Patent Publication Number: US-2023149667-A1

Title: Splittable Needle for Catheter Placement System

Description:
PRIORITY 
     This application claims the benefit of priority to U.S. Provisional Application No. 63/281,008, filed Nov. 18, 2021, which is incorporated by reference in its entirety into this application. 
    
    
     BACKGROUND 
     Central venous catheter (“CVCs”) are commonly introduced into patients and advanced through their vasculatures by way of the Seldinger technique. The Seldinger technique utilizes a number of steps and medical devices (e.g., a needle, a scalpel, a guidewire, an introducer sheath, a dilator, a CVC, etc.). While the Seldinger technique is effective, the number of steps are time consuming, handling the number of medical devices is awkward, and both of the foregoing can lead to patient trauma or increased risk of infection. There is a relatively high potential for touch contamination due to the number of medical devices that need to be interchanged during the Seldinger technique. As such, advanced catheter placement systems have been developed to reduce the number of steps and medical devices involved in placing a catheter, such as a CVC, into a patient. 
     Some of these advanced catheter placement systems include accessing a vasculature with a needle and stabilizing the access site with a guidewire. Preferably, a distal portion of the guidewire is disposed within a lumen of the needle and is advanced concurrently. As such, the guidewire is already in place once the vasculature is accessed, expediting the process. Further, a proximal portion of the guidewire can include a catheter disposed thereon (termed “preloaded”) to further expedite advancing the catheter over the guidewire and into the vasculature. Problems can arise however with how to remove the needle safely without dislodging a distal tip of the guidewire and without removing the catheter from a proximal portion of the guidewire Disclosed herein are advanced catheter placement systems and associated methods for removing the needle from the access site without disturbing the position of the guidewire. 
     SUMMARY 
     Disclosed herein is a catheter placement system including, a needle defining a needle lumen, a guidewire extending through a portion of the needle lumen, a housing defining a needle channel and having a portion of the needle slidably engaged therewith, and a splitter system disposed within the housing and configured to split the needle longitudinally as the needle is withdrawn proximally through the needle channel. 
     In some embodiments, the needle is supported at a proximal end by one or both of a needle hub and a syringe system, the syringe system configured to draw a fluid flow proximally through the needle lumen. 
     In some embodiments, the housing further includes a guidewire channel communicating with the needle channel, the guidewire channel aligned with an aperture disposed in a wall of the needle and communicating with the needle lumen, a portion of the guidewire extending through the guidewire channel, through the aperture and into the needle lumen. 
     In some embodiments, the splitter system includes a wedge disposed distally of the aperture and configured to split the needle along a longitudinal axis. 
     In some embodiments, the needle further includes a tear line extending longitudinally and aligned with the splitter system, the tear line configured to facilitate separation of the needle therealong. 
     In some embodiments, the splitter system further includes a valve extending between an outer surface of the needle and an inner surface of the needle channel and configured to mitigate fluid leakage to or from the needle lumen, the splitter system configured to split the valve as the needle is withdrawn proximally. 
     In some embodiments, the catheter placement further includes a needle safety system having one or both of a first tape and a second tape configured to encapsulate one or both of a first portion and a second portion of the needle after the needle has been split by the splitter system. 
     In some embodiments, one or both of the first tape and the second tape are disposed within the housing in a rolled configuration and are configured to transition to an unrolled configuration as the needle is withdrawn proximally from the housing. 
     In some embodiments, wherein a top edge of the first tape is configured to adhere to a top edge of the second tape, and a bottom edge of the first tape is configured to adhere to a bottom edge of the second tape to encapsulate the first portion and the second portion of the needle therebetween. 
     In some embodiments, the first tape in the unrolled configuration is designed to encapsulate to the first portion of the needle, and the second tape in the unrolled configuration is designed to encapsulate the second portion of the needle. 
     In some embodiments, wherein a top edge of the first tape is configured to overlap a bottom edge of the first tape to encapsulate one or both of the first portion and the second portion of the needle. 
     In some embodiments, wherein the first tape is adhered to an inner surface of the first portion of the needle, a distal end of the first tape configured to fold outwards and adhere to an outer surface of the first portion, and wherein the second tape is adhered to an inner surface of the second portion of the needle, a distal end of the first tape configured to fold outwards and adhere to an outer surface of the second portion. 
     In some embodiments, wherein one or both of the first tape and the second tape include a first material, the first material including one or more of a plastic, polymer, metal, alloy, composite, KEVLAR®, or a puncture-resistant material. 
     In some embodiments, wherein one or both of the first tape and the second tape include a reinforcement portion. 
     In some embodiments, wherein the reinforcement portion includes one of a thickened portion or a second material different from the first material, the second material including one of a plastic, polymer, metal, alloy, composite, KEVLAR®, or a puncture-resistant material. 
     In some embodiments, the catheter placement further includes a catheter disposed on a proximal portion of the guidewire. 
     In some embodiments, the catheter includes a first section disposed distally and defining a first diameter, a second section disposed proximally and defining a second diameter, larger than the first diameter, and a transition section extending therebetween. 
     In some embodiments, the first section defines a single lumen and the second section defines two or more lumen. 
     Also disclosed is a method of encapsulating a needle of a catheter placement system including, accessing a vasculature of a patient with a needle, advancing a portion of a guidewire through a lumen of the needle, withdrawing the needle proximally through a channel of a housing, splitting the needle longitudinally into a first needle half and a second needle half, disengaging the guidewire from the needle by passing the portion of the guidewire longitudinally between the first needle half and the second needle half, and engaging one or both of the first needle half and the second needle half with one or both of a first adhesive tape and a second adhesive tape. 
     In some embodiments, the needle further includes a tear line extending longitudinally and configured to facilitate separating the needle longitudinally into the first needle half and the second needle half. 
     In some embodiments, the method further includes advancing the portion of the guidewire through an aperture extending through a side wall of the needle and communicating with the needle lumen. 
     In some embodiments, the method further includes withdrawing the needle over a splitter wedge to split the needle into the first needle half and the second needle half. 
     In some embodiments, the method further includes adhering a top edge of the first adhesive tape to a top edge of the second adhesive tape, and adhering a bottom edge of the first adhesive tape to a bottom edge of the second adhesive tape to encapsulate the first needle half and the second needle half between the first adhesive tape and the second adhesive tape. 
     In some embodiments, the method further includes adhering the first adhesive tape to the first needle half, a top edge of the first adhesive tape extending over a top edge of the first needle half to adhere to an inner surface thereof, and a bottom edge of the first adhesive tape extending over a bottom edge of the first needle half to adhere to an inner surface thereof. 
     In some embodiments, the method further includes adhering the second adhesive tape to the second needle half, a top edge of the second adhesive tape extending over a top edge of the second needle half to adhere to an inner surface thereof, and a bottom edge of the second adhesive tape extending over a bottom edge of the second needle half to adhere to an inner surface thereof. 
     In some embodiments, the method further includes adhering the first adhesive tape to one or both of the first needle half and the second needle half, a top edge of the first adhesive tape overlapping a bottom edge of the first adhesive tape. 
     In some embodiments, the method further includes adhering the first adhesive tape to an inner surface of the first needle half, and folding a distal portion of the first adhesive tape outwards to engage an outer surface of the first needle half, and adhering the second adhesive tape to an inner surface of the second needle half, and folding a distal portion of the second adhesive tape outwards to engage an outer surface of the second needle half. 
     In some embodiments, one or both of the first adhesive tape and the second adhesive tape include a first material, the first material including one or more of a plastic, polymer, metal, alloy, composite, KEVLAR®, or a puncture-resistant material. 
     In some embodiments, one or both of the first adhesive tape and the second adhesive tape include a reinforcement portion having one of a thickened portion or a second material different from the first material, the second material including one of a plastic, polymer, metal, alloy, composite, KEVLAR®, or a puncture-resistant material. 
    
    
     
       DRAWINGS 
       A more particular description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Example embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which: 
         FIG.  1 A  shows a perspective view of a catheter placement system in an unfolded configuration, in accordance with embodiments disclosed herein. 
         FIG.  1 B  shows a plan view of a catheter placement system in a folded configuration ready for use, in accordance with embodiments disclosed herein. 
         FIG.  1 C  shows a perspective view of a catheter placement system in a folded configuration, in accordance with embodiments disclosed herein. 
         FIG.  2    shows a side view of a catheter of a catheter placement system in an unfolded configuration, in accordance with embodiments disclosed herein. 
         FIG.  3 A  shows close up detail of a distal portion of the catheter of  FIG.  2   , in accordance with embodiments disclosed herein. 
         FIGS.  3 B- 3 C  show cross-section views of the catheter of  FIG.  3 A , in accordance with embodiments disclosed herein. 
         FIG.  4    shows a longitudinal cross-section view of a distal portion of a catheter placement system, in accordance with embodiments disclosed herein. 
         FIGS.  5 A- 5 E  show an exemplary method of use for a catheter placement system, in accordance with embodiments disclosed herein. 
         FIG.  6 A  shows a side cross-section view of a needle for a catheter placement system prior to needle removal, in accordance with embodiments disclosed herein. 
         FIG.  6 B  shows a plan cross-section view of a needle for a catheter placement system prior to needle removal, in accordance with embodiments disclosed herein. 
         FIG.  6 C  shows a plan cross-section view of a needle for a catheter placement system after needle removal, in accordance with embodiments disclosed herein. 
         FIG.  7 A  shows a perspective view of a needle and needle safety system for a catheter placement system, in accordance with embodiments disclosed herein. 
         FIG.  7 B  shows close up detail of a needle safety system, in accordance with embodiments disclosed herein. 
         FIG.  7 C  shows a perspective view of a needle disposed between a first tape and a second tape of a needle safety system, in accordance with embodiments disclosed herein. 
         FIG.  7 D  shows a side view of a needle encapsulated by a needle safety system, in accordance with embodiments disclosed herein. 
         FIGS.  8 A- 8 E  show lateral cross-section views of exemplary methods of use for a needle and needle safety system, in accordance with embodiments disclosed herein. 
         FIGS.  9 A- 9 B  show plan views of an exemplary method of use for a needle and needle safety system, in accordance with embodiments disclosed herein. 
         FIGS.  10 A- 10 B  show plan views of an exemplary method of use for a needle and needle safety system, in accordance with embodiments disclosed herein. 
         FIG.  10 C  shows a side view of a needle and needle safety system, in accordance with embodiments disclosed herein. 
     
    
    
     DESCRIPTION 
     Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein. 
     Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. 
     In the following description, the terms “or” and “and/or” as used herein are to be interpreted as inclusive or meaning any one or any combination. As an example, “A, B or C” or “A, B and/or C” mean “any of the following, A, B, C, A and B, A and C, B and C, A, B and C.” An exception to this definition will occur only when a combination of elements, components, functions, steps or acts are in some way inherently mutually exclusive. 
     With respect to “proximal,” a “proximal portion” or a “proximal end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near a clinician when the catheter is used on a patient. Likewise, a “proximal length” of, for example, the catheter includes a length of the catheter intended to be near the clinician when the catheter is used on the patient. A “proximal end” of, for example, the catheter includes an end of the catheter intended to be near the clinician when the catheter is used on the patient. The proximal portion, the proximal end portion, or the proximal length of the catheter can include the proximal end of the catheter; however, the proximal portion, the proximal end portion, or the proximal length of the catheter need not include the proximal end of the catheter. That is, unless context suggests otherwise, the proximal portion, the proximal end portion, or the proximal length of the catheter is not a terminal portion or terminal length of the catheter. 
     With respect to “distal,” a “distal portion” or a “distal end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near or in a patient when the catheter is used on the patient. Likewise, a “distal length” of, for example, the catheter includes a length of the catheter intended to be near or in the patient when the catheter is used on the patient. A “distal end” of, for example, the catheter includes an end of the catheter intended to be near or in the patient when the catheter is used on the patient. The distal portion, the distal end portion, or the distal length of the catheter can include the distal end of the catheter; however, the distal portion, the distal end portion, or the distal length of the catheter need not include the distal end of the catheter. That is, unless context suggests otherwise, the distal portion, the distal end portion, or the distal length of the catheter is not a terminal portion or terminal length of the catheter. 
     To assist in the description of embodiments described herein, as shown in  FIG.  1 A , a longitudinal axis extends substantially parallel to an axial length of the needle. A lateral axis extends normal to the longitudinal axis, and a transverse axis extends normal to both the longitudinal and lateral axes. 
     Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art. 
       FIGS.  1 A- 1 C  show an exemplary advanced catheter placement system (“system”)  100 , generally including a needle  120 , a guidewire  130 , a syringe system  140 , a catheter  150 , and a needle housing (“housing”)  170 .  FIG.  1 A  shows the system  100  in an unfolded configuration for ease of illustration.  FIG.  1 B  shows a plan view of the system  100  in a folded configuration ready for use.  FIG.  1 C  shows a perspective view the system  100  in a folded configuration. In an embodiment the catheter placement system  100  can be a Rapidly Insertable Central Catheter (RICC) placement system  100  configured to place a RICC  150 . However, it will be appreciated that other catheter placement systems configured to place other types of catheters are also contemplated. Exemplary catheters  150  can also include peripheral intravenous (PIV) catheters, peripherally inserted central catheter (PICC), central venous catheters (CVC), midline catheters, dialysis catheters, single lumen catheters, multi-lumen catheters, or the like. 
     In an embodiment, the catheter  150  can generally include a catheter body  152  supported at a proximal end by a catheter hub (“hub”)  160 . The hub  160  can include one or more extension legs  162  extending proximally therefrom. Each extension leg of the one or more extension legs  162  can be in fluid communication with a lumen of the catheter body  152 . The catheter body  152  can include a first section  154  disposed distally, a second section  156  disposed proximally, and a transition section  158  disposed therebetween. The first section  154  can define a single lumen and have a first outer diameter, the second section  156  can define two or more lumen and can have a second diameter larger than the first diameter. The transition section  158  disposed between the first section  154  and the second section  156  can define a tapered shape extending from the first diameter of the first section to the second diameter of the second section. A guidewire  130  can extend through a lumen of the catheter  150  from a proximal end of an extension leg  162 , to a distal tip of the first section  154 . 
       FIG.  2    shows further details of an exemplary catheter  150  of the system  100 . As described herein, different sections of the catheter  150  are required to perform different functions and as such are required to display different mechanical properties. For example, the first section  154  and the transition section  158  can provide more rigid mechanical properties or harder durometer material relative to the second section  156 . As such, the first section  154  and transition section  158  can withstand greater axial forces without kinking or collapsing, as these sections are urged distally, forming and dilating the insertion site. The second section  156  can be formed of a softer durometer, or a more compliant material to facilitate negotiating the second section  156  through tortuous vascular pathways. 
       FIGS.  3 A- 3 C  show further details of a distal portion of the catheter  150 , including the first section  154 , the second section  156 , and the transition section  158 . In an embodiment, the second section  156  can include a proximal lumen  114 A terminating at a proximal lumen aperture  116 A, and a medial lumen  114 B terminating at a medial lumen aperture  116 B. Each of the proximal lumen aperture  116 A and the medial lumen aperture  116 B can extend through a side wall of the second section  156 . Each of the proximal lumen aperture  116 A and the medial lumen aperture  116 B can be disposed proximally of the transition section  158 . The proximal lumen aperture  116 A can be disposed proximally of the medial lumen aperture  116 B. In an embodiment, the proximal lumen aperture  116 A and the medial lumen aperture  116 B can be disposed equidistant from the distal tip  118  of the catheter  150 . 
       FIG.  3 B  shows a cross section view of the catheter body  152  at point “A” of  FIG.  3 A . As shown, the first section  154  can define a single lumen and a relatively smaller outer diameter. In an embodiment, a proximal portion of the first section  154  can be received within a distal portion of the transition section  158 . A distal lumen  114 C of the catheter  150  can extend to a distal tip  118  of the catheter  150  and can communicate with a distal lumen aperture  116 C.  FIG.  3 C  shows a cross section view of the second section  156  at point “B” of  FIG.  3 A , showing the proximal lumen  114 A, medial lumen  114 B and distal lumen  114 C. 
       FIG.  4    shows a longitudinal cross-section view of a distal portion of a catheter placement system  100  including the needle  120 , guidewire  130 , a distal portion of the syringe system  140 , and a needle housing (“housing”)  170  including a needle splitter system  180 , as described in more detail herein. In an embodiment, a proximal end of the needle  120  can be supported by a needle hub which can be coupled to, and supported by, a distal end of the syringe system  140 . The syringe system  140  can be in fluid communication with the needle lumen  122 . The syringe system  140  can be configured to form a vacuum within the needle lumen  122  and draw a fluid flow proximally therethrough. In an embodiment, the needle  120  can include a guidewire aperture  124  disposed in a wall of the needle  120  and communicating with a needle lumen  122 . A distal portion of the guidewire  130  can extend through the guidewire aperture  124  and into the needle lumen  122 . In an embodiment, a distal tip  138  of the guidewire  130  can be disposed proximate a distal tip  128  of the needle  120 . As such, once the needle  120  accesses the vasculature, the distal tip  138  of the guidewire  130  can be positioned within the vasculature, expediting the placement of the catheter  150 . 
     In an embodiment, the catheter placement system  100  can include a housing  170 . The housing  170  can include a needle channel  172  extending between a proximal end  176  and a distal end  178  of the housing  170 . The housing  170  can further include a guidewire channel  174  communicating with the needle channel  172  and extending at an angle therefrom. A portion of the needle  120  can slidably engage the needle channel  172 . Further, the proximal end  176  of the housing can releasably engage one or both of a needle hub and a distal portion of the syringe system  140 . When the housing  170  is engaged with the syringe system  140  the guidewire aperture  124  of the needle  120  can align with the guidewire channel  174  of the housing  170 . As such, the guidewire  130  can extend through the guidewire channel  174  of the housing  170 , through the guidewire aperture  124  of the needle  120  and into the needle lumen  122 . 
       FIGS.  5 A- 5 E  show an exemplary method of placing a catheter  150  using the catheter placement system  100 . As shown in  FIG.  5 A , the needle  120  can penetrate surface tissues  90  of the patient and access a vasculature  80 , forming an insertion site. As shown in  FIG.  5 B , a syringe system  140 , or similar device can form a vacuum and draw a fluid flow proximally through a needle lumen  122 . A user can observe a color or pulsatile flow and confirm correct vascular access. Where incorrect vascular access is confirmed, the needle  120  can be withdrawn and the insertion site can be closed. As shown in  FIG.  5 C , once correct vascular access has been confirmed, the guidewire  130  can then be advanced through the needle lumen  122  and into the vasculature  80  to maintain patency of the insertion site. 
     As shown in  FIG.  5 D , the needle  120  and syringe system  140  assembly can be withdrawn proximally to disengage the needle  120  from the guidewire  130  while leaving a distal portion of the guidewire  130  in place within the vasculature  80 . As described in more detail herein, the housing  170  can include a splitter system  180  configured to split the needle  120  longitudinally, as the needle  120  is withdrawn proximally. A portion of the guidewire  130  can pass between the two halves of the needle  120  to allow the needle  120  to disengage the guidewire  130 . 
     As shown in  FIG.  5 E , with the needle  120  and syringe system  140  assembly disengaged from the guidewire  130 , the catheter  150  can then be advanced over the guidewire  130  and into the vasculature. The first section  154  of the catheter  150 , having only a single lumen and defining a relatively smaller outer diameter, can enter the vasculature  80  over the guidewire  130 , anchoring the insertion site. The transition section  158  can then be urged distally, dilating the insertion site to allow the relatively larger diameter second section  156 , defining two or more lumen, to enter the vasculature  80 . Once the catheter  150  has been placed, the guidewire  130  can be withdrawn proximally. 
     Further details and embodiments of RICC systems  100  can be found, for example, in U.S. Pat. No. 10,376,675, U.S. 2019/0255294, U.S. 2021/0069471, U.S. 2021/0085927, U.S. 2021/0113809, U.S. 2021/0113810, U.S. 2021/0121661, U.S. 2021/0228843, U. S. 2021/0283368, U. S. 2021/0283381, U. S. 2021/0322729, U. S. 2021/0330941, U. S. 2021/0330942, U. S. 2021/0361915, U. S. 2021/0379336, U. S. 2021/0402142, U. S. 2021/0402149, U. S. 2021/0402153, U. S. 2021/0121667, U. S. 2022/0001138, U. S. 2022/0032013, U. S. 2022/0032014, U. S. 2022/0062528, U. S. 2022/0126064, U.S. 2022/0152368, U.S. 2022/0176081, U.S. 2022/0176082, U.S. 2022/0193376, U.S. 2022/0193377, U.S. 2022/0193378, U.S. 2022/0193379, and U.S. 2022/0296862, each of which is incorporated by reference in its entirety into this application. 
     In an embodiment, as shown in  FIGS.  6 A- 6 C , the catheter placement system  100  can include a splittable needle  120  and splitter system  180  configured to separate the needle  120  along a longitudinal axis into a first portion  120 A and a second portion  120 B. As such, the guidewire  130  can pass between the first portion  120 A and the second portion  120 B of the needle  120  to facilitate disengaging the needle  120  from the guidewire  130  during placement, (e.g.  FIG.  5 D ). Advantageously, the catheter placement system  100  can quick remove the needle  120  without disturbing the position of the guidewire  130 . Further, the needle  120  can be removed while the catheter  150  remains “preloaded” on a proximal portion of the guidewire  130 . As such the placement process can be expedited and the number of inserted and removed from the insertion site can be reduced, mitigating the introduction of infection. 
       FIG.  6 A  shows a longitudinal cross-sectional side view of the needle  120  and splitter system  180  prior to removal of the needle  120 .  FIG.  6 B  shows a longitudinal cross-sectional plan view of the needle  120  and splitter system  180  prior to removal of the needle  120 .  FIG.  6 C  shows a longitudinal cross-sectional plan view of the needle  120  and splitter system  180  after removal of the needle  120 . 
     Once the guidewire  130  has been advanced through the needle lumen  122  and into the vasculature  80 , the needle  120  can be withdrawn proximally ( FIG.  5 D ). To disengage the needle  120  from the guidewire  130 , the needle  120  can be withdrawn over a splitter system  180  disposed within the needle housing  170 . The splitter system  180  can include a splitter wedge (“wedge”)  182  supported by the housing  170  and extending radially inward into the needle channel  172 . In an embodiment, the wedge  182  can extend radially inward through a wall of the needle  120 . In an embodiment, the splitter system  180  can include a first wedge and a second wedge, disposed opposite the first wedge across a central longitudinal axis of the needle  120 . The wedge(s)  182  can be configured to split the needle  120  along a longitudinal axis and separate the needle  120  into a first portion  120 A and a second portion  120 B. In an embodiment, the wedge(s)  182  can be arranged along a transverse plane, a lateral plane, or along a plane extending at an angle relative thereto. In an embodiment, the wedge  182  can include a blade or similar sharpened edge, disposed at a distal end thereof. The wedge  182  can include a plastic, polymer, metal, alloy, hardened steel, composite, mineral, diamond cutting edge, or combinations thereof. In an embodiment, the wedge  182  can be disposed distally of one or both of the guidewire aperture  124  and guidewire channel  174  of the housing  170 . In an embodiment, the wedge  182  can be disposed proximally of one or both of the guidewire aperture  124  and guidewire channel  174  of the housing  170 . 
     In an embodiment, the needle  120  can include a tear line  126  extending longitudinally along the needle  120  and aligned with the wedge  182 . The tear line  126  can include a perforation, laser cut line, groove, score line, or similar line of weakness configured to facilitate separation of the needle  120  therealong. It is important to note that the tear line  126  can also be configured to be fluid impermeable and can prevent any fluid passing therethrough prior to the needle  120  being split into two separate portions  120 A,  120 B. As such, the needle  120  can maintain the integrity of the needle lumen  122  and does not require any secondary sheath, or the like, disposed over the tear line  124  to mitigate fluids from leaking into or out of the needle lumen  122 . 
     In an embodiment, the splitter system  180  can further include a valve  184 . The valve  184  can extend annularly about the needle  120  and extend between an outer surface of the needle  120  and an inner surface of the needle channel  172  to maintain a fluid tight seal therebetween. In an embodiment, the valve  184  can extend longitudinally from a first point that is distal of one or both of the wedge  182  and the guidewire aperture  124 , to a second point that is proximal of one or both of the wedge  182  and the guidewire aperture  124 . In an embodiment, the splitter system  180  includes a first valve  184  disposed at the first point that is distal of one or both of the wedge  182  and the guidewire aperture  124 , and a second valve  184  disposed at the second point that is proximal of one or both of the wedge  182  and the guidewire aperture  124 . 
     In an embodiment, the splitter system  180  can further include a third valve  184  disposed within the guidewire channel  174  of the housing  170  and configured to mitigate fluid leakage therethrough. The third valve  184  can extend between an outer surface of the guidewire  130  and an inner wall of the guidewire channel  174  to provide a fluid tight seal therebetween. As such, the valve(s)  184  can prevent or mitigate a fluid from escaping from needle lumen, for example through one or both of the guidewire aperture  124  and the guidewire channel  174  of the housing  170 . Optionally, when the syringe system  140  applies a vacuum to the needle lumen  122 , the valve  184  can maintain the integrity of the vacuum within the needle lumen  122  to draw a fluid from a distal tip  128  and prevent a fluid flow from entering the needle lumen  122  through a proximal portion, for example, the guidewire aperture  124 . As shown in  FIG.  6 C , as the needle  120  is withdrawn proximally over the splitter system  180 , the wedge  182  can separate both the needle  120  and the valve  184  along a longitudinal axis. The guidewire  130  can then pass between the two portions of the needle  120  and the valve  184  to disengage the needle  120 , splitter system  180  and housing  170  assembly. 
     In an embodiment, as shown in  FIGS.  7 A- 10 C , the catheter placement system  100  can further include a needle safety system  190 . The needle safety system  190  can be configured to engage one or both of the first needle portion  120 A and the second needle portion  120 B, and encapsulate theses portions  120 A,  120 B, mitigating any damage to surrounding structures, causing trauma, or exposing a user to body fluids, as the needle  120  withdrawn proximally. For example, splitting the needle  120  longitudinally can create a sharpened edge along a longitudinal top edge or bottom edge of the first portion  120 A or the second portion  120 B. These sharpened edges can cause damage to surrounding structures of the system  100  or can cause injury to the user or patient, as the needle  120  is withdrawn proximally. Further, the needle  120  being withdrawn from the vasculature  80  may include body fluids, e.g. blood etc., disposed thereon. Encapsulation of the needle  120  by the needle safety system  190  can mitigate damage to surrounding structures, trauma to the user or patient, and exposure of these body fluids to the user. 
     In an embodiment, the needle safety system  190  can include one or more tapes  192 , for example a first tape  192 A and a second tape  192 B. The tape  192  can be formed of a first material and can include a flexible, puncture-resistant material such as a plastic, polymer, metal, alloy, composite, KEVLAR®, combinations thereof, or the like. In an embodiment, as shown in  FIGS.  7 B,  8 A- 8 B , the tape  192  can include a reinforcement  188 . In an embodiment, the reinforcement  188  can include a thickened portion of the first material of the tape  192 . In an embodiment, the reinforcement  188  can include a second material, different from the first material, and can include more rigid, or more puncture-resistant mechanical properties. For example the reinforcement  188  can include, a metal, alloy, polymer, composite, KEVLAR®, combinations thereof, or the like. In an embodiment, the reinforcement  188  can be disposed on an outer surface, an inner surface, or disposed within a wall of the tape  192 . In an embodiment, the reinforcement  188  can extend longitudinally along a length of the tape  192 . Advantageously, the reinforcement  188  can mitigate sharpened edges of the needle portions  120 A,  120 B from penetrating the tape  192  and exposing the needle portions  120 A,  120 B risking damage, trauma, or exposure to the user, as described herein. 
     In an embodiment, the tape  192  can include an adhesive layer  186  disposed on a surface of the tape  192 , e.g. one or both of an inner surface and an outer surface. The adhesive layer  186  can be configured to adhere the tape  192  to the needle  120 , or a portion thereof. In an embodiment, the adhesive layer  186  can include a backing layer  194  configured to protect the adhesive layer prior to use, and prevent the adhesive layer  186  from adhering to a surface prematurely. 
     With continued reference to  FIGS.  7 A- 7 D ,  FIG.  7 A  shows the needle  120  and the needle safety system  190 , with the housing  170  and needle splitter system  180  removed for ease of illustration.  FIG.  7 B  shows close up detail of the needle  120  and needle safety system  190  with the housing  170 , splitter system  180  and guidewire  130  shown in wire frame for ease of illustration. In an embodiment, the tape  192  can be disposed in a rolled configuration within the housing  170 , however, other configurations of the tape  192 , prior to deployment, are also contemplated. The tape  192  in the rolled configuration can be disposed proximally of the wedge  182 . In an embodiment, a proximal end  196  of the tape  192  can be adhered to a proximal portion of the needle  120 , for example a first proximal end  196 A of the first tape  192 A can be adhered to the first needle portion  120 A, and a second proximal end  196 B of the second tape  192 B can be adhered to the second needle portion  120 B. 
     In an embodiment, as shown in  FIGS.  7 C- 7 D , as the needle  120  is withdrawn proximally, the tapes  192 A,  192 B can transition from the rolled configuration to an unrolled configuration and adhere to the respective portions  120 A,  120 B of the needle, encasing the portions  120 A,  120 B and more specifically the sharpened edges, along an entire length of the needle  120 . 
       FIG.  7 C  shows a perspective view of the needle  120  disposed between the tapes  192 A,  192 B, in the unrolled configuration. The tapes  192 A,  192 B can then adhere together to encapsulate the needle  120  therebetween.  FIG.  7 D  shows a side view of the needle  120  encapsulated within tapes  192 A,  192 B adhered together. In an embodiment, a distal end  198  of the tape  192  can extend distally of the distal needle tip  128 . As such, a distal portion of the first tape  192 A adhered to a distal portion of the second tape  192 B can mitigate the sharpened needle tip  128  from causing any accidental needle stick injuries. In an embodiment, a distal portion of the tape  192  can include a reinforcement  188 , as described herein. The reinforcement  188  can create a hardened, or reinforced distal portion of the tapes  192 A,  192 B to encapsulate the sharpened distal needle tip  128  and mitigate accidental needle stick injuries. In an embodiment, an outer surface of one or both of the first tape  192 A and the second tape  192 B can include symbol  164  such as by way of non-limiting examples, an alphanumeric symbol, a Globally Harmonized System of Classification and Labeling (“GHS”) symbol, a Hazard Communication Standard (HCS) symbol, a color, a texture, or similar visual or tactile indication that the tape  192  is engaged with a bio hazard, or a sharp object, and requires suitable disposal. Advantageously, the symbol  164  can mitigate mishandling of used needle  120 . Further, pre-printing the symbol  164  and can reduce the workload to the user, mitigating human error in the handling of the used needle  120 . 
       FIGS.  8 A- 8 E  show exemplary methods of encapsulating the needle  120  within the tapes  192 A,  192 B.  FIGS.  8 A- 8 E  show lateral cross section views of the needle  120  and tapes  192 A,  192 B.  FIG.  8 A  shows the needle  120  and the tapes  192 A,  192 B before the needle  120  is split by the splitter system  180 .  FIG.  8 B  shows the needle  120  having been split into a first portion  120 A and a second portion  120 B. With the backing layer(s)  194  removed, an adhesive surface  186  of the first tape  192 A can adhere to an outer surface of the first needle portion  120 A and an adhesive surface  186  of the second tape  192 B can adhere to an outer surface of the second needle portion  120 B. In an embodiment, the tape  192  can include a reinforcement  188  extending longitudinally, as described herein. To note, in splitting the needle  120  along tear lines  126 , the longitudinal top edge and the longitudinal bottom edge of the first needle portion  120 A and the second needle portion  120 B can be sharpened and can cause damage or trauma. Encapsulating the top edge and the bottom edge of the first needle portion  120 A and the second needle portion  120 B can mitigate any damage or trauma. 
       FIG.  8 C  shows an embodiment of encapsulating the first portion  120 A and the second portion  120 B of the needle  120  where a top portion of the first tape  192 A adheres to a top portion of the second tape  192 B, and a bottom portion of the first tape  192 A adheres to a bottom portion of the second tape  192 B, encapsulating the needle  120  therebetween. In an embodiment, as shown in  FIG.  7 B , the encapsulation of the needle portions  120 A,  120 B can occur within the housing  170  and proximal of the guidewire  130  disengaging the needle  120 . As such, the needle  120  can be encapsulated prior to exiting the housing  170 , mitigating any accidental damage or trauma, or accidental exposure of the user to body fluids. 
     In an embodiment, as shown in  FIG.  8 D , a top edge  166  and a bottom edge  168  of the tape  192  can fold over a top edge and a bottom edge of a respective needle portion and can adhere to an inner surface thereof. As such, the first tape  192 A can encapsulate a first needle portion  120 A, and the second tape  192 B can encapsulate a second needle portion  120 B. In an embodiment, as shown in  FIG.  8 E , the needle safety system  190  can include a single tape  192 , as described herein, having a width sufficient to encapsulate one or both of the first needle portion  120 A and the second needle portion  120 B. For example, a width of the tape  192  can extend between the top edge  166  and the bottom edge  168  substantially perpendicular to a longitudinal axis. As shown in  FIG.  8 E , the width of the tape  192  can be configured to encircle the needle  120 , or a portion thereof, and a bottom edge  168  can overlap a top edge  166 . In an embodiment, a top edge  166  can overlap a bottom edge  168 , encapsulating the needle  120 , or a portion thereof. Advantageously, these methods of encapsulating the needle portion  120 A,  120 B can mitigate contact between the sharpened edges of the needle and the tape  192 . As such, this can mitigate the sharpened edges from rubbing against, and penetrating the tape  192 , which might expose the needle  120  to the user. 
     In an embodiment, as shown in  FIGS.  9 A- 9 B  the needle safety system  190  can include one or more gears, spindles, or the like configured to peel the backing layer  194  off of the tape  192  and adhere the tape  192  to the needle  120 , or a portion thereof, as the needle  120  is withdrawn proximally, encapsulating the needle  120  as described herein. As shown in  FIGS.  9 A- 9 B , the tape  192  can include an adhesive surface  186  disposed on an inner surface and can be adhered to an outer surface of the needle  120 , encapsulating the needle  120  as described herein. 
     In an embodiment, as shown in  FIGS.  10 A- 10 C  the needle safety system  190  can be configured to remove the backing layer  194  and adhere the tape  192  to an inner surface of the needle portions  120 A,  120 B. The tapes  192 A,  192 B can include an adhesive layer disposed on an outer surface.  FIGS.  10 A- 10 B  show a plan view of the needle  120  and needle safety system  190 .  FIG.  10 C  shows a side view of a first needle portion  120 A adhered to a first tape  192 A. In an embodiment, as shown in  FIG.  10 B , a distal end  198  of the tape  192  can be folded outwards and over the distal tip  128  of the needle  120  to mitigate accidental needle stick injuries. For example, a first distal end  198 A of the first tape  192 A can be folded outwards and back on to the first tape  192 A to encapsulate the sharpened distal tip  128 A of the first portion  120 A of the needle  120 . Similarly, a second distal end  198 B of the second tape  192 B can be folded outwards and back on to the second tape  192 B to encapsulate the sharpened distal tip  128 B of the second portion  120 B of the needle  120 . In an embodiment, a top edge  166  and a bottom edge  168  of the tape  192  can fold outwards and adhere to an outer surface, or can overlap, to encapsulate the needle portions  120 A,  120 B, as described herein. 
     Advantageously, these methods of encapsulating the needle portion  120 A,  120 B can mitigate contact between the sharpened edges of the needle and the tape  192 . As such, this can mitigate the sharpened edges from rubbing against, or penetrating, the tape  192 , which might expose the needle  120  to the user. 
     While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and/or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and/or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.