US20210052859A1 - Safety needle assemblies and related methods - Google Patents

Abstract

A safety needle assembly having 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. The needle guard has a proximal wall having an opening and two arms each with an end and wherein the two ends spaced from and biased toward the needle in a ready position. 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.

Description

FIELD OF ART
• The present invention is generally directed to needle safety assemblies and related methods and more particularly to needle safety assemblies and related methods utilizing needle guards having unique mounting for low friction between the needle guard and the needle during needle movement, such as during retraction of the needle relative to the needle guard.
BACKGROUND
• Insertion procedure for an intravenous (IV) catheter assembly contains four basic steps: (1) the healthcare worker inserts the needle and catheter together into the patient's vein; (2) 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; (3) 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 (4) 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.
SUMMARY
• 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 alongside 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.
BRIEF DESCRIPTION OF THE DRAWINGS
• 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:
• FIG. 1 is a schematic cross-sectional side view of one embodiment of a safety needle assembly having a guide arm.
• FIG. 2A is a close up view of the assembly of claim1 showing a needle guard located inside a cavity of a first hub of the safety needle assembly ofFIG. 1.
• FIG. 2B shows a needle guard protecting the needle tip of the needle.
• FIG. 3 is a schematic cross-sectional view of another embodiment of a safety IV catheter assembly having a needle guard located in another embodiment of a third hub.
• FIG. 4 is a schematic cross-sectional view of a needle assembly coupled to another embodiment of a catheter assembly with a needle guard support on a valve opener.
• FIG. 5 is a schematic cross-sectional view of the catheter assembly ofFIG. 4 with the needle assembly removed.
• FIG. 6 is a schematic cross-sectional view of the catheter assembly ofFIG. 4 coupled with a syringe.
• FIG. 7 is a cross-sectional view of one embodiment of the valve opener with the needle guard.
• FIG. 8 is a cross-sectional view of one embodiment of the valve opener with the needle guard mounted on a support of the valve opener ofFIG. 7.
• FIGS. 9-11 are various end views looking proximal to distal of embodiments of a valve opener.
DETAILED DESCRIPTION
• 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 devices, systems, and methods and is not intended to represent the only forms in which the present devices, systems, and methods may be constructed or utilized. The description sets forth the features and the steps for constructing and using the embodiments of the present devices, systems, and methods in connection with the illustrated embodiments. It is to be understood, however, that the same or equivalent functions and structures may be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the present disclosure. As denoted elsewhere herein, like element numbers are intended to indicate like or similar elements or features.
• FIG. 1 is a schematic cross-sectional side view of one embodiment of asafety needle assembly100 provided in accordance with aspects of the present disclosure, which in the present embodiment is an indwelling needle. As shown, theneedle assembly100 comprises an outsideflexible tube102 attached to afirst hub104 and aneedle106 disposed internally of theflexible tube102 and attached to asecond hub108. Theneedle106 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 aneedle tip110 and a change inprofile112, such as a needle bulge or crimp, located proximally of theneedle tip110. Thesecond hub108 can be removably coupled to thefirst hub104, but is preferably only in abutting contact and not friction fit inside the female Luer taper of thefirst hub104.
• Thesafety needle assembly100 may be used as a peripheral vein catheter and therefore normally has a length L of up to about 50.0 cm. At this length, theflexible tube102 and theneedle106 can flex or bend when attempting to perform a medical procedure by pushing on thefirst hub104, thesecond hub108, or both. Thus, aguide arm114 is provided having aguide section116 and acontact flange118 to facilitate the process. Theguide section116 is configured to press against theouter tube102 while a finger may push against thecontact flange118 to steady the insertion during the medical procedure.
• Theguide arm114 can be pivotably connected to thefirst hub104 at thepivot connection point120. As theneedle106 andtube102 penetrate the vein, theguide arm114 can rotate in a direction (shown inFIG. 1 as counter-clockwise) to provide the necessary clearance for the insertion. After successful catheterization, thesecond hub108 and theneedle106 are retracted away from thefirst hub104 and thetube102.
• A tip protector orneedle guard122 can be provided in theinterior cavity124 of thefirst hub104. The interior cavity is further provided with asupport126. In the present embodiment, thesupport126 can embody a ring, which is coaxially disposed with theflexible tube102. In one example, thesupport126 is attached to the interior of thefirst hub104 to provide a support surface for theneedle guard122, as further discussed below. In another example, thesupport126 is a molded projection, such as a rib, on the interior of thefirst hub104. Further, instead of a continuous or complete ring, thesupport126 may embody two or more separate sections, such as two or more ribs, formed around thebore inlet128 to thetube102. Thesupport126 can be any structure so long as it does not interfere with theneedle106 passing through and can provide a support surface for theneedle guard122.
• With reference now toFIG. 2A, theneedle guard122 is shown disposed in theinterior cavity124 of thefirst hub104. Theneedle guard122 comprises aproximal wall130 comprising aproximal opening132 having the needle passing therethrough and twoarms134,136 each having anend138,140 biasing against thesupport126 in the ready position in which the needle is ready for use on a patient. The twoarms134,136 can have the same length or different lengths so that the two ends are staggered axially. Eachend138,140 can comprise a curved section having a relatively smooth surface for biasing against or contacting thesupport126 so as to avoid biasing the support with a sharp edge. In other examples, theends138,140 contact thesupport126 by way of a sharp end edge, which is less preferred. Theneedle guard122 can be made of a metal or other biocompatible material, such as plastics or a combination of metal and plastic.
• In one embodiment, theneedle guard122 and theneedle106 only contact one another, if at all, at theproximal opening132 of theproximal wall130. In another embodiment, theneedle guard122 and theneedle106 can also contact each other, if at all, at the cross-section orintersection142 of the two arms. Thus, during retraction of theneedle106 from theflexible tube102, the only drag experienced or felt, if at all, by the user as the needle is retracted away is at theopening132 of the proximal wall. The two ends138,140 are spaced from theneedle106, such as by a gap or space or thesupport126, during most if not all of the retraction of theneedle106 away from theflexible tube102 andfirst hub104.
• During removal of theneedle106 away from thefirst hub104, the change inprofile112 near theneedle tip110 eventually abuts the perimeter of theproximal opening132 of the needle guard. Because the change inprofile112 is physically larger than the perimeter of theproximal opening132 on the needle guard at least along the cross-section, the crimp will engage theopening132 and will pull theneedle guard122 out of thecavity124 of thefirst hub104 upon retraction of thesecond hub108 and the needle105 away from thefirst hub104. 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 theneedle guard122 moves in the proximal direction with the needle change inprofile112 engaged to theproximal wall130, theends138,140 of the twoarms134,136 on theneedle guard122 slide proximally off of thesupport126 to close over theneedle tip110 to prevent inadvertent needle sticks with the sharp tip.FIG. 2B illustrates the change inprofile112 contacting theopening132 at theproximal wall130 and the two ends138,140 overlap just distal of theneedle tip110. Alternatively only one arm has the curved end to block the distal path of theneedle tip110.
• 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 toFIGS. 1 and 2 and be adopted for use with a safety intravenous catheter. For example, 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 ofFIG. 1 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.
• A further aspect of the present disclosure is understood to include a support formed with a catheter hub, a third hub (as shown with reference toFIG. 3), or a valve opener located inside the catheter hub (as shown with reference toFIGS. 4-11) that spaces the two ends138,140 of theneedle guard122 from theneedle158, such as away from the needle so that the ends do not touch the needle in a ready position. As thesupport126 is formed with the catheter hub, the third hub, or the valve opener, the support is spaced from theproximal opening132 of the proximal wall of the needle guard in both a ready position, as shown inFIG. 2A, and in a protective position, as shown inFIG. 2B. InFIG. 2B, thesupport126 is located with the first hub and is therefore spaced from theproximal opening132 of the proximal wall of the needle guard. Still further, as thesupport126 is formed with the catheter hub, the third hub, or the valve opener, the support is spaced from theproximal opening132 of the proximal wall of the needle guard in both a ready position, as shown inFIG. 2A, and in a protective position, as shown inFIG. 2B, and spaced from the needle guard in the protective position. InFIG. 2B, thesupport126 is located with the first hub and is therefore spaced from theproximal opening132 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 toFIGS. 1 and 2, 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 ofFIGS. 1 and 2. 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 toFIG. 3, asafety IV catheter150 comprises a first hub orcatheter hub152 having acatheter tube154 attached thereto, and a second hub orneedle hub156 having aneedle158 attached thereto and extending partially through thecatheter hub152. As shown, theneedle158 is in the process of being removed from thecatheter hub152, such as following successful venipuncture. Thesafety IV catheter150 can further comprise avalve160 positioned at a distal end of an interior of thecatheter hub152, avalve opener162 positioned proximally of thevalve160, and athird hub164, which can also be referred to as a third housing or a guard housing, positioned proximally to thecatheter hub152. Thethird hub164 can couple directly to thecatheter hub152, such as having a Luer projection for frictionally engaging the female Luer of thecatheter hub152. Thevalve160 can be any check valve configured to prevent fluid or blood from leaking proximally out of the catheter hub. Theneedle158 can pass through thevalve160 in a ready position, such as through one or more slits provided centrally of the valve.
• Thevalve opener162 is configured to press against thevalve160 and open thevalve160 to allow fluid or solution to pass distally through thecatheter hub152 and thecatheter tube154. For example, thevalve opener162 can be advanced distally by a male medical implement, such as a syringe tip, which presses against the proximal end of thevalve opener162 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, thevalve opener162 has a wedge shape nose section to press open thevalve160 and an extension orleg1622 to be pushed against by a male medical implement. Although a single extension orleg1622 is usable to push the valve opener, two or more extensions are preferred. Theextension1622 can be one or more separate sections that can be pressed against by a male medical implement to advance thevalve opener162 against thevalve160. Thevalve opener162 has anopening1620 defined through a center of the nose section of thevalve opener162 for theneedle158 to pass therethrough.
• Thethird hub164 has asidewall167 extending from thedistal wall165 and aproximal wall169 such that thesidewall167 extends between thedistal wall165 and theproximal wall169 of thethird hub164. Theproximal wall169 of thethird hub164 has an opening for theneedle158 to pass therethrough. Theneedle158 also passes through theopening163 of thedistal wall165 of thethird hub164. Thedistal wall165, thesidewall167, and theproximal wall169 of thethird hub164 cooperatively define an interior cavity orspace170 having aneedle guard122 disposed therein. The shape of thethird hub164 can be hemispherical, cylindrical, rectangular, polygonal, or irregular shaped, so long as theneedle158 can pass through theproximal wall169 and thedistal wall165, and theneedle guard122 can fit inside theinterior cavity170 of thethird hub164. In other words,side wall167 can be made up of multiple portions each having their own plane. Accordingly thesidewall167 can be cylindrical, rectangular, polygonal, or irregular shaped. In one example, thesidewall167 is unitarily formed to thedistal wall165 and the proximal wall is separately formed and subsequently attached to the sidewall after theneedle guard122 is placed inside theinterior cavity170. In another embodiment, thesidewall167 is unitarily formed with theproximal wall169 and the sidewall is attached to thedistal wall165 after theneedle guard122 is placed into theinterior cavity170.
• Thethird hub164 can be made of metal, plastic, or a biocompatible material. Thedistal wall165 abuts against thecatheter hub152 such that thethird hub164 is positioned between thecatheter hub152 and theneedle hub156. Theneedle158 passes through theopening163 of thedistal wall165 of thethird hub164. Thethird hub164 can have at least onearm166 sized and shaped to engage thecatheter hub152 in the ready position. As shown, twoarms166 extend distally and engage the annular projection or bump168 inside thecatheter hub152 to retain thethird hub164 to thecatheter hub152 in the ready position and during retraction of theneedle106 following successful venipuncture. Thearms166 andvalve opener162 are sized so as to avoid interference with the operation of each other. Thewall165 can be a circular plate or any other shape that completely covers or partially covers the interior of thecatheter hub152.
• Asupport126 is provided in thethird hub164. Thesupport126 can be centered around theopening163 or near theopening163 of thedistal wall165 of thethird hub164. As described above for thesupport126 ofFIG. 2A, thesupport126 can embody a ring, which is coaxially disposed with thecatheter tube154. In one example, thesupport126 is attached to thethird hub164 to provide a support surface for theneedle guard122. In another example, thesupport126 is a molded projection, such as a rib, to thedistal wall165 of thethird hub164. In yet another example, thesupport126 is integrally formed with thethird hub164, such as by way of glue or detents. Further, instead of a continuous or complete ring, thesupport126 may embody two or more separate sections, such as two or more ribs, formed around thebore inlet128 to thetube102. Thesupport126 can be any structure so long as it does not interfere with theneedle106 passing through and can provide a support surface for theneedle guard122.
• Theneedle guard122 shown inFIG. 3 is similar to the needle guard ofFIG. 2A. The two ends138,140 of the two arms are similarly spaced from the needle shaft in the ready position. As shown, the two ends138,140 are biased against thesupport126 located inside thethird hub164 and are spaced from the needle shaft in the ready position and during retraction of theneedle158 from thecatheter hub152. As previously discussed, when theneedle158 is retracted away from thecatheter hub152, the change inprofile112, such as a needle crimp, abuts a perimeter defining theopening132 on the proximal wall of the needle guard and theneedle guard122 eventually separates from thesupport126 to block theneedle tip110 from inadvertent needle sticks in a similar manner as previously discussed and as shown with reference toFIG. 2B.
• With reference now toFIGS. 4-6, analternative catheter assembly150 provided in accordance with further aspects of the present devices, systems, and methods is shown. In the present catheter assembly, a support for the needle guard can be implemented directly with avalve opener162. Furthermore, thecatheter hub152 can be a single piece or formed from two separate pieces that are attached together. Thevalve opener162 can have asupport1624 extending from a proximal end of the nose section of thevalve opener162 to support theneedle guard122. In one embodiment, thesupport1624 is a stub having a bore and is shorter in height or width than the width of theextension1622. Theneedle guard122 rests on thevalve opener support1624 until theneedle158 is retracted out of thecatheter hub152 and the needle crimp abuts the opening on theneedle guard122 as discussed above to separate the needle guard from thesupport1624 to then block theneedle tip110, similar to that shown inFIG. 2B.
• Specifically, the distal ends138,140 of theneedle guard122 are shown rested on thesupport1624 and theproximal wall130 of theneedle guard122 is recessed into the interior of the catheter hub and the proximal end most part of the catheter hub is located proximally of theproximal wall130 so that a nose section of theneedle hub156 can project into thecatheter hub152 without interfering with theextension1622 or theneedle guard122 in a ready position (FIG. 4). Alternatively the distal portion of theneedle hub156 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 theextension1622 and thesupport1624 can vary so long as theneedle hub156 does not interfere with theneedle guard122 or theextension1622. The valve opener can be made from any biocompatible material. In the three figures shown, thecatheter assembly150 is shown in a ready position inFIG. 4, in a used position shown inFIG. 5, in which theneedle guard122 covers the needle tip of the needle and the valve is closed, and in valve opened position inFIG. 6, 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, thesupport1624 can be centered around or located near theopening1620 through the nose section of thevalve opener162. As described above for thesupport126 ofFIG. 2A, thesupport1624 of the present embodiment can embody many shapes and configurations to support theneedle guard122. Thesupport1624 can be any structure so long as it does not interfere with theneedle106 passing through thevalve opener162 and can provide a support surface for theneedle guard122. Thesupport1624 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 theneedle guard122 onto thesupport1624 comprises a step of sliding the distal end of theneedle guard122 onto thesupport1624 of avalve opener162 so that the twoarms134,136 are spaced from the needle shaft in the ready position. With reference toFIG. 7, to ensure theneedle guard122 is able to slide onto thesupport1624, the distance x between the needle shaft and outer surface of thesupport1624 should be less than the distance y between the needle shaft and the transition point of theneedle guard122. The transition point can be the turning point where the curved section of theends138,140 of theneedle guard122 have reached a maximum and begins to curve inward thereby allowing the curved surface of theends138,140 to engage the outer surface of thesupport1624 thereby spreading theends138,140 apart from each other away from the needle shaft and biasing against thesupport1624. If the distance x between thesupport1624 and the needle shaft is greater than the distance y between the needle shaft and the transition point, then the end of thesupport1624 can be tapered (as shown inFIGS. 7 and 8) until the distance x between thesupport1624 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 thesupport1624 can be tapered inwardly (as shown inFIG. 8), such as incorporating recessed sections, from the end of thesupport1624 towards the main body of thevalve opener162 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 theneedle guard122 from unintended premature separation from thesupport1624 of the valve opener. In another embodiment, thesupport1624 has a groove (as shown inFIG. 8) or other resistant means to prevent unintended premature separation of theneedle guard122 from thesupport1624. Obviously, the valve opener shown inFIGS. 7 and 8 may be usable with any of the catheter assemblies disclosed elsewhere herein having a valve.
• Referring now toFIG. 9, an end view of avalve opener162 provided in accordance with aspects of the present disclosure is shown, which has asupport1624 embodied as a ring like structure located between twoextensions1622 and formed around theopening1620 of thevalve opener162. The space between the twoextensions1622 allows theends138,140 of theneedle guard122 to be located there and over thesupport1624 in a ready to use position, similar to that shown inFIGS. 7 and 8.
• With reference now toFIG. 10, an end view of avalve opener162 provided in accordance with further aspects of the present disclosure is shown, which has asupport1624 embodied as two or more separate sections, such as two or more ribs, formed around theopening1620 of the nose section of thevalve opener162. The two or more ribs can be generally rectangular, arc shape, or combinations thereof. Thesupport1624 can have a mating surface for theends138,140 of theneedle guard122 to rest thereon in a ready to use position.
• FIG. 11 is an end view of avalve opener162 provided in accordance with still yet further aspects of the present disclosure, which has asupport1624 formed by a generally square shape stub connecting a distal portion of the twoextensions1622. The depth of the square shape stub determines the height of thesupport1624. Alternatively, thesupport1624 can have a flat surface to engage with theends138,140 of theneedle guard122.
• Although limited embodiments of the safety needle assemblies and their components have been specifically described and illustrated herein, many modifications and variations 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. Accordingly, it is to be understood that the safety needle assembly and their components constructed according to principles of the disclosed devices, systems, and methods may be embodied other than as specifically described herein. The disclosure is also defined in the following claims.

Claims (19)

1-18. (canceled)

19. A safety catheter assembly comprising:

a catheter hub comprising an interior cavity;

a valve and a valve opener having a head sized and shaped for pushing into the valve to open one or more slits of the valve, said valve and said valve opener being located in the interior cavity of the catheter hub;

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 having a needle tip extending out of a distal end of the catheter tube in a ready to use position;

a needle guard positioned in an interior space of a third hub located proximally of the catheter hub;

wherein the needle guard comprises a proximal wall having an opening and two arms;

wherein the needle guard comprises two ends, one on each of the two arms;

wherein a support is formed in an interior space of the third hub and fixed in the interior space thereof; and

wherein the support comprises surfaces that space the two ends of the two arms of the needle guard from the needle in the ready to use position, and the two ends otherwise contact the needle if not for the support, so as to reduce drag between the needle and the needle guard when the needle retracts from the catheter tube and the catheter hub following vascular access.

20. The safety catheter assembly ofclaim 19, wherein each of the two ends has a curved lip.

21. The safety catheter assembly ofclaim 20, wherein the support is ring shaped and the support is coaxially disposed with the catheter tube.

22. The safety catheter assembly ofclaim 19, wherein the support is located at a distal end of the third hub.

23. The safety catheter assembly ofclaim 19, wherein the third hub has a proximal wall with a proximal opening.

24. The safety catheter assembly ofclaim 19, wherein the third hub comprises a distal wall and at least one arm extending from the distal wall and engaging the catheter hub to retain the third hub in the ready to use position.

25. The safety catheter assembly ofclaim 24, wherein the third hub further comprises a second arm and wherein the at least one arm and the second arm engage a holding portion in the interior cavity of the catheter hub.

26. The safety catheter assembly ofclaim 19, wherein the two arms of the needle guard cross each other forming a cross-section and the support is spaced from the cross-section.

27. The safety catheter assembly ofclaim 20,

wherein the needle comprises a change in profile located proximal of the needle tip; and

wherein the change in profile abuts against the proximal wall of the needle guard before the needle guard separates from the support.

28. The safety catheter assembly ofclaim 20, wherein the third hub comprises a distal wall and an opening formed through the distal wall of the third hub, the support is centered around the opening of the distal wall of the third hub, and the needle passes through the support and the opening of the distal wall of the third hub.

29. The safety catheter assembly ofclaim 19, wherein the support is spaced from the needle.

30. The safety catheter assembly ofclaim 19, wherein the valve opener comprises at least one leg.

31. The safety catheter assembly ofclaim 19, wherein the support has a body with a ring shape, has a body with a bore, is formed from two or more ribs, or has multiple sides.

32. A safety catheter assembly comprising:

a catheter hub comprising an interior cavity;

a valve having one or more slits and a valve opener having a head sized and shaped for opening the valve, said valve and said valve opener being located in the interior cavity of the catheter hub;

a catheter tube attached to the catheter hub;

a needle hub;

a needle attached to the needle hub and projecting through the catheter tube in a ready to use position, said needle having a needle tip and a shaft;

a needle guard positioned in an interior space of a third hub located proximally of the catheter hub;

wherein the needle guard comprises a proximal wall having a perimeter defining an opening, two arms, and two ends, one on each of the two arms;

wherein a support interacts with the needle guard to bias the two ends of the two arms of the needle guard away from the needle in the ready to use position, and the two ends otherwise contact the needle if not for the support, so as to reduce drag between the needle and the needle guard when the needle retracts from the catheter tube and the catheter hub following vascular access; and

wherein the support is fixed in the interior space of the third hub, and wherein the support is spaced from the proximal opening of the proximal wall of the needle guard and spaced from the needle in the ready to use position and in a protective position, the needle tip being blocked from inadvertent needlestick in the protective position.

33. The safety catheter assembly ofclaim 32, wherein the two arms of the needle guard are separated from the support when in the protective position.

34. The safety catheter assembly ofclaim 32, wherein the support is fixed to the third hub at a distal end of the third hub.

35. The safety catheter assembly ofclaim 32, wherein the support has a body with a ring shape, is a body with a bore, is formed from two or more ribs, or has multiple sides.

36. The safety catheter assembly ofclaim 32, wherein the third hub has a proximal wall with a proximal opening.

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