Patent Description:
Embodiments disclosed herein are directed to catheter placement systems including a splittable needle and a splittable dilator. The system includes a housing having one or more flexible sections and a pleated section. A user can grasp an elongate medical device using the flexible sections and transition the housing pleated section between an extended and a collapsed configuration to urge the elongate medical device proximally or distally. Further, the housing includes a needle retraction mechanism configured to split the needle along a longitudinal axis and roll up the separate portions to allow one or more elongate medical devices to pass therebetween. 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 elongate medical devices to pass therebetween. Advantageously, the system maintains the elongate medical device in a sterile environment, mitigating the introduction of pathogens and the like.

Disclosed herein is a catheter placement system as described in claim <NUM>. The catheter placement system includes a catheter housing defining a longitudinal axis, an elongate medical device disposed within an interior 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, retract the needle into the needle housing and roll the needle up on itself.

In some embodiments, the needle housing includes a needle retraction lever hingedly coupled thereto and configured to actuate a gear mechanism disposed within the needle retraction mechanism. In some embodiments, the needle retraction mechanism is configured to roll up a portion of the needle about an axis extending perpendicular to the longitudinal axis. In some embodiments, the needle includes a sheath disposed on an surface thereof, one of the needle or the sheath includes a breach line. In some embodiments, the elongate medical device includes one of a dilator, a catheter, or a guidewire. In some embodiments, one of the dilator or the catheter includes one of a polyether ether ketone (PEEK) material, or a fluorinated ethylene propylene (FEP) material. In some embodiments, the catheter housing includes a flexible section configured to elastically deform along an axis extending perpendicular to the longitudinal axis.

In some embodiments, the catheter housing includes an aperture extending through a side wall of the catheter housing and including a flexible film barrier disposed thereover. In some embodiments, the catheter housing includes a pleated section transitionable along the longitudinal axis between an extended configuration and a collapsed configuration. In some embodiments, the catheter housing is configured to rotate about the longitudinal axis to detach from the needle housing and split the needle housing along a longitudinal axis. In some embodiments, the catheter placement system further includes a dilator wedge splitter disposed within the catheter housing and configured split the dilator along the longitudinal axis. In some embodiments, the catheter housing includes a blood flash indicator releasably coupled to a proximal end thereof. In some embodiments, the catheter housing includes a guidewire housing extending from a proximal end thereof and configured to receive a portion of the guidewire therein. In some embodiments, a portion of one of the housing or the guidewire housing includes transparent material.

Also disclosed is a method (not claimed) of placing a catheter including, providing a catheter placement system having, a catheter housing including a flexible section and a pleated section, an elongate 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 vasculature of a patient, deforming the flexible section to grasp the portion of the elongate medical device disposed therebelow, transitioning the pleated section between an extended configuration and a collapsed configuration, releasing the flexible section to release the portion of the elongate medical device, and transitioning the pleated section between a configuration and an extended configuration.

In some embodiments, the elongate medical device includes one of a dilator, a catheter, or a guidewire. In some embodiments, the method further includes compressing a blood flash indicator to draw a fluid flow through the needle and confirm vascular access. In some embodiments the method further includes deforming a distal flexible section to grasp a first portion of the elongate medical device, transitioning the pleated section from the extended configuration to the collapsed configuration, deforming a proximal flexible section to grasp a second portion of the elongate medical device, releasing the first flexible section, and transitioning the pleated section from the collapsed configuration to the extended configuration to withdraw the elongate medical device proximally.

In some embodiments, the method further includes withdrawing the elongate medical device proximally, over a splitter disposed within the housing to split the elongate 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 hingedly coupled to the needle housing, the needle retraction lever actuating a gear mechanism within the needle retraction mechanism. In some embodiments, retracting the needle into the needle housing includes splitting the needle along a longitudinal axis and rolling up the needle about an axis extending perpendicular to the longitudinal axis. In some embodiments, the method further includes rotating the catheter housing to detach the catheter housing from the needle housing. In some embodiments, detaching 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 of the needle housing. In some embodiments, the method further includes attaching a connector set to a hub of the catheter. In some embodiments, coupling the connector set to the catheter hub includes one of an interference fit, a push fit, a snap fit, a threaded engagement, or a bayonet fitting.

With respect to "proximal," a "proximal portion" or a "proximal end portion" of, for example, a needle disclosed herein includes a portion of the needle intended to be near a clinician when the needle is used on a patient. Likewise, a "proximal length" of, for example, the needle includes a length of the needle intended to be near the clinician when the needle is used on the patient. A "proximal end" of, for example, the needle includes an end of the needle intended to be near the clinician when the needle is used on the patient. The proximal portion, the proximal end portion, or the proximal length of the needle can include the proximal end of the needle; however, the proximal portion, the proximal end portion, or the proximal length of the needle need not include the proximal end of the needle. That is, unless context suggests otherwise, the proximal portion, the proximal end portion, or the proximal length of the needle is not a terminal portion or terminal length of the needle.

With respect to "distal," a "distal portion" or a "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 on the patient. Likewise, a "distal length" of, for example, the needle includes a length of the needle intended to be near or in the patient when the needle is used on the patient. A "distal end" of, for example, the needle includes an end of the needle intended to be near or in the patient when the needle is used on the patient. The distal portion, the distal end portion, or the distal length of the needle can include the distal end of the needle; however, the distal portion, the distal end portion, or the distal length of the needle need not include the distal end of the needle. That is, unless context suggests otherwise, the distal portion, the distal end portion, or the distal length of the needle is not a terminal portion or terminal length of the needle.

As shown in <FIG>, and to assist in the description of embodiments described herein, a longitudinal axis extends substantially parallel to an axial length of a needle <NUM>. 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 can extend normal to the horizontal plane.

The present disclosure relates generally to a catheter placement system <NUM> including a splittable needle and dilator, and associated methods thereof. As used herein, a catheter placement system <NUM> can be used to place a central venous catheter (CVC) to access a vasculature of a patient. However, it will be appreciated that embodiments disclosed herein can be used to place various catheters, cannulas, single lumen catheters, multi-lumen catheters, intravenous (IV) catheters, peripherally inserted central catheters (PICC), Rapid Insertion Central Catheter (RICC), dialysis catheters, drainage catheters, and the like, without limitation.

<FIG> shows an exemplary embodiment of a catheter placement system ("system") <NUM> that generally includes a catheter housing <NUM> and a splittable needle housing <NUM>, releasably coupled to a distal end of the catheter housing <NUM>. The system <NUM> further includes a needle <NUM>, a dilator <NUM>, a guidewire <NUM>, and a catheter <NUM>. The catheter housing <NUM> defines a substantially elongate, cylindrical shape including a circular cross-sectional shape. However, it will be appreciated that other elongate and cross-sectional shapes including triangular, square, hexagonal, polygonal, or combinations thereof, are also contemplated. In an embodiment, a portion of the catheter housing <NUM> can define a polygonal cross-sectional shape to provide a gripping surface and facilitate rotation of a catheter housing <NUM>.

In an embodiment, the catheter housing <NUM> can be formed of a rigid or semirigid material including metal, alloy, polymer, plastic, thermoplastic, elastomer, rubber, silicone rubber, combinations thereof, or the like. In an embodiment, an outer surface of the catheter housing <NUM> includes a compliant material, elastomer, or the like, to provide a comfortable gripping surface and facilitate manipulation of the system <NUM>. In an embodiment, the catheter housing <NUM> can be formed of a translucent or transparent material to allow a user to observe structures, components, or elongate medical devices, disposed therein.

In an embodiment, the catheter housing <NUM> can include a barrier <NUM> extending over an outer surface thereof. The barrier <NUM> can extend from the needle housing <NUM>, disposed at a distal end, to a proximal end of the catheter housing <NUM>, and extend annularly about a longitudinal axis of the catheter housing <NUM>. In an embodiment, the barrier <NUM> can be formed of a thin polymer film or similar flexible material configured to allow a user to manipulate one of the catheter housing <NUM>, or an elongate medical device disposed therein. As used herein, an "elongate medical device" can include one or more of the needle <NUM>, dilator <NUM>, catheter <NUM>, guidewire <NUM>, or one or more advancement assemblies configured to manipulate one of the needle <NUM>, dilator <NUM>, catheter <NUM>, guidewire <NUM>, combinations thereof, or the like. In an embodiment, the barrier <NUM>, or portion thereof, can be transparent to allow a user to observe one of the catheter housing <NUM>, or an elongate medical device, disposed therein.

In an embodiment, the catheter housing <NUM> can include one or more flexible sections <NUM>, for example a distal flexible section 112A and a proximal flexible section 112B. As used herein a "flexible section" can include a portion of the catheter housing that can be elastically deformed along an axis that is perpendicular to a longitudinal axis of the system <NUM>. The flexible section <NUM> can include a portion of the wall of the catheter housing <NUM> that defines more flexible mechanical properties. In an embodiment, as shown in FIG. 1A, a flexible section <NUM> can include a portion of a side wall of the catheter housing <NUM>, e.g. a top side wall. In an embodiment, the flexible section <NUM> can include a first portion of a side wall and a second portion of the side wall, disposed opposite the first portion across a central longitudinal axis <NUM>, e.g. 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 an embodiment the flexible section <NUM> can include a portion of the side wall that extends annularly about the longitudinal axis.

In an embodiment, the flexible section <NUM> can include a different material from that of the catheter housing <NUM>. In an embodiment, the flexible section <NUM> can define a different wall thickness of material from that of the catheter housing <NUM>. In an embodiment, a user can elastically deform the flexible section <NUM> to grasp or manipulate an elongate medical device or advancement assembly disposed within the catheter housing <NUM>.

For example, as shown in <FIG>, a user can deform a portion of the flexible section <NUM> to constrict the interior cavity of the catheter housing <NUM> disposed therebelow. The constricted portion can be distally or proximally of an end of an elongate medical device (e.g. dilator <NUM>) or an advancement assembly coupled to an elongate medical device, disposed within the catheter housing <NUM>. The deformed portion can constrict the interior diameter of the catheter housing <NUM> to a diameter that is less than an outer diameter of the elongate medical device <NUM>.

As shown in <FIG>, the user can then slide the deformed portion along a longitudinal axis of the flexible section <NUM> in a "wave-like" action. Worded differently, a user can constrict adjacent portions of the flexible section <NUM> along a longitudinal axis of the flexible section <NUM>. As such, the elongate medical device <NUM> can be urged through the interior cavity of the catheter housing <NUM> in front of the deformed portion.

In an embodiment the flexible section <NUM> can include more transparent properties relative to the catheter housing <NUM> to allow a user to observe an elongate medical device disposed therebelow. Advantageously, a user can manipulate the elongate medical device, disposed within the catheter housing <NUM> without having to directly contact the elongate medical device. This maintains the elongate medical device in a sealed environment and mitigates the introduction of pathogens, or similar infection causing agents.

In an embodiment, the flexible section <NUM> can include an aperture extending through a side wall of the catheter housing <NUM>. For example, as shown in <FIG>, in an embodiment, the aperture flexible section <NUM> can include a flexible barrier <NUM> disposed thereover to maintain a sterile environment. As shown in <FIG>, a user can compress a portion of the barrier <NUM> through one or more flexible section apertures <NUM> to grasp an elongate medical device, (e.g. dilator <NUM>), disposed within the catheter housing <NUM>. As shown in <FIG>, a user can then slide the grasped portion longitudinally to advance proximally, or withdraw distally, the elongate medical device though the catheter housing <NUM>. Advantageously, the aperture flexible section <NUM> together with the barrier <NUM> disposed thereover can allow a user to manipulate an elongate medical device disposed within the catheter housing <NUM> while maintaining a sterile barrier therebetween.

In an embodiment, the catheter housing <NUM> can include a pleated section <NUM>. As used herein a "pleated section" includes a portion of the catheter housing <NUM> that can be expanded or collapsed along a longitudinal axis. In an embodiment, the pleated section <NUM> can include one or more folded pleats configured to allow the catheter housing <NUM> to transition between an extended configuration and a collapsed configuration, extending or collapsing along a longitudinal axis. However, it will be appreciated that other configurations of the catheter housing <NUM> configured to extend or collapse along a longitudinal axis, such as a telescoping section, sliding section, folding section, combinations thereof, or the like, are also contemplated to fall within the scope of the present invention.

<FIG> show a cross-sectional view of the catheter housing <NUM> including a distal flexible section 112A, a proximal flexible section 112B, a pleated section <NUM>, and an elongate medical device, e.g. a dilator <NUM>, disposed within the catheter housing <NUM>. In an exemplary method of use, a user can compress a proximal flexible section 112B to grasp a portion of the dilator <NUM> disposed therein. The user can transition the pleated section <NUM> from the extended configuration (<FIG>) to the collapsed configuration (<FIG>). As such, the dilator <NUM> grasped within the housing <NUM>, can be advanced distally. The user can then release the proximal flexible section 112B and transition the pleated section <NUM> from the collapsed configuration (<FIG>) to the extended configuration (<FIG>). Optionally, a user can compress the distal flexible section 112A to grasp the dilator <NUM> in the distal position as the pleated section <NUM> transitions from the collapsed configuration to the extended configuration to prevent retrograde movement of the dilator <NUM> during the transition. As will be appreciated, a user can repeat the process as necessary to continue to advance the dilator <NUM> in a proximal direction.

In like manner, to withdraw the elongate medical device proximally, a user can compress a distal flexible section 112A to grasp a portion of the dilator <NUM> disposed therein. The user can then transition the pleated section <NUM> from the extended configuration to the collapsed configuration. A user can release the portion of the dilator <NUM> disposed adjacent the distal flexible section 112A and deform the proximal flexible section 112B to grasp a second portion of the dilator <NUM>. The user can then transition the pleated section <NUM> from the collapsed configuration to the extended configuration to withdraw the dilator <NUM> proximally. A user can repeat the process as necessary to continue to withdraw the dilator <NUM> in a proximal direction. As will be appreciated, the dilator <NUM> is an exemplary elongate medical device and that the dilator <NUM>, guidewire <NUM>, catheter <NUM>, combinations thereof, or the like can be advanced distally, or withdrawn proximally, as described herein. As will be appreciated, while a compressible flexible section <NUM> is shown, one or more aperture flexible sections <NUM> (e.g. <FIG>) can be also be used in place of one or more compressible flexible sections <NUM> and still fall within the scope of the present invention.

With continued reference to <FIG>, the system <NUM> can include a needle <NUM>, supported by a needle hub <NUM>, coupled to a distal end of the needle housing <NUM>. The needle <NUM> can define a needle lumen <NUM> and, in an embodiment, include a needle sheath <NUM> disposed on an outer surface thereof. In an embodiment, the sheath <NUM> can be a peripherally inserted venous (PIV) catheter that can define a smaller outer diameter than the catheter <NUM>. The sheath <NUM> can maintain access to the insertion site as one or more of the needle <NUM>, dilator <NUM>, guidewire <NUM> or catheter <NUM> are exchanged. In an embodiment, the sheath <NUM> can be configured to support a first half and a second half of a needle <NUM> to define a needle lumen <NUM>, as described in more detail herein. In an embodiment, the sheath <NUM> can be formed of a plastic, polymer, elastomer, urethane, or similar suitable material.

In an embodiment, the system <NUM> can further include a dilator <NUM> disposed within the catheter housing <NUM>. The dilator <NUM> can be supported by a dilator hub <NUM> and define a dilator lumen <NUM>. In an embodiment, the dilator <NUM> can include a plastic, polymer, polyether ether ketone (PEEK) material, or a fluorinated ethylene propylene (FEP) material, or similar suitable material. In an embodiment, the dilator <NUM> can be supported by a dilator advancement assembly (not shown) configured to facilitate manipulation of the dilator <NUM> within the catheter housing <NUM> by way of one of the flexible sections <NUM>, or pleated section <NUM>, as described herein.

In an embodiment, a catheter <NUM> can be disposed within the catheter housing <NUM> and can be supported by a catheter hub <NUM>. The catheter <NUM> can be configured to fit through the dilator lumen <NUM>. The catheter hub <NUM> can be configured to be manipulated by a user, through one or more of the flexible sections <NUM> to advance or withdraw the catheter <NUM>, as described herein. In an embodiment, the catheter <NUM> can be supported by a catheter advancement assembly (not shown) configured to facilitate manipulation of the catheter <NUM> within the catheter housing <NUM> by way of one of the flexible sections <NUM>, or pleated section <NUM>, as described herein. In an embodiment, the catheter <NUM> can include a plastic, polymer, polyether ether ketone (PEEK) material, or a fluorinated ethylene propylene (FEP) material, or similar suitable material.

In an embodiment, a guidewire housing <NUM> can extend from a proximal end of the catheter housing <NUM> and define an interior cavity that communicates with an interior cavity of the catheter housing <NUM>. The guidewire housing <NUM> can be configured to receive a portion of the guidewire <NUM> disposed therein. In an embodiment, the guidewire housing <NUM> can be formed of a flexible material and can allow a user to manipulate the guidewire <NUM> disposed therein. In an embodiment, the guidewire housing <NUM> is formed of flexible plastic, polymer, elastomer, or the like. A user can compress a portion of the guidewire housing <NUM> disposed proximally of the proximal end of the guidewire <NUM> to occlude the interior cavity of the guidewire housing <NUM>. The user can then slide the occluded portion of the guidewire housing <NUM> distally in a "wave-like" manner, as described herein, to urge the guidewire <NUM> distally, ahead of the occluded portion.

In an embodiment, the guidewire housing <NUM> is formed of a thin film or similar collapsible barrier. A user can grasp the guidewire <NUM> by compressing an outer portion of the guidewire housing <NUM>. The user can then urge the guidewire <NUM> distally into the catheter housing <NUM>. The portion of guidewire housing <NUM> disposed distally of the grasped portion of guidewire <NUM> can collapse to allow distal advancement of the guidewire <NUM>. In an embodiment, the guidewire housing <NUM> can be formed of a transparent material to allow a user to observe a portion of the guidewire <NUM> disposed therein. In an embodiment, the guidewire <NUM> can extend from the guidewire housing <NUM> through one of the catheter <NUM>, dilator <NUM>, needle <NUM>, or portion thereof, disposed within the catheter housing <NUM>.

In an embodiment, the system <NUM> can further include a blood flash indicator <NUM>. The blood flash indicator <NUM> can include a tube or similar structure formed from a flexible, transparent material and can extend from a proximal end of the catheter body <NUM>. The blood flash indicator <NUM> can define an interior cavity. In an embodiment, the interior cavity can be configured to maintain a vacuum therein. The blood flash indicator <NUM> can be in fluid communication with a lumen of the needle <NUM> by way of a communicating tube <NUM>. As a distal tip of the needle <NUM> accesses a vasculature of the patient, a fluid (e.g. blood) can flow proximally into the blood flash indicator <NUM> to be observed by a user. In an embodiment, a vacuum disposed within the blood flash indicator <NUM> can draw a fluid (e.g. blood) proximally through the communicating tube <NUM> and into the blood flash indicator <NUM>. A user can then observe a color or pulsatile flow characteristics to confirm correct vascular access.

In an embodiment, the system <NUM> further includes a cap <NUM> configured to releasably engage with a distal end of one of the catheter housing <NUM> or the needle housing <NUM>, and cover a distal portion of one or more of the needle <NUM>, needle sheath <NUM>, or the dilator <NUM>. The cap <NUM> can mitigate accidental needle stick injuries during storage or transport and maintains the needle <NUM>, needle sheath <NUM>, the dilator <NUM> etc. in a sterile environment. The system <NUM> can further include a connector set <NUM> configured to engage a proximal end of the catheter <NUM>. The connector set <NUM> can include a connector hub <NUM> and one or more extension legs <NUM> configured to provide fluid communication with one or more lumen of the catheter <NUM>.

<FIG> show further details of the needle <NUM> and the splittable needle housing <NUM>. The needle housing <NUM> can include a coupling <NUM> configured to releasably couple the needle housing <NUM> to the catheter housing <NUM>. The needle housing <NUM> can further include one or more stabilization wings ("wings") <NUM>, e.g. a right stabilization wing 134A and a left stabilization wing 134B. The wing(s) <NUM> can extend laterally from the needle housing <NUM> and define an extended lower surface configured to engage a skin surface of the patient and mitigate rotational movement about the longitudinal axis. Optionally, the wing(s) <NUM> can include one or more apertures configured to engage a strap, tape, dressing, bandage, or similar securement device to facilitate securing the needle housing <NUM> to a skin surface of the patient. In an embodiment, a surface of the needle housing <NUM> can include an adhesive layer disposed thereon and configured to secure the needle housing <NUM> to a skin surface of the patient. Optionally the strap, tape, dressing, bandage, adhesive layer or the like can provide a sterile barrier between catheter placement system <NUM> and the insertion site.

The needle housing <NUM> can further include a needle retraction mechanism <NUM>. The needle retraction mechanism <NUM> can include one or more levers, gear mechanisms, ratchet mechanisms, sector gears, over-run slip clutches, or the like, configured to couple with the needle hub <NUM> and retract the needle <NUM> proximally into one of the needle housing <NUM> or the catheter housing <NUM> leaving the sheath <NUM> within the insertion site to maintain patency of the insertion site. In an embodiment, the guidewire <NUM> can be advanced through the needle lumen <NUM> to maintain patency of the insertion site and one or both of the needle <NUM> and the sheath <NUM> can be retracted into the needle housing <NUM>, as described herein.

In an embodiment, the needle retraction mechanism <NUM> can be configured to split the needle <NUM> along a longitudinal axis and roll up the needle <NUM> on itself. The needle <NUM> can then be stored within the needle housing <NUM>. Splitting and storing the needle <NUM> in this manner displaces the needle radially outward from a central longitudinal axis <NUM>, and provides a clear channel for one or more elongate medical devices to advance distally therebetween.

As shown in <FIG>, in an embodiment, one of the needle <NUM> or the sheath <NUM> can include a breach line <NUM> extending longitudinally. As used herein, a "breach line" can include a laser cut line, perforation, groove, score line, or the like configured to facilitate separation therealong. As shown in <FIG>, in an embodiment, the needle <NUM> can include a single breach line <NUM> extending longitudinally through one side of the needle <NUM>. The needle <NUM> can be split along this breach line <NUM> to form a first side edge 148A and a second side edge 148B. The cylindrical shape of the needle <NUM> extending longitudinally can then be transitioned to a planar shape extending along an axis from the first side edge 148A to the second side edge 148A. The needle <NUM> can then be rolled up on itself along an axis extending perpendicular to the longitudinal axis and sequestered within the needle housing <NUM>.

In an embodiment, the needle retraction mechanism <NUM> can be configured to split the needle <NUM> along two breach lines <NUM> to separate the needle <NUM> in to a first portion 140A and a second portion 140B. In an embodiment, as shown in <FIG>, the needle <NUM> can be formed as two separate portions 140A, 140B extending longitudinally that co-operate to form a needle lumen <NUM> and are held in place by the needle sheath <NUM>. The needle retraction mechanism <NUM> then breaches the needle sheath <NUM> to separate the needle portions 140A, 140B. As shown in <FIG>, each of the needle portions 140A, 140B can be then be transitioned from a semi-cylindrical shape to a planar shape before being rolled up on itself along an axis that extends perpendicular to the longitudinal axis.

In an embodiment, as shown in <FIG>, the needle retraction mechanism <NUM> can include one or more levers <NUM> hingedly coupled to the needle housing <NUM> and configured to rotate through a horizontal plane. However, it will be appreciated that the one or more levers <NUM> may also rotate through a vertical plane, or along a plane extending at an angle therebetween. Rotating the one or more levers <NUM> can split the needle hub <NUM> and proximally retract the needle <NUM> into the needle housing <NUM>. In an embodiment, a single rotation of the lever(s) <NUM> can split and fully retract the needle <NUM>. In an embodiment, the needle retraction mechanism <NUM> can include a ratchet mechanism configured to allow one or more rotations of the lever(s) <NUM> to split and fully retract the needle <NUM>. In an embodiment, the retraction mechanism <NUM> can link the first retraction lever 192A and the second retraction lever 192B such that actuating one of the first retraction lever 192A or the second retraction lever 192B causes both of the retractions levers 192A, 192B to rotate. In an embodiment, the needle retraction mechanism <NUM> can further include a biasing member to bias the levers towards a starting position, e.g. as shown in <FIG>. A user can then actuate the levers <NUM> from the starting position to an actuated position. Releasing the retraction levers <NUM> can then allow the biasing member to transition the retraction levers <NUM> from the actuated position to the starting position.

<FIG> show an exemplary method (not claimed) of use for a catheter placement system <NUM> as described herein. Initially, as shown in <FIG>, a user can flush the connector set <NUM> and cap off the ends of the connector set <NUM> and set to one side. The catheter placement system cap <NUM> can be removed from the needle housing <NUM> to expose the needle <NUM>. As shown in <FIG>, a user can grasp the catheter housing <NUM> and urge the needle tip <NUM> into a vasculature <NUM> of a patient. It is important to note that the catheter placement system <NUM> provides all of the components for placing a catheter <NUM>, i.e. needle <NUM>, blood flash indicator <NUM>, PIV sheath <NUM>, dilator <NUM>, guidewire <NUM>, as well as the catheter <NUM> itself (e.g. a CVC catheter), contained within a single sterile unit. This maintains all components that may be exposed to the patient's vasculature <NUM> within a sterile environment and contrasts with existing procedures that require multiple components, which are exposed, and risk introducing infection at every stage. Further, the catheter placement system <NUM> maintains a barrier between the user and exposure to the patients' blood that also protects the user from potential exposure.

As shown in <FIG>, as the needle tip <NUM> accesses a vasculature <NUM> a blood flow can flow proximally through the needle lumen <NUM>. In an embodiment, the vacuum disposed within the blood flash indicator <NUM> draws the blood flow through the communicating tube <NUM> and into the blood flash indicator <NUM>. A user can then observe a color and pulsatile flow characteristics of the fluid disposed within the blood flash indicator <NUM> to confirm correct vascular access. For example a bright red color or strong pulsatile flow can indicate arterial access, a dark red color and low pulsatile flow can indicate venous access. Optionally, a user can compress the flexible blood flash indicator tube <NUM> to induce blood to flow therein.

As shown in <FIG>, with the vascular access confirmed, the blood flash indicator <NUM> can be urged proximally to disengage the blood flash indicator <NUM> from the proximal end of the catheter housing <NUM>. A portion of the communicating tube <NUM> is also withdrawn from the catheter housing <NUM> which in turn withdraws a distal end of the communicating tube <NUM>, disengaging the communicating tube <NUM> from the needle lumen <NUM>. The blood flash indicator <NUM> can then be removed and discarded, or secured to an outer surface of the catheter housing <NUM> using a clip or similar suitable means.

With the communicating tube <NUM> disengaged from the needle lumen <NUM>, one of the catheter <NUM> or the dilator <NUM> can be advanced slightly so that a distal tip of the dilator <NUM> can engage a proximal end of the needle lumen <NUM>. As shown in <FIG>, a distal tip <NUM> of the catheter <NUM> engages a proximal end of the dilator <NUM>. As such the catheter <NUM>, dilator <NUM> and needle <NUM> co-operate to provide a continuous path for the guidewire <NUM> to be advanced into the vasculature <NUM> of the patient.

In an embodiment, the catheter housing <NUM> includes a locking mechanism <NUM> configured to engaged the guidewire <NUM> extending therethrough and lock the guidewire <NUM> relative to the catheter housing <NUM>. A user can unlock the guidewire <NUM>, advance a portion of the guidewire <NUM> and then lock the guidewire <NUM> in position to prevent the guidewire being drawn into the vasculature <NUM> of the patient. In an embodiment, the guidewire <NUM> can advance through the catheter <NUM>, through the dilator <NUM>, through the needle <NUM> until a guidewire distal tip <NUM> advances distally of a needle distal tip <NUM>. In an embodiment, the guidewire tip <NUM> can be advanced to a target location within the vasculature <NUM> of the patient. In an embodiment, the guidewire lock <NUM> can include either rotational locking mechanism or a push-button locking mechanism.

As shown in <FIG>, with the guidewire tip <NUM> advanced into the vasculature <NUM> of the patient, the needle <NUM> can be withdrawn out of the way to allow the dilator <NUM> to advance. In an embodiment, the dilator <NUM> and the catheter <NUM> can be withdrawn slightly to disengage a dilator tip <NUM> from the needle lumen <NUM>. A user can then manipulate the needle retraction levers 192A, 192B, to retract the needle <NUM> proximally.

Actuating the needle retraction levers 192A, 192B can retract and split the needle hub <NUM> and the needle <NUM> into two separate portions 140A, 140B. Each portion 140A, 140B can then be rolled up on itself within the needle housing <NUM> to sequester the needle <NUM> away from the central longitudinal axis <NUM> to allow one or more elongate medical devices to pass axially therebetween. As described herein, the needle retraction mechanism <NUM> can include a biasing member, ratchet mechanism and the like to provide mechanical advantage and facilitate splitting and removal of the needle <NUM>.

In an embodiment, the sheath <NUM> can be split and rolled up along with the needle <NUM>. In an embodiment, the needle <NUM> is formed from two separate halves 140A, 140B, which are held together by the sheath <NUM>. As such, removal of the needle <NUM> includes splitting the sheath <NUM> along a longitudinal axis and rolling up a first half of the sheath with a first half of the needle 140A, and a second half of the sheath with a second half of the needle 140B. In an embodiment, the needle is withdrawn, split and rolled up, and the sheath <NUM> is left in place within the insertion site to maintain patency of the vascular access site.

As shown in <FIG>, with the needle <NUM> withdrawn and sequestered into the needle housing <NUM>, the dilator <NUM> can be advanced distally over the guidewire <NUM>, and optionally over the sheath <NUM> into the vasculature <NUM> of the patient to dilate the vascular access site. The dilator <NUM> can be advanced by manipulating the dilator hub <NUM> through the flexible sections 112A, 112B and/or pleated section <NUM> as described herein. In an embodiment, the dilator hub <NUM> can be coupled to a distal end of a dilator advancement assembly (not shown) that extends proximally through the catheter housing <NUM>. The user can then manipulate the dilator advancement assembly to advance or withdraw the dilator <NUM>, through the flexible sections 112A, 112B and/or pleated section <NUM>, as described herein.

As shown in <FIG>, with the insertion site dilated, the dilator <NUM> can be withdrawn proximally either by manipulating the dilator hub <NUM> through the distal flexible section 112A, or by manipulating the dilator advancement assembly, as described herein. As the dilator <NUM> is being urged proximally into the catheter housing <NUM>, the dilator <NUM> can be urged over a dilator splitter <NUM>. As shown in <FIG>, the splitter <NUM> can include a wedge-shaped distal tip configured to split the dilator <NUM> along a longitudinal axis as the dilator <NUM> is urged proximally thereover. In an embodiment, the dilator <NUM> can further include a breach line <NUM> to facilitate separation of the dilator <NUM> into two halves. In an embodiment, the splitter <NUM> can be urged distally by manipulating a splitter arm <NUM> through the proximal flexible section 112B. The two dilator halves can be displaced radially outward relative to a central axis to allow one of the catheter <NUM> or guidewire <NUM> to pass longitudinally therebetween.

As shown in <FIG>, the catheter <NUM> can be advanced distally, over the guidewire <NUM> until a distal tip enters the vasculature <NUM> of the patient. The guidewire <NUM> can then be unlocked, using the guidewire lock <NUM>, and withdrawn back into the catheter housing <NUM> and guidewire housing <NUM>. When a distal tip of the guidewire <NUM> is disposed within the catheter housing <NUM>, the guidewire <NUM> can then be locked into place using guidewire lock <NUM>.

As shown in <FIG>, the catheter housing <NUM> with the dilator <NUM>, splitter <NUM>, and guidewire <NUM>, disposed therein, can be detached from the needle housing <NUM> and discarded. In an embodiment, the catheter housing <NUM> can be detached by rotating the catheter housing <NUM> about the central longitudinal axis <NUM>. With the catheter housing <NUM> detached from the needle housing <NUM>, the needle housing <NUM> can be split along a longitudinal axis into two separate halves 130A, 130B. Each half 130A, 130B can then be separated perpendicular to the longitudinal axis to disengage the catheter hub <NUM>. In an embodiment, the needle housing <NUM> can include a breach line <NUM> extending longitudinally and configured to facilitate separation of the needle housing first half 130A from the needle housing second half 130B. In an embodiment, the coupling <NUM> between the catheter housing <NUM> and the needle housing <NUM> can be configured to separate the needle housing <NUM> into two halves as the catheter housing <NUM> is rotated. For example, a distal end of the catheter housing <NUM> can include a cam lobe structure that engages needle housing <NUM> as the catheter housing <NUM> is rotated about the longitudinal axis. The cam lobe can provide a mechanical advantage to facilitate separation of the needle housing <NUM>.

As shown in <FIG>, with the catheter housing <NUM> and needle housing <NUM> disengaged from the catheter <NUM>, the connector set <NUM> can be coupled to the catheter hub <NUM>. Each of the one or more extension legs <NUM> can fluidly communicate with a lumen of the catheter <NUM>. In an embodiment, the connector set <NUM> can coupled to the catheter hub <NUM> with an interference fit, push fit, snap fit, threaded engagement, bayonet fitting, or the like.

Claim 1:
A catheter placement system (<NUM>), comprising:
a catheter housing (<NUM>) defining a longitudinal axis;
an elongate medical device (<NUM>, <NUM>, <NUM>) disposed within an interior cavity of the catheter housing; and
a needle housing (<NUM>) including a needle (<NUM>) extending distally therefrom, the needle housing (<NUM>) releasably coupled to a distal end of the catheter housing (<NUM>) and including a needle retraction mechanism (<NUM>) configured to split the needle along a longitudinal axis, retract the needle (<NUM>) into the needle housing (<NUM>) and roll the needle (<NUM>) up on itself.