Patent Description:
Insertion procedure for an IV catheter assembly contains four basic steps: (<NUM>) the healthcare worker inserts the needle and catheter together into the patient's vein; (<NUM>) after insertion into the vein with the needle point, the catheter is forwarded into the vein of the patient by the healthcare worker pushing the catheter with his or her finger; (<NUM>) the healthcare worker withdraws the needle by grasping the hub end (opposite the point end) while at the same time applying pressure to the patient's skin at the insertion site with his or her free hand to stop the flow of blood through the catheter; and (<NUM>) the healthcare worker then tapes the exposed end of the catheter (the catheter hub) to the patient's skin and connects it to the source of the fluid to be administered into the patient's vein.

The problem is that, immediately after the withdrawal of the needle from the patient's vein, the healthcare worker, who is at this time involved in at least two urgent procedures, must place the exposed needle tip at a nearby location and address the tasks required to accomplish the needle withdrawal. It is at this juncture that the exposed needle tip creates a danger of an accidental needle stick, which, under the circumstances, leaves the healthcare worker vulnerable to the transmission of various dangerous blood-borne pathogens, including AIDS and hepatitis.

Other needle types similarly expose healthcare workers to risks of accidental needle sticks. For example, a doctor administering an injection, using a straight needle, a Huber needle, an epidural needle, etc., may place the used needle on a tray for subsequent disposal by a nurse. For the period between placing the used needle on a tray or a work station to the time it is discarded, the used needle is a potential source for disease transmissions for those that work near or around the needle.

Accordingly, all needles should be covered immediately following use to ensure greater worker safety. Ideally, the procedure for covering the needle tip should be passive, self activating, or at least simple to perform. In addition, the device for covering the needle should be reliable and robust.

More advantageously, a valve should be incorporated in the catheter assembly to minimize blood exposure following successful catherization. In addition, as blood comes in contact with the needle and is deposited on the needle, the needle assembly should further incorporate means for wiping the needle of the deposited blood upon retracting the needle.

<CIT> discloses a catheter insertion device having a needle protective element, a check valve, and a valve actuating element.

<CIT> discloses a catheter assembly which includes an outer cannula which is insertable into a body conduct such as a vein, in particular, an over-the-needle insertable multi-lumen catheter assembly comprising an attachment structure.

The present invention is directed to a safety catheter assembly as determined by the appended the claims. According to the present disclosure, there is provided a safety catheter assembly comprising:
a catheter hub comprising a housing comprising an exterior surface and an interior surface defining an interior cavity; a catheter tube attached to the catheter hub and extending distally of the catheter hub; a needle hub comprising a housing comprising an exterior surface and an interior surface defining an interior cavity; a needle having a needle tip attached to the needle hub and projecting distally of the needle hub and into the catheter tube; a valve comprising a top surface, a skirt depending therefrom, and an opening on the top surface having the needle projecting therethrough; a valve opener for opening the valve and positioned in the interior cavity of the catheter hub proximal of the valve; a safety device for covering the needle comprising a tip protector housing for receiving the needle tip in a protected position and having a housing section positioned proximally of a proximal end of the catheter hub in a ready position; and wherein the valve opener comprises two proximally extending legs having a gap there between, the valve opener being sized and shaped to be pushed distally towards the valve to transfer a force imparted by an IV-set Luer connector to the valve.

In accordance with aspects of the present disclosure not forming part of the claimed invention, there is provided a catheter assembly comprising: a first hub comprising a housing comprising an exterior surface and an interior surface defining an interior cavity; a tube attached to the first hub and extending distally of the first hub; a second hub comprising a housing comprising an exterior surface and an interior surface defining an interior cavity; a needle having a needle tip attached to the second hub and projecting distally of the second hub and into the tube; a valve comprising a top surface, a skirt depending therefrom, and an opening on the top surface having the needle projecting therethrough; a valve opener comprising an actuating end, at least one leg extending proximally therefrom, and a wiper comprising a perimeter defining an opening and the needle in contact with the perimeter for wiping the needle as the needle is retracted away from the tube.

Other aspects of the present disclosure not forming part of the claimed invention include a catheter assembly comprising: a) a catheter hub comprising a housing comprising an exterior surface and an interior surface defining an interior cavity; b) a catheter tube attached to the catheter hub and extending distally of the catheter hub; c) a needle hub comprising a housing; d) a needle having a needle tip attached to the needle hub and projecting distally of the needle hub and into the catheter tube; e) a valve for limiting blood backflow positioned in the interior cavity of the catheter hub; f) a valve opener for opening the valve positioned proximally of the valve; and g) a tip protector positioned adjacent the valve opener for blocking the needle tip, wherein the tip protector comprises: (<NUM>) a tip protector housing having an interior surface; (<NUM>) a first arm extending from a distal wall of the tip protector housing biased towards the interior surface of the catheter hub; (<NUM>) a second arm extending from a proximal wall of the tip protector housing biased towards the interior surface of the catheter hub; and (<NUM>) a third arm extending from the proximal wall of the tip protector housing biased against a side of the needle.

In accordance with other aspects of the present disclosure not forming part of the claimed invention, there is provided a catheter assembly comprising: a catheter hub comprising a housing defining an interior cavity and having a catheter tube extending distally thereof; a needle hub comprising a housing defining an interior cavity and having a needle having a needle tip extending distally thereof; the needle projecting into the catheter tube; a hemostatic valve positioned within the interior cavity of the catheter hub having an opening; a valve opener positioned adjacent the hemostatic valve and comprising an actuating end comprising a cone section and a pair of legs defining a gap extending proximally thereof; a wiper having the needle passing therethrough for wiping the needle as the needle is retracted from the catheter tube; and wherein a tip protector comprising an arm and a wall comprising an opening and is positioned in the gap defined by the two legs.

Still yet in accordance with other aspects of the present disclosure not forming part of the claimed invention include provisions for registering a pair of legs on the valve opener to the catheter hub by forming two axially extending undercut within the interior wall surface of the catheter hub for cooperating with the two legs.

In a preferred examples of the present disclosure not forming part of the claimed invention, a raised bump or projection is formed within the interior cavity of the catheter hub for retaining a tip protector within the catheter hub during retraction of the needle hub away from the catheter hub.

In yet other aspects of the present disclosure not forming part of the claimed invention, a wiper in the form of an O-ring is used to wipe the needle from blood deposits.

Other aspects and features of the catheter assemblies provided herein may be better appreciated as the same become better understood with reference to the specification, claims, and appended drawings.

The detailed description set forth below in connection with the appended drawings is intended as a description of the presently preferred embodiments of a catheter assembly for use with valves and needle tip protectors provided in accordance with aspects of the present disclosure and is not intended to represent the only forms in which the present invention may be constructed or utilized. The description sets forth the features and the steps for constructing and using the catheter assembly of the present invention in connection with the illustrated embodiments. It is to be understood, however, that the same functions and structures may be accomplished by different embodiments are also intended to be encompassed within the scope of the invention, especially those incorporating a combination of features shown in the different embodiments included herein. As denoted elsewhere herein, like element numbers are intended to indicate like or similar elements or features.

Referring now to <FIG>, a partial cross-sectional side view of a catheter assembly provided in accordance with aspects of the present disclosure is shown, which is generally designated <NUM>. The catheter assembly <NUM> comprises a catheter tube <NUM> attached to a catheter hub <NUM> having a needle <NUM>, which is attached to a needle hub <NUM>, projecting through the catheter tube <NUM> in a ready to use position. The needle <NUM> has a sharpened needle tip <NUM> and a crimp, bump, or clip engagement section <NUM>. The catheter hub <NUM> comprises an exterior surface <NUM> and an interior surface defining an interior cavity <NUM>. A needle hub nose section <NUM> preferably projects into the interior cavity <NUM> of the catheter hub <NUM> and a combination groove and projection (not shown) incorporated between the catheter hub <NUM> and needle hub <NUM> to fix relative angular rotation between the two.

In one exemplary embodiment, a pair of diametrically opposed channels <NUM> are formed in the interior wall surface <NUM> of the catheter hub <NUM>. The channels <NUM> are formed as indentations in the interior wall surface <NUM> of the catheter hub and each has a length measured about <NUM> % to about <NUM> % of the length of the catheter hub, measured from the proximal threads <NUM> to the distal shoulder <NUM> adjacent a frusto-conical nose section <NUM>. The channels <NUM> may be formed by known injection molding techniques.

In one exemplary embodiment, a pair of projections <NUM> are incorporated in the interior cavity <NUM> of the catheter hub <NUM>. The two projections <NUM> are preferably symmetrical about the two channels <NUM> and each comprises two ends <NUM> that contact the two channels <NUM>. In an alternative embodiment, the two ends <NUM> can be spaced apart from the two channels <NUM> and each projection <NUM> may be an indentation rather than a raised bump. Thus, in a preferred embodiment, the interior cavity <NUM> of the catheter hub, at the two projections or bumps <NUM>, have a diameter measured from one bump to another bump, called a bump diameter, that is smaller than the diameter of the interior cavity of the catheter hub <NUM> measured from a point <NUM> adjacent the two bumps, called a bore diameter. Also at the two projection or bumps <NUM>, the interior cavity <NUM> of the catheter hub <NUM> has a diameter measured from one channel <NUM> to another channel <NUM>, called a mean channel diameter, that is larger than the bump diameter and the bore diameter <NUM>.

<FIG> is a cross-section side view of the catheter hub <NUM> of <FIG> taken along a transverse plane and with the needle <NUM> and needle hub <NUM> removed therefrom. Although relative positions of the channel <NUM> to the hub <NUM> and of the bump <NUM> to the channel <NUM> are shown, they can each vary proximally towards the proximal opening <NUM> or distally towards the nose section <NUM> and relative to one another or in a rotation relative to the needle bevel <NUM> without deviating from the scope of the present invention.

Referring now to <FIG>, a partial cross-sectional side-view of a safety IV catheter assembly provided in accordance with aspects of the present disclosure is shown, which is generally designated <NUM>. In one exemplary embodiment, the catheter assembly <NUM> comprises a hemostatic valve <NUM>, a valve opener <NUM>, and a tip protector <NUM> positioned inside the interior cavity <NUM> of the catheter hub <NUM> of <FIG>. The tip protector <NUM> may be the same as one of the many tip protectors shown and described in <CIT> The tip protector <NUM> is seated within the interior cavity <NUM> by moving the tip protector distally in the direction of the needle tip <NUM> until the two elbow sections <NUM> (only one shown) located between the two arms <NUM> and the two fingers or distal walls <NUM> (only one shown) move distally of the projection <NUM> inside the catheter hub. Alternatively, two recesses may be incorporated instead of the two bumps for interacting with the two elbow sections <NUM>.

The hemostatic valve <NUM> may be made from a thermoplastic elastomer (TPE), such as polyisoprene or silicone rubber, and generally speaking comprises a skirt section <NUM> and a top <NUM> having a cut-out <NUM> comprising a plurality of slits, such as three slits resembling a three-sided star or a single slit, for expanding the cut-out when deflected. The hemostatic valve <NUM> is widely commercially available and is a well known component in the relevant art. In accordance with aspects of the present invention, a plurality of bumps, stretched ridges, or protuberances may be incorporated around the external circumference of the skirt section <NUM> for ensuring sufficient air flow between the valve skirt <NUM> and the inside surface <NUM> of the catheter hub for purposes of blood flashback. In yet other aspects of the present invention, the cut-out <NUM> is provided with a sufficient gap to permit air movement for purposes of blood flashback. In the latter alternative embodiment, an air tight seal is preferred between the exterior skirt section and the interior surface <NUM> of the catheter hub.

The valve opener <NUM> comprises an actuating end <NUM> and a pair of legs <NUM>. In one exemplary embodiment, the actuating end <NUM> comprises a frusto-conical shape distal end configured to project against the top <NUM> of the valve <NUM>, as further discussed below with reference to <FIG>. In accordance with aspects of the present invention, the actuating end <NUM> comprises one or more undulating surfaces or barbs <NUM> for mating engagement with the cut-out <NUM> and plurality of slits on the hemostatic valve.

In one exemplary embodiment, the valve opener <NUM> is formed from a hard plastic material, which may be a polycarbonate material, a polyoximethylene material or the like. The two legs <NUM> are formed such that they spread radially outwardly relative to the needle shaft <NUM>. In a specific aspect of the present invention, the two legs <NUM> are aligned with the two channels <NUM> and are registered to the two channels. The length and geometry of the valve opener <NUM> are such that the nose section <NUM> abuts the skirt section <NUM> of the valve <NUM> and the valve exerts a counter force pushing the two proximal ends <NUM> of the two legs <NUM> against the proximal ledge <NUM> of each respective channel <NUM> (See, e.g., <FIG>). The skirt section <NUM> is therefore under a slight compression caused by the nose section <NUM> of the valve opener <NUM> pushing against the skirt section. Alternatively, the nose section <NUM> may be spaced apart from and not contact the valve <NUM> in the ready to use position (<FIG>).

The two legs <NUM> are preferably registered to the two channels <NUM> without a radial compression. In other words, the radial most tip <NUM> of each leg <NUM> is not biased against the wall surface <NUM> of the respective channel <NUM>. However, a slight radial compression may be practiced without deviating from the scope of the present invention.

Referring now to <FIG>, the safety IV catheter assembly of <FIG> is shown with the needle <NUM>, tip protector <NUM>, and needle hub <NUM> removed. In practice, this represents the position of the catheter following successful catheterization. As disclosed in the '<NUM> Woehr et al. patent, when the needle <NUM> is withdrawn following catheterization, the tip protector <NUM> is withdrawn with the needle and remains with the needle to block the needle tip <NUM>. In certain aspects of the present invention, a crimp, bump, or clip engagement section <NUM> is used to engage the opening on the tip protector <NUM> to secure the tip protector to the needle. <CIT>, entitled Needle Assembly and Components Thereof discloses a tip protector comprising side walls for surrounding the needle tip, which may be useable with the catheter assemblies provided in accordance with aspects of the present invention. In yet other aspects of the present invention, the tip protector <NUM> incorporates an opening that cants over to grip the needle. Exemplary tip protectors that cant over to grip the needle are disclosed in <CIT>, patent application Ser. No. <CIT>, entitled Protective Needle Clips, and patent application Ser. No. <CIT>, entitled Protective Clips.

As shown in <FIG>, the top section <NUM> of the valve <NUM> recoils when no longer deflected by the needle and the cut-out <NUM> closes to form a seal. Thus, blood flow from the direction of the catheter tube <NUM> is stopped. Although not depicted, the exterior circumference of the valve <NUM> is wedged into the interior cavity and the valve is under compression by the interference fit. As the blood flow has been stopped, a health care worker can take his or her time in connecting an IV set luer connector to the catheter hub <NUM>, fix the catheter hub with tape to the patient, and dispose of the used needle without excessive blood leakage through the catheter hub. Alternatively, the valve can provide a semi-permeable seal, which gives the health care worker ample time to make the required connections, fixations, and disposal of used needles before blood would exit the catheter hub <NUM> at the proximal end <NUM>.

Assuming the opening <NUM> of the hub <NUM> defines a planar surface <NUM>, in one exemplary embodiment, the end surface <NUM> of the two legs <NUM> at the two proximal ends <NUM> are positioned at an angle to the planar surface <NUM>. The two legs <NUM> should also project radially inwardly of the nominal internal diameter of the catheter hub <NUM> at a position just proximal to the two proximal ends <NUM>, i.e., the bore diameter <NUM>. As further discussed below with reference to <FIG>, the projection provides a contact surface on each proximal end <NUM> of the valve opener <NUM> for urging by a IV-set Luer connector. In an alternative embodiment, the end surfaces are generally parallel to the planar surface <NUM> defined by the opening <NUM>.

<FIG> depicts an IV-set Luer connector <NUM> pushed into the opening <NUM> of the catheter hub <NUM>. As the connector <NUM> is pushed distally forward, its distal end <NUM> abuts the two end surfaces <NUM> of the seal opener <NUM> and advances the opener <NUM> distally forward. The opener <NUM> in turn moves into the top area <NUM> of the seal and forces the cut-out <NUM> to deflect. The combination friction and barbs <NUM> on the actuating end <NUM> of the valve opener <NUM> allow the two to remain engaged. The valve <NUM> remains opened and fluid communication is provided between the catheter tube <NUM> and the interior cavity <NUM> of the catheter hub <NUM>. Medicaments, IV solutions, or other fluids may now be introduced through the connector <NUM> and catheter <NUM>. If the IV set luer connector <NUM> is subsequently withdrawn from the catheter hub <NUM>, then the valve <NUM> would remain open and consequently there could be blood leakage. Alternatively, the actuating end <NUM> does not incorporate barbs <NUM> as shown in <FIG> thus allowing the top section <NUM> of the valve to separate from the actuating end <NUM>. This allows the valve opener <NUM> to be moved proximally by action of the resilient top section while at the same time allows the cut-out to reseal itself.

<FIG> is a cross-sectional side view of a needle hub <NUM> having a needle <NUM> attached at end thereof and a tip protector <NUM> covering the needle tip <NUM>. As known in the art, a flashback plug (not shown) is normally placed in the proximal end of the needle hub <NUM>. The tip protector <NUM> is the same as that shown and described in application Ser. As disclosed in the '<NUM> application,-the tip protector <NUM> comprises a first protector body <NUM> surrounded by a second protector body <NUM>. The- first protector body comprises a short arm <NUM> and a long arm <NUM>, which both have portions that, at least in part, extend to one side of the centerline of the needle <NUM>. The second protector body <NUM> (<FIG>) partially surrounds the-first protector body and comprises a deflector plate <NUM>, a front wall <NUM> having an opening <NUM> and two side walls <NUM> (only one shown). When the tip protector <NUM> is in the protective position over the needle tip (<FIG>), the needle tip is surrounded by the plurality of walls.

In one exemplary embodiment, the combination needle hub <NUM>, needle <NUM>, and tip protector <NUM> of <FIG> may be used with the catheter shown in FTG. The projection <NUM> on the hub <NUM> would be positioned proximally relative to the apex <NUM> of the long arm <NUM> of the tip protector <NUM> to retain the tip protector <NUM> in the catheter hub <NUM>. Alternatively, the projections <NUM> may be omitted and the arm <NUM> and deflector plate <NUM> resiliently engage the interior wall surface <NUM> to retain the tip protector <NUM> to the catheter hub.

Generally speaking, when a needle is withdrawn from a catheter tube following successful catheterization, residue blood may deposit on the needle shaft. The sight and presence of blood on a retracted needle are undesirable and potentially contagious. Thus; in accordance with aspects of the present invention, wipers are provided for wiping the needle upon retracting the same from a catheter. <FIG>, <FIG> are plan views of four different wipers <NUM>, <NUM>, <NUM> and <NUM> provided in accordance with aspects of the present invention. As further discussed below with reference to <FIG> and <FIG>, the wipers are configured to be attached to a valve opener or a catheter hub for scraping or wiping fluid from the surface of a needle as the needle is withdrawn from a catheter tube.

<FIG> shows a wiper <NUM> made from a liquid impermeable film, such as blown PE film, comprising a generally circular configuration with two cut-outs <NUM>. The cut-outs <NUM> are sized and shaped to permit assembly to a valve opener and are incorporated along a perimeter of the wiper. Thus, the cut-out shape and the wiper's overall configuration may vary depending on the mounting surface of the valve opener. In one exemplary embodiment, the wiper <NUM> has a solid center section (i.e., no center opening) configured for puncturing by a needle during assembly, as further discussed below.

<FIG> is a perspective view of a valve opener <NUM> provided in accordance with aspects of the present invention. In one exemplary embodiment, the valve opener comprises an actuating end <NUM> and two legs <NUM> connected to and extend proximally of the actuating end. Like the valve opener <NUM> shown in <FIG>, the actuating end <NUM> comprises a frusto-conical configuration and incorporates barbs (not shown in <FIG>) and a passage for accommodating a needle. In one specific aspect of the present invention, the passage is funnel-like in shape. The two legs <NUM>, while shown extended parallel and offset to an axis defined by the center of the passage, may be angled radially outwardly as they extend proximally. The two legs may also incorporate a slight arc or bend, such as that shown in <FIG>.

In one exemplary embodiment, a proximally facing wall surface <NUM> on the actuating end is provided and serves as a mounting surface for a wiper. The wiper <NUM> of <FIG> may be attached to the mounting surface <NUM> with the cut-outs <NUM> aligned to the two legs <NUM>. The wiper can be welded to the mounting surface or glued thereto with an appropriate adhesive, such cyanoacrylate or UV cure adhesive. In practice, the valve opener <NUM> and wiper <NUM> may be installed as shown in <FIG> and when a needle <NUM> is inserted, the needle tip <NUM> penetrates the wiper and the wiper subsequently provides a wiping function for the needle. When the wiper <NUM> is penetrated by the needle tip <NUM>, the needle <NUM> will open and dilate the wiper putting the needle in a close contact relationship with the wiper <NUM>. Thus, when an upstream section <NUM> of the needle <NUM> (i.e., upstream of the wiper) is exposed to blood from blood flashback and is subsequently withdrawn proximally (i.e., to the right of <FIG>) to remove the needle <NUM>, the close contact relationship between the wiper <NUM> and the needle <NUM> allows the wiper to wipe blood deposits from the needle as the needle is being withdrawn. Consequently, when the needle <NUM> is fully retracted from the valve opener <NUM>, the needle will appear clean, or at least for the most part visually blood-free, and the tip protector that surrounds the needle tip will likely remain visually blood-free.

<FIG> shows a wiper <NUM> having a generally circular configuration of a first wiper material <NUM>, which may be a microporous plastic film membrane filter, surrounding a plastic inner layer <NUM>, such as a polyethylene (PC) blown film layer. The outer wiper material <NUM> is preferably air permeable to permit blood flashback. The membrane may be made from PP (polypropylene) or PA (polyamide or Nylon®) spun bound fibers, such as those known in the art from flashback plugs. In a preferred embodiment, the inner layer <NUM> is plastic film configured for puncturing by a needle when assembling the combination needle hub and needle to a catheter hub, such as the one shown in <FIG> having a wiper attached to the valve opener. The wiper should be sufficiently thin so as to not damage the needle tip when the same is passed therethrough. The inner and outer layers can be welded to another.

In one exemplary embodiment, the wiper <NUM> shown in <FIG> is identical to the wiper <NUM> shown in <FIG> with the exception of a pre-formed opening <NUM>. The opening <NUM> is preferably sized the same as a needle diameter. In other words, the opening is sized with a zero clearance around the outside diameter of the needle. More preferably, the opening <NUM> is sized the same as the inside diameter of a catheter tip, which is slightly smaller than the outside diameter of the needle.

<FIG> shows yet another wiper embodiment <NUM> provided in accordance with aspects of the present invention. In one exemplary embodiment, the wiper comprises a single membrane layer <NUM> having an opening <NUM>, which has a same diameter size as the inside diameter of a catheter tip. A plurality of micro-holes are formed in the membrane layer <NUM> for venting air. The holes are each sized about <NUM> (micro-meter) to about <NUM>. The membrane may be made from PE, or spun bound PA or PP.

<FIG> is a cross-sectional side view of an alternative safety IV catheter assembly provided in accordance with aspects of the present disclosure, which is generally designated <NUM>. The catheter assembly <NUM> is similar to the catheter assembly <NUM> of <FIG> and includes a catheter tube <NUM> and hub <NUM>, a needle <NUM> and needle hub <NUM>, a tip protector <NUM>, a valve opener <NUM>, and a valve <NUM>. However, in the alternative safety IV catheter assembly <NUM>, an air permeable fluid impermeable wiper <NUM> is incorporated distal of the valve <NUM>. In one exemplary embodiment, the wiper <NUM> may be one of the wipers <NUM>, <NUM> or <NUM> shown in <FIG> and may be attached to a tube bushing <NUM> for retaining the catheter tube <NUM> to the catheter hub <NUM>. The tube bushing <NUM> is preferably made from a thermoplastic material to facilitate attaching the wiper <NUM> thereon, such as by adhesive or welding. In an alternative embodiment (not shown), a shoulder or seat may be provided within the interior cavity of the catheter hub <NUM> for accommodating the wiper <NUM>.

<FIG> is a partial perspective view of a needle <NUM> projecting through a valve opener <NUM> having a wiper <NUM> attached thereto. The valve opener <NUM> is similar to the valve opener shown and described with reference to <FIG>. <FIG>, as well as <FIG> discussed further below, may be viewed as a safety catheter assembly, such as the assembly of <FIG>, shown without a catheter hub, a needle hub, or a tip protector for clarity and for purposes of discussing only the functions of the wiper. Accordingly, it should be understood that the components shown in <FIG>, as well as those in <FIG>, are adapted for use with a catheter hub, needle hub, and tip protector in the same manner as those described with reference to <FIG>.

In one exemplary embodiment, the valve opener <NUM> comprises two legs <NUM> extending proximally of a frusto-conical shape actuating end <NUM>. Although not shown, the actuating end <NUM> may comprise an undulating surface or barbs for gripping engagement with a hemostatic valve. The actuating end <NUM> comprises a generally planar proximally facing surface <NUM> and a passage or lumen <NUM> for receiving the needle <NUM>. The two legs are radially spaced apart from the needle <NUM> and has a gap <NUM> therebetween for accommodating a tip protector.

<FIG> is a partial perspective partial cross-sectional rotated and magnified view of the valve opener <NUM> of <FIG>. The valve opener <NUM> is shown with the wiper <NUM> having a ring or cylinder seated within a recessed section of the actuating end <NUM>. The wiper <NUM> maybe insert molded into the opener <NUM>. The tab <NUM> is the material left between the wiping ring and the cavity gate. Alternatively the wiper can be integral with the actuating end <NUM><NUM>. The wiper <NUM> comprises a passage <NUM> having a first diameter that is slightly larger than the outside diameter of the needle <NUM> and a lip <NUM> having a second diameter, which is preferably the size of the inside diameter of a catheter tip of a catheter tube, that the needle <NUM> is configured to position in. As discussed above with reference to <FIG>, when the needle <NUM> is withdrawn proximally, blood deposits along the upstream end (distal) <NUM> of the needle is wiped off by the wiper <NUM>.

<FIG> shows the valve opener <NUM> having a single leg <NUM>. However, a valve opener with two legs having a gap therebetween is more preferred. The gap between the two legs <NUM> is configured to accommodate a tip protector <NUM>, such as that shown in <FIG> and <FIG>.

<FIG> is a partial perspective partial cross-sectional side view of an alternative valve opener <NUM> provided in accordance with aspects of the present invention. The valve opener <NUM> is shown with a needle <NUM> projecting through the actuating end <NUM>. In the' embodiment shown, a well or recessed area <NUM> is incorporated for accommodating a wiper in a form of an O-ring <NUM>, which may be made from an elastomeric or TPE material. The Oaring <NUM> can be slid into the well <NUM> and a retaining ring <NUM> pushed against the O-ring <NUM> to retain the O-ring therein. The retaining ring <NUM> is secured to the well <NUM> using simple interference fit. In an alternative embodiment, the retaining ring <NUM> is welded to the valve opener.

As before, the O-ring <NUM> is preferably in a contact relationship with the needle <NUM> so that it may wipe the needle as the needle is withdrawn proximally (to the right in <FIG>) away from the opener <NUM>. The opener <NUM> is shown having a gap between the two legs <NUM> for accommodating a tip protector (not shown). The opener <NUM> and the needle <NUM> are configured to be used with a catheter hub in the same manner as the opener and needle shown in <FIG>.

<FIG> is a partial cross-sectional perspective view of yet another alternative valve opener <NUM> provided in accordance with aspects of the present invention. In the embodiment shown, an annular groove <NUM> is incorporated in a well <NUM> for accommodating an elastomeric or TPE wiper <NUM>. The wiper <NUM> resembles a flattened O-ring, like a doughnut, but may in fact also be an O-ring. This configuration enables a common valve opener to be used with various needle outside and O-ring inside diameters. The wiper <NUM> is retained within the well <NUM> without a separate retaining ring, such as the ring <NUM> in <FIG>. The wiper <NUM> may be snapped-fit into the groove <NUM> during assembling.

<FIG> is a cross-sectional side view of an inventive catheter assembly provided in accordance with the present invention, which is generally designated <NUM>. The catheter assembly <NUM> incorporates similar components as the assembly shown in <FIG>, including a catheter tube <NUM> attached to a catheter hub <NUM>, a needle <NUM> attached to a needle hub <NUM>, a hemostatic valve <NUM>, a valve opener <NUM> comprising a pair of legs <NUM> (only one shown) positioned in corresponding channels <NUM> in the catheter hub <NUM>, a wiper (not shown) attached to either the catheter hub <NUM> or the valve opener <NUM>, and a tip protector <NUM> for blocking the needle tip <NUM>. However, rather than placing the tip protector <NUM> in a gap defined by-the two legs <NUM> in the valve opener <NUM>, a third housing <NUM> is incorporated for accommodating the tip protector as is defined in independent claim <NUM>. Additionally, the wiper (not shown) may be attached to the third housing <NUM>, distal of the tip protector <NUM>, for wiping the needle as the needle is retracted following catheterization.

In one exemplary embodiment, the third housing <NUM> incorporates a rear plate or panel <NUM> attached to an enclosed housing section <NUM> for closing an opening <NUM> on the enclosed housing section <NUM>. The opening <NUM> on the enclosed housing section <NUM> allows the tip protector <NUM> to be placed therein during assembly. The rear plate <NUM> may be attached to the housing section <NUM> using adhesive, welding, or detents. Alternatively, the enclosed housing section <NUM> may incorporate an opening on a side, orthogonal to the rear plate <NUM>.

The third housing <NUM> incorporates a pair of arms <NUM> each comprising a hook <NUM>. The two hooks <NUM> are configured to engage the two bumps <NUM> to retain the third housing <NUM> to the catheter hub <NUM> in a ready to use position. The two arms <NUM> are preferably flexible to provide a gripping force against the two bumps <NUM>, which is higher than the frictional force to withdraw the needle through the tip protector <NUM>, hemostatic valve <NUM>, and catheter <NUM>. Alternatively the two arms <NUM> can be biased radially outward to increase the gripping force. Further, the two arms can be biased inwardly against the needle shaft to decrease the gripping force after the needle is withdrawn proximal of the arms <NUM>.

Following successful catheterization, the needle <NUM> is retracted proximally away from the catheter tube <NUM> in the same mariner as previously discussed (i.e., to the right of <FIG>). As the needle tip <NUM> moves proximally of the distal wall <NUM> of the tip protector <NUM>, the tip protector <NUM> engages the needle <NUM> and further proximal movement of the needle <NUM> causes the tip protector <NUM> to pull on the rear plate <NUM> of the third housing <NUM>, which then disengages the two hooks <NUM> from the two bumps <NUM>. Thus, the gripping force between the two hooks <NUM> and the two bumps <NUM> should be less than the gripping force between the tip protector <NUM> and the needle <NUM>.

Referring now to <FIG>, the tip protector <NUM> comprises a proximal wall <NUM> comprising an opening <NUM>, an arm <NUM> comprising an opening <NUM> (<FIG>), and a distal wall <NUM> at a distal end of the arm <NUM>. The proximal wall <NUM> and the arm <NUM> define an angle □ therebetween. In a ready to use position (not shown), the end edge <NUM> of the tip protector <NUM> is biased against the side of the needle <NUM> and the angle □ has a ready angle value □ready. When in the activated position (<FIG>), the angle □ increases to a protected angle value □protected, which is larger than the ready angle value □ready When this occurs, the arm is further canted and the opening <NUM> on the arm grips the needle to engage the needle without a crimp.

<FIG> shows a longitudinal section of a further embodiment of a valve opener <NUM>. The actuating end <NUM> is connected with two legs <NUM>, one of which is shown in <FIG>. In the passage <NUM> for accommodating a needle a wiper in the form of a ring lip <NUM> is provided wherein this ring lip <NUM> tapers in distal direction. This lip <NUM> can be integrated with the actuating end <NUM> by injection molding. It is also possible to provide the ring lip <NUM> of a suitable other material than the actuating end <NUM> wherein the ring lip <NUM> can be connected with the actuating end by a two-component injection molding: The passage <NUM> has on the proximal side a portion with a larger taper of <NUM>° followed by a portion with a taper of <NUM>°.

Claim 1:
A safety catheter assembly (<NUM>) comprising:
a catheter hub (<NUM>) comprising a housing comprising an exterior surface (<NUM>) and an interior surface defining an interior cavity (<NUM>);
a catheter tube (<NUM>) attached to the catheter hub (<NUM>) and extending distally of the catheter hub;
a needle hub (<NUM>, <NUM>) comprising a housing comprising an exterior surface and an interior surface defining an interior cavity;
a needle (<NUM>) having a needle tip (<NUM>) attached to the needle hub and projecting distally of the needle hub (<NUM>) and into the catheter tube (<NUM>);
a valve (<NUM>) comprising a top surface, a skirt (<NUM>) depending therefrom, and an opening on the top surface having the needle projecting therethrough;
a valve opener (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) for opening the valve (<NUM>) and positioned in the interior cavity (<NUM>) of the catheter hub (<NUM>) proximal of the valve (<NUM>);
wherein the valve opener (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) comprises two proximally extending legs (<NUM>, <NUM>) having a gap there between, the valve opener being sized and shaped to be pushed distally towards the valve to transfer a force imparted by an IV-set Luer connector to the valve (<NUM>);
characterized in that
a third housing (<NUM>) for accommodating a tip protector (<NUM>, <NUM>) is incorporated.