Removable Skin Nicking Blade for Catheter Placement System

Abstract

The catheter placement system (100) includes a removable skin nicking device (150) that is coupled to a catheter, for example, a rapid insertion central venous catheter. The skin nicking device includes a handle (152) and a blade (154) extending from the handle. The blade is disposed within a notch (156) that extends along the expanded section (124) of the catheter. The blade includes a radially outwardly directed sharp edge that is configured to cut the skin adjacent the catheter insertion site. The distal end of the blade is disposed within the notch to prevent skin bridging during insertion of the catheter. A needle is inserted into the access lumen of the catheter through the needle access port, and an access guidewire is disposed within the lumen of the needle. An advancement guidewire is also disposed within the access lumen.

Description

[Technical field]

[0001] The present disclosure relates to skin nicking blades for catheter placement systems. [Background technology]

[0002] Central venous catheters ("CVCs") are typically introduced into a patient via the Seldinger technique and advanced through the patient's vascular system. 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 of the steps are time consuming and the handling of numerous medical devices is cumbersome, both of which may lead to increased risk of trauma or infection for the patient. Due to the large number of medical devices that need to be replaced during the Seldinger technique, the potential for contamination through contact is relatively high. Thus, to reduce the number of steps and medical devices involved in placing a catheter such as a CVC in a patient, Rapidly Insertable Central Catheter (RICC) systems have been developed.

[0003] Whether using the traditional Seldinger technique or a catheter placement system, clinicians are often required to widen the insertion site after gaining access to the vasculature. This involves sliding the trailing or blunt side of the scalpel along the guidewire, which is stabilizing the insertion site. The sharp side of the scalpel may face outward. As the scalpel slides over the guidewire and into the insertion site, the sharp edge can engage and widen the insertion site in preparation for the CVC to be advanced through the insertion site. Summary of the Invention [Problem to be solved by the invention]

[0004] However, maintaining contact between the scalpel tip and the guidewire as the scalpel is slid along the guidewire requires great skill. The scalpel must be perfectly aligned with the guidewire and held securely in place. Gaps between the scalpel and the guidewire can result in the formation of a "skin bridge" across the insertion site, complicating the procedure. The embodiments described herein are directed to addressing the above. [Means for solving the problem]

[0005] A catheter placement system disclosed herein, according to some embodiments, includes a catheter including an extension section, an access section extending distally from the extension section, a catheter section extending proximally from the extension section, and a notch extending longitudinally along at least a portion of the extension section. The system further includes a skin nicking device coupled to the catheter, the skin nicking device including a handle and a blade extending distally from the handle, a portion of the blade disposed within the notch. In some embodiments, the blade is removable from the notch.

[0006] In some embodiments, the catheter is a rapid insertion central venous catheter, hi some embodiments, the access section is single lumen and the catheter section is multi-lumen.

[0007] In some embodiments, the access section defines a first outer diameter, the catheter section defines a second outer diameter larger than the first outer diameter, and the expansion section defines a tapered profile including the first outer diameter at a distal end of the expansion section and the second outer diameter at a proximal end of the expansion section.

[0008] In some embodiments, the notch defines a width that is less than a thickness of the blade such that the notch defines an interference fit with the blade. The blunt edge of the blade is disposed within the notch and the sharp edge of the blade is directed radially outward from the catheter. In some embodiments, the sharp edge defines an angle with respect to the longitudinal axis of the catheter such that a distal portion of the sharp edge is closer to the longitudinal axis of the catheter than a proximal portion of the sharp edge. In some embodiments, the sharp edge is parallel to an outer surface of the expansion section.

[0009] In some embodiments, the distal end of the blade is disposed radially inward of the outer surface of the expansion section. In some embodiments, the blade includes a tab extending distally from the distal end of the blade, the notch includes a cavity at the distal end of the notch, and the tap is disposed within the cavity. In some embodiments, during use, a distally directed force applied by the clinician to the handle is transferred to the catheter via the cavity. In some embodiments, the handle extends proximally along the catheter section. In some embodiments, the notch is configured to align the blade with the longitudinal axis.

[0010] In some embodiments, the notch is formed with a slit such that when the blade is removed from the notch, the notch transitions to a closed state and the outer surface of the expansion section forms a continuous circumferential surface.

[0011] In some embodiments, the catheter includes an access section, an extension section, and an access lumen extending along the catheter section, the access section including a needle access port in fluid communication with the access lumen.

[0012] In some embodiments, the system further includes a needle disposed within the access lumen between the needle access port and the distal end of the catheter. In some embodiments, the system further includes an access guidewire disposed within the lumen of the needle. In some embodiments, the system further includes an advancement guidewire disposed within the access lumen proximal access port.

[0013] Also disclosed herein, according to some embodiments, is a method of placing a catheter within a patient's vasculature, comprising: (i) forming an insertion site with a needle disposed within an access lumen of an access section of the catheter, the needle being inserted through a needle access port of the access section; (ii) advancing an expansion section disposed proximal to the access section into the insertion site, the expansion section being coupled with a skin nicking device having a blade; (iii) cutting the skin adjacent to the insertion site with a sharp edge of the blade during advancement of the expansion section; (iv) expanding the insertion site from a first diameter of the access section to a second diameter of the catheter section disposed proximal to the expansion section during advancement of the expansion section; (v) detaching the skin nicking device from the expansion section; and (vi) advancing the catheter section into the vasculature through the insertion site.

[0014] In some embodiments, the blade includes a handle and advancing the expansion section includes applying a distally directed force to the handle. In some embodiments, the method further comprises advancing an access guidewire through the lumen of the needle and into the vasculature.In some embodiments, the method further comprises advancing an advancement guidewire through the access lumen and into the vasculature.

[0015] In some embodiments, a portion of the blade is disposed within a notch extending along at least a portion of the expansion section, the notch including a cavity at a distal end thereof, and the blade includes a tab extending distally from the distal end of the blade, In such embodiments, the tab is disposed within the cavity such that a distally directed force applied to the handle is transferred to the catheter via the tab disposed within the cavity.

[0016] A more particular description of the present disclosure will be provided by reference to specific embodiments thereof, which are illustrated in the accompanying drawings, which depict only typical embodiments of the invention and therefore should not 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, in which: [Brief description of the drawings]

[0017] [Figure 1] FIG. 1 illustrates a top view of a rapid insertion central venous catheter (catheter) placement system including a removable skin nicking device, according to an embodiment disclosed herein. [Diagram 2] FIG. 13 shows an enlarged detailed view of a detachable skin nicking device coupled to a distal portion of a catheter, according to an embodiment disclosed herein. [Figure 3A] FIG. 1 illustrates a cross-sectional view of a removable skin nicking device engaged with a catheter, according to an embodiment disclosed herein. [Figure 3B] FIG. 1 illustrates a cross-sectional view of a removable skin nicking device disengaged from a catheter, according to an embodiment disclosed herein. [Figure 4] FIG. 1 illustrates a longitudinal cross-sectional view of a removable skin nicking device engaged with a catheter, according to an embodiment disclosed herein. [Figure 5A] A diagram of a system 100 is shown illustrating an exemplary method of use of a catheter placement system including a removable skin nicking device according to embodiments disclosed herein. [Figure 5B] A diagram of a system 100 is shown illustrating an exemplary method of use of a catheter placement system including a removable skin nicking device according to embodiments disclosed herein. [Figure 5C] A diagram of a system 100 is shown illustrating an exemplary method of use of a catheter placement system including a removable skin nicking device according to embodiments disclosed herein. [Figure 5D] A diagram of a system 100 is shown illustrating an exemplary method of use of a catheter placement system including a removable skin nicking device according to embodiments disclosed herein. [Figure 5E] A diagram of a system 100 is shown illustrating an exemplary method of use of a catheter placement system including a removable skin nicking device according to embodiments disclosed herein. [Figure 6] 2 shows a block diagram of a method of placing the catheter of FIG. 1 within a patient's vasculature according to an embodiment disclosed herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts presented herein. It should also be understood that a specific embodiment disclosed herein may have features that can be easily separated from the specific embodiment and that can be optionally combined or substituted with features of any of the other embodiments disclosed herein.

[0019] With regard to the terms used herein, it should also be understood that each term is intended to describe certain embodiments and does not limit the scope of the concepts presented herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps among a group of features or steps, and do not impose any order or numerical limitations. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in this 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 any particular fixed position, orientation, or direction, for example. Rather, such designations are used to indicate relative positions, orientations, or directions, for example. Unless the context clearly indicates otherwise, the singular forms "a", "an", and "the" include the plural.

[0020] In the following description, the terms "or" and "and / or" as used herein should be interpreted to include or mean any one or any combination. For example, "A, B, or C" or "A, B, and / or C" means "any of A, B, C, A and B, A and C, B and C, A, B and C." Exceptions to this definition occur only when elements, components, features, steps or actions are in some way inherently mutually exclusive.

[0021] With respect to "proximal," for example, the "proximal portion" or "proximal end portion" of a catheter disclosed herein includes the portion of the catheter intended to be near the clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter intended to be near the clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter includes the end of the catheter intended to be near the clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter. However, the proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context suggests otherwise, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0022] 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, end portion, or length of a catheter can include the distal end of the catheter. However, a distal portion, end portion, or length of a catheter need not include the distal end of the catheter. That is, unless the context suggests otherwise, a distal portion, end portion, or length of a catheter is not a terminal portion or length of the catheter.

[0023] Any method disclosed herein includes one or more steps or actions for carrying out the described method. Steps and / or actions of the method may be interchanged with one another. In other words, unless a particular 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 the methods described herein may be separate methods within the scope of the present disclosure. In other words, some methods may include only some 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 enablement of any embodiment.

[0024] 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. To aid in illustrating the embodiments described herein, the longitudinal direction extends substantially parallel to the axial length of the catheter, as shown in Figure 1. The lateral direction extends perpendicular to the longitudinal direction, and the transverse direction extends perpendicular to both the longitudinal and lateral axes.

[0025] 1 illustrates an exemplary catheter placement system ("system") 100, which generally includes a needle 110, a catheter 120 (e.g., a rapid insertion central venous catheter), an access guidewire 140, and an advancement guidewire 142. In some embodiments, the system 100 may include an additional guidewire. The needle 110 may include a needle hub 114 disposed at its proximal end. In some embodiments, the system 100 may further include a blood flush system (not shown) configured to withdraw fluid from the distal tip 112 of the needle 110 to confirm that the distal tip 112 of the needle is properly positioned within the vasculature.

[0026] The catheter 120 includes an access section 122 extending proximally from a distal end 120A of the catheter 120, a catheter section 126 extending distally from a catheter hub 128, and an extension section 124 disposed between the access section 122 and the catheter section 126. The access section 122 may define a single lumen and a first outer diameter 122A. The catheter section 126 may define two or more lumens and a second outer diameter 126A. The second outer diameter 126A is larger than the first outer diameter 122A. In the illustrated embodiment, the catheter section 126 defines three lumens. However, it should be understood that the catheter section 126 may define more or less than three lumens. The expansion section 124 may define a tapered profile having a first outer diameter 122A at a distal end of the expansion section 124 and a second outer diameter 126A at a proximal end of the expansion section 124.

[0027] The hub 128 is disposed at a proximal end of the catheter section 126 and is coupled to one or more extension legs 130 extending proximally from the hub 128. Each extension leg 130 can be in fluid communication with a lumen of the catheter 120. For example, the first extension leg 130A can be in fluid communication with a distal (or access) lumen 132A (see FIG. 2), the second extension leg 130B can be in fluid communication with an intermediate lumen 132B, and the third extension leg 130C can be in fluid communication with a proximal lumen 132C. The distal lumen 132A can extend to a distal lumen opening 134A disposed at the distal end 120A of the catheter 120. The intermediate lumen 132B can extend to an intermediate lumen opening 134B that extends through the wall of the catheter section 126. The proximal lumen 132C may extend to a proximal lumen opening 134C that extends through the wall of the catheter section 126.

[0028] In one embodiment, the intermediate lumen opening 134B may be disposed adjacent to the expansion section 124 and the proximal lumen opening 134C may be disposed proximal to the intermediate lumen opening 134B, or vice versa. In one embodiment, the intermediate lumen opening 134B and the proximal lumen opening 134C may be disposed equidistant from the distal lumen opening 134A. In one embodiment, one or both of the intermediate lumen opening 134B and the proximal lumen opening 134C may be disposed along the expansion section 124.

[0029] In an embodiment, the needle 110 can extend through a portion of the distal lumen 134A until the distal tip 112 of the needle 110 extends distally from the distal lumen opening 134A. The needle 110 can access a portion of the distal lumen 132A through a needle opening 116 that extends through the wall of the catheter 120 and communicates with the distal lumen 132A. As shown, the needle opening (or needle access port) 116 may extend through the wall of the access section 122. Alternatively, the needle opening 116 may extend through the wall of the extension section 124 or the catheter section 126.

[0030] In one embodiment, the access guidewire 140 may be inserted through the needle lumen 118 such that the access guidewire 140 is disposed within the access section 122. In some embodiments, the access guidewire 140 may be configured to (i) stabilize the insertion site 90 once the needle 110 is removed from the access section 122, and (ii) facilitate distal advancement of the access section 122. Similarly, in one embodiment, the advancement guidewire 142 may be inserted through the first extension leg 130A and into the distal lumen (or access lumen) 132A. The advancement guidewire 142 is configured to facilitate distal advancement of the catheter section 126 along the vasculature.

[0031] Further details of such catheter deployment systems 100 can be found in, for example, U.S. Pat. No. 10,376,675, U.S. Patent Application Publication No. 2019 / 0255294, U.S. Patent Application Publication No. 2021 / 0069471, U.S. Patent Application Publication No. 2021 / 0085927, U.S. Patent Application Publication No. 2021 / 0113809, U.S. Patent Application Publication No. 2021 / 0113810, U.S. Patent Application Publication No. 2021 / 0121661, U.S. Patent Application Publication No. 2021 / 0121667, U.S. Patent Application Publication No. 2021 / 0121668, U.S. Patent Application Publication No. 2021 / 0121669, U.S. Patent Application Publication No. 2021 / 0121670, U.S. Patent Application Publication No. 2021 / 0121681, U.S. Patent Application Publication No. 2021 / 0121682, U.S. Patent Application Publication No. 2021 / 0121683, U.S. Patent Application Publication No. 2021 / 0121684, U.S. Patent Application Publication No. 2021 / 0121685, U.S. Patent Application Publication No. 2021 / 0121686, U.S. Patent Application Publication No. 2021 / 0121687, U.S. Patent Application Publication No. 2021 / 0121688, U.S. Patent Application Publication No. 2021 / 0121689, U.S. Patent Application Publication No. 2021 / 0121690, U.S. Patent Application Publication No. 20 No. 2021 / 0228843, U.S. Patent Application Publication No. 2021 / 0322729, U.S. Patent Application Publication No. 2021 / 0330941, U.S. Patent Application Publication No. 2021 / 0330942, U.S. Patent Application Publication No. 2021 / 0361915, U.S. Patent Application Publication No. 2021 / 0402153, U.S. Patent Application Publication No. 2021 / 0402149, and U.S. Patent Application Publication No. 2022 / 0001138, each of which is incorporated by reference in its entirety into this application.

[0032] The system 100 further includes a skin nicking device ("device") 150 coupled to the catheter 120. In some embodiments, the device 150 may be coupled to the extension section 124 of the catheter 120. The device 150 includes a blade 154 coupled to a handle 152. The blade 154 extends distally from the handle 152. In some embodiments, a proximal end of the blade 154 is supported by the handle 152. The handle 152 may include one or more gripping surfaces configured to allow a clinician to grasp the handle, for example, between a thumb and index finger, and manipulate the skin nicking device 150. Optionally, the handle 152 may include one or more gripping features having a high coefficient of friction, such as ridges, ribs, or a second material, such as silicone rubber. FIGS. 1 and 2 show the device 150 engaged with the catheter 120.

[0033] Figure 3A shows a cross-sectional view of the expansion section 124 of the catheter 120 with the device 150 engaged with the expansion section 124. Figure 3B shows a cross-sectional view of the expansion section 124 with the device 150 separated from the expansion section 124. Figure 4 shows a longitudinal cross-sectional view of a portion of the system 100 with the device 150 engaged with the expansion section 124 of the catheter 120.

[0034] As shown in FIGS. 3A and 3B, the catheter 120 includes a notch 156 extending radially inward from an outer surface of the catheter 120 (e.g., the expansion section 124) toward the longitudinal axis 120B (see also FIG. 4). The notch 156 extends longitudinally along the expansion section 124. In one embodiment, as shown in FIG. 3A, the notch 156 may be configured to receive at least a portion of the blade 154 of the device 150 therein. In some embodiments, the notch 156 defines a notch width 156A in a free state that is less than a thickness 154A of the blade 154. In one embodiment, the notch 156 may elastically deform to receive the blade 154 therein. Thus, the notch 156 may engage the blade 154 with an interference fit to retain the blade 154 therein. 3B, the notch 156 may be formed by a slit, and in a free state, i.e., in an elastically undeformed configuration, a first longitudinal sidewall may contact a second longitudinal sidewall opposite the first longitudinal sidewall (i.e., the notch width 156A may be zero). Thus, when the blade 154 is removed from the notch 156, the notch 156 may transition to a closed state.

[0035] In one embodiment, as shown in FIG. 4, the blade 154 defines an inner edge 154A, which may be flat and / or blunt. Thus, the inner edge 154A may mitigate cutting or damage to the catheter 120 when the blade 154 is disposed within the notch 156. The blade 154 further defines a sharp edge 158 configured to cut the patient's skin during use. The sharp edge 158 may extend along a radially outer edge of the blade 154 that extends radially away from the catheter 120. In one embodiment, the sharp edge 158 may protrude from an outer surface of the catheter 120 when the blade 154 engages the notch 156. The sharp edge 158 defines an angle 158A with respect to the longitudinal axis 120B such that a distal portion of the sharp edge 158 is closer to the longitudinal axis 120B than a proximal portion of the sharp edge 158. In some embodiments, the angle 158A may be defined such that the sharp edge 158 is parallel to the outer surface of the expansion section 124. As shown in FIG 4, the handle 152 may extend proximally along the catheter section 126. In some embodiments, the handle 152 may be disposed parallel to the longitudinal axis 120B.

[0036] In one embodiment, the notch 156 may further include a recess (or cavity) 160 disposed at a distal end of the notch 156. The recess 160 defines a lip 162. The blade 154 may further include a tab 164 extending distally from a distal end of the blade 154. The tab 163 may extend longitudinally, laterally, or at an angle therebetween. The tab 164 may engage the recess 160 and the lip 162 when the blade 154 engages the notch 156. Thus, when disposed within the recess 160, the tab 164 may hold the distal end of the blade 154 within the notch 156 such that the distal end of the blade 154 is disposed radially on the outer surface of the expansion section 124. Additionally, the lip 162 and tab 164 structures can cooperate to prevent skin or tissue from passing between the blade 154 and the catheter 120 during insertion and to prevent the formation of a skin bridge, as described in more detail herein.

[0037] 5A-5E show cross-sectional views of the system 100 illustrating various stages of an exemplary method of use as described herein. As shown in FIG. 5A, the device 150 engages the expansion section 124 of the catheter. A portion of the blade 154 engages the notch 156 and is held therein via an interference fit. Additionally, a tab 164 extending from the distal end of the blade 154 is disposed within the recess 160 below the lip 162 to prevent the distal end of the sharp edge 158 from separating from the expansion section 124 as the catheter 120 is pushed into the insertion site 90. If the distal end of the sharp edge 158 separates from the catheter 120 during insertion, a portion of the skin or tissue may pass between the blade 154 and the catheter 120, creating a skin bridge across the insertion site 90, thereby complicating the procedure. Needle 110 is shown disposed within distal lumen 132A along access section 122, with distal tip 112 of needle 110 extending distally from distal end 120A. An access guidewire 140 is also shown disposed within needle lumen 118.

[0038] Initially, the needle 110, positioned within the access section 122 of the catheter 120, may puncture the skin surface 80 and access the patient's vasculature. A blood flush indicator system (not shown) draws fluid proximally through the needle lumen 118, allowing observation of fluid color (e.g., red with blood) and / or pulsatile flow to confirm that the needle tip 112 is properly positioned within the vasculature. Note that the diameter 122A of the access section 122 is smaller than the diameter 126A of the catheter section 126. The diameter 122A of the access section 122 is such that in the event that the needle 110 fails to properly access the vasculature, the needle 110 and access section 122 may be withdrawn from the insertion site 90, allowing the insertion site 90 to be repaired without the need for vascular surgery.

[0039] If proper vascular access is confirmed, the access guidewire 140 may be advanced through the needle lumen 118 and into the vasculature. The needle 110 may then be removed proximally from the distal lumen 132A via the needle opening 116 (see FIG. 1). The access section 122 may then be advanced over the access guidewire 140 until the expansion section 124 engages the insertion site 90, as shown in FIG. 5A. In one embodiment of the method, the access guidewire 140 may then be removed and the advancement guidewire 142 may be advanced through the distal lumen 132A and into the vasculature until the distal tip of the advancement guidewire 142 is positioned at the target location within the vasculature.

[0040] As shown in FIG. 5B, when the expansion section 124 of the catheter 120 is pushed into the insertion site 90, the tapered profile of the expansion section 124 can expand the insertion site 90 from a first diameter 122A to a second diameter 126A. In one embodiment of the method, the clinician can advance the catheter 120 by grasping the handle 152 and urging the handle distally. The blade 154 engaged with the notch 156, and more specifically, the tab 164 disposed within the recess 160, can engage the catheter 120 and push the expansion section 124 into the insertion site 90. Advantageously, the blade 154 can provide additional columnar support to the expansion section 124 as well as apply a distal force to the distal end of the expansion section 124, thereby drawing the proximal end of the expansion section 124 into the insertion site 90. This can reduce twisting or collapsing of the expansion section 124 as the expansion section 12 is forced into the insertion site 90. Additionally, the tabs 164 can enhance engagement between the blade 154 and the expansion section 124 of the catheter 120. The lip 162 can direct skin tissue at the insertion site 90 over the radially outer edge (i.e., the sharp edge 158) of the blade 154, preventing skin tissue from passing between the blade 154 and the catheter 120 and forming a skin bridge.

[0041] 5C, the removable skin nicking device 150 is configured to facilitate expanding the insertion site 90 to the second diameter 126A. When the expansion section 124 is forced into the insertion section 90, the sharp edge 158 of the blade 154, retained by the notch 156 and facing radially outward from the catheter 120, can engage the edge of the insertion site 90 and cut the skin tissue, facilitating the expansion of the insertion site 90 to the second diameter 126A.

[0042] 5D, once the blade 154 has sufficiently expanded the insertion site 90, the clinician can remove the blade 154 from the notch 156 in the catheter 120. The clinician can grasp the handle 152 and pull the device 150 proximally and upwardly to disengage the blade 154 from the notch 156 and separate the blade 154 from the catheter 120. As described, the material of the expansion section 124 can elastically deform to receive the blade 154 within the notch 156 and hold the blade 154 in an interference fit. In embodiments in which the notch 156 is formed as a slit, the blade 154 can be removed from the notch 156 and the notch 156 can return to an undeformed position forming a substantially continuous circumferential surface. In embodiments in which the notch 156 defines a gap, when the blade 154 is removed from the notch 156, radially inward pressure from the tissue surrounding the expansion section 124 can elastically deform the notch 156 to a closed state, forming a substantially continuous circumferential surface, as shown in FIG. 3B.

[0043] As shown in FIGURE 5E, the skin nicking device 150 may be removed and discarded in a "sharps" box or similar appropriate container. The insertion site 90 is now expanded to accommodate the second diameter 126A, and the clinician can continue to advance the catheter 120 over the advancement guidewire 142 until one or more of the distal lumen opening 134A, the middle lumen opening 134B, or the proximal lumen opening 134C are positioned at the target location within the vasculature. The advancement guidewire 142 can then be proximally removed from the distal lumen 132A.

[0044] 6 illustrates a block diagram of a method of placing a catheter within a patient's vasculature, which may include all or any subset of the following steps, actions, or processes. The method 200 may include forming an insertion site with a needle (block 210). The needle is placed within an access lumen of an access section of the catheter and inserted through a needle access port in the access section.

[0045] The method 200 may further include advancing the dilator section to the insertion site (Block 220). The dilator section is coupled with a skin nicking device. The method 200 may further include cutting the skin adjacent to the insertion site (Block 230). The skin may be cut with a sharp edge of a blade, and the cutting of the skin may occur during advancement of the dilator section to the insertion site. Since the blade includes a handle, advancing the dilator section may include applying a distally directed force to the handle. When a portion of the blade is positioned within the notch that includes a cavity at a distal end, the blade includes a tab disposed within the cavity extending distally from the distal end of the blade, such that a distally directed force applied to the handle may be transferred to the catheter via the tab disposed within the cavity.

[0046] The method 200 may further include expanding the insertion site from a first diameter of the access section to a second diameter of the catheter section (Block 240). The method 200 may further include detaching the skin nicking device from the catheter, and more specifically, from the expansion section (Block 250). The method 200 may further include advancing the catheter section through the insertion site and into the vasculature (Block 260).

[0047] The method 200 may further include advancing an access guidewire through the lumen of the needle and into the vasculature (Block 270). The method 200 may further include advancing an advancement guidewire through the access lumen and into the vasculature (Block 280).

[0048] Some specific embodiments are disclosed herein, and although the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concept provided herein. Additional adaptations and / or modifications may be apparent to those skilled in the art, and the broader aspects also encompass these adaptations and / or modifications. Thus, one may deviate from the specific embodiments disclosed herein without departing from the scope of the concept provided herein.

Claims

1. 1. A catheter placement system comprising: A catheter, The extension section and an access section extending distally from the extension section; a catheter section extending proximally from the dilation section; a notch extending longitudinally along at least a portion of the expansion section; a catheter having a skin nicking device coupled to the catheter, The handle and a blade extending distally from the handle, a portion of the blade disposed within the notch; a skin nicking device having A catheter placement system comprising:

2. The system of claim 1 , wherein the catheter is a rapid insertion central venous catheter.

3. The system of claim 1 or 2, wherein the access section is single-lumen and the catheter section is multi-lumen.

4. the access section defines a first outer diameter; the catheter section defines a second outer diameter greater than the first outer diameter; The extension section comprises: the first outer diameter at a distal end of the expansion section; and the second outer diameter at the proximal end of the expansion section.

5. The system of claim 1 or 2, wherein the blade is removable from the notch.

6. The system of claim 1 or 2, wherein the notch defines a notch width that is less than a thickness of the blade such that the notch defines an interference fit with the blade.

7. The blunt edge of the blade is disposed within the notch; The system of claim 1 or 2, wherein the sharp edges of the blades are directed radially outward from the catheter.

8. The system of claim 7 , wherein the sharp edge defines an angle with respect to the longitudinal axis of the catheter such that a distal portion of the sharp edge is closer to the longitudinal axis of the catheter than a proximal portion of the sharp edge.

9. The system of claim 7 , wherein the sharp edge is parallel to an outer surface of the expansion section.

10. The system of claim 1 or 2, wherein the distal ends of the blades are disposed radially inward of the outer surface of the expansion section.

11. the blade includes a tab extending distally from a distal end of the blade; the notch includes a cavity at a distal end of the notch; The system of claim 1 or 2, wherein the tab is disposed within the cavity.

12. The system of claim 11 , wherein, during use, a distally directed force applied by a clinician to the handle is transmitted to the catheter via the tab disposed within the cavity.

13. The system of claim 1 or 2, wherein the handle extends proximally along the catheter section.

14. 6. The system of claim 5, wherein the notch is formed with a slit such that when the blade is removed from the notch, the notch transitions to a closed state and the outer surface of the expansion section forms a continuous circumferential surface.

15. The system of claim 8 , wherein the notch is configured to align the blade with the longitudinal axis.

16. the catheter includes the access section, the extension section, and an access lumen extending along the catheter section; The system of claim 1 or 2, wherein the access section includes a needle access port in fluid communication with the access lumen.

17. 17. The system of claim 16, further comprising a needle disposed within the access lumen between the needle access port and the distal end of the catheter.

18. The system of claim 17 , further comprising an access guidewire disposed within the lumen of the needle.

19. The system of claim 16 , further comprising an advancement guidewire disposed within the access lumen proximal access port.

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