SKIN NICKING DEVICE FOR A CATHETER DEPLOYMENT SYSTEM - Patent application

Abstract

The catheter deployment system (100) includes a catheter (150) having a catheter tube (152) distally coupled to a catheter hub (160) having one or more extension legs (162) proximally coupled to the catheter hub. The catheter tube defines one or more lumens (114A, 114B), each of the one or more lumens in fluid communication with one of the extension legs. The catheter deployment system further includes a skin nicking device (210, 310) configured to transition between a covered configuration and a deployed configuration. The skin nicking device includes a needle defining a needle lumen (222, 322) having a needle wall (221, 321) including a slot (223, 323) in fluid communication with an outer surface of the needle (220, 320), and a blade (214, 314A, 314B) configured to align with the slot, the blade being coupled to a distal end of a connecting member (212, 312A, 312B) within the needle lumen.

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, which, according to some embodiments, includes: (i) a needle defining a needle lumen and a needle wall, the needle including a slot extending through the needle wall, (ii) a blade disposed within the needle lumen in alignment with the slot, and (iii) a connecting member disposed within the needle lumen, the connecting member operably coupled to the blade to facilitate transition of the blade between a covered configuration in which the blade is disposed completely inside an outer surface of the needle and a deployed configuration in which the blade projects radially outward through the slot and beyond the outer surface of the needle.

[0005] In some embodiments, the blade defines a sharp edge disposed opposite the blunt edge, and the blade is oriented within the needle lumen such that the sharp edge is oriented radially inward in the covered configuration, hi some embodiments, the blade is oriented such that the sharp edge is oriented distally in the deployed configuration.

[0006] In some embodiments, the blade rotates between a covered configuration and a deployed configuration, and in some embodiments, the connecting member is slidably disposed within the needle lumen, hi some embodiments, the connecting member is coupled with the blade such that longitudinal displacement of the connecting member rotates the blade.

[0007] In some embodiments, the connecting member is longitudinally positionable within the needle lumen between a first position and a second position, where (i) displacement of the connecting member from the first position toward the second position transitions the blade from the covered configuration to the deployed configuration, and (ii) displacement of the connecting member from the second position toward the first position transitions the blade from the deployed configuration to the covered configuration. In some embodiments, the first position is proximal to the second position.

[0008] In some embodiments, the blade is a first blade, the skin nicking device further comprises a second blade, the slot is a first slot, the needle further comprises a second slot, the connecting member is a first connecting member, and the skin nicking device further comprises a second connecting member coupled to the second blade to facilitate transitioning the second blade between (i) a covered configuration in which the second blade is disposed completely inside an outer surface of the needle and (ii) a deployed configuration in which the second blade projects radially outwardly through the second slot and beyond the outer surface of the needle. In some embodiments, the second slot is disposed opposite the first slot.

[0009] In some embodiments, the first connecting member is configured to rotationally bias the first blade from the covered configuration toward the deployed configuration and the second connecting member is configured to rotationally bias the second blade from the covered configuration toward the deployed configuration, hi some embodiments, the first connecting member and the second connecting member are attached to the needle wall.

[0010] In some embodiments, the needle is configured to be inserted into a lumen of the catheter, and the first blade and the second blade are configured to engage a distal end of the catheter such that when the catheter is displaced distally along the needle, the first blade and the second blade transition from the deployed configuration toward the covered configuration as the distal end of the catheter moves from the proximal ends of the first and second slots toward the distal ends of the first and second slots.

[0011] 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.

[0012] Also disclosed herein is a method of placing a catheter in a patient's blood vessel, according to some embodiments, the method including: (i) inserting a needle of a skin nicking device through the skin and into the blood vessel to define an insertion site, wherein a blade of the skin nicking device is transitionable between a covered configuration and a deployed configuration, the blade extending radially from an outer surface of the needle in the deployed configuration; (ii) scoring the skin with the blade to enlarge the insertion site; and (iii) inserting the catheter into the blood vessel through the insertion site.

[0013] In some embodiments, the method further includes transitioning the blade from the covered configuration to the deployed configuration, and in some embodiments of the method, transitioning the blade from the covered configuration to the deployed configuration includes rotating the blade.

[0014] In some embodiments of the method, the skin nicking device includes a connecting member disposed within a needle lumen of the needle, the connecting member operably coupled to the blade, the connecting member configured to transition the blade between the covered configuration and the deployed configuration.

[0015] In some embodiments of the method, the longitudinal displacement of the connecting member causes rotation of the blade. In some embodiments of the method, in the covered configuration, the blade is positioned entirely radially inward of the outer surface of the needle.

[0016] In some embodiments of the method, the connecting member is longitudinally positionable within the needle lumen between a first position and a second position, and transitioning the blade from the covered configuration to the deployed configuration includes displacing the connecting member from the first position to the second position.

[0017] In some embodiments of the method, the blade is rotatably coupled to the needle wall. In some embodiments, the method further includes transitioning the blade from the deployed configuration to the covered configuration.

[0018] In some embodiments of the method, (i) the blade is a first blade and the skin nicking device further comprises a second blade, (ii) the slot is a first slot and the needle further comprises a second slot, and (iii) the connecting member is a first connecting member and the skin nicking device further comprises a second connecting member coupled to the second blade to facilitate transitioning the second blade between a covered configuration in which the second blade is disposed completely inside an outer surface of the needle and a deployed configuration in which the second blade protrudes radially outward through the second slot beyond the outer surface of the needle.

[0019] In some embodiments of the method, the first connecting member is configured to rotationally bias the first blade from the covered configuration toward the deployed configuration and the second connecting member is configured to rotationally bias the second blade from the covered configuration toward the deployed configuration.

[0020] In some embodiments, the method further includes advancing the catheter distally along the needle to engage the first blade and the second blade with a distal end of the catheter, the engagement transitioning the first blade and the second blade from the deployed configuration toward the covered configuration.

[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) disposing a blade within a needle lumen of the needle adjacent the slot such that a sharp edge of the blade is oriented radially inward relative to the needle; (iii) disposing a connecting member within the needle lumen; and (iv) coupling the connecting member to the blade.

[0022] In some embodiments of the method of manufacture, coupling the connecting member to the blade comprises rotatably coupling the connecting member to the blade. In some embodiments, the method of manufacture further comprises rotatably coupling the blade to the needle wall.

[0023] In some embodiments of the method of manufacture, coupling the connecting member with the blade includes fixedly attaching the connecting member to the blade. In some embodiments, the method of manufacture further includes fixedly attaching the connecting member to the needle wall.

[0024] In some embodiments, the method of manufacture further includes (i) forming a second slot extending through the needle wall; (ii) disposing a second blade within the needle lumen adjacent the second slot such that a sharp edge of the second blade is oriented radially inward relative to the needle; (iii) disposing a second connecting member within the needle lumen; (iv) fixedly attaching the second connecting member to the second blade; and (iv) fixedly attaching the second connecting member to the needle wall.

[0025] 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.

[0026] 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]

[0027] [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] FIG. 1B shows a top view of the catheter deployment system of FIG. 1A in a folded configuration ready for use, according to an embodiment disclosed herein. [Figure 1C] FIG. 1B shows a perspective view of the catheter deployment system of FIG. 1A in a folded configuration, according to an embodiment disclosed herein. [Diagram 2]FIG. 1B shows a side view of the catheter of the catheter deployment system of FIG. 1A 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] 1B shows a longitudinal cross-sectional view of a distal portion of the catheter deployment system of FIG. 1A according to an embodiment disclosed herein. [Figure 5A] 1B shows various cross-sectional side views of the catheter deployment system of FIG. 1A illustrating an exemplary method of use according to an embodiment disclosed herein. [Figure 5B] 1B shows various cross-sectional side views of the catheter deployment system of FIG. 1A illustrating an exemplary method of use according to an embodiment disclosed herein. [Figure 5C] 1B shows various cross-sectional side views of the catheter deployment system of FIG. 1A illustrating an exemplary method of use according to an embodiment disclosed herein. [Figure 5D] 1B shows various cross-sectional side views of the catheter deployment system of FIG. 1A illustrating an exemplary method of use according to an embodiment disclosed herein. [Figure 5E] 1B shows various cross-sectional side views of the catheter deployment system of FIG. 1A illustrating an exemplary method of use according to an embodiment disclosed herein. [Figure 6A] FIG. 1 illustrates a cross-sectional side view of a first embodiment of a skin nicking device in a deployed configuration, according to some embodiments. [Figure 6B] FIG. 6B shows a cross-sectional side view of the skin nicking device of FIG. 6A in a covered configuration, according to some embodiments. [Figure 7A] FIG. 13 shows a cross-sectional side view of a second embodiment of a skin nicking device in a deployed configuration, according to some embodiments. [Figure 7B]FIG. 7B shows a cross-sectional side view of the skin nicking device of FIG. 7A in a partially transitioned configuration, according to some embodiments. [Figure 7C] FIG. 7B shows a cross-sectional side view of the skin nicking device of FIG. 7A in a covered configuration, according to some embodiments. [Figure 7D] FIG. 7B illustrates a cross-sectional end view of the skin nicking device of FIG. 7A in a covered configuration, according to some embodiments. [Figure 7E] 7B shows a cross-sectional view of the skin nicking device of FIG. 7A in a deployed configuration, according to some embodiments. [Figure 8] 1 shows a flowchart of an exemplary method of placing a catheter using a skin nicking device, according to some embodiments. [Figure 9] 1 shows a flowchart of an exemplary method of manufacturing a skin nicking device, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0028] 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.

[0029] 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.

[0030] 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.

[0031] 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.

[0032] 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. The phrases "connected to," "coupled to," and "in communication with" refer to any form of interaction between two or more entities, including, but not limited to, mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interactions. Two components can be coupled to one another even if they are not in direct contact with one another. For example, two components can be coupled to one another by an intermediate component.

[0033] 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.

[0034] 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.

[0035] 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 .

[0036] 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.

[0037] 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.

[0038] 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.

[0039] 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.

[0040] 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.

[0041] 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.

[0042] 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.

[0043] 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.

[0044] 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.

[0045] 6A and 6B show cross-sectional side views of a skin nicking device 210 in a deployed configuration and a covered configuration, respectively, according to some embodiments. As illustrated in FIG. 6A, the skin nicking device 210 may include a needle 220 having a slot 223 extending through the needle wall 221 between the needle lumen 222 and the outer surface 225 of the needle 220.

[0046] The skin nicking device 210 includes a blade 214 coupled at its distal end to a connecting member 212 disposed within the needle lumen 222. The connecting member 212 is generally configured to extend the entire length of the needle 220. The connecting member 212 is generally configured to apply a pushing and / or pulling force to the blade 214 in response to manipulation of a proximal portion of the connecting member 212. In some embodiments, the connecting member 212 may be rigid, such as, for example, a stylet. In other embodiments, the connecting member 212 is flexible in bending, such as, for example, a guidewire. In some embodiments, the connecting member 212 may include one or more rigid portions and one or more flexible portions.

[0047] The blade 214 is rotatably coupled to the needle 220 at a pivot point 215. The connecting member 212 is coupled to the blade 214 at an attachment point 213, which is radially offset from the pivot point 215 such that longitudinal displacement of the connecting member 212 rotates the blade 214 about the pivot point 215. The connecting member 212 is thus configured to transition (i.e., rotate) the blade 214 between the deployed configuration shown in FIG. 6A and the covered configuration shown in FIG. 6B. In the illustrated embodiment, distal displacement of the connecting member 212 transitions the blade 214 from the covered configuration to the deployed configuration. Conversely, proximal displacement of the connecting member 212 transitions the blade 214 from the deployed configuration to the covered configuration. In other embodiments, the skin nicking device 210 may be configured such that distal displacement of the connecting member 212 transitions the blade 214 to the covered configuration and proximal displacement of the connecting member 212 transitions the blade 214 to the deployed configuration. FIGURE 6A illustrates the connecting member 212 in a second position that coincides with the blade 214 disposed in the deployed configuration. Similarly, FIGURE 6B illustrates the connecting member 212 in a first position that coincides with the blade 214 disposed in the covered configuration. In the illustrated embodiment, the second position is distal to the first position. In other embodiments, the second position may be proximal to the first position.

[0048] The blade 214 includes a sharp edge 216 and a blunt edge 218. In some embodiments, as illustrated in FIG. 6A, in the deployed configuration, the blade 214 may extend radially away from the outer surface 225 such that the sharp edge 216 faces distally, i.e., toward the distal end 229 of the needle 220, and the blunt edge 218 faces proximally, i.e., toward the proximal end 227 of the needle 220. In some embodiments, the blade 214 may protrude vertically away from the outer surface 225. In the deployed configuration, the blade 214 extends through the slot 223. In some embodiments, in the deployed configuration, the blunt edge 218 may contact the needle wall 221 (e.g., at the proximal end of the slot 223) to provide a stabilizing force to the blade 214 (e.g., preventing further rotation) as the needle 220 is inserted into the vasculature 80. In the deployed configuration, the sharp edge 216 of the blade 214 may contact a portion of the skin or surface tissue 90 as the needle 220 is inserted into the vasculature 80 and cut the skin (e.g., score the skin), thereby enlarging the insertion site to accommodate the catheter.

[0049] In some embodiments, when the blade 214 is in the covered configuration, the entire blade 214 may be disposed within the needle lumen 222. In some embodiments, in the covered configuration as illustrated in FIG. 6B, the blunt edge 218 of each of the blades 214 may extend longitudinally along a slot 223 within the needle lumen 222. In some embodiments, the connecting member 212 may be manually displaced by a user to transition the blade 214 between the covered configuration and the deployed configuration. In some embodiments, the connecting member 212 may be manually actuated via a lever, spring, or the like (not shown). In one embodiment, the blade 214 may be configured to transition only from the covered configuration to the deployed configuration and not vice versa. In some embodiments, the blade 214 may be rotatably biased about the pivot point 215 toward the deployed configuration. For example, the blade 214 may be coupled to the needle wall 221 via a torsion spring (not shown), which applies a biasing torque to the blade 214. In other embodiments, the blade 214 may be rotatably biased about a pivot point 215 towards the covering configuration.

[0050] In some embodiments, the skin nicking device 210 may be provided together with the introducer catheter 150, including coupled with the introducer catheter 150 to define a catheter assembly. In some embodiments, the catheter assembly may include a needle 220 disposed within a lumen of the introducer catheter 150.

[0051] In some embodiments, it may be provided in a covered configuration, such that during use, the skin nicking device 210 may be transitioned from the covered configuration to the deployed configuration. According to another embodiment, the blade 214 may be rotatably coupled only to the connecting member 212 such that the blade 214 may be longitudinally displaced within the needle lumen 222 together with the connecting member 212. In such an embodiment, the blade 214 may be rotatably biased relative to the connecting member 212 toward the deployed configuration. In use, the blade 214 may be displaced between a proximal position proximal to the slot 223 and a distal position adjacent to the slot 223. In the proximal position, the blade 214 is contained within the lumen 222 to define a covered configuration. As the blade 214 is displaced distally toward the distal position, the biasing force may rotate the blade 214 such that the blade 214 enters and passes through the slot 223. As the blade 214 is disposed in the distal position, the biasing force may fully transition / rotate the blade 214 to the deployed configuration. In some embodiments, the blade 214 and / or the needle 220 may be configured to align with the slot 223 to constrain the blade 214. In one embodiment, the needle wall 221 opposite the slot 223 may include a recess / channel configured to receive a portion of the blade 214 therein. The recess may be configured to align with the slot 223 and restrain the blade 214.

[0052] In some embodiments, the skin nicking device 210 may include a blade barrier 250 that projects inwardly from the needle wall 221 into the needle lumen 222. In some embodiments, the blade barrier 250 may be located distal to the slot 223. In some embodiments, the blade barrier 250 may be located on the same side of the needle wall 221 as the slot 223 or may be located on the opposite side of the needle wall 221 from the slot 223. The blade barrier 250 may be configured to limit distal displacement of the blade 214 through the needle lumen 222.

[0053] 7A-7E show another embodiment of a skin nicking device 310 that may be similar in some respects to the components of the skin nicking device 210 described in connection with FIGS. 6A and 6B. It will be understood that all of the illustrated embodiments may have similar features. Accordingly, similar features are indicated with similar reference numbers with the leading digit incremented to "3". For example, a needle is indicated as "220" in FIGS. 6A and 6B, and a similar needle is indicated as "320" in FIGS. 7A-7E. Accordingly, the relevant disclosure set forth above with respect to similarly identified features may not be repeated below. Additionally, certain features of the skin nicking device 210 and associated components shown in FIGS. 6A and 6B may not be indicated or identified by reference numbers in the drawings or specifically described in the following description. However, such features may be clearly the same or substantially the same as features shown in and / or described in connection with other embodiments. Thus, the relevant descriptions of such features apply equally to the features of the skin nicking device 310 of Figures 7A-7E. Any suitable combination of the features and variations thereof described with respect to the skin nicking device 210 and components shown in Figures 6A and 6B may be used with the skin nicking device 310 and components of Figures 7A-7E, and vice versa.

[0054] 7A shows a cross-sectional view of the skin nicking device 310 in a deployed configuration. In the illustrated embodiment, the skin nicking device 310 includes two blades 314A / 314B that extend in opposite directions radially / laterally away from the needle 320. In other embodiments, the skin nicking device 310 may include only one blade, or three or more blades. The two blades 314A / 314B extend through the needle wall 321 via two corresponding slots 323A / 323B, respectively. The two blades 314A / 314B are coupled with two corresponding connecting members 312A / 312B that extend proximally along the needle lumen 222. The two connecting members 312A / 312B are configured to transition the two blades 314A / 314B from the covered configuration to the deployed configuration. In the illustrated embodiment, the connecting members 312A / 312B define a biasing force / torque applied to the blades 314A / 314B toward the deployed configuration. In some embodiments, the connecting members 312A / 312B (e.g., their proximal ends) may be coupled (e.g., attached) to the needle wall 321. The connecting members 312A / 312B may be formed of any material suitable for applying a biasing force / torque to the blades 314A / 314B, such as stainless steel or nitinol.

[0055] In the illustrated embodiment, in the deployed configuration, the sharp edges 316A / 316B of the blades 314A / 314B may be oriented distally with the blunt edges 318A / 318B of the blades 314A / 314B oriented proximally. In some embodiments, with the skin nicking device 310 in the deployed configuration, the skin nicking device 310 may be inserted into the vasculature 80 and may be configured to score the skin and superficial tissue 90 as the skin nicking device 310 is inserted into the vasculature 80, thereby enlarging the insertion site to accommodate a catheter.

[0056] 7B shows the skin nicking device 310 in a transition between the deployed and covered configurations. As illustrated in FIG. 7B, the introducer catheter 150 may be disposed over the needle 320, and the introducer catheter 150 may be displaced distally and / or proximally along the needle 320. The introducer catheter 150 may engage the blades 314A / 314B (e.g., blunt edges 318A / 318B) to transition the blades 314A / 314B from the deployed configuration toward the covered configuration. More specifically, the engagement of the introducer catheter 150 with the blades 314A / 314B may rotate and / or displace the blades 314A / 314B inwardly into the needle lumen 222 through the slots 323A / 323B against the biasing force of the connecting members 312A / 312B. As the blades 314A / 314B rotate inward, the sharp edges 316A / 316B may be oriented radially inward such that the blunt edges 318A / 318B are oriented outward facing the slots 323A / 323B. The rotation / displacement of the blades 314A / 314B inward toward the needle lumen 322 transitions the skin nicking device 310 from the deployed configuration to the covered configuration.

[0057] In some embodiments, the skin nicking device 310 may be provided together with the introducer catheter 150, including coupled with the introducer catheter 150 to define a catheter assembly. In some embodiments, the catheter assembly may include a needle 320 disposed within a lumen of the introducer catheter 150. In some embodiments of the catheter assembly, the introducer catheter 150 may extend over the slots 323A / 323B to constrain the blades 314A / 314B in a covered configuration. Thus, in use, the introducer catheter 150 may be displaced proximally along the needle 220 to transition the blades 314A / 314B from the covered configuration to the deployed configuration.

[0058] 7C illustrates the skin nicking device 310 in a covered configuration. As shown, the introducer catheter 150 is displaced distally beyond the slots 323A / 323B such that the blades 314A / 314B are constrained within the lumen 222 by the introducer catheter 150, thereby defining the covered configuration. As shown, the blades 314A / 314B rotate to be received within the needle lumen 322.

[0059] 7D and 7E show cross-sectional end views of the skin nicking device 310 transitioning between a covered configuration (FIG. 7D) and a deployed configuration (FIG. 7E). In some embodiments, the blades 314A / 314B may be laterally and / or transversely offset, as illustrated in FIG. 7D. In the covered configuration, the blades 314A / 314B may be rotated and housed within the needle lumen 322. The blades 314A / 314B may be rotated such that the blunt edges 318A / 318B face the slots 323A / 323B. In some embodiments, when the blades 314A / 314B are laterally and / or transversely offset, the sharp edges 316A / 316B may be positioned adjacent to or in physical contact with one another within the needle lumen 322, as illustrated in FIG. 7D.

[0060] In the deployed configuration (FIG. 7E), the blades 314A / 314B may rotate outward from the needle lumen 322 through corresponding slots 323A / 323B. As the blades 314A / 314B rotate outward, the sharp edges 316A / 316B are oriented toward the distal end of the needle 320 such that the sharp edges 316A / 316B can score the skin and surface tissue 90 as the needle 320 is inserted through the skin and into a blood vessel. The blunt edges 318A / 318B are oriented toward the proximal end of the needle 320. In some embodiments, the blades 314A / 314B may occupy a portion of the cross-sectional area of ​​the needle lumen 322 regardless of whether the blades 314A / 314B are in the covered and / or deployed configurations. The blades 314A / 314B may occupy a portion of the cross-sectional area of ​​the needle lumen 322, which may be configured to receive an additional device therein (e.g., a guidewire 130). In some embodiments, the guidewire 130 may be configured to travel through the needle lumen 322 in parallel with the blades 314A / 314B. In one embodiment, at least one of the blades 314A / 314B may include a channel 390 thereon, which is configured to allow passage of the guidewire 130 through the needle lumen 322. The channel 390 may be oriented (i) parallel to the guidewire 130 when the blades 314A / 314B are in the covered configuration, or (ii) parallel to the guidewire when the blades 314A / 314B are in the deployed configuration as illustrated in FIG. 7E. In some embodiments, the blades 314A / 314B and / or needle 320 may be configured to constrain the blades 314A / 314B in a lateral plane defined by the slots 323A / 323B.

[0061] 8 shows a flowchart of an exemplary method 400 of placing a catheter in a patient's blood vessel, including all or any subset of the following steps, actions, or processes. Method 400 may include inserting a needle of a skin nicking device through the skin and into the blood vessel to define an insertion site (block 410), where a blade of the skin nicking device is transitionable between a covered configuration and a deployed configuration, where the blade extends radially away from an outer surface of the needle in the deployed configuration. In some embodiments of method 400, in the covered configuration, the entirety of the blade is disposed radially inward of the outer surface of the needle.

[0062] The method 400 may further include scoring the skin with a blade to enlarge the insertion site (Block 420). In some embodiments of the method 400, the skin nicking device includes a connecting member disposed within a needle lumen of the needle, the connecting member operably coupled to a blade within the needle lumen such that longitudinal displacement of the connecting member causes rotation of the blade. In some embodiments of the method 400, the blade is rotatably coupled to the needle wall. The method 400 may further include inserting a catheter into the blood vessel through the insertion site (Block 430).

[0063] The method 400 may further transition the blade from the covered configuration to the deployed configuration (Block 440). In some embodiments of the method 400, transitioning the blade from the covered configuration to the deployed configuration includes rotating the blade. In some embodiments of the method 400, the connecting member is longitudinally positionable within the needle lumen between a first position and a second position, and transitioning the blade from the covered configuration to the deployed configuration includes displacing the connecting member from the first position to the second position.

[0064] In some embodiments, the method 400 may further include transitioning the blade from the deployed configuration to the covered configuration (block 450). In some embodiments of method 400, the blade is a first blade and the skin nicking device further comprises a second blade, further, the slot is a first slot and the needle further comprises a second slot, and further, the connecting member is a first connecting member and the skin nicking device further comprises a second connecting member coupled to the second blade to facilitate transitioning the second blade between (i) a covered configuration in which the second blade is disposed completely inside an outer surface of the needle and (ii) a deployed configuration in which the second blade projects radially outwardly through the second slot beyond the outer surface of the needle.

[0065] In some embodiments of method 400, the first connecting member is configured to rotationally bias the first blade from the covered configuration toward the deployed configuration, and the second connecting member is configured to rotationally bias the second blade from the covered configuration toward the deployed configuration.

[0066] In some embodiments, the method 400 further includes advancing the catheter distally along the needle to engage the first and second blades with a distal end of the catheter (block 460), the engagement transitioning the first and second blades from the deployed configuration toward the covered configuration.

[0067] 9 shows a flow chart of an exemplary method 500 of manufacturing a catheter placement device, which may include all or any subset of the following steps, actions, or processes: The method 500 may include forming a slot extending through a needle wall of the needle (block 510).

[0068] The manufacturing method 500 may further include disposing a blade within the needle lumen of the needle (block 520), the blade being positioned adjacent the slot such that a sharp edge of the blade is oriented radially inward relative to the needle.

[0069] The method of manufacture 500 may further include disposing a connecting member within the needle lumen (block 530). In some embodiments of the method 500, the connecting member may extend proximally along the needle beyond the proximal end of the needle. The method of manufacture 500 may further include rotatably coupling a blade to the needle wall (block 540).

[0070] The method of manufacture 500 may further include coupling a connecting member to the blade (block 550). In some embodiments of the method of manufacture 500, coupling the connecting member to the blade includes rotatably coupling the connecting member to the blade. In some embodiments of the method of manufacture 500, coupling the connecting member to the blade includes fixedly attaching the connecting member to the blade. The method of manufacture 500 may further include fixedly attaching the connecting member to the needle wall (block 560).

[0071] In some embodiments, the manufacturing method 500 further includes (i) forming a second slot extending through the needle wall; (ii) disposing a second blade within the needle lumen adjacent the second slot such that a sharp edge of the second blade is oriented radially inward relative to the needle; (iii) disposing a second connecting member within the needle lumen; (iv) fixedly attaching the second connecting member to the second blade; and (iv) fixedly attaching the second connecting member to the needle wall.

[0072] 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 connecting member disposed within the needle lumen, the connecting member operably coupled to the blade to facilitate transition of the blade between a covered configuration in which the blade is disposed completely inside an outer surface of the needle and a deployed configuration in which the blade projects radially outward through the slot beyond the outer surface of the needle.

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 inward in the sheathed configuration.

3. The device of claim 2 , wherein the blade is oriented such that the sharp edge is oriented distally in the deployed configuration.

4. The device of any one of claims 1 to 3, wherein the blade rotates between the covered configuration and the deployed configuration.

5. The device of any one of claims 1 to 3, wherein the connecting member is slidably disposed within the needle lumen.

6. The device of claim 5 , wherein the connecting member is coupled with the blade such that longitudinal displacement of the connecting member causes the blade to rotate.

7. the connecting member is longitudinally positionable within the needle lumen between a first position and a second position; displacement of the connecting member from the first position toward the second position transitions the blade from the covered configuration to the deployed configuration; The device of claim 6 , wherein displacement of the connecting member from the second position toward the first position transitions the blade from the deployed configuration to the sheathed configuration.

8. The device of claim 7 , wherein the first location is proximal to the second location.

9. the blade is a first blade, and the skin nicking device further includes a second blade; the slot is a first slot and the needle further includes a second slot; 4. The device of claim 1, wherein the connecting member is a first connecting member, and the skin nicking device further includes a second connecting member coupled to the second blade to facilitate transitioning the second blade between the covered configuration in which the second blade is positioned completely inside the outer surface of the needle and the deployed configuration in which the second blade protrudes radially outward beyond the outer surface of the needle through the second slot.

10. The device of claim 9 , wherein the second slot is disposed opposite the first slot.

11. the first connecting member is configured to rotationally bias the first blade from the covered configuration toward the deployed configuration; The device of claim 9 , wherein the second connecting member is configured to rotationally bias the second blade from the covered configuration toward the deployed configuration.

12. The device of claim 9 , wherein the first connecting member and the second connecting member are attached to the needle wall.

13. the needle is configured to be inserted into a lumen of a catheter; 10. The device of claim 9, wherein the first blade and the second blade are configured to engage the distal end of the catheter as the catheter is displaced distally along the needle such that the first blade and the second blade transition from the deployed configuration toward the covered configuration as the distal end of the catheter moves from proximal ends of the first and second slots toward distal ends of the first and second slots.

14. 1. A catheter assembly comprising: a catheter including a catheter tube distally coupled to a catheter hub having one or more extension legs proximally coupled to 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.

15. The assembly of claim 14 , wherein the needle of the catheter placement device is inserted into one of the one or more lumens of the catheter tube.

16. 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 needle lumen of the needle adjacent the slot such that a sharp edge of the blade is oriented radially inward relative to the needle; placing a connecting member within the needle lumen; and coupling the connecting member to the blade.

17. The method of claim 16 , wherein coupling the connecting member to the blade comprises rotatably coupling the connecting member to the blade.

18. The method of claim 16 or 17, further comprising rotatably coupling the blade with the needle wall.

19. The method of claim 16 , wherein coupling the connecting member with the blade comprises fixedly attaching the connecting member to the blade.

20. The method of claim 18 further comprising fixedly attaching the connecting member to the needle wall.

21. forming a second slot extending through the needle wall; positioning a second blade within the needle lumen adjacent the second slot such that a sharp edge of the second blade is oriented radially inward relative to the needle; disposing a second connecting member within the needle lumen; fixedly attaching the second connecting member to the second blade; The method of claim 19 further comprising fixedly attaching the second connecting member to the needle wall.

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