Patent Description:
Various exemplary embodiments of the invention relate to catheter assemblies.

Catheter assemblies are used to place a catheter properly into the vascular system of a patient. Once in place, catheters such as intravenous catheters may be used to infuse fluids including normal saline, medicinal compounds, and/or nutritional compositions into a patient in need of such treatment. Catheters additionally enable the removal of fluids from the circulatory system and monitoring of conditions within the vascular system of the patient.

<CIT> describes an indwelling needle comprising an outer needle including a narrow tube like cannula and an outer needle body connected to the basal end of the cannula; a valve holding plates each provided within the outer needle body; a valve; a connector part; and a coil spring. <CIT>, <CIT>, and <CIT> show additional state of the art relevant for the present disclosure.

Objects of the invention are achieved with a catheter assembly as defined in claim <NUM>.

It is an aspect of the present invention to provide a catheter assembly in which a valve actuator includes a plurality of windows specifically sized and disposed to enhance saline flushing capability. Additionally, a catheter hub includes a floating spring design that improves manufacturability and performance. Finally, the catheter hub also uses one of a plurality of materials to reduce magnetic susceptibility in the spring so that the catheter assembly can be used on a patient during a magnetic resonance imaging (MRI) procedure.

The foregoing and/or other aspects of the present invention can be achieved by providing a valve actuator that moves in a catheter assembly between a first position where a valve is closed and a second position where the valve is open, the valve actuator comprising a shaft portion at a distal end of the valve actuator that is configured to pierce the valve, a mating portion at a proximal end of the valve actuator that is configured to engage a Luer device, a diameter reduction region that connects the shaft portion and the mating portion, and a plurality of windows that extend through the valve actuator for flushing fluid, the plurality of windows being disposed in the diameter reduction region, wherein each of the plurality of windows does not extend a full length of the diameter reduction region.

The foregoing and/or other aspects of the present invention can further be achieved by providing a valve actuator that moves in a catheter assembly between a first position where a valve is closed and a second position where the valve is open, the valve actuator comprising a shaft portion at a distal end of the valve actuator that is configured to pierce the valve, a mating portion at a proximal end of the valve actuator that is configured to engage a Luer device, a diameter reduction region that connects the shaft portion and the mating portion, and a plurality of windows that extends through the valve actuator for flushing fluid, wherein the plurality of windows is disposed outside the diameter reduction region.

The foregoing and/or other aspects of the present invention can also be achieved by providing a catheter assembly comprising a catheter, a needle having a sharp distal tip disposed within the catheter, a catheter hub connected to the catheter having the needle passing therethrough, the catheter hub including a valve that selectively permits or blocks a flow of fluid through the catheter, a valve actuator that moves between a first position and a second position, and a return member that returns the valve actuator from the second position to the first position, and a needle protection member that encloses the sharp distal tip of the needle, wherein the valve actuator includes a diameter reduction region having a plurality of windows, and each of the plurality of windows does not extend a full length of the diameter reduction region.

The foregoing and/or other aspects of the present invention can also be achieved by providing a catheter assembly comprising a catheter, a needle having a sharp distal tip disposed within the catheter, a catheter hub connected to the catheter having the needle passing therethrough, the catheter hub including a valve that selectively permits or blocks a flow of fluid through the catheter, a valve actuator that moves between a first position and a second position, a return member that returns the valve actuator from the second position to the first position, and a needle protection member that encloses the sharp distal tip of the needle, wherein the valve actuator including a diameter reduction region, and a plurality of windows that extends through the valve actuator for flushing fluid, the plurality of windows being disposed outside the diameter reduction region.

The foregoing and/or other aspects of the present invention can also be achieved by providing a catheter assembly comprising a catheter, a needle having a sharp distal tip disposed within the catheter, a catheter hub connected to the catheter having the needle passing therethrough, the catheter hub including an inner diameter, a valve that selectively permits or blocks a flow of fluid through the catheter, a valve actuator that moves between a first position and a second position, and a spring that returns the valve actuator from the second position to the first position, wherein a clearance fit is provided between the spring and the inner diameter.

The foregoing and/or other aspects of the present invention can also be achieved by providing a catheter assembly comprising a catheter, a needle having a sharp distal tip disposed within the catheter, a catheter hub connected to the catheter having the needle passing therethrough, the catheter hub including a valve that selectively permits or blocks a flow of fluid through the catheter, a valve actuator that moves between a first position and a second position, and a return member that returns the valve actuator from the second position to the first position, and a needle protection member that encloses the sharp distal tip of the needle, wherein the return member comprises a metallic member with a magnetic relative permeability of less than <NUM>.

Additional and/or other aspects and advantages of the present invention will be set forth in the description that follows, or will be apparent from the description, or may be learned by practice of the invention.

The above aspects and features of the present invention will be more apparent from the description for the exemplary embodiments of <FIG> of the present invention. The other figures, and their corresponding passages in the description, make reference to illustrative examples which are not claimed.

A catheter assembly <NUM>, as shown in <FIG> and <FIG>, includes a hollow introducer needle <NUM>, a catheter hub <NUM>, and a needle hub <NUM>. The introducer needle <NUM> has a sharpened distal end and extends through the catheter hub <NUM>. A flexible catheter tube <NUM> extends from the distal end of the catheter hub <NUM>, with the needle <NUM> passing through the catheter tube <NUM>. Initially, the needle <NUM> is inserted into a patient's vein. The catheter tube <NUM> is pushed along the needle <NUM> and into the vein following the needle <NUM>. After the catheter tube <NUM> is inserted, the needle <NUM> is removed from the patient's vein and the catheter hub <NUM>, leaving the catheter tube <NUM> in the patient as the needle <NUM> is discarded.

According to various exemplary embodiments, the catheter hub <NUM> has a distal end <NUM>, a proximal end <NUM>, an inner surface <NUM>, and an outer surface <NUM>. The distal end <NUM> includes a catheter opening and the proximal end includes a Luer connector opening. The inner surface <NUM> surrounds a channel <NUM> that permits fluid passage through the catheter hub <NUM>. The outer surface <NUM> includes one or more projections <NUM> to secure a Luer connector <NUM> (<FIG>) to the catheter hub <NUM>. The projections <NUM> may form a threaded connection with the Luer connector <NUM> or they may connect to the Luer connector <NUM> through a snap fit or other twisting connection. One example of a standard connection is a LUER-LOK® connection. Certain types of Luer connectors <NUM> utilize a slip fit into the catheter hub <NUM>. The catheter hub <NUM> may be made from a polymer material that is transparent or semi-transparent so that fluid flow through the catheter hub may be observed by a user or it may be made from an opaque material.

The flexible catheter tube <NUM> extends through the catheter opening. A metal wedge <NUM> may be positioned in the channel to secure the catheter tube <NUM> in the catheter opening. The wedge <NUM> has a first end engaging the catheter tube <NUM> and a second end engaging the inner surface <NUM> of the catheter hub <NUM>. The first end of the wedge <NUM> has a tapered nose that allows it to easily engage the catheter tube <NUM>. As the wedge <NUM> is inserted into the catheter tube <NUM>, the catheter tube <NUM> expands, creating an interference fit between the catheter tube <NUM>, the wedge <NUM>, and the inner surface <NUM> of the catheter hub <NUM>. The second end of the wedge <NUM> has a substantially frusto-conical shaped portion with an outer edge that engages the inner surface <NUM> of the catheter hub <NUM>. A wedge flange <NUM> may be formed on the inner surface <NUM> to create a limit for distal movement of the wedge <NUM>. A similar shoulder, tab, or groove may limit the distal movement of the wedge <NUM>.

A pre-slit resilient septum <NUM> is positioned in the channel <NUM> and functions as a valve that forms a fluid-tight seal and selectively admits fluid to or from the flexible catheter tube <NUM>. In other words, the valve selectively permits or blocks the flow of fluid through the flexible catheter tube <NUM>. The septum <NUM> may be seated against a septum flange <NUM> to limit distal movement. Protrusions or other internal structure may form an interference fit with the septum <NUM> to retain it in place or limit its proximal movement. As best shown in <FIG>, the septum <NUM> has one or more pre-formed openings or slits <NUM> designed to selectively prevent unwanted fluid flow through the septum <NUM>. The septum <NUM> preferably has three intersecting slits <NUM> forming three flaps that open when engaged by a valve actuator or a septum actuator (hereinafter actuator).

The septum <NUM> further includes a plurality of axial flow channels <NUM>. The flow channels <NUM> are disposed on an outer circumference of the septum <NUM>. Eight flow channels <NUM> equidistant from each other are illustrated, although various quantities and positions are contemplated. The flow channels <NUM> have an appropriate width and depth so that when the septum <NUM> is not opened, blood can enter and air can escape the space distal of the septum <NUM> in the front portion of the catheter hub <NUM>. At the same time, the flow channels <NUM> are sized small enough to prevent the blood from exiting past the septum <NUM> (at least for some period of time). Such a configuration is possible because the intermolecular forces in the blood are greater than the intermolecular forces in air.

The septum <NUM> shown in <FIG> may be used in any of the embodiments discussed herein. Other septum configurations may be used as would be understood by one of ordinary skill in the art. When the catheter tube <NUM> is initially inserted into a patient, and the introducer needle <NUM> is removed, the septum <NUM> prevents blood from flowing through the channel <NUM> and out of the distal end. The septum <NUM> is made of an elastic material to form the valve, for example silicone rubber. Other elastic materials may be used and non-elastic materials may be incorporated in the septum <NUM> as needed.

<FIG> depicts an exemplary embodiment of an actuator <NUM> having an actuator barrel <NUM> surrounding an internal passage 46A. Actuators similar to that of <FIG> may be used in any of the embodiments described herein. The actuator <NUM> is positioned in the channel <NUM> and is axially moveable in the channel <NUM> to engage and open the slits <NUM>. The actuator barrel <NUM> is a substantially tubular member and the internal passage 46A is substantially cylindrical to allow fluid to flow through the actuator <NUM> and through the septum <NUM> when the septum <NUM> is opened or penetrated by the actuator <NUM>. The tubular member has a distal opening 46B, one or more side openings 46C, and a distal end 46D that engages and opens the slits <NUM>. The side openings 46C of the actuator <NUM> allow for fluid flushing.

A conical section <NUM> forms the proximal end of the actuator <NUM>. The conical section <NUM> is a substantially frusto-conical member that is tapered towards the actuator barrel <NUM> and has one or more proximal openings 48A to permit fluid flow. The conical section <NUM> receives or engages or abuts the end of a Luer connector (not shown). One or more tabs <NUM> extend from the actuator <NUM> to engage a respective flange <NUM> or one or more shoulders on the inner surface <NUM> of the catheter hub <NUM>. The interaction between the tabs <NUM> and the flange <NUM> limits proximal movement of the actuator <NUM>. The proximal opening 48A and an internal passage 48B communicating with the internal passage 46A preferably allow fluid to flow between the Luer connector and the catheter tube <NUM>. Side openings 48C in the conical section <NUM> allow for fluid flushing. The actuator <NUM> is preferably made in one piece from a rigid or semi-rigid material, for example a rigid polymer material or a metal.

As a male Luer connector is inserted in the catheter hub <NUM>, the end of the Luer connector slides toward the conical section <NUM> and abuts the actuator <NUM>. Further movement of the Luer connector moves the actuator <NUM> axially toward and through the septum <NUM> with the distal end 46D of the actuator barrel <NUM> separating the one or more slits <NUM> to engage and open the septum <NUM>. After the septum <NUM> is opened by the actuator <NUM>, fluid is permitted to flow from the Luer connector, through the internal passages 48B and 48D of the actuator <NUM>, and into the flexible catheter <NUM> or vice versa. When the Luer connector <NUM> is removed, the actuator barrel <NUM> remains in the septum <NUM>.

<FIG> depict an embodiment of the catheter assembly <NUM> that includes a return member <NUM> which provides a multi-use function for blood control, for example. The actuator <NUM> has an actuator barrel 59A surrounding an internal passage 59B. The actuator barrel 59A is a substantially tubular member and the internal passage 59B is substantially cylindrical. The tubular member has one or more openings <NUM> to permit fluid flow through and around the actuator barrel 59A. The openings <NUM> advantageously provide increased area for the fluid to move inside the catheter hub assembly. The increased area advantageously allows for fluid flushing and to prevent coagulation of fluid in the proximal and distal ends of the septum <NUM>. Additionally, the openings <NUM> advantageously minimize the stagnation of fluid and allow for greater mixing.

A first end of the actuator barrel has a nose <NUM> with a chamfered outer surface to engage the septum <NUM>. A frusto-conical section 61A extends from the second end of the actuator barrel 59A. The frusto-conical section 61A has one or more openings 61B to permit fluid flow therethrough. A cylindrical section 61C extends from the frusto-conical section 61A to engage a male Luer connector <NUM>. One or more hooks <NUM> having an angled front surface and a slot <NUM> extend from the actuator barrel 59A.

In the exemplary embodiment shown in <FIG>, the return member <NUM> is a biasing member such as a coil spring, for example a helical compression spring with a distal end <NUM> and a proximal end <NUM>. The spring can be, but is not limited to, rubber, silicone rubber, a thermal plastic, a thermal plastic elastomer, metal, plastic, an elastomeric member such as an elastomer, or another suitable resilient material. The distal end <NUM> of the spring forms an interference fit with the inner surface <NUM> of the catheter hub <NUM>. The interference fit may be sufficient to retain the spring, even during loading, or the distal end <NUM> of the spring may also abut the septum <NUM>. The proximal end <NUM> of the spring connects to the actuator <NUM>, for example by fitting over the hook <NUM> and into the slot <NUM>.

In other various embodiments, the actuator <NUM> and the biasing member <NUM> are combined to be a unitary structure. In various exemplary embodiments, the inner surface <NUM> of the catheter hub <NUM> and/or the outer surface of the actuator <NUM> and/or biasing member <NUM> includes undercuts, bumps, projections, tines, or other suitable structure to form a snap connection between the catheter hub <NUM> and the biasing member <NUM>, and the biasing member <NUM> and the actuator <NUM>. In further various exemplary embodiments, the biasing member or spring <NUM> and actuator <NUM> may be attached to each other via an engagement that does not require a snap connection including a diametric interference fit or a press fit.

<FIG> depict the operation of the catheter hub <NUM> having an actuator <NUM> and a return member such as a biasing member or spring <NUM>. The return member functions by returning the actuator <NUM> from a second position engaging the septum <NUM> (opening or penetrating the septum, for example) to open the valve, to a first position at a proximal end of the septum <NUM> (not engaging the septum <NUM>) to close the valve. The needle <NUM> initially extends through the actuator <NUM>, the septum <NUM>, the wedge <NUM>, and the catheter tube <NUM>. After the needle <NUM> and the catheter tube <NUM> are inserted into a patient, the needle <NUM> is withdrawn, closing the septum <NUM>.

There are two basic ways to open the septum <NUM>, either of which can be used in the practice of the present invention. In the first way, the septum <NUM> can be in an opened state when the actuator <NUM> contacts or pushes against the slits <NUM> of the septum <NUM>. When the septum <NUM> is opened in this way, the actuator <NUM> does not extend through the septum <NUM>. Rather, the end surface of the actuator <NUM> is disposed on the slits <NUM> of the septum <NUM>. Either the resilient slits <NUM> or flaps of the septum <NUM>, or the spring <NUM>, or both, can cause the actuator <NUM> to retract when operation is complete and upon removal of the axial pressure on the actuator <NUM>. In the second way, the septum <NUM> can be in a penetrated state where the actuator <NUM> extends through the septum <NUM> causing the septum <NUM> to open. In this state, the actuator <NUM> requires an external force, such as the spring <NUM>, to retract the actuator <NUM> and close the septum <NUM>. In the penetrated state, the resilient slits <NUM> of the septum <NUM> cannot retract the actuator <NUM> on their own. Both septum states can open the septum <NUM> and allow fluid to be exchanged.

As shown in <FIG> and <FIG>, as the male Luer connector <NUM> is inserted into the catheter hub <NUM>, the Luer connector <NUM> moves the actuator <NUM> in the distal direction, compressing the spring <NUM>. Further insertion of the Luer connector <NUM> moves the actuator <NUM> through the septum <NUM>, opening the slits <NUM> and allowing fluid to flow through the catheter hub <NUM>. As best shown in <FIG> and <FIG>, when the Luer connector <NUM> is removed, the spring <NUM> removes the actuator <NUM> from the septum <NUM>, closing the slits <NUM> and preventing fluid from flowing therethrough. This allows the catheter assembly <NUM> to be reused through multiple Luer connections, as opposed to a single use catheter where the actuator would remain in the septum <NUM> after a Luer connector is removed. The features of the exemplary embodiments of <FIG> may be combined with features of the other exemplary embodiments disclosed herein as appropriate.

Although the return member <NUM> is shown as a biasing member (e.g. spring or other resilient member) in all of the embodiments disclosed herein, the invention is not so limited. The return member may be any element or assembly that returns the actuator from its second position to its first position when a Luer connector is removed. The return member <NUM> can also be constituted by the resilient slits <NUM> or flaps of the septum <NUM>, as discussed above.

<FIG> depicts an alternative embodiment of the actuator <NUM> and the biasing member 70A. The actuator <NUM> has an actuator barrel 69A surrounding an internal passage 69B. The actuator barrel 69A is a substantially tubular member and the internal passage 69B is substantially cylindrical. A series of openings 69C are formed in the actuator barrel 69A to allow fluid to flow through and around the actuator <NUM>. The actuator barrel 69A has a distal end 69D that engages and opens the septum <NUM>. The distal end 69D includes a nose having a chamfered outer surface. A conical section 71A extends from the proximal end 71B of the actuator barrel 69A. The conical section 71A is a substantially frusto-conical member receives or engages the end of a Luer connector.

The biasing member is a helical metal compression spring 70A with a distal end 70B and a proximal end 70C. The distal end 70B of the spring 70A has a first outer diameter and a first inner diameter. The proximal end 71B of the spring 70A has a second outer diameter and a second inner diameter. The second outer diameter may be different from the first outer diameter and the second inner diameter may be different from the first inner diameter. The spring 70A may have a general conical shape.

In various exemplary embodiments, the first outer diameter is sized to create a first interference fit with the inner surface of the catheter hub <NUM>. The first interference fit may be sufficient to allow compression of the spring 70A without contact between the spring 70A and the septum <NUM>. In alternative embodiments, the septum <NUM> may assist in limiting the axial movement of the spring 70A. The second inner diameter is sized to create a second interference fit with the actuator <NUM>, for example the actuator barrel 69A. The second interference fit is sufficient to retain and support the actuator <NUM> in place in an unstressed condition, both axially and radially, with respect to the catheter hub <NUM>. The second interference fit may be sufficient to allow compression of the spring 70A without contact between the spring 70A and the catheter hub <NUM>. Because of the support provided by the spring 70A, the actuator <NUM> is held, substantially self-centered and does not touch the inside walls of the catheter hub <NUM> as shown. The spring 70A retaining the actuator <NUM> in the catheter hub <NUM> provides an advantage over the catheter shown in <FIG>, because the actuator tabs <NUM> and the corresponding shoulder <NUM> extending from the inner surface are removed. Removal of the tabs <NUM> and shoulder <NUM> reduces complexity of the device. In various alternative embodiments, the tabs <NUM> are used to retain the actuator and the spring 70A is freely positioned in the catheter hub <NUM> without an interference fit with the catheter hub <NUM> or the actuator <NUM>.

In accordance with the illustrated embodiment, the spring's first outer and inner diameters are greater than the second outer and inner diameters. The pitch of the spring 70A also varies from the distal end to the proximal end. The spring 70A may have one or more coils that are touching or very closely positioned at the distal end and one or more coils that are touching or very closely positioned at the proximal end in an unloaded state. The variable pitch of the spring 70A allows stiffness to be concentrated at the distal and proximal ends to assist in retaining the interference fit while also allowing for sufficient compression through the middle of the spring 70A. The features of the exemplary actuator <NUM> and biasing member 70A depicted in <FIG> may be combined with features of the other exemplary embodiments disclosed herein as appropriate.

As a Luer connector (not shown) is inserted in the catheter hub <NUM>, the end of the Luer connector abuts the conical section of the actuator <NUM>. Further movement of the Luer connector moves the actuator <NUM> axially toward and through the septum <NUM> with the first end of the actuator barrel separating the one or more slits. Movement of the actuator <NUM> toward the septum <NUM> compresses the spring 70A. After the septum <NUM> is opened, fluid is permitted to flow through the catheter hub <NUM>. The compression of the spring 70A is maintained by the Luer connector. As the Luer connector is removed, the spring 70A returns the actuator to its initial position, removing the actuator <NUM> from the septum <NUM>. After the actuator <NUM> is removed, the septum <NUM> returns to the closed position, preventing fluid from flowing therethrough. The features of the exemplary embodiments of <FIG> may be combined with features of the other exemplary embodiments disclosed herein as appropriate.

<FIG> depicts another alternative embodiment of a catheter hub <NUM> having an actuator <NUM> and a return or biasing member <NUM>. The actuator <NUM> has an actuator barrel 73A surrounding an internal passage. The actuator barrel 73A is a tubular member surrounding a cylindrical internal passage. A series of openings 73B are formed in the tubular member to allow fluid to flow through and around the actuator <NUM>. The actuator barrel 73A has a first end 75A that engages and opens the slits of the septum <NUM>. The first end 75A includes a nose having a chamfered outer surface. A cylindrical section 75C extends from the second end 75B of the tubular portion. The cylindrical section 75C may have a conical aperture for receiving a Luer connector or the aperture may be a continuation of the cylindrical internal passage.

The return or biasing member in <FIG> is a helical metal compression spring <NUM> with a distal end and a proximal end. The distal end is interference fit with the inner surface of the catheter hub <NUM> and the proximal end is interference fit with the actuator <NUM>. The inner surface may have a channel, groove, slot, or other depression <NUM> to receive the distal end of the spring <NUM>. The spring <NUM> depicted in <FIG> may be similar to, or the same as, the spring 70A depicted in <FIG>.

As discussed above, the conical spring <NUM> supports the actuator end and thereby allows for removal of the actuator tabs <NUM>. The catheter <NUM> is designed for use with different sized Luer connectors that penetrate the interior channel at different lengths. Because the tabs <NUM> of the exemplary actuator <NUM> depicted in <FIG> cannot travel through the septum <NUM>, the length of the tubular portion is increased to accommodate the different sized Luer connectors. As best shown in the exemplary embodiment of <FIG>, by removing the tabs <NUM>, the actuator <NUM> and the catheter hub <NUM> can be shortened, reducing the size and the cost of the device. The features of the exemplary embodiments of <FIG> may be combined with features of the other exemplary embodiments disclosed herein as appropriate.

<FIG> depicts another alternative embodiment of a catheter hub <NUM> having an actuator <NUM> and a return or biasing member <NUM>. The actuator <NUM> has an actuator barrel surrounding an internal passage. The actuator barrel and the internal passage have a conical shape tapering from the proximal end to the distal end of the catheter hub. The actuator barrel has a first end that engages and opens the slits <NUM>. The first end includes a nose having a chamfered outer surface. One or more protrusions <NUM> extend radially from the barrel to engage the biasing member <NUM>. The protrusions <NUM> may be a single, frusto-conical flange extending around the outer surface of the barrel, one or more tabs extending from the barrel, or other similar structure.

The biasing member <NUM> in <FIG> is preferably an elastomer spring having an outer surface engaging the inner surface of the catheter hub <NUM> and an aperture receiving at least a portion of the actuator <NUM>. The biasing member <NUM> can also be, but is not limited to, rubber, silicone rubber, a thermal plastic, or a thermal plastic elastomer. In accordance with an exemplary embodiment, the aperture includes a proximal opening <NUM>, a middle opening <NUM>, and a distal opening <NUM>. The proximal opening <NUM> has a substantially cylindrical shape with a first diameter. The middle opening <NUM> has a second diameter larger than the first diameter. The middle opening <NUM> may cylindrical or it may be bound by one or more angled walls to having a substantially frusto-conical shape. For example, the middle opening <NUM> may be bound by walls having an angle that corresponds to the angle of the actuator protrusions <NUM>. The distal opening <NUM> has a substantially cylindrical shape and diameter that is smaller than the diameter of the proximal opening <NUM> and a diameter smaller than the middle opening <NUM>. In various exemplary embodiments, the size, shape, and configuration of the elastomer spring and the openings may vary depending on the catheter hub <NUM> and the actuator <NUM>.

The actuator <NUM> is placed into the elastomer spring <NUM> so that at least a portion of the first end of the actuator barrel extends through and protrudes from the elastomer spring <NUM>. The actuators protrusions <NUM> sit in the middle opening <NUM> to retain the actuator <NUM> in place and resist proximal movement of the actuator <NUM>. The second end of the actuator extends from the proximal opening <NUM> to receive or engage a male Luer connector (not shown). As a Luer connector is inserted, the actuator <NUM> is moved in the distal direction against the bias of the elastomer spring <NUM>, elastically deforming the elastomer spring <NUM>. As the Luer connector is removed, the elastomer spring <NUM> returns the actuator <NUM> substantially to its initial position. The features of the exemplary actuator and biasing member depicted in <FIG> may be combined with features of the other exemplary embodiments disclosed herein.

<FIG> depicts another alternative embodiment of a catheter hub <NUM> having an actuator <NUM> and a return or biasing member <NUM>. A first end of the actuator <NUM> has an actuator barrel surrounding an internal passage. The actuator barrel has a substantially frusto-conical shape tapering from the distal end to the proximal end of the catheter hub. The actuator barrel has one or more openings permitting fluid flow through the actuator. The actuator <NUM> includes a second end for receiving or engaging a Luer connector. The second end has a substantially frusto-conical shape. The second end may also include one or more openings and an internal passage. A middle portion <NUM> connects the first end and the second end of the actuator <NUM>. The middle portion <NUM> has a substantial cylindrical shape surrounding an internal passage.

The biasing member <NUM> in <FIG> is preferably an elastic washer. The washer <NUM> has an outer surface that engages the inner surface of the catheter hub <NUM>. The inner surface of the catheter hub may include a slot or groove <NUM> to receive and retain the washer <NUM>. The washer <NUM> has an inner diameter that receives the middle portion <NUM> of the actuator <NUM>. The middle portion <NUM> may have a diameter that is smaller than the frustum of the second end and smaller than the base of the first end, retaining the washer against a first flange formed by the first end and a second flange formed by the second end. The shape, size, and configuration of the actuator <NUM> and the washer <NUM> may vary to accommodate one another.

The actuator <NUM> is placed into the washer <NUM> so that the first end of the actuator <NUM> extends through and protrudes from one side of the washer <NUM> to engage the septum <NUM>. The second end of the actuator <NUM> extends from the washer <NUM> to receive or engage a male Luer connector <NUM>. As the Luer connector <NUM> is inserted, the actuator <NUM> is moved in the distal direction against the bias of the washer <NUM>, elastically stretching the washer <NUM>. Further insertion of the Luer connector <NUM> moves the actuator <NUM> through the septum <NUM>, opening the slits <NUM>. As the Luer connector <NUM> is removed, the washer <NUM> returns the actuator <NUM> to its initial position. In various additional embodiments, the washer <NUM> can be, but is not limited to, rubber, silicone rubber, a thermal plastic, a thermal plastic elastomer, a spring washer, an elastomeric washer, a plurality of elastic bands, a compression spring, an extension spring, a disc spring, or other suitable biasing member. The features of the exemplary actuator <NUM> and biasing member <NUM> depicted in <FIG> may be combined with features of the other exemplary embodiments disclosed herein as appropriate.

<FIG> depicts another alternative embodiment of a catheter hub <NUM> having an actuator <NUM> and a return or biasing member <NUM>. The actuator <NUM> has an actuator barrel surrounding an internal passage. The actuator barrel has a first end that engages and opens the slits <NUM>. The actuator <NUM> includes a second end for receiving or engaging a male Luer connector (not shown).

The biasing member in <FIG> can be, but not limited to, one or more elastic members <NUM>, for example, a circular or radially extending silicone member, a plurality of elastic bands, rubber, silicone rubber, a thermal plastic, or a thermal plastic elastomer. In various exemplary embodiments, the elastic bands are made from silicone or silicone rubber. The biasing member <NUM> is connected to a fixed support <NUM> attached to the inner surface of the catheter hub <NUM>. The fixed support may be a single member extending radially around the inner surface or it may be one or more isolated blocks depending on the type of biasing member.

The biasing member <NUM> receives and/or connects to the actuator <NUM> to retain the actuator <NUM> in an unstressed position. As a male Luer connector is inserted, the actuator <NUM> is moved in the distal direction stretching the biasing member <NUM>. As the Luer connector is removed, the biasing member <NUM> returns the actuator <NUM> to its initial position. The features of the exemplary actuator <NUM> and biasing member <NUM> depicted in <FIG> may be combined with features of the other exemplary embodiment disclosed herein as appropriate.

<FIG> depicts another alternative embodiment of a catheter hub <NUM> having an actuator <NUM> and a return or biasing member <NUM>. The biasing member <NUM> is similar to those discussed above with respect to <FIG>. The actuator has an actuator barrel surrounding an internal passage. The actuator barrel has a first end that engages and opens the slits <NUM>. The actuator includes a second end for receiving or engaging a Luer connector (not shown). The actuator barrel and catheter hub <NUM> are shorter than those depicted in other embodiments, although any of the actuators or catheter hubs described herein may be used with this embodiment. The biasing member <NUM> may be, but is not limited to, rubber, silicone rubber, a thermal plastic, a thermal plastic elastomer, one or more bands, a radially extending member, or other suitable biasing member. The biasing member <NUM> includes a flange <NUM> that fits into a groove or slot in the catheter hub <NUM>. The features of the exemplary actuator <NUM> and biasing member <NUM> depicted in <FIG> may be combined with features of the other exemplary embodiments disclosed herein as appropriate.

<FIG> depicts another alternative embodiment of a catheter hub <NUM> having an actuator <NUM> and a return or biasing member <NUM>. The actuator <NUM> has an actuator barrel surrounding an internal passage. The actuator barrel has a first end that engages and opens the slits <NUM>. The first end includes a nose having a chamfered outer surface. The second end of the actuator barrel receives or engages a male Luer connector <NUM>.

The biasing member is an elastic band or disk <NUM> that is connected near the second end of the actuator <NUM>. The elastic band <NUM> may be made from, but is not limited to, latex, rubber, silicone rubber, a thermal plastic, a thermal plastic elastomer, or other suitable elastic material. A first end of the elastic band <NUM> is connected to the catheter hub <NUM>. A second end of the elastic band <NUM> is connected to the actuator <NUM>, for example by an interference fit, or other mechanical connection, or through a chemical bond such as an adhesive or molded bond. The features of the exemplary actuator <NUM> and biasing member <NUM> depicted in <FIG> may be combined with features of the other exemplary embodiments disclosed herein as appropriate.

<FIG> depicts another alternative embodiment of a catheter hub <NUM> having an actuator <NUM> and a return member comprising a first biasing member <NUM> and a second biasing member <NUM>. The actuator <NUM> has an actuator barrel surrounding an internal passage. The actuator barrel has a first end that engages and opens the slits <NUM>. The first end includes a nose having a chamfered outer surface. Extending from the second end of the actuator barrel is a cylindrical member for receiving or engaging a Luer connector (not shown). A compressible section <NUM> is positioned in the actuator barrel. The compressible section <NUM> is made from a suitable compressible material, for example an elastomer or a polymer.

Similar to the biasing members depicted in <FIG>, the first and second biasing members <NUM>, <NUM> of <FIG> may be one or more bands of elastic material, a radially extending member, or other suitable biasing member. In various additional embodiments, the biasing members depicted in <FIG> may be, but are not limited to, a spring washer, an elastomeric washer, a plurality of elastic bands, a compression spring, an extension spring, a disc spring, rubber, silicone rubber, a thermal plastic, a thermal plastic elastomer or other suitable biasing member. The first and second biasing members <NUM>, <NUM> are connected to the catheter hub <NUM> through one or more support blocks <NUM>. In various exemplary embodiments, only a single biasing member is used.

As a Luer connector is inserted, the Luer connector engages the compressible insert <NUM> and moves the actuator <NUM> in the distal direction against the bias of the first and second biasing members <NUM>, <NUM>. Further insertion of the Luer connector moves the actuator through the septum (not shown), opening the slits <NUM>. The first and second biasing member <NUM>, <NUM> and the compressible insert <NUM> are configured so that the actuator <NUM> may advance a certain distance until the resilient force of the biasing members <NUM>, <NUM> is greater than the force needed to compress the insert <NUM>. At this point, the insert <NUM> deforms so that further insertion of the Luer connector does not result in further distal movement of the actuator <NUM>. As the Luer connector is removed, the insert <NUM> expands to its normal volume and the first and second biasing members <NUM>, <NUM> return the actuator <NUM> to its initial position. The features of the exemplary actuator <NUM> and biasing members <NUM>, <NUM> depicted in <FIG> may be combined with features of the other exemplary embodiments disclosed herein.

<FIG> depicts another alternative embodiment of a catheter hub <NUM> having an actuator <NUM> and a return or biasing member <NUM>. The actuator <NUM> has an actuator barrel surrounding an internal passage. The actuator barrel has a first end that engages and opens the slits <NUM>. Extending from the second end of the actuator barrel is a member (not shown) for receiving or engaging a Luer connector. One or more protrusions <NUM> extend from the actuator radially towards the inner surface of the catheter hub <NUM>. The protrusions <NUM> engage tabs (not shown) on the catheter hub <NUM> to limit the axial movement of the actuator <NUM>, similar to the embodiment depicted in <FIG>.

The biasing member <NUM> of <FIG> extends from the septum <NUM> in the distal direction. The biasing member <NUM> includes two or more arms <NUM> connected to a central hub <NUM>. The central hub <NUM> is shown as a cylindrical member having an opening. The central hub <NUM> is configured to engage at least a portion of a front end of the actuator <NUM>. Various sizes, shapes, and configurations of the central hub <NUM> may be used depending on the catheter hub <NUM> and the actuator <NUM>. The biasing member <NUM> is preferably made from an elastic material, for example a silicone rubber. The biasing member <NUM> can also be made from, but is not limited to, rubber, silicone rubber, a thermal plastic, or a thermal plastic elastomer. The septum <NUM> and the biasing member <NUM> may be unitarily formed or the septum <NUM> and/or slits <NUM> may be formed separately from the biasing member.

In various exemplary embodiments, the septum <NUM> is configured to return the actuator to its initial position. As a male Luer connector (not shown) is inserted, the actuator <NUM> is moved in the distal direction, opening the slits <NUM> and passing through the septum <NUM>. The septum <NUM> includes one or more slits <NUM> with the slits <NUM> defining two or more flaps. In the exemplary embodiment illustrated in <FIG>, the septum <NUM> has three slits <NUM> defining three triangular flaps. As the actuator <NUM> is inserted into the septum <NUM>, the flaps move in the distal direction to receive the actuator <NUM>. The flaps are resilient and exert a biasing force on the actuator <NUM>, which may be sufficient, depending on the depth of insertion of the actuator <NUM>, to return the actuator <NUM> substantially to its initial position or at least to a position that allows the slits <NUM> to close.

As mentioned above, the length of a Luer connector varies, and the depth of penetration of the Luer connector into the catheter hub <NUM> and the resulting movement of the actuator <NUM> varies depending on the Luer connector. At a certain travel distance of the actuator <NUM> through the septum <NUM>, the septum <NUM> is not capable of returning the actuator <NUM> to a position that allows the slits <NUM> to close. In accordance with the exemplary embodiment, the biasing member <NUM> is configured to bias the actuator <NUM> at least to a point where the slits <NUM> can move the actuator <NUM> to a position that allows the septum <NUM> to close. If the penetration of the Luer connector is long enough, the first end of the actuator <NUM> moves through the septum <NUM> and engages the biasing member <NUM>, for example the central hub <NUM>. Further movement of the actuator <NUM> stretches the arms <NUM>. As the Luer connector is removed, the biasing member <NUM> moves the actuator <NUM> in the proximal direction until the biasing member <NUM> is in an unstressed state. At this point, the septum <NUM> moves the actuator <NUM> in the proximal direction a sufficient distance to allow the slits <NUM> to close. The features of the exemplary actuator <NUM> and biasing member <NUM> depicted in <FIG> may be combined with features of the other exemplary embodiments disclosed herein as appropriate.

<FIG> depicts another alternative embodiment of a catheter hub <NUM> having an actuator <NUM> and a return or biasing member <NUM>. The actuator <NUM> has an actuator barrel surrounding an internal passage. The actuator barrel has a first end that engages and opens a septum <NUM>. The first end includes a nose having a chamfered outer surface. The second end of the actuator barrel receives or engages a Luer connector (not shown). A pin <NUM> extends radially from the side of the actuator barrel. The pin <NUM> mates with a slot <NUM> formed in the catheter hub <NUM>. In an exemplary embodiment, the slot <NUM> is a cam slot that has a first portion extending substantially in an axial direction of the catheter hub <NUM> and a second portion extending obliquely, axially in the distal direction and radially upwards, from the first portion.

The biasing member <NUM> of <FIG> can be, but is not limited to, rubber, silicone rubber, a thermal plastic, a thermal plastic elastomer, a spring, leaf spring, an elastic band, or other resilient member. The biasing member <NUM> may exert a force on the actuator <NUM> in both the axial and radial directions or only in the radial direction. In an exemplary embodiment, the majority of the force exerted by the biasing member <NUM> is in the radial direction. As the Luer connector is inserted into the catheter hub <NUM>, the Luer connector moves the actuator <NUM> in the distal direction. Movement of the actuator <NUM> causes the pin <NUM> to slide in the cam slot <NUM>, forcing the actuator <NUM> to move radially as well as axially. As the Luer connector is removed, the biasing member <NUM> forces the actuator back down, moving the pin <NUM> along the cam slot <NUM> to its initial position. In various exemplary embodiments, the biasing member <NUM> may only act in the radial direction, for example radially downward in the depicted orientation, with sufficient force to slide the pin <NUM> along the cam slot <NUM> to the initial position. The features of the exemplary actuator <NUM> and biasing member <NUM> depicted in <FIG> may be combined with features of the other exemplary embodiments disclosed herein as appropriate.

<FIG> depict another alternative embodiment of a catheter hub <NUM> wherein the actuator and the return or biasing member are constituted by a single spring <NUM>. The spring <NUM> has a first series of windings <NUM> that extend in the axial direction. The first series of windings <NUM> have a first end that extends through the septum <NUM>. The first series of windings <NUM> may have a first inner diameter at a distal end and a second inner diameter larger than the first inner diameter at a proximal end. A second series of windings <NUM> extend around at least a portion of the first series of windings <NUM>. The second series of windings <NUM> may be coaxial with the first series of windings <NUM> and have a first inner diameter at a proximal end and a second inner diameter greater than the first inner diameter at a distal end. The second series of windings <NUM> has at least one coil that forms an interference fit with the catheter hub <NUM>. The catheter hub <NUM> may have a shoulder extending around the inner surface to limit movement of the first and second windings <NUM>, <NUM>.

As a male Luer connector is inserted, the first series of windings <NUM> are moved in the distal direction, compressing the second series of windings <NUM>. Further insertion of the Luer connector moves the first set of windings <NUM> through the septum <NUM>, opening the slits <NUM>. As the Luer connector is removed, the second set of windings <NUM> return the first set of windings <NUM> to their initial position. The features of the exemplary actuator and biasing member <NUM> depicted in <FIG> may be combined with features of the other exemplary embodiments disclosed herein as appropriate.

<FIG> depict another alternative embodiment of a catheter hub <NUM> having an actuator <NUM> and a return or biasing member <NUM>. The actuator <NUM> has an actuator barrel surrounding an internal passage. The actuator barrel has a first end that engages and opens the slits <NUM>. The first end includes a rounded nose. A flange <NUM> for engaging the Luer connector <NUM> extends from the second end of the actuator barrel. The flange <NUM> is positioned in a slot <NUM> formed in the catheter hub. The engagement of the flange <NUM> with the slot <NUM> limits the axial movement of the actuator.

The biasing member in <FIG> is preferably an elastomer tube <NUM> that is positioned around the actuator barrel. However, the biasing member can also be, but is not limited to, rubber, silicone rubber, a thermal plastic, or a thermal plastic elastomer. In various exemplary embodiments, the elastomer tube <NUM> is molded to the actuator <NUM>, for example in a multi-shot molding process, although other suitable mechanical and chemical connections may be used. The elastomer tube <NUM> has one or more slits <NUM> that open to allow passage of the actuator therethrough.

As a male Luer connector <NUM> is inserted, the actuator <NUM> is moved in the distal direction so that the elastomer tube <NUM> engages the septum <NUM>. Further insertion of the Luer connector <NUM> causes the actuator barrel to pass through the slits in the elastomer tube <NUM> and compress the elastomer tube <NUM> as the actuator <NUM> moves through the septum <NUM>. As the Luer connector <NUM> is removed, the elastomer tube <NUM> returns the actuator <NUM> to its initial position. In various exemplary embodiments, the septum <NUM> may assist in moving the actuator <NUM> in the proximal direction. The features of the exemplary actuator <NUM> and biasing member <NUM> depicted in <FIG> may be combined with any features of the other exemplary embodiments disclosed herein as appropriate.

<FIG> depict another alternative embodiment of a catheter hub <NUM> having an actuator <NUM> and a return or biasing member <NUM>. The actuator <NUM> has an actuator barrel surrounding an internal passage. The actuator barrel has a first end that engages and opens the slits <NUM>. Extending from the second end of the actuator barrel is a cylindrical member for engaging the male Luer connector <NUM>. The actuator is made from a rigid or semi-rigid material.

The biasing member of <FIG> preferably includes a compressible elastic sleeve <NUM>. However, the biasing member can also be, but is not limited to, rubber, silicone rubber, a thermal plastic, or a thermal plastic elastomer. In various exemplary embodiments, the elastic sleeve <NUM> is unitarily formed with the septum <NUM>. In a further embodiment, the septum <NUM> and biasing member <NUM> are unitarily formed with the actuator <NUM>, for example by a multi-shot molding process that over-molds the septum <NUM> and biasing member <NUM> onto the actuator. In other alternative embodiments, the septum <NUM> and biasing member <NUM> may be connected, wrapped, or held together by an interference fit, for example with the cylindrical member pressing a portion of the elastic sleeve <NUM> against the inner surface of the catheter hub <NUM>. The septum <NUM> and elastic sleeve <NUM> include a silicone material though other suitable materials may be used.

As best shown in <FIG>, the septum <NUM> has an oval configuration and is formed with a single slit <NUM>. The slit <NUM> may be formed during molding or cut into the septum <NUM> after the molding operation. The septum <NUM> is configured so that the slit is in an open orientation in an unstressed condition. The septum <NUM> is fit into a slot or groove in the inner surface of the catheter hub <NUM>. The groove is sized to compress the slit into a closed orientation, forming a fluid tight seal. As best shown in <FIG>, an elastomer <NUM> may be over-molded or assembled on the front edge of the conductor.

As a male Luer connector <NUM> is inserted, the actuator is moved in the distal direction, compressing the sleeve <NUM>. Further insertion of the Luer connector <NUM> moves the actuator <NUM> through the septum <NUM>, opening the slits <NUM>. As the Luer connector <NUM> is removed, the sleeve <NUM> returns the actuator <NUM> to its initial position. The septum <NUM> may also assist in moving the actuator <NUM> in the proximal direction. The features of the exemplary actuator <NUM> and biasing member <NUM> depicted in <FIG> may be combined with features of the other exemplary embodiments disclosed herein as appropriate.

<FIG> depicts a side-port catheter hub <NUM> and <FIG> depict various exemplary embodiments of an actuator <NUM> and a return or biasing member <NUM> used with a side-port catheter hub <NUM>. The catheter hub <NUM> includes a channel and a side port <NUM> extending substantially orthogonal to the channel. A septum <NUM> forming a first valve is positioned in the channel. A side valve, for example a valve sleeve <NUM>, is also positioned in the channel to form a second valve for the side port <NUM>. The valve sleeve is an elastic member, for example a length of silicone or rubber tubing. The valve sleeve <NUM> is compression fit in the catheter hub. When fluid is introduced into the side port <NUM>, the valve sleeve <NUM> deforms in the radial direction, permitting fluid to flow around the valve sleeve <NUM> and into the channel. Reference is made to <CIT>, for a side port catheter with a valve sleeve of the type described herein.

<FIG> depict an actuator <NUM> having an actuator barrel surrounding an internal passage. The actuator barrel has a first end that engages and opens the valve. A cylindrical or frusto-conical member extends from the second end of the actuator barrel to engage a male Luer connector. The biasing member <NUM> is depicted as a metal spring. However, the biasing member <NUM> can also be, but is not limited to, rubber, silicone rubber, a thermal plastic, or a thermal plastic elastomer.

In the exemplary configuration of <FIG>, the septum <NUM> is positioned in catheter hub <NUM> distal to the side valve <NUM> and the biasing member <NUM> is positioned in the catheter hub <NUM> proximal to the side valve <NUM>. The biasing member <NUM> is connected at a first end to the inner surface of the catheter hub <NUM> and at a second end to the actuator <NUM>, for example by a pair of interference fits. The biasing member <NUM> may also abut the side valve <NUM> to limit distal movement.

In the exemplary configuration of <FIG>, the septum <NUM> and the biasing member <NUM> are positioned distal to the side valve <NUM>. The biasing member <NUM> is connected at a first end to the inner surface of the catheter hub <NUM> and at a second end to the actuator <NUM>, for example by a pair of interference fits. The actuator <NUM> includes a flange <NUM> or one or more tabs extending radially from the actuator barrel to receive or abut the second end of the biasing member <NUM>.

In the exemplary configuration of <FIG>, the septum <NUM> and the biasing member <NUM> are positioned proximal to the side valve <NUM>. The biasing member <NUM> is connected at a first end to the inner surface of the catheter hub <NUM> and at a second end to the actuator <NUM>, for example by a pair of interference fits. The biasing member may also abut the septum <NUM> to limit distal movement.

In the exemplary configuration of <FIG>, the septum <NUM> and the side valve <NUM> are unitarily formed. The biasing member <NUM> is connected at a first end to the inner surface of the catheter hub <NUM> and at a second end to the actuator <NUM>, for example by a pair of interference fits. The biasing member <NUM> may also abut the side valve <NUM> to limit distal movement. The features of the exemplary actuator and biasing member depicted in <FIG> may be combined with features of the other exemplary embodiments disclosed herein as appropriate.

Any of the catheters described herein can be used in combination with the features as depicted in <FIG>. The needle hub <NUM> extends around a needle tip shield <NUM> and retains a proximal end of a needle <NUM>. A needle cover <NUM> initially covers the needle <NUM>, the catheter tube <NUM>, and at least a portion of the catheter hub <NUM>. The needle cover <NUM> can connect to the catheter hub <NUM> or to the needle hub <NUM>. The needle <NUM> initially extends through the needle tip shield <NUM> and the catheter hub <NUM>. The flexible catheter tube <NUM> extends from the distal end of the catheter hub <NUM>, with the needle <NUM> passing through the catheter tube <NUM>. Initially, the needle <NUM> is inserted into a patient's vein. The catheter tube <NUM> is pushed along the needle <NUM> and into the vein following the needle <NUM>. After the catheter tube <NUM> is inserted, the needle <NUM> is removed from the patient's vein and through the catheter hub <NUM>. The needle tip shield <NUM> provides protection from being stuck by the needle <NUM> as it is retracted from the catheter hub.

In accordance with the exemplary embodiments depicted in <FIG>, the needle tip shield <NUM> includes an outer sleeve <NUM>, an inner sleeve <NUM>, and a resilient metal clip <NUM>. The outer sleeve <NUM> connects to the catheter hub <NUM> and surrounds the inner sleeve <NUM>, and the clip <NUM>. The inner sleeve <NUM> is positioned in the outer sleeve <NUM> and is moveable in the axial direction. The clip <NUM> is connected to, and axially moveable with, the inner sleeve <NUM>.

In accordance with the exemplary embodiments depicted in <FIG>, the outer sleeve <NUM> includes an outer surface <NUM>, an inner surface <NUM>, a channel bound by the inner surface <NUM>, a proximal opening, and a distal opening. The outer surface <NUM> has an octagonal configuration with eight planar sides, although other curvilinear and/or rectilinear shapes may be used. The inner surface <NUM> has a planar top wall and a planar bottom wall connected by a pair of curved sides. A slot <NUM> extends through a wall of the outer sleeve <NUM>.

A catch <NUM> extends from the outer surface to engage a protrusion on the catheter hub <NUM>. In the exemplary embodiment, the catheter hub protrusion is a Luer connector receiving thread, for example a LUER-LOK® style of thread. The catch <NUM> has a front edge, a back edge, and a pair of side edges. An opening or depression is formed between the front edge and the back edge to receive the catheter hub protrusion. The opening allows the catch <NUM> to be formed with a clearance approximately equal to, or slightly greater than the height of the projection, allowing the catch <NUM> to engage the front, back, and/or sides of the connection while minimizing the amount of material and space needed. In various exemplary embodiments, the catch <NUM> is formed without the opening. The catch <NUM> resists premature release of the needle tip shield <NUM> from the catheter hub <NUM>.

In accordance with the exemplary embodiments depicted in <FIG>, the inner sleeve <NUM> includes a base <NUM>, a distal side <NUM>, and a proximal side <NUM>. A resilient arm <NUM> and a tab <NUM> extend from an outer surface of the base <NUM>. The resilient arm <NUM> and the tab <NUM> engage the slot <NUM> in the outer sleeve <NUM>. One or more clip retainers <NUM> extend from an inner surface of the base <NUM>. The clip is positioned between the clip retainers <NUM> and the proximal side <NUM>. An opposing member <NUM> extends from the distal side <NUM> in the distal direction. The opposing member <NUM> is tubular and configured to be inserted into the catheter hub <NUM>. The proximal side <NUM>, distal side <NUM>, and opposing member <NUM> each have an opening for receiving the needle <NUM>.

In accordance with the exemplary embodiments depicted in <FIG>, the resilient metal clip <NUM> includes a base <NUM> having an opening for receiving the needle <NUM>, a first arm <NUM>, and a second arm <NUM> extending from the base <NUM>. The first arm <NUM> extends further in the axial direction than the second arm <NUM>. The first arm <NUM> has a first hook <NUM> and the second arm <NUM> has a second hook <NUM>. A first tab <NUM> is formed in the first arm <NUM> and a second tab <NUM> is formed in the second arm <NUM>.

Initially, the needle <NUM> passes through the outer sleeve <NUM>, the inner sleeve <NUM>, and the clip <NUM>. The needle <NUM> biases the clip <NUM> into an open position, so that the first and second hooks <NUM>, <NUM> are resting along the needle shaft. In the assembled position, the catch <NUM> engages the Luer threads on the outer surface of the catheter hub <NUM> and the opposing member <NUM> extends into the proximal opening of the catheter hub <NUM>. In order to remove the catch <NUM> from the catheter hub <NUM>, the outer sleeve <NUM> of the needle tip shield <NUM> must be raised so that the catch <NUM> can slide over the Luer threads. Raising the needle tip shield <NUM> relative to the catheter hub <NUM>, however, is initially prevented by the opposing member <NUM> extending into the catheter hub <NUM>.

As the needle <NUM> is withdrawn from the catheter hub <NUM>, the tip of the needle <NUM> clears the first and second hooks <NUM>, <NUM>, as illustrated in <FIG>, causing the first and second arms <NUM>, <NUM> to close and the first and second hooks <NUM>, <NUM> to surround the tip of the needle <NUM>. As such, the clip <NUM> is in a closed position where the distal tip of the needle <NUM> is blocked. This needle protection mechanism, via the clip <NUM>, operates passively (automatically) when the needle <NUM> is removed from the catheter hub <NUM> because user actuation is not required to initiate needle protection.

As the needle <NUM> is pulled further, the shaft of the needle slides through the needle tip shield <NUM> until a deformation, for example a crimp or protrusion <NUM> formed near the distal end of the needle <NUM> to increase its diameter in at least one direction, engages the clip base <NUM>. The opening in the clip base <NUM> is sized to interact with the deformation such that the needle shaft passes through, but not the deformation. Accordingly, a sharp distal tip area, which includes the sharp distal tip and the deformation of the needle <NUM>, for example, is enclosed by the clip <NUM>.

Further movement of the needle <NUM> results in the inner sleeve <NUM> being drawn further into the outer sleeve <NUM>, removing the opposing member <NUM> from the catheter hub <NUM>. When the opposing member <NUM> is withdrawn from the catheter hub <NUM>, the catch <NUM> may be removed from the Luer thread protrusion and the needle tip shield <NUM>, needle <NUM>, and needle hub <NUM> separated from the catheter <NUM>.

<FIG> shows the arm <NUM> and tab <NUM> of the inner sleeve <NUM> positioned in the slot <NUM> of the outer sleeve <NUM>. After the tip of the needle <NUM> passes the first and second hooks <NUM>, <NUM> and the first and second arms <NUM>, <NUM> move into a closed orientation, the tab <NUM> can engage the slot <NUM> to resist separation of the inner sleeve <NUM> and the outer sleeve <NUM> and possible exposure of the needle <NUM>.

<FIG> shows the first and second tabs <NUM>, <NUM> engaging a first shoulder <NUM> and a second shoulder <NUM> on the outer sleeve. The tabs <NUM>, <NUM> help prevent the clip <NUM> and the inner sleeve <NUM> from unintentionally sliding into the outer sleeve <NUM>, for example during shipping. The needle <NUM> biases the first and second arms <NUM>, <NUM> into an open position so that the tabs <NUM>, <NUM> engage the outer sleeve <NUM>.

Any of the various exemplary embodiments discussed herein may include an antimicrobial system, such that one or more antimicrobial agents or coatings may be incorporated or applied to any of the components of the catheter discussed herein. For example, the spring may be coated with a UV curable antimicrobial adhesive coating. The coating may be applied spraying, batch tumbling, or during formation of the spring windings. A suitable coating is described in <CIT>. Antimicrobial agents suitable for use in this is type of application included, chlorhexidine gluconate, chlorhexidine diacetate, chloroxylenol, triclosan, hexetidine, and may be included in a actuator lubricant applied to assist in easy penetration and opening of the septum, and return of the actuator to the closed position after Luer connector disengagement.

<FIG> illustrates an exemplary embodiment of an actuator <NUM>. The actuator <NUM> can be used in any of the embodiments disclosed herein. The actuator <NUM> includes a nose <NUM> that reduces friction when the actuator <NUM> penetrates into a septum <NUM> of a catheter hub assembly. The actuator <NUM> further includes openings <NUM> that extend through the actuator <NUM> in a direction perpendicular to a centerline of the actuator <NUM>. For example, the actuator <NUM> can include two rectangular shaped openings <NUM>, although more or less are contemplated.

The actuator <NUM> also includes a plurality of grooves <NUM> that extend axially along the distal portion of an outer surface of the actuator <NUM> in a plane parallel to the centerline of the actuator <NUM>. For example, four grooves <NUM>, substantially radially equidistant from each other, can be present along an external surface of the distal portion of the actuator <NUM>, although more or less grooves <NUM> are contemplated. The grooves <NUM> can be of varying depths into the actuator <NUM>. The grooves <NUM> are different from the openings <NUM> because the grooves <NUM> do not extend completely through the thickness of the actuator <NUM>.

The openings <NUM> and the grooves <NUM> advantageously provide increased area for the fluid to move inside the catheter hub assembly. The increased area advantageously allows for fluid flushing and to prevent coagulation of fluid in the proximal and distal ends of the septum. Additionally, the openings <NUM> and the plurality of grooves <NUM> advantageously minimize the stagnation of fluid and allow for greater mixing. The grooves <NUM> further prevent the septum from sealing on an outside surface of the actuator during operation. By not forming a sealing interface, the fluid is permitted to leak through the septum via the grooves <NUM> and provide additional flushing.

<FIG> illustrates the actuator <NUM> of <FIG> in the catheter hub assembly. Similar to the embodiments described above, the catheter hub assembly further includes a catheter hub <NUM>, a septum <NUM> and a biasing member <NUM>. As illustrated, the openings <NUM> and the grooves <NUM> of the actuator <NUM> provide more area for fluid flow inside the catheter hub <NUM>, thus achieving the advantages described above.

<FIG> and <FIG> illustrate the catheter hub assembly when the biasing member <NUM> is compressed and the actuator <NUM> penetrates the septum <NUM>. The catheter hub assembly may be configured such that the openings <NUM> and/or the grooves <NUM> of the actuator <NUM> optionally penetrate the septum <NUM>. In this embodiment, the openings <NUM> in the actuator <NUM> do not penetrate the septum <NUM>. However, the grooves <NUM> in the actuator <NUM> penetrate the septum <NUM>. This configuration allows for increased fluid flow from the proximal end to the distal end of the septum <NUM> through the grooves <NUM>, in addition to the advantages described above. After operation of the catheter assembly is complete, the actuator <NUM> is retracted from the septum <NUM> via the force exerted by the biasing member <NUM>. The catheter assembly is configured for multiple uses upon depression of the actuator <NUM>. The features described in this embodiment, such as the actuator, can be used in combination with the features described throughout this application.

<FIG> illustrates another embodiment of an actuator <NUM> in a catheter hub assembly. The catheter hub assembly includes a catheter hub <NUM> having a side port <NUM>. The side port <NUM> provides secondary access to the fluid flow in the catheter hub <NUM>. The intersection of the main bore of the catheter hub <NUM> and the side port <NUM> includes a sleeve <NUM>. The sleeve <NUM> provides selective fluid communication between the side port <NUM> and the catheter hub <NUM>. Specifically, when sufficient fluid pressure is applied through the side port <NUM>, the sleeve <NUM> compresses. The compression of the sleeve <NUM> allows for fluid to enter the catheter hub <NUM>. The catheter hub assembly further includes a septum <NUM> and a biasing member <NUM> that provides tension to the actuator <NUM>.

The actuator <NUM> includes a plurality of openings <NUM> that extend through the actuator <NUM> in a similar manner as described above. The actuator <NUM> includes two rows of four openings <NUM> having different sizes and spacing, although various quantities, sizes and spacing of the openings <NUM> are contemplated. As illustrated, the openings <NUM> provide more area for fluid flow inside the catheter hub <NUM>, thus achieving similar advantages described above with respect to <FIG>.

<FIG> and <FIG> illustrate the catheter hub assembly when the actuator <NUM> penetrates the septum <NUM> and compresses the biasing member <NUM>. The catheter hub assembly is configured such that the openings <NUM> of the actuator <NUM> optionally penetrate the septum <NUM>. In this embodiment, the openings <NUM> in the actuator <NUM> do not penetrate the septum <NUM>. This configuration allows for increased fluid flow between the side port <NUM> and the catheter hub <NUM> at the proximal end of the septum <NUM>, in addition to the advantages described above. If the openings <NUM> in the actuator <NUM> penetrate the septum <NUM>, increased mixing of fluid would also take place at a distal end of the septum <NUM>.

When operation of the catheter assembly is complete, the actuator <NUM> is retracted from the septum <NUM> via the force exerted by the biasing member <NUM>. The catheter assembly is configured for multiple uses upon depression of the actuator <NUM>. The features described in this embodiment, such as the actuator, can be used in combination with the features described throughout this application.

<FIG> illustrates a cross sectional view of another exemplary embodiment of a catheter assembly <NUM> with a different type of needle protection mechanism, in this case one that houses the entire needle within a protective tube or barrel, rather than shielding only the needle tip. The catheter assembly <NUM> employs active (rather than passive or automatic) needle protection because user activation, via depression of an activation button <NUM>, is required to initiate needle protection. However, both active and passive needle protection are within the scope of the present invention.

Operation of the catheter assembly <NUM> is described as follows. The catheter <NUM> and the needle <NUM> are inserted into a vein of a patient. When the needle <NUM> and catheter <NUM> are securely disposed, the activation button <NUM> is depressed. Upon depression of the activation button <NUM>, as illustrated in <FIG>, an inner needle hub or housing <NUM> is disengaged from a wall (not shown) of the activation button <NUM>. The needle <NUM> then retracts into a catheter hub <NUM>. A spring <NUM> surrounding the inner needle housing <NUM> is released by the activation button <NUM> which causes the inner needle housing <NUM> to travel to the opposite end of the outer needle housing <NUM>. Thus, the needle <NUM> is now in a retracted position where the complete needle <NUM> (including its sharp distal tip) is retained in the outer needle housing <NUM>. The inner needle housing <NUM> holding the needle <NUM> is retained in the outer needle housing <NUM> via the force exerted by the spring <NUM>. Accordingly, the combination of the inner needle housing <NUM>, the outer needle housing <NUM> and the spring <NUM> is an exemplary needle protection member.

More information regarding the active needle protection mechanism used in this embodiment can be found in <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>,<CIT>, <CIT>, <CIT>,<CIT>, and <CIT>. The features described in this embodiment, including the active needle protection features, can be used in combination with the catheter assemblies described throughout this application.

<FIG> illustrates a cross sectional view of another exemplary embodiment of a catheter assembly <NUM> with a different type of needle protection mechanism, in this case one like that of <FIG> that shields only the needle tip. The needle protection mechanism disclosed in the catheter assembly <NUM> operates passively (automatically) when the needle <NUM> is removed from the catheter hub <NUM> because user actuation is not required to initiate needle protection. Operation of the catheter assembly <NUM> is described as follows. The catheter <NUM> and the needle <NUM> are inserted into a vein of a patient. When the needle <NUM> and catheter <NUM> are securely disposed, the needle <NUM> is withdrawn by a user.

The needle <NUM> is withdrawn from the catheter <NUM> when the user pulls the outer needle housing or hub <NUM>. The needle <NUM> subsequently retracts into the catheter hub <NUM> and a sharp distal tip of the needle <NUM> ultimately enters into the inner needle housing <NUM>. Prior to the distal tip of the needle <NUM> entering into the inner needle housing <NUM>, the needle <NUM> contacts and biases a longitudinal metal clip <NUM> into an open position. The longitudinal clip <NUM> can be, for example, a leaf spring that extends and compresses in a longitudinal direction. When the distal tip of the needle <NUM> sufficiently enters into the inner needle housing <NUM>, as illustrated in <FIG>, the clip <NUM> extends into the inner needle housing <NUM> towards a centerline of the needle <NUM>. Accordingly, the clip <NUM> is no longer biased and enters into a closed position where the distal tip of the needle <NUM> is blocked.

The needle <NUM> further includes a deformation <NUM> adjacent to its distal tip. In at least one direction, the diameter of the deformation <NUM> is greater than the diameter of the remainder of the needle <NUM>. The deformation <NUM> prevents the needle <NUM> from exiting the inner needle housing <NUM> during retraction of the needle <NUM>. Specifically, when the distal tip of the needle <NUM> is in the inner needle housing <NUM>, the deformation <NUM> contacts a rear wall of the inner needle housing <NUM> and prevents the needle <NUM> from exiting the inner needle housing <NUM>. Thus, the distal tip and the deformation <NUM> of the needle <NUM> are enclosed in the inner needle housing <NUM>. The clip <NUM>, needle <NUM>, inner needle housing <NUM> and outer needle housing <NUM> are an exemplary needle protection member.

As illustrated in <FIG>, when the user continues to pull the outer needle housing <NUM>, the inner needle housing <NUM> and the catheter hub <NUM> disengage and separate. Specifically, a boss <NUM> of the inner needle housing <NUM> disengages from a bore in the catheter hub <NUM>.

After the needle <NUM> is used, the inner needle housing <NUM> enclosing the tip of the needle <NUM> and the outer needle housing <NUM> are discarded. The catheter hub assembly can be subsequently used. Specifically, the user can engage a Luer connector <NUM> with the catheter hub <NUM> to cause the actuator to open or penetrate the septum and establish fluid communication.

More information regarding the needle tip protection mechanism used in this embodiment can be found in <CIT> and <CIT>. The features described in this embodiment, including the passive needle protection, can be used in combination with the catheters described throughout this application.

<FIG> illustrates a cross sectional view of another exemplary embodiment of a catheter assembly <NUM> with a needle tip shield. The needle protection mechanism disclosed in the catheter assembly <NUM> operates passively (automatically) when the needle <NUM> is removed from the catheter hub <NUM> because user actuation is not required to initiate needle protection. Operation of the catheter assembly <NUM> is described as follows. During operation, a needle <NUM> extends through an actuator <NUM> that pierces a septum <NUM> in a catheter hub <NUM>, as similarly described in the embodiments above. A V-clip <NUM>, located in a needle tip shield <NUM>, is biased by the needle <NUM> into an open position (the V-clip <NUM> is collapsed) to allow the needle <NUM> to pass beyond the V-clip <NUM>. The V-clip <NUM> comprises a resilient metal clip. After operation of the catheter assembly <NUM>, the biasing member <NUM> retracts the actuator <NUM> into the catheter hub <NUM>.

<FIG> illustrates a cross sectional view of the catheter assembly <NUM> when the needle <NUM> is in a retracted position. When a distal tip of the needle <NUM> enters into the needle tip shield <NUM> and is positioned on the proximal end of the V-clip <NUM>, the V-clip <NUM> is no longer biased. Rather, the V-clip <NUM> expands in the needle tip shield <NUM> into a closed position (the V-clip is expanded) to prevent the needle <NUM> from traveling beyond the V-clip <NUM>. The expansion of the V-clip <NUM> in the needle tip shield <NUM> forms one or more barriers (as described below) that prevent the distal tip of the needle <NUM> from exiting the needle tip shield <NUM>.

The needle tip shield <NUM> includes a metal washer <NUM> and the needle <NUM> includes a deformation <NUM> adjacent to the distal tip of the needle <NUM>. In at least one radial direction, the diameter of the deformation is greater than the diameter of the remainder of the needle <NUM>. In at least one radial direction, the diameter of the deformation <NUM> is bigger than a through-hole in the washer <NUM> where the needle <NUM> travels. Thus, the deformation <NUM> prevents the needle <NUM> from exiting the washer <NUM> during needle <NUM> retraction. Accordingly, when the needle <NUM> is in the retracted position, the distal tip of the needle <NUM> and the deformation <NUM> are enclosed via the washer <NUM> and the barrier of the V-clip <NUM>.

<FIG> illustrates a bottom plan view of the catheter hub assembly and the needle hub assembly when the needle is retracted. The catheter hub <NUM> includes a collar <NUM> having a collar opening <NUM> and Luer threads <NUM>. When the needle <NUM> biases the V-clip <NUM> into an open position as described above, a latch <NUM> that is connected to a foot <NUM> of the V-clip <NUM> engages the collar <NUM>. The V-clip <NUM> being engaged with the collar <NUM> keeps the catheter hub <NUM> and the needle tip shield <NUM> connected.

On the other hand, when the needle <NUM> is in the retracted position and no longer biases the V-clip <NUM>, the V-clip <NUM> moves to the closed position. In the closed position, the latch <NUM> and the foot <NUM> of the V-clip <NUM> move into axial alignment with the collar opening <NUM>. The collar opening <NUM> thus allows the catheter hub <NUM> to disengage from the needle tip shield <NUM>.

Additionally, when the V-clip <NUM> moves to the closed position, a barrier <NUM> in the V-clip <NUM> prevents the distal tip of the needle <NUM> from exiting the needle tip shield <NUM>. Preferably, the barrier <NUM> includes two barriers although more or less are contemplated. The combination of the V-clip <NUM> and the washer <NUM> is an exemplary needle protection member.

The V-clip <NUM> further includes an outer wall <NUM> and a spade <NUM> that are configured to attach the V-clip <NUM> to an outer wall of the needle tip shield <NUM>. The outer wall of the needle tip shield <NUM> includes projections <NUM> that secure the V-clip <NUM> by creating friction between the V-clip <NUM> and the needle tip shield <NUM>. This configuration advantageously secures the V-clip <NUM> to the needle tip shield <NUM> and avoids the use of an outer housing for mounting. Accordingly, the width of the needle tip shield <NUM> is advantageously reduced.

Upon separation of the catheter hub assembly and the needle tip shield <NUM>, the catheter hub assembly can be subsequently used as a multi-use blood control apparatus. Specifically, the actuator <NUM> can be engaged multiple times through the use of the Luer threads <NUM> in a similar manner as described in the above embodiments.

More information regarding the needle tip protection mechanism used in this embodiment can be found in <CIT>, <CIT> and <CIT>. The features described in this embodiment, including the passive needle protection features, can be used in combination with the features described throughout this application.

Needle protection members other than those disclosed herein may be used in the present invention. These may be needle tip shields as exemplified by the embodiments of <FIG>, <FIG>, and <FIG>, needle-enclosing tubes or barrels as exemplified by the embodiment of <FIG>, or other arrangements. They may operate passively (automatically) when the needle is removed from the catheter hub as in the embodiments of <FIG>, <FIG> and <FIG>, or they may require active user actuation as in the embodiments of <FIG>.

<FIG> illustrate various exemplary embodiments of blood flashback features in the catheter assembly. Flashback is the visibility of blood that confirms the entry of the needle tip into the vein. Primary flashback <NUM> is seen through the catheter tubing as blood travels into the open distal end of the hollow needle <NUM>, out a notch or opening <NUM> in the needle <NUM> near the needle tip, and up through the internal annular space between the needle <NUM> and the inside of the catheter tubing. The secondary flashback <NUM> is seen in the needle hub/grip when it comes out of the back of the needle <NUM> and enters a flash chamber in the needle hub/grip. Air is vented by the plug in the back of the needle hub/grip by a porous membrane or micro grooves. Tertiary flashback <NUM> is visible in the catheter hub <NUM> when the blood from the primary flashback <NUM> flows into it and stops at the blood control septum. Air is vented by the micro grooves in the periphery of the blood control septum. The features described in these embodiments, including the blood flashback features, can be used in combination with the features described throughout this application.

In another embodiment similar to the embodiment illustrated in <FIG>, the assembly <NUM> does not include a return member <NUM>. Rather, as described earlier, the flaps defined by the slits <NUM> of the resilient septum <NUM> act as the return member <NUM>. Prior to operation, the actuator <NUM> is in a free state and does not contact the septum <NUM> (first position of the actuator <NUM>). In operation, the septum <NUM> is in an opened state where the actuator <NUM> (second position of the actuator <NUM>) contacts or pushes against the slits <NUM> of the septum <NUM>. The opened state of the septum <NUM> permits fluid communication. In the opened state of the septum <NUM>, the actuator <NUM> does not extend through the septum <NUM>. In other words, the actuator <NUM> does not penetrate the septum <NUM>. As a result, the resilient flaps defined by the open slits <NUM> of the septum <NUM> cause the actuator <NUM> to retract to the first position when operation is complete and upon removal of the axial pressure on the actuator <NUM>.

In another embodiment, as illustrated in <FIG>, the valve actuators <NUM> function in a similar manner to the valve actuators of the catheter assembly as described in the embodiments of <FIG>. However, for the reasons described below, the valve actuators <NUM> of the following embodiments improve the flushing capability of the catheter assembly during a saline flush.

Similar to the embodiment of <FIG>, the valve actuators <NUM> include a shaft portion <NUM>, a diameter reduction region <NUM> and a mating portion <NUM>. The valve actuators <NUM> may be approximately <NUM> (<NUM> inches) in length. The shaft portion <NUM> is configured to penetrate a septum of a catheter assembly. Specifically, the shaft portion <NUM> includes a distal opening 746b that provides an entrance into a hollow internal passage 746a that extends through a length of the valve actuator <NUM>. When the valve actuator <NUM> penetrates the septum, fluid, such as blood or saline, travels through the hollow internal passage 746a. The valve actuator <NUM> also includes a plurality of openings 746c that provide a passageway for the fluid to exit the hollow internal passage 746a.

The mating portion <NUM> is disposed at a distal end of the valve actuator <NUM>. An outer diameter of the mating portion <NUM> may be approximately <NUM> (<NUM> inches). The outer diameter of the mating portion <NUM> is larger than an outer diameter of the shaft portion <NUM> so that the mating portion <NUM> can engage and disengage with a Luer connector.

The diameter reduction region <NUM> is an inclined member disposed near a proximal end of an inner diameter of the valve actuator <NUM>. The diameter reduction region <NUM> is disposed between the shaft portion <NUM> and the mating portion <NUM> to connect the shaft portion <NUM> and mating portion <NUM> and to provide a continuous outer surface of the valve actuator <NUM>. The diameter reduction region <NUM> includes a plurality of protrusions <NUM> on an outer diameter as illustrated in <FIG>, as well as on an inner diameter as illustrated in <FIG>. The protrusions <NUM> advantageously aid in assembling a spring and securing the spring in the catheter assembly during operation.

The diameter reduction region <NUM> further includes a plurality of windows <NUM>. As illustrated in <FIG>, the windows can extend the full length of the diameter reduction region of the valve actuator. In a valve actuator <NUM> having a length of approximately <NUM> (<NUM> inches) and a maximum outside diameter of approximately <NUM> (<NUM> inches), the full length (or height) of the diameter reduction region of <FIG> can be <NUM> - <NUM> (<NUM> - <NUM> inches), for example. However, in <FIG> the windows <NUM> extend only a portion of the diameter reduction region <NUM>.

Specifically, <FIG> illustrate that for an actuator of the overall size mentioned, the windows <NUM> can extend approximately <NUM> (<NUM> inches), <NUM> (<NUM> inches), <NUM> (<NUM> inches) and <NUM> (<NUM> inches) from a distal end of the diameter reduction region <NUM>, respectively. Other embodiments include windows <NUM> at any length less than the full length of the diameter reduction region <NUM>. Alternately, the windows <NUM> can extend approximately <NUM>/<NUM> or <NUM>/<NUM> of the length of the diameter reduction region <NUM>. <FIG> illustrate windows <NUM> adjacent to a distal end of the diameter reduction region <NUM> but outside the diameter reduction region <NUM>. The windows <NUM> of <FIG> are in the mating portion <NUM> of the valve actuator <NUM>. The windows <NUM> of <FIG> can extend at a length of approximately <NUM> (<NUM> inches) and <NUM> (<NUM> inches), respectively. Advantages of the windows <NUM> are provided below.

During use, the valve actuator <NUM> is typically flushed with saline, for example, to remove any remaining blood or fluid. However, blood or fluid deposits can remain even after the saline flush. The windows <NUM> are reduced in size and placed at a proximal end of the diameter reduction region <NUM> to advantageously improve saline flushing.

Specifically, the size (length or height) of the windows <NUM> increases the velocity of the saline flow. The saline flow <NUM> of <FIG> is representative of each of the windows <NUM> of <FIG>. As illustrated in <FIG>, the fluid flushing velocity of the saline flows almost entirely in a radial direction when exiting the windows <NUM>. This is because the size of the windows <NUM> is smaller than the windows of the valve actuators in <FIG>. The size of the windows <NUM> causes the fluid that is traveling through the internal passage 746a in a longitudinal direction (axial direction) to shift into a perpendicular direction (radial direction) to exit the valve actuator <NUM>. For an actuator of the overall size mentioned, the preferred optimal size (length or height) is approximately <NUM> ± <NUM> (. <NUM> ± <NUM> inches). The closer the size of the windows <NUM> to the preferred size, the more radial the direction of flow of fluid will exit out of the windows <NUM>. The radial flow at a higher velocity will optimize flushing performance.

When compared to the embodiments of <FIG>, the flushing fluid velocity traveling through the windows of the valve actuators in <FIG> has a higher axial component and travels at a lower velocity because of the large window size. As a result, a small section of reduced flushing can remain near a corner between the inner diameter of the adapter and the proximal end of the flushing window.

The placement of the windows <NUM> at the distal end of the diameter reduction region <NUM> improves the speed and direction of flow. The windows <NUM> outside the diameter reduction portion <NUM> cause the flow of fluid in the internal passage 746a to change direction more abruptly compared to the windows in the valve actuators of <FIG>. This is because the fluid flowing through the internal passage 746a travels shorter by the time the flow reaches the windows <NUM>. Thus, the windows <NUM> outside the proximal end of the diameter reduction portion <NUM> forces flow to change into more of a radial direction when exiting the windows <NUM>.

The fluid traveling through the windows <NUM> in the diameter reduction region <NUM> responds similarly. In these embodiments, the distance of the windows <NUM> from the centerline of the valve actuator <NUM> is variable between the distal end and the proximal end of the diameter reduction region <NUM>. This variable flow travel length slightly alters the flushing performance of the windows <NUM>. As described above, for an actuator of the overall size mentioned, the optimal window size (length or height) is approximately <NUM> ± <NUM> (. <NUM> ± <NUM> inches). The combination of the radial flow direction and the increased velocity advantageously enhances flushing.

<FIG> are graphical illustrations of the improved flushing performance of the valve actuator. <FIG> represents the valve actuator with the windows of <FIG> and <FIG> represents the valve actuator with the windows <NUM> of <FIG>. The hash lines identified by a number represent the amount of blood remaining in the catheter hub after a saline flush. The remaining blood is measured by a ratio of blood mass to <NUM> milliliters of saline where <NUM> has a ratio of <NUM>, <NUM> has a ratio of <NUM>, <NUM> has a ratio of <NUM>, <NUM> has a ratio of <NUM> and <NUM> has a ratio <NUM>. As indicated in the window section of <FIG>, the amount of blood remaining in the reduced window design of <FIG> is significantly less than the amount of blood remaining in the normal window design of <FIG>.

<FIG> shows another illustration of the amount of blood remaining after a <NUM> milliliter saline flush. Data points show the amount of blood remaining after a saline flush in the various sizes of the windows <NUM> in the valve actuators <NUM> of <FIG> and in the window of the valve actuator of <FIG>. Specifically, the amount of blood remaining is approximately <NUM>% with the <NUM> (<NUM> inch) window height. The amount of blood remaining is approximately <NUM>% with the <NUM> (<NUM> inch) window height of <FIG>. Thus, as illustrated, the fluid flushing performance is approximately <NUM>% improved when the window is approximately <NUM> (. <NUM> inches) when compared to the windows in the valve actuators of <FIG>.

<FIG> illustrate an embodiment of the invention of the catheter assembly <NUM> with various components that function in a similar manner to the embodiments described above. In particular, a needle hub <NUM> operates in a similar manner as the embodiment of <FIG>. The catheter hub <NUM> operates in a similar manner as the embodiment of <FIG> except for the differences detailed below.

The needle and catheter tubing of the catheter assembly <NUM> are enclosed by a needle cover <NUM> when not in use. The needle cover <NUM> is removed to begin operation of the catheter assembly <NUM>. The catheter assembly <NUM> also includes a flow control plug <NUM> that is similarly described in <FIG>. Specifically, the plug <NUM> includes a porous membrane or micro grooves being disposed at a proximal end of the needle hub <NUM> to vent air while containing blood.

<FIG> illustrates the catheter hub <NUM> and the needle hub <NUM> of the catheter assembly <NUM>. Specifically, the catheter hub <NUM> includes a metal wedge <NUM> made of, for example, <NUM>, <NUM> or <NUM> stainless steel in an annealed state. Alternately, the metal wedge <NUM> can be <NUM> or <NUM> stainless steel in the annealed or close to annealed state. <NUM> and <NUM> stainless steels have a very low magnetic susceptibility in the annealed state, which is advantageous when the catheter assembly is left in place on a patient during a magnetic resonance imaging (MRI) procedure.

<FIG> illustrates the catheter hub <NUM> and <FIG> illustrates a valve actuator <NUM> of the catheter hub <NUM> prior to operation. Specifically, the catheter hub <NUM> includes an inner diameter <NUM>, as well as an undercut <NUM>. The inner diameter <NUM> is larger than the undercut <NUM>. The undercut <NUM> is used to secure a spring <NUM>, as further described below.

The catheter hub <NUM> also includes a septum <NUM>. The septum <NUM> is secured via an interference fit to the inner diameter <NUM> of the catheter hub <NUM> to ensure proper operation of the septum <NUM>. The septum <NUM> contacts an inner wall of the catheter hub <NUM> for proper positioning. The septum <NUM> passes the undercut <NUM> when assembled from a proximal end of the catheter hub <NUM>.

The valve actuator <NUM> is configured to penetrate the septum <NUM> during operation of the catheter assembly <NUM>. The spring <NUM> is compressed when the valve actuator <NUM> penetrates the septum <NUM>. Subsequently, the spring <NUM> retracts the valve actuator <NUM> after piercing the septum <NUM>. The spring <NUM> includes center coils <NUM> and two or more end coils <NUM>. The end coils <NUM> have a greater outer diameter than the center coils <NUM>.

Tests show that the material of the metal wedge <NUM> does not cause magnetic problems during MRI procedures, but this is not necessarily the case for the spring <NUM>. Either <NUM> or <NUM> stainless steel is the conventional material used for springs because of its higher carbon content and ease of manufacturability. However, the catheter assembly including the spring composed of <NUM> or <NUM> stainless steel has very high magnetic properties when hardened to the level that a spring requires. Specifically, the metal of the spring must be cold worked to spring temper in order to have the higher shear strength, which consequentially makes the metal more magnetically susceptible.

Accordingly, springs composed of <NUM> or <NUM> stainless steel in the catheter assembly may not be compatible for use during magnetic resonance imaging (MRI) procedures. This is because the magnets of an MRI device can cause susceptible metals in the catheter assembly to pull, twist and heat up. As a result, a catheter assembly with springs composed of <NUM> or <NUM> stainless steel should be removed from the patient prior to MRI procedures.

<NUM> stainless steel is not commonly used as a spring material because of its low strength, high cost and difficulty in processing. However, <NUM> stainless steel is the material for the spring <NUM> and advantageously improves in strength as the temper of the material changes. In this embodiment, the temper of <NUM> stainless steel is increased to satisfy an ASTM F138-<NUM> material strength standard for stainless steel surgical implant devices. Preferably, the strength requirement for the spring <NUM> exceeds what is specified in ASTM F138.

As the temper of <NUM> stainless steel increases, the magnetic attraction also increases. However, the magnetic properties of <NUM> stainless steel are less than <NUM> or <NUM> stainless steel because of the lower carbon content. Specifically, the composition of the <NUM> series stainless steel or their equivalents, especially the chromium and nickel content and the ratio of Cr/Ni content in these alloys, helps the austenite phase remain stable through the cold working process and resist transformation to martensite. The low carbon content of an 'L' grade <NUM> stainless steel also aids in alloy stability. Thus, when <NUM> stainless steel achieves spring temper, the spring <NUM> in the catheter assembly <NUM> is compatible for use during MRI procedures.

In particular, the spring <NUM> is advantageously made of <NUM> stainless steel that is cold worked to a spring temper. Other preferred materials of the spring <NUM> include <NUM> stainless steel, <NUM> LVM stainless steel (bare wire with no nickel coating having a 240ksi minimum strength). In addition, the spring <NUM> is plated with a diamagnetic material, such as palladium, to reach the desired magnetic permeability. The spring <NUM> can be magnetically susceptible but plated with a diamagnetic material to substantially cancel out the overall magnetism of the material. Thus, the diamagnetic material can help achieve a zero net attraction force of the metal.

These material and process selections allow the spring <NUM> in the catheter assembly <NUM> to achieve a magnetic relative permeability that is less than <NUM> and preferably less than <NUM>. The magnetic relative permeability is a dimensionless value that is commonly understood by one of ordinary skill in the art. The material and associated processing selection for the spring <NUM> advantageously allows the catheter assembly <NUM> to remain attached to the patient during MRI procedures. In other words, the correct alloys and tempers of metals are used in the catheter assembly <NUM> to keep magnetic susceptibility low enough so that there is no compatibility concern with the catheter assembly <NUM> during MRI procedures.

During assembly, one of the end coils <NUM> of the spring <NUM> travels past the undercut <NUM> and is snapped into place. Specifically, the end coil <NUM> is movably captured between the septum <NUM> and the undercut <NUM>. The end coils <NUM> of the spring <NUM> advantageously do not have to be disposed at a precise location. The outer diameter of the end coils <NUM> is greater than the diameter of the undercut <NUM> to movably retain the spring <NUM>. Thus, the spring <NUM> and catheter hub <NUM> advantageously prevent the inadvertent removal of the valve actuator <NUM>. Also, the improved assembly advantageously causes less variation to the function of the catheter assembly <NUM>.

An outer diameter of the center coils <NUM> is smaller than the diameter of the undercut <NUM>. This advantageously prevents interference and allows the spring <NUM> to move axially in the catheter hub <NUM> by a limited amount, until a Luer connector is attached.

A clearance fit is present between the inner diameter <NUM> of the catheter hub <NUM> and the outer diameter of the end coils <NUM> of the spring <NUM>. A clearance fit advantageously facilitates assembly and operation of the spring <NUM>. Specifically, once the end coils <NUM> pass the undercut <NUM> during assembly, the spring <NUM> is properly located. The other end coil <NUM> is immovably fixed to the valve actuator <NUM>. Thus, the spring <NUM> and the valve actuator <NUM> can axially move "or float" (within limits) inside the catheter hub <NUM> when no Luer connector is present. The actuator does not contact the inner diameter <NUM> of the catheter hub <NUM>.

When an interference fit is present between the spring and the inner diameter of the catheter hub as described in the embodiment of <FIG>, it can be difficult to place the spring in the correct position. Specifically, it can be difficult to set the exact position of the spring because of the length of the inner diameter in the catheter hub. Also, the shoulder that the septum rests on is deep inside the length of the inner diameter of the catheter hub.

Moreover, an interference fit requires very tight tolerances on the outer diameter of the spring, as well as the inner diameter of the catheter hub. If the interference fit is too severe, the life of the spring may be compromised. If the interface between the spring and the inner diameter of the catheter hub becomes loose, then the spring and the valve actuator may be inadvertently removed.

The interference fit can also present problems in operation because the septum may move with the spring during retraction. This is because the interference fit between the spring and the inner diameter of the catheter hub may create a jam where the septum moves with the spring. The high forces in an interference fit can overcome the frictional forces of the septum and cause the septum to move with the spring. Additionally, the interference fit can cause undue pressure on the valve actuator <NUM> during retraction. Also, if the spring <NUM> is compressed too far distally such that the septum <NUM> is compressed, an interference fit may not allow the septum <NUM> to retract or relax. As a result, the septum <NUM> may leak over time due to the excessive and continuous compression.

On the other hand, when a clearance fit is present between the spring <NUM> and the inner diameter <NUM> of the catheter hub <NUM>, the spring <NUM> can move axially when no Luer connector is present and can apply pressure to a proximal face of the septum <NUM> only when a Luer connector is inserted. Thus, the combination of the clearance fit and the undercut <NUM> advantageously improves the operation, the ability to position the spring <NUM>, and the manufacturability of the catheter assembly.

According to another embodiment, as illustrated in <FIG>, a valve actuator <NUM> with a single-stepped distal tip includes a side opening <NUM>, a distal end <NUM>, a distal end opening <NUM>, a step <NUM>, radii <NUM>, and an outer diameter <NUM>. The openings <NUM>, <NUM> provide for fluid flushing and flow through the valve actuator <NUM> when engaged to a septum in a catheter hub. The openings <NUM>, <NUM> operate in a similar manner described above in previous embodiments.

The step <NUM> is disposed between the distal end <NUM> and the outer diameter <NUM> of the valve actuator <NUM>. Since the valve actuator <NUM> is injection molded, no sharp edges are formed on its outer surface. Instead, radii <NUM> are disposed on either end surface of the step <NUM>. Specifically, a radius <NUM> is disposed at the interface of the step <NUM> and the distal end <NUM>, as well as at the interface between the step <NUM> and the outer diameter <NUM>. The step <NUM> at the distal end <NUM> of the valve actuator <NUM> replaces the taper at the distal end of the valve actuators of previous embodiments. The radii <NUM> advantageously allow for ease of manufacturability during injection molding.

<FIG> illustrate a valve actuator <NUM> with a double-stepped distal tip according to another embodiment. In this embodiment, the valve actuator <NUM> includes an opening <NUM>, a distal end <NUM>, a distal end opening <NUM>, radii <NUM>, and an outer diameter <NUM> in a similar manner as described in the embodiment of <FIG>. However, the valve actuator <NUM> has two steps <NUM> between the outer diameter <NUM> and the distal end <NUM>. The two steps <NUM> have two different diameters with appropriate radii <NUM> on each end surface. Likewise, the radii <NUM> advantageously allow for ease of manufacturability during injection molding.

The foregoing detailed description of the certain exemplary embodiments has been provided for the purpose of explaining the principles of the invention and its practical application, thereby enabling others skilled in the art to understand the invention for various embodiments and with various modifications as are suited to the particular use contemplated. This description is not necessarily intended to be exhaustive or to limit the invention to the precise embodiments disclosed. Any of the embodiments and/or elements disclosed herein may be combined with one another to form various additional embodiments not specifically disclosed. Accordingly, additional embodiments are possible and are intended to be encompassed within this specification and the scope of the invention. The specification describes specific examples to accomplish a more general goal that may be accomplished in another way.

Claim 1:
A catheter assembly (<NUM>) comprising:
a catheter;
a needle having a distal tip disposed within the catheter;
a catheter hub (<NUM>) connected to the catheter having the needle passing therethrough,
the catheter hub including:
a valve (<NUM>) that selectively permits or blocks a flow of fluid through the catheter;
a valve actuator (<NUM>) that moves between a first position and a second position; and
a return member (<NUM>) that returns the valve actuator from the second position to the first position; and
a needle protection member (<NUM>) that encloses the distal tip of the needle, wherein
the return member comprises <NUM> stainless steel.