DIVISIBLE NEEDLE AND DILATING CATHETER PLACEMENT DEVICE AND ASSOCIATED METHODS

Abstract

This document discloses a catheter placement system that includes a divisible needle and a dilator; the system may include a housing having one or more flexible sections and a pleated section; a user may grasp an elongated medical device using the flexible sections and change the pleated section of the housing between an extended and collapsed configuration to push the elongated medical device proximally or distally; the system may also include a needle retraction mechanism configured to split the needle along a longitudinal axis and coil the separated parts to allow one or more elongated medical devices to pass between them; the system may also include a dilator splitter configured to separate a dilator along a longitudinal axis and radially displace the dilator parts to allow one or more elongated medical devices to pass between them;Advantageously, the system can keep the elongated medical device in a sterile environment, mitigating the introduction of pathogens.

Description

This application claims the benefit of priority from U.S. Patent Application No. 63 / 060,639, filed on August 3, 2020, which is incorporated by reference in its entirety into this application. BRIEF DESCRIPTION OF THE INVENTION The modalities described herein are for catheter placement systems that include a divisible needle and dilator. The system includes a housing with one or more flexible sections and a pleated section. A user can grasp an elongated medical device using the flexible sections and change the pleated section of the housing between an extended and collapsed configuration to push the elongated medical device proximally or distally. Additionally, the housing includes a needle retraction mechanism configured to split the needle along a longitudinal axis and coil the separated portions to allow one or more elongated medical devices to pass between them. The system also includes a dilator splitter configured to separate a dilator along a longitudinal axis and radially displace the dilator portions to allow one or more elongated medical devices to pass between them.Advantageously, the system keeps the elongated medical device in a sterile environment, mitigating the introduction of pathogens and the like. This document discloses a catheter placement system that includes a catheter housing defining a longitudinal axis, an elongated medical device disposed within an inner cavity of the catheter housing, and a needle housing that includes a needle extending distally therefrom, the needle housing releasably coupled to a distal end of the catheter housing, and including a needle retraction mechanism configured to split the needle along a longitudinal axis and retract the needle into the needle housing. In some embodiments, the needle housing includes a needle retraction lever hinged to it and configured to actuate a gear mechanism located within the needle retraction mechanism. In some embodiments, the needle retraction mechanism is configured to wind a portion of the needle around a shaft extending perpendicular to the longitudinal axis. In some embodiments, the needle includes a sheath disposed on its outer surface; one of the needles or the sheath includes a break line. In some embodiments, the elongated medical device includes a dilator, catheter, or guidewire. In some embodiments, one of the dilators or the catheter includes one made of polyether ether ketone (PEEK) or fluorinated ethylene propylene (FEP) material.In some modalities, the catheter housing includes a flexible section configured to deform elastically along an axis that extends perpendicular to the longitudinal axis. In some embodiments, the catheter housing includes an opening that extends through a side wall of the catheter housing and includes a flexible film barrier positioned over it. In some embodiments, the catheter housing includes a pleated section traversable along the longitudinal axis between an extended and a collapsed configuration. In some embodiments, the catheter housing is configured to rotate around the longitudinal axis to separate from the needle housing and divide the needle housing along a longitudinal axis. In some embodiments, the catheter placement system further includes a dilator wedge divider disposed within the catheter housing and configured to divide the dilator along the longitudinal axis. In some embodiments, the catheter housing includes a blood flash indicator releasably attached to a proximal end of the catheter.In some designs, the catheter housing includes a guidewire housing that extends from a proximal end of the catheter and is configured to receive a portion of the guidewire. In some designs, a portion of one of the housings or the guidewire housing includes transparent material. Also described is a method for placing a catheter that includes providing a catheter placement system having a catheter housing that includes a flexible section and a pleated section, an elongated medical device, a portion thereof disposed within the catheter housing, and a needle housing releasably coupled to a distal end of the catheter housing and including a needle extending therefrom, accessing a patient's vasculature, deforming the flexible section to hold the portion of the elongated medical device disposed below, changing the pleated section between an extended configuration and a collapsed configuration, releasing the flexible section to release the portion of the elongated medical device, and changing the pleated section between a collapsed and an extended configuration. In some modalities, the elongated medical device includes a dilator, catheter, or guidewire. In some modalities, the method also includes compressing a blood flash indicator to draw fluid through the needle and confirm vascular access. In some modalities, the method further includes deforming a distal flexible section to grasp a first part of the elongated medical device, transitioning the folded section from the extended to the collapsed configuration, deforming a proximal flexible section to grasp a second part of the elongated medical device, releasing the first flexible section, and transitioning the folded section from the collapsed to the extended configuration to withdraw the proximal elongated medical device. In some embodiments, the method further includes withdrawing the elongated medical device proximally over a divider arranged within the housing to split the elongated medical device along a longitudinal axis. In some embodiments, the method further includes actuating a needle retraction mechanism to retract the needle into the needle housing. In some embodiments, actuating the needle retraction mechanism includes rotating a needle retraction lever that is hinged to the needle housing, engaging a gear mechanism within the needle retraction mechanism, and retracting the needle into the needle housing. In some embodiments, retracting the needle into the needle housing includes splitting the needle along a longitudinal axis and winding the needle around a shaft that extends perpendicular to the longitudinal axis.In some embodiments, the method further includes rotating the catheter housing to separate it from the needle housing. In some embodiments, separating the catheter housing from the needle housing includes splitting the needle housing along a longitudinal axis to separate a first portion of the needle housing from a second portion. In some embodiments, the method further includes attaching a set of connectors to a catheter connector. In some embodiments, attaching the set of connectors to the catheter hub includes an interference fit, a press fit, a threaded connection, or a bayonet fit. BRIEF DESCRIPTION OF THE FIGURES A more specific description of this disclosure will be given with reference to specific embodiments thereof illustrated in the accompanying drawings. It should be noted that these drawings represent only typical embodiments of the invention and, therefore, should not be considered limiting of its scope. Example embodiments of the invention will be described and explained with further specificity and detail by means of the accompanying drawings, in which: Figure 1 illustrates a perspective view of a catheter placement system, according to the modalities disclosed in this document. Figures 2A to 2B illustrate cross-sectional side views of a catheter placement system, according to the modalities disclosed in this document. Figures 3A to 3C illustrate cross-sectional side views of a catheter placement system, according to the modalities disclosed in this document. Figures 4A to 4C illustrate cross-sectional side views of a catheter placement system, according to the modalities disclosed in this document. Figures 5A to 5B illustrate perspective views of a needle housing of a catheter placement system, according to the modalities disclosed in this document. Figure 5C illustrates a cross-sectional view of a needle and sheath of a catheter placement system, according to the modalities disclosed in this document. Figure 5D illustrates a perspective view of a coiling needle, according to the modalities disclosed in this document. Figure 5E illustrates a cross-sectional view of a needle and sheath of a catheter placement system, according to the modalities disclosed in this document. Figure 5F illustrates a perspective view of a coiling needle, according to the modalities disclosed in this document. Figures 6A to 6J illustrate several steps in an exemplary method of using a catheter placement system, according to the modalities disclosed in this document. DETAILED DESCRIPTION OF THE INVENTION Before some specific modalities are described in greater detail, it should be understood that the specific modalities disclosed in this document do not limit the scope of the concepts provided herein. It should also be understood that a specific modality disclosed herein may have characteristics that can be easily separated from that particular modality and optionally combined with or replaced by characteristics of any of the other modalities disclosed herein. With regard to the terms used in this document, it should also be understood that the terms are intended to describe certain particular modalities, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different functions or steps within a group of functions or steps, and do not provide a numerical or sequential limitation. For example, the features or steps first, second, and third do not necessarily have to appear in that order, and the particular modalities that include such features or steps do not necessarily have to be limited to those three features or steps. Labels such as left, right, up, down, front, back, and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction.Instead, these labels are used to reflect, for example, relative location, orientation, or directions. The singular forms of a, one, and the include plural references unless the context clearly dictates otherwise. With respect to "proximal," a proximal portion or proximal end portion of, for example, a needle disclosed herein includes a portion of the needle intended to be near a physician when the needle is used in a patient. Likewise, a proximal length of, for example, the needle includes a length of the needle intended to be near the physician when the needle is used in the patient. A proximal end of, for example, the needle includes an end of the needle intended to be near the physician when the needle is used in the patient. The proximal portion, end portion, or proximal length of the needle may include the proximal end of the needle; however, the proximal portion, end portion, or proximal length of the needle need not include the proximal end of the needle.That is, unless the context suggests otherwise, the proximal portion, end portion, or proximal length of the needle is not a terminal portion or terminal length of the needle. With respect to "distal," a distal portion or distal end portion of, for example, a needle disclosed herein includes a portion of the needle intended to be near or in a patient when the needle is used in the patient. Likewise, a distal length of, for example, the needle includes a length of the needle intended to be near or within the patient when the needle is used in the patient. A distal end of, for example, the needle includes an end of the needle intended to be near or within the patient when the needle is used in the patient. The distal portion, distal end portion, or distal length of the needle may include the distal end of the needle; however, the distal portion, distal end portion, or distal length of the needle need not include the distal end of the needle.That is, unless the context suggests otherwise, the distal portion, the end portion, or the distal length of the needle is not a terminal portion or a terminal length of the needle. As shown in Figure 1, and to aid in the description of the modalities described herein, a longitudinal axis extends substantially parallel to an axial length of a 140 needle. A lateral axis extends normal to the longitudinal axis, and a transverse axis extends normal to both the longitudinal and lateral axes. A horizontal plane is defined by the longitudinal and lateral axes. A vertical plane may extend normal to the horizontal plane. Unless otherwise defined, all technical and scientific terms used in this document have the same meaning as commonly understood by those skilled in the art. This disclosure relates generally to a catheter placement system 100 that includes a divisible needle and dilator and associated methods thereof. As used here, a Catheter Placement System 100 can be used to place a central venous catheter (CVC) to access a patient's vasculature. However, it will be appreciated that the modalities disclosed herein can be used to place various catheters, cannulas, single-lumen catheters, multi-lumen catheters, intravenous (IV) catheters, peripherally inserted central catheters (PICCs), rapid-insertion central catheters (RICCs), dialysis catheters, drainage catheters, and the like, without limitation. Figure 1 shows an example embodiment of a catheter placement system (system) 100, which typically includes a catheter housing 110 and a divisible needle housing 130, releasably coupled to a distal end of the catheter housing 110. The system 100 further includes a needle 140, a dilator 150, a guidewire 160, and a catheter 170. The catheter housing 110 defines a substantially elongated cylindrical shape, including a circular cross-section. However, other elongated shapes and cross-sections, including triangular, square, hexagonal, polygonal, or combinations thereof, are also contemplated. In one embodiment, a portion of the catheter housing 110 may define a polygonal cross-section to provide a gripping surface and facilitate rotation of the catheter housing 110. In one embodiment, the catheter housing 110 may be made of a rigid or semi-rigid material, including metal, alloy, polymer, plastic, thermoplastic, elastomer, rubber, silicone rubber, combinations thereof, or similar materials. In one embodiment, an outer surface of the catheter housing 110 includes a flexible material, elastomer, or similar material to provide a comfortable gripping surface and facilitate manipulation of the system 100. In one embodiment, the catheter housing 110 may be made of a translucent or transparent material to allow a user to view elongated structures, components, or medical devices arranged within it. In one embodiment, the catheter housing 110 may include a barrier 116 extending over an outer surface thereof. The barrier 116 may extend from the needle housing 130, disposed at a distal end, to a proximal end of the catheter housing 110, and extend annulus around a longitudinal axis of the catheter housing 110. In one embodiment, the barrier 116 may be formed of a thin polymer film or similar flexible material configured to permit a user to manipulate one of the catheter housings 110, or an elongated medical device disposed therein. As used herein, an elongated medical device may include one or more of the needle 140, dilator 150, catheter 170, guidewire 160, or one or more advancement assemblies configured to manipulate one of the needle 140, dilator 150, catheter 170, guidewire 160, combinations thereof, or the like.In one embodiment, the barrier 116, or part thereof, may be transparent to allow a user to observe one of the catheter housings 110, or an elongated medical device, disposed therein. In one embodiment, the catheter housing 110 may include one or more flexible sections 112, for example, a distal flexible section 112A and a proximal flexible section 112B. As used herein, a flexible section may include a portion of the catheter housing that can be elastically deformed along an axis perpendicular to the longitudinal axis of the system 100. The flexible section 112 may include a portion of the catheter housing wall 110 that defines more flexible mechanical properties. In one embodiment, as shown in Figure 1, a flexible section 112 may include a portion of a side wall of the catheter housing 110, for example, a top side wall.In one embodiment, the flexible section 112 may include a first portion of a side wall and a second portion of the side wall, arranged opposite the first portion along a central longitudinal axis 80, for example, laterally where the flexible section includes a left portion and a right portion, transversely where the flexible section includes a top portion and a bottom portion, or combinations thereof. In one embodiment, the flexible section 112 may include a portion of the side wall that extends annulus around the longitudinal axis. In one embodiment, the flexible section 112 may include a material different from that of the catheter housing 110. In one embodiment, the flexible section 112 may define a wall thickness of material different from that of the catheter housing 110. In one embodiment, a user may elastically deform the flexible section 112 to grasp or manipulate an elongated medical device or advancement assembly disposed within the catheter housing 110. For example, as shown in Figure 2A, a user can deform a portion of the flexible section 112 to narrow the inner cavity of the catheter housing 110 disposed below. The constricted portion can be distal or proximal to one end of an elongated medical device (e.g., dilator 150) or an advancement assembly attached to an elongated medical device, disposed within the catheter housing 110. The deformed portion can contract the inner diameter of the catheter housing 110 to a diameter smaller than the outer diameter of the elongated medical device 150. As shown in Figure 2B, the user can then slide the deformed portion along a longitudinal axis of the flexible section 112 in a wave-like motion. In other words, a user can contract adjacent parts of the flexible section 112 along a longitudinal axis of the flexible section 112. As such, the elongated medical device 150 can be pushed through the inner cavity of the catheter housing 110 opposite the deformed portion. In one embodiment, the flexible section 112 may include more transparent properties relative to the catheter housing 110 to allow a user to observe an elongated medical device positioned beneath it. Advantageously, a user can manipulate the elongated medical device, positioned within the catheter housing 110, without having to directly contact it. This maintains the elongated medical device in a sealed environment and mitigates the introduction of pathogens or similar infection-causing agents. In one embodiment, the flexible section 112 may include an opening that extends through a side wall of the catheter housing 110. For example, as shown in Figures 3A to 3C, in one embodiment, the flexible opening section 112 may include a flexible barrier 116 disposed above it to maintain a sterile environment. As shown in Figure 3B, a user may compress a portion of the barrier 116 through one or more openings in the flexible section 112 to grasp an elongated medical device (e.g., dilator 150) disposed within the catheter housing 110. As shown in Figure 3C, a user may then slide the grasped portion longitudinally to advance proximally, or withdraw distally, the elongated medical device through the catheter housing 110.Advantageously, the flexible opening section 112 together with the barrier 116 disposed above it can allow a user to manipulate an elongated medical device disposed within the catheter housing 110 while maintaining a sterile barrier between them. In one embodiment, the catheter housing 110 may include a pleated section 114. As used herein, a pleated section includes a portion of the catheter housing 110 that can be expanded or collapsed along a longitudinal axis. In one embodiment, the pleated section 114 may include one or more pleats configured to allow the catheter housing 110 to pass from an extended to a collapsed configuration by extending or collapsing along a longitudinal axis. However, it will be appreciated that other configurations of the catheter housing 110 configured to extend or fold along a longitudinal axis, such as a telescoping section, a sliding section, a folding section, combinations thereof, or the like, are also contemplated to fall within the scope of the present invention. Figures 4A to 4C show a cross-sectional view of the catheter housing 110, which includes a distal flexible section 112A, a proximal flexible section 112B, a pleated section 114, and an elongated medical device, for example, a dilator 150, disposed within the catheter housing 110. In one exemplary method of use, a user can compress a proximal flexible section 112B to grasp a portion of the dilator 150 disposed within it. The user can then transition the pleated section 114 from the extended configuration (Figure 4A) to the collapsed configuration (Figure 4B). As such, the dilator 150 grasped within the housing 110 can be advanced distally. The user can then release the proximal flexible section 112B and transition the pleated section 114 from the collapsed configuration (Figure 4B) to the extended configuration (Figure 4C).Optionally, a user can compress the distal flexible section 112A to hold the dilator 150 in the distal position while the pleated section 114 moves from the collapsed to the extended configuration to prevent retrograde movement of the dilator 150 during the transition. As will be seen, a user can repeat the process as needed to continue advancing the dilator 150 in a proximal direction. Similarly, to remove the proximally elongated medical device, a user can compress a distal flexible section 112A to grasp a portion of the dilator 150 disposed therein. The user can then transition the pleated section 114 from the extended to the collapsed configuration. A user can release the portion of the dilator 150 disposed adjacent to the distal flexible section 112A and deform the proximal flexible section 112B to grasp a second portion of the dilator 150. The user can then transition the pleated section 114 from the collapsed to the extended configuration to remove the dilator 150 proximally. A user can repeat the process as needed to continue removing the dilator 150 in a proximal direction.As will be seen, the dilator 150 is an example of an elongated medical device, and the dilator 150, the guide wire 160, the catheter 170, combinations thereof, or similar devices can be advanced distally or withdrawn proximally, as described herein. As will be seen, although a compressible flexible section 112 is shown, one or more flexible opening sections 112 (for example, Figures 3A to 3C) can also be used instead of one or more compressible flexible sections 112 and are still within the scope of the present invention. With continued reference to Figure 1, the 100 system may include a needle 140, held by a needle hub 142, coupled to a distal end of the needle housing 130. The needle 140 may define a needle lumen 144 and, in one modality, include a needle sheath 146 disposed on an outer surface thereof. In one modality, the sheath 146 may be a peripherally inserted venous (PIV) catheter that may define a smaller outer diameter than the catheter 170. The sheath 146 may maintain access to the insertion site when one or more of the needle 140, dilator 150, guidewire 160, or catheter 170 are exchanged. In one modality, the sheath 146 may be configured to support a first half and a second half of a needle 140 to define a needle lumen 140, as described in further detail herein. In one embodiment, the sheath 146 may be made of a plastic, polymer, elastomer, urethane or a similar suitable material. In one embodiment, the 100 system may further include a dilator 150 disposed within the 110 catheter housing. The dilator 150 may be supported by a dilator hub. 152 and define a dilating lumen 154. In one embodiment, the dilator 150 may include a plastic, polymer, polyether ether ketone (PEEK), or fluorinated ethylene propylene (FEP) material, or a similar suitable material. In one embodiment, the dilator 150 may be supported by a dilator advancement assembly (not shown) configured to facilitate manipulation of the dilator 150 within the catheter housing 110 by means of one of the flexible sections 112, or pleated section 114, as described herein. In one embodiment, a catheter 170 can be positioned within the catheter housing 110 and held in place by a catheter connector 172. The catheter 170 can be configured to pass through the lumen of the dilator 154. The catheter hub 172 can be configured for manipulation by a user, via one or more of the flexible sections 112, to advance or withdraw the catheter 170, as described herein. In one embodiment, the catheter 170 can be supported by a catheter advancement assembly (not shown) configured to facilitate manipulation of the catheter 170 within the catheter housing 110 by means of one of the flexible sections 112, or pleated section 114, as described herein. In one embodiment, the catheter 170 can be made of a plastic, polymer, polyether ether ketone (PEEK), or fluorinated ethylene propylene (FEP) material, or a similar suitable material. In one embodiment, a guidewire housing 120 may extend from a proximal end of the catheter housing 110 and define an internal cavity that communicates with an internal cavity of the catheter housing 110. The guidewire housing 120 may be configured to receive a portion of the guidewire 160 disposed therein. In one embodiment, the guidewire housing 120 may be formed of a flexible material and may allow a user to manipulate the guidewire 170 disposed therein. In another embodiment, the guidewire housing 120 is formed of flexible plastic, polymer, elastomer, or similar material. A user may compress a portion of the guidewire housing 120 disposed proximal to the proximal end of the guidewire 160 to occlude the internal cavity of the guidewire housing 120.Next, the user can slide the occluded portion of the guide wire housing 120 distally in a wave-like motion, as described herein, to push the guide wire 160 distally, in front of the occluded portion. In one embodiment, the guidewire housing 120 is formed from a thin film or similar collapsible barrier. A user can grasp the guidewire 160 by compressing an outer portion of the guidewire housing 120. The user can then push the guidewire 160 into the catheter housing 110. The portion of the guidewire housing 120 distal to the grasped portion of the guidewire 160 can collapse to allow distal advancement of the guidewire 160. In another embodiment, the guidewire housing 120 can be formed from a transparent material to allow a user to observe a portion of the guidewire. 170 arranged therein. In one embodiment, the guide wire 170 can be extended from the guide wire housing 120 through one of the catheters 170, dilator 150, needle 140 or part thereof, arranged within the catheter housing 110. In one modality, the 100 system may further include a blood flash indicator 122. The blood flash indicator 122 may include a tube or similar structure made of a flexible, transparent material and may extend from a proximal end of the catheter body 110. The blood flash indicator 122 may define an internal cavity. In one modality, the internal cavity may be configured to maintain a vacuum within it. The blood flash indicator 122 may be in fluid communication with a needle lumen 140 by means of a communication tube 124. As a distal tip of the needle 140 accesses a patient's vasculature, a fluid (e.g., blood) may flow proximally into the blood flash indicator 122 for observation by a user. In one modality, a vacuum arranged within the blood flash indicator 122 may draw a fluid (e.g., blood) into the blood flash indicator., blood) proximally through communication tube 124 and into blood flash indicator 122. A user can then observe a color or pulsatile flow characteristics to confirm correct vascular access. In one embodiment, System 100 further includes a cap 108 configured to releasably engage with a distal end of one of the catheter housings 110 or the needle housing 130, and to cover a distal portion of one or more needles 140, a needle sheath 146, or a dilator 150. The cap 108 can mitigate accidental needlestick injuries during storage or transport and maintains the needle 140, needle sheath 146, dilator 150, etc., in a sterile environment. System 100 may further include a connector assembly 180 configured to engage a proximal end of the catheter 170. The connector assembly 180 may include a connector 182 and one or more extension legs 184 configured to provide seamless communication with one or more lumens of the catheter 170. Figures 5A to 5D show further details of the needle 140 and the divisible needle housing 130. The needle housing 130 may include a coupling 132 configured to releasably couple the needle housing 130 to the catheter housing 110. The needle housing 130 may further include one or more stabilizing wings (wings) 134, for example, a right stabilizing wing 134A and a left stabilizing wing 134B. The wing(s) 134 may extend laterally from the needle housing 130 and define an extended lower surface configured to engage a surface of the patient's skin and mitigate rotational movement about the longitudinal axis. Optionally, wing(s) 134 may include one or more openings configured to attach a strap, tape, dressing, bandage, or similar fastening device to facilitate securing the needle housing 130 to the patient's skin surface.In one embodiment, a surface of the 130 needle housing may include an adhesive layer disposed upon it and configured to fix the 130 needle housing to the patient's skin surface. Optionally, a strap, tape, bandage, dressing, adhesive layer, or similar material may provide a sterile barrier between the 100 catheter placement system and the insertion site. The needle housing 130 may further include a needle retraction mechanism 190. The needle retraction mechanism 190 may include one or more levers, gear mechanisms, ratchet mechanisms, sector gears, overdrive slip clutches, or the like, configured to engage with the needle hub 142 and retract the needle 140 proximally into one of the needles, the housing 130, or the catheter housing 110, leaving the sheath 146 within the insertion site to maintain insertion site patency. In one modality, the guidewire 160 may be advanced through the lumen of the needle 144 to maintain insertion site patency, and the needle 140 and sheath 146, or both, may be retracted into the needle housing 130, as described herein. In one embodiment, the needle retraction mechanism 190 can be configured to split the needle 140 along a longitudinal axis and coil the needle 140 upon itself. The needle 140 can then be stored within the needle housing 130. Splitting and storing the needle 140 in this manner displaces the needle radially outward from a central longitudinal axis 80, and provides a clear channel for one or more elongated medical devices to advance distally between them. As shown in Figures 5C through 5F, in one embodiment, one of the needle 140 or sheath 146 may include a longitudinally extending break line 148. As used herein, a break line may include a laser-cut line, a perforation, a groove, a slotted line, or the like, configured to facilitate separation along it. As shown in Figures 5C through 5D, in one embodiment, the needle 140 may include a single break line 148 extending longitudinally across one side of the needle 140. The needle 140 may be split along this break line 148 to form a first side edge 148A and a second side edge 148B. The cylindrical shape of the needle 140 that extends longitudinally can then change to a flat shape that extends along an axis from the first lateral edge 148A to the second lateral edge 148A.The needle 140 can then coil around itself along an axis that extends perpendicular to the longitudinal axis and be sequestered within the housing of the needle 130. In one embodiment, the needle retraction mechanism 190 can be configured to split the needle 140 along two break lines 148 to separate the needle 140 into a first part 140A and a second part 140B. In one embodiment, as shown in Figure 5E, needle 140 can be formed as two separate longitudinally extending portions 140A, 140B that cooperate to form a needle lumen 144 and are held in place by the needle sheath 146. The needle retraction mechanism 190 opens a gap in the needle sheath 146 to separate the needle portions 140A, 140B. As shown in Figure 5F, each of the needle portions 140A, 140B can then pass from a semicylindrical to a flat shape before coiling upon itself along an axis that extends perpendicular to the longitudinal axis. In one embodiment, as shown in Figure 5B, the needle retraction mechanism 190 may include one or more levers 192 hinged to the needle housing 130 and configured to rotate through a horizontal plane. However, it will be noted that the one or more levers 192 may also rotate through a vertical plane, or along a plane extending at an angle to them. Rotating one or more levers 192 can split the needle hub 142 and proximally retract the needle 140 into the needle housing 130. In one modality, a single rotation of lever(s) 192 can split and fully retract the needle 140. In one modality, the needle retraction mechanism 190 may include a ratchet mechanism configured to allow one or more rotations of lever(s) 192 to split and fully retract the needle 140.In one embodiment, the retraction mechanism 190 can link the first retraction lever 192A and the second retraction lever 192B such that actuating either the first retraction lever 192A or the second retraction lever 192B causes both retraction levers 192A and 192B to rotate. In another embodiment, the needle retraction mechanism 190 can further include a push element for pushing the levers to an initial position, for example, as shown in Figure 5A. A user can then actuate the levers 192 from the initial position to an actuated position. Releasing the retraction levers 192 can then allow the push element to transition the retraction levers 192 from the actuated position to the initial position. Figures 6A through 63 illustrate an exemplary method of use for a catheter placement system 100 as described herein. Initially, as shown in Figure 6A, a user can rinse the connector assembly 180, cap the ends of the connector assembly 180, and set it aside. The catheter placement system cap 108 can then be removed from the needle housing 130 to expose the needle 140. As shown in Figures 6A through 6B, a user can grasp the catheter housing 110 and push the needle tip 141 into a patient's vasculature 90. It is important to note that the catheter placement system 100 provides all the components for placing a catheter 170, i.e., needle 140, blood flash indicator 122, PIV sheath 146, dilator 150, guidewire 160, as well as the catheter itself 170 (e.g., a CVC catheter), contained within a single sterile unit.This keeps all components that may be exposed to the patient's vasculature within a sterile environment, unlike existing procedures that require multiple components, which are exposed and at risk of introducing infection at each stage. Furthermore, the catheter placement system maintains a barrier between the user and exposure to the patient's blood, also protecting the user from potential exposure. As shown in Figure 6B, when the needle tip 141 accesses a vasculature 90, blood flow may be directed proximally through the needle lumen 144. In one mode, the vacuum within the blood flash indicator 122 draws blood flow through the communication tube 124 and into the blood flash indicator 122. A user can then observe the color and pulsatile flow characteristics of the fluid within the blood flash indicator 122 to confirm correct vascular access. For example, a bright red color or strong pulsatile flow may indicate arterial access, while a dark red color and low pulsatile flow may indicate venous access. Optionally, a user can compress the flexible blood flash indicator tube 122 to induce blood flow within it. As shown in Figure 6C, with vascular access confirmed, the blood flash indicator 122 can be pushed proximally to disconnect it from the proximal end of the catheter housing 110. A portion of the communication tube 124 is also withdrawn from the catheter housing 110, which in turn withdraws a distal end of the communication tube 124, disconnecting it from the needle lumen 144. The blood flash indicator 122 can then be removed and discarded, or attached to an external surface of the catheter housing 110 using a clip or similar suitable means. With the communication tube 124 disengaged from the lumen of the needle 144, one of the catheters 170 or dilator 150 can be advanced slightly so that a distal tip of the dilator 150 can engage a proximal end of the lumen of the needle 144. As shown in Figure 6D, a distal tip 171 of the catheter 170 engages with a proximal end of the dilator 150. As such, the catheter 170, dilator 150, and needle 140 cooperate to provide a continuous pathway for the guidewire 160 to advance into the patient's vasculature 90. In one embodiment, the catheter housing 110 includes a locking mechanism 126 configured to engage the guidewire 160 extending through it and lock the guidewire 160 relative to the catheter housing 110. A user can unlock the guidewire 160, advance a portion of the guidewire 160, and then lock the guidewire 160 in position to prevent the guidewire from being introduced into the patient's vasculature 90. In one embodiment, the guidewire 160 can be advanced through the catheter 170, through the dilator 150, through the needle 140 until the distal tip 161 of the guidewire advances distally from the distal tip 141 of the needle. In one embodiment, the tip of the guidewire 161 can be advanced to a target location within the patient's vasculature 90. In one embodiment, the guidewire 126 locking mechanism can include either a rotary locking mechanism or a push-button locking mechanism. As shown in Figure 6E, with the guidewire tip 161 advanced into the patient's vasculature 90, the needle 140 can be withdrawn to allow the dilator 150 to advance. In one modality, the dilator 150 and catheter 170 can be withdrawn slightly to disengage the dilator tip 151 from the needle lumen 144. A user can then manipulate the needle retraction levers 192A, 192B to retract the needle 140 proximally. By actuating the needle retraction levers 192A and 192B, the needle hub 142 and needle 140 can be retracted and separated into two separate parts 140A and 140B. Each part 140A and 140B can be coiled upon itself within the needle housing 130 to sequester needle 140 away from the central longitudinal axis 80, allowing one or more elongated medical devices to pass axially between them. As described herein, the needle retraction mechanism 190 may include a push element, a ratchet mechanism, and the like to provide mechanical advantage and facilitate the separation and removal of needle 140. In one modality, the 146 sheath can be split and rolled together with the 140 needle. In one modality, the 140 needle consists of two separate halves, 140A and 140B, held together by the 146 sheath. Therefore, needle 140 removal involves splitting the 146 sheath along a longitudinal axis and rolling one half of the sheath with the first half of the 140A needle and the second half of the sheath with the second half of the 140B needle. In this modality, the needle is withdrawn, split, and rolled, and the 146 sheath is left in place within the insertion site to maintain patency of the vascular access site. As shown in Figure 6F, with needle 140 withdrawn and sequestered in needle housing 130, dilator 150 can be advanced distally over guidewire 160 and, optionally, over sheath 146 into the patient's vasculature 90 to dilate the vascular access site. Dilator 150 can be advanced by manipulating the dilator hub 152 through flexible sections 112A, 112B, and / or pleated section 114 as described herein. In one embodiment, the dilator hub 152 can be attached to a distal end of a dilator advancement assembly (not shown) that extends proximally through the catheter housing 110. The user can then manipulate the dilator advancement assembly to advance or withdraw the dilator 150, through the flexible sections 112A, 112B and / or the pleated section 114, as described herein. As shown in Figure 6G, with the insertion site dilated, dilator 150 can be withdrawn proximally by manipulating the dilator hub 152 through the distal flexible section 112A, or by manipulating the dilator advancement assembly, as described herein. As dilator 150 is pushed proximally into the catheter housing 110, it can be pushed over a dilator splitter 158. As shown in Figure 6D, the splitter 158 may include a distal wedge-shaped tip configured to split dilator 150 along a longitudinal axis when it is pushed proximally over it. In one modality, dilator 150 may further include a rupture line 148 to facilitate separation of the dilator 150 into two halves. In one embodiment, the retractor 158 can be pushed distally by manipulating a retractor arm 156 through the proximal flexible section 112B.The two halves of the dilator can be displaced radially outward about a central axis to allow one of the catheters 170 or guide 160 to pass longitudinally between them. As shown in Figure 6H, catheter 170 can be advanced distally over guidewire 160 until a distal tip enters the patient's vasculature 90. Guidewire 170 can then be unlocked using guidewire 126 lock and withdrawn back into catheter housing 110 and guidewire 120 housing. When a distal tip of guidewire 161 is positioned within catheter housing 110, guidewire 160 can be locked in place using guidewire 126 lock. As shown in Figure 61, the catheter housing 110, with the dilator 150, retractor 158, and guidewire 160 arranged therein, can be separated from the needle housing 130 and discarded. In one embodiment, the catheter housing 110 can be separated by rotating it around its central longitudinal axis 80. With the catheter housing 110 separated from the needle housing 130, the needle housing 130 can be divided along a longitudinal axis into two separate halves 130A, 130B. Then, each half 130A, 130B can be separated perpendicular to the longitudinal axis to decouple the catheter hub 172. In one modality, the needle housing 130 may include a gap line 138 that extends longitudinally and is configured to facilitate separation of the first half 130A of the needle housing from the second half 130B of the needle housing.In one embodiment, the coupling 132 between the catheter housing 110 and the needle housing 130 can be configured to separate the needle housing 130 into two halves as the catheter housing 110 rotates. For example, a distal end of the catheter housing 110 may include a cam lobe structure that engages with the needle housing 130 when the catheter housing 110 rotates about its longitudinal axis. The cam lobe can provide a mechanical advantage to facilitate separation of the needle housing 130. As shown in Figure 6J, with the catheter housing 110 and needle housing 130 detached from the catheter 170, the connector assembly 180 can be coupled to the catheter hub 172. Each one or more extension legs 184 can communicate seamlessly with one lumen of the catheter 170. In one configuration, the connector assembly 180 can be coupled to the catheter hub 172 with an interference fit, press fit, snap fit, threaded hook, bayonet fit, or similar. Although some specific modalities have been described in this document, and although these specific modalities have been described in some detail, it is not intended that these 10 specific modalities limit the scope of the concepts presented herein. Further adaptations and / or modifications may seem appropriate to those skilled in the art, and these adaptations and / or modifications are also covered in a broader sense. Consequently, deviations from the specific modalities described herein are permissible without departing from the scope of the concepts presented herein.

Claims

1. A catheter placement system, comprising: a catheter housing defining a longitudinal axis; an elongated medical device disposed within an inner cavity of the catheter housing; and a needle housing including a needle extending distally therefrom, the needle housing releasably coupled to a distal end of the catheter housing and including a needle retraction mechanism configured to split the needle along a longitudinal axis and retract the needle within the needle housing.

2. The catheter placement system according to claim 1, further characterized in that the needle housing includes a needle retraction lever articulated thereto and configured to actuate a gear mechanism disposed within the needle retraction mechanism. 3 - The catheter placement system according to any of claims 1 to 2, further characterized in that the needle retraction mechanism is configured to wind a portion of the needle around an axis extending perpendicular to the longitudinal axis.

4. The catheter placement system according to any of claims 1 to 3, further characterized in that the needle includes a sheath disposed on an outer surface thereof, one of the needle or the sheath includes a break line.

5. The catheter placement system according to any of claims 1 to 4, further characterized in that the elongated medical device includes one of a dilator, a catheter or a guide wire.

6. The catheter placement system according to claim 5, further characterized in that the dilator or catheter includes one made of a polyether ether ketone (PEEK) material or a fluorinated ethylene propylene (FEP) material.

7. The catheter placement system according to any of claims 5 to 6, further characterized in that it additionally includes a dilator wedge divider disposed within the catheter housing and configured to divide the dilator along the longitudinal axis.

8. The catheter placement system according to any of claims 1 to 7, further characterized in that the catheter housing includes a flexible section configured to deform elastically along an axis extending perpendicular to the longitudinal axis.

9. The catheter placement system according to any of claims 1 to 8, further characterized in that the catheter housing includes an opening extending through a side wall of the catheter housing and including a flexible film barrier disposed above it.

10. The catheter placement system according to any of claims 1 to 9, further characterized in that the catheter housing includes a foldable section traversable along the longitudinal axis between an extended configuration and a collapsed configuration.

11. The catheter placement system according to any of claims 1 to 10, further characterized in that the catheter housing is configured to rotate about the longitudinal axis to separate from the needle housing and to split the needle housing along a longitudinal axis. 12.- The catheter placement system according to any of claims 1 to 11, further characterized in that the catheter housing includes a blood flash indicator releasably coupled to a proximal end thereof. 13.- The catheter placement system according to any of claims 5 to 12, further characterized in that the catheter housing includes a guide wire housing extending from a proximal end thereof and configured to receive a portion of the guide wire therein. 14.- The catheter placement system according to claim 13, further characterized in that a part of one of the housing or guide wire housing includes transparent material.

15. A method for placing a catheter, comprising: providing a catheter placement system comprising: a catheter housing including a flexible section and a pleated section; an elongated medical device, a portion thereof disposed within the catheter housing; and a needle housing releasably coupled to a distal end of the catheter housing and including a needle extending therefrom; accessing a patient's vasculature; deforming the flexible section to grasp the portion of the elongated medical device disposed beneath; transitioning the pleated section between an extended configuration and a collapsed configuration; releasing the flexible section to release the portion of the elongated medical device; and transitioning the pleated section between a collapsed configuration and an extended configuration.

16. The method according to claim 15, further characterized in that the elongated medical device includes one of a dilator, a catheter or a guide wire.

17. The method according to any of claims 15 to 16, further characterized in that it additionally includes compressing a blood flash indicator to draw a flow of fluid through the needle and confirm vascular access.

18. The method according to any of claims 15 to 17, further characterized in that it additionally includes: deforming a distal flexible section to hold a first part of the elongated medical device; transitioning the folded section from the extended configuration to the collapsed configuration; deforming a proximal flexible section to hold a second part of the elongated medical device; releasing the first flexible section; and transitioning the pleated section from the collapsed configuration to the extended configuration to remove the elongated medical device proximally.

19. The method according to any of claims 15 to 18, further characterized in that it additionally includes removing the elongated medical device proximally, on a divider arranged within the housing to divide the elongated medical device along a longitudinal axis.

20. The method in accordance with any of claims 15 to 19, further characterized in that it additionally includes actuating a needle retraction mechanism to retract the needle into the needle housing. 21.- The method according to claim 20, further characterized in that actuating the needle retraction mechanism includes rotating a needle retraction lever that is articulated to the needle housing, the needle retraction lever actuating a gear mechanism within the needle retraction mechanism.

22. The method according to any of claims 20 to 21, further characterized in that retracting the needle into the needle housing includes splitting the needle along a longitudinal axis and winding the needle around an axis extending perpendicular to the longitudinal axis.

23. The method according to any of claims 15 to 22, further characterized in that it additionally includes rotating the catheter housing to separate the catheter housing from the needle housing.

24. The method according to claim 23, further characterized in that separating the catheter housing from the needle housing includes dividing the needle housing along a longitudinal axis to separate a first part of the needle housing from a second part of the needle housing.

25. The method according to claim 24, further characterized in that it additionally includes joining a set of connectors with a catheter control center.

26. The method according to claim 25, further characterized in that attaching the connector assembly to the catheter control center includes one of an interference fit, one push fit, one press fit, one threaded coupling, or one bayonet fit.

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