Patent Description:
Insertion procedure for an intravenous (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.

One 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.

<CIT> discloses catheter assemblies having a tip protector, a valve, a valve opener, and optionally a needle wiper.

<CIT> discloses safety IV catheter including a unitary, resilient needle guard received in a catheter hub.

<CIT> discloses a needle safety device for a medical device comprising: a base portion having a bore extending along a longitudinal center axis therethrough for receiving a needle; and two opposing jaws extending from the base portion generally in the axial direction and each having a head portion in the region of its free end, wherein the needle safety device includes a locking projection for securing the needle safety device to the medical device.

The various embodiments of a needle assembly have several features, no single one of which is solely responsible for their desirable attributes. Without limiting the scope of the present embodiments as set forth in the claims that follow, their more prominent features now will be discussed briefly.

Aspects of the present disclosure include an indwelling needle assembly that includes a first hub, a flexible tube attached to a distal end of the first hub, a second hub connected to a proximal end of the first hub, a needle attached to the second hub and projecting through the flexible tube, and a needle guard positioned in an interior cavity of the first hub, the needle guard comprising a proximal wall having an opening and two arms each comprising an end located opposite the proximal wall, the two ends being biased away from and spaced from the needle in a ready position, and the needle passing through the opening of the needle guard.

The indwelling needle can further include a support located inside the interior cavity of the first hub wherein the two ends of the two arms on the needle guard rest against the support in the ready position.

The support can be ring shaped and coaxially disposed with the flexible tube. The support can also be a projection protruding from a distal surface of the interior cavity of the first hub. Each of the two ends of the two arms can have a sharp end contacting the support. The two arms of the needle guard can cross each other to form an intersection or a cross-section, and the needle further passes through the cross-section.

The needle can include a needle tip and a change in profile located proximal of the needle tip. When the change in profile abuts against the proximal wall of the needle guard and the ends of the arms no longer bias against the support, the two arms close over the needle tip in a needle protective position.

The indwelling needle can further include a guide arm attached to the first hub, wherein the guide arm is configured for pressing against the flexible tube. The guide arm can include a guide section configured to press against the flexible tube and a contact flange extending from the guide section. The guide arm can be pivotably attached to the first hub.

Another aspect of the present disclosure includes a safety catheter assembly that includes a catheter hub comprising a valve and a valve opener for opening the valve, a catheter tube attached to the catheter hub, a needle hub, a needle attached to the needle hub and projecting through the catheter tube, and a needle guard positioned in an interior cavity of the catheter hub or an interior cavity of a third hub located proximally of the catheter hub. The needle guard can include a proximal wall having an opening and two arms each comprising an end and wherein a support formed with the catheter hub, the third hub, or a valve opener located inside the catheter hub spaces the two ends of the needle guard from the needle in a ready position.

The safety catheter assembly can further include a support located inside the cavity of the third hub wherein the two ends of the two arms on the needle guard rest on the support in the ready position. The support can be ring shaped and coaxially disposed with the flexible tube. The support can be located in the interior cavity of the catheter hub in which the two ends of the two arms on the needle guard rest on the support. The support can also be formed with the valve opener.

The third hub can include a distal wall and at least one arm extending from the distal wall engaged with the catheter hub to retain the third hub in the ready position. The third hub can include two arms engaged with a holding portion of the catheter hub.

The two arms of the needle guard can cross each other to form an intersection or a cross-section. The needle can further pass through the cross-section. Alternatively the two arms can run along side the needle in a ready position and do not intersect. The guard can have end walls that overlap when in a protective position over the needle without also incorporating intersecting arms.

The needle can include a needle tip and a change in profile located proximal of the needle tip. When the change in profile abuts against the proximal wall of the needle guard, the ends of the arms of the needle guard are no longer biasing against the support in a protective position.

The third hub can include a distal wall and an opening defined through the distal wall of the third hub. The distal wall can abut against the catheter hub, with the support centered around the opening of the distal wall of the third hub and extending proximally into a chamber of the third housing. The needle can pass through the opening of the distal wall of the third hub.

The third hub can further include a proximal wall and a sidewall or sidewalls extending between the distal wall of the third hub and the proximal wall of the third hub. The proximal wall of the third hub can define an opening. The needle can pass through the opening of the distal wall of the third hub. The distal wall, the sidewall, and the proximal wall of the third hub can cooperatively define an interior cavity. The needle guard can be positioned in the interior cavity.

The valve can include a plurality of slits or one slit and the valve opener at least one leg.

Yet another aspect of the present disclosure includes a safety catheter assembly including a catheter tube attached to a catheter hub, a needle attached to a needle hub and projecting through the catheter tube and the catheter hub and a needle guard positioned in an interior cavity of the catheter hub and comprising a proximal wall having an opening and two arms each comprising an end biased away from and spaced from the needle and supported by a support located in the interior cavity of the catheter hub in a ready position.

The support can be near a bore at a distal end of the catheter hub. The support can be provided on a valve opener located inside the catheter hub. The valve opener can be sized and shaped to open a valve comprising at least one slit.

Still yet another aspect of the present disclosure includes a method of reducing resistance on a needle of a catheter assembly. The method includes retracting the needle in a proximal direction through a needle guard and a catheter tube attached to a catheter hub. The needle guard has a proximal wall having a proximal opening and two arms each comprising an end. A needle tip of the needle extends out a distal end of the catheter tube prior to retracting.

The method can further include abutting a change in profile of the needle against the proximal wall. For example, when a change in profile abuts the proximal wall, it can abut a perimeter defining a proximal opening of the proximal wall. The proximal wall prevents the change in profile from passing therethrough.

The method can further include covering the needle tip of the needle with at least one end of the arms of the needle guard.

The method can further include a support formed with the catheter hub, a third hub, or a valve opener located inside the catheter hub that spaces the two ends of the needle guard from the needle in a ready position.

The needle can further project through a valve in the catheter hub, and a valve opener in the catheter hub. The valve opener can be configured to press against the valve to open the valve.

The needle guard can be positioned in an interior cavity of the catheter hub or located proximally of the catheter hub or partially in the catheter hub and partially proximal of the catheter hub.

The ends of the arms are supported by a support to prevent the ends from pressing against the needle in the ready position.

A yet further aspect of the present disclosure includes a safety catheter assembly comprising: a catheter hub comprising a valve and a valve opener for opening the valve; a catheter tube attached to the catheter hub; a needle hub; a needle attached to the needle hub and projecting through the catheter tube; a needle guard positioned in an interior cavity of the catheter hub or an interior cavity of a third hub located proximally of the catheter hub; wherein the needle guard comprises a proximal wall having an opening and two arms each comprising an end and wherein the two ends are spaced from and biased toward the needle in a ready position; and wherein a support formed with the catheter hub, the third hub, or a valve opener located inside the catheter hub biases the two ends of the needle guard apart in the ready position.

A still yet further aspect of the present disclosure includes a method of reducing resistance on a needle of a catheter assembly. In an example, the method comprises: retracting the needle held with a needle hub in a proximal direction through a needle guard and a catheter tube attached to a catheter hub, the needle guard comprising a proximal wall having a proximal opening and two arms each comprising an end spaced from and biased towards the needle in a ready position, a needle tip of the needle extending out a distal end of the catheter tube prior to retracting; abutting a change in profile of the needle against the proximal opening on the proximal wall, the proximal opening of the proximal wall preventing the change in profile from passing therethrough; covering the needle tip of the needle with at least one end of the arms of the needle guard in a protective position; and wherein a support formed with the catheter hub, a third hub, or a valve opener located inside the catheter hub biases the two ends of the needle guard apart in the ready position.

Yet another feature of the present disclosure includes a safety catheter assembly comprising: a catheter hub comprising a valve and a valve opener for opening the valve; a catheter tube attached to the catheter hub; a needle hub; a needle attached to the needle hub and projecting through the catheter tube; a needle guard positioned in an interior cavity of the catheter hub or an interior cavity of a third hub located proximally of the catheter hub; wherein the needle guard comprises a proximal wall having an opening and two arms each comprising an end; and wherein a support biases the two ends of the needle guard away from the needle in a ready position and the support is spaced from the proximal opening of the proximal wall in the ready position and a protective position.

Yet another aspect of the present disclosure includes a method of reducing resistance on a needle of a catheter assembly comprising: retracting the needle held with a needle hub in a proximal direction through a needle guard and a catheter tube attached to a catheter hub, the needle guard comprising a proximal wall having a proximal opening and two arms each comprising an end, a needle tip of the needle extending out a distal end of the catheter tube prior to retracting; abutting a change in profile of the needle against the proximal opening on the proximal wall, the proximal opening of the proximal wall preventing the change in profile from passing therethrough; covering the needle tip of the needle with at least one end of the arms of the needle guard in a protective position; and wherein a support biases the two ends of the needle guard away from the needle in a ready position and the support is spaced from the proximal opening of the proximal wall in the ready position and the protective position.

These and other features and advantages of the present devices, systems, and methods will become appreciated as the same becomes better understood with reference to the specification, claims and appended drawings wherein:.

The detailed description set forth below in connection with the appended drawings is intended as a description of the presently preferred embodiments of safety needle assemblies provided in accordance with aspects of the present assemblies and is not intended to represent the only forms in which the present assemblies may be constructed or utilized. The description sets forth the features and the steps for constructing and using the embodiments of the present assemblies in connection with the illustrated embodiments that define the invention as defined in claims <NUM>,<NUM>,<NUM>. Preferable embodiments are defined in the dependent claims.

<FIG> is a schematic cross-sectional side view of one embodiment of a safety needle assembly <NUM> provided in accordance with aspects of the present disclosure, which in the present embodiment is an indwelling needle. As shown, the needle assembly <NUM> comprises an outside flexible tube <NUM> attached to a first hub <NUM> and a needle <NUM> disposed internally of the flexible tube <NUM> and attached to a second hub <NUM>. The needle <NUM> may be hollow, such as having a lumen, or solid, such as a stylet, and can be made of a metal or other biocompatible material. The needle has a needle tip <NUM> and a change in profile <NUM>, such as a needle bulge or crimp, located proximally of the needle tip <NUM>. The second hub <NUM> can be removably coupled to the first hub <NUM>, but is preferably only in abutting contact and not friction fit inside the female Luer taper of the first hub <NUM>.

The safety needle assembly <NUM> may be used as a peripheral vein catheter and therefore normally has a length L of up to about <NUM>. At this length, the flexible tube <NUM> and the needle <NUM> can flex or bend when attempting to perform a medical procedure by pushing on the first hub <NUM>, the second hub <NUM>, or both. Thus, a guide arm <NUM> is provided having a guide section <NUM> and a contact flange <NUM> to facilitate the process. The guide section <NUM> is configured to press against the outer tube <NUM> while a finger may push against the contact flange <NUM> to steady the insertion during the medical procedure.

The guide arm <NUM> can be pivotably connected to the first hub <NUM> at the pivot connection point <NUM>. As the needle <NUM> and tube <NUM> penetrate the vein, the guide arm <NUM> can rotate in a direction (shown in <FIG> as counter-clockwise) to provide the necessary clearance for the insertion. After successful catheterization, the second hub <NUM> and the needle <NUM> are retracted away from the first hub <NUM> and the tube <NUM>.

A tip protector or needle guard <NUM> is provided in the interior cavity <NUM> of the first hub <NUM>. The interior cavity is further provided with a support <NUM>. In the present embodiment, the support <NUM> can embody a ring, which is coaxially disposed with the flexible tube <NUM>. The support <NUM> is attached to the interior of the first hub <NUM> to provide a support surface for the needle guard <NUM>, as further discussed below. In another example, the support <NUM> is a molded projection, such as a rib, on the interior of the first hub <NUM>. Further, instead of a continuous or complete ring, the support <NUM> may embody two or more separate sections, such as two or more ribs, formed around the bore inlet <NUM> to the tube <NUM>. The support <NUM> can be any structure so long as it does not interfere with the needle <NUM> passing through and can provide a support surface for the needle guard <NUM>.

With reference now to <FIG>, the needle guard <NUM>, as defined in the present invention, is shown disposed in the interior cavity <NUM> of the first hub <NUM>. The needle guard <NUM> comprises a proximal wall <NUM> comprising a proximal opening <NUM> having the needle passing therethrough and two arms <NUM>, <NUM> each having an end <NUM>, <NUM> biasing against the support <NUM> in the ready position in which the needle is ready for use on a patient. The two arms <NUM>, <NUM> can have the same length or different lengths so that the two ends are staggered axially. Each end <NUM>, <NUM> can comprise a curved section having a relatively smooth surface for biasing against or contacting the support <NUM> so as to avoid biasing the support with a sharp edge. In other examples, the ends <NUM>, <NUM> contact the support <NUM> by way of a sharp end edge, which is less preferred. The needle guard <NUM> can be made of a metal or other biocompatible material, such as plastics or a combination of metal and plastic.

In the present invention, in the ready position, the needle guard <NUM> and the needle <NUM> only contact one another, if at all, at the proximal opening <NUM> of the proximal wall <NUM>. In one example, the needle guard <NUM> and the needle <NUM> can also contact each other, if at all, at the cross-section or intersection <NUM> of the two arms. Thus, during retraction of the needle <NUM> from the flexible tube <NUM>, the only drag experienced or felt, if at all, by the user as the needle is retracted away is at the opening <NUM> of the proximal wall. The two ends <NUM>, <NUM> are spaced from the needle <NUM>, such as by a gap or space or the support <NUM>, during most if not all of the retraction of the needle <NUM> away from the flexible tube <NUM> and first hub <NUM>.

During removal of the needle <NUM> away from the first hub <NUM>, the change in profile <NUM> near the needle tip <NUM> eventually abuts the perimeter of the proximal opening <NUM> of the needle guard. Because the change in profile <NUM> is physically larger than the perimeter of the proximal opening <NUM> on the needle guard at least along the cross-section, the crimp will engage the opening <NUM> and will pull the needle guard <NUM> out of the cavity <NUM> of the first hub <NUM> upon retraction of the second hub <NUM> and the needle <NUM> away from the first hub <NUM>. It is understood that when the crimp or change in profile engages the opening on the proximal wall, it actually engages a perimeter defining the proximal opening, or more broadly engages the proximal wall of the needle guard which has the opening. As the needle guard <NUM> moves in the proximal direction with the needle change in profile <NUM> engaged to the proximal wall <NUM>, the ends <NUM>, <NUM> of the two arms <NUM>, <NUM> on the needle guard <NUM> slide proximally off of the support <NUM> to close over the needle tip <NUM> to prevent inadvertent needle sticks with the sharp tip. <FIG> illustrates the change in profile <NUM> contacting the opening <NUM> at the proximal wall <NUM> and the two ends <NUM>, <NUM> overlap just distal of the needle tip <NUM>. Alternatively only one arm has the curved end to block the distal path of the needle tip <NUM>.

Thus, aspects of the present disclosure is understood to include an indwelling needle assembly comprising a first hub attached to a flexible tube and a second hub attached to a needle projecting through the flexible tube. A needle guard is positioned in an interior cavity of the first hub. Wherein the needle guard comprises a proximal wall having an opening and two arms each comprising an end and wherein the two ends are spaced from the needle in a ready position and are in tension so as to bias towards the needle. In a particular example, a support is located inside the cavity of the first hub and wherein the two ends of the two arms on the needle guard rest on the support in the ready position. Thus, upon retraction of the needle and until a change in profile on the needle engages the proximal wall of the needle guard and pulls the proximal wall in a proximal direction which then pulls the two arms from the support, contact between the needle and the needle guard is minimized.

In an example, the indwelling needle assembly discussed with reference to <FIG> and <FIG> and be adopted for use with a safety intravenous catheter of the present invention wherein the first hub can be a catheter hub attached to a catheter tube and the second hub can be a needle hub attached to a needle projecting through the catheter tube. The guide arm of <FIG> can be omitted. A needle guard is positioned in an interior cavity of the catheter hub. Wherein the needle guard comprises a proximal wall having an opening and two arms each comprising a distal end and wherein the two distal ends are spaced from the needle in a ready position inside the catheter hub. The two arms are resilient and therefore bias toward the needle. In a particular example, a support is located inside the cavity of the catheter hub and wherein the two ends of the two arms on the needle guard rest on the support in the ready position so that they are spaced from the needle shaft. Thus, upon retraction of the needle and until a change in profile on the needle engages the proximal wall of the needle guard and pulls the proximal wall in a proximal direction which then pulls the two arms from the support, contact between the needle and the needle guard is minimized.

Further aspects of the present invention is understood to include a support formed with a catheter hub, a third hub (as shown with reference to <FIG>), or a valve opener located inside the catheter hub (as shown with reference to <FIG>) that spaces the two ends <NUM>, <NUM> of the needle guard <NUM> from the needle <NUM>, such as away from the needle so that the ends do not touch the needle in a ready position. As the support <NUM> is formed with the catheter hub, the third hub, or the valve opener, the support is spaced from the proximal opening <NUM> of the proximal wall of the needle guard in both a ready position, as shown in <FIG>, and in a protective position, as shown in <FIG>. In <FIG>, the support <NUM> is located with the first hub and is therefore spaced from the proximal opening <NUM> of the proximal wall of the needle guard. Still further, as the support <NUM> is formed with the catheter hub, the third hub, or the valve opener, the support is spaced from the proximal opening <NUM> of the proximal wall of the needle guard in both a ready position, as shown in <FIG>, and in a protective position, as shown in <FIG>, and spaced from the needle guard in the protective position. In <FIG>, the support <NUM> is located with the first hub and is therefore spaced from the proximal opening <NUM> of the proximal wall of the needle guard as well as the entire needle guard.

For other safety needle assemblies and safety needle assembly components disclosed herein below, it is understood that where a feature is shown but not expressly described and is otherwise the same or similar to the feature or features described elsewhere, such as above with reference to <FIG> and <FIG>, the disclosed part or parts shown in the subsequent drawing figures but not expressly described because of redundancy and because knowledge is built on a foundation laid by earlier disclosures may nonetheless be understood to be described or taught by the same or similar features expressly set forth in the text for the embodiments in which the feature or features are described, such as for the safety needle assembly of <FIG> and <FIG>. Said differently, subsequent disclosures of the present application are built upon the foundation of earlier disclosures unless the context indicates otherwise. The disclosure is therefore understood to teach a person of ordinary skill in the art the disclosed embodiments and the features of the disclosed embodiments without having to repeat similar components and features in all embodiments since a skilled artisan would not disregard similar structural features having just read about them in several preceding paragraphs nor ignore knowledge gained from earlier descriptions set forth in the same specification. As such, the same or similar features shown in the following safety needle assemblies incorporate the teachings of earlier embodiments unless the context indicates otherwise. Therefore, it is contemplated that later disclosed embodiments enjoy the benefit of earlier expressly described embodiments, such as features and structures of earlier described embodiments, unless the context indicates otherwise.

With reference now to <FIG>, a safety IV catheter <NUM> comprises a first hub or catheter hub <NUM> having a catheter tube <NUM> attached thereto, and a second hub or needle hub <NUM> having a needle <NUM> attached thereto and extending partially through the catheter hub <NUM>. As shown, the needle <NUM> is in the process of being removed from the catheter hub <NUM>, such as following successful venipuncture. The safety IV catheter <NUM> can further comprise a valve <NUM> positioned at a distal end of an interior of the catheter hub <NUM>, a valve opener <NUM> positioned proximally of the valve <NUM>, and a third hub <NUM>, which can also be referred to as a third housing or a guard housing, positioned proximally to the catheter hub <NUM>. The third hub <NUM> couples directly to the catheter hub <NUM>, such as having a Luer projection for frictionally engaging the female Luer of the catheter hub <NUM>. The valve <NUM> can be any check valve configured to prevent fluid or blood from leaking proximally out of the catheter hub. The needle <NUM> can pass through the valve <NUM> in a ready position, such as through one or more slits provided centrally of the valve.

The valve opener <NUM> is configured to press against the valve <NUM> and open the valve <NUM> to allow fluid or solution to pass distally through the catheter hub <NUM> and the catheter tube <NUM>. For example, the valve opener <NUM> can be advanced distally by a male medical implement, such as a syringe tip, which presses against the proximal end of the valve opener <NUM> to push the nose section of the valve opener distally forward into the valve to open, such as by opening one or more slits. In one example, the valve opener <NUM> has a wedge shape nose section to press open the valve <NUM> and an extension or leg <NUM> to be pushed against by a male medical implement. Although a single extension or leg <NUM> is usable to push the valve opener, two or more extensions are preferred. The extension <NUM> can be one or more separate sections that can be pressed against by a male medical implement to advance the valve opener <NUM> against the valve <NUM>. The valve opener <NUM> has an opening <NUM> defined through a center of the nose section of the valve opener <NUM> for the needle <NUM> to pass therethrough.

The third hub <NUM> has a sidewall <NUM> extending from the distal wall <NUM> and a proximal wall <NUM> such that the sidewall <NUM> extends between the distal wall <NUM> and the proximal wall <NUM> of the third hub <NUM>. The proximal wall <NUM> of the third hub <NUM> has an opening for the needle <NUM> to pass therethrough. The needle <NUM> also passes through the opening <NUM> of the distal wall <NUM> of the third hub <NUM>. The distal wall <NUM>, the sidewall <NUM>, and the proximal wall <NUM> of the third hub <NUM> cooperatively define an interior cavity or space <NUM> having a needle guard <NUM> disposed therein. The shape of the third hub <NUM> can be hemispherical, cylindrical, rectangular, polygonal, or irregular shaped, so long as the needle <NUM> can pass through the proximal wall <NUM> and the distal wall <NUM>, and the needle guard <NUM> fits inside the interior cavity <NUM> of the third hub <NUM>. In other words, side wall <NUM> can be made up of multiple portions each having their own plane. Accordingly the sidewall <NUM> can be cylindrical, rectangular, polygonal, or irregular shaped. In one example, the sidewall <NUM> is unitarily formed to the distal wall <NUM> and the proximal wall is separately formed and subsequently attached to the sidewall after the needle guard <NUM> is placed inside the interior cavity <NUM>. In another embodiment, the sidewall <NUM> is unitarily formed with the proximal wall <NUM> and the sidewall is attached to the distal wall <NUM> after the needle guard <NUM> is placed into the interior cavity <NUM>.

The third hub <NUM> can be made of metal, plastic, or a biocompatible material. The distal wall <NUM> abuts against the catheter hub <NUM> such that the third hub <NUM> is positioned between the catheter hub <NUM> and the needle hub <NUM>. The needle <NUM> passes through the opening <NUM> of the distal wall <NUM> of the third hub <NUM>. The third hub <NUM> can have at least one arm <NUM> sized and shaped to engage the catheter hub <NUM> in the ready position. As shown, two arms <NUM> extend distally and engage the annular projection or bump <NUM> inside the catheter hub <NUM> to retain the third hub <NUM> to the catheter hub <NUM> in the ready position and during retraction of the needle <NUM> following successful venipuncture. The arms <NUM> and valve opener <NUM> are sized so as to avoid interference with the operation of each other. The wall <NUM> can be a circular plate or any other shape that completely covers or partially covers the interior of the catheter hub <NUM>.

A support <NUM> is provided in the third hub <NUM>. The support <NUM> can be centered around the opening <NUM> or near the opening <NUM> of the distal wall <NUM> of the third hub <NUM>. As described above for the support <NUM> of <FIG>, the support <NUM> can embody a ring, which is coaxially disposed with the catheter tube <NUM>. In one example, the support <NUM> is attached to the third hub <NUM> to provide a support surface for the needle guard <NUM>. In another example, the support <NUM> is a molded projection, such as a rib, to the distal wall <NUM> of the third hub <NUM>. In yet another example, the support <NUM> is integrally formed with the third hub <NUM>, such as by way of glue or detents. Further, instead of a continuous or complete ring, the support <NUM> may embody two or more separate sections, such as two or more ribs, formed around the bore inlet <NUM> to the tube <NUM>. The support <NUM> can be any structure so long as it does not interfere with the needle <NUM> passing through and can provide a support surface for the needle guard <NUM>.

The needle guard <NUM> shown in <FIG> is similar to the needle guard of <FIG>. The two ends <NUM>, <NUM> of the two arms are similarly spaced from the needle shaft in the ready position. As shown, the two ends <NUM>, <NUM> are biased against the support <NUM> located inside the third hub <NUM> and are spaced from the needle shaft in the ready position and during retraction of the needle <NUM> from the catheter hub <NUM>. As previously discussed, when the needle <NUM> is retracted away from the catheter hub <NUM>, the change in profile <NUM>, such as a needle crimp, abuts a perimeter defining the opening <NUM> on the proximal wall of the needle guard and the needle guard <NUM> eventually separates from the support <NUM> to block the needle tip <NUM> from inadvertent needle sticks in a similar manner as previously discussed and as shown with reference to <FIG>.

With reference now to <FIG>, an alternative catheter assembly <NUM> provided in accordance with further aspects of the present invention is shown. In the present catheter assembly, a support for the needle guard is implemented directly with a valve opener <NUM>. Furthermore, the catheter hub <NUM> can be a single piece or formed from two separate pieces that are attached together. The valve opener <NUM> can have a support <NUM> extending from a proximal end of the nose section of the valve opener <NUM> to support the needle guard <NUM>. In one embodiment, the support <NUM> is a stub having a bore and is shorter in height or width than the width of the extension <NUM>. The needle guard <NUM> rests on the valve opener support <NUM> until the needle <NUM> is retracted out of the catheter hub <NUM> and the needle crimp abuts the opening on the needle guard <NUM> as discussed above to separate the needle guard from the support <NUM> to then block the needle tip <NUM>, similar to that shown in <FIG>.

Specifically, the distal ends <NUM>, <NUM> of the needle guard <NUM> are shown rested on the support <NUM> and the proximal wall <NUM> of the needle guard <NUM> is recessed into the interior of the catheter hub and the proximal end most part of the catheter hub is located proximally of the proximal wall <NUM> so that a nose section of the needle hub <NUM> can project into the catheter hub <NUM> without interfering with the extension <NUM> or the needle guard <NUM> in a ready position (<FIG>). Alternatively the distal portion of the needle hub <NUM> can extend around the exterior of the proximal end portion of catheter hub or there can be a simple abutment without overlapping of the catheter hub and needle hub. Thus, the height or width of the extension <NUM> and the support <NUM> can vary so long as the needle hub <NUM> does not interfere with the needle guard <NUM> or the extension <NUM>. The valve opener can be can be made from any biocompatible material. In the three figures shown, the catheter assembly <NUM> is shown in a ready position in <FIG>, in a used position shown in <FIG>, in which the needle guard <NUM> covers the needle tip of the needle and the valve is closed, and in valve opened position in <FIG>, in which a male Luer taper of a syringe is inserted into the catheter hub and advances the valve opener distally forward to open the valve.

As shown, the support <NUM> can be centered around or located near the opening <NUM> through the nose section of the valve opener <NUM>. As described above for the support <NUM> of <FIG>, the support <NUM> of the present embodiment can embody many shapes and configurations to support the needle guard <NUM>. The support <NUM> can be any structure so long as it does not interfere with the needle <NUM> passing through the valve opener <NUM> and can provide a support surface for the needle guard <NUM>. The support <NUM> can be a cylindrical ring, such as a stub, or two separate sections. In some examples, the support can incorporate exterior surface features to enable the two ends of the needle guard to easily separate from the support or to make the separation more difficult. For example, the exterior surface can be smooth and can even taper inwardly in the proximal direction to facilitate separation. Alternatively, gripping features, such as bumps or notches, may be incorporated to make the separation between the two ends of the needle guard and the support more difficult by increasing the resistance. The exterior features discussed herein may be incorporated on any of the supports discussed elsewhere herein.

One method for mounting the needle guard <NUM> onto the support <NUM> not forming part of the invention comprises a step of sliding the distal end of the needle guard <NUM> onto the support <NUM> of a valve opener <NUM> so that the two arms <NUM>, <NUM> are spaced from the needle shaft in the ready position. With reference to <FIG>, to ensure the needle guard <NUM> is able to slide onto the support <NUM>, the distance x between the needle shaft and outer surface of the support <NUM> should be less than the distance y between the needle shaft and the transition point of the needle guard <NUM>. The transition point can be the turning point where the curved section of the ends <NUM>, <NUM> of the needle guard <NUM> have reached a maximum and begins to curve inward thereby allowing the curved surface of the ends <NUM>, <NUM> to engage the outer surface of the support <NUM> thereby spreading the ends <NUM>, <NUM> apart from each other away from the needle shaft and biasing against the support <NUM>. If the distance x between the support <NUM> and the needle shaft is greater than the distance y between the needle shaft and the transition point, then the end of the support <NUM> can be tapered (as shown in <FIG> and <FIG>) until the distance x between the support <NUM> and the needle shaft is less than the distance y between the needle shaft and the transition point. In one embodiment, the outer surface of the support <NUM> can be tapered inwardly (as shown in <FIG>), such as incorporating recessed sections, from the end of the support <NUM> towards the main body of the valve opener <NUM> so that the two ends of the needle guard can settle into the space and be more secured to the support. This helps to prevent the needle guard <NUM> from unintended premature separation from the support <NUM> of the valve opener. In another embodiment, the support <NUM> has a groove (as shown in <FIG>) or other resistant means to prevent unintended premature separation of the needle guard <NUM> from the support <NUM>. Obviously, the valve opener shown in <FIG> and <FIG> may be usable with any of the catheter assemblies disclosed elsewhere herein having a valve.

Referring now to <FIG>, an end view of a valve opener <NUM> provided in accordance with aspects of the present disclosure is shown, which has a support <NUM> embodied as a ring like structure located between two extensions <NUM> and formed around the opening <NUM> of the valve opener <NUM>. The space between the two extensions <NUM> allows the ends <NUM>, <NUM> of the needle guard <NUM> to be located there and over the support <NUM> in a ready to use position, similar to that shown in <FIG> and <FIG>.

With reference now to <FIG>, an end view of a valve opener <NUM> provided in accordance with further aspects of the present disclosure is shown, which has a support <NUM> embodied as two or more separate sections, such as two or more ribs, formed around the opening <NUM> of the nose section of the valve opener <NUM>. The two or more ribs can be generally rectangular, arc shape, or combinations thereof. The support <NUM> can have a mating surface for the ends <NUM>, <NUM> of the needle guard <NUM> to rest thereon in a ready to use position.

Although limited embodiments of the safety needle assemblies and their components have been specifically described and illustrated herein, many modifications will be apparent to those skilled in the art. Furthermore, elements and features expressly discussed for one embodiment but not for another may equally apply provided the functionality or structures do not conflict. Thus, unless the context indicates otherwise, like features for one embodiment are applicable to another embodiment.

Claim 1:
A safety catheter assembly comprising:
a catheter hub (<NUM>);
a catheter tube (<NUM>) attached to the catheter hub (<NUM>);
a needle hub (<NUM>);
a needle (<NUM>) attached to the needle hub (<NUM>) and projecting through the catheter tube (<NUM>);
a needle guard (<NUM>) positioned in an interior cavity of the catheter hub (<NUM>);
wherein the needle guard (<NUM>) comprises a proximal wall (<NUM>) having an opening (<NUM>) and two arms (<NUM>, <NUM>) each comprising an end (<NUM>,<NUM>);
characterized in that
a support (<NUM>) formed with the catheter hub (<NUM>), spaces the two ends (<NUM>, <NUM>) of the needle guard (<NUM>) from the needle (<NUM>) in a ready position.