Dividable needle for catheter placement system

Abstract

An improved catheter placement system (100) is required to disengage the needle (120) from the guidewire (130) without shifting the position of the guidewire (130) within the vasculature. An embodiment includes withdrawing the needle (120) proximally and pulling the needle (120) through a splitter system (180) including a splitter wedge (182). The splitter system (180) separates the needle (120) along its longitudinal axis. A portion of the guidewire (130) can then pass between the first and second needle portions (120A and 120B), allowing the needle (120) to disengage from the guidewire (130). A catheter (150) disposed on the proximal portion of the guidewire (130) can then be advanced over the guidewire into the vasculature. The needle safety system 190 can adhere a puncture resistant adhesive tape 192 to the split portions 120A, 120B of the needle 120. The tape 192 can seal the portions 120A, 120B of the needle 120 to reduce damage or trauma caused by sharp edges of the needle portions 120A, 120B.

Description

[Background technology]

[0001] Central venous catheters ("CVCs") are typically introduced into a patient and advanced through the patient's vasculature via the Seldinger technique. The Seldinger technique utilizes several steps and medical devices (e.g., needles, scalpels, guidewires, introducer sheaths, dilators, CVCs, etc.). Although the Seldinger technique is effective, the many steps make it time-consuming and the handling of many medical devices 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, there is a relatively high chance of contact contamination. Thus, improved 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's body.

[0002] Some of these improved catheter placement systems include using a needle to access the vasculature and a guidewire to stabilize the access site. Preferably, a distal portion of the guidewire is placed within the lumen of the needle and advanced simultaneously. Thus, when the vasculature is reached, the guidewire is already in place, expediting the process. Additionally, the proximal portion of the guidewire can include a catheter placed over the guidewire (referred to as "preloaded"), further facilitating advancement of the catheter over the guidewire and into the vasculature. Summary of the Invention [Problem to be solved by the invention]

[0003] However, problems can arise as to how to safely remove the needle without displacing the distal tip of the guidewire and removing the catheter from the proximal portion of the guidewire. Disclosed herein is an improved catheter placement system and associated method for removing the needle from the access site without displacing the position of the guidewire. [Means for solving the problem]

[0004] Disclosed herein is a catheter placement system that includes a needle defining a needle lumen, a guidewire extending through a portion of the needle lumen, a housing defining a needle channel and having a portion of the needle slidably engaged with the needle channel, and a splitter system disposed within the housing and configured to longitudinally split the needle as the needle is withdrawn proximally through the needle channel.

[0005] In some embodiments, the needle is supported at a proximal end by one or both of a needle hub and a syringe system, the syringe system configured to draw a fluid flow proximally through the needle lumen.

[0006] In some embodiments, the housing further includes a guidewire channel in communication with the needle channel, the guidewire channel being aligned with an opening disposed in the wall of the needle and in communication with the needle lumen, and a portion of the guidewire extending through the guidewire channel, through the opening, and into the needle lumen.

[0007] In some embodiments, the splitter system includes a wedge disposed distal to the aperture and configured to split the needle along the longitudinal axis. In some embodiments, the needle further includes a tear line extending longitudinally and aligned with the splitter system, the tear line configured to facilitate separation of the needle along the tear line.

[0008] In some embodiments, the splitter system further includes a valve extending between an outer surface of the needle and an inner surface of the needle channel and configured to mitigate leakage of fluid into or from the needle lumen, and the splitter system is configured to split the valve when the needle is retracted proximally.

[0009] In some embodiments, the catheter placement system further includes a needle safety system having one or both of a first tape and a second tape configured to seal one or both of the first and second portions of the needle after the needle is split by the splitter system.

[0010] In some embodiments, one or both of the first tape and the second tape are disposed within the housing in a wound configuration and are configured to transition to an unwound configuration when the needle is withdrawn proximally from the housing.

[0011] In some embodiments, the top end of a first tape is configured to be adhered to the top end of a second tape and the bottom end of the first tape is configured to be adhered to the bottom end of the second tape, sealing the first and second portions of the needle between the first and second tapes.

[0012] In some embodiments, a first tape in the unwrapped configuration is designed to seal a first portion of the needle and a second tape in the unwrapped configuration is designed to seal a second portion of the needle.

[0013] In some embodiments, the top end of the first tape is configured to overlap the bottom end of the first tape to seal one or both of the first and second portions of the needle. In some embodiments, a first tape is adhered to an inner surface of a first portion of the needle and a distal end of the first tape is configured to be folded outward to adhere to the outer surface of the first portion, and a second tape is adhered to an inner surface of a second portion of the needle and a distal end of the first tape is configured to be folded outward to adhere to the outer surface of the second portion.

[0014] In some embodiments, one or both of the first tape and the second tape comprise a first material, the first material comprising one or more of a plastic, a polymer, a metal, an alloy, a composite, KEVLAR®, or a puncture resistant material.

[0015] In some embodiments, one or both of the first tape and the second tape include a reinforcing portion. In some embodiments, the reinforcement portion includes one of a thickened portion or a second material different from the first material, and the second material includes one of a plastic, a polymer, a metal, an alloy, a composite material, KEVLAR®, or a puncture resistant material.

[0016] In some embodiments, the catheter placement system further includes a catheter disposed on a proximal portion of the guidewire. In some embodiments, the catheter includes a first section disposed distally and defining a first diameter, a second section disposed proximally and defining a second diameter larger than the first diameter, and a transition section extending between the first and second sections.

[0017] In some embodiments, the first section defines a single lumen and the second section defines two or more lumens. Also disclosed is a method of sealing a needle of a catheter placement system, the method including the steps of accessing a patient's vasculature with the needle, advancing a portion of a guidewire through a lumen of the needle, withdrawing the needle proximally through a channel in the housing, longitudinally splitting the needle into a first needle half and a second needle half, disengaging the guidewire from the needle by passing a portion of the guidewire longitudinally between the first needle half and the second needle half, and engaging one or both of the first needle half and the second needle half with one or both of a first adhesive tape and a second adhesive tape.

[0018] In some embodiments, the needle further includes a tear line extending longitudinally and configured to facilitate longitudinal separation of the needle into the first and second needle halves.

[0019] In some embodiments, the method further includes advancing a portion of a guidewire through an opening extending through a sidewall of the needle and in communication with the needle lumen. In some embodiments, the method further includes withdrawing the needle through a splitter wedge to split the needle into a first needle half and a second needle half.

[0020] In some embodiments, the method further includes adhering an upper end of the first adhesive tape to an upper end of the second adhesive tape and adhering a lower end of the first adhesive tape to a lower end of the second adhesive tape to seal the first needle half and the second needle half between the first adhesive tape and the second adhesive tape.

[0021] In some embodiments, the method further includes adhering a first adhesive tape to the first needle half, an upper end of the first adhesive tape extending over an upper end of the first needle half and adhering to an inner surface of the first needle half, and a lower end of the first adhesive tape extending over a lower end of the first needle half and adhering to the inner surface of the first needle half.

[0022] In some embodiments, the method further includes adhering a second adhesive tape to the second needle half, an upper end of the second adhesive tape extending over an upper end of the second needle half and adhering to an inner surface of the second needle half, and a lower end of the second adhesive tape extending over a lower end of the second needle half and adhering to the inner surface of the second needle half.

[0023] In some embodiments, the method further includes adhering a first adhesive tape to one or both of the first needle half and the second needle half, wherein an upper end of the first adhesive tape overlaps a lower end of the first adhesive tape.

[0024] In some embodiments, the method further includes adhering a first adhesive tape to an inner surface of the first needle half, folding a distal portion of the first adhesive tape outwardly to engage an outer surface of the first needle half, adhering a second adhesive tape to an inner surface of the second needle half, and folding a distal portion of the second adhesive tape outwardly to engage an outer surface of the second needle half.

[0025] In some embodiments, one or both of the first adhesive tape and the second adhesive tape comprise a first material, the first material comprising one or more of a plastic, a polymer, a metal, an alloy, a composite material, KEVLAR®, or a puncture resistant material.

[0026] In some embodiments, one or both of the first adhesive tape and the second adhesive tape include a thickened portion or a reinforced portion having one of a second material different from the first material, and the second material includes one of a plastic, a polymer, a metal, an alloy, a composite material, KEVLAR®, or a puncture resistant material. [Brief description of the drawings]

[0027] A more particular description of the present disclosure will be provided by reference to specific embodiments thereof, which are illustrated in the accompanying drawings, in which it is understood that these drawings depict only typical embodiments of the invention and therefore should not be considered as limiting the scope of the invention, which exemplary embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which: [Figure 1A] FIG. 1 is a perspective view of a catheter placement system in a deployed configuration according to an embodiment disclosed herein. [Figure 1B] FIG. 1 is a plan view of a catheter placement system in a folded configuration ready for use, according to an embodiment disclosed herein. [Figure 1C] FIG. 1 is a perspective view of a catheter placement system in a folded configuration according to an embodiment disclosed herein. [Diagram 2] FIG. 2 is a side view of a catheter of a catheter placement system in a deployed configuration according to an embodiment disclosed herein. [Figure 3A] FIG. 3 illustrates an enlarged detailed view of a distal portion of the catheter of FIG. 2 according to an embodiment disclosed herein. [Figure 3B-3C] FIG. 3B is a cross-sectional view of the catheter of FIG. 3A according to an embodiment disclosed herein. [Figure 4] FIG. 2 is a longitudinal cross-sectional view of a distal portion of a catheter placement system according to an embodiment disclosed herein. [Figure 5A] 1A-1C illustrate an exemplary method of use for a catheter placement system according to embodiments disclosed herein. [Figure 5B] 1A-1C illustrate an exemplary method of use for a catheter placement system according to embodiments disclosed herein. [Figure 5C] 1A-1C illustrate an exemplary method of use for a catheter placement system according to embodiments disclosed herein. [Figure 5D] 1A-1C illustrate an exemplary method of use for a catheter placement system according to embodiments disclosed herein. [Figure 5E]1A-1C illustrate an exemplary method of use for a catheter placement system according to embodiments disclosed herein. [Figure 6A] FIG. 1 is a side cross-sectional view of a needle for a catheter placement system prior to removal of the needle according to an embodiment disclosed herein. [Figure 6B] FIG. 2 is a top cross-sectional view of a needle for a catheter placement system prior to removal of the needle, according to an embodiment disclosed herein. [Figure 6C] FIG. 13 is a top cross-sectional view of a needle for a catheter placement system after removal of the needle according to an embodiment disclosed herein. [Figure 7A] FIG. 1 is a perspective view of a needle and needle safety system for a catheter placement system according to an embodiment disclosed herein. [Figure 7B] FIG. 2 shows an enlarged detail of a needle safety system according to an embodiment disclosed herein. [Figure 7C] FIG. 2 is a perspective view of a needle disposed between a first tape and a second tape of a needle safety system according to an embodiment disclosed herein. [Figure 7D] FIG. 2 is a side view of a needle sealed by a needle safety system according to an embodiment disclosed herein. [Figure 8A-8B] 1A-1D are transverse cross-sectional views of an exemplary method of use for a needle and needle safety system according to embodiments disclosed herein. [Fig. 8C-8D] 1A-1D are transverse cross-sectional views of an exemplary method of use for a needle and needle safety system according to embodiments disclosed herein. [Figure 8E] 1A-1D are transverse cross-sectional views of an exemplary method of use for a needle and needle safety system according to embodiments disclosed herein. [Figure 9A] 1A-1D are plan views of an exemplary method of use for a needle and needle safety system according to embodiments disclosed herein. [Figure 9B] 1A-1D are plan views of an exemplary method of use for a needle and needle safety system according to embodiments disclosed herein. [Figure 10A-10B]1A-1D are plan views of an exemplary method of use for a needle and needle safety system according to embodiments disclosed herein. [Figure 10C] FIG. 1 is a side view of a needle and needle safety system according to an embodiment disclosed herein. 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, and that the specific embodiments disclosed herein can have features that can be easily separated from the specific embodiment and can be combined or substituted in any way with the features of any of the several other embodiments disclosed herein.

[0029] 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 result in sequential or numerical limitations. For example, "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 are not intended to imply, for example, any particular fixed position, orientation, or direction. Instead, such designations are used to reflect, for example, relative positions, orientations, or directions. The singular forms "a", "an", and "the" include plural references unless the context clearly dictates otherwise.

[0030] In the following description, the terms "or" and "and / or" as used herein should be interpreted as being inclusive or meaning any one or any combination. As an 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 combinations of elements, components, features, steps or operations are in some way mutually exclusive in nature.

[0031] With respect to "proximal," for example, a "proximal portion" or "proximal end portion" of a catheter disclosed herein includes a portion of the catheter that is intended to be near the clinician when the catheter is used on a patient. Similarly, for example, a "proximal length" of a catheter includes a length of the catheter that is intended to be near the clinician when the catheter is used on a patient. For example, a "proximal end" of a catheter includes an end of the catheter that is intended to be near the clinician when the catheter is used on a patient. A proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter. However, a 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, a proximal portion, proximal end portion, or proximal length of a catheter is not a terminal portion or terminal length of the catheter.

[0032] 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. However, a distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless the context suggests otherwise, a distal portion, distal end portion, or distal length of a catheter is not a terminal portion or terminal length of the catheter.

[0033] As shown in Figure 1A, to aid in illustrating the embodiments described herein, the longitudinal axis extends substantially parallel to the axial length of the needle, the lateral axis extends perpendicular to the longitudinal axis, and the transverse axis extends perpendicular to both the longitudinal and lateral axes.

[0034] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. 1A-1C generally illustrate an exemplary improved 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 a deployed configuration for ease of illustration. FIG. 1B illustrates a plan 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 can 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. Additionally, exemplary catheters 150 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, or 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 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. 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 may have a first outer diameter, and the second section 156 may define two or more lumens and may have a second diameter greater than the first diameter. A transition section 158 disposed between the first section 154 and the second section 156 can define a tapered shape extending from a first diameter in the first section to a second diameter in the second section. The guidewire 130 can extend through the lumen of the catheter 150 from a proximal end of the extension leg 162 to a 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 can provide stiffer mechanical properties or a 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 biased distally to form an insertion site and expand. The second section 156 can be formed of a softer durometer or more compliant material to facilitate passage of the second section 156 through tortuous vascular pathways.

[0037] 3A-3C show further details of the distal portion of the catheter 150, including the first section 154, the second section 156, and the transition section 158. In one embodiment, the second section 156 can include a proximal lumen 114A terminating at a proximal lumen opening 116A and a middle lumen 114B terminating at a middle lumen opening 116B. Each of the proximal lumen opening 116A and the middle lumen opening 116B can extend through a sidewall of the second section 156. Each of the proximal lumen opening 116A and the middle lumen opening 116B can be disposed proximal to the transition section 158. The proximal lumen opening 116A can be disposed proximal to the middle lumen opening 116B. In one embodiment, the proximal lumen opening 116A and the middle lumen opening 116B can be disposed equidistant from the distal tip 118 of the catheter 150.

[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] 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 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 create a vacuum within the needle lumen 122 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 can extend through the guidewire aperture 124 and into 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, once the needle 120 reaches the vasculature, the distal tip 138 of the guidewire 130 can be positioned within the vasculature, allowing rapid 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 needle channel 172 extending between a proximal end 176 and a distal end 178 of the housing 170. The housing 170 can further include a guidewire channel 174 in communication with the needle channel 172 and extending at an angle from the needle channel 172. A portion of the needle 120 can be slidably engaged with the needle channel 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 channel 174 of the housing 170. Thus, the guidewire 130 can extend through the guidewire channel 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 and reach the vasculature 80 to form 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 blood flow or pulsatile flow to confirm correct vascular access. If incorrect vascular access is confirmed, the needle 120 can be withdrawn to close the insertion site. 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] 5E, with the needle 120 and syringe system 140 assembly disengaged from the guidewire 130, the catheter 150 can then be advanced over the guidewire 130 and into the vasculature. A first section 154 of the catheter 150, having only a single lumen and defining a relatively small outer diameter, can be advanced over the guidewire 130 and into the vasculature 80 to secure the insertion site. The transition section 158 can then be urged distally, expanding 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 in place, the guidewire 130 can be withdrawn proximally.

[0044] Further details and embodiments of the RICC system 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 / 0133821, U.S. Patent Application Publication No. 2021 / 0133831, U.S. Patent Application Publication No. 2021 / 0133841, U.S. Patent Application Publication No. 2021 / 0133852, U.S. Patent Application Publication No. 2021 / 0133861, U.S. Patent Application Publication No. 2021 / 0133871, U.S. Patent Application Publication No. 2021 / 0133881, U.S. Patent Application Publication No. 2021 / 0133891, U.S. Patent Application Publication No. 2021 / 0133892, U.S. Patent Application Publication No. 2021 / 0133893, U.S. Patent Application Publication No. 2021 / 0133894, U.S. Patent Application Publication No. 2021 / 0133895, U.S. Patent Application Publication No. 2021 / 0133896, U.S. Patent Application Publication No. 2021 / 0133897, U.S. Patent Application Publication No. No. 2021 / 0228843, U.S. Patent Application Publication No. 2021 / 0283368, U.S. Patent Application Publication No. 2021 / 0283381, 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 / 0379336, U.S. Patent Application Publication No. 2021 / 0402142, U.S. Patent Application Publication No. No. 2021 / 0402149, U.S. Patent Application Publication No. 2021 / 0402153, U.S. Patent Application Publication No. 2021 / 0121667, U.S. Patent Application Publication No. 2022 / 0001138, U.S. Patent Application Publication No. 2022 / 0032013, U.S. Patent Application Publication No. 2022 / 0032014, U.S. Patent Application Publication No. 2022 / 0062528, U.S. Patent Application Publication No. 2022 / 0126064, U.S. Patent Application Publication No. 2022 / 0152368, U.S. No. 2022 / 0176081, U.S. Patent Application Publication No. 2022 / 0176082, U.S. Patent Application Publication No. 2022 / 0193376, U.S. Patent Application Publication No. 2022 / 0193377, U.S. Patent Application Publication No. 2022 / 0193378, U.S. Patent Application Publication No. 2022 / 0193379, and U.S. Patent Application Publication No. 2022 / 0296862, each of which is incorporated by reference in its entirety herein.

[0045] In one embodiment, as shown in Figures 6A-6C, the catheter placement system 100 can include a splittable needle 120 and a splitter system 180 configured to separate the needle 120 into a first portion 120A and a second portion 120B along a longitudinal axis. Thus, the guidewire 130 can pass between the first portion 120A and the second portion 120B of the needle 120 to allow the needle 120 to be disengaged from the guidewire 130 during placement (e.g., Figure 5D). Advantageously, the catheter placement system 100 can quickly remove the needle 120 without shifting the position of the guidewire 130. Furthermore, the needle 120 can be removed while the catheter 150 remains "pre-loaded" on the proximal portion of the guidewire 130. Thus, the placement process can be expedited and the number of insertions and removals from the insertion site can be reduced, reducing the incidence of infection.

[0046] Figure 6A shows a longitudinal cross-sectional side view of the needle 120 and splitter system 180 prior to removal of the needle 120. Figure 6B shows a longitudinal cross-sectional top view of the needle 120 and splitter system 180 prior to removal of the needle 120. Figure 6C shows a longitudinal cross-sectional top view of the needle 120 and splitter system 180 after removal of the needle 120.

[0047] Once the guidewire 130 has been advanced through the needle lumen 122 and into the vasculature 80, the needle 120 may be withdrawn proximally (FIG. 5D). To disengage the needle 120 from the guidewire 130, the needle 120 may be withdrawn through a splitter system 180 disposed within the needle housing 170. The splitter system 180 may include a splitter wedge ("wedge") 182 supported by the housing 170 and extending radially inward into the needle channel 172. In one embodiment, the wedge 182 may extend radially inward through a wall of the needle 120. In one embodiment, the splitter system 180 may include a first wedge and a second wedge disposed opposite the first wedge across a central longitudinal axis of the needle 120. The wedge(s) 182 may be configured to divide the needle 120 along the longitudinal axis, separating the needle 120 into the first portion 120A and the second portion 120B. In one embodiment, the wedge(s) 182 may be disposed along a transverse plane, along a lateral plane, or along a plane extending at an angle thereto. In one embodiment, the wedge 182 may include a blade or similar sharp edge disposed at a distal end of the wedge 182. The wedge 182 may include a plastic, polymer, metal, alloy, hardened steel, composite material, mineral, diamond cutting edge, or combinations thereof. In one embodiment, the wedge 182 may be disposed distal to one or both of the guidewire opening 124 and the guidewire channel 174 of the housing 170. In one embodiment, the wedge 182 may be disposed proximal to one or both of the guidewire opening 124 and the guidewire channel 174 of the housing 170.

[0048] In one embodiment, the needle 120 can include a tear line 126 extending longitudinally along the needle 120 and aligned with the wedge 182. The tear line 126 can include perforations, laser cut lines, grooves, score lines, or similar lines of weakness configured to facilitate separation of the needle 120 along the tear line 126. It is also important to note that the tear line 126 can be configured to be fluid impermeable and can prevent fluid from passing through the tear line 126 before the needle 120 is split into the two separate portions 120A, 120B. Thus, the needle 120 can maintain the integrity of the needle lumen 122 and does not require a secondary sheath or equivalent disposed over the tear line 124 to mitigate leakage of fluid into or out of the needle lumen 122.

[0049] In one embodiment, the splitter system 180 can further include a valve 184. The valve 184 can extend annularly around the needle 120 and between an outer surface of the needle 120 and an inner surface of the needle channel 172 to maintain a fluid-tight seal between the needle 120 and the needle channel 172. In one embodiment, the valve 184 can extend longitudinally from a first point distal to one or both of the wedge 182 and the guidewire aperture 124 to a second point proximal to one or both of the wedge 182 and the guidewire aperture 124. In one embodiment, the splitter system 180 includes a first valve 184 disposed at a first point distal to one or both of the wedge 182 and the guidewire aperture 124 and a second valve 184 disposed at a second point proximal to one or both of the wedge 182 and the guidewire aperture 124.

[0050] In one embodiment, splitter system 180 can further include a third valve 184 disposed within guidewire channel 174 of housing 170 and configured to mitigate leakage of fluid through guidewire channel 174. Third valve 184 can extend between an outer surface of guidewire 130 and an inner wall of guidewire channel 174 to provide a fluid-tight seal between the outer surface of guidewire 130 and an inner wall of guidewire channel 174. Valve(s) 184 can thus prevent or mitigate fluid from leaking out of the needle lumen, for example, through one or both of guidewire opening 124 and guidewire channel 174 of housing 170. Optionally, when syringe system 140 applies a vacuum to needle lumen 122, valve 184 can maintain the integrity of the vacuum within needle lumen 122 to draw fluid from distal tip 128 and prevent fluid flow from entering needle lumen 122 through a proximal portion, for example, guidewire opening 124. 6C, as the needle 120 is withdrawn proximally through the splitter system 180, the wedge 182 can separate both the needle 120 and the valve 184 along the longitudinal axis. The guidewire 130 can then be passed between the two portions of the needle 120 and the valve 184 to disengage the needle 120, splitter system 180, and housing 170 assembly.

[0051] In one embodiment, as shown in FIGS. 7A-10C, the catheter placement system 100 may further include a needle safety system 190. The needle safety system 190 may be configured to engage one or both of the first needle portion 120A and the second needle portion 120B to seal the portions 120A, 120B to mitigate against causing damage to surrounding structures, causing trauma, or exposing the user to bodily fluids when the needle 120 is withdrawn proximally. For example, the needle 120 may be split longitudinally to form sharp edges along the upper or lower longitudinal ends of the first portion 120A or the second portion 120B. These sharp edges may cause damage to surrounding structures of the system 100 or cause trauma to the user or patient when the needle 120 is withdrawn proximally. Additionally, the needle 120 withdrawn from the vascular structure 80 may include bodily fluids (e.g., blood, etc.) disposed on the needle 120. Sealing the needle 120 with the needle safety system 190 can reduce damage to surrounding structures, trauma to the user or patient, and exposure of such users to bodily fluids.

[0052] In one embodiment, the needle safety system 190 can include one or more tapes 192, such as a first tape 192A and a second tape 192B. The tape 192 can be formed of a first material and can include a flexible, puncture-resistant material, such as a plastic, a polymer, a metal, an alloy, a composite, KEVLAR®, a combination thereof, or the like. In one embodiment, the tape 192 can include a reinforcement 188, as shown in Figures 7B, 8A-8B. In one embodiment, the reinforcement 188 can include a thickened portion of the first material of the tape 192. In one embodiment, the reinforcement 188 can include a second material that is different from the first material and can include stiffer or more puncture-resistant mechanical properties. For example, the reinforcement 188 can include a metal, an alloy, a polymer, a composite, KEVLAR®, a combination thereof, or the like. In one embodiment, the reinforcement 188 may be disposed on an exterior surface, an interior surface, or may be disposed within the walls of the tape 192. In one embodiment, the reinforcement 188 may extend longitudinally along the length of the tape 192. Advantageously, the reinforcement 188 may reduce the risk of sharp edges of the needle portions 120A, 120B penetrating the tape 192 and exposing the needle portions 120A, 120B to injury, trauma, or exposure to a user, as described herein.

[0053] In one embodiment, the tape 192 may include an adhesive layer 186 disposed on one or both of a surface, e.g., an inner and outer surface, of the tape 192. The adhesive layer 186 may be configured to adhere the tape 192 to the needle 120 or a portion thereof. In one embodiment, the adhesive layer 186 may include a backing layer 194 configured to protect the adhesive layer prior to use and to prevent premature adhesion of the adhesive layer 186 to a surface.

[0054] 7A-7D, FIG. 7A shows needle 120 and needle safety system 190 with housing 170 and needle splitter system 180 removed for ease of illustration. FIG. 7B shows enlarged detail of needle 120 and needle safety system 190 with housing 170, splitter system 180, and guidewire 130 shown in wire frame for ease of illustration. In one embodiment, tape 192 may be disposed within housing 170 in a wound configuration, although other configurations of tape 192 prior to deployment are contemplated. Tape 192 in a wound configuration may be disposed proximal to wedge 182. In an embodiment, the proximal ends 196 of the tapes 192 can be adhered to the proximal portions of the needles 120, e.g., a first proximal end 196A of a first tape 192A can be adhered to the first needle portion 120A and a second proximal end 196B of a second tape 192B can be adhered to the second needle portion 120B.

[0055] In one embodiment, as shown in Figures 7C-7D, as the needle 120 is withdrawn proximally, the tapes 192A, 192B can transition from a wrapped to an unwrapped configuration and adhere to the individual portions 120A, 120B of the needle, enveloping the portions 120A, 120B, and more specifically the sharp edges, along the entire length of the needle 120.

[0056] FIG. 7C shows a perspective view of the needle 120 disposed between the tapes 192A, 192B in an unwrapped configuration. The tapes 192A, 192B can then be bonded together to seal the needle 120 between the tapes 192A, 192B. FIG. 7D shows a side view of the needle 120 sealed within the tapes 192A, 192B bonded together. In one embodiment, the distal end 198 of the tape 192 can extend distal to the distal needle tip 128. Thus, the distal portion of the first tape 192A bonded to the distal portion of the second tape 192B can mitigate the sharp needle tip 128 from causing an accidental needle stick injury. In one embodiment, the distal portion of the tape 192 can include a reinforcement 188 as described herein. The stiffener 188 can stiffen or reinforce the distal portions of the tapes 192A, 192B to encase the sharp distal needle tip 128 and reduce accidental needlestick injuries. In one embodiment, the exterior surface of one or both of the first tape 192A and the second tape 192B can include symbols 164, such as, by way of non-limiting example, alphanumeric symbols, Globally Harmonized System of Classification and Labeling ("GHS") symbols, Hazard Communication Standard (HCS) symbols, colors, textures, or similar visual or tactile indications that the tape 192 involves a biohazard or sharp object and requires proper disposal. Advantageously, the symbols 164 can reduce mishandling of used needles 120. Additionally, pre-printing the symbols 164 can reduce the workload on the user and reduce human error in handling used needles 120.

[0057] 8A-8E illustrate an exemplary method of sealing the needle 120 within the tapes 192A, 192B. FIGS. 8A-8E illustrate transverse cross-sectional views of the needle 120 and tapes 192A, 192B. FIG. 8A illustrates the needle 120 and tapes 192A, 192B before the needle 120 is split by the splitter system 180. FIG. 8B illustrates the needle 120 split into a first portion 120A and a second portion 120B. Once the backing layer 194 is removed, the adhesive surface 186 of the first tape 192A can be adhered to an outer surface of the first needle portion 120A, and the adhesive surface 186 of the second tape 192B can be adhered to an outer surface of the second needle portion 120B. In one embodiment, the tape 192 can include a longitudinally extending reinforcement 188 as described herein. It should be noted that upon splitting of the needle 120 along the tear line 126, the upper and lower longitudinal ends of the first and second needle portions 120A, 120B may become sharp and cause damage or trauma. By sealing the upper and lower ends of the first and second needle portions 120A, 120B, the damage or trauma may be mitigated.

[0058] 8C illustrates an embodiment in which the first and second portions 120A, 120B of the needle 120 are sealed, with an upper portion of the first tape 192A adhering to an upper portion of the second tape 192B and a lower portion of the first tape 192A adhering to a lower portion of the second tape 192B, sealing the needle 120 therebetween. In one embodiment, as shown in FIG. 7B, sealing of the needle portions 120A, 120B can be performed within the housing 170 and proximal to the guidewire 130 that disengages the needle 120. Thus, the needle 120 can be sealed before it exits the housing 170, reducing the risk of accidental injury or trauma to the user and accidental exposure to bodily fluids.

[0059] In an embodiment, as shown in FIG. 8D, the top end 166 and bottom end 168 of the tape 192 can be folded over the top and bottom ends of the individual needle portions and adhered to the inner surface of the individual needle portions. Thus, the first tape 192A can seal the first needle portion 120A, and the second tape 192B can seal the second needle portion 120B. In one embodiment, as shown in FIG. 8E, the needle safety system 190 can include a single tape 192 having a width sufficient to seal one or both of the first needle portion 120A and the second needle portion 120B, as described herein. For example, the width of the tape 192 can extend substantially perpendicular to the longitudinal axis between the top end 166 and the bottom end 168. As shown in FIG. 8E, the width of the tape 192 can be configured to surround the needle 120 or a portion of the needle 120, and the bottom end 168 can overlap the top end 166. In one embodiment, the top end 166 may overlap the bottom end 168, sealing off the needle 120 or a portion of the needle 120. Advantageously, these methods of sealing the needle portions 120A, 120B may reduce contact between the sharp edges of the needle and the tape 192. This may therefore reduce the sharp edges from rubbing against and penetrating the tape 192, exposing the needle 120 to the user.

[0060] 9A-9B, needle safety system 190 can include one or more gears, spindles, or the like configured to peel backing layer 194 from tape 192 and adhere tape 192 to needle 120 or a portion of needle 120 to seal needle 120 when needle 120 is withdrawn proximally, as described herein. As shown in FIGs. 9A-9B, tape 192 can include an adhesive surface 186 disposed on an interior surface and adhered to an exterior surface of needle 120 to seal needle 120 as described herein.

[0061] In one embodiment, as shown in Figures 10A-10C, the needle safety system 190 can be configured to remove the backing layer 194 and adhere the tape 192 to the inner surface of the needle portions 120A, 120B. The tapes 192A, 192B can include an adhesive layer disposed on the outer surface. Figures 10A-10B show a top view of the needle 120 and the needle safety system 190. Figure 10C shows a side view of the first needle portion 120A adhered to the first tape 192A. In one embodiment, as shown in Figure 10B, the distal end 198 of the tape 192 can be folded outwardly to cover the distal tip 128 of the needle 120 to mitigate accidental needlestick injuries. For example, the first distal end 198A of the first tape 192A can be folded outwardly back onto the first tape 192A to seal the sharp distal tip 128A of the first portion 120A of the needle 120. Similarly, the second distal end 198B of the second tape 192B can be folded outwardly and back onto the second tape 192B to seal the sharp distal tip 128B of the second portion 120B of the needle 120. In one embodiment, the top and bottom ends 166, 168 of the tape 192 can be folded outwardly and adhered to or overlapped on an outer surface to seal the needle portions 120A, 120B as described herein.

[0062] Advantageously, these methods of sealing the needle portions 120A, 120B can reduce contact between the sharp edges of the needles and the tape 192, thus reducing the risk of the sharp edges rubbing against or penetrating the tape 192 and exposing the needle 120 to the user.

[0063] Although some specific embodiments are disclosed herein, and the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Further adaptations and / or modifications may be apparent to those skilled in the art, and in the broader aspects, these adaptations and / or modifications are also encompassed. Thus, one may depart from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. 1. A catheter placement system, comprising: a needle defining a needle lumen; a guidewire extending through a portion of the needle lumen; a housing defining a needle channel and having a portion of the needle slidably engaged with the needle channel; a splitter system disposed within the housing and configured to longitudinally split the needle as the needle is withdrawn proximally through the needle channel.

2. 10. The catheter placement system of claim 1, wherein the needle is supported at a proximal end by one or both of a needle hub and a syringe system, the syringe system configured to draw fluid flow proximally through the needle lumen.

3. 3. The catheter placement system of claim 1, wherein the housing further includes a guidewire channel in communication with the needle channel, the guidewire channel being aligned with an opening disposed in the wall of the needle and in communication with the needle lumen, and a portion of the guidewire extending through the guidewire channel, through the opening, and into the needle lumen.

4. The catheter placement system of claim 3 , wherein the splitter system includes a wedge positioned distal to the opening and configured to split the needle along a longitudinal axis.

5. 3. The catheter placement system of claim 1, wherein the needle further includes a longitudinally extending tear line aligned with the splitter system, the tear line configured to facilitate separation of the needle along the tear line.

6. 3. The catheter placement system of claim 1, wherein the splitter system further comprises a valve extending between an outer surface of the needle and an inner surface of the needle channel and configured to mitigate fluid leakage into or from the needle lumen, the splitter system being configured to split the valve when the needle is retracted proximally.

7. 3. The catheter placement system of claim 1, further comprising a needle safety system having one or both of a first tape and a second tape configured to seal one or both of a first portion and a second portion of the needle after the needle is split by the splitter system.

8. 8. The catheter placement system of claim 7, wherein one or both of the first tape and the second tape are disposed within the housing in a wound configuration and configured to transition to an unwound configuration when the needle is withdrawn proximally from the housing.

9. 8. The catheter placement system of claim 7, wherein an upper end of the first tape is configured to adhere to an upper end of the second tape and a lower end of the first tape is configured to adhere to a lower end of the second tape, sealing the first and second portions of the needle between the first and second tapes.

10. 8. The catheter placement system of claim 7, wherein the first tape in the unwrapped configuration is designed to seal the first portion of the needle and the second tape in the unwrapped configuration is designed to seal the second portion of the needle.

11. 8. The catheter placement system of claim 7, wherein an upper end of the first tape is configured to overlap a lower end of the first tape to seal one or both of the first and second portions of the needle.

12. 8. The catheter placement system of claim 7, wherein the first tape is adhered to an inner surface of the first portion of the needle, and a distal end of the first tape is configured to be folded outward and adhere to the outer surface of the first portion, and the second tape is adhered to an inner surface of the second portion of the needle, and a distal end of the first tape is configured to be folded outward and adhere to the outer surface of the second portion.

13. 8. The catheter placement system of claim 7, wherein one or both of the first tape and the second tape comprise a first material, the first material comprising one or more of a plastic, a polymer, a metal, an alloy, a composite, KEVLAR®, or a puncture-resistant material.

14. The catheter placement system of claim 13 , wherein one or both of the first tape and the second tape include a reinforcement portion.

15. 15. The catheter placement system of claim 14, wherein the reinforcement portion comprises one of a thickened portion or a second material different from the first material, and the second material comprises one of a plastic, a polymer, a metal, an alloy, a composite, KEVLAR®, or a puncture-resistant material.

16. The catheter placement system according to claim 1 or 2, further comprising a catheter disposed in a proximal portion of the guidewire.

17. 17. The catheter placement system of claim 16, wherein the catheter includes a distally disposed first section defining a first diameter, a proximally disposed second section defining a second diameter larger than the first diameter, and a transition section extending between the first and second sections.

18. 18. The catheter placement system of claim 17, wherein the first section defines a single lumen and the second section defines two or more lumens.

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