SKIN NICKING DEVICE FOR A CATHETER DEPLOYMENT SYSTEM - Patent application

Abstract

The catheter deployment assembly (100) includes a catheter (150) and a skin nicking device (200) having a blade (230) configured to transition between a covered configuration and a deployed configuration. The skin nicking device (200) includes a needle (120) having a slot (228) extending through a needle wall (224), the blade (230) being disposed within the slot (228) and hinged to the needle wall (224) defining a fulcrum (260). The skin nicking device (200) includes a push rod (250) within the needle lumen (222), the push rod (250) having a distal end (251, 258) that operably engages the blade (230) such that displacement of the push rod (250) between a proximal position and a distal position, respectively, transitions the blade (230) between the covered configuration and the deployed configuration.

Description

[Technical field]

[0001] The present disclosure relates to a skin nicking device for a catheter placement system. [Background technology]

[0002] Central venous catheters ("CVCs") are typically introduced into a patient and advanced through the patient's vascular system via the Seldinger technique. The Seldinger technique utilizes many steps and medical devices (e.g., needles, scalpels, guidewires, introducer sheaths, dilators, CVCs, etc.). Although the Seldinger technique is effective, many steps are time consuming and many medical devices are cumbersome to handle, which may lead to trauma or increased risk of infection for the patient. Due to the large number of medical devices that need to be replaced during the Seldinger technique, there is a relatively high chance of contact contamination. Thus, 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, in a patient.

[0003] Some of these advanced catheter placement systems include using a needle to access the vasculature and a guidewire to stabilize the access site. Once the guidewire is in place, a scalpel may be used to cut or score the skin and fascia at the insertion site to facilitate insertion of the catheter. If the skin incision is not made properly, a skin bridge may form, preventing insertion of the catheter through the skin and into the blood vessel. A skin nicking device may be used to create a repeatable cut depth and reduce the likelihood of leaving a skin bridge around the insertion site. Disclosed herein are advanced catheter placement systems and associated methods for scoring the skin at the insertion site to eliminate skin bridges that would prevent insertion of the catheter into the vasculature. Summary of the Invention

[0004] Disclosed herein is a catheter placement device including a skin nicking device configured to enlarge an insertion site opening. According to some embodiments, the skin nicking device includes: (i) a needle defining a needle lumen and a needle wall, the needle including a slot extending through the needle wall, a blade disposed within the needle lumen and aligned with the slot, and (iii) a push rod disposed within the needle lumen, the push rod including a distal portion configured to operably engage the blade such that proximal displacement of the push rod displaces the blade radially outward through the slot.

[0005] In some embodiments, the blade defines a sharp edge disposed opposite a blunt edge, and the blade is oriented within the needle lumen such that the sharp edge is directed radially outward, hi some embodiments, the sharp edge is disposed at an angle relative to the blunt edge such that a proximal width of the blade is greater than a distal width of the blade.

[0006] In some embodiments, the blade is transitionable between a covered configuration and a deployed configuration, where (i) in the covered configuration, the entire sharp edge is disposed radially inward of the outer surface of the needle, and (ii) in the deployed configuration, at least a portion of the sharp edge extends radially beyond the outer surface.

[0007] In some embodiments, the push rod is longitudinally positionable within the needle lumen between a proximal position and a distal position, and a distal portion of the push rod engages the blade such that distal displacement of the push rod from the proximal position toward the distal position transitions the blade from the covered configuration toward the deployed configuration.

[0008] In some embodiments, the operative engagement of the distal portion with the blade comprises sliding contact between the distal portion and a dull edge of the blade. In some embodiments, the distal portion comprises an angled surface and the operative engagement of the distal portion with the blade comprises sliding contact between the angled surface and the dull edge of the blade. In some embodiments, the distal portion comprises a taper that defines the angled surface. In some embodiments, the push rod comprises a channel along the distal portion, the blade is disposed within the channel, and a bottom surface of the channel defines the angled surface.

[0009] In some embodiments, the distal end of the blade is hinged to the needle wall defining a fulcrum such that the blade rotates between the covered and deployed configurations. In some embodiments, the blade is biased toward the covered configuration such that proximal displacement of the push rod from a distal position toward a proximal position allows the blade to self-rotate toward the covered configuration.

[0010] In some embodiments, the needle wall includes a push rod barrier that protrudes radially into the needle lumen, the push rod barrier configured to engage the push rod to limit distal displacement beyond a distal position of the push rod.

[0011] In some embodiments, the push rod includes a push rod lumen having an open proximal end and an open distal end, the push rod lumen configured to have a guidewire inserted therethrough, hi some embodiments, the skin nicking device includes a guidewire disposed within the push rod lumen.

[0012] In some embodiments, the skin nicking device includes an actuator operably coupled to the push rod, the actuator configured to displace the push rod between the proximal and distal positions.

[0013] In some embodiments, the skin nicking device includes a locking mechanism configured to lock the push rod in at least one of a proximal position or a distal position. Also disclosed herein, according to some embodiments, is a catheter assembly including: (i) a catheter including a catheter tube proximally coupled to a catheter hub having one or more extension legs proximally coupled from the catheter hub, the catheter tube defining one or more lumens, each of the one or more lumens in fluid communication with one of the extension legs; and (ii) a catheter placement device according to any of the embodiments described above. In some embodiments of the assembly, a needle of the catheter placement device is inserted into one of the one or more lumens of the catheter tube.

[0014] Also disclosed herein is a method of placing a catheter within a patient's blood vessel, which, according to some embodiments, includes: (i) inserting a needle of a skin nicking device through the skin and into the blood vessel to define an insertion site; (ii) transitioning a blade of the skin nicking device from a covered configuration to a deployed configuration such that a sharp edge of the blade extends radially away from an outer surface of the needle; (iii) scoring the skin with the sharp edge to enlarge the insertion site; and (iv) inserting the catheter into the blood vessel through the insertion site.

[0015] In some embodiments of the method, the skin nicking device includes a push rod disposed within a needle lumen of the needle, the push rod including a distal portion configured to operably engage a blade within the needle lumen such that distal displacement of the push rod displaces the blade radially outward through a slot extending through a wall of the needle.

[0016] In some embodiments of the method, the blade is transitionable between a covered configuration and a deployed configuration, where in the covered configuration the entire sharp edge is disposed radially inward of the outer surface of the needle and where in the deployed configuration at least a portion of the sharp edge extends radially beyond the outer surface.

[0017] In some embodiments of the method, the push rod is longitudinally positionable within the needle lumen between a proximal position and a distal position, and the distal portion engages the blade such that distal displacement of the push rod from the proximal position toward the distal position transitions the blade from the covered configuration toward the deployed configuration. In such embodiments, transitioning the blade of the skin nicking device from the covered configuration to the deployed configuration includes displacing the push rod from the proximal position to the distal position.

[0018] In some embodiments of the method, the distal end of the blade is hinged to the needle wall defining a fulcrum, and transitioning the blade from the covered configuration to the deployed configuration includes rotating the blade about the fulcrum.

[0019] In some embodiments, the method further includes displacing the push rod from a distal position toward a proximal position to transition the blade from the deployed configuration to the covered configuration. In some embodiments of the method, the blade is biased toward the covered configuration such that proximal displacement of the push rod toward the proximal position allows the blade to self-rotate toward the covered configuration.

[0020] In some embodiments of the method, the push rod includes a push rod lumen extending between an open proximal end and an open distal end, the push rod lumen configured to allow a guidewire to be inserted therethrough, and the method further includes inserting a guidewire through the push rod lumen.

[0021] Also disclosed herein is a method of manufacturing a catheter placement device, which according to some embodiments includes: (i) forming a slot extending through a needle wall of a needle; (ii) positioning a blade within the slot such that a sharp edge of the blade is oriented radially outward relative to the needle and the sharp edge is located inside an outer surface of the needle; and (iii) inserting a push rod into the needle lumen of the needle such that an angled surface of the push rod engages the blade.

[0022] In some embodiments, the method of manufacture further comprises hinging the blade to the needle wall such that the blade is pivotable through the slot. In some embodiments, the method of manufacture further includes forming a protrusion on an inner surface of the needle lumen to define a push rod barrier configured to limit distal displacement of the push rod within the needle lumen.

[0023] These and other features of the concepts provided herein will become more apparent to those of ordinary skill in the art upon consideration of the following description and accompanying drawings, which describe in more detail certain embodiments of such concepts.

[0024] A more particular description of the present disclosure will be made by reference to specific embodiments that are illustrated in the accompanying drawings. It is to be understood that these drawings depict only typical embodiments of the invention and are therefore not to be considered as limiting its scope. Exemplary embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief description of the drawings]

[0025] [Figure 1A] FIG. 1 shows a perspective view of a catheter deployment system in an unfolded configuration according to an embodiment disclosed herein. [Figure 1B] 1 shows a top view of a catheter deployment system in a folded configuration ready for use, according to an embodiment disclosed herein. [Figure 1C] FIG. 1 shows a perspective view of a catheter deployment system in a folded configuration according to an embodiment disclosed herein. [Diagram 2] FIG. 2 shows a side view of a catheter of a catheter deployment system in an unfolded configuration according to an embodiment disclosed herein. [Figure 3A] 3 shows an enlarged detailed view of a distal portion of the catheter of FIG. 2 according to an embodiment disclosed herein. [Figure 3B] 3B shows a cross-sectional view of the catheter of FIG. 3A according to an embodiment disclosed herein. [Figure 3C] 3B shows a cross-sectional view of the catheter of FIG. 3A according to an embodiment disclosed herein. [Figure 4] 1 shows a longitudinal cross-sectional view of a distal portion of a catheter deployment system according to an embodiment disclosed herein. [Figure 5A] 1 illustrates an exemplary method of use of a catheter deployment system according to embodiments disclosed herein. [Figure 5B] 1 illustrates an exemplary method of use of a catheter deployment system according to embodiments disclosed herein. [Figure 5C] 1 illustrates an exemplary method of use of a catheter deployment system according to embodiments disclosed herein. [Figure 5D] 1 illustrates an exemplary method of use of a catheter deployment system according to embodiments disclosed herein. [Figure 5E] 1 illustrates an exemplary method of use of a catheter deployment system according to embodiments disclosed herein. [Figure 6A] 1 shows a cross-sectional view of a skin nicking device, according to some embodiments. [Figure 6B] FIG. 6B is a side view of the distal portion of the push rod of FIG. 6A showing a second embodiment of an angled surface, according to some embodiments. [Figure 6C] FIG. 6B is a side view of the distal portion of the push rod of FIG. 6A showing a third embodiment of an angled surface, according to some embodiments. [Figure 7A] 1A-1D show cross-sectional views of a skin nicking device in a concealed configuration and a deployed configuration, according to some embodiments. [Figure 7B] 1A-1D show cross-sectional views of a skin nicking device in a concealed configuration and a deployed configuration, according to some embodiments. [Figure 8] 1 shows a flowchart of an exemplary method of placing a catheter using a catheter insertion system, according to some embodiments. [Figure 9] 6B shows a flowchart of an exemplary method of manufacturing the skin nicking device of FIG. 6A, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] Before some specific embodiments are disclosed in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein can have features that can be easily separated from the specific embodiment and, optionally, combined with or substituted for features of any of the other numerous embodiments disclosed herein.

[0027] With regard to the terms used herein, it should also be understood that the terms are intended to describe some particular embodiments, and that 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 within a group of features or steps, and do not provide sequential or numerical limitations. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Designations such as "left", "right", "up", "down", "front", "rear", etc. are used for convenience and do not imply, for example, a particular fixed position, orientation, or direction. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "one", "one", and "the" also include plural references unless the context clearly dictates otherwise.

[0028] With respect to "proximal," for example, a "proximal portion" or "proximal end portion" of a catheter disclosed herein includes a portion of the catheter intended to be near a clinician when the catheter is used on a patient. Similarly, for example, a "proximal length" of a catheter includes a length of the catheter intended to be near a clinician when the catheter is used on a patient. For example, a "proximal end" of a catheter includes an end of the catheter intended to be near a clinician when the catheter is used on a patient. Although a proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter, a proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless otherwise suggested by context, a proximal portion, proximal end portion, or proximal length of a catheter is not a terminal portion or terminal length of a catheter.

[0029] With respect to "distal," for example, a "distal portion" or "distal end portion" of a catheter disclosed herein includes a portion of the catheter that is intended to be near or within a patient when the catheter is used with a patient. Similarly, for example, a "distal length" of a catheter includes a length of the catheter that is intended to be near or within a patient when the catheter is used with a patient. For example, a "distal end" of a catheter includes an end of the catheter that is intended to be near or within a patient when the catheter is used with a patient. A distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter, but a distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless otherwise suggested by context, a distal portion, distal end portion, or distal length of a catheter is not a terminal portion or terminal length of a catheter.

[0030] Any method disclosed herein includes one or more steps or actions for carrying out the described method. Method steps and / or actions may be interchangeable with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and / or use of specific steps and / or actions may be modified. Furthermore, only subroutines or portions of methods described herein may be separate methods within the scope of the present disclosure. In other words, some methods may include only a portion of the steps described in a more detailed method. In addition, all embodiments disclosed herein are combinable and / or interchangeable unless otherwise stated or unless such combination or interchange is contrary to the described operability of any embodiment.

[0031] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. 1A-1C generally illustrate an exemplary advanced catheter placement system ("system") 100 including a needle 120, a guidewire 130, a syringe system 140, a catheter 150, and a needle housing ("housing") 170. FIG. 1A illustrates the system 100 in an unfolded configuration for ease of illustration. FIG. 1B illustrates a top view of the system 100 in a folded configuration ready for use. FIG. 1C illustrates a perspective view of the system 100 in a folded configuration. In one embodiment, the catheter placement system 100 may be a Rapidly Insertable Central Catheter (RICC) placement system 100 configured to place a RICC 150. However, it will be understood that other catheter placement systems configured to place other types of catheters are also contemplated. Exemplary catheters 150 may also include peripheral intravenous (PIV) catheters, peripherally inserted central catheters (PICCs), central venous catheters (CVCs), midline catheters, dialysis catheters, single lumen catheters, multi-lumen catheters, and the like.

[0032] In one embodiment, the catheter 150 may generally include a catheter body 152 supported at a proximal end by a catheter hub ("hub") 160. The hub 160 may include one or more extension legs 162 extending proximally therefrom. Each extension leg of the one or more extension legs 162 may be in fluid communication with a lumen of the catheter body 152. The catheter body 152 may include a distally disposed first section 154, a proximally disposed second section 156, and a transition section 158 disposed therebetween. The first section 154 may define a single lumen and have a first outer diameter, and the second section 156 may define two or more lumens and have a second diameter greater than the first diameter. The transition section 158 disposed between the first section 154 and the second section 156 may define a tapered shape extending from a first diameter of the first section to a second diameter of the second section. The guidewire 130 may extend through the lumen of the catheter 150 from the proximal end of the extension leg 162 to the distal tip of the first section 154 .

[0033] FIG. 2 shows further details of an exemplary catheter 150 of the system 100. As described herein, different sections of the catheter 150 must perform different functions and therefore must exhibit different mechanical properties. For example, the first section 154 and the transition section 158 may be provided with stiffer mechanical properties or harder durometer material relative to the second section 156. Thus, the first section 154 and the transition section 158 can withstand greater axial forces without kinking or collapsing as the sections are forced distally to form and expand the insertion site. The second section 156 may be formed from a softer durometer or more flexible material to facilitate passing the second section 156 through tortuous vascular pathways.

[0034] 3A-3C show further details of a distal portion of catheter 150, including first section 154, second section 156, and transition section 158. In one embodiment, second section 156 can include a proximal lumen 114A terminating at a proximal lumen opening 116A and an intermediate lumen 114B terminating at an intermediate lumen opening 116B. Each of proximal lumen opening 116A and intermediate lumen opening 116B can extend through a sidewall of second section 156. Each of proximal lumen opening 116A and intermediate lumen opening 116B can be disposed proximal to transition section 158. Proximal lumen opening 116A can be disposed proximal to intermediate lumen opening 116B.

[0035] FIG 3B shows a cross-sectional view of the catheter body 152 at point "A" in FIG 3A. As shown, the first section 154 can define a single lumen and a relatively small outer diameter. In one embodiment, a proximal portion of the first section 154 can be received within a distal portion of the transition section 158. The distal lumen 114C of the catheter 150 can extend to the distal tip 118 of the catheter 150 and can communicate with the distal lumen opening 116C. FIG 3C shows a cross-sectional view of the second section 156 at point "B" in FIG 3A, showing the proximal lumen 114A, the intermediate lumen 114B, and the distal lumen 114C.

[0036] FIG. 4 shows a longitudinal cross-sectional view of a distal portion of the catheter placement system 100 including the needle 120, the 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 one embodiment, the proximal end of the needle 120 may be supported by a needle hub, which may be coupled to and supported by a distal end of the syringe system 140. The syringe system 140 may be in fluid communication with the needle lumen 122. The syringe system 140 may be configured to form a vacuum therein to draw a fluid flow proximally through the needle lumen 122. In one embodiment, the needle 120 may include a guidewire aperture 124 disposed in a wall of the needle 120 and in communication with the needle lumen 122. A distal portion of the guidewire 130 may extend into the needle lumen 122 through the guidewire aperture 124. In one embodiment, the distal tip 138 of the guidewire 130 can be disposed proximate to the distal tip 128 of the needle 120. Thus, when the needle 120 accesses the vasculature, the distal tip 138 of the guidewire 130 can be positioned within the vasculature to facilitate placement of the catheter 150.

[0037] In one embodiment, the catheter placement system 100 can include a housing 170. The housing 170 can include a housing lumen 172 extending between a proximal end 176 and a distal end 178 of the housing 170. The housing 170 can further include a guidewire lumen 174 in communication with the housing lumen 172 and extending at an angle therefrom. A portion of the needle 120 can be slidably engaged with the housing lumen 172. Additionally, the proximal end 176 of the housing can be releasably engaged with one or both of the needle hub and the distal portion of the syringe system 140. When the housing 170 is engaged with the syringe system 140, the guidewire opening 124 of the needle 120 can be aligned with the guidewire lumen 174 of the housing 170. In this manner, the guidewire 130 can extend through the guidewire lumen 174 of the housing 170, through the guidewire opening 124 of the needle 120, and into the needle lumen 122.

[0038] 5A-5E illustrate an exemplary method of placing a catheter 150 using the catheter placement system 100. As shown in FIG. 5A, the needle 120 can penetrate the patient's superficial tissue 90 to access the vasculature 80 and create an insertion site. As shown in FIG. 5B, a syringe system 140 or similar device can create a vacuum to draw fluid flow proximally through the needle lumen 122. The user can observe color or pulsatile flow characteristics to confirm correct vascular access. If incorrect vascular access is confirmed, the needle 120 can be removed and the insertion site can be closed. As shown in FIG. 5C, once correct vascular access is confirmed, a guidewire 130 can then be advanced through the needle lumen 122 and into the vasculature 80 to maintain patency of the insertion site.

[0039] 5D, 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 longitudinally split the needle 120 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.

[0040] With the needle 120 and syringe system 140 assembly disengaged from the guidewire 130, as shown in FIG. 5E, the catheter 150 may then be advanced over the guidewire 130 into the vasculature. A first section 154 of the catheter 150, having only a single lumen and defining a relatively small outer diameter, may enter the vasculature 80 over the guidewire 130 and anchor the insertion site. The transition section 158 may then be urged distally to expand the insertion site to allow a relatively larger diameter second section 156, defining two or more lumens, to enter the vasculature 80. Once the catheter 150 is positioned, the guidewire 130 may be withdrawn proximally.

[0041] Further details and embodiments of such a catheter deployment system 100 can be found in, for example, U.S. Pat. No. 10,376,675; U.S. Patent Application Publication Nos. 2019 / 0255294, 2021 / 0069471, 2021 / 0085927, 2021 / 0113809, 2021 / 0113810, 2021 / 0121661, 2021 / 0121667, 2021 / 0228843, 2021 / 0322729, and US Pat. Nos. 2021 / 0330941, 2021 / 0330942, 2021 / 0361915, 2021 / 0402153, 2021 / 0402149, 2022 / 0001138, U.S. Patent Application Publication No. 17 / 390682, filed July 30, 2021, and U.S. Provisional Patent Application No. 63 / 229862, filed August 5, 2021, each of which is incorporated by reference in its entirety into this application.

[0042] 6A shows a cross-sectional view of a skin nicking device 200 according to some embodiments, which may generally comprise a catheter placement device. The skin nicking device 200 may be used in cooperation with the catheter placement system 100. In some embodiments, the skin nicking device 200 may be integrated into the catheter placement system 100. In some embodiments, the skin nicking device 200 may be pre-attached or pre-integrated into the catheter placement system 100. Similarly, the skin nicking device 200 may be coupled with a catheter, such as catheter 150, to define a catheter assembly. In some embodiments of the catheter assembly, the skin nicking device 200 may be inserted into a lumen of the catheter.

[0043] The skin nicking device 200 includes a needle 220 having a needle lumen 222 extending therethrough. The needle 220 defines a needle wall 224 including a slot (or opening) 228 extending through the needle wall 224 between the needle lumen 222 and an outer surface 226 of the needle 220. The skin nicking device 200 further includes a blade 230 and a push rod 250, each disposed at least partially within the needle lumen 222, with the blade 230 in physical contact with the push rod 250. In some embodiments, the skin nicking device 200 may include two or more blades 230 in physical contact with the push rod 250. In some embodiments in which the skin nicking device 200 includes two or more blades 230, the needle 220 may correspondingly include two or more slots 228, e.g., a slot 228 for each blade 230. In some embodiments, each set of blades 230 and slots 228 may be laterally or transversely offset from the other set(s) of blades 230 and slots 228.

[0044] The push rod 250 may be configured to transition the blade 230 from the covered configuration to the deployed configuration, as described in more detail herein. The blade 230 includes a sharp edge 236 and a blunt edge 238 opposite the sharp edge 236. The blade 230 may be aligned with the slot 228 such that a portion of the blade 230 or the entire blade 230 may be displaced through the slot 228. The sharp edge 236 is oriented radially outwardly and the blunt edge 238 is oriented radially inwardly relative to the needle 220. The blade 230 defines a proximal end 232 and a distal end 234.

[0045] In some embodiments, the distal end 234 of the blade 230 is hinged to the needle wall 224, which defines a fulcrum 260, such that the blade 230 is rotatable or pivotable about the fulcrum 260 through the slot 228. In some embodiments, the fulcrum 260 may be configured to allow the proximal end 232, including a portion of the sharp edge 236 of the blade 230, to rotate out of the needle lumen 222 through the slot 228 such that the sharp edge 236, or a portion thereof, extends radially outward of the outer surface 226. In some embodiments, the blade 230 may be tapered (i.e., the sharp edge 236 is disposed at an angle relative to the blunt edge 238 such that the blade width 240 at the proximal end 232 is greater than the blade width 240 at the distal end 234).

[0046] The push rod 250 includes a push rod body 252 that includes a distal portion 251. In the illustrated embodiment, the distal portion 251 defines a conical taper such that a push rod diameter 254 at a proximal end of the distal portion 251 is larger than the push rod diameter 254 at the distal portion 251 and at a distal end 258. In the illustrated embodiment, the conical taper defines an angled surface 253A configured to engage (e.g., slidably contact) the blade 230. In some embodiments, the distal portion 251 may have a consistent taper rate from the proximal end to the distal end 258 of the distal portion 251. In some embodiments, the consistent taper rate may be configured to allow the blade 230 to slide smoothly along the angled surface 253A, thereby allowing the blade 230 to smoothly transition between the covered configuration and the deployed configuration. The push rod 250 may be biased (or displaced) distally or proximally along the needle lumen 222. In some embodiments, the push rod 250 may be manually moved through the needle lumen 222. In other embodiments, the push rod 250 may be coupled to an actuator (not shown), e.g., a spring, button, etc., that displaces the push rod 250 along the needle lumen 222 or allows a user to displace the push rod 250 along the needle lumen 222. In some embodiments, the push rod 250 may have high stiffness from the proximal end (not shown) of the distal portion 251 / push rod 250 to the distal end 258. In other embodiments, the push rod 250 may include one or more flexible portions and one or more rigid portions. In some embodiments, the angled surface 253A may slide along the blunt edge 238 of the blade 230 or vice versa, displacing the sharp edge 236 of the blade 230 radially outward through the slot 228.

[0047] In some embodiments, the push rod 250 may include a push rod lumen 259 extending along the entire length or a portion thereof, the push rod lumen 259 defining an open proximal end and an open distal end. The push rod lumen 259 is configured to allow a guide wire (e.g., guide wire 130) to be passed therethrough. In some embodiments, the skin nicking device 200 includes a guide wire inserted within the push rod lumen 259. The push rod 250 may extend through a portion or the entirety of the needle lumen 222. In some embodiments, the push rod 250 may be removable from the needle lumen 222. For example, the push rod 250 may be retractable from the proximal end of the needle lumen 222. In some embodiments, the angled surface 253A may include one or more notches (not shown) along the distal portion 251 or the angled surface 253A, each notch corresponding to an extension distance of the blade 230 beyond the outer surface 226. In some embodiments, the proximal end 232 of the blade 230 may operatively engage respective notches that define detents as the push rod 250 is distally displaced, and in some embodiments the detents provide tactile feedback. In use, the one or more notches may allow a user to variably define the depth of the incision / cut in the skin.

[0048] 6B is a side view of the distal portion 251 of the push rod 250 showing a second embodiment of the angled surface 253B. The angled surface 253B is formed from an angled cut across the push rod 250 to define a flat angled surface 253B extending along the distal portion 251.

[0049] 6C is a side view of distal portion 251 of push rod 250 with the front half of push rod 250 cut away to show a third embodiment of angled surface 253C. According to this embodiment, push rod 250 includes a channel (or slot) 257 extending along distal portion 251, with a bottom of channel 257 defining angled surface 253C. Channel 257 is configured to allow blade 230 to slidably fit therein such that blunt edge 238 of blade 230 may slide along angled surface 253C.

[0050] 7A-7B show cross-sectional views of the skin nicking device 200 showing the blade 230 transitioning from a covered configuration to a deployed configuration, according to some embodiments. FIG. 7A shows (i) the blade 230 in the covered configuration and (ii) the push rod 250 in a corresponding proximal position. As shown in FIG. 7A, the angled surface 253A can engage / contact the proximal end 232 of the blunt edge 238 of the blade 230. In the covered configuration, the entirety of the blade 230 is disposed below the outer surface 226. In some embodiments, the blade 230 may be biased toward the covered configuration, such as via a bond between the blade 230 and the needle wall 224. In one embodiment, the skin nicking device 200 may include a locking mechanism (not shown), such as a clip or detent, to latch the push rod 250 in the proximal position.

[0051] FIG. 7B shows the push rod 250 disposed in a corresponding distal position with the blade 230 in the deployed configuration. In use, a user can distally displace the push rod 250 from a proximal position to a distal position to transition the blade 230 from the covered configuration to the deployed configuration. As shown in FIG. 7B, the blunt edge 238 of the blade 230 slides along the angled surface 253A to displace the blade 230 radially outward through the slot 228. Furthermore, as the distal end 234 of the blade 230 is coupled to the needle wall 226 defining the fulcrum 260, the blade 230 is rotatably displaced through the slot 228 as the push rod 250 is distally displaced toward the distal position. Once the blade 230 is in the deployed configuration, the needle 220 can be used to score / cut the skin or other body tissue 90 (FIG. 5A). In some embodiments, a locking mechanism can latch the push rod 250 in the distal position, thereby latching the blade 230 in the deployed configuration.

[0052] In some embodiments, the longitudinal displacement of the push rod 250 may be constrained or limited within the needle lumen 222. For example, in one embodiment, the push rod barrier 270 may be suspended / projected inwardly from the needle wall 224 within the needle lumen 220. The push rod barrier 270 may be configured to limit distal displacement beyond a distal position of the push rod 250 within the needle lumen 222. In some embodiments, the push rod 250 may be pre-positioned at a proximal position. In one embodiment, the push rod barrier 270 may be configured to latch or be temporarily attached to the push rod 250 when the push rod 250 physically contacts the push rod barrier 270. In one embodiment, the push rod barrier 270 may be latched to the push rod 250 with a snap fit, an interference fit, or the like. In one embodiment, the push rod barrier 270 may have a magnetic element and the push rod 250 may have a ferrous element, allowing the push rod barrier 270 to be magnetically latched to the push rod 250 when the push rod 250 is in a distal position.

[0053] 8 shows a flowchart of an exemplary method 300 of placing a catheter in a patient's blood vessel, the method 300 including all or any subset of the following steps, actions, or processes: The method 300 may include inserting a needle of a skin nicking device through the skin and into the blood vessel to define an insertion site (block 310).

[0054] The method 300 may further include transitioning a blade of the skin nicking device from a covered configuration to a deployed configuration (block 320) such that a sharp edge of the blade extends radially away from an outer surface of the needle. In some embodiments of the method 300, the blade is transitionable between a covered configuration and a deployed configuration, where in the covered configuration the sharp edge is disposed entirely radially inward of the outer surface of the needle and in the deployed configuration at least a portion of the sharp edge extends radially beyond the outer surface. In some embodiments of the method 300, the skin nicking device includes a push rod disposed within a needle lumen of the needle, the push rod including a distal portion configured to operably engage the blade within the needle lumen such that distal displacement of the push rod displaces the blade radially outward through a slot in the needle wall. In some embodiments of the method 300, the push rod is longitudinally positionable within the needle lumen between a proximal position and a distal position, the distal portion engages the blade such that distal displacement of the push rod from the proximal position toward the distal position transitions the blade from the covered configuration toward the deployed configuration. In such embodiments, transitioning the blade from the covered configuration to the deployed configuration includes displacing the push rod from a proximal position to a distal position. In some embodiments of method 300, the distal end of the blade is hinged to the needle wall defining a fulcrum, and transitioning the blade from the covered configuration to the deployed configuration includes rotating / pivoting the blade about the fulcrum.

[0055] The method 300 may further include scoring the skin with a sharp edge to enlarge the insertion site (Block 330) and may further include inserting the catheter into the blood vessel through the insertion site (Block 340).

[0056] The method 300 may further include transitioning the blade from the deployed configuration to the covered configuration (block 350), which may include displacing the push rod from a distal position toward a proximal position to transition the blade from the deployed configuration to the covered configuration. In some embodiments of the method 300, the blade is biased toward the covered configuration such that proximal displacement of the push rod toward the proximal position allows the blade to self-rotate toward the covered configuration.

[0057] In some embodiments of method 300, the push rod includes a push rod lumen extending between an open proximal end and an open distal end, the push rod lumen configured for a guidewire to be inserted therethrough, and method 300 may further include inserting the guidewire through the push rod lumen. In such embodiments, method 300 further includes withdrawing the guidewire from the push rod lumen, thereby displacing the skin nicking device proximally along the guidewire until the skin nicking device is separated from the guidewire.

[0058] FIG. 9 shows a flow chart of an exemplary method of manufacturing a skin nicking device. The method of manufacturing 400 may include forming a slot extending through a needle wall of the needle (block 410). The method of manufacturing 400 may further include disposing a blade in the slot (block 420), with a sharp edge of the blade oriented radially outward relative to the needle and the sharp edge disposed inside the outer surface of the needle. The method of manufacturing 400 may further include inserting a push rod into the needle lumen of the needle (block 430) such that an angled surface of the push rod engages the blade. The method of manufacturing 400 may further include hingedly coupling the blade to the needle wall such that the blade is pivotable through the slot (block 440). The method of manufacturing 400 may further include forming a protrusion on an inner surface of the needle lumen to define a push rod barrier configured to limit distal displacement of the push rod within the needle lumen (block 450).

[0059] Although some specific embodiments have been disclosed herein, and those specific embodiments have been disclosed in some detail, those specific embodiments are not intended to limit the scope of the concepts provided herein. Further adaptations and / or modifications may become apparent to those skilled in the art, and are likewise encompassed in the broader aspects. Thus, departures from the specific embodiments disclosed herein may be made without departing from the scope of the concepts provided herein.

Claims

1. 1. A catheter placement device comprising: a skin nicking device configured to enlarge an insertion site opening, said skin nicking device comprising: a needle defining a needle lumen and a needle wall, the needle including a slot extending through the needle wall; a blade positioned within the needle lumen in alignment with the slot; a push rod disposed within the needle lumen, the push rod including a distal portion configured to operably engage the blades such that proximal displacement of the push rod displaces the blades radially outward through the slots.

2. the blade defines a sharp edge disposed opposite a dull edge; The device of claim 1 , wherein the blade is oriented within the needle lumen such that the sharp edge is oriented radially outward.

3. The device of claim 2 , wherein the sharp edge is disposed at an angle relative to the blunt edge such that the proximal width of the blade is greater than the distal width of the blade.

4. the blade is transitionable between a covered configuration and a deployed configuration; In the coated configuration, the entire sharp edge is disposed radially inward of the outer surface of the needle; The device of claim 2 or 3, wherein in the deployed configuration, at least a portion of the sharp edge extends radially beyond the outer surface.

5. the push rod is longitudinally positionable within the needle lumen between a proximal position and a distal position; 5. The device of claim 4, wherein the distal portion engages the blade such that distal displacement of the push rod from the proximal position toward the distal position transitions the blade from the covered configuration toward the deployed configuration.

6. The device of claim 2 or 3, wherein the operable engagement of the distal portion with the blade comprises sliding contact between the distal portion and the blunt edge of the blade.

7. the distal portion includes an angled surface; The device of claim 6 , wherein the operable engagement of the distal portion with the blade comprises sliding contact between the angled surface and the blunt edge of the blade.

8. The device of claim 7 , wherein the distal portion includes a taper that defines the angled surface.

9. the push rod includes a channel along the distal portion; The blade is disposed within the channel; The device of claim 7 , wherein a bottom surface of the channel defines the angled surface.

10. The device of claim 4 , wherein a distal end of the blade is hinged to the needle wall defining a fulcrum such that the blade rotates between the covered configuration and the deployed configuration.

11. 11. The device of claim 10, wherein the blade is biased toward the sheathed configuration such that proximal displacement of the push rod from the distal position toward the proximal position allows the blade to self-rotate toward the sheathed configuration.

12. 6. The device of claim 5, wherein the needle wall includes a push rod barrier that protrudes radially into the needle lumen, the push rod barrier configured to engage the push rod to limit distal displacement of the push rod beyond the distal position.

13. 4. The device of claim 1, wherein the push rod includes a push rod lumen having an open proximal end and an open distal end, the push rod lumen configured to allow a guide wire to be inserted therethrough.

14. The device of claim 13 , further comprising the guidewire disposed within the push rod lumen.

15. 6. The device of claim 5, wherein the skin nicking device includes an actuator operably coupled to the push rod, the actuator configured to displace the push rod between the proximal position and the distal position.

16. 6. The device of claim 5, wherein the skin nicking device includes a locking mechanism configured to lock the push rod in at least one of the proximal position or the distal position.

17. 1. A catheter assembly comprising: a catheter including a catheter tube proximally coupled to a catheter hub having one or more extension legs proximally coupled from the catheter hub, the catheter tube defining one or more lumens, each of the one or more lumens in fluid communication with one of the extension legs; A catheter assembly comprising: a catheter placement device according to any one of claims 1 to 3 coupled to the catheter.

18. 18. The assembly of claim 17, wherein the needle of the catheter placement device is inserted into one of the one or more lumens of the catheter tube.

19. 1. A method of manufacturing a catheter placement device, comprising: forming a slot extending through a needle wall of the needle; positioning the blade within the slot such that a sharp edge of the blade is oriented radially outward relative to the needle and the sharp edge is disposed within an outer surface of the needle; and inserting a push rod into the needle lumen of the needle such that an angled surface of the push rod engages the blade.

20. The method of claim 19 further comprising hinging the blade to the needle wall so that the blade is pivotable through the slot.

21. 21. The method of claim 19 or 20, further comprising forming a protrusion on an inner surface of the needle lumen to define a push rod barrier configured to limit distal displacement of the push rod within the needle lumen.

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