SKIN NICKING DEVICE FOR A CATHETER DEPLOYMENT SYSTEM - Patent application
Patent Information
- Application Number
- JP2024547912
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-02-15
- Filing Date
- 2023-02-14
- Publication Date
- 2026-01-22
Smart Images
Figure 00000000_0000_ABST
Abstract
Description
[Technical field]
[0001] The present disclosure relates to skin nicking devices 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 can 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. As such, advanced catheter placement systems have been developed to reduce the number of steps and medical devices involved in placing a catheter such as a CVC in a patient. Summary of the Invention [Problem to be solved by the invention]
[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 placed, a scalpel may be used to cut or incise the skin and fascia at the insertion site to facilitate catheter insertion. If the skin incision is not made properly, a skin bridge may form that may prevent the catheter from being inserted through the skin and into the vessel. A skin nicking device may be used to create an incision of reproducible depth, reducing the likelihood of leaving a skin bridge around the insertion site. Disclosed herein are advanced catheter placement systems and associated methods for incising the skin at the insertion site to eliminate skin bridges that would prevent the insertion of the catheter into the vasculature. [Means for solving the problem]
[0004] Disclosed herein is a catheter placement system including a catheter and a skin nicking device. According to some embodiments, the catheter includes a catheter tube having two or more lumens extending along the catheter tube and two or more extension legs. Each of the two or more extension legs is in fluid communication with one of the two or more lumens. The skin nicking device is disposed within one of the two or more lumens. The skin nicking device includes a blade at a distal end of the skin nicking device. The blade is configured to score the skin adjacent an insertion site of the catheter during use to dilate the insertion site. Additionally, the blade protrudes from an opening of one of the two or more lumens.
[0005] In some embodiments, the catheter tube includes a first section having a first outer diameter and a second section having a second outer diameter greater than the first outer diameter. According to such embodiments, the catheter tube further includes a transition section extending between the first section and the second section. The transition section transitions the first outer diameter to the second outer diameter. The first section is disposed distal to the second section. In some embodiments, the opening is disposed along the transition section.
[0006] In some embodiments, the blade includes a sharp edge that is directed toward a distal end of the skin nicking device. In some embodiments, the skin nicking device includes a skin nicking device body that extends along the catheter tube. In some embodiments, the skin nicking device body extends proximally along the catheter tube and proximally along one of the two or more extension legs such that a proximal end of the skin nicking device exits one of the two or more extension legs.
[0007] In some embodiments, the skin nicking device body is rigid from the proximal end to the distal end. In some embodiments, it comprises one or more rigid portions and one or more flexible portions. In some embodiments, the distal portion of the skin nicking device body is flexible and the proximal portion of the skin nicking device body is rigid.
[0008] In some embodiments, the skin nicking device is positionable within the lumen between (i) a distal position where the blade protrudes from the opening, and (ii) a proximal position where the blade is disposed within the lumen proximal to the opening.
[0009] In some embodiments, the skin nicking device is rotatable within the lumen between (i) a first orientation in which the blades are oriented radially inward, and (ii) a second orientation in which the blades are oriented radially outward, thereby allowing the blades to cut into the skin.
[0010] Also disclosed herein is a method of placing a catheter within a patient's blood vessel. According to some embodiments, the method includes: (i) accessing the blood vessel with a needle to define an insertion site, (ii) inserting a guidewire through the needle and advancing the guidewire along the blood vessel, (iii) removing the needle from the guidewire, (iv) threading a catheter over the guidewire, the catheter including a skin nicking device disposed within a lumen of the catheter, the skin nicking device having a blade, (v) making an incision in the skin adjacent the insertion site to enlarge the insertion site, and (vi) advancing the catheter along the blood vessel.
[0011] In some embodiments of the method, incising the skin adjacent the insertion site includes inserting a catheter through the insertion site. In some embodiments of the method, the blade protrudes from an opening in the lumen. In some embodiments, the method further includes displacing the skin nicking device distally within the lumen to cause the blade to protrude from the opening.
[0012] In some embodiments of the method, the skin nicking device includes a skin nicking device body extending along the lumen, and the blade is fixedly attached to the skin nicking device body at a distal end of the skin nicking device body.
[0013] In some embodiments of the methods, the catheter includes a transition section extending between a distal portion of the catheter defining a first diameter and a proximal portion of the catheter defining a second diameter larger than the first diameter, and the opening is disposed along the transition section.
[0014] In some embodiments, the method further comprises proximally displacing the skin nicking device within the lumen to position the blade within the lumen. In some embodiments, the method further comprises positioning the skin nicking device within the catheter lumen. In some embodiments, the method further comprises removing the skin nicking device from the lumen.
[0015] Also disclosed herein is a catheter placement device that, according to some embodiments, includes an elongate body defining a proximal end and a distal end, and a blade fixedly attached to the elongate body at the distal end, the blade including a sharp edge configured to incise the patient's skin adjacent the catheter insertion site, thereby dilating the insertion site. According to such embodiments, the catheter placement device is configured to be placed within a lumen of the catheter. The blade is configured to protrude from an opening of the lumen.
[0016] In some embodiments, the sharp edge of the blade is oriented distally. In some embodiments, the elongate body includes a lateral slot extending proximally from the distal end, the sharp edge being disposed at a bottom of the lateral slot.
[0017] In some embodiments, the elongate body includes a flexible distal portion having a preformed curved shape. In some embodiments, the curved shape includes a 180 degree bend. In some embodiments, the sharp edge extends along an outer surface of the curved shape.
[0018] In some embodiments, the elongate body includes a longitudinal slit extending proximally from the distal end, the longitudinal slit defining a first flexible distal portion and a second distal portion. According to such embodiments, the first flexible distal portion includes a preformed curved shape such that the first flexible distal portion curves away from the second distal portion, and a sharp edge extends along the first flexible distal portion and is directed inwardly toward the second distal portion.
[0019] 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 accompanying drawings and the following description, which describe in more detail certain embodiments of such concepts.
[0020] 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]
[0021] [Figure 1A] FIG. 1 shows a perspective view of a catheter deployment system in an unfolded configuration according to an embodiment disclosed herein. [Figure 1B] 1 shows a top view of a catheter deployment system in a folded configuration ready for use, according to an embodiment disclosed herein. [Figure 1C] FIG. 1 shows a perspective view of a catheter deployment system in a folded configuration according to an embodiment disclosed herein. [Diagram 2] FIG. 1 illustrates a side view of a catheter of a catheter deployment system in an unfolded configuration, according to an embodiment disclosed herein. [Figure 3A] 3 shows an enlarged detailed view of a distal portion of the catheter of FIG. 2 according to an embodiment disclosed herein. [Figure 3B] 3B shows a cross-sectional view of the catheter of FIG. 3A according to an embodiment disclosed herein. [Figure 3C] 3B shows a cross-sectional view of the catheter of FIG. 3A according to an embodiment disclosed herein. [Figure 4] 1 shows a longitudinal cross-sectional view of a distal portion of a catheter deployment system according to an embodiment disclosed herein. [Figure 5A]1 illustrates an exemplary method of using a catheter deployment system according to embodiments disclosed herein. [Figure 5B] 1 illustrates an exemplary method of using a catheter deployment system according to embodiments disclosed herein. [Figure 5C] 1 illustrates an exemplary method of using a catheter deployment system according to embodiments disclosed herein. [Figure 5D] 1 illustrates an exemplary method of using a catheter deployment system according to embodiments disclosed herein. [Figure 5E] 1 illustrates an exemplary method of using a catheter deployment system according to embodiments disclosed herein. [Figure 6A] 1 shows a cross-sectional view of a skin nicking device, according to some embodiments. [Figure 6B] 1 shows a cross-sectional view of a skin nicking device, according to some embodiments. [Figure 6C] 1 shows a cross-sectional view of a catheter according to some embodiments. [Figure 6D] 14A-14C illustrate additional embodiments of a skin nicking device, according to some embodiments. [Figure 6E] 14A-14C illustrate additional embodiments of a skin nicking device, according to some embodiments. [Figure 6F] 14A-14C illustrate additional embodiments of a skin nicking device, according to some embodiments. [Figure 6G] 14A-14C illustrate additional embodiments of a skin nicking device, according to some embodiments. [Figure 7A] 1A-1C are diagrams of a catheter placement system illustrating an exemplary method of placing a catheter using a system including a skin nicking device, according to some embodiments. [Figure 7B] 1A-1C are diagrams of a catheter placement system illustrating an exemplary method of placing a catheter using a system including a skin nicking device, according to some embodiments. [Figure 7C]1A-1C are diagrams of a catheter placement system illustrating an exemplary method of placing a catheter using a system including a skin nicking device, according to some embodiments. [Figure 8] 1 shows a flowchart of an exemplary method of placing a catheter using a catheter placement system, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0022] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein are not intended to limit the scope of the concepts provided herein. It should also be understood that a specific embodiment disclosed herein may have features that are easily separable from the specific embodiment and that may be combined or substituted in any way with features of any of the numerous other embodiments disclosed herein.
[0023] With regard to the terms used herein, it should also be understood that these terms are intended to describe certain embodiments and are not intended to 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 specific fixed position, orientation, or direction. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise.
[0024] 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.
[0025] With respect to "distal," for example, a "distal portion" or "distal end portion" of a catheter disclosed herein includes a portion of the catheter 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 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 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.
[0026] 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. Any method disclosed herein includes one or more steps or actions for carrying out the method described. The steps and / or actions of the method may be interchanged with one another. In other words, the order and / or use of certain steps and / or actions may be modified unless a specific order of steps or actions is required to properly implement the embodiment. 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.
[0027] The phrases "connected to," "coupled to," and "in communication with" refer to any form of interaction between two or more elements, including but not limited to mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be connected to one another even if they are not in direct contact with one another. For example, two components may be coupled to one another through an intermediate component.
[0028] 1A-1C generally illustrate an exemplary catheter placement system ("system") 100 including a needle 120 having a needle housing ("housing") 170, a guidewire 130, a syringe system 140, and a catheter 150. 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 other types of catheters may 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.
[0029] In one embodiment, the catheter 150 may generally include a catheter body (or tube) 152 coupled to a catheter hub ("hub") 160 at a proximal end of the catheter body 152. The catheter 150 further includes one or more extension legs 162 (e.g., three extension legs 162 as illustrated) extending proximally from the hub 160. Each extension leg of the one or more extension legs 162 may be in fluid communication with a lumen of the catheter body 152. In the illustrated embodiment, the catheter body 152 may include a first section 154 extending proximally from the distal end 118 of the catheter body 152 and a second section 156 extending distally from the hub 160. A transition portion 158 is disposed between the first section 154 and the second section 156. The first section 154 may include a single lumen and may define a first outer diameter 154A (see FIG. 3A). The second section 156 may include two or more lumens and may define a second outer diameter 155A (see FIG. 3A) that is greater than the first outer diameter 154A. A transition section 158 disposed between the first section 154 and the second section 156 may define a tapered shape to transition the first outer diameter to the second outer diameter. The guidewire 130 may extend from the proximal end of the extension leg 162 through a lumen of the catheter 150 to the distal end 118 of the catheter body 152.
[0030] FIG. 2 shows further details of the catheter 150 of the system 100. As described herein, different sections of the catheter 150 may be configured to perform different functions and therefore may include different mechanical properties. For example, the first section 154 and the transition section 158 may be harder than the second section 156. In some embodiments, the first section 154 and the transition section 158 may be formed from a harder durometer material relative to the second section 156. Thus, the first section 154 and the transition section 158 can withstand a greater axial force than the second section 156 without kinking, buckling, or collapsing during use. The second section 156 may be formed from a softer durometer, or more flexible material, to facilitate advancing the second section 156 through tortuous vascular pathways of the vasculature.
[0031] 3A-3C show further details of the distal portion of catheter 150, including first section 154, second section 156, and transition section 158. In one embodiment, second section 156 may include proximal lumen 114A terminating at proximal lumen opening 116A and intermediate lumen 114B terminating at intermediate lumen opening 116B. In some embodiments, each of proximal lumen opening 116A and intermediate lumen opening 116B may extend through a sidewall of second section 156. One or both of proximal lumen opening 116A and intermediate lumen opening 116B may be disposed along transition section 158. In some embodiments, proximal lumen opening 116A may be disposed proximal of intermediate lumen opening 116B.
[0032] FIG. 3B shows a cross-sectional end view of the catheter body 152 at position "A" of FIG. 3A. As shown, the first section 154 may define a single lumen and a first outer diameter 154A. The distal lumen 114C of the catheter 150 may extend to the distal end 118 of the catheter 150 and defines a distal lumen opening 116C (FIG. 3A). FIG. 3C shows a cross-sectional end view of the second section 156 at position "B" of FIG. 3A, illustrating the proximal lumen 114A, the intermediate lumen 114B, and the distal lumen 114C. Each of the proximal lumen 114A, the intermediate lumen 114B, and the distal lumen 114C may be in fluid communication with one or more of the extension legs 162.
[0033] 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. A needle splitter system 180 is also shown, as described in more detail herein. The needle 120 may include a needle hub 120A at a proximal end of the needle 120. The needle hub 120 may be coupled to and supported by the 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 draw fluid proximally through the needle lumen 122. In one embodiment, the needle 120 may include a guidewire opening 124 that extends through a wall of the needle 120 to the needle lumen 122. A guidewire 130 can be inserted through the guidewire opening 124 and advanced along the needle lumen 122. In one embodiment, the distal tip 138 of the guidewire 130 can be positioned proximate to the distal tip 128 of the needle 120. Thus, when the distal tip 128 of the needle 120 is positioned within the vasculature, the distal tip 138 of the guidewire 130 is also positioned within the vasculature.
[0034] The housing 170 may include a housing lumen 172 extending between a proximal end 176 and a distal end 178 of the housing 170. The housing lumen 172 is configured to slidably receive the needle 120 therethrough. The housing 170 may further include a guidewire lumen 174 connecting with and extending at an angle therefrom. Additionally, the proximal end 176 of the housing may be releasably engaged with one or both of the needle hub 120A and the distal portion of the syringe system 140. In the illustrated embodiment, when the housing 170 is coupled with the syringe system 140, the guidewire opening 124 of the needle 120 may be positioned in alignment with the guidewire lumen 174 of the housing 170. Thus, the guidewire 130 may be inserted through the guidewire lumen 174 of the housing 170, through the guidewire opening 124 of the needle 120, and into the needle lumen 122.
[0035] 5A-5E show various views of the catheter placement system 100 illustrating an exemplary method of placing a catheter 150 in a blood vessel using the system 100. As shown in FIG. 5A, the needle 120 can penetrate the patient's superficial tissue 90 (e.g., skin) to access the vasculature 80 and form an insertion site. As shown in FIG. 5B, a syringe system 140 or similar device can draw fluid (e.g., blood) proximally via the needle lumen 122. The user can observe the color and / or pulsatile flow characteristics of the fluid, thereby confirming that the distal tip 128 is located within the vasculature 80. If incorrect vascular access is confirmed, the needle 120 can be withdrawn and the insertion site can be closed. As shown in FIG. 5C, once the presence of the distal tip 128 in the vasculature 80 is confirmed, a guidewire 130 can then be advanced through the needle lumen 122 and into the vasculature 80.
[0036] 5D , the needle 120 and syringe system 140 assembly can be laterally separated 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. A portion of the guidewire 130 can pass between the two halves of the needle 120, allowing the needle 120 to be laterally separated from the guidewire 130.
[0037] With the needle 120 and syringe system 140 assembly disengaged from the guidewire 130, as shown in FIG. 5E, the catheter 150 can 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 first outer diameter 154A, can be passed through an insertion site and over the guidewire 130 into the vasculature 80. The catheter 150 is moved to insert a transition section 158 through the insertion site. The transition section 158 expands the insertion site to allow a second section 156, having a second outer diameter 156A, to enter the vasculature 80. Once the catheter 150 is positioned in the vasculature 80, the guidewire 130 can be withdrawn proximally.
[0038] Further details and embodiments of such a catheter system 100 may 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 / 0228843, U.S. Patent Application Publication No. 2021 / 0228844, U.S. Patent Application Publication No. 2021 / 0228845, U.S. Patent Application Publication No. 2021 / 0228846, U.S. Patent Application Publication No. 2021 / 0228847, U.S. Patent Application Publication No. 2021 / 0228848, U.S. Patent Application Publication No. 2021 / 0228849 ... 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, U.S. Patent Application Publication No. 2022 / 0001138, U.S. Patent Application Publication No. 2022 / 0032013, and U.S. Patent Application No. 17 / 882,388, filed August 5, 2022, each of which is incorporated by reference in its entirety into this application.
[0039] In some instances, it may be beneficial to expand the insert to accommodate the catheter 150. FIG. 6A shows a side view of a skin nicking device 210, according to some embodiments. In some embodiments, the skin nicking device 210 may be coupled or integrated with the catheter placement system 100. In some embodiments, the skin nicking device 210 may be a catheter placement device and may be used with the catheter placement system 100 to place the catheter 150. As shown in FIG. 6A, the skin nicking device 210 may include a skin nicking device body 212 defining a proximal end 214 and a distal end 216. In some embodiments, the skin nicking device body 212 may include a reinforcing stylet. In some embodiments, the skin nicking device 210 may be inserted into a lumen of the catheter 150, such as, for example, the intermediate lumen 114B of the catheter 150. In the illustrated embodiment, the skin nicking device 210 includes a blade 220 defining a sharp edge 224. The blade 220 is disposed adjacent the distal end 216. In other embodiments, the skin nicking device 210 may include two or more blades 220. The blade 220 is generally configured to be capable of scoring or cutting the surface tissue 90 (e.g., skin) via the sharp edge 224. In some embodiments, the skin nicking device body 212 may be rigid from the proximal end 214 to the distal end 216. For example, a portion of the skin nicking device body 212 adjacent the distal end 216 may be more flexible relative to a portion of the skin nicking device body 212 adjacent the proximal end 214. In some embodiments, the blade 220 may also include a blunt edge 222. In some embodiments, the sharp edge 224 may be oriented in a direction toward the distal end 216. Meanwhile, the blunt edge 222 may be oriented in a different direction, e.g., toward the proximal end 214. The skin nicking device body 212 may generally define a body diameter 212A.In the illustrated embodiment, the sharp edge 224 may be disposed toward the inside of the body diameter 212A such that the sharp edge 224 is constrained away from the inner surface of the catheter lumen to prevent cutting the catheter 150. In other embodiments, the sharp edge 224 may extend radially beyond the body diameter 212A. In some embodiments, the proximal end 214 may include an attachment member (not shown) configured to releasably couple the skin nicking device 210 to the catheter 150 to properly position the skin nicking device 210 within the catheter 150 as the catheter 150 is inserted into the vasculature 80.
[0040] 6B shows a cross-sectional detailed side view of a distal portion of the catheter 150, according to some embodiments. As described above, the catheter 150 may include a proximal lumen 114A (see FIG. 3A), an intermediate lumen 114B, and a distal lumen 114C. The distal lumen 114C includes a distal lumen opening 116C, and the intermediate lumen 114B includes an intermediate lumen opening 116B. The intermediate lumen opening 116B is a side opening disposed proximal to the distal lumen opening 116C. Any or all of the proximal lumen 114A, intermediate lumen 114B, and distal lumen 114C may be configured to have a skin nicking device 210 disposed therein. In the illustrated embodiment, the intermediate lumen opening 116B may be disposed along the transition section 158.
[0041] FIG. 6C shows a cross-sectional detailed side view of FIG. 6B coupled with a skin nicking device 210, according to some embodiments. As shown in FIG. 6C, in the illustrated embodiment, the skin nicking device 210 may be inserted into the intermediate lumen 114B and advanced through the intermediate lumen 114B until the distal end 216 of the skin nicking device 210, including the blade 220, extends out of the intermediate lumen opening 116B. In some embodiments, the skin nicking device 210 may be axially rotated within the intermediate lumen 114B to orient the blade 220 such that the blade is directed, i.e., oriented, radially outward from the catheter 150 to facilitate scoring the skin. In some embodiments, as shown in FIG. 6C, when inserting the skin nicking device 210 into the intermediate lumen 114B, the skin nicking device 210 may be oriented with the blade 220 directed toward the distal lumen 114C. In some embodiments, when inserting the skin nicking device 210 into the intermediate lumen 114B, the skin nicking device 210 may be oriented with the blades 220 oriented radially outward, i.e., opposite the direction shown. In some embodiments, when the distal end 216 extends from the intermediate lumen opening 116B, the distal end 216 may be configured to extend parallel to the catheter 150, for example, to seat flush against the transition section 158, to form a cut into the skin of a reproducible depth and reduce the likelihood of skin bridging during placement of the catheter 150.
[0042] Although not shown, the skin nicking device 210 (or more specifically, the skin nicking device body 212) may extend proximally along the intermediate lumen 114B and may extend further along the corresponding extension leg 162 (see FIG. 2) such that the proximal end 214 extends beyond (i.e., exits) the corresponding extension leg 162. During use, a user may grasp the proximal end 214 and thereby manipulate the skin nicking device 210. For example, a user may displace the skin nicking device 210 longitudinally within the inner lumen 114B. In some embodiments, a user may displace the skin nicking device 210 between (i) a distal position in which the blade 220 protrudes from the intermediate lumen opening 116B (FIG. 6C) and (ii) a proximal position (not shown) in which the blade 220 is disposed within the intermediate lumen 114B proximal to the intermediate lumen opening 116B. Similarly, in some embodiments, a user may rotate the skin nicking device 210 within the intermediate lumen 114B. In some embodiments, a user may rotate the skin nicking device 210 between (i) a first orientation (FIG. 6C) in which the blades 220 are oriented radially inward, and (ii) a second orientation (not shown) in which the blades 220 are oriented radially outward, thereby enabling the blades 220 to cut a cut in the skin.
[0043] FIG. 6D illustrates a second 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 FIG. 6A. 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 skin nicking device body is indicated as "212" in FIG. 6A, and a similar skin nicking device body is indicated as "312" in FIG. 6D. Thus, the relevant disclosure set forth above with respect to similarly identified features may not be repeated hereafter. Additionally, certain features of the skin nicking device 210 and related components illustrated in FIG. 6A may not be indicated or identified by reference numbers in the drawings or described in detail in the following description. However, such features may obviously be the same or substantially the same as features illustrated in and / or described in connection with other embodiments. Thus, the relevant discussion of such features applies equally to the features of the skin nicking device 310 of FIG. 6D. Any suitable combination of features, and variations thereof, described with respect to the skin nicking device 210 and components shown in Figure 6A may be used with the skin nicking device 310 and components of Figure 6A, and vice versa. This pattern of disclosure applies equally to further embodiments shown in subsequent figures and described below.
[0044] The skin nicking device 310 includes a skin nicking device body 312 in which a distal portion 315 is flexible to bend. For example, the distal portion 315 may be flexible while the remaining portion of the skin nicking device body 312 extending distally from the proximal end 314 may be rigid. In some embodiments, the distal end portion 315 may include a preformed shape, such as, for example, a preformed curved shape as shown in FIG. 6D. In some embodiments, the preformed shape may include an approximately 180 degree bend such that the distal end 316 is oriented toward the proximal end 314. The structure of the skin nicking device body 312 may be generally configured such that the distal portion 315 (i) is constrained to a straight shape (or the shape of the catheter 150) when the skin nicking device 310 is disposed within the intermediate lumen 114B, and (ii) resumes the preformed shape when the distal portion 315 extends from the intermediate opening 114B. In the illustrated embodiment, the sharp edge 324 of the blade 320 is oriented opposite the distal end 316 such that it is oriented distally as a result of the 180 degree bend. Similarly, the sharp edge 324 may be oriented proximally when the distal portion 315 is constrained toward a straight configuration. In some embodiments, the distal end 316 curving back toward the proximal end 314 may allow the distal end 316, including the blade 320, to extend out of the intermediate lumen opening 116B while the remainder of the skin nicking device body 312 resides within the intermediate lumen 114B.
[0045] FIG. 6E illustrates a third embodiment of a skin nicking device 410 including a skin nicking device body 412 in which a distal portion 415 is flexible to bending. For example, the distal portion 415 may be flexible while the remaining portion of the skin nicking device body 412 extending distally from the proximal end 414 may be rigid. In some embodiments, the distal end portion 412 may include a preformed shape, such as the preformed curved shape shown in FIG. 6E. The structure of the skin nicking device body 412 may be generally configured such that the distal portion 415 (i) is constrained to a straight shape (or the shape of the catheter 150) when the skin nicking device 410 is disposed within the intermediate lumen 114B, and (ii) resumes the preformed curved shape when the distal portion 415 extends from the intermediate lumen opening 114B. In the illustrated embodiment, the sharp edge 424 of the blade 420 is oriented away from the outer surface of the curve.
[0046] 6F shows a fourth embodiment of a skin nicking device 510 including a skin nicking device body 512 with a distal end 516 including a lateral slot 518 extending proximally from the distal end 516. A blade 520 is positioned at the bottom of the lateral slot 518 such that a sharp edge 524 is oriented distally. In use, as the skin nicking device 510 is displaced distally, the lateral slot 518 captures the skin or tissue such that the sharp edge 524 can cut the skin or tissue.
[0047] 6G illustrates a fifth embodiment of a skin nicking device 610 including a skin nicking device body 612 having a longitudinal slit 618 extending proximally from a distal end 616. The longitudinal slit 618 defines a first distal portion 615A and a second distal portion 615B. As shown in FIG. 6G, the first distal portion 615A is flexible to bending and defines a preformed curved shape, where the first distal portion 615A curves away from the second distal portion 615B. The structure of the skin nicking device body 612 may generally be configured such that the first distal portion 615A (i) is constrained to a straight shape (or the shape of the catheter 150) when the skin nicking device 610 is disposed within the intermediate lumen 114B, and (ii) resumes a preformed curved shape when the first distal portion 615A extends from the intermediate lumen opening 114B. In the illustrated embodiment, the sharp edge 624 of the blade 620 is oriented radially inward. In use, as the skin nicking device 610 is displaced distally, skin or tissue is captured between the first distal portion 615A and the second distal portion 615B such that the sharp edge 624 can cut the skin or tissue.
[0048] 7A-7C show various cross-sectional views of the catheter placement system 100 illustrating an exemplary method of placing a catheter 150 using the catheter placement system 100 including a skin nicking device 210, according to some embodiments. In some embodiments, when placing the catheter 150, the introducer needle 120 accesses the vasculature 80 and the guidewire 130 is threaded through the needle 120 and into the vasculature 80. The introducer needle 120 is removed from the vasculature 80 leaving a distal portion of the guidewire 130 within the vasculature 80 (see FIGS. 5C-5D). As illustrated in FIG. 7A, the skin nicking device 210 may be disposed within the intermediate lumen 150 of the catheter 114B and extend through the intermediate lumen opening 116B. The catheter 150 may include a transition section 158 that tapers from a smaller first outer diameter 154A of the first section 154 to a larger second diameter 156A of the second section 156. A guidewire 130 may be threaded through distal lumen 114C, and a catheter 150 may be slid over (or advanced along) the guidewire 130 toward the insertion site.
[0049] As shown in FIG. 7B, the transition section 158 can dilate the insertion site and hold the skin and superficial tissue 90 around the insertion site taut as the catheter 150 slides over the guidewire 130. The skin nicking device 210 with the blade 220 extending out of the intermediate lumen opening 116B can incise the skin and nearby tissue 90 at the insertion site, thereby dilating the insertion site while reducing the likelihood of forming a skin bridge. Advantageously, the skin nicking device 210 incise the skin and superficial tissue 90 to provide an appropriately sized incision for the catheter 150 as well as provide an incision on the same path as the catheter 150. As shown in FIG. 7C, once the skin is incised, the skin nicking device 210 can be displaced proximally within the intermediate lumen 114B such that the blade 220 is disposed within the intermediate lumen 114B, thereby preventing the blade 220 from further cutting the tissue. The catheter 150 may then be inserted completely into the vasculature 80. In some embodiments, the skin nicking device 210 may be removed from the intermediate lumen 114B.
[0050] 8 illustrates a flowchart of an exemplary method 800 of placing a catheter 150 using the catheter placement system 100, which may include all or any subset of the following steps, actions, or processes, according to some embodiments. The method 800 may include accessing a blood vessel with a needle to define an insertion site (block 810).
[0051] The method 800 may further include (i) inserting a guidewire through the needle and advancing the guidewire along the blood vessel (block 820), and removing the needle from the guidewire (block 830).
[0052] The method 800 may further include threading a catheter over the guidewire (block 840), the catheter including a skin nicking device disposed within a lumen of the catheter. In some embodiments of the method 800, the blade protrudes from an opening of the lumen. In some embodiments, the method 800 further includes displacing the skin nicking device distally within the lumen, causing the blade to protrude from the opening. In some embodiments of the method 800, the skin nicking device includes a skin nicking device body extending along the lumen, the blade being fixedly attached to the skin nicking device body at a distal end of the skin nicking device body. In some embodiments, the method 800 may further include displacing the skin nicking device proximally within the lumen to position the skin nicking device within the lumen such that the blade protrudes from the opening. In some embodiments, the method 800 may further include rotating the skin nicking device within the lumen to orient the blade to be directed radially outward. In some embodiments, the method 800, the catheter, and the skin nicking device may be provided separately. Thus, the method 800 may further include initially placing a skin nicking device within the catheter lumen.
[0053] The method 800 may further include incising the skin adjacent the insertion site to enlarge the insertion site (block 850). In some embodiments of the method 800, incising the skin may occur during or as a result of insertion of the catheter through the insertion site. In some embodiments of the method 800, the catheter includes a transition section extending between a distal portion of the catheter defining a first diameter and a proximal portion of the catheter defining a second diameter larger than the first diameter, and the opening is disposed along the transition section.
[0054] The method 800 may further include advancing the catheter along the blood vessel to complete placement of the catheter (block 860). In some embodiments, the method 800 may further include removing the skin-nicking device from the lumen.
[0055] In some embodiments, the method 800 may include detecting the target vessel, which may include detecting the target vessel within the vasculature using one or more medical devices. In some embodiments, the one or more medical devices may include an ultrasound probe.
[0056] 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 comprising: a catheter tube having two or more lumens extending therealong; a catheter comprising two or more extension legs, each of the two or more extension legs in fluid communication with one of the two or more lumens; a skin nicking device disposed within one of the two or more lumens; the skin nicking device includes a blade at a distal end of the skin nicking device, the blade configured to incise the skin adjacent an insertion site of the catheter during use to dilate the insertion site; A catheter deployment system, wherein the blade protrudes from an opening of one of the two or more lumens.
2. The catheter tube a first section having a first outer diameter; a second section having a second outer diameter greater than the first outer diameter; a transition section extending between the first section and the second section; the transition section is configured to transition the first outer diameter to the second outer diameter; The system of claim 1 , wherein the first section is disposed distal to the second section.
3. The system of claim 2 , wherein the opening is disposed along the transition section.
4. The system of any one of claims 1 to 3, wherein the blade includes a sharp edge directed toward the distal end of the skin nicking device.
5. The system of any one of claims 1 to 3, wherein the skin nicking device includes a skin nicking device body that extends along the catheter tube.
6. 6. The system of claim 5, wherein the skin nicking device body extends proximally along the catheter tube and also extends proximally along one of the two or more extension legs such that a proximal end of the skin nicking device exits one of the two or more extension legs.
7. 6. The system of claim 5, wherein the skin-nicking device body is rigid from the proximal end to the distal end.
8. 6. The system of claim 5, wherein the skin-nicking device body includes one or more rigid portions and one or more flexible portions.
9. 10. The system of claim 8, wherein a distal portion of the skin nicking device body is flexible and a proximal portion of the skin nicking device body is rigid.
10. The skin nicking device is disposed within the lumen. a distal position where the blade protrudes from the opening; A system according to any one of claims 1 to 3, wherein the blade is positionable between a proximal position where the blade is positioned within the lumen proximal to the opening.
11. The skin nicking device is disposed within the lumen. a first orientation in which the blades are oriented radially inward; A system according to any one of claims 1 to 3, wherein the blade is rotatable between a first orientation and a second orientation in which the blade is directed radially outward, thereby enabling the blade to make an incision in the skin.
12. 1. A catheter placement device comprising: an elongate body defining a proximal end and a distal end; a blade fixedly attached to the elongate body at the distal end, the blade including a sharp edge configured to incise the patient's skin adjacent to an insertion site of the catheter, thereby dilating the insertion site; the catheter placement device is configured to be placed within a lumen of the catheter; The catheter placement device, wherein the blade is configured to protrude from an opening of the lumen.
13. The device of claim 12 , wherein the sharp edge of the blade is oriented distally.
14. the elongate body includes a transverse slot extending proximally from the distal end; 14. The device of claim 12 or 13, wherein the sharp edge is located at the bottom of the lateral slot.
15. The device of claim 12 , wherein the elongate body includes a flexible distal portion having a preformed curved shape.
16. The device of claim 15 , wherein the curved shape comprises a 180 degree bend.
17. The device of claim 15 , wherein the sharp edge extends along an outer surface of the curved shape.
18. the elongate body includes a longitudinal slit extending proximally from the distal end, the longitudinal slit defining a first flexible distal portion and a second flexible distal portion; the first flexible distal portion includes a preformed curved shape such that the first flexible distal portion curves away from the second distal portion; The device of claim 12 , wherein the sharp edge extends along the first flexible distal portion and is directed inwardly toward the second distal portion.