Patent Publication Number: US-2020297969-A1

Title: Closed system catheter

Description:
RELATED APPLICATIONS 
     This application is a division of application Ser. No. 15/435,700 filed Feb. 17, 2017, which claims the benefit of U.S. Provisional Application Nos. 62/296,865 filed Feb. 18, 2016; 62/351,040 filed. Jun. 16, 2016; 62/367,748 filed Jul. 28, 2016; and 62/413,784 filed Oct. 27, 2016, each of which are fully incorporated herein by reference. 
    
    
     TECHNICAL FIELD 
     The present disclosure relates generally to intravenous catheters, and more particularly to closed system intravenous catheter assemblies having an improved catheter hub design. 
     BACKGROUND 
     Intravenous (IV) therapy is a versatile technique used for the administration of medical fluids to and withdrawal of bodily fluids from patients. IV therapy has been used for various purposes such as the maintenance of fluid and electrolyte balance, the transfusion of blood, the administration of nutritional supplements, chemotherapy, and the administration of drugs and medications. These fluids, collectively referred to herein as medicaments, may be administered intravenously by injection through a hypodermic needle, or intermittently or continuously by infusion using a needle or catheter. A common intravenous access device utilized by clinicians is the peripheral IV catheter. 
     A peripheral IV catheter is made of soft, flexible plastic or silicone, generally between fourteen to twenty-four gauge in size. In the conventional venipuncture procedure, a catheter is inserted into a vein in the patient&#39;s hand, foot, or the inner aspect of the arm or any vein in the body that will accept an IV catheter. In order to place the IV catheter into a patient&#39;s vein, a sharp introducer needle is used to puncture the skin, tissue, and vein wall to provide a path for placement of the catheter into the vein. 
     Referring to  FIGS. 1A-B , a conventional IV needle assembly  50  configured for insertion of an “over the needle” catheter  52  is depicted. Catheter  52  generally includes a catheter tube  54  having a distal end  56  for insertion into a biological site, a proximal end  58  and a flexible wall defining a lumen extending therebetween. Frequently, the proximal end  58  of the catheter tube  54  is operably coupled to a catheter hub  60 . Catheter  52  can be operably coupleable to the needle assembly  50 , in part by positioning the catheter  52  coaxially over a needle  62  of the needle assembly  50 . The catheter  52  thus rides with the needle  62  through the skin, tissue and vein wall and into the patient&#39;s vein. Once the catheter tube  54  has been entered into the patient&#39;s vein, the catheter  52  can be advanced further into the vein as desired and the needle  62  can be withdrawn from the catheter  52 . The catheter  52  can then be secured into place on the patient and connected to an IV fluid supply. In some instances, catheter  52  can include an extension tube  64  having a clamp  66  and a Luer lock connector  68  for connection to an IV fluid supply. Such catheters are often referred to as closed system catheters, as typically they include a septum that seals the needle path after the needle  62  has been withdrawn from the catheter  52 , thereby preventing blood or bodily fluid from the patient from escaping from the catheter to the ambient environment. 
     SUMMARY OF THE DISCLOSURE 
     Embodiments of the present disclosure provide a simple and reliable method of constructing a catheter hub in which the various components of the catheter hub are snap fit together, such that adhesives and ultrasonic welding are not required, thereby reducing the expense and labor required during construction of a catheter assembly. Some embodiments of the present disclosure further provide a mechanism for inhibiting rotation of the various components within the catheter hub, as well as inhibiting rotation of the catheter hub relative to a needle insertion device. Some embodiments of the present disclosure provide a catheter hub having an improved wing design configured to improve contact with a patient&#39;s skin when a portion of the catheter assembly is inserted into a vein of the patient. 
     One embodiment of the present disclosure provides a catheter hub assembly including a catheter hub body, a septum and a septum retainer. The catheter hub body can have a distal end operably coupled to a catheter tube, a proximal end, and an internal wall defining an internal fluid passageway therebetween. The internal wall can define a transitional step within the internal fluid passageway between a smaller diameter portion proximal to the distal end, and a larger diameter portion proximal to the proximal end. The septum can have a distal end and a proximal end. The septum can be positioned within the internal fluid passageway such that the distal end of the septum abuts up against the transitional step. The septum retainer can be at least partially receivable within the internal fluid passageway of the catheter hub body. The septum retainer can have an outer wall and an inner wall. The outer wall of the septum retainer can be shaped and sized to interlock with the inner wall of the catheter hub body and can include one or more lateral ribs configured to inhibit rotation of the septum retainer relative to the catheter hub body. 
     One embodiment of the present disclosure further provides a catheter insertion device having a needle assembly and a needle housing. The needle assembly can include an insertion needle presenting a sharpened needle tip. The insertion needle can be operably coupled to the needle housing and can be shiftable between a ready for use position in which the sharp needle tip of the insertion needle extends from the needle housing, and a safe position in which the sharpened needle tip of the insertion needle is housed within the needle housing. 
     In one embodiment, the proximal end of the catheter hub body includes a lug configured to align a catheter hub relative to the catheter insertion device and aid in coupling of the catheter hub assembly to a passive release mechanism of the catheter insertion device. In one embodiment, the septum is configured to seal the internal fluid passageway upon removal of the needle from the needle insertion device passing therethrough. In one embodiment, the septum includes an internal surface defining an aperture. In one embodiment, the septum is circumferentially compressed by the internal wall of the catheter hub to aid in resealing of the septum upon removal of the needle. 
     In one embodiment, the internal wall of the catheter hub body further defines a side port. In one embodiment, the catheter assembly further includes extension tubing operably coupled to the side port, wherein a lumen of the extension tube is in fluid communication with the internal fluid passageway. In one embodiment, the catheter assembly further includes an extension tube clamp operably coupled to the extension tube and configured to selectively occlude the extension tube to inhibit flow through the extension tube lumen. 
     In one embodiment, the catheter assembly further includes a needleless connector operably coupled to and in fluid communication with a lumen of the extension tube. In one embodiment, the needleless connector is shiftable between an actively open position and a biased close position. In one embodiment, the catheter assembly further includes a vent cap operably coupled to the needleless connector. In one embodiment, the vent cap is configured to shift between a first, storage position in which the needleless connector remains closed, and a second, actively depressed position in which the needleless connector is opened, thereby venting air trapped within the catheter assembly. 
     Another embodiment of the present disclosure provides a catheter hub assembly including a catheter hub body, a septum and a septum retainer. The catheter hub body can have a distal end operably coupled to a catheter tube, a proximal end, and an internal wall defining an internal fluid passageway therebetween. The internal wall can define a transitional step within the internal fluid passageway between a smaller diameter portion proximal to the distal end and a larger diameter portion proximal to the proximal end. The septum can have a distal end and a proximal end. The septum can be positioned within the internal fluid passageway such that the distal end of the septum abuts up against the transitional step. The septum retainer can be at least partially receivable within the internal fluid passageway of the catheter hub body, and can be configured to secure the septum in position within the internal fluid passageway. The septum retainer can have an outer wall and an inner wall. The outer wall can be shaped and sized to interlock with the inner wall of the catheter hub body and can include one or more lateral ribs configured to inhibit rotation of the septum retainer relative to the catheter hub body. The inner wall can be shaped and sized to selectively couple the catheter hub assembly to a catheter insertion device, and can include one or more lateral nubs configured to inhibit rotation of the septum retainer relative to the catheter insertion device. In one embodiment, a frictional resistance provided by the one or more lateral ribs can exceed a frictional resistance provided by the one or more lateral nubs, such that the septum retainer is configured to rotate relative to the catheter insertion device before rotating relative to the catheter hub body. 
     One embodiment of the present disclosure further provides a closed system catheter assembly including a catheter insertion device. The catheter insertion device can include a needle assembly and a needle housing. The needle assembly can include an insertion needle presenting a sharpened needle tip. The insertion needle can be operably coupled to the needle housing and shiftable between a ready for use position in which the sharpened needle tip of the insertion needle extends from the needle housing, and a safe position in which the sharpened needle tip of the insertion needle is housed within the needle housing. 
     In one embodiment, the proximal end of the catheter hub body can include a lug configured to align the catheter hub relative to the catheter insertion device and aid in coupling the catheter hub assembly to a passive release mechanism of the catheter insertion device. In one embodiment, the septum can be configured to seal the internal fluid passageway upon removal the insertion needle of the catheter insertion device passing therethrough. In one embodiment, the septum can include an internal surface defining an aperture. In one embodiment, the septum can be circumferentially compressed by the internal wall of the catheter hub to aid in resealing of the septum upon removal of the insertion needle. 
     In one embodiment, the internal wall of the catheter hub body can define a side port. In one embodiment, an extension tube can be operably coupled to the side port, Therein a lumen of the extension tube is in fluid communication with the internal fluid passageway. In one embodiment, an extension tube clamp can be operably coupled to the extension tube and can be configured to selectively occlude the extension tube to inhibit flow through the extension tube lumen. In one embodiment, a needleless connector can be operably coupled to and in fluid communication with the lumen of the extension tube. In one embodiment, the needleless connector can be shiftable between an actively open position and a biased closed position. In one embodiment, the catheter hub assembly can further include a vent cap operably coupled to the needleless connector. In one embodiment, the vent cap can be configured to shift between a first, storage position in which the needleless connector remains closed, and a second, actively depressed position in which the needleless connector is opened, thereby venting air trapped within the catheter hub assembly. 
     Another embodiment of the present disclosure provides a catheter assembly configured for insertion into a subject&#39;s vein, including a catheter hub and a wing assembly. The catheter hub can have a distal end operably coupled to a catheter tube and a proximal end configured to be operably coupled to a catheter insertion device. The wing assembly can be operably coupled to the catheter hub and can include a pair of flexible wings, a heel portion and a collar. The pair of flexible wings can extend outwardly from a central axis of the catheter hub. The heel portion can extend from a proximal end of the pair of flexible wings towards the proximalend of the catheter hub. The collar can wrap around a central axis of the catheter hub. The bottom surface of the pair of wings and a bottom surface of the heel portion can form a contiguous surface that is angled relative to an axis of the catheter tube such that the catheter tube is substantially straight when inserted into vein of the subject and the contiguous surface is substantially parallel to the skin of the subject. 
     One embodiment of the present disclosure further provides a closed system catheter assembly including a catheter insertion device. The catheter insertion device can include a needle assembly and a needle housing. The needle assembly can include an insertion needle presenting a sharpened needle tip. The insertion needle can be operably coupled to the needle housing and shiftable between a ready for use position in which the sharpened needle tip of the insertion needle extends from the needle housing, and a safe position in which the sharpened needle tip of the insertion needle is housed within the needle housing. 
     In one embodiment, the contiguous surface can be offset from the axis of the catheter tube by a range of between seven and nine degrees. In one embodiment, the contiguous surface can be offset from the axis of the catheter tube by approximately eight degrees. In one embodiment, a distal portion of the pair of wings can form a substantially straight line extending substantially orthogonal to the axis of the catheter tube for improved contact with the skin of the subject. In another embodiment, a distal portion of the pair of wings can be concave, so as to form a slight arc, such that the distal edge of the wings extends distally farther than the distal portion of the pair of wings proximal to the catheter tube. In one embodiment, a top surface of the pair of wings can define a concave surface configured to aid a clinician and gripping the catheter assembly. In one embodiment, the wing assembly can have a lower modulus of elasticity than the catheter hub. In one embodiment, a textured pattern can be formed into the contiguous surface to increase the frictional resistance with the skin of the subject when the catheter tube is inserted into vein of the subject. In one embodiment, the textured pattern can aid in preventing perspiration build up, which can occur with a flat or smooth surface. In one embodiment, the textured pattern inhibits the creation of high-pressure areas that may cause discomfort. In one embodiment, the wing assembly is integrally molded onto the catheter hub. In one embodiment, the collar at least partially wraps around the proximal portion of the catheter hub. In one embodiment, the catheter hub can include one or more ledges configured to provide a structural reinforcement for the pair of flexible wings. 
     Another embodiment of the present disclosure provides a vent cap configured to be operably coupled to a needleless connector and shiftable relative to the needleless connector between a storage position and an actively depressed, venting position. The vent cap can include a nose, a push plate and one or more resilient needleless connector engagement arms. The nose can be configured to be inserted at least partially into the needleless connector when the vent cap is pushed to the actively depressed, venting position. The push plate can be operably coupled to the proximal end of the nose and can define a vent aperture comprising an air permeable membrane. The one or more resilient needleless connector engagement arms can be operably coupled to the nose and can be configured to grip a portion of the needleless connector, wherein the one or more resilient needleless connector engagement arms bias the vent cap to the storage position. 
     In one embodiment, the vent cap is selectively coupled to a closed system catheter assembly, including a catheter tube, catheter hub, extension tube, and needleless connector. In one embodiment, the one or more resilient needleless connector engagement arms can include a ridge to improve a grip of the one or more resilient needleless connector engagement arms to the needleless connector. In one embodiment, shifting of the vent cap to the actively depressed, venting position enables air trapped within the needleless connector to be purged. In one embodiment, shifting the vent cap to the actively depressed, venting position forces the one or more resilient needleless connector engagement arms apart, and where upon release from the actively depressed position, the resiliency of the one or more resilient needleless connector engagement arms biases the vent cap back to the storage position. In one embodiment, the vent cap is removable from the needieless connector after use. In one embodiment, the nose of the vent cap is tapered to improve a fluid tight seal with the needieless connector when shifted to the actively depressed, venting position. 
     In one embodiment, the nose includes a vent path sealed at one end by the air permeable membrane. In one embodiment, the vent path is constructed of at least one of a transparent and translucent material. In one embodiment, the vent cap is configured to provide a flashback indication as fluid flows into the vent path. In one embodiment, the push plate can define an eyelet configured to provide a fluid path for air escaping from the vent path. 
     Another embodiment of the present disclosure provides an intravenous catheter assembly including a catheter insertion device and a closed system catheter. The catheter insertion device can include a needle assembly and a needle housing. The needle assembly can include an insertion needle presenting a sharpened needle tip. The insertion needle can be operably coupled to the needle housing and shiftable between a ready for use position in which the sharpened needle tip of the insertion needle extends from the needle housing, and a safe position in which the sharpened needle tip of the insertion needle is housed within the needle housing. The insertion needle can include structure presenting a notch position proximal to the sharpened needle tip of the insertion needle that is configured to enable blood to flow therethrough to provide a primary indication of catheter placement. The needle assembly can include structure defining a flash chamber in communication with a lumen of the insertion needle to provide a secondary indication of catheter placement. 
     The closed system catheter can include a catheter tube, a catheter hub, an extension tube, a needleless connector, and a vent cap. The vent cap can include a wall defining a vent path sealed at one end by an air permeable barrier. The vent cap can be shiftable between a first storage position in which the needleless connector is in a closed position, and a second actively depressed position in which the needleless connector is shifted to an open position, thereby venting air trapped within the closed system catheter and enabling blood to flow into the vent path to provide a tertiary indication of catheter placement. 
     A method of the present disclosure provides using an intravenous catheter assembly including a flash chamber and a vent cap including one or more of the following steps: 
     introducing an insertion needle and catheter tube coaxially positioned there about into a vein of the subject, wherein an annular space is present between the insertion needle and the coaxially positioned catheter tube; 
     receiving a primary indication of proper catheter placement via blood flow through a notch defined in the insertion needle into the annular space; 
     receiving a secondary indication of proper catheter placement via blood flow through a lumen of the insertion needle and into the flash chamber; 
     venting air from within the intravenous catheter assembly by shifting the vent cap from a storage position to an actively depressed position; and 
     receiving a tertiary indication of proper catheter placement via blood flow into the vent cap. 
     The summary above is not intended to describe each illustrated embodiment or every implementation of the present disclosure. The figures and the detailed description that follow more particularly exemplify these embodiments. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The disclosure can be more completely understood in consideration of the following detailed description of various embodiments of the disclosure, in connection with the accompanying drawings, in which: 
         FIG. 1A  is a perspective view depicting a conventional IV needle assembly with a catheter positioned over a needle. 
         FIG. 1B  is a perspective view depicting the conventional IV needle assembly of  FIG. 1A  with the catheter removed from the needle. 
         FIG. 2A  is a perspective view depicting a catheter assembly, with an extension tube, extension tube clamp, needleless connector and vent cap, in accordance with an embodiment of the disclosure. 
         FIG. 2B  is a top view depicting the catheter assembly of  FIG. 2A . 
         FIG. 2C  is a bottom view depicting the catheter assembly of  FIG. 2A . 
         FIG. 2D  is a right side view depicting the catheter assembly of  FIG. 2A . 
         FIG. 2E  is a left side view depicting the catheter assembly of  FIG. 2A . 
         FIG. 2F  is a rear view depicting the catheter assembly of  FIG. 2A . 
         FIG. 2G  is a front view depicting the catheter assembly of  FIG. 2A . 
         FIG. 3A  is a top perspective view depicting a closed system catheter assembly including a catheter assembly operably coupled to a catheter insertion device, in accordance with an embodiment of the disclosure. 
         FIG. 3B  is a top view depicting the closed system catheter assembly of  FIG. 3A . 
         FIG. 3C  is a bottom view depicting the closed system catheter assembly of  FIG. 3A . 
         FIG. 3D  is a right side view depicting the closed system catheter assembly of  FIG. 3A . 
         FIG. 3E  is a left side view depicting the closed system catheter assembly of  FIG. 3A . 
         FIG. 3F  is a rear view depicting the closed system catheter assembly of  FIG. 3A . 
         FIG. 3G  is a front view depicting the closed system catheter assembly of  FIG. 3A . 
         FIG. 4A  is a perspective view depicting an intravenous catheter assembly having a catheter operably coupled to a catheter insertion device in accordance with an embodiment of the disclosure, wherein the catheter insertion device is in the ready for use position. 
         FIG. 4B  is a perspective view depicting the intravenous catheter assembly of  FIG. 4A , wherein the intravenous catheter assembly is decoupled from the catheter insertion device, and the catheter insertion device is in the needle retracted, safe position. 
         FIG. 5A  is a side perspective view depicting a needle assembly of a catheter insertion device in accordance with an embodiment of the disclosure. 
         FIG. 5B  is a distal end view depicting the catheter insertion device of  FIG. 5A . 
         FIG. 5C  is a bottom perspective view depicting the catheter insertion device of  FIG. 5A . 
         FIG. 6A  is a bottom perspective view depicting an interaction between a needle assembly and a needle housing of a catheter insertion device, in accordance with an embodiment of the disclosure, wherein the needle assembly is positioned relative to the needle housing in a distal, engaged, ready for use position. 
         FIG. 6B  is a bottom perspective view depicting the interaction between a needle assembly and a needle housing of the catheter insertion device of  FIG. 6A , wherein the needle assembly is positioned relative to the needle housing in a proximal, disengaged, safe position. 
         FIG. 7A  is a perspective view depicting an intravenous catheter assembly having a passive release mechanism in accordance with an embodiment of the disclosure, wherein the intravenous catheter assembly includes a catheter operably coupled to an catheter insertion device via a passive release mechanism, and wherein the catheter insertion device is in the ready for use position. 
         FIG. 7B  is a perspective view depicting the intravenous catheter assembly of  FIG. 7A , wherein the intravenous catheter assembly is decoupled from the catheter insertion device, and the catheter insertion device is in the needle retracted, safe position. 
         FIG. 8A  is an exploded, perspective view depicting a first side of a passive release mechanism in accordance with an embodiment of the disclosure. 
         FIG. 8B  is an exploded, perspective view depicting a second side of the passive release mechanism of  FIG. 8A . 
         FIG. 9A  is a fragmentary, cross-sectional view depicting an intravenous catheter assembly in accordance with an embodiment of the disclosure, wherein the intravenous catheter assembly includes a passive release mechanism having a retainer and collar positioned relative to one another so as to engage a catheter hub in a ready for use position. 
         FIG. 9B  is a fragmentary, cross-sectional view depicting the intravenous catheter assembly of  FIG. 9A , wherein the retainer and collar are positioned relative to one another so as to disengage from the catheter hub in a safe position. 
         FIG. 10A  is a profile view depicting a catheter tube, catheter hub and wing assembly in accordance with an embodiment of the disclosure. 
         FIG. 10B  is a cross-sectional view depicting the catheter tube, catheter hub and wing assembly of  FIG. 10A . 
         FIG. 11  depicts an exploded, perspective view depicting the catheter hub body and a septum retainer in accordance with an embodiment of the disclosure. 
         FIG. 12  a perspective view depicting another embodiment of a septum retainer in accordance with the disclosure. 
         FIG. 13  is a partial view depicting a catheter assembly in accordance with an embodiment of the disclosure. 
         FIG. 14  is a partial, semitransparent view depicting an assembled catheter assembly operably coupled to a catheter insertion device in accordance with an embodiment of the disclosure. 
         FIG. 15  is an end view of a proximal end depicting a septum retainer in accordance with an embodiment of the disclosure. 
         FIG. 16  is a partial, semitransparent view depicting a septum retainer and septum operably coupled to a catheter insertion device in accordance with an embodiment of the disclosure. 
         FIG. 17  is a partial, cross-sectional view depicting a septum retainer and a septum operably coupled to a catheter insertion device in accordance with an embodiment of the disclosure. 
         FIG. 18A  is a fragmentary, top view depicting an intravenous catheter assembly in accordance with an embodiment of the disclosure. 
         FIG. 18B  is a fragmentary, perspective view depicting the intravenous catheter assembly of  FIG. 18A . 
         FIG. 18C  is a fragmentary, profile view depicting the intravenous catheter assembly of  FIG. 18A . 
         FIG. 19A  is a partial cross sectional view depicting a catheter hub, septum retainer and a septum in accordance with an embodiment of the disclosure. 
         FIG. 19B  is a cross sectional view depicting the catheter hub, septum retainer and septum of  FIG. 19A . 
         FIG. 20  is an end view depicting a septum having a slit with a needle passing therethrough in accordance with an embodiment of the disclosure. 
         FIG. 21A  is a partial cross sectional view depicting a catheter hub, septum retainer and a septum in accordance with an embodiment of the disclosure. 
         FIG. 21B  is a cross sectional view depicting the catheter hub, septum retainer and septum of  FIG. 21A . 
         FIG. 22A  is a partial cross sectional view depicting a catheter hub, septum retainer and a septum in accordance with an embodiment of the disclosure. 
         FIG. 22B  is a cross sectional view depicting the catheter hub, septum retainer and septum of  FIG. 22A . 
         FIG. 23A  is a partial cross sectional view depicting a catheter hub, septum retainer and a septum in accordance with an embodiment of the disclosure. 
         FIG. 23B  is a cross sectional view depicting the catheter hub, septum retainer and septum of  FIG. 23A . 
         FIG. 24A  is a partial cross sectional view depicting a catheter hub, septum retainer and a septum in accordance with an embodiment of the disclosure. 
         FIG. 24B  is a cross sectional view depicting the catheter hub, septum retainer and septum of  FIG. 24A . 
         FIG. 25A  is a partial cross sectional view depicting a catheter hub, septum retainer and a septum in accordance with an embodiment of the disclosure. 
         FIG. 25B  is a cross sectional view depicting the catheter hub, septum retainer and septum of  FIG. 25A . 
         FIG. 26A  is a partial cross sectional view depicting a catheter hub, septum retainer and a septum in accordance with an embodiment of the disclosure. 
         FIG. 26B  is a cross sectional view depicting the catheter hub, septum retainer and septum of  FIG. 26A . 
         FIG. 27A  is a profile view depicting a needleless connector in accordance with an embodiment of the disclosure. 
         FIG. 27B  is a cross sectional view depicting the needleless connector of  FIG. 27A  in a closed configuration. 
         FIG. 27C  is a cross sectional view depicting the needleless connector of  FIG. 27A  in an open configuration coupled to an IV fluid supply. 
         FIG. 28  is a perspective view of an intravenous catheter assembly having a “Y” connector connecting to two needleless connectors in accordance with an embodiment of the disclosure. 
         FIG. 29A  is a perspective view depicting a vent cap in accordance with an embodiment of the disclosure. 
         FIG. 29B  is another perspective view depicting the vent cap of  FIG. 29A . 
         FIG. 29C  is a sectional view depicting the vent cap of  FIG. 29A . 
         FIG. 30A  is a cross-sectional view depicting a vent cap and needleless connector in accordance with an embodiment of the disclosure, wherein the vent cap is in a first, storage position relative to the needleless connector. 
         FIG. 30B  is a cross-sectional view depicting the vent cap and needleless connector of  FIG. 30A , wherein the vent cap is in a second, actively depressed position relative to the needleless connector. 
         FIG. 31A  depicts the preparation of a biological site for insertion of a catheter insertion device in accordance with an embodiment of the disclosure. 
         FIG. 31B  depicts the insertion of a needle and catheter tube into the vein of a patient in accordance with an embodiment of the disclosure. 
         FIG. 31C  depicts the retraction of the needle from the catheter tube in accordance with an embodiment of the disclosure. 
         FIG. 31D  depicts the removal of a catheter insertion device from a biological site in accordance with an embodiment of the disclosure. 
     
    
    
     While embodiments of the disclosure are amenable to various modifications and alternative forms, specifics thereof shown by way of example in the drawings will be described in detail. It should be understood, however, that the intention is not to limit the disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure as defined by the appended claims. 
     DETAILED DESCRIPTION 
     Referring to  FIGS. 1A-B , a conventional IV catheter assembly  20  is depicted. Details of the conventional IV catheter assembly  20  are described in the Background section above. 
     Referring to  FIGS. 2A-G , a catheter assembly  100  is depicted in accordance with an embodiment of the disclosure. In one embodiment, the catheter assembly  100  can be a closed system catheter. Referring to  FIGS. 3A-G , a closed system catheter assembly  101  is depicted in accordance with an embodiment of the disclosure. In one embodiment, the closed system catheter assembly  101  can include a catheter assembly  100  operably coupled to a catheter insertion device  102 . 
     I. Catheter Insertion Device 
     Catheter insertion device  102  can provide an insertion needle  104 , over which a portion of a catheter tube  108  coaxially rides. Various types of catheter insertion devices  102  are marketed by Smiths Medical ASD, Inc. of St. Paul, Minn., under the TELCO trademark. One embodiment of a catheter insertion device  102  (such as that depicted in  FIGS. 1A-B ) is described in U.S. Pat. Nos. 7,291,130 and 8,257,322 (depicting an IV catheter insertion device marketed by Smiths Medical ASD, Inc. under the INTUITIV trademark), both of which are incorporated by reference herein. 
     In other embodiments, the catheter insertion device  102  can provide a safety needle assembly (such as that depicted in  FIGS. 3A-G  and  FIGS. 4A-B ), which functions to house the sharpened needle tip  106  of the insertion needle  104  to reduce the likelihood of an inadvertent needle stick.  FIG. 4A  depicts the catheter insertion device  102  in a first or ready for use position, in which the catheter assembly  100  is selectively coupled to the catheter insertion device  102 . In particular, the catheter assembly  100 , which can include a catheter tube  108  and a catheter hub  110 , can be positioned over the insertion needle  104  of the catheter insertion device  102 , with a sharpened needle tip  106  of the insertion needle  104  protruding from a distal end of the catheter tube  108 . In some embodiments, a protective sheath or needle cover (not depicted) can be operably coupled to either the catheter assembly  100  or the catheter insertion device  102 , and positioned over the sharp needle tip  106  to inhibit unwanted needle sticks. The closed system catheter assembly  101 , which can include the catheter assembly  100  and catheter insertion device  102 , can be provided for use in a sterilized and assembled state, contained within a hermetically sealed package. 
     To insert the catheter tube  108  into a vein of a patient or subject, a clinician first removes the closed system catheter assembly  101  from the packaging. The needle sheath is removed to expose the sharp needle tip  106  of the insertion needle  104  protruding from the distal end of the catheter tube  108 . The clinician then punctures an identified site of the subject with the sharpened needle tip  106  and urges the needle  104  forward until the sharpened needle tip  106  enters the vein of the subject. In some embodiments, an initial amount of blood or bodily fluid can pass through a lumen of the needle  104 , and enter the catheter assembly  100  and/or catheter insertion device  102  such that the clinician can view the “flashback” of the blood or bodily fluid to confirm entry into the vein. The catheter assembly  100  can then be moved distally over the needle  104 , threading the catheter tube  108  into the vein of the subject as the needle  104  is held stationary. With the catheter assembly  100  positioned as desired, the clinician can withdraw the needle  104  by pulling a needle assembly  103  of the catheter insertion device  102  proximally, away from the subject while holding the catheter assembly  100  generally stationary with respect to the subject. The needle assembly  103  can be pulled proximally until the needle  104  of the catheter insertion device  102  is separated from the catheter assembly  100  and safely housed within the needle housing  105  of the catheter insertion device  102 , which is referred to as the second or safe position.  FIG. 4B  depicts the intravenous catheter assembly  100  and the safe position. In the safe position, the clinician can dispose of the catheter insertion device  102  in a sharps container. 
     It is to be appreciated that the term “distal,” as used herein, refers to the direction along an access that lies parallel to the needle  104  of the closed system catheter assembly  101  that is closest to the subject during catheter insertion. Conversely, the term “proximal,” as used herein, refers to the direction lying along the axis parallel to the needle  104  that is further away from the subject when the catheter is inserted into the vein of the subject, opposite to the distal direction. 
     As depicted in  FIGS. 5A-C , the needle assembly  103  can include an insertion needle  104  operably coupled to a needle hub  262 . Needle  104  can include an elongate, cylindrically shaped metal structure defining a lumen that extends between a sharpened distal needle tip  106  and a proximal end  264 . The sharp needle tip  106  can be constructed and arranged to pierce the skin of a subject during catheter insertion. For example, in one embodiment, the sharp needle tip  106  can include a V-point designed to reduce the penetration force used to penetrate the needle  104  and a portion of the catheter insertion assembly  102  through the skin, tissue, and vein wall of a subject. In one embodiment, the length of the needle  104  can be extended to aid in the insertion of the catheter assembly  100  into obese patients. 
     Needle  104  can further include a transition  266  that has a different cross-sectional size and/or shape than portions of the needle  104  that lie proximal to the transition  266 . Needle transition  266  (alternatively referred to as a needle pump or cannula bump) can be created by crimping opposed sides of the needle  104 , or otherwise disrupting the structure of the needle  104 , so that the outer surfaces of the needle  104  extend to a larger radial position than other portions of the needle  104 , as measured from the center of the needle axis. Transitionals  266  can be formed differently, according to alternate embodiments, such as by adding material to the exterior of the needle, among other ways. 
     Proximal end  264  of the needle  104  can be operably coupled to the needle hub  262 . Needle hub  262  can be connected to a needle grip  268  positioned on the exterior of the needle housing  105  when assembled thereto for access by a clinician. The needle hub  262  and the needle grip  268  can be operably coupled to one another by a protuberance  270  that can be formed from the same unitary structure as the needle grip  268  and the needle hub  262 . 
     In one embodiment, the needle assembly  103  can be constructed to provide a visual indication of flashback when the sharpened needle tip  106  of the needle  104  enters the vein of a subject. In this embodiment, the needle hub  262  includes a flash chamber  272  in fluid communication with the lumen of the needle  104 . When the sharp needle tip  106  enters a vein during catheter insertion, blood or bodily fluid enters the needle lumen from the vein and flows proximally through the needle  104  into the flash chamber  272 . The flash chamber  272  can be sealed at one end by a flash plug  274 . Flash plug  274  can be made out of an air permeable, hydrophilic material that enables the passage of air, but inhibits the passage of liquid. Air that resides in the needle lumen and flash chamber  272  is therefore pushed through the flash plug  274  by the incoming blood, until the blood reaches the flash plug  274  or is otherwise stopped. Needle hub  262 , or portions thereof, can be constructed of a clear or translucent material to enable a clinician to view the presence of blood within the flash chamber  272 . In this respect, the clinician can be alerted when the needle has entered the vein of the subject by the presence of blood in the flash chamber  272 . 
     In one embodiment, features of the needle assembly  103 , other than a flash chamber  272  can provide an indication that the sharp needle tip  106  has entered the vein of a subject. For example, the needle  104  can include a notch  276 . In this embodiment blood flow enters the needle lumen when the sharpened needle tip  106  enters the vein. As blood flows proximally in the needle lumen, some blood passes through the notch  276  and into the annular space that lies between the exterior of the needle  104  and the interior of the catheter tube  108 . The presence of blood in the annular space can be viewed by a clinician through clear or translucent portions of the catheter tube  108 , providing an indication that the sharpened needle tip  106  is present in a vein. 
     As depicted in  FIG. 6A-B , the needle housing  105  can have a generally cylindrical, elongate body  278  that extends from a proximal end  280  to a distal end  282 . A longitudinal slot  284  can be formed along and underside of the needle housing  105  and extend from a proximal slot end  286  near the proximal end  280  of the needle housing  105  to a distal slot end  288  near the distal end  282  of the needle housing  105 . 
     Needle assembly  103  can be slidably coupled to the needle housing  105 . For example, the needle assembly  103  can have a “C” shaped cross section conformed to fit around the outer surface of the needle housing  105  in a manner that inhibits the needle assembly  103  from readily separating from the needle housing  105 , yet enabling the needle assembly  103  to slide along the longitudinal axis of the needle housing  105  with minimal resistance. In one embodiment, the longitudinal slot  284  can slidably receive the protuberance  270  of the needle assembly  103 , with the needle grip  268  positioned outside of the needle housing  105  and at least a portion of the needle hub  262  and the needle  104  positioned internally to the needle housing  105 , thereby at least partially housing these features. Accordingly, the needle assembly  103  can be configured to slide along the longitudinal slot  284  to restrict the needle assembly  103  from rotating about the longitudinal axis of the needle housing  105 . The protuberance  270  slidably received within the longitudinal slot  284  enables linear movement of the needle hub  262  substantially parallel to the longitudinal axis of the needle housing  105 , but restricts the rotational movement of the needle assembly  103  relative to the needle housing  105 . 
     Longitudinal slot  284  can guide the needle assembly  103  in motion with respect to the needle housing  105  between the ready for use position (as depicted in  FIG. 6A ) and the safe position (as depicted in  FIG. 6B ). In the ready for use position a portion of the needle  104  extends from the needle housing  105 , such that the sharp needle tip  106  of the needle  104  protrudes beyond the needle housing  105 . In the safe position, the needle  104  is withdrawn, and the sharp needle tip  106  is housed within the needle housing  105  in a manner intended to reduce or eliminate the likelihood of an inadvertent needle stick. 
     Catheter insertion device  102  can include a needle lock  290  that engages a needle assembly at a position that is proximal to the sharp needle tip  106  to inhibit the sharp needle tip  106  from being accessed after the needle  104  is used to insert the catheter assembly  100 . In this manner, access to the sharp needle tip  106  is inhibited when the needle  104  is in the safe position. Needle lock  290  can thus be configured to interlock the needle assembly  103  to the needle housing  105  in the safe position. In one embodiment, the needle lock  290  can be positioned on a proximal portion of the needle housing  105  at the proximal slot end  286  to engage the protuberance  270 . Several different types of locking mechanisms can be used for this purpose. For example, in one embodiment, the longitudinal slot  284  of the needle housing  105  can have a bottleneck  292  defined in it, where the bottleneck  292  of the longitudinal slot  284  generally has a narrower width than the rest of the longitudinal slot  284 . Protuberance  270  of the needle assembly  103  can be triangular or wedge like in shape where the apex of the wedge faces the bottleneck  292  when in the ready for use position. When an external force is applied to the needle assembly  103  in an effort to slide it to the safe position, the apex of the wedge of the protuberance  270  can come into contact with the bottleneck  292 . Bottleneck  292 , which can have a width narrower than that of the protuberance  270 , can initially resist movement of the protuberance  270  through the bottleneck  292 . However, with sufficient force, the wedge shape protuberance  270  can cause the bottleneck  292  to temporarily deform, thereby enabling the protuberance  270  to pass through the bottleneck  292 . For example, in one embodiment, the interaction between the wedge shape protuberance  270  and the bottleneck  292  can create an audible “click” noise, tactile, or visual indication that the protuberance  270  has passed through the bottleneck  292 . Thereafter, the protuberance  270  will be unable to pass back through the bottleneck  292  in the opposite direction, and the needle  104  will be locked in the safe position relative to the needle housing  105 . 
     In some embodiments, the catheter insertion device  102  can include an end cap  263  (as depicted in  FIGS. 3A-G ). The end cap  263  can be coupled to the needle grip  268  and/or needle hub  262 , thereby covering the proximal end  280  of the needle housing  105 . End cap  263  can have a proximal end  265  that can provide a surface against which a clinician can press during the catheter insertion procedure, as discussed herein. 
     Referring to  FIGS. 7A-B , in one embodiment the intravenous catheter assembly  100  can include a passive release mechanism  298 . Passive release mechanism  298  can be configured to couple the catheter hub  110  to the catheter insertion device  102  in the ready for use position (as depicted in  FIG. 7A ) and release the catheter hub  110  from the catheter insertion device  102  and the safe position (as depicted in  FIG. 7B ). In some embodiments, the passive release mechanism  298  can include one or more catheter hub contacts that inhibit release of the catheter assembly  100  from the catheter insertion device  102  until after the sharp needle tip  106  of the catheter insertion device  102  is in the safe position, where access to the sharp needle tip  106  is inhibited. Release of the catheter assembly  100  from the catheter insertion device  102  can occur during a catheter insertion procedure without the need to perform additional steps aside from safely retracting the needle  104 . In this respect, the catheter can be “passively” released by a clinician to obtain “passive” safety. By way of example, the catheter assembly  100  can be released when a clinician pulls on a portion of the catheter insertion device  102  as the clinician withdraws the needle  104  from the catheter assembly  100 . 
     Referring to  FIGS. 8A-B , an exploded view of a passive release mechanism  298  is depicted in accordance with an embodiment of the disclosure. Passive release mechanism  298  can include a retainer  302  and a collar  304 . Retainer  302  can be received within the collar  304 , and can include an actuator  306  and a nose  308 , such that the actuator  306  and the nose  308  can form a unitary structure. Retainer  302  can be slidably engaged with the collar  304 . Retainer  302  can include one or more external hub contacts  310  and one or more interior hub contacts  312 , wherein both the external hub contacts  310  and internal hub contacts are configured to contact the catheter hub  110 , thereby securely engaging the catheter hub  110  to the passive release mechanism  298  when the actuator  306  is in the distal, engaged position. Additionally, collar  304  can include one or more exterior hub contacts  313 . 
     Referring to  FIGS. 9A-B , the retainer  302  and the collar  304  can be shaped and sized such that the catheter hub  110  is receivable at least partially within the collar  304  and at least partially over the nose  308 . Actuator  306  can be shiftable between a distal, engaged, ready for use position (as depicted in  FIG. 9A ), wherein the collar  304  can receive a proximal end of the catheter hub  110  and the nose  308  can engage with an interior of the catheter hub  110 , and a proximal, disengaged, safe position (as depicted in  FIG. 9B ), wherein the catheter hub  110  is released from the retainer  302  and the collar  304 . 
     When the nose  308  is in the distal, engaged, ready for use position, a length of the nose  308  that extends within the interior of the catheter hub  110  can be at least twice the diameter of the nose  308 . The interior of the catheter hub  110  can be resilient to facilitate disengagement of the catheter hub  110  from the nose  308 . 
     Nose  308  can include a needle passage  314  that can include a wider portion  316  and a narrower portion  318 . The wider portion  316  can be distal to the narrower portion  318 . The wider portion  316  can be sized so that the needle  104 , including the needle transition  266  can be received therein. The narrower portion  318  can be sized to closely approximate the diameter of the needle  104  without the needle transition  266 . Accordingly, the needle transition  266  will contact a needle abutment  320  at the juncture of the wider portion  316  and the narrower portion  318  to inhibit further passage of the needle  104 . Contact between the needle transition  266  and the needle abutment  320  enables proximal movement of the needle  104  to shift the retainer  302  proximally to the proximal, disengaged, safe position. Nose  308  can be structured to sheath the sharpened needle tip  106  when the sharp needle tip  106  is retracted to the disengaged, safe position. 
     Shifting of the retainer  302  can occur just prior to the needle assembly  103  reaching the safe position, such that in the proximal, disengaged safe position the exterior hub contacts  310 ,  313  and/or the interior hub contacts  312  can be disengaged from the catheter hub  110 , thereby enabling the catheter hub  110  to be released from the passive release mechanism  298 . In particular, when the actuator  306  is in the distal, engaged, ready for use position, a longitudinal axis of the needle assembly  103  and a longitudinal axis of the catheter hub  110  can be substantially coaxial or parallel. When actuator  306  is shifted to the proximal, disengaged, safe position, the catheter hub  110  can be disengaged from the retainer  302  and the collar  304  by angular rotation of the catheter hub  110  relative to the needle assembly  103 , such that the longitudinal axis of the catheter hub  110  is not aligned with the longitudinal axis of the needle assembly  103 . 
     The term “passive release mechanism,” as used herein, is understood to refer to features of a catheter insertion device  102  that inhibit the release of a catheter assembly  100  until after the catheter insertion device  102  is in the safe position. Some or all of the features of the passive release mechanism  298  can be integral with other components of the catheter insertion device  102 . In this respect, the term “passive release mechanism” does not necessarily refer to a component that is separate from the needle assembly  103  and/or needle housing  105 . Rather, it is to be appreciated that the passive release mechanism  298 , the needle assembly  103 , and/or needle housing  105  can comprise the passive release mechanism  298 . 
     II. Catheter Assembly 
     Catheter assembly  100  generally includes a catheter tube  108  and a catheter hub  110 . As depicted in  FIG. 2A-G , in one embodiment, the catheter assembly  100  can optionally include a wing assembly  112 , an extension tube  114 , an extension tube clamp  116 , a needleless connector  118 , and a vent cap  120 . Accordingly, catheter assembly  100  can be a closed system catheter configured to inhibit blood from escaping after withdrawal of the needle  104 , thereby reducing the risk of exposure of blood or other bodily fluids to clinicians, particularly a consideration of sensitivity where blood-borne diseases may be present. Additionally, embodiments of catheter assembly  100  can inhibit the introduction of unwanted contaminants into the interior of catheter assembly  100  prior to the connection to an IV fluid supply. 
     A. Catheter Tube, Hub and Wings 
     Referring to  FIGS. 10A-B  the catheter tube  108  and catheter hub  110  are depicted in accordance with an embodiment of the disclosure. Catheter tube  108  can extend from a distal end  124  to a proximal end  126 , where the catheter tube  108  can be operably coupled to the catheter hub  110 . The catheter tube  108  can define a lumen  128  configured to provide a fluid pathway between the vein of a subject and the catheter hub  110 . In one embodiment, the catheter tube  108  can include a barium radio opaque line  129  to ease in the identification of the catheter tube  108  during radiology procedures. 
     Catheter hub  110  can include a catheter hub body  130 , a septum  132  and a septum retainer  134 . Catheter hub body  130  can have a distal end  136 , a proximal end  138  and an internal wall  140  defining a first internal fluid passageway  142  therebetween. In one embodiment, the distal end  136  of the catheter hub body  130  is operably coupled to the proximal end  126  of the catheter tube  108 , such that the lumen  128  of the catheter tube  108  is in fluid communication with the first internal fluid passageway  142 . In one embodiment, the internal wall  140  further defines a transitional step  144  within the first internal fluid passageway  142  between a smaller diameter portion  146  of the first internal fluid passageway  142  proximal to the distal end  136 , and a larger diameter portion  148  of the first internal fluid passageway  142  distal to the proximal end  138 . 
     In one embodiment, the internal wall  140  further defines a side port  150 . In one embodiment, the side port  150  is in fluid communication with the first internal fluid passageway  142 . In one embodiment, the side port  150  extends away from the first internal fluid passageway  142  and at an oblique angle to the lumen  128  of the catheter tube  108 . Side port  150  can provide a connection point to one or more lengths of extension tube  114 , so that the inside of the extension tube  114  is in fluid communication with the first internal fluid passageway  142 . In one embodiment, the internal wall can further include an extension tube connection point  152 . 
     Septum  132  can have a distal end  154 , a proximal end  156  and an outer perimeter  158 . Septum  132  can be self-sealing, so that when the needle  104  is withdrawn through the septum  132 , any void left by the withdrawn needle  104  will close to provide a seal, and the septum  132  will maintain its fluid impermeability. In one embodiment, the septum  132  is positioned partially within the first internal fluid passageway  142 , such that the distal end  154  of the septum  132  abuts up against the transitional step  144 , thereby inhibiting forward movement of the septum  132  within the first internal fluid passageway  142 . Septum  132  can be constrained about its outer perimeter  158  by the internal wall  140  of the catheter hub body  130 . Rearward movement of the septum  132  can be restricted or inhibited by the septum retainer  134 . 
     In one embodiment, the shape of the first internal fluid passageway  142  is configured to promote a more even flow of fluid throughout the first internal fluid passageway  142  to improve flushability of the catheter assembly  100 . For example, in one embodiment the first internal fluid passageway is shaped to reduce the occurrence of dead spaces or pockets, thereby reducing the areas where microbial growth is more likely to occur. In one embodiment, the angles of the internal wall  140  of the first internal fluid passageway  142  can be chamfered or filleted to reduce the dead spaces or pockets that may otherwise exist in the interior corners of the internal fluid passageway  142 . Additionally, in one embodiment, the septum  132  can be positioned in close proximity to the side port  150  to reduce the dead spaces or pockets and proximal portions of the first internal fluid passageway  142 . 
     Septum retainer  134  can be configured to secure the septum  132  in position within the first internal fluid passageway  140 . In one embodiment, the septum retainer  134  can have a distal end  160 , a proximal end  162 , an inner wall  164 , and an outer wall  166  therebetween. Septum retainer  134  can be at least partially or fully receivable within the first internal fluid passageway  140  of the catheter hub body  130 . In one embodiment, the proximal end  162  of the septum retainer  134  is flush with, or recessed with respect to the proximal end  138  of the catheter hub body  130  (as depicted in  FIGS. 10B and 12 ). In one embodiment, the inner wall  164  defines a second internal passageway  168  that can be used to accommodate an insertion needle  104  of the catheter insertion device  102 . In one embodiment, the outer wall  166  defines an aperture  170  configured to enable the needle  104  to pass therethrough. 
     Referring to  FIG. 11 , an exploded, perspective view of the catheter hub body  130  and a septum retainer  134  is depicted in accordance with an embodiment of the disclosure. Referring to  FIG. 12 , a perspective view of another embodiment of a septum retainer  134  is depicted in accordance with the disclosure. In one embodiment, the outer wall  166  is shaped and sized to interlock with the internal wall  140  of the catheter hub body  130 , thereby coupling the septum retainer  134  to the catheter hub body  130 . 
     Referring to  FIG. 13 , a partial view of an assembled catheter assembly  100  is depicted in accordance with an embodiment of the disclosure. Referring to  FIG. 14 , a partial, semitransparent view of an assembled catheter assembly  100  operably coupled to a catheter insertion device  102  is depicted in accordance with an embodiment of the disclosure. In one embodiment, the septum retainer  134  is snap fit into the catheter hub body  130 , without the use of adhesives or ultrasonic welding to couple the septum retainer  134  to the catheter hub body  130 . To facilitate a snap fit, in one embodiment, a circumferential retainer ridge  172  can be formed into a portion of the outer wall  166 , such that the outer wall  166  and the circumferential retainer ridge  172  are shaped and sized to interlock with the internal wall  140  of the catheter hub body  130 . In some embodiments, the internal wall  140  of the catheter hub body  130  can include a circumferential channel  174 , configured to receive the circumferential retainer ridge  172  (depicted in  FIGS. 10B and 14 ). 
     In one embodiment, the septum retainer  134  can include a plurality of lateral ribs  176  positioned on the outer wall  166 . Lateral ribs  176  can be configured to provide friction between the septum retainer  134  and the catheter hub body  130 , so as to inhibit the septum retainer  134  from rotating relative to the catheter hub body  130  when the septum retainer  134  is assembled with the catheter hub body  130 . In one embodiment, the internal wall  140  of the catheter hub body  130  can be configured to at least partially receive a portion of the plurality of lateral ribs  176 . 
     Referring to  FIG. 15 , an end view of the proximal end  162  of septum retainer  134  is depicted in accordance with an embodiment of the disclosure. In one embodiment, the septum retainer  134  can include one or more lateral nubs  177  positioned on the interior wall  164 . For example, in one embodiment, three lateral nubs  177  can be positioned on the interior wall  164  and can be configured to protrude inwardly from the interior wall  164  toward the second internal fluid passageway  168 . 
     Referring to  FIG. 16 , a partial, semitransparent view of a septum retainer  134  and septum  132  operably coupled to a catheter insertion device  102  is depicted in accordance with an embodiment of the disclosure. Referring to  FIG. 17 , a partial, cross-sectional view of a septum retainer  134  and a septum  132  operably coupled to a catheter insertion device  102  is depicted in accordance with an embodiment of the disclosure. In one embodiment, lateral nubs  177  can be configured to provide friction between the septum retainer  134  and the nose  308  of the passive release mechanism  298 , so as to inhibit the septum retainer  134 , and the catheter hub  110  generally, from rotating relative to the catheter insertion device  102  when the catheter assembly  100  is coupled to the catheter insertion device  102 . 
     In one embodiment, the friction provided by the lateral ribs  176  is greater than the friction provided by the lateral nubs  177 , such that when a rotational force is applied, the septum retainer  134  will rotate relative to the catheter insertion device  102  before the septum retainer  134  will rotate relative to the catheter hub body  130 . 
     In one embodiment, the proximal end  138  of the catheter hub body  130  can include a lug  139 . Lug  139  can be configured to orient the catheter hub  110  relative to the catheter insertion device  102 , such that the catheter hub  110  can be captured by the passive release mechanism  298 . For example, in one embodiment, lug  139  can be configured as a portion of the Luer lock connection. 
     In one embodiment, the catheter hub body  130  can include one or more ledges  178  configured to provide structural reinforcement as support for a wing assembly  112 . In one embodiment, the ledges  178  can define one or more holes  180 . The holes  180  can provide improved contact with the wing assembly  112 , when the wing assembly  112  is integrally molded onto a portion of the catheter hub body  130 . Accordingly, the ledges  178  can serve to both increase the bonding surface between the catheter hub  110  and the wing assembly  112 , as well as to serve as a partial structural reinforcement for the wing assembly  112 , while at the same time enabling the wing assembly  112  to maintain its flexibility. 
       FIGS. 18A-C  depict partial views of the intravenous catheter assembly  100  having a wing assembly  112  in accordance with an embodiment of the disclosure. In one embodiment, the wing assembly  112  can include one or more flexible wings  181 A/B, a heel portion  182  and a collar  183 . The one or more wings  181 A/B can generally extend outwardly from a central axis of the catheter tube  108 /catheter hub  110 , so as to provide an adequate gripping surface for a clinician, as well as an extended surface for aid in securing the catheter hub  110  in place on the patient. The one or more wings  181 A/B can have a front edge or distal portion  185  and a rear edge or proximal portion  187 . In one embodiment, the distal portion  185  of the wings  181  can form a substantially straight line, extending substantially orthogonal to the axis of the catheter tube  108 /catheter hub  110  for improved contact with the skin of the patient. In another embodiment the distal portion  185  of the wings  181  can be concave, so as to form a slight arc, such that the distal edge of the wings  181  extends distally farther than the distal portion of the pair of wings proximal to the catheter tube  108 . In one embodiment, a top surface of the wings  181  can define a concave surface configured to aid a clinician in gripping the catheter hub  110   
     The heel portion  182  can extend from the proximal portion  187  of the wings  181  towards the proximal end  138  of the catheter hub  110 . In one embodiment, the heel portion  182  can be a wedge shaped structure configured to support a proximal portion of the catheter hub  110  proximal to the one or more wings  181 . 
     The collar  183  can at least partially wrap around a central axis of the catheter hub  110 . For example, in one embodiment, the wing assembly  112  can be integrally molded onto the catheter hub  110 , such that the collar at least partially wraps around a proximal portion of the catheter hub  110 . In one embodiment, wing assembly  112  can be integrally molded over the one or more ledges  178 , with one or more holes  180  defined therein, such that the one or more ledges  187  provide structural reinforcement and support for the wing assembly  112 . 
     As best depicted in  FIG. 18C , the bottom surface of the wings  181  and a bottom surface of the heel portion  182  can form a contiguous surface  184 . In one embodiment, the contiguous surface  184  can be angled relative to the catheter tube  108 , such that the catheter tube  108  can remain in a substantially straight line configuration, without a significant bend or hinge point when the catheter tube  108  is inserted into a patient and the wings  181  are secured to the patient&#39;s skin. Sloped contiguous surface  184  enables the wings  181  to be substantially parallel to the skin of the patient, thereby increasing the surface contact between the one or more wings  181  and the patient&#39;s skin. In one embodiment, the contiguous surface  184  is angularly offset from the axis of the catheter tube  108  by an angle that ranges between seven and nine degrees. In one embodiment, the contiguous surface  184  is offset from the axis of the catheter tube  108  by approximately eight degrees. 
     For the purpose of conforming to the skin of the patient, the wing assembly  112  can have a lower modulus of elasticity the catheter hub  110 , thereby enabling the wing assembly  112  to more easily twist and bend to conform to the contours of the skin of the patient. In one embodiment, the contiguous surface  184  can include a textured pattern, such as a tread, to increase the frictional resistance with the skin of the patient (as best depicted in  FIG. 2C ). For example, in one embodiment, the contiguous surface  184  can include a plurality of grooves positioned substantially orthogonal to the longitudinal axis of the catheter tube  108  to inhibit the catheter hub  110  from sliding proximally during use. In one embodiment, the contiguous surface  184  can include a plurality of grooves positioned substantially parallel to the longitudinal axis of the catheter tube  108  to inhibit the catheter hub  110  from sliding side to side during use. In one embodiment, the substantially orthogonal grooves can be positioned on the one or more wings  181  and the substantially parallel grooves can be positioned on the heel portion  182 . In one embodiment, the textured pattern can aid in preventing perspiration build up, which can occur with a flat or smooth surface. In one embodiment, the textured pattern inhibits the creation of high-pressure areas that may cause discomfort. 
     B. Septum 
     One purpose of the septum  132  is to inhibit fluid from passing from the first internal fluid passageway  142  to the second internal fluid passageway  168 , or vice versa, in two different configurations. First, the septum  132  can be configured to inhibit fluid passage during catheter assembly  100  insertion and/or when the needle  104  extends through the septum  132 . In particular, in some embodiments, a resilient design of the septum  132  can inhibit the septum  132  from retaining a “set” or memory of the opening caused by the needle  104  passing therethrough over the course of the often three or more years that the intravenous catheter assembly  100  may remain in storage prior to use. 
     Second, the septum  132  can be configured to provide a fluid tight seal under pressure injection, in which the injected medicament can be pressurized to 300 psi or greater, up to 325 psi or greater, or up 350 psi or greater, according to various example embodiments. Septum  132  can also maintain a fluid tight seal under increased flow rates, in which the injected medicament can be administered at up to a rate of 3 mL per second or up to 5 mL per second, according to various example embodiments. 
     Additionally, while the septum  132  can be configured to provide good sealing properties to inhibit fluid from passing from the first internal fluid passageway  142  to the second internal fluid passageway  168 , it can also enable the needle  104  to be retracted without undue resistance, or “drag” force between the interaction of the needle  104  and the septum  132  as the needle  104  is retracted. Accordingly, septum  132  can create a balance between good sealing properties and the reduction of frictional drag on the needle  104  as it is retracted into the safe position. 
     In one embodiment, the septum  132  is sized to fit within the first internal fluid passageway  142  to create a fluid tight seal with the internal wall  140  to inhibit fluid within the lumen  128  or the first internal fluid passageway  142  from escaping through the proximal end  138  of the catheter hub body  130 . In one embodiment, the septum  132  is constructed of a flexible, fluid impermeable material. For example, the septum  132  can be constructed of silicone, isoprene, or other flexible materials. The septum  132  may be radially compressed within the catheter hub body  130  to promote a seal with the catheter hub body  130  and/or the insertion needle  104  when present in the septum  132 . According to some embodiments, the septum is compressed up to 10% by volume, up to 15% by volume, up to 20% by volume, or even greater. 
     Referring to  FIGS. 19A-B , septum  126 B can have an internal surface  216  defining a slit  218  passing from the distal end  154  to the proximal end  156 . In one embodiment, the slit  218  can be configured to enable an insertion needle to pass therethrough. Referring to  FIG. 20 , an end view of a septum  126 B having a needle  104  passing through slit  218  is depicted in accordance with an embodiment of the disclosure. 
     During catheter insertion, needle  104  slides relative to the septum  126 B through slit  218 . The configuration of the slit  218  generally provides a reduced amount of frictional resistance or drag force in comparison to conventional septum designs. The reduction in drag force is due in part to the “cat&#39;s-eye” shape formed by the slit  218  when the needle passes therethrough. The width and/or configuration of the slit  218  can affect the degree to which the cat&#39;s-eye shape is formed. 
     Referring to  FIGS. 16A-B , septum  126 C can have an internal surface  216  defining an aperture  220  passing from the distal end  154  to the proximal end  156 . In one embodiment, the aperture  220  can be configured to enable an insertion needle  104  to pass therethrough. The configuration of the aperture  220  generally provides good sealing properties in comparison to conventional septum designs. 
     Referring to  FIGS. 22A-B , septum  126 D can have an internal surface  216  defining an aperture  220  originating at the distal end  154  and passing through a first thickness  222 , and a slit  218  originating at the termination of the aperture  224  and passing through the proximal end  156 , thereby passing through a second thickness  226 . In one embodiment, the aperture  220  and slit  218  are together configured to enable the needle  104  to pass therethrough. In one embodiment, a portion of slit  218  proximal to aperture  220  can be tapered towards aperture  220 . Accordingly, this embodiment complements the reduced drag force of the slit  218  with the good sealing properties of the aperture  220 . 
     Referring to  FIGS. 23A-26B , septum  126 E-H can include a first septum portion  228 A-D having a distal end  230  and a proximal end  232 , and a second septum portion  234 A-D having a distal end  236  and a proximal end  238 , wherein the proximal end  232  of the first septum portion  228 A-D is operably coupled to the distal end  236  of the second septum portion  234 A-D. 
     Referring to  FIGS. 23A-24B , first septum portion  228 A-B can have an internal surface  240  defining an aperture  220  passing from the distal end  230  to the proximal end  232 . Second septum portion  234 A-B can have an internal surface  242  defining a slit  218  passing from the distal end  236  to the proximal end  238 . In some embodiments, the slit  218  can pass entirely through second septum portion  234 A-B to the outer perimeter  158 . The aperture  220  and slit  218  together are configured to enable an insertion needle to pass therethrough. In other embodiments, the slit  218  can be smaller, such that it does not extend to the outer perimeter  158 . For example, the length of the slit can be 0.040 inches, 0.060 inches, or 0.080 inches. 
     Referring to  FIGS. 25A-B , the thickness  244  of the first septum portion  228 C can be greater than the thickness  246  of the second septum portion  234 C. In other embodiments, the thickness  244  of the first septum portion  228 C can be less than, or substantially equal to the thickness  246  of the second septum portion  234 C. In one embodiment, the first septum portion  228 C can have an internal surface  240  defining an aperture  220  passing from the distal end  230  to the proximal end  232 . Second septum portion  234 C can have an internal surface  240  defining a plurality of slits  248  passing from the distal end  236  to the proximal end  238 . For example, as depicted, in one embodiment, the plurality of slits  248  can be in a tri-slit configuration. In one embodiment, the aperture  220  and plurality of slits  248  together are configured to enable an insertion needle to pass therethrough. Additionally, in some embodiments, the first septum portion  228  and/or the second septum portion  234  can have a larger diameter than the inside of the catheter hub body  130 , such that the septum portion  228 ,  234  can be circumferentially compressed within the catheter hub body  130 . 
     Referring to  FIGS. 26A-B , first septum portion  228 D can have an internal surface  240  defining a large diameter aperture  250  passing from the distal end  230  to the proximal end  232 . Second septum portion  234 D can have an internal surface  242  defining an aperture  220  passing from the distal end  236  to the proximal end  238 . In one embodiment, the aperture  220  and aperture  250  together are configured to enable an insertion needle to pass therethrough. In one embodiment, the aperture  250  can be slightly smaller than the diameter of the needle  104  that passes therethrough. 
     C. Extension Tube and Clamp 
     Referring to  FIGS. 2A-G , an extension tube  114  and an optional extension tube clamp  116  are depicted in accordance with an embodiment of the disclosure. In one embodiment, the extension tube  114  can be substantially transparent or translucent to enable the observation of fluid within the extension tube  114 . In one embodiment, the optional extension tube clamp  116  can be constructed of a resilient material that can be deformed to selectively occlude the extension tube  114  to restrict the passage of fluid. 
     D. Needleless Connector 
     Referring to  FIGS. 27A-C , a needleless connector  118  is depicted in accordance with an embodiment of the disclosure. In one embodiment, the needleless connector  118  is configured to connect the extension tube  114  to a connector of an IV fluid supply line, as partially shown in  FIG. 27C . In particular, the needleless connector  118  can be biased to a closed or sealed position (as depicted in  FIG. 27B ). Connection of the needleless connector  118  to an IV fluid supply  186  can cause the needleless connector  118  to shift to the open position (as depicted in  FIG. 27C ). Upon disconnection of the needleless connector  118  from the IV fluid supply  186 , the needleless connector  118  can be biased back to the closed or sealed position. 
     In one embodiment, the needleless connector  118  includes a Luer lock connector  119  for connection to an IV fluid supply  186 . For example, needleless connector  118  can be a connector described in U.S. Pat. No. 7,713,248 (depicting a needle-free connector marketed by ICU Medical, Inc. under the CLAVE trademark), which is hereby incorporated by reference. 
     In one embodiment, the needleless connector  118  is comprised of a conical internal conduit  188  with one or more fluid path windows  190 , a flexible compression seal  192  capable of selectively covering the internal conduit  188 , and a housing  194  substantially surrounding the internal conduit  188  and the compression seal  192 . The exterior of housing  194  can have a substantially smooth surface, in which crevices are minimized to promote ease in having a surface that is readily swabbed or cleaned to prevent the growth and/or presence of microbes. The interior of housing  194  can be configured to promote a more even flow of fluid to improve flushability of the needleless connector  118 . In one embodiment, the interior of housing  194  can be shaped to reduce the occurrence of dead spaces or pockets, thereby reducing the areas where microbial growth is likely to occur. 
     Needleless connector  118  can prevent the escape of bodily fluid and/or guard against contamination of the fluid path. As depicted in  FIG. 27B , in the closed or sealed position, the compression seal  192  extends over the fluid path windows  190  of internal conduit  188 , thereby creating a fluid seal to prevent fluid from escaping from the extension tube  114 . Conversely, as depicted in  FIG. 27C , when an IV fluid supply connector  186  is inserted into the housing  194 , the compression seal  192  is shifted to an open position, thereby exposing the fluid path windows  190  to the fluid path of the IV fluid supply connector  186 . Accordingly, the needleless connector  118  selectively enables the flow of fluid through the extension tube  114 , while both sealing the intravenous catheter assembly  100  from the ambient environment and inhibiting the escape of bodily fluid from a patient when the IV fluid supply connector  186  is not attached. 
     Needleless connector  118  thus enables the intravenous catheter assembly  100  to act as a closed system when not connected to either the catheter insertion device  102  or an IV fluid supply connector  186 . That is the needleless connector  118 , in combination with various embodiments of the vent cap described herein, prevent blood from escaping from the intravenous catheter assembly  100  until an IV fluid supply  186  (or other similar type device) is connected. Additionally, the interior portions of the needleless connector  118  and the extension tube  114  are protected from exposure to the ambient environment. By contrast, many conventional designs (such as that depicted in  FIGS. 1A-B ) employ only a Luer lock connector  68 . Accordingly, prior to connecting the catheter  52  to an IV fluid supply, a clamp  66  designed to crimp the extension tube  64  is engaged to prevent blood from flowing freely from the patient when the needle assembly  50  is removed. Moreover, the interior of the extension tube  64  between the clamp  66  and the Luer lock connector  68  is exposed to the ambient environment prior to connection to an IV fluid supply. 
     Referring to  FIG. 28 , an intravenous catheter assembly  100  having a first needleless connector  118 A and a second needleless connector  118 B is depicted in accordance with an embodiment of the disclosure. In other embodiments, the intravenous catheter assembly  100  can include more than two needleless connectors. Needleless connectors  118 A/B can be operably coupled to extension tube  114  by a “Y” coupling  115 . In one embodiment, coupling  115  is fixedly coupled to the extension tube  114  at one end, and includes one or more portions of a Luer lock connection at the other ends for respective coupling to needleless connectors  118 A/B. 
     E. The Vent Cap 
     Referring to  FIGS. 29A-C , various views of a vent cap  120  are depicted in accordance with n embodiment of the disclosure. One function of the vent cap  120  is to shift the needleless connector  118  from the closed or sealed position to the open position when an IV fluid supply  186  is not attached to the needleless connector  118  for the purpose of venting gas trapped within the intravenous catheter assembly  100  while preventing the escape of blood. In particular, under normal conditions bodily fluid from a patient in which the catheter tube  108  has been inserted can provide the necessary pressure to push the trapped gas through the vent cap  120 . In some embodiments, the vent cap  120  can be disposable after use. 
     Accordingly, during or after the catheter insertion procedure, blood or bodily fluid from a patient enters the catheter tube  108  and other portions of the intravenous catheter assembly  100 , thereby purging air from within the catheter assembly  100 , either through a gas porous barrier of the catheter insertion device  102  or the needleless connector  118 , when activated by the vent cap  120 . In some embodiments, the compression seal  192  can be shipped with a vent cap  120  assembled thereto in an activated or open position. However, it has been found that extended compression of the compression seal  192  of some needleless connector  118  embodiments can cause the compression seal  192  to permanently deform. Accordingly, some example embodiments are configured with a vent cap  120  that can be coupled to the needleless connector  118  in a first, initial position, where the vent cap  120  is retained by the needleless connector  118  with the needleless connector  118  in a closed or sealed position. In connection with the catheter insertion procedure, or shortly thereafter, the vent cap  120  can be moved or shifted to a second position to compress the compression seal  192 , thereby shifting the needleless connector  118  to the open position and enabling the purging of the air trapped therein. 
     In one embodiment, the vent cap  120  can include a nose  196 , a flash plug  198 , a push plate  202 , and one or more needleless connector engagement arms  204 . Nose  196  can be sized and shaped to fit within the housing  194  of the needleless connector  118  in place of the IV fluid supply connector  186 . In some embodiments, the nose  196  can be tapered. Nose  196  can include a vent path wall  206  defining a vent path  208 . The vent path  208  can have a diameter sufficient to receive the portion of internal conduit  188  that would otherwise extend into the IV supply connector, such that the fluid path windows  190  of the needleless connector  118  at least partially reside within the vent path  208 . A distal end  210  of the nose  196  can be in abutting contact with the compression seal  192  and can provide a fluidic seal therebetween. 
     Referring to  FIGS. 30A-B , the vent cap  120  can be assembled to a needleless connector and movable or shiftable between a first, storage position (as depicted in  FIG. 30A ), in which the compression seal  192  of the needleless connector  118  is in an uncompressed state, thereby inhibiting fluid from passing through the vent path  208 , and a second, actively depressed position (as depicted in  FIG. 30B ), in which the compression seal  192  of the needleless connector  118  is in a compressed state, thereby permitting fluid to pass through vent path  208 . 
     Air permeable barrier  198  can be positioned within a portion of the vent path  208 . Air permeable barrier  198  can be comprised of an air permeable matrix that enables air or gas to vent as blood or bodily fluid fills the vent path  208 , but inhibits the blood or bodily fluid from passing entirely through the vent path  208 . In some embodiments, the vent cap  120  can be constructed of a transparent or translucent material. During the venting of air, blood or other bodily fluid can fill a portion of the vent path  208 , thereby providing a visual confirmation to the clinician that the catheter tube  108  has been inserted into a patient&#39;s vein. Such visual confirmation can be referred to as secondary or tertiary flashback, wherein a primary and/or secondary flashback occurs in one or more flashback indicators associated with the catheter insertion device  102 . For example, in one embodiment, upon insertion of the needle  104  into the vein of the patient, a clinician may initially see flashback as blood flow passes through the notch  276  and into the annular space that lies between the exterior of the needle  104  and the interior of the catheter tube  108 . A secondary flashback indication may be present when blood from the patient flows proximally through the lumen of the needle  104  and into the flashback chamber  272 . A tertiary flashback indication may be present when blood flows through the catheter tube  108 , extension tube  114 , needleless connector  118 , and into vent path  208 . The time differential between the initial, secondary and tertiary flashbacks may enable a clinician to confirm that the needle has not extended beyond the subject&#39;s vasculature, as may be associated with infiltration/extravasation. 
     Nose  196  can terminate in a push plate  202 . Push plate  202  can include a flange  212  configured to provide a surface area for a clinician to push on as the vent cap  120  is manually shifted between the first, storage position and the second, actively depressed position. In one embodiment, a portion of the vent path wall  206  can further define an eyelet  214 . Eyelet  214  can be configured to provide a fluid path for venting air between the vent path  208  and an exterior of the vent path wall  206 . In particular, eyelet  214  can provide a path for escaping air in the event that the clinician seals the end of the vent path  208  with their finger as the vent cap  120  is shifted to the second, actively depressed position. In one embodiment, portions of the vent cap  120  can include a mechanism configured to provide an audible click and/or tactile feedback when the vent cap  120  has been shifted to the second, actively depressed position. 
     The one or more needleless connector engagement arms  204  can be configured to grip a portion of the needleless connector  118 . In one embodiment, one or more needleless connector engagement arms  204  can include a ridge  203  to improve a grip of the one or more needleless connector engagement arms to the needleless connector  118 . In some embodiments, the needleless connector engagement arms  204  can be constructed of a resilient material, such that the needleless connector engagement arms  204  tend to regain their original shape after temporary deformation. In some embodiments, the resiliency of the needleless connector arms  204  enables the vent cap  122  to be biased to the first, storage position when coupled to the needleless connector  118 . In some embodiments, the outer surface of the housing  194  of the needleless connector  118  can be tapered to increase in diameter, such that when the vent cap  120  is shifted to the second, actively depressed position, the needleless connector engagement arms  204  are deflected away from one another. When the clinician releases the vent cap  20 , the resiliency of the needleless connector engagement arms  204  can bias the vent cap  120  back to the first, storage position. Accordingly, biasing the vent cap  122  to the first, storage position reduces the likelihood that the compression seal  192  of the needleless connector  118  will permanently deform, as can occur when the compression seal  192  is compressed for long periods of time, according to some embodiments. 
     F. Operation 
     In operation, placement of intravenous catheter assembly  100  generally includes preparation of the biological site of the patient. Often a tourniquet is applied proximal to the biological site and a variety of techniques can be used to dilate the patient&#39;s vein. While wearing disposable gloves, the clinician cleanses the biological site and a vein is retracted or anchored by placing a thumb over the vein about fifty to seventy-five mm distal to the site. 
     Referring to  FIG. 31A , the needle  104  and catheter tube  108  are introduced into the vein by inserting the bevel of the sharp needle tip  106  into the vein at about a twenty to thirty degree angle with the bevel facing up in order to pierce one wall of the vein. In some embodiments, during this process the clinician grips the catheter insertion device  102  for optimum control. If successful, blood from the vein flows through the lumen of the needle  104 , thereby providing a positive indication of vein entry through one or more flashback mechanisms. 
     Referring to  FIG. 31B , to finish placement, the intravenous catheter assembly  100  is lowered towards the skin to decrease the entry angle, and the catheter tube  108  is advanced slightly into the vein. The needle  104  is loosened and the catheter tube  108  is gently advanced farther up into the vein until the catheter hub  110  is against the biological site. 
     Referring to  FIG. 31C , the tourniquet is loosened and the needle  104  is withdrawn from the catheter tube  108 . As the needle  104  is withdrawn, the sharp needle tip  106  is withdrawn through catheter tube lumen  128  and the septum  132 . As the sharp needle tip  106  passes through the septum  132 , the self-sealing nature of the septum  132  closes any void left by the needle  104  to create a fluid tight barrier. As the needle  104  is further withdrawn, the needle transition  266  shifts the actuator  306  of the passive release mechanism  298  proximally, thereby enabling release of the catheter assembly  100  from the catheter insertion device  102 . 
     The clinician can then secure the catheter assembly  100  in place by securing the catheter hub  110  and/or wing assembly  112  to the biological site by gauze and adhesive tape. The air or gaseous fluid trapped within the catheter assembly  100  can be vented by moving the vent cap  120  from the first, storage position to the second actively depressed position, thereby both evacuating the air within intravenous catheter assembly  100 , as well as providing a positive indication of placement of the catheter tube  108  in the patient&#39;s vein through a flashback mechanism. 
     Needleless connector  118  can then be connected to an IV fluid supply  186  configured to supply medicament to a patient, or withdraw fluid from the patient. Extension tube clamp  116  can be manipulated as desired to open and close the fluid path of extension tube  114 . 
     Referring to  FIG. 31D , when appropriate to remove the catheter assembly  100 , the clinician can remove the gauze and/or adhesive tape securing the catheter hub  110  and/or wing assembly  112  to the biological site of the patient. The catheter assembly  100  can then be gently extracted by pulling on the assembly in the direction indicated by the arrow of  FIG. 31D . 
     It should be understood that the individual steps used in the methods of the present teachings may be performed in any order and/or simultaneously, as long as the teaching remains operable. Furthermore, it should be understood that the apparatus and methods of the present teachings can include any number, or all, of the described embodiments, as long as the teaching remains operable. 
     Various example intravenous catheter assembly  100  embodiments are described herein for use in accessing the vein of the subject. It is to be appreciated, however, that the example embodiments described herein can alternatively be used to access the vasculature of a subject in locations other than the vein, including but not limited to the artery of the subject. It is additionally to be appreciated that the term “clinician” refers to any individual that can perform a catheter insertion procedure with any of the example embodiments described herein or combinations thereof. Similarly, the term “subject,” as used herein, is to be understood to refer to an individual or object in which a catheter is to be inserted, whether human, animal, or inanimate. Various descriptions are made herein, for the sake of convenience, with respect to procedures being performed by a clinician to access the vein of the subject, while the disclosure is not limited in this respect. 
     Persons of ordinary skill in the relevant arts will recognize that embodiments may comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, embodiments can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art. Moreover, elements described with respect to one embodiment can be implemented in other embodiments even when not described in such embodiments unless otherwise noted. Although a dependent claim may refer in the claims to a specific combination with one or more other claims, other embodiments can also include a combination of the dependent claim with the subject matter of each other dependent claim or a combination of one or more features with other dependent or independent claims. Such combinations are proposed herein unless it is stated that a specific combination is not intended. Furthermore, it is intended also to include features of a claim in any other independent claim even if this claim is not directly made dependent to the independent claim. 
     Moreover, reference in the specification to “one embodiment,” “an embodiment,” or “some embodiments” means that a particular feature, structure, or characteristic, described in connection with the embodiment, is included in at least one embodiment of the teaching. The appearances of the phrase “in one embodiment” in various places in the specification are not necessarily all referring to the same embodiment. 
     Any incorporation by reference of documents above is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. Any incorporation by reference of documents above is further limited such that no claims included in the documents are incorporated by reference herein. Any incorporation by reference of documents above is yet further limited such that any definitions provided in the documents are not incorporated by reference herein unless expressly included herein. 
     For purposes of interpreting the claims, it is expressly intended that the provisions of Section 112, sixth paragraph of 35 U.S.C. are not to be invoked unless the specific terms “means for” or “step for” are recited in a claim.