Integrated catheter with independent fluid paths

Abstract

To provide a catheter device that allows reliable confirmation that an introducer needle is inserted sufficiently to enter a blood vessel.SOLUTION: A catheter system comprises a chamber, a catheter hub, a catheter adapter in communication with the chamber and the catheter hub, and a needle hub anchored to a needle configured to slidably fit within the catheter, where an outer surface of the needle comprises an axial channel extending along the outer surface from a distal end of the needle, which extends into the chamber of the catheter hub and provides a flow path of blood flashback. In an insertion configuration, the catheter hub is removably coupled within a distal opening of the hub. After the catheter is placed, the needle hub is retracted from the catheter adapter to slidably remove the needle from the catheter and to separate the needle hub from the catheter adapter.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present disclosure relates generally to intravenous catheters (e.g., vascular access devices). More specifically, the present application discloses various methods of using and systems of integrated catheter assemblies with independent fluid paths. Generally, vascular access devices are inserted into veins via peripheral or central vessels for diagnostic or therapeutic reasons. Vascular access devices can be used to infuse fluids (e.g., saline, blood, medications, and / or total parenteral nutrition) into a patient, withdraw fluids (e.g., blood) from a patient, and / or monitor various parameters of the patient's vascular system. Additionally, in this disclosure, and following convention, the term "proximal" is used to refer to the portion of the device closest to the medical practitioner, and the term "distal" is used to refer to the portion of the device toward or away from the patient. [Background technology]

[0002] An intravenous (IV) catheter assembly is one of various types of vascular access devices. An over-the-needle peripheral IV catheter is a common IV catheter configuration. As the name suggests, an over-the-needle IV catheter is installed over an introducer needle (introducer) with a sharp distal tip. The introducer needle is generally a venipuncture needle coupled to a needle assembly, which helps guide the needle and facilitates cooperation with the catheter. At least the inner surface of the distal portion of the catheter tightly engages the outer surface of the needle to prevent "peel-back" of the catheter and thereby facilitate insertion of the catheter into a blood vessel. The catheter and introducer needle are usually assembled so that the sharp distal tip of the introducer needle extends beyond the distal tip of the catheter. Furthermore, the catheter and needle are usually assembled so that the bevel of the needle faces up, away from the patient's skin, during insertion. The catheter and introducer needle are generally inserted into a blood vessel through the patient's skin at a shallow angle.

[0003] Following insertion of the catheter and introducer needle into a blood vessel at the catheter insertion site, the introducer needle is removed, leaving the catheter within the blood vessel. The catheter is then used to inject fluid into the patient's vasculature. Removed introducer needles are considered "blood-contaminated sharps" and, as a result, must be handled and disposed of appropriately. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent No. 8,496,623 [Patent Document 2] U.S. Patent No. 9,399,120 [Patent Document 3] U.S. Patent Application Publication No. 62 / 314,262 [Patent Document 4] U.S. Patent No. 6,117,108 [Patent Document 5] U.S. Patent Application Publication No. 14 / 295,953 Summary of the Invention [Problem to be solved by the invention]

[0005] Although conventional indwelling needle catheters may offer various benefits, they are not without their drawbacks. For example, after the introducer needle is removed, it can pose a needlestick risk to the physician and / or patient. Also, in placing the catheter, the physician must be careful to ensure that the introducer needle (and catheter) is inserted sufficiently to enter the blood vessel without penetrating the vein.

[0006] Thus, while a variety of indwelling needle catheters currently exist, problems, including those listed above, still exist. As a result, enhancing or even replacing current systems and techniques with other systems and techniques would be an improvement in the art. [Means for solving the problem]

[0007] The present disclosure relates generally to catheter systems with independent fluid paths. More specifically, the present disclosure discusses catheter systems that provide primary and secondary blood flashback to indicate when a needle of the catheter system has entered a patient's blood vessel. Methods of using these catheter systems are also discussed.

[0008] Some exemplary catheter systems can include a catheter hub including a distal end and a proximal end and defining a chamber extending between the distal and proximal ends, a catheter extending from the distal end of the catheter hub and in fluid communication with the chamber, a catheter adapter including a stabilization platform, and a needle hub including a needle configured to slidably fit within the catheter and a needle hub body secured to the proximal end of the needle, wherein in an insertion configuration, the proximal end of the catheter hub is removably coupled within the distal opening of the needle hub, and after placement of the catheter, the needle hub is retracted from the catheter adapter to slidably remove the needle from the catheter and separate the needle hub from the catheter adapter. In some embodiments, the needle includes an axial channel configured to provide a temporary blood flashback within the chamber of the catheter hub to indicate that the needle has entered the patient's vasculature. In other embodiments, the needle includes an open bore in fluid communication with the chamber of the needle hub, and blood flows through the open bore into the chamber of the needle hub, providing a secondary blood flashback indicating that the needle has entered the patient's vasculature.

[0009] In some cases, the fixation platform can further include a first wing portion including a generally planar shape for stably maintaining the catheter adapter against the patient's skin. In other cases, the fixation platform can further include a soft push tab configured to provide a grasping surface for manipulating and advancing the catheter adapter. In yet other cases, the catheter hub can further include a Y-port in fluid communication with the chamber of the catheter hub. In some examples, the needle hub can further include a paddle grip extending from the distal end of the needle hub and configured to provide a gripping surface for manipulating the needle hub. In other examples, the catheter hub can further include a septum configured to allow the needle to removably and slidably pass through a slit in the septum. In yet other examples, the catheter hub can further include a septum canister configured to secure the septum within the catheter hub. In another example, the catheter system can further include a needle safety configured to protect against needle sticks by engaging the distal tip of the needle when the needle is retracted from the catheter adapter.

[0010] In some embodiments, a method can include a method of catheterization including providing a catheter system including a catheter adapter including a catheter hub defining a chamber extending between a distal end and a proximal end, a catheter extending from the distal end of the catheter hub and in fluid communication with the chamber, and a fixation platform; and a needle hub including a needle configured to slidably fit within the catheter and a needle hub body secured to the proximal end of the needle; inserting the needle and catheter at a catheter insertion site; advancing the needle and catheter at the catheter insertion site until a primary blood flashback is provided in the chamber of the catheter hub through an axial channel on the needle; securing the catheter at the catheter insertion site; and retracting the needle hub from the catheter adapter to slidably remove the needle from the catheter and separate the needle hub from the catheter adapter. In other embodiments, the method further includes advancing the needle and catheter at the catheter insertion site until a secondary blood flashback is provided in the chamber of the needle hub. In yet another embodiment, securing the catheter further includes securing the fixation platform against skin adjacent to the catheter insertion site. In some embodiments, the method further includes engaging a needle safety device with the distal tip of the needle as the needle is retracted from the catheter adapter.

[0011] In some embodiments, the catheter system includes a catheter adapter including a catheter hub defining a chamber extending between the distal and proximal ends of the catheter hub, a catheter extending from the distal end of the catheter hub and in fluid communication with the chamber, and a fixation platform including a first wing and a soft push tab; and a needle hub including a needle configured to slidably fit within the catheter and a needle hub body secured to the proximal end of the needle, wherein in an insertion configuration, a proximal extension of the catheter hub is removably coupled within a distal opening of the needle hub, and after placement of the catheter, the needle hub is retracted from the catheter adapter to slidably remove the needle from the catheter and separate the needle hub from the catheter adapter. In other embodiments, the needle includes an axial channel configured to provide a primary blood flashback to indicate that the needle has entered a blood vein. In yet another embodiment, blood flows through an open hole in the needle into the chamber of the needle hub to provide a secondary blood flashback to indicate that the needle has entered the patient's vasculature.

[0012] In some cases, the catheter hub can further include a septum with a slit configured to allow the needle to slidably pass therethrough and to fit within the axial channel while the axial channel slidably passes through the slit to expel any fluid within the axial channel. In other cases, the catheter hub can further include a septum canister configured to secure the septum within the catheter hub, and the septum canister includes a retaining ridge configured to secure the septum canister to the catheter hub. In yet other cases, the system can further include a needle safety device removably disposed within the proximal extension of the catheter hub and configured to protect against needle sticks by engaging the distal tip of the needle when the needle is retracted from the catheter adapter.

[0013] In order that the manner in which the above-enumerated and other features and advantages of the invention may be readily understood, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof which are illustrated in the accompanying drawings, which illustrate merely exemplary embodiments of the invention and, therefore, should not be considered as limiting the scope of the invention. [Brief explanation of the drawings]

[0014] [Figure 1] FIG. 1 is a perspective view of a catheter system according to some embodiments. [Figure 2A] FIG. 1 is a top cutaway view of a catheter system according to some embodiments. [Figure 2B] FIG. 1 is a top cutaway view of a catheter system according to some embodiments. [Figure 3A] FIG. 1 is a perspective view of a needle according to some embodiments. [Figure 3B] 3B is a cross-sectional view of the needle of FIG. 3A according to some embodiments. [Figure 3C] FIG. 10 is a cutaway view of a needle and septum according to some embodiments. [Figure 3D] FIG. 10 is a cutaway view of a needle and septum according to some embodiments. [Figure 4] FIG. 1 is a cutaway view of a catheter hub body according to some embodiments. [Figure 5A] FIG. 1 is a side view of a septum and septum canister according to some embodiments. [Figure 5B] 1A-1C are cutaway views of a septum and septum canister according to some embodiments. [Figure 5C] FIG. 1 is a side view of a septum and septum canister according to some embodiments. [Figure 5D] 1A-1C are cutaway views of a septum and septum canister according to some embodiments. [Figure 5E] FIG. 1 is a side view of a septum and septum canister according to some embodiments. [Figure 5F]1A-1C are cutaway views of a septum and septum canister according to some embodiments. [Figure 5G] FIG. 1 is a side view of a septum and septum canister according to some embodiments. [Figure 5H] 1A-1C are cutaway views of a septum and septum canister according to some embodiments. [Figure 6] FIG. 1 is a side view of a needle hub and a needle safety device according to some embodiments. [Figure 7A] FIG. 1B is a cutaway view of a needle and needle safety device as the needle is retracting, according to some embodiments. [Figure 7B] FIG. 1 is a cutaway view of the needle and needle safety device with the needle retracted, according to some embodiments. [Figure 8A] FIG. 10 is a cutaway view of the needle and needle safety device as the needle is being retracted, according to some embodiments. [Figure 8B] FIG. 10 is a cutaway view of the needle and needle safety device with the needle retracted, according to some embodiments. [Figure 9A] FIG. 10 is a cutaway view of the needle and needle safety device as the needle is being retracted, according to some embodiments. [Figure 9B] FIG. 10 is a cutaway view of the needle and needle safety device with the needle retracted, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0015] The presently preferred embodiments of the present invention will be best understood by reference to the drawings, where like reference numbers indicate identical or functionally similar elements. It will be readily understood that the components of the present invention, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description, as represented in the figures, is not intended to limit the scope of the invention as claimed, but is merely representative of presently preferred embodiments of the invention.

[0016] Generally, the present disclosure relates to a catheter system and a method of catheter insertion using such a catheter system. In some examples, the catheter system may include a catheter adapter and a needle hub disposed along a longitudinal axis. The catheter hub may include an indwelling needle-catheter configured for catheterization of a patient. The needle hub may include a needle secured to a needle hub body. The needle may be slidably fitted within the catheter in an insertion configuration. The needle hub may be separated from the catheter adapter to slidably remove the needle from the catheter. Using a gripping surface on the catheter adapter and the needle hub, a physician may insert the indwelling needle catheter into the patient's vasculature at a catheter insertion site. As the needle enters the blood vessel, an axial channel on the needle provides a primary blood flush to notify the physician that the needle has entered the blood vessel. The physician may then secure the catheter in place and retract and separate the needle hub from the catheter adapter to slidably remove the needle from the catheter. Blood flowing through the open bore of the needle into a chamber in the needle hub may provide a secondary blood flush to also notify the physician that the needle has entered the blood vessel. When the needle is slidably removed from the catheter, the needle safety device can engage the distal tip of the needle to prevent inadvertent needle sticks.

[0017] Referring now to FIG. 1 , a catheter system 100 is shown. The catheter system 100 can be configured to connect to intravenous fluids and / or medications and to infuse the intravenous fluids and / or medications into a patient's vasculature. While the catheter system 100 can include any suitable components and / or structures, in at least some embodiments, it includes a catheter adapter 102, a needle hub 104, and extension tubing 106. The catheter adapter 102 can be inserted into the patient's vasculature at a catheter insertion site with the aid of the needle hub 104. In some cases, the extension tubing 106 can be fluidly coupled to the catheter adapter 102 and configured to convey intravenous fluid from an intravenous fluid supply into the patient's vasculature through the inserted catheter adapter 102. In other cases, the extension tubing can include a clamp 108 configured to manually obstruct or allow the flow of intravenous fluid into the catheter adapter 102. The extension tubing 106 may also include a luer fitting 110 configured to easily connect the extension tubing 106 to a supply of intravenous fluid (e.g., an IV solution bag). In yet another case, the extension tubing 106 may include a sampling port 112 configured to provide a physician access to the patient's vasculature through the extension tubing 106. For example, a physician may use the sampling port 112 to withdraw a blood sample from the patient and / or inject medications directly into the patient's vasculature through the sampling port 112. FIG. 1 shows the catheter system 100 with the needle hub 104 partially retracted from the catheter adapter 102.

[0018] In some embodiments, the catheter adapter 102 includes a catheter hub 114 fluidly coupled to a catheter 115. The catheter 115 can include a distal end 116 configured to enter the patient's vasculature. The catheter 115 can also include a proximal end 117 fluidly connected to the catheter hub 114. The catheter adapter 102 can also include an anchoring platform 118 and a catheter hub body 120. In some cases, the catheter hub 120 can include a generally tubular and / or hollow configuration and have a distal end 122 and a proximal end 124. In other cases, the catheter hub body 120 can define a chamber 126 spanning the entire length of the catheter hub 120. The catheter hub 120 can also include a Y-port 128 that fluidly couples the catheter hub 120 to the extension tubing 106. In yet other cases, the catheter hub body 120 can include a proximal extension 130 with a proximal extension tab 132. The proximal extension 130 can be configured to slidably couple with the needle hub 104. The proximal extension tab 132 can prevent and / or limit rotational movement of the needle hub 104 relative to the catheter adapter 102 when the proximal extension 130 is slidably coupled with the needle hub 104.

[0019] In some embodiments, the fixation platform 118 includes a generally planar configuration suitable for resting flat against the patient's skin adjacent the catheter insertion site. The fixation platform 118 can allow the fixation platform 118 and / or the catheter hub 114 to be secured against the patient's skin, allowing the catheter adapter 102 to be stably maintained in place during infusion. The fixation platform 118 can include a distal end 134 and a proximal end 136 and can be disposed at least partially below the catheter hub body 120. The fixation platform 118 can include a strain relief coupling 138 configured to couple the proximal end 117 of the catheter 115 to the chamber 126 of the catheter hub body 120. In some cases, the strain relief coupling 138 can be configured as a soft, compliant material that allows the catheter 115 to flex relative to the catheter hub body 120. In other cases, the strain relief coupling 138 can be configured as a hard, compliant material that limits the catheter 115 to flex relative to the catheter hub body 120. In yet another case, the fixation platform 118 may include a strain relief connection tab 140 configured to couple at least a portion of the strain relief coupling 138 to the distal end 134 of the fixation platform 118 .

[0020] In some embodiments, the fixation platform 118 includes a soft push tab 142 configured to provide a gripping surface for the physician to grasp while manipulating and advancing the catheter system 100. In some cases, the physician can place his or her thumb on the soft push tab 142 as he or she grasps the catheter hub 114 and inserts the catheter 115. In other cases, the fixation platform 118 can be disposed on an upper surface of the catheter hub body 120 and can include a soft push tab connector 144 configured to couple the soft push tab 142 to the proximal end 136 of the fixation platform 118.

[0021] In some embodiments, the anchoring platform 118 includes a first wing 146 having a generally planar shape. The anchoring platform 118 can also include a second wing 148 having a generally planar shape that can be generally coplanar with the first wing 146. The second wing 148 can be located on an opposite side of the catheter hub 114 from the first wing 146. In some cases, the first wing 146 and the second wing 148 can extend from opposite sides of the catheter hub 114. The first wing 146 and the second wing 148 can include any suitable shape, but in at least some cases, when the catheter hub 114 is viewed from above, the first wing 146 and the second wing 148 each include a generally triangular shape. In other cases, the first wing 146 and the second wing 148 can include a triangular shape, a rounded triangular shape, a rectangular shape, and a rounded rectangular shape. In yet other cases, the first and second wings 146, 148 can include circular, semicircular, oval, oblong, and other suitable shapes. The first and second wings 146, 148 can include leading edges 150 oriented toward the distal end 134 of the fixation platform 118. The first and second wings 146, 148 can include trailing edges 152 oriented toward the proximal end 136 of the fixation platform 118. One or more of the first and second wings 146, 148 can include gripping features 154. The grip features 154 can be configured to provide a gripping surface for a physician to manipulate the catheter system 100. In other embodiments, the fixation platform 118 includes a hardness appropriate to enable the fixation platform 118 to function as intended. For example, in some cases, the fixed platform 118 includes a material durometer range of about 30 Shore A to about 90 Shore D. In other cases, the fixed platform 118 includes a material durometer range of about 50 Shore A to about 90 Shore A.

[0022] In some embodiments, the needle hub 104 includes a needle hub body 156. The needle hub body 156 may include a generally tubular shape with a distal end 158 and a proximal end 160. The needle hub body 156 may also include a grip surface 162 configured to provide a physician with a gripping surface for manipulating the catheter system 100 and / or retracting the needle hub 104 from the catheter adapter 102. In some examples, the needle hub body 156 may include a distal opening 164 configured to slidably receive the proximal extension 130 of the catheter hub body 120. In yet other examples, the needle hub body 156 defines a chamber 168 extending from the distal opening 164 to a proximal opening 170. The needle hub 104 may also include a paddle grip 186 extending from the distal end 158 of the needle hub 104. The paddle grip 186 can include a generally planar shape and can be generally coplanar with the first wing 146 and / or the second wing 148. The paddle grip 186 can also include a gripping surface 188 configured to provide a physician with a gripping surface for manipulating the catheter system 100 and / or the needle hub 104 and / or retracting the needle hub 104 from the catheter adapter 102. The paddle grip 186 can include a lip 190 configured to receive the trailing edge 152 of the first wing 146 and / or the second wing 148. In some examples, a bottom portion of the first wing 146 and / or the second wing 148 can be received by a top portion of the paddle grip 186.

[0023] In some embodiments, the needle hub 104 includes a needle 172. The needle 172 may be mounted within the needle hub body 156 and may extend through the distal opening 164. The needle 172 may be configured to removably and slidably pass through a septum 200 (not shown) in the chamber 126 of the catheter hub body 120, traverse the chamber 126, and removably and slidably pass through the catheter 115.

[0024] 2A and 2B, cutaway views of a catheter system 100 are shown. FIG. 2A shows the catheter system 100 in an insertion configuration, ready to be used to position a catheter 115 within a patient's vasculature. In the insertion configuration as shown in FIG. 2A, the proximal extension 130 of the catheter hub body 120 is slidably received within a distal opening 164 of the needle hub body 156. As seen in FIG. 2A, the distal opening 164 may also include a distal opening groove 166 configured to slidably receive the proximal extension tab 132 of the proximal extension 130. The distal opening groove 166 may be configured such that rotational movement of the catheter adapter 102 relative to the needle hub 104 is prevented or limited when the proximal extension tab 132 engages the distal opening groove 166. In another example, when the proximal extension tab 132 engages the distal opening groove 166, the rotational movement of the catheter adapter 102 relative to the needle hub 104 is limited to a particular range of rotational motion.

[0025] 2A , when the catheter system 100 is in the insertion configuration, the paddle grip 186 slidably receives the first wing 146. In the insertion configuration, the trailing edge 152 of the first wing 146 can be disposed adjacent to the lip 190 of the paddle grip 186 and the grip surface 188 of the paddle grip 186. In some cases, the trailing edge 152 of the first wing 146 can contact the lip 190 of the paddle grip 186.

[0026] 2A , in the insertion configuration, the needle 172 removably and slidably passes through the catheter 115 and extends through the catheter 115 beyond the distal end 116 of the catheter 115. The needle 172 may include a proximal end 174 and a distal tip 176. The distal tip 176 may include a beveled opening 178 configured to pierce the patient's skin at the catheter insertion site. The needle 172 may include an open bore 180 therethrough. The needle 172 may also include an axial channel 182 beginning at the distal tip 176 and continuing along at least a portion of the length of the needle 172. The needle 172 may removably and slidably pass through a septum 200, a septum canister 300, and a needle safety device 400. The septum canister is configured to be disposed within the chamber 126 of the catheter hub body 120. Similarly, a septum canister 300 is disposed within the chamber 126 of the catheter hub body 120 and is configured to secure the septum 200 in place. A needle safety device 400 can be at least partially disposed within the proximal extension 130 of the catheter hub body 120. The needle 172 can further extend into the distal opening 164 of the needle hub body 156. The needle 172 can be secured to the needle hub 104 by a needle mount 184 within the needle hub body 156. The proximal end 174 of the needle 172 can be disposed within the chamber 168 with an open bore 180 opening into the chamber 168. The open bore 180 of the needle 172 can thus allow fluid entering the beveled opening 178 to be in fluid communication with the chamber 168 and the proximal chamber opening 170.

[0027] In some embodiments, a physician inserts the catheter system 100 into the patient's vasculature when the catheter system 100 is in the insertion configuration. The physician can grasp the catheter system 100 by one or more gripping surfaces (e.g., soft push tab 142, grip mechanism 154, grip surface 162, and grip surface 188) and manipulate the catheter system 100 into a position proximate to the catheter insertion site. The physician can then pierce the patient's skin with the beveled opening 178 of the needle 172 and advance the needle 172 through the patient's tissue until the patient's vasculature (e.g., a vein) is reached by the needle 172 and catheter 115. Once the patient's vasculature is reached, the physician can retract the needle 172 by slidably removing the needle 172 from the catheter 115, leaving the catheter 115 inserted within the vasculature. While retracting the needle 172, the physician can maintain the catheter 115 in place by holding the catheter adapter 102 in place via one or more soft push tabs 142 and gripping mechanism 154. The physician can retract the needle by grasping the gripping surface 162 of the needle hub body 156 and slidably removing the needle 172 proximally toward the physician. In some cases, after the needle 172 has been advanced into the patient's vasculature, the physician can advance the distal end 116 of the catheter 115 into the patient's vasculature by maintaining the needle 172 in place and slidably advancing the distal end 116 into the patient's vasculature. Once the catheter 115 is inserted into the patient's vasculature, the needle 172 can be retracted as described above.

[0028] 2B, a cutaway view of the catheter system 100 is shown with the needle hub 104 partially retracted from the catheter adapter 102. The needle hub 104 can be moved longitudinally along axis "A" to separate the needle hub 104 from the catheter adapter 102 and slidably remove the needle 172 from the catheter 115. As the needle hub 104 is retracted, the proximal extension 130 of the catheter hub body 120 slidably disengages from the distal opening 164 of the needle hub body 156. Similarly, the first wing 146 separates from the paddle grip 186. As the needle hub 104 is retracted from the catheter adapter 102, the needle 172 is slidably removed from the catheter 115, septum 200, and septum canister 300. As described in more detail below, the distal tip 176 of the needle 172 slidably fits within and is engaged by the needle safety device 400. When engaged, the safety device 400 is retained on the distal tip 176 of the needle 172, and the needle safety device 400 is removably disengaged from the catheter adapter 102 (see FIG. 6), thereby protecting the physician from an inadvertent needle stick.

[0029] Referring now to FIG. 3A, a perspective view of the distal tip 176 of the needle 172 is shown. FIG. 3A shows that an axial channel 182 extends longitudinally along the needle 172 from an beveled opening 178. The axial channel may be disposed along the needle 172 but does not enter the open bore 180 of the needle 172. FIG. 3B shows a cross-sectional view of the needle 172. FIG. 3B shows that the axial channel 182 does not enter the open bore 180 of the needle 172. While FIG. 3B shows the axial channel 182 as including a rounded, semicircular cross-sectional shape, the axial channel 182 may include any suitable cross-sectional shape. For example, the axial channel 182 may include a square, rectangular, or other polygonal cross-sectional shape.

[0030] In some embodiments, the axial channel 182 is configured to provide the physician with a temporary indicator of blood flow or a temporary "blood flush" when the needle 172 and catheter 115 enter the patient's vasculature (e.g., a vein). When the physician advances the needle 172 and catheter 115 sufficiently and the needle 172 and catheter 115 pass through the wall of the vein, blood is drawn along the axial channel 182 between the needle 172 and the catheter 115. This blood can then be seen by the physician through the translucent catheter 115. Upon seeing the drawn blood or temporary blood flush along the axial channel 182, the physician knows that the catheter 115 has passed through the wall of the vein and that the catheter 115 is inserted into the vein. The physician can then retract the needle 172 and secure the catheter 115 in place. The temporary blood flush can also indicate to the physician that the vein has been accessed and that the needle 172 and / or catheter 115 do not need to be advanced further, thereby preventing the physician from over-advancing the needle 172 and crossing the vein. In some cases, the temporary blood flush can be seen by the physician when blood reaches the translucent chamber 126 of the catheter body 120.

[0031] In some embodiments, the catheter system 100 is configured to provide a secondary blood flush to the physician during the extended phase by providing a continuous blood flush within the chamber 168 to ensure that the catheter 115 remains properly positioned within the vein. When the physician fully advances the needle 172 and it enters the vein, blood can flow through the open hole 180 in the needle 172 and into the chamber 168 of the needle hub body 156. With a translucent needle hub body 156, the chamber 168 can become a secondary flashback chamber, and the presence of visible blood within this secondary flashback chamber can indicate to the physician that the needle 172 has entered the vein. The physician can then perform the extended phase of insertion by simultaneously advancing the catheter 115 into position and retracting the needle 172. During this extension phase of insertion, the physician can continually monitor for secondary flashbacks to provide continuous reassurance that catheter 115 remains properly positioned within the vein (e.g., catheter 115 has not punctured the vein and / or clotting has not occurred). Once catheter 115 is fully positioned, the physician can completely remove needle 172 and secure catheter 115 to the patient's skin.

[0032] 3C and 3D, cutaway views of a septum 200 and needle 172 are shown. FIG. 3C shows a cutaway view of the septum 200 as the needle 172 is being retracted. The septum 200 generally comprises a tubular and / or cylindrical shape. While the septum 200 can comprise any suitable component or configuration, in at least some cases, the septum 200 includes a septum body 202 having a distal end 204 and a proximal end 206. In other cases, the septum 200 can include a distal wall 207 with a slit 208 therethrough. The slit 208 can be configured to prevent the passage of fluid through the slit 208 while allowing the needle 172 to pass therethrough. The septum 200 can also include an extension 210 extending from the septum body 202 at a shoulder 212. The septum body 202 and / or extension 210 can define a lumen 214 with a proximal opening 216. FIG. 3C also shows the orientation of the axial channel 182 with respect to the septum 200 and the slit 208. In some cases, the axial channel 182 slidably passes through the slit 208 when the needle 172 is retracted. The slit 208 can be configured to fit the axial channel 182 as it slidably passes through the slit 208, thereby excluding any fluid (e.g., blood) that may be within the axial channel 182. The slit 208 therefore excludes any fluid that may be within the axial channel 182 and prevents the fluid from entering the lumen 214 of the septum 200.

[0033] 3D shows that one potential consequence of employing the notched opening 183 is leakage through the notched opening 183 into the lumen 214 of the septum 200 as the needle 172 is retracted. As the needle 172 is retracted, the notched opening 183 crosses the slit 208 and enters the lumen 214 of the septum 200. When the notched opening 183 is within the lumen 214 of the septum 200, fluid (e.g., blood) can pass through the open hole 180 of the needle 172 and enter the lumen 214. The fluid can then leak from the lumen 214 into the proximal extension 130 and then out of the catheter system 100.

[0034] Another potential consequence of employing the notched opening 183 is flooding of the chamber 168 of the needle hub body 156 during pre-priming. This flooding of the chamber 168 can occur when a physician pre-primes the catheter system 100 with saline. During pre-priming of the catheter system 100, the physician injects saline into the Y-port 128. The injected saline passes through the Y-port 128 and enters the chamber 126 of the catheter hub body 120, and then can migrate into the interstitial space between the outer diameter of the needle 172 and the inner diameter of the catheter 115. The injected saline can flow through this interstitial space and through the notched opening 183 into the open hole 180. Once in the open hole 180, the injected saline can flow into the chamber 168 of the needle hub body and flood it. Flooded saline in chamber 168 can often prevent effective blood flashback in chamber 168. Flooding of chamber 168 when using notched opening 183 is more likely to occur under certain conditions. For example, in some cases, when distal end 116 of catheter 115 is oriented vertically upward during pre-priming, gravity may help pull the injected saline through notched opening 183, down open bore 180, and into chamber 168. In other cases, larger gauge catheters 115 and / or needles 172 may also result in flooding of chamber 168.

[0035] In some embodiments, when the needle 172 is configured with an axial channel 182 instead of a notched opening 183, independent fluid pathways are provided in each of the open bore 180 of the needle 172 and the axial channel 182 of the needle 172. For example, when the needle 172 is configured with an axial channel 182 instead of a notched opening 183, an independent fluid pathway can be provided along the open bore 180 from the distal tip 176 to the proximal end 174 and open into the chamber 168. Similarly, the axial channel 182 can provide an independent fluid pathway along the outer diameter of the needle 172 and into the chamber 126 of the catheter hub body 120. In each case, the independent fluid pathways in the open bore 180 of the needle 172 and the independent fluid pathways formed by the axial channel 182 can be fluidly isolated from each other, and fluid flow between each of the independent fluid pathways can be prevented.

[0036] In some embodiments, when needle 172 is configured with axial channel 182 instead of notched opening 183, the independent fluid pathway provided by axial channel 182 prevents blood from leaking into lumen 214 of septum 200 when needle 172 is retracted. When axial channel 182 is employed instead of notched opening 183, the independent fluid pathway provided by axial channel 182 is fluidly isolated from the independent fluid pathway provided by open hole 180, allowing needle 172 to be retracted without any blood leaking into lumen 214. When needle 172 is retracted, axial channel 182 can slidably pass through slit 208, with slit 208 fitting into axial channel 182 and excluding any blood that may be in axial channel 182, thereby preventing any blood from entering lumen 214 of septum 200. Therefore, the configuration including the axial channel 182 instead of the notched opening 183 can avoid leakage of blood into the lumen 214 and any further leakage of blood into the proximal extension 130.

[0037] In some embodiments, when the needle 172 is configured with an axial channel 182 instead of a notched opening 183, the independent fluid pathway provided by the axial channel 182 of the needle 172 avoids flooding of the chamber 168 during pre-priming with saline. For example, when the needle 172 is configured with an axial channel 182 instead of a notched opening 183, a physician can inject saline into the chamber 126 of the catheter hub body 120 through the Y-port 128. The injected saline can then flow into the interstitial space between the outer diameter of the needle 172 and the inner diameter of the catheter 115. In some cases, the injected saline can also flow along the independent fluid pathway provided by the axial channel 182. Because the independent fluid pathway provided by the open hole 180 is fluidically isolated, the injected saline from pre-priming cannot enter the independent fluid pathway provided by the open hole 180 and avoid flooding of the chamber 168. This configuration can be used to similarly avoid flooding of chamber 168 when the distal end 116 of catheter 115 is pointed vertically upward during pre-priming and when larger gauge catheters 115 and / or needles 172 are used.

[0038] Referring now to FIG. 4, a cutaway view of the catheter hub body 120 in an insertion configuration with the needle 172 in place is shown. FIG. 4 shows that a septum 200 can mate with the catheter hub body 120 to define a chamber 126 in the catheter hub body 120. A distal wall 207 of the septum 200 can seal the chamber 126 to prevent fluid from escaping past the septum 200. The slit 208 can also be configured to prevent fluid from escaping past the septum 200 when the needle 172 is in place within the slit 208 and when the needle 172 is removed from the slit 208. A septum canister 300 can be configured to secure the septum 200 within the catheter hub body 120. The septum canister 300 can also be configured to secure the septum 200 within the catheter hub body 120 to prevent fluid from leaking past the septum 200. The septum canister 300 may include a body 302 with a distal end 304 and a proximal end 306. In some cases, the septum canister 300 may include a wall 307. The septum canister 300 may also include a septum canister opening 308 configured to allow the needle 172 to pass therethrough. In other cases, the septum canister 300 may include a distal extension 310 extending distally from the wall 307. The distal extension 310 may define a first lumen 312. In yet other cases, the septum 300 may include a retention ridge 314 configured to retain the septum 300 within the catheter hub body 120.

[0039] In some embodiments, the needle safety device 400 is disposed within the catheter hub body 120 adjacent to the septum canister 300. The needle safety device 400 can include a body 402 having a distal end 404 and a proximal end 406. The needle safety device 400 can also include a central passageway 408. As described below, the needle safety device 400 can protect the physician from an inadvertent needle stick by engaging the distal tip 176 of the needle 172. The engaged safety device 400 is maintained on the distal tip 176 of the needle 172 when the needle safety device 400 is removably disengaged from the catheter adapter 102 (see FIG. 6 ).

[0040] 5A through 5H, several embodiments of various configurations of the septum 200 and septum canister 300 are shown. FIG. 5A shows a side view of the septum 200 and septum canister 300, and FIG. 5B shows a cutaway view of FIG. 5A. FIGS. 5A and 5B show that the septum 200 can include a generally tubular and / or cylindrically shaped septum body 202 including a distal end 204 and a proximal end 206. The septum body 202 can include a distal wall 207 with a slit 208 therethrough. The septum body 202 can also include an extension 210 extending from the septum body 202 at a shoulder 212. The septum body 202 and / or the extension 210 can define a lumen 214 with a proximal opening 216.

[0041] The septum canister 300 may include a generally tubular and / or cylindrically shaped body 302 with a distal end 304 and a proximal end 306. The septum canister 300 may include a wall 307 and a septum canister opening 308 in the wall 307. The septum canister 300 may include a distal extension 310 extending distally from the wall 307 and defining a first lumen 312. A retaining ridge 314 may be disposed at the distal end of the distal extension 310. In some cases, the extension 210 of the septum body 202 may be configured to be slidably received within the first lumen 312 of the septum canister 300. In other cases, the retaining ridge 314 of the septum canister 300 may fit against a shoulder 212 of the septum 200.

[0042] 5C-5D, several embodiments of various configurations of the septum 200 and septum canister 300 are shown. FIG. 5C shows a side view of the septum 200 and septum canister 300, and FIG. 5D shows a cutaway view of FIG. 5C. FIGS. 5C and 5D illustrate that the septum 200 can include a generally tubular and / or cylindrically shaped septum body 202 including a distal end 204 and a proximal end 206. The septum body 202 can include a distal wall 207 with a slit 208 therethrough. The septum body 202 can also include an extension 210 extending from the septum body 202 at a shoulder 212. The septum body 202 and / or the extension 210 can define a lumen 214 with a proximal opening 216.

[0043] The septum canister 300 may include a generally tubular and / or cylindrically shaped body 302 with a distal end 304 and a proximal end 306. The septum canister 300 may include a wall 307 and a septum canister opening 308 in the wall 307. The septum canister 300 may include a distal extension 310 extending distally from the wall 307 and defining a first lumen 312. A retention ridge 314 may be disposed at the distal end of the distal extension 310. The extension 210 of the septum body 202 may be configured to be slidably received within the first lumen 312 of the septum canister 300, and the retention ridge 314 of the septum canister 300 may fit against the shoulder 212 of the septum 200.

[0044] In some examples, the septum canister 300 can include a proximal extension 316 extending from the wall 307. The proximal extension 316 of the septum canister 300 can define a second lumen 318. In other examples, the proximal extension 316 of the septum canister 300 can be configured to extend into the proximal extension 130 of the catheter hub body 120. In yet other examples, the second lumen 318 can be configured to selectively and removably receive at least a portion of the needle safety device 400.

[0045] 5E-5F, several embodiments of various configurations of septum 200 and septum canister 300 are shown. FIG. 5E shows a side view of septum 200 and septum canister 300, and FIG. 5F shows a cutaway view of FIG. 5E. FIGs. 5E and 5F show that septum 200 can include a generally disk-shaped septum body 202 that includes a distal end 204 and a proximal end 206 and defines a lumen 214. Septum body 202 can include a slit 208. Septum canister 300 can include a generally tubular and / or cylindrically shaped body 302 with a distal end 304 and a proximal end 306.

[0046] The septum canister 300 can include a wall 307 and a septum canister opening 308 within the wall 307. The septum canister 300 can include a proximal extension 316 extending proximally from the wall 307 and defining a second lumen 318. The proximal extension 316 of the septum canister 300 can be configured to extend into the proximal extension 130 of the catheter hub body 120. The second lumen 318 can also be configured to selectively and removably receive at least a portion of the needle safety device 400. In some cases, the retention ridge 314 can extend outward from the wall 307. In other cases, the retention ridge 314 of the septum canister 300 can fit against the shoulder 212 of the septum 200.

[0047] 5G-5H, several embodiments of various configurations of septum 200 and septum canister 300 are shown. FIG. 5G shows a side view of septum 200 and septum canister 300, and FIG. 5H shows a cutaway view of FIG. 5G. FIG. 5G and FIG. 5H show that septum 200 can include a generally solid, disk-shaped septum body 202 including a distal end 204 and a proximal end 206. Septum body 202 can include a slit 208 therethrough.

[0048] The septum canister 300 may include a generally tubular and / or cylindrically shaped body 302 with a distal end 304 and a proximal end 306. The septum canister 300 may include a wall 307 and a septum canister opening 308 within the wall 307. The septum canister 300 may include a proximal extension 316 extending proximally from the wall 307 and defining a second lumen 318. The proximal extension 316 of the septum canister 300 may be configured to extend within the proximal extension 130 of the catheter hub body 120. The second lumen 318 may also be configured to selectively and removably receive at least a portion of the needle safety device 400. A retaining ridge 314 may extend outward from the wall 307. In some cases, the distal side of the wall 307 may fit against the proximal end 206 of the septum 200.

[0049] Referring now to FIG. 6, a side view of the needle hub 104 in a detached configuration is shown. FIG. 6 illustrates that in the detached configuration, the needle hub 104 can be fully retracted and separated from the catheter adapter 102. The first wing 146 is also separated from the paddle grip 186. In the detached configuration, the needle 172 can be completely removed from the catheter adapter 102. Similarly, the engaged safety device 400 is removably disengaged from the catheter adapter 102, and the engaged safety device 400 is retained on the distal tip 176 of the needle 172 to protect the physician from an inadvertent needle stick. The detached needle hub 104 can then be properly disposed of.

[0050] In some embodiments, a catheter system 100, such as the catheter system 100 described in any of Figures 1-6, may include a needle safety device 400. The needle safety device 400 may include any safety mechanism configured to secure the distal tip 176 and / or beveled opening 178 of the needle 172 when the needle 172 is withdrawn from the catheter 115 of the catheter system 100, preventing an accidental needle stick.

[0051] The needle safety device 400 may be coupled to the catheter system 100 in any number of ways. In some embodiments, the needle safety device 400 may include an internal interlock in which the needle safety device 400 is coupled to the interior surface of the catheter adapter 102. The coupling may include threading, fitting, snapping, connecting, attaching, fastening, clipping, hooking, or any other suitable means of coupling. Non-limiting examples of needle safety devices 400 including internal interlocks are provided in U.S. Patent Application Publication No. 2009 / 0023999, entitled "BI-DIRECTIONAL CANNULA FEATURE CAPTURE MECHANISM," filed March 2, 2009; U.S. Patent Application Publication No. 2009 / 0023999, entitled "BI-DIRECTIONAL CANNULA FEATURE CAPTURE MECHANISM," filed July 11, 2013; and U.S. Patent Application Publication No. 2016 / 0023999, entitled "CANNULA CAPTURE MECHANISM," filed March 28, 2016, each of which is incorporated herein by reference in its entirety. In some embodiments, the needle safety device 400 may include a clip disposed within the catheter adapter 102, a non-limiting example of which is provided in U.S. Patent Application Publication No. 2007 / 012998, entitled "SPRING CLIP SAFETY IV CATHETHER," filed June 12, 1998, which is incorporated herein by reference in its entirety.

[0052] In some embodiments, the needle safety device 400 may include an external interlock in which the needle safety device 400 is coupled to the exterior surface of the catheter adapter 102. In some embodiments, the needle safety device 400 may be coupled to the exterior surface of the catheter adapter 102 and the interior and / or exterior surface of the needle hub 104. The coupling may include threading, fitting, snapping, connecting, attaching, fastening, clipping, hooking, or any other suitable means of coupling. A non-limiting example of a needle safety device 400 including an external interlock is provided in U.S. Patent Application Publication No. 2014 / 0129999, entitled "PORTED IV CATHETER HAVING EXTERNAL NEEDLE SHIELD AND INTERNAL BLOOD CONTROL SEPTUM," filed June 4, 2014, which is incorporated herein by reference in its entirety. In some embodiments, the needle safety device 400 may include a V-clip or similar clip. A non-limiting example of a V-clip is provided in U.S. Patent Application Publication No. 2014 / 0129999, entitled "PORTED IV CATHETER HAVING EXTERNAL NEEDLE SHIELD AND INTERNAL BLOOD CONTROL SEPTUM," filed June 4, 2014, which is incorporated herein by reference in its entirety. The V-clip may selectively retain a portion of the catheter adapter 102.

[0053] In some embodiments, a defeatable mechanical connection is provided between the needle safety device 400 and at least one other component of the catheter system 100. In some instances, the mechanical connection is defeated upon fixation of the distal tip 176 of the needle 172 within the needle safety device 400. In some embodiments, a surface of the needle safety device 400 selectively couples to one or more of the following: the catheter adapter 102, the needle hub 104, the fixation platform 118, the proximal extension 130, the paddle grip 186, and the septum canister 300.

[0054] In some embodiments, the needle safety device 400 may include a safety barrel, which may be spring-loaded. For example, the safety barrel may be a BD™ Insight® Autoguard™ BC Shielded Protective IV Catheter (BD TM Insyte® Autoguard TM It may be spring-loaded, such as in the BC shielded protective IV catheter. In some embodiments, the needle safety device 400 may be passively and / or actively activated. In some embodiments, the needle safety device 400 may be configured to interact with a needle feature, such as a ferrule, notch, crimp, or bump on the needle 172. In some embodiments, the needle safety device 400 may include an arm or lever that may be activated to capture the distal tip 176 within the needle safety device 400 and prevent the distal tip 176 from surfacing prior to safe handling. In some embodiments, the needle safety device 400 may be attached to the body of the needle 172 and may be able to slide along its length.

[0055] In some embodiments, in the insertion configuration, the needle safety device 400 may be positioned between the catheter adapter 102 and the needle hub 104 prior to catheter insertion. In some embodiments, the catheter adapter 102 and the needle hub 104 may be spaced apart by at least a portion of the needle safety device 400 prior to catheter insertion in the insertion configuration. In some embodiments, in the insertion configuration, the proximal end of the catheter adapter 102 may be positioned between the distal end 404 of the needle safety device 400 and the distal end of a grip of the needle hub 104, such as the paddle grip 186, prior to catheter insertion. In some embodiments, in the insertion configuration, the proximal end 124 of the catheter hub body 120 may be positioned between the distal end 404 of the needle safety device 400 and the proximal end 124 of the grip of the needle hub 104 prior to catheter insertion. In some embodiments, a portion of the needle safety device may overlap a portion of the grip of the needle hub 104. In some embodiments, at least a portion of at least one of the catheter adapter 102 and the grip overlaps at least some portion of the needle safety device 400. In some embodiments, no portion of the catheter hub body 120 or the grip overlaps any portion of the needle safety device 400.

[0056] 7A-7B, several embodiments of a needle safety device 400 are shown that are similar to the embodiments disclosed in U.S. Patent Application Publication No. 2016 / 0122999, entitled "CANNULA CAPTURE MECHANISM," filed March 28, 2016. FIG. 7A illustrates an embodiment of the needle safety device 400 when the distal tip 176 of the needle 172 is retracted within the needle safety device 400. FIG. 7B illustrates an embodiment of the needle safety device 400 with the distal tip 176 of the needle engaged within the needle safety device 400. In some cases, the needle safety device 400 includes a body 402 with a distal end 404, a proximal end 406, and a central passageway 408 therethrough. The needle safety device 400 can include a base 410 attached to a first splayed member 412 and a second splayed member 414. The first splayed member 412 can include a first end piece 416. The second flared member 414 can include a second end piece 418. The needle safety device 400 can also include a spring 420 configured to bias a retaining collar 422 against the first end piece 416 and the second end piece 418, thereby biasing the first end piece 416 against the second end piece 418.

[0057] As shown in FIG. 7A , as the needle 172 is retracted, the needle 172 can slidably move between the first and second end pieces 416, 418. The needle 172 can include a needle feature, such as a bulge 192 near the distal tip 176 of the needle 172. As the bulge 192 is drawn through the first and second end pieces 416, 418, the first and second end pieces 416, 418 are biased open, allowing the bulge 192 to pass between them. As shown in FIG. 7B , once the distal tip 176 passes between the first and second end pieces 416, 418, the first and second end pieces 416, 418 are biased together, preventing the distal tip 176 of the needle 172 from exiting the needle safety device 400. Bulge 192 prevents needle 172 from continuing through needle safety device 400, effectively irreversibly engaging needle safety device 400 with distal tip 176 to prevent inadvertent needle sticks.

[0058] 8A-8B, several embodiments of a needle safety device 400 are shown that are similar to the embodiments disclosed in U.S. Patent Application Publication No. 2016 / 0129999, entitled "CANNULA CAPTURE MECHANISM," filed March 28, 2016. FIG. 8A illustrates an embodiment of the needle safety device 400 when the distal tip 176 of the needle 172 is retracted within the needle safety device 400. FIG. 8B illustrates an embodiment of the needle safety device 400 with the distal tip 176 of the needle engaged within the needle safety device 400. In some cases, the needle safety device 400 includes a body 402 with a distal end 404, a proximal end 406, and a central passageway 408 therethrough. The needle safety device 400 can include a base 430 attached to a first splayed member 432 and a second splayed member 434. The first splayed member 432 can include a first end piece 436. The second flared member 434 can include a second end piece 438. The first flared member 432 can include a first cutout 440. The second flared member 434 can include a second cutout 442. The first and second cutouts 440, 442 can be dimensioned to receive the bulge 192 of the needle 172. The first flared member 432 and the second flared member 434 bias the first end piece 436 and the second end piece 438 together.

[0059] As shown in FIG. 8A , when the needle 172 is retracted, the needle 172 can slidably move between the first and second end pieces 436, 438. The needle 172 can include a bulge 192 near the distal tip 176 of the needle 172. As the bulge 192 is withdrawn from the first and second end pieces 436, 438, the first and second end pieces 416, 418 are biased open by the bulge 192, and the bulge 192 can pass between the first and second end pieces 436, 438. As shown in FIG. 7B , once the distal tip 176 passes between the first and second end pieces 436, 438, the first and second end pieces 436, 438 are biased together, preventing the distal tip 176 of the needle 172 from exiting the needle safety device 400. The bulge 192 can be received by the first and second cutouts 440, 442 to effectively engage the bulge 192 and effectively irreversibly engage the needle safety device 400 to the distal tip 176 to prevent inadvertent needle sticks.

[0060] 9A-9B, several embodiments of a needle safety device 400 comprising a V-spring are shown. FIG. 9A illustrates an embodiment of the needle safety device 400 when the distal tip 176 of the needle 172 is retracted within the needle safety device 400. FIG. 9B illustrates an embodiment of the needle safety device 400 with the distal tip 176 of the needle engaged within the needle safety device 400. In some cases, the needle safety device 400 includes a body 402 having a distal end 404, a proximal end 406, and a central passageway 408 therethrough. The needle safety device 400 can include a spring frame 450 having a proximal opening 452 and a distal opening 454. The spring frame 450 can include a V-spring 456 with a shutter 458. The V-spring 456 can be configured to bias against the needle 172. 9A, as the needle 172 is retracted, the needle 172 can slidably move between the distal opening 454 and the proximal opening 452. The needle 172 can include a bulge 192 near the distal tip 176 of the needle 172. The needle 172 and / or the bulge 192 maintain the V-spring 456 in a biased position against the spring frame 450 as the needle 172 is pulled between the distal opening 454 and the proximal opening 452.

[0061] 9B, once distal tip 176 passes through V-spring 456, V-spring 456 opens and shutter 458 blocks distal opening 454, thereby preventing distal tip 176 of needle 172 from re-exiting needle safety device 400. Bulge 192 can be retained by proximal opening 452, which effectively engages bulge 192 and effectively irreversibly engages needle safety device 400 to distal tip 176, preventing an inadvertent needle stick.

[0062] While the catheter system 100 can be manufactured from any suitable material, in at least some embodiments, the catheter adapter 102 and needle hub 104 are formed from a thermoplastic polymeric resin, such as polycarbonate, polystyrene, polypropylene, and other similar materials. The catheter adapter 102 and needle hub 104 can be formed from a substantially transparent material to allow a physician to visually confirm the needle 172 as it is slidably removed and to view primary and / or secondary blood flashback. The catheter 115 can be formed from a thermoplastic resin, such as polytetrafluoroethylene (FIFE), polyurethane, and other similar materials. In some cases, the catheter 115 can be formed from a thermoplastic hydrophilic polyurethane that softens upon exposure to physiological conditions within a patient's body. The needle 172, spring 420, and V-spring 456 can be formed from a stainless steel alloy or other similar material.

[0063] The present invention may be embodied in other specific forms without departing from its structure, methods, or other essential characteristics as broadly described herein and claimed below. The described embodiments are to be considered in all respects merely as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims, rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims

1. A catheter adapter, A catheter hub including a distal end and a proximal end and defining a chamber extending between the distal end and the proximal end, a septum disposed within the chamber; a septum canister disposed within the chamber and configured to secure the septum within the catheter hub; a catheter extending from the distal end of the catheter hub and in fluid communication with the chamber; and Fixed platform, a catheter adapter including: A needle hub, a needle configured to slidably fit within the catheter, the outer surface of the needle includes an axial channel extending along the outer surface from the distal end of the needle, the axial channel extending into the chamber of the catheter hub in the insertion configuration to provide a flow path for blood flashback; a needle hub body secured to the proximal end of the needle; a needle hub including: A catheter system comprising: In an insertion configuration, the proximal end of the catheter hub is removably coupled within the distal opening of the needle hub; and After placement of the catheter, the needle hub is retracted from the catheter adapter to slidably remove the needle from the catheter and to separate the needle hub from the catheter adapter; The septum canister (300) a wall (307) with an opening (308); a distal extension (310) extending distally from said wall (307) and defining a first lumen (312); a distal extension (310) whose distal end includes a retention ridge (314) configured to retain the septum (200) and septum canister (300) within the catheter hub; and a proximal extension (316) extending proximally from the wall (307) and defining a second lumen (318).

2. 10. The catheter system of claim 1, wherein the needle comprises an annular wall and an open bore extending distally from the needle, the annular wall separating the open bore and the axial channel such that the axial channel does not enter the open bore of the needle.

3. 10. The catheter system of claim 1, wherein the needle includes an open hole in fluid communication with the chamber of the needle hub, and blood flows through the open hole into the chamber of the needle hub to provide a secondary blood flashback indicating that the needle has entered the patient's vasculature.

4. 10. The catheter system of claim 1, wherein the anchoring platform further includes wings that include a generally planar shape for maintaining the catheter adapter stable against the patient's skin.

5. 10. The catheter system of claim 1, wherein the fixation platform further comprises a soft push tab configured to provide a gripping surface for manipulating and advancing the catheter adapter.

6. 10. The catheter system of claim 1, wherein the catheter hub further comprises a Y-port in fluid communication with the chamber of the catheter hub.

7. 10. The catheter system of claim 1, wherein the needle hub further includes a paddle grip extending from a distal end of the needle hub and configured to provide a gripping surface for manipulating the needle hub.

8. 8. The catheter system of claim 7, wherein the fixation platform includes wings having a planar shape, the paddle grip includes another planar shape that is coplanar with the planar shape of the wings, and the paddle grip includes a lid configured to receive a trailing edge of the wings.

9. 10. The catheter system of claim 1, further comprising a needle safety device configured to protect against needle sticks by engaging a distal tip of the needle as the needle is retracted from the catheter adapter.

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