed and locked to the medical connector 10. The recessed vent 76 also allows water, cleaning or disinfecting solution, or other fluid to escape from the luer cavity 74 when the medical connector 10 is connected to another medical device. In some embodiments, it may be desirable to provide a vent on the sleeve 20 itself.

Referring to fig. 7-11, in some embodiments, the soft clip medical connector includes a housing formed from more than one housing portion. In the illustrated embodiment, the housing is shown formed by a first housing portion 41 and a second housing portion 51. Fig. 7 illustrates an exploded view of a two-piece housing. Fig. 8A and 8B are perspective views of the first housing portion 41, and fig. 9A and 9B are perspective views of the second housing portion 51.

In some embodiments, a two-piece housing may include many or all of the structural features of the housing shown in fig. 2-6 and described above. In other embodiments, the housing may comprise more than two pieces. The two-piece housing shown in fig. 7-11 includes raised ears 71 for receiving a threaded medical connector such as a luer connector of a medical device such as a syringe. The first housing portion 41 also includes longitudinal slots 49 oriented approximately 180 deg. with respect to each other. In some embodiments, a different number of slots or ridges may be provided and the slots or ridges may have a size or location. The first housing portion 41 has an upper cavity 43 for receiving the flexible member 80. The second housing portion 51 includes a threaded luer cavity 59. In addition, the second housing portion may include recessed vent holes 77 located in the lower surface of the luer cavity 59. Said second housing part comprises an inner cannula 53, said inner cannula 53 comprising a chamber 55 extending through said second housing part 51. Also, the second housing portion may include a vent 57 between the first housing portion 41 and the second housing portion 51. Furthermore, the dimensions of the two-piece housing may also be in accordance with the ranges discussed above with respect to the one-piece housing 12 embodiment shown in fig. 2-6. Thus, in some embodiments of the medical connector, the two-piece housing may be used interchangeably with the one-piece housing.

The upper and lower two-piece housings shown in fig. 7-11 may also include additional features. For example, the two-piece housing may include various alignment and connection features to facilitate assembly of the first housing portion 41 and the second housing portion 51 into a complete housing. For example, for alignment, the second housing portion may include at least one protuberance 65 and the first housing portion includes at least one corresponding recess 63. As shown in fig. 7, the ridges 65 and side walls 63 serve to align the first housing portion 41 and the second housing portion 51 in the proper orientation during assembly of the housing. To maintain the housings in the connected orientation, the first housing portion 41 includes at least one tab 89 and the second housing portion 51 includes at least one recess 85 for receiving the tab 89. As shown, the tab 89 has a wedge-shaped profile including a lead-in surface and an interference surface, such that the lead-in surface facilitates insertion of the tab 89 into the recess 85 and the interference surface prevents removal of the tab 89 from the recess 85. Although described and illustrated herein with respect to a particular configuration, it is contemplated that other alignment and connection features may be used to connect the two housing portions 41, 51.

In the housing shown in fig. 7-11, assembling the first and second housing parts 41, 51 creates a space 61 between the two housing parts 41, 51. The space 61 may be advantageously sized and configured to retain one end of the flexible member 81. Thus, in this configuration, the loop portion 60 for the one-piece housing 12 (fig. 2-6) need not be present in a two-piece housing to reduce sliding of the housing relative to the flexible member 80 thereon. To further reduce slippage of the flexible member 80 relative to the housing, the region of the first housing portion adjacent the ears 71 may include recesses 73 for receiving an adhesive to adhere the flexible member 80 to the housing. The adhesive and the housing material should be selected to be compatible with each other. For example, a silicon-based adhesive may be used to bond a glass-reinforced thermoplastic polyester resin housing to a silicone rubber sleeve 20. In addition to the aforementioned reduction in slippage, the two-piece housing shown in fig. 7-11 is manufactured in two separate one-step molding processes, which is faster and less expensive to manufacture than the two-step molding process required to manufacture a more complex single housing.

As shown in fig. 12-14, in some embodiments, the valve member 14 and the sleeve 20 are formed as a unit in the flexible member 80. The flexible member 80 is shown removed from the housing 12 for purposes of emphasis. Some embodiments of valve member 14 have a sealing body 82 in the form of a flat plate-like structure that is relatively thin in one dimension and relatively wide in another dimension. The valve member 14 is used to selectively seal the connector. The term "seal" is used herein for convenience to refer to a structure that is capable of impeding fluid flow, but does not necessarily indicate that such structure, alone or in combination with other structures, forms a barrier that completely blocks fluid flow. In some embodiments, the body 82 includes a lateral extension 84 that projects laterally from the body 82. The body 82 may also include a flat, generally rectangular neck 86 and a transverse flange 90. In some embodiments, the sleeve 20 is integral with the flange 90 and is axially remote from the seal body 82.

The neck 86 is positioned between first and second lateral extensions 84, each of which has a shoulder 92 that includes those portions of the lateral extension that are closest to the flange 90. Thus, the body 82, neck 86, flange 90 and sleeve 20 may form an integral unit. The body 82 is generally configured to include a narrow passage or slot 94 extending through the entire body 82. The entire body 82 through which the slit 94 typically extends includes the neck 86 and the flange 90. In fig. 14, the vertical cross-section coincides with the vertical plane of the slit 94, showing the horizontal width of the slit 94 at the upstream and downstream ends in this dimension. The slit 94 also includes tapered sides 95 and a narrower neck 97. Fig. 13 illustrates the narrow slit 94 in a cross-sectional view orthogonal to the cross-sectional view shown in fig. 14.

The valve member 14 is inserted into the cavity 42 of the housing 12 as will be described more fully below. The slit 94 is generally sized and shaped to fit into a cannula of a syringe or other medical device therein. The connector is adapted to receive an ANSI standard luer syringe end. In some embodiments, the configuration of the slit 94 assists in creating a valve that exhibits positive flow characteristics.

The slit 94 extends from the slit opening 100 in the flange 90 to an intake chamber 102, the intake chamber 102 being formed at a downstream end of the body 82 opposite the flange 90. In some embodiments, the intake chamber 102 may be substantially cylindrical and centered on an axis that is substantially parallel to or collinear with the longitudinal axis of the valve member 14. The intake chamber 102 may also be provided with an enlarged outer diameter portion 104 (as shown in fig. 14) for assisting in positioning the intake chamber 102 on the inner cannula 50 of the housing 12 and for avoiding unduly reduced fluid flow cross-sections after the flexible member 80 has been so positioned.

As shown in FIG. 13, some embodiments of the slit 94 are substantially planar and have a very small thickness in the undisturbed state (i.e., when a syringe cannula is not inserted into the valve member 14). Such that the slit 94 forms a selectively restricted fluid flow path from the slit opening 100 to the intake chamber 102. The flow path preferably allows no fluid, or a clinically negligible amount of fluid, to flow through the flexible member 80 under different standard fluid pressures for patient treatment.

The slit 94 generally serves to provide a sealable fluid flow path between the slit opening 100 and the introduction chamber 102. In some embodiments, the slit 94 may be configured as shown and described herein, or as shown and described in any of the patents and applications incorporated by reference herein. The slits 94 are typically made with substantially no spacing between adjacent faces of the slits. Examples of methods of making suitable seal configurations are described in further detail below.

In the embodiment shown in FIG. 12, the lateral extension 84 generally comprises a polygonal, angular shape, although other suitable shapes may be used in view of particular design goals. The lateral extension 84 is generally used to provide structure that interacts with portions of the housing 12 in order to maintain the valve member 14 in proper orientation within the housing 12. As shown in fig. 12, a pocket 110 may be formed on a planar surface of the lateral extension 84. In other embodiments, the pocket 110 may be formed on another surface of the valve member 14, or in these other embodiments, the valve member 14 does not include the pocket 110. The pocket 110 is used to retain and position the valve member 14 and the lateral extension 84 during molding and assembly of the connector, as will be described further below.

In the embodiment shown in fig. 13 and 14, the sleeve 20 extends axially from a transverse flange 90 of the valve member 14 to an opposite end of the flexible member 80. The sleeve 20 includes a first section 112 having a first diameter D1 substantially corresponding to the diameter of the transverse flange 90, and a second section 114 having a second, slightly larger diameter D2. In some embodiments, the length of the first section 112 having the first diameter D1 is approximately equal to the distance between the upstream end 16 of the housing 12 and the upper ring 60a of the housing 12. The second section 114 of the sleeve 20 is generally equal in size to, or slightly smaller than, the diameter of the narrowest portion of the hourglass-shaped housing. Thus, when the sleeve 20 is inverted and spread to encompass the housing 12, the sleeve 20 will adhere well to the outer surface of the housing 12 along substantially the entire length of the housing.

To retain the sleeve 20 in an inverted position about the housing 12, retaining structure may be provided on the sleeve 20 to engage portions of the housing 12. Such retaining structures may include any of a variety of structures, such as protrusions, ribs, ridges, and constrictions. In the embodiment shown in fig. 12-14, the sleeve 20 includes a plurality of protrusions 120. In other embodiments, a continuous longitudinal fin may be used in place of the protrusion. This continuous ridge tends to catch when the sleeve is turned inside out, causing wrinkles and irregularities in the outer surface of the final assembled device. Thus, multiple rows of protrusions 120 as shown in FIG. 12 are used in many embodiments to present the sleeve 20 more smoothly on the outer surface of the housing 12. These rows are typically configured such that adjacent projections abut one another without deforming the sleeve 20 when the sleeve 20 is inverted. Each of the protrusions 120 may have a number of shapes, including rectangular, circular, and/or oval shapes.

The projections 120 may be configured in annular rows that are generally configured to conform to the spacing between the various rings of the ring portion 60 of the housing 12. The length of each row is generally sized so that the projections are located between the linear flanges 62 of adjacent slots 46. In other embodiments, the sleeve protrusions 120 and/or the collar portion 60 and the flange 62 of the housing 12 may be configured in any manner of cooperative structure to retain the sleeve 20 from axial and/or rotational movement with respect to the housing 12. For example, in some embodiments, the cannula 20 also includes a recess or window 126 for receiving and enclosing a portion of the housing, such as the luer lock 70 (FIG. 1). In other embodiments, as discussed above with respect to the two-piece housing shown in fig. 7-11, the housing does not have a ring portion 60, and thus the flexible member need not have a protrusion (e.g., fig. 16-18).

In the illustrated embodiment, the sleeve 20 includes a constriction 122 surrounding an opening 124 of the sleeve 20. The constriction 122 generally comprises a section of the sleeve having a reduced diameter compared to the second section 114. The constriction 122 is operable to engage a feature on the housing 12, such as the annular groove 54 (see fig. 24 and 25), when the sleeve 20 is inverted onto the housing 12. In other embodiments, the constriction 122 may be used to engage the space 61 between the first housing portion 41 and the second housing portion 51 and be maintained by the space 61 between the first housing portion 41 and the second housing portion 51 (see fig. 10 and 11).

As previously mentioned, some embodiments of cannula 20 may be configured with one or more windows 126 to receive and enclose one or more structures on the housing such as tabs 70 (also referred to as luer lugs), or sized to receive a standard luer connector. In these embodiments, the window 126 may be molded to include thicker edges to prevent undue tearing of the sleeve material during assembly or use.

Moreover, as previously mentioned, in some embodiments the sleeve 20 is not integral with the valve member 14. The sleeve 20 may also be made by: adhered, coated, or otherwise provided with a suitable gripping area on the outer surface of the housing 12 (instead of mechanically spreading a separately formed sleeve member over the outer surface of the housing 12). The sleeve 20 may also be shaped as a band or clip that extends only from around a portion of the housing 12 where a medical practitioner's fingers may be expected to grip the connector 10. Furthermore, in some embodiments, the connector 10 may be constructed without the ferrule 20.

In the embodiment shown in fig. 16-18, the flexible member 81 includes at least one hardened rib 87, the rib 87 being oriented substantially along the longitudinal axis of the valve member 14 and extending transversely to the planar surface of the transverse extension 84. Fig. 16 shows a perspective view of a different embodiment of the flexible member comprising two hardened fins 87, and fig. 17 and 18 show cut views of the flexible member 81 shown in fig. 16. In the illustrated embodiment, the flexible member 81 is adapted to be assembled with a housing lacking the collar 60 when the flexible member 81 does not include any protrusions 70 (see fig. 12-14). In other embodiments, the flexible member 81 may include both hardened ribs 87 and protrusions 120 for application to a housing having a collar 60 as shown in FIG. 2.

The hardened ribs 87 may provide resiliency and durability to the valve member. In some embodiments, the ribs 87 help the valve member 14 resist buckling substantially longitudinally when a medical implement is introduced into the slit opening 100. Such buckling may block or restrict fluid flow, preventing the connector from closing, or otherwise causing some degree of inconsistent operation. Because this tendency for buckling may be exacerbated by aging and repeated cycling of the medical connector, the hardened ribs may greatly extend the life expectancy of valve member 14 in the medical connector. In some embodiments, additional structure and/or materials may also be used in the medical connector 10, either in combination with the hardened ribs 87 or in the absence of the hardened ribs 87, to resist buckling of the valve member. For example, the valve member 14 may alternatively be made of a material that is flexible enough to allow insertion of a medical implement into the slit opening 100, but stiff enough to resist buckling from repeated cycling. Also, a balance between flexibility and valve life and resistance to buckling is required, which can be achieved by selecting a valve member 14 of an appropriate thickness (using a relatively thicker material for the valve member 14 increases valve life and buckling resistance at the expense of flexibility and ease of insertion of medical implements into the slit opening 100). For example, in some embodiments, the thickness of the wall of the valve member 14 may be about as thick across most, almost all, or all of its outer surface area as the thickness of the wall of the valve member 14 plus the hardened bead. In some embodiments, the thickness of the wall of the valve member 14, in at least some areas, is at least as large as the diameter of the introduction chamber 102, or at least about 11/2-2 times the diameter of the introduction chamber 102.

Fig. 19-21 illustrate a flexible member 83 for another embodiment of a soft clip medical connector that is adapted to extend the useful life of the valve member. Fig. 19 is a perspective view of the flexible member 83. As shown in fig. 19, the flexible member 83 may support many of the internal components of the flexible members 80, 81 of the other embodiments discussed above (including, but not limited to, those shown in fig. 19-21). For example, the flexible member 83 includes a valve member 153 and a sleeve 165. In some embodiments, the sleeve 165 includes a protrusion 157 for coupling with a corresponding flange on a housing. The sleeve 165 includes a constriction 161 surrounding the opening 163. The sleeve may include one or more windows 159 to receive and enclose one or more tabs 70 or other structures on the housing. The flexible member includes a transverse flange 155, a neck 167, and a transverse extension 169. As shown in fig. 20 and 21, the flexible member 83 includes an inlet chamber 173 having a downstream opening 151.

As shown in fig. 20 and 21, which show cut views of the flexible member 83 shown in fig. 19, the internal structure of the flexible member 83 of the embodiment shown in fig. 19-21 may not include some of the features of the flexible members 80, 81 of the other embodiments shown herein. The valve member 153 of the flexible member includes a pair of opposing sidewalls 177, 179 that intersect at the upstream end of the valve member 153 to form a slit 171 for insertion of a medical implement. In an undisturbed state, the slit 171 sealingly closes the medical device to prevent fluid from passing therethrough. In the downstream direction, the side walls 177, 179 diverge so that, in the undisturbed state, the passage 175 defined by the valve member has a non-zero volume. Thus, unlike the previously described embodiments of flexible members 80, 81, such flexible member 83 need not have a substantially flat channel in an undisturbed state.

In some embodiments, such a non-zero volume channel 175, in an undisturbed state, prevents the flexible member 83 of the illustrated embodiment from exhibiting positive flow characteristics when a medical implement fully inserted into the slit 171 is removed in some instances. This configuration of the channel 175 also has several other advantages. As previously described, the flexible member 83 resists buckling. The diverging of the sidewalls 177, 179 enhances the durability of the valve member 153 compared to the flat sidewalls of the flexible members 80, 81 of other embodiments.

In addition, the slit 171 of the flexible member 83 has a relatively small contact area between the sidewalls 177, 179. The relatively small contact area will cause a correspondingly small resistance to flow in the undisturbed state. Thus, by only partially inserting the medical implement into the passageway, or even merely placing the medical implement adjacent to, rather than into, the slit 171, flow through the valve member can be initiated quickly. Thus, the tip of the instrument or the pressure of the fluid flow will break the contact of the side walls 177, 179 at the slit 171 to open the valve. Advantageously, when a medical implement is used partially inserted, or just adjacent to a point of contact, the valve member 153 will exhibit a positive flow characteristic when the internal volume of the passage 175 in the undisturbed state is less than the internal volume of the passage in the partially inserted state.

Moreover, if, in the illustrated flexible member 83, the channel 175 does not provide a positive flow feature when the medical implement is fully inserted, the channel 175 of the flexible member 83 need not include a region of relatively large width. Thus, the channel 175 and the lateral extension 169 of the flexible member 83 may be relatively narrow. Accordingly, the housing may have a relatively small diameter compared to a forward flow medical connector. Thus, a reduction in material cost and connector weight may be achieved by using the flexible member 83 of the non-forward flow embodiment.

Some embodiments of methods for manufacturing the valve member 14 of the flexible connectors 80, 81 will now be discussed with reference to fig. 12-18. In general, the valve member 14 used in the present system may be manufactured according to any suitable process available to those skilled in the art. In some advantageous embodiments, the valve member 14 is constructed by molding first and second "preforms" 130, and then the first and second "preforms" 130 are placed in a second mold facing each other. The preform 130 is then overmolded in a separate molding process to form an integral flexible member 80 having portions of the valve member 14 and the sleeve 20, such as those illustrated and described herein.

In one embodiment, valve member 14 may be molded according to the general procedure described in U.S. patent application publication No. 2004/0006330. A pair of preforms are molded between the first and second mold pairs. After this initial molding step, the counter forms, with the preforms still inside, are stamped together by a clad steel sheet located between the counter forms. The clad steel sheet is typically used to make the final shape of the valve member 14. When the mold assembly (including the preform mold pair and clad steel plate) is fully assembled, additional uncured material is then poured into the mold assembly to fill the additional space in the mold cavity created by the clad steel plate, thereby forming the remainder of the valve member 14. In some embodiments, the method of cladding described in the' 330 publication is suitable for forming the valve member 14 described herein as being integral with the sleeve. Alternatively, a valve member 14 may be molded according to the method of the' 2004/0006330 patent, and the sleeve 20 may be subsequently attached to the valve member 14 by any suitable process, such as molding, welding, or gluing.

An embodiment of another cladding method is provided with reference to fig. 15. According to this method, preforms 130 are molded and completely removed from their mold prior to the preform overcladding and joining steps. Fig. 15 shows an embodiment of a preform 130 for forming a valve member 14. Each preform 130 has a generally flat front face 132 which, in a completed valve member 14, forms the walls of the slit 94. A flange portion 134 is also molded integrally with each preform front face 132. The sides of the flange portions 134 may be provided with a space 136 from behind the front face 132 of the flat portion to allow the overcladding material to flow between and join the two flange portions 134 of the two preforms 130. Molding the preform 130 is generally accomplished by infusing a thermosetting material into the cavity formed between the mold pair and heating the mold and/or material to the set temperature of the particular material used. Pressure may be used when it is desired to prevent material from leaking between peer models (not shown) of the preform. In some embodiments, preform 130 may be provided with pocket 110 on backside 138 opposite front side 132.

After each preform 130 is molded, it may be removed from the preform mold and placed in an overmold. The overmold is typically used to form the final desired valve member/sleeve structure 80. In some embodiments, the overmold includes first and second opposing portions. Each half may include pins that position preform 130 into the overmold by aligning the pins with pockets 110 in preform 130.

Once the preforms are properly placed into the peer overmold, the peer overmold may be brought together and an uncured overmold material may be poured into the mold cavity. In some embodiments, the additional (overcladding) material is injected very quickly (i.e., a few seconds) after the preforms 130 are molded and while they are still somewhat hot from the initial molding. The extra material poured into the mold cavity bonds to the edges of the preform 130 and forms the edges of the slit 94 in the completed valve member 14 and sleeve 20. In this way, the remainder of the valve member 14 and the sleeve 20 are overclad and integral with each other and with a pair of preforms formed in an overcladding step.

In some embodiments, the preforms 130 are pressed together during the overcladding process with sufficient force to prevent the overcladding material from moving between the contacting surfaces of the preforms 130. This protects the openness of the slit 94 by preventing the contacting surfaces of the preforms 130 from sticking to each other during the overcladding step.

In other embodiments of this method, additional material flows between and bonds the preform contact surfaces to each other. The valve member 14 can then be reopened by inserting a blade between the preforms, thereby cutting open the slit 94. In another embodiment, the entire valve member/sleeve structure may be molded in one process step (i.e., without the use of pre-formed slits), and the slits 94 may be subsequently formed by inserting a blade into a solid valve member segment. In another alternative embodiment, the sleeve 20 and valve member 14 may be separately preformed and then adhered to one another, such as by cladding, welding, or the use of an adhesive.

In some embodiments, the material added to the overcladding step is similar to the material used to mold the preform 130. However, in other embodiments the preform material and the overcladding material may comprise different but suitable materials for making the valve member 14 and the sleeve 20.

Generally, the sleeve 20 is generally made of a material that is sufficiently flexible to allow the sleeve 20 to be inverted and spread around the housing 12, yet sufficiently resilient to tightly hold the housing 12 in the inverted orientation. Likewise, the valve member 14 is typically made of a material that is sufficiently flexible to allow a cannula to be inserted therein to open the slit, yet sufficiently resilient to close the valve member 14 once the cannula is withdrawn. In some embodiments, the valve member 14 and the sleeve 20 may be formed as a unit from a resilient material such as silicone rubber. In a preferred embodiment, the valve member 14 and the sleeve 20 may be molded as one piece from 50 durometer silicone rubber. Alternatively, the valve member 14 and sleeve 20 may be formulated from synthetic polyisoprene, other silicone rubber and/or ethane, or other materials acceptable for medical use. In some embodiments, the sleeve 20 may be molded from a first material and the valve member 14 may be molded from a second, different material.

Flexible members 83 (fig. 19-21) of some embodiments that do not include a forward flow feature may be more efficiently manufactured. The manufacture of the flexible member 83 shown in fig. 19-21 can be accomplished in fewer steps and therefore at a lower cost than other embodiments featuring a forward flow function. The relatively small contact area between the sidewalls 177, 179 facilitates the manufacture of the flexible member 83 of the embodiment shown in fig. 19-21.

Referring now to fig. 22-25, some embodiments of a method of assembling the soft clip medical connector 10 will be described. The valve member 14 may be inserted into the upper housing cavity 42 portion of the housing 12 by: the lateral extension 84 is partially folded or compressed inwardly and the valve member 14 is pushed into the upper housing cavity 42 until the compressed or folded lateral extension 84 reaches the slot 46 and is decompressed or stretched out and out of the housing 12 through the slot 46. In some embodiments, a machining tool may be used to grip the lateral extension 84 and pull the valve member 14 into the upper housing cavity 42. In some of these embodiments, the tool may be used to engage a pocket 110 in the lateral extension 84 to grip and pull the valve member 14. When the lateral extension 84 is aligned and pulled or pushed through the slot 46, an additional downward force may be applied to slightly extend the valve member 14 and cause the shoulder 92 to engage the top edge 140 of the slot 46. In this manner, a preload (described in further detail below) may be applied to the valve member 14. This downward force also causes the introduction chamber to more securely engage the inner cannula 50 in the housing 12.

Once the valve member 14 is fully inserted into the upper housing 40 (as shown, for example, in fig. 25), the sleeve portion 20 can be inverted and spread over the housing 12. This may be done using any suitable tool. The sleeve 20 may also be gripped by a person's finger and pulled outwardly and downwardly in the direction of arrow 146 in fig. 23. The projections 120 are generally aligned with the spaces between the collar portions 60 of the housing 12 when the sleeve 20 is inverted. If a window 126 is provided, it is also aligned with the tab 70 so that the tab 70 passes through and extends beyond the flexible member 80.

When a cleaning solution or other liquid is applied to the medical connector 10, the liquid may seep around the protrusion 70 between the cannula 20 and the housing 12, thereby causing the cannula to slide relative to the housing 12 and making it more difficult for a medical practitioner to grip the outer surface of the medical connector 10. To reduce the risk of the sleeve 20 slipping or separating from the housing 12, the sleeve 20 may be bonded to the housing 12. Furthermore, in various embodiments, the sleeve 20 may be stretched over an annular groove 54 (fig. 24) or sandwiched between the spaces 61 between the housing portions 41, 51 (fig. 10, 11) to reduce the risk of slippage. An adhesive may be applied to either the housing 12 or the ferrule 20 at the contact location between the housing 12 and the ferrule 20 of an assembled connector 10 before the ferrule 20 is inverted and spread over the housing 12. For example, in some embodiments, the housing may include a recess 73 (FIG. 11) adjacent the luer lug 71, to which an adhesive may be applied. Alternatively, the adhesive may be applied to the outer surface of the housing 12.

Preferably, the housing 12, sleeve 20, and adhesive are selected from compatible materials to reduce the risk of material degradation due to the application of the adhesive. For example, sleeve 20 may be made of silicone rubber, bonded to housing 12 using a silicone-based adhesive, such as an adhesive comprising dimethylpolysiloxane. In certain embodiments, the binder may require a mixture of two components, at least one of which includes a catalyst such as a platinum-based catalyst. In certain embodiments, the adhesive may require curing, for example, by heating the adhesive to a set temperature for a set period of time. To achieve material compatibility with the silicone-based adhesive, the housing 12 may be made of a glass-reinforced thermoplastic polyester resin, e.g., glass-filled ValoxManufactured by General Electric Company, which includes about 30% glass filler. In some embodiments, housing 12 may be made of a polycarbonate material, although in some cases polycarbonate may not be compatible with a silicon-based adhesive.

Fig. 24 and 25 illustrate a cross-sectional view of one embodiment of the fully assembled soft clip medical connector 10. In the illustrated embodiment, the cannula 20 completely surrounds the housing 12, including the upper housing 40, the ring portion 60, and most of the luer skirt 52. However, it is contemplated that in other embodiments, the sleeve may extend over a portion of the housing 12. For example, in certain embodiments, the sleeve may extend from the upstream end 16 of the housing 12 down to between about one-half of the height of the upper housing 40 and the entire upper housing 40. In other embodiments, the sleeve 20 may extend from the upstream end 16 of the housing 12 down to between about one-quarter of the height of the upper housing 40 and about one-half of the height of the upper housing 40. Likewise, in the embodiment of the medical connector 10 including a two-piece housing as shown in fig. 7-11, in various embodiments, the cannula 20 may surround a portion of the first housing portion 41, a majority of the entire first housing portion 41, the entire first housing portion, and a portion of the second housing portion 51, or the entire first housing portion 51, and a majority of the entire second housing portion 51. The sleeve 20 may also surround a lateral extension 84 that protrudes through the slot 46 of the housing 12.

Fig. 24 and 25 illustrate an example of an assembled connector in a sealed state (i.e., a state in which fluid flow through the connector is prevented). Valve member 14 is positioned in upper housing cavity 42 of housing 12 with first and second lateral extensions 84 of valve member 14 extending from first and second slots 46 in housing 12. The inlet chamber 102 of the valve member 14 is positioned so that the inner cannula 50 extends at least halfway into the inlet chamber 102 of the valve member 14 with the connector in the open position (as shown in fig. 15 and 16) facilitating fluid communication between the valve member 14 and the luer cannula 32. The flange 90 covers the axial opening at the upstream end 16 of the housing 12.

A cannula 20 located on the outer surface of the housing 12 provides a more comfortable and effective grip of the connector 10 by a medical practitioner. The flexible material of the sleeve 20 provides a softer surface for fitting to a finger. A better high friction interface between the flexible material of the cannula 20 and the rubber gloves typically worn by medical personnel requires less finger pressure to screw the connector 10 onto a catheter or other instrument to hold the connector 10 in place and orientation during connection and fluid management.

In addition to providing a soft, easily gripped outer surface, the outer face of the sleeve 20 surrounding the housing 12 protects the lateral extension from being crushed or improperly handled during handling and use of the connector. In one embodiment, the valve member 14 and the housing 12 are configured such that the distance between the upstream end 16 of the housing 12 and the top edge 140 of the slot 46 is slightly greater than the distance between the flange 90 of the valve member 14 and the shoulder 92 of the lateral extension 84. This configuration will result in a tension or preload being applied to the valve member 14 between the flange 90 and the lateral extension 84.

Preloading occurs when the shoulder 92 abuts the top edge 140 of the housing and the sealing flange 90 abuts the upstream end 16 and/or the axially open shoulder 142 of the upstream end of the housing. In some embodiments, this preload causes the flange 90 to assume a somewhat bowl-shaped or concave profile as the edge of the upstream end of the housing abuts the underside of the flange 90. The bowl-shaped flange 90 tends to grip the closed slit opening 100 more tightly and thereby enhances the ability of the valve member 14 to block fluid flow. This preload also prevents the valve member 14 from buckling along its longitudinal axis and keeps the sides of the slit 94 close to each other along their entire length. The preload thus promotes the relative fineness of the slit 94 under the flange 90, which enhances the sealing performance of the slit 94. In some embodiments, the distance between the shoulder 92 and the opening 148 of the inner cannula 50 is sized such that the intake chamber 102 of the valve member 14 engages and seals to the inner cannula 50 of the housing 12.

Referring to fig. 26 and 27, during use of the connector 10, a cannula 200 of a medical device 202, such as a syringe, may be inserted into the valve member 14 of the connector 10, thereby opening the valve member 14 to fluid flow 204 between the medical device 202 and the luer cannula 32 of the connector 10.

Before the cannula 200 is inserted, the connector 10 is in a sealed state (as shown in fig. 24 and 25). In this state, the slit 94 defines a substantially closed or height-limited flow path through the valve member 14. As shown in FIG. 16, when cannula 200 is inserted through the slit 94, valve member 14 opens a fluid flow path within connector 10 while exerting an inwardly directed force on cannula 200 of medical device 202, preferably forming a tight seal around the circumference of cannula 200 to prevent leakage of fluid past the upstream end of the connector 10. Inserting the cannula 200 into the valve member will also cause the valve member 14 to spread in the downstream direction over the inner cannula 50.

As fluid is injected from the medical device 202, through the cannula 200 and into the interior space of the valve member 14, the space also increases between the slit walls 206, and the slit walls 206 also extend and lengthen in the downstream direction. The valve member 14 thus selectively allows fluid 204 to flow between the medical device 202 at the upstream end of the connector 10 and the medical implement (not shown) to which the lower luer connector 30 is attached.

As shown in fig. 26 and 27, the connector 10, when in the open position, provides a more substantially unobstructed and linear flow of the fluid stream 204. This generally allows the connector to achieve higher flow rates. In some embodiments, the fluid flow rate through the connector 10 can exceed 600 cubic centimeters per minute. In addition, the unobstructed and linearly flowing liquid stream 204 interferes very little with the inherent properties of the flowing liquid stream 204. For example, if the fluid stream 204 is blood, there is less likelihood that various blood cells and other components will be damaged in the illustrated connector 10 than in a connector having a tortuous fluid flow path therein, which would impinge violently on its hard and/or angular inner surface.

When the flow 204 decreases and/or the cannula 200 of the medical device 202 is withdrawn from the valve member 14, the slit walls 206 retract and return to their original configuration to again define a narrow, restrictive flow path width therebetween (e.g., as shown in fig. 24 and 25). Retraction of the slit wall 206 causes the volume within the slit 94 to decrease to a specified minimum. The retracting action of the slit walls 206 also forces out fluid remaining in the area between the walls 206. When the syringe cannula 200 is withdrawn, the displaced fluid cannot flow out of the slit 94 through the upstream end of the valve member 14 because this space is occupied by the syringe cannula 200. By forming a tight seal around the circumference of the cannula 200, the resilient narrow neck 97 of the slit 94 properly blocks any substantial fluid flow between the outer surface of the cannula 200 and the inner surface of the flexible member 80. Thus, the displaced fluid is instead forced downward from the slit 94, through the inner cannula 50 and downward toward the cannula 32, and eventually out of the housing 12. This advantageously causes an automatic forward flow from the connector 10 to the patient when the medical device 202 is withdrawn from the upstream end of the connector 10, and avoids or minimizes back-flow of fluid toward the connector 10 and away from the patient.

Although the foregoing description refers to a syringe, any type of suitable medical device may be attached to either end of the connector 10, such as an IV bag, other connectors, and tubing, for the purpose of transferring fluid or for any other desired purpose. An auxiliary connector may also be connected to the soft clip connector and both connectors may be in fluid communication with a catheter positioned at one end in the patient. This arrangement may provide several advantages in situations where it is desirable to use a single auxiliary connector. For example, when it is desired to replace or reconfigure a fluid line connected to the auxiliary connectorIn the event that the lines are removed from the fluid carrying conduit without creating a reflux in the conduit, they may be replaced with a similar conduit or any other medical device. In some embodiments, one such auxiliary connector may be CLAVE sold by ICU MEDICAL INCA connector is provided. However, any connector or other medical instrument or device may be in fluid communication with the soft clip-on connector 10 for introducing fluid into or withdrawing blood from a patient, including without limitation, a pierceable connector, a needleless connector, a medical tube, a syringe, or any other medical instrument or device.

While certain embodiments and examples have been described herein, it will be apparent to those of ordinary skill in the art that many of the aspects of the methods and apparatus shown and described in this disclosure can be variously combined and/or modified to form yet other embodiments. For example, the housings of the different embodiments may be interchangeably applied to the flexible members of the different embodiments to achieve various embodiments of soft clip medical connectors. Further, the methods described herein may be practiced using any apparatus suitable for performing the described steps. These other embodiments and/or the methods and apparatus used as described above, and obvious modifications and equivalents thereof, are intended to be within the scope of the present disclosure. Accordingly, the scope of the invention should not be limited by the specific embodiments described above, but should be determined by reference to the appended claims.

Claims (34)

1. A medical connector for selectively flowing fluid at a high flow rate between a first medical device and a second medical device having a standard medical luer end at a first end thereof, the medical connector comprising

A housing comprising an upstream end adapted to receive the second medical device, a downstream end with an interface configured to receive the first medical device, and an outer surface, a base member with an annular surface, an upper housing cavity extending from the upstream end of the housing to the annular surface of the base member, and an inner cannula extending from the annular surface toward the upstream end of the housing, the inner cannula having a height defined by a distance between the annular surface and an upstream end of the inner cannula, the upstream end of the housing having a circular, rigid, and continuous periphery; and

a valve member positioned at least partially within the housing and configured to control a flow of fluid through the housing, the valve member including a sealing element made of a flexible material having a downstream end, an upstream end configured to receive at least a portion of the second medical device, and a through-closed channel fluidly coupled to the downstream end of the sealing element and the upstream end of the sealing element, the sealing element including a first sidewall and a second sidewall, the second sidewall being opposite the first sidewall;

wherein the medical connector is configured such that when a portion of the first end of the second medical device is fully inserted into the passageway, a distance between a lead-in surface of the luer end at the first end of the second medical device and the upstream end of the inner cannula is substantially equal to an inner diameter dimension of the inner cannula;

wherein the valve member further comprises an introduction chamber at the downstream end of the sealing element for fitting onto an outer surface of the inner cannula such that when the valve member is in a closed state, the downstream end of the sealing element is separated from the annular surface of the base member by a first distance, and wherein when the portion of the first end of the second medical device is inserted into the channel, the downstream end of the sealing element slides in a downstream direction along the outer surface of the inner cannula such that the downstream end of the sealing element is separated from the annular surface of the base member by a second distance, the first distance being greater than the second distance;

wherein the valve member further comprises a transverse flange having a slit opening from which the transverse flange is in fluid communication with the passage.

Wherein each of the first and second sidewalls includes a portion having a lateral thickness greater than the lateral flange thickness.

2. The connector of claim 1, wherein the housing comprises an hourglass-shaped profile.

3. The connector of claim 1, wherein the housing comprises: an upstream housing portion comprising the valve member; and a downstream housing portion for matable connection to the upstream housing portion.

4. The connector of claim 1, wherein the housing includes a protrusion on an upper portion thereof for engaging internal threads of a luer connector to secure the second medical device to an upstream end of the connector.

5. The connector of claim 1, wherein the housing is made of a polycarbonate material.

6. The connector of claim 1, wherein said housing is made of glass reinforced thermoplastic polyester resin.

7. The connector of claim 1, wherein the connector comprises an hourglass-shaped profile.

8. The connector of claim 1, wherein the sealing element is made of silicone rubber.

9. The connector of claim 1, wherein the valve member includes a feature configured to interact with a feature of the housing to limit movement of the valve member relative to the housing.

10. The connector of claim 1 wherein the housing further comprises at least one vent between the upper housing cavity and the luer lock cavity in the housing.

11. The connector of claim 1, wherein the lower surface of the housing includes at least one vent for allowing airflow into and out of the luer lock cavity of the housing when the lower portion of the connector is connected to the first medical device.

12. The connector of claim 1, wherein the valve member is made of silicone rubber.

13. The connector of claim 1, wherein the valve member is to apply pressure to a volume of fluid passing down the inner cannula when the second medical device is removed from the upstream end of the housing.

14. The connector of claim 13, wherein the channel is adapted to have a relatively small internal volume in an undisturbed state and a larger volume than before when the second medical device is introduced into the channel, the channel is adapted to contract to define a restricted flow path and a relatively small internal volume when the second medical device is removed from the channel, at least a portion of the upstream end of the sealing element is adapted to begin to bear against the inserted portion of the second medical device when the second medical device is removed such that fluid occupying the internal volume is urged towards the downstream end of the sealing element when the channel contracts.

15. The connector of claim 14, wherein the passage is flat in the undisturbed state and the sealing element further comprises at least one rib on an outer surface of the sealing element, the rib projecting transversely to a plane defined by the passage and spanning longitudinally from a region proximate the upstream end of the sealing element to a region proximate the downstream end of the sealing element.

16. The connector of claim 1, wherein the valve member is glued to the housing to restrict movement of the valve member relative to the housing.

17. The connector of claim 1, wherein at least a portion of the housing has a dimension that is greater than a corresponding dimension of the valve member in an unfurled state.

18. The connector of claim 1, wherein the valve member further defines an unobstructed linear flow path when the second medical device is inserted into the medical connector.

19. The connector of claim 1, wherein the first and second sidewalls are to separate to expand the passage when fluid is flowing through the valve member.

20. The connector of claim 1, wherein the channel is to selectively allow unimpeded fluid flow therethrough at a flow rate of at least 600 cubic centimeters per minute.

21. The connector of claim 1, wherein the medical connector is configured to selectively allow an unobstructed, linear fluid flow therethrough.

22. The connector of claim 1, wherein the circular, rigid and continuous periphery of the housing extends from the upstream end toward a downstream end of the housing.

23. The connector of claim 1, wherein said medical connector is configured such that when said portion of said first end of said second medical device is fully inserted into said passageway, said distance between said lead-in surface of said luer end of said first end of said second medical device and said upstream end of said inner cannula is less than said height of said inner cannula.

24. The connector of claim 1, wherein the sealing element includes a neck positioned in a region proximate the upstream end of the sealing element, the channel being relatively narrow in the region of the upstream end of the sealing element.

25. The connector of claim 24, wherein the transverse flange extends from the neck toward the housing.

26. The connector of claim 1, wherein the upstream end and the downstream end of the housing are disposed on the same axis so as to participate in providing a straight flow path through the medical connector.

27. The connector of claim 1, wherein the first and second side walls define a contact area of an upstream end of the valve member at least when the valve member is in the closed state.

28. The connector of claim 27, wherein the contact area between the first and second sidewalls is relatively small to facilitate opening of the medical connector.

29. The connector of claim 1, wherein the passage has a non-zero volume when the valve member is in the closed state.

30. The connector of claim 1, wherein the upstream end of the housing and the downstream end of the housing are disposed on the same axis to facilitate providing a straight fluid flow path through the medical connector, wherein at least when the valve member is in the closed state, the first and second sidewalls define a contact area at the upstream end of the sealing element, the contact area between the first and second sidewalls being relatively small to facilitate opening of the medical connector, wherein the passageway has a non-zero volume when the valve member is in the closed state, and wherein the passageway is to selectively allow unimpeded flow of fluid therethrough at a flow rate of at least 600 cubic centimeters per minute.

31. The connector of claim 1, wherein at least one of the first and second sidewalls has a transverse thickness that increases in a downstream direction along a length of the sealing element.

32. The connector of claim 1, wherein the transverse flange abuts against the upstream end of the housing such that the valve member is preloaded toward a closed position.

33. The connector of claim 32, wherein the valve member includes a shoulder for engaging a corresponding edge of the housing, wherein a distance between the upstream end of the housing and the edge is greater than a relaxed distance between the transverse flange and the shoulder, such that when the shoulder engages the edge, the valve member is spread causing the transverse flange to ride over the upstream end of the housing.

34. The connector of claim 32, wherein the lateral flange has a concave profile to urge the slit opening toward a closed position when in a closed state.