Collapsible needle and dilator catheter placement device and related methods

Abstract

A catheter placement system including detachable needles and dilators is disclosed herein. The system can include a housing having one or more flexible sections and having a pleated section. A user can use the flexible sections to grasp an elongated medical device and transition the pleated section of the housing between an extended configuration and a collapsed configuration to push the elongated medical device proximally or distally. The system can also include a needle retraction mechanism configured to detach the needles along a longitudinal axis and roll up the detached portions to allow one or more elongated medical devices to pass therebetween. The system can also include a dilator detacher configured to separate the dilators along the longitudinal axis and displace the dilator portions radially to allow one or more elongated medical devices to pass therebetween. Advantageously, the system can maintain the elongated medical devices in a sterile environment, mitigating introduction of pathogens.

Description

[0001] priority

[0002] This application claims the priority benefit of U.S. Patent Application No. 63 / 060,639, filed August 3, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This application relates to the field of medical devices, and more specifically to devices and methods for placing detachable needles and dilators. Summary of the Invention

[0004] The embodiments disclosed herein relate to a catheter placement system 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 elongated medical device using the flexible sections and shift the pleated section of the housing between an extended and collapsed configuration to push the elongated medical device proximally or distally. Furthermore, the housing includes a needle retraction mechanism configured to split the needle along a longitudinal axis and coil up the separated portions to allow one or more elongated medical devices to pass through therebetween. The system also includes a dilator splitter configured to separate the dilator along a longitudinal axis and radially displace these dilator portions to allow one or more elongated medical devices to pass through therebetween. Advantageously, the system keeps the elongated medical device in a sterile environment, thereby reducing the introduction of pathogens, etc.

[0005] This document discloses a catheter placement system comprising: a catheter housing defining a longitudinal axis; an elongated medical device disposed within an internal cavity of the catheter housing; and a needle housing including a needle extending distally from the needle housing, the needle housing being releasably coupled to a distal end of the catheter housing and including a needle retraction mechanism configured to disengage the needle along the longitudinal axis and retract the needle into the needle housing.

[0006] In some embodiments, the needle housing includes a needle retraction rod hinged to the needle housing and configured to actuate a gear mechanism disposed within a needle retraction mechanism. In some embodiments, the needle retraction mechanism is configured to coil a portion of the needle about an axis extending perpendicular to the longitudinal axis. In some embodiments, the needle includes a sheath disposed on its outer surface, and one of the needle or the sheath includes a rupture line. In some embodiments, the elongated medical device includes one of a dilator, a catheter, or a guidewire. In some embodiments, one of the dilator or catheter includes a polyetheretherketone (PEEK) material or a fluorinated ethylene propylene (FEP) material. In some embodiments, the catheter housing includes a flexible segment configured to elastically deform along an axis extending perpendicular to the longitudinal axis.

[0007] In some embodiments, the catheter housing includes an aperture extending through a sidewall of the catheter housing and including a flexible membrane barrier disposed on the aperture. In some embodiments, the catheter housing includes a pleated section that can transition between an extended configuration and a collapsed configuration along a longitudinal axis. In some embodiments, the catheter housing is configured to rotate about a longitudinal axis to remove and disassemble the needle housing along the longitudinal axis. In some embodiments, the catheter placement system also includes a dilator wedge disassembler disposed within the catheter housing and configured to disassemble the dilator along the longitudinal axis. In some embodiments, the catheter housing includes a blood flash indicator releasably coupled to the proximal end of the catheter housing. In some embodiments, the catheter housing includes a guidewire housing extending from the proximal end of the catheter housing and configured to receive a portion of a guidewire therein. In some embodiments, a portion of one of the housings or the guidewire housing includes a transparent material.

[0008] A method for placing a catheter is also disclosed, comprising: providing a catheter placement system having: a catheter housing including a flexible segment and a pleated segment; an elongated medical device, a portion of which is disposed within the catheter housing; and a needle housing releasably coupled to a distal end of the catheter housing and including a needle extending from the needle housing; accessing a patient's vascular system; deforming the flexible segment to grasp a portion of the elongated medical device disposed below the flexible segment; shifting the pleated segment between an extended configuration and a collapsed configuration; releasing the flexible segment to release a portion of the elongated medical device; and shifting the pleated segment between the collapsed configuration and the extended configuration.

[0009] In some embodiments, the elongated medical device includes one of a dilator, a catheter, or a guidewire. In some embodiments, the method further includes compressing a blood return indicator to aspirate fluid flow through a needle and confirm vascular access. In some embodiments, the method further includes deforming a distal flexible segment to grasp a first portion of the elongated medical device; changing a pleated segment from an extended configuration to a collapsed configuration; deforming a proximal flexible segment to grasp a second portion of the elongated medical device; releasing the first flexible segment; and changing the pleated segment from a collapsed configuration to an extended configuration to retract the elongated medical device proximally.

[0010] In some embodiments, the method further includes retracting the elongated medical device proximally on a splitter disposed 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 hinged to the needle housing, the needle retraction lever actuating a gear mechanism located within the needle retraction mechanism. In some embodiments, retracting the needle into the needle housing includes splitting the needle along a longitudinal axis and coiling the needle about an axis extending perpendicular to the longitudinal axis. In some embodiments, the method further includes rotating the catheter housing to remove the catheter housing from the needle housing. In some embodiments, removing 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 bushing of the catheter. In some embodiments, attaching the connector set to the bushing of the catheter includes one of an interference fit, a push fit, a snap fit, a threaded engagement, or a bayonet fit. Attached Figure Description

[0011] A more specific description of the disclosure will be presented with reference to specific embodiments shown in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and should not be considered as limiting the scope of the invention. Exemplary embodiments of the invention will be described and explained using the accompanying drawings, with the aid of additional features and details, wherein:

[0012] Figure 1 A perspective view of a catheter placement system according to an embodiment disclosed herein is shown.

[0013] Figures 2A to 2B A cross-sectional side view of a catheter placement system according to an embodiment disclosed herein is shown.

[0014] Figures 3A to 3C A cross-sectional side view of a catheter placement system according to an embodiment disclosed herein is shown.

[0015] Figures 4A to 4CA cross-sectional side view of a catheter placement system according to an embodiment disclosed herein is shown.

[0016] Figures 5A to 5B A perspective view of the needle housing of a catheter placement system according to an embodiment disclosed herein is shown.

[0017] Figure 5C A cross-sectional view of the needle and sheath of a catheter placement system according to an embodiment disclosed herein is shown.

[0018] Figure 5D A perspective view of a needle being wound up according to an embodiment disclosed herein is shown.

[0019] Figure 5E A cross-sectional view of the needle and sheath of a catheter placement system according to an embodiment disclosed herein is shown.

[0020] Figure 5F A perspective view of a needle being wound up according to an embodiment disclosed herein is shown.

[0021] Figures 6A to 6J The steps of an exemplary method of using a catheter placement system according to an embodiment disclosed herein are shown. Detailed Implementation

[0022] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that are readily separable from the specific embodiments and may optionally be combined with or substitute for features of any of the many other embodiments disclosed herein.

[0023] Regarding the terminology used herein, it should also be understood that these terms are for the purpose of describing certain specific embodiments, and that they do not limit the scope of the concepts presented herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a set of features or steps, and do not provide for sequential or numerical limitations. For example, the features or steps “first,” “second,” and “third” do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. For convenience, labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” etc., are used, and these labels are not intended to imply, for example, any particular fixed position, orientation, or direction. Rather, such labels are used to reflect, for example, relative position, orientation, or direction. The singular forms “a,” “an,” and “the” include plural references unless the context clearly indicates otherwise.

[0024] The terms "proximal," "proximal portion," or "proximal portion" of a needle, as disclosed herein, include a portion of the needle intended to be close to the clinician when used with a patient. Similarly, the term "proximal length" of a needle includes the length of the needle intended to be close to the clinician when used with a patient. For example, the term "proximal end" of a needle includes the tip of the needle intended to be close to the clinician when used with a patient. A proximal portion, proximal portion, or proximal length of a needle may include the proximal end of the needle; however, a proximal portion, proximal portion, or proximal length of a needle does not necessarily include the proximal end of the needle. That is, unless the context otherwise suggests, a proximal portion, proximal portion, or proximal length of a needle is not the distal portion or distal length of the needle.

[0025] The terms "distal," "distal portion," or "distal part" of a needle, as disclosed herein, include a portion of the needle intended to be near or within the patient when used with the needle. Similarly, the term "distal length" of a needle, for example, includes the length of the needle intended to be near or within the patient when used with the needle. For instance, the term "distal end" of a needle includes the tip of the needle intended to be near or within the patient when used with the needle. A distal portion, distal part, or distal length of a needle may include the distal end of the needle; however, a distal portion, distal part, or distal length of a needle does not necessarily include the distal end of the needle. That is, unless the context otherwise suggests, a distal portion, distal part, or distal length of a needle is not the distal end portion or distal length of the needle.

[0026] like Figure 1 As shown, to aid in describing the embodiments described herein, the longitudinal axis extends substantially parallel to the axial length of the needle 140. The lateral axis extends perpendicular to the longitudinal axis, and the transverse axis extends perpendicular to both the longitudinal and lateral axes. The horizontal plane is defined by the longitudinal and lateral axes. The vertical plane may extend perpendicular to the horizontal plane.

[0027] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0028] The disclosed text generally relates to a catheter placement system 100 including a detachable needle and dilator, and related methods thereof. As used herein, the catheter placement system 100 can be used to place a central venous catheter (CVC) to access a patient's vascular system. However, it should be understood that the embodiments 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-injection central catheters (RICCs), dialysis catheters, drainage catheters, etc., without limitation.

[0029] Figure 1An exemplary embodiment of a catheter placement system (“System”) 100 is shown. The System typically includes a catheter housing 110 and a detachable needle housing 130, releasably coupled to the distal end of the catheter housing 110. System 100 also includes a needle 140, a dilator 150, a guidewire 160, and a catheter 170. The catheter housing 110 defines a generally elongated cylindrical shape comprising a circular cross-sectional shape. However, it should be understood that other elongated shapes and cross-sectional shapes are also contemplated, including triangular, square, hexagonal, polygonal, or combinations thereof. In one embodiment, a portion of the catheter housing 110 may define a polygonal cross-sectional shape to provide a gripping surface and facilitate rotation of the catheter housing 110.

[0030] In one embodiment, the catheter housing 110 may be formed of a rigid or semi-rigid material, including metals, alloys, polymers, plastics, thermoplastics, elastomers, rubber, silicone rubber, combinations thereof, etc. In one embodiment, the outer surface of the catheter housing 110 includes a compliant material, elastomer, etc., to provide a comfortable grip surface and facilitate manipulation of the system 100. In one embodiment, the catheter housing 110 may be formed of a translucent or transparent material to allow a user to observe the structures, components, or elongated medical devices disposed therein.

[0031] In one embodiment, the catheter housing 110 may include a barrier 116 extending on its outer surface. The barrier 116 may extend from a needle housing 130 disposed distally to a proximal end of the catheter housing 110 and extend circumferentially around the 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 allow a user to manipulate one of the catheter housing 110 or an elongated medical device disposed therein. As used herein, an "elongated medical device" may include one or more of a needle 140, a dilator 150, a catheter 170, a guidewire 160, or include one or more propulsion assemblies (configured to manipulate one of the needle 140, dilator 150, catheter 170, guidewire 160), combinations thereof, etc. In one embodiment, the barrier 116 or a portion thereof may be transparent to allow a user to observe the catheter housing 110 or an elongated medical device disposed therein.

[0032] In one embodiment, the catheter housing 110 may include one or more flexible segments 112, such as a distal flexible segment 112A and a proximal flexible segment 112B. As used herein, a "flexible segment" may include a portion of the catheter housing that is elastically deformable along an axis perpendicular to the longitudinal axis of the system 100. The flexible segment 112 may include a portion of the wall of the catheter housing 110 that defines more flexible mechanical properties. In one embodiment, as... Figure 2A As shown, the flexible section 112 may include a portion of the sidewall of the conduit housing 110, such as the top sidewall. In one embodiment, the flexible section 112 may include a first portion and a second portion of the sidewall, the second portion being arranged opposite the first portion across the central longitudinal axis 80, for example, the flexible section includes a left portion and a right portion in the lateral direction, and a top portion and a bottom portion in the transverse direction, or a combination thereof. In one embodiment, the flexible section 112 may include a portion of the sidewall extending annularly around the longitudinal axis.

[0033] In one embodiment, the flexible section 112 may comprise a material different from that of the catheter housing 110. In one embodiment, the flexible section 112 may define a wall thickness different from that of the material 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 propulsion assembly disposed within the catheter housing 110.

[0034] For example, such as Figure 2A As shown, a user can deform a portion of the flexible section 112 to shrink the internal chamber of the catheter housing 110 disposed beneath it. The shrinking portion can be located distal or proximal to the end of an elongated medical device (e.g., dilator 150), or distal or proximal to a propulsion assembly coupled to the elongated medical device disposed within the catheter housing 110. The deforming portion can shrink the inner diameter of the catheter housing 110 to a diameter smaller than the outer diameter of the elongated medical device.

[0035] like Figure 2B As shown, the user can then slide the deformable portion along the longitudinal axis of the flexible section 112 in a "wavy" motion. In other words, the user can contract adjacent portions of the flexible section 112 along its longitudinal axis. This allows the elongated medical device to be pushed through the internal chamber of the catheter housing 110 in front of the deformable portion.

[0036] In one embodiment, the flexible section 112 may include a more transparent feature relative to the catheter housing 110 to allow a user to observe the elongated medical device disposed beneath it. Advantageously, the user can manipulate the elongated medical device disposed within the catheter housing 110 without having to directly contact it. This keeps the elongated medical device in a sealed environment and reduces the introduction of pathogens or similar mediators of infection.

[0037] In one embodiment, the flexible section 112 may include an aperture extending through the sidewall of the conduit housing 110. For example, as Figures 3A to 3C As shown, in one embodiment, the flexible perforation segment may include a flexible barrier 116 disposed thereon to maintain a sterile environment. Figure 3B As shown, a user can compress a portion of the barrier 116 through one or more flexible segmental orifices to grasp an elongated medical device (e.g., a dilator 150) disposed within the catheter housing 110. Figure 3C As shown, the user can then slide the grasped portion longitudinally to advance the elongated medical device proximally through the catheter housing 110, or withdraw the elongated medical device distally through the catheter housing 110. Advantageously, the flexible orifice section, together with the barrier 116 disposed thereon, allows the user to manipulate the elongated medical device disposed within the catheter housing 110 while maintaining a sterile barrier therebetween.

[0038] 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 extend or collapse along a longitudinal axis. In one embodiment, the pleated section 114 may include one or more folded pleats configured to allow the catheter housing 110 to transition between an extended and collapsed configuration, thereby extending or collapsing along the longitudinal axis. However, it should be understood that other configurations of the catheter housing 110 configured to extend or collapse along the longitudinal axis, such as telescopic sections, sliding sections, folded sections, combinations thereof, etc., are also considered to fall within the scope of the invention.

[0039] Figures 4A to 4C A cross-sectional view of a catheter housing 110 is shown. The catheter housing includes a distal flexible segment 112A, a proximal flexible segment 112B, a pleated segment 114, and an elongated medical device, such as a dilator 150, disposed within the catheter housing 110. In one exemplary method of use, a user can compress the proximal flexible segment 112B to grasp a portion of the dilator 150 disposed therein. The user can extend the pleated segment 114 from its extended configuration (…). Figure 4A ) transforms into a collapsed configuration ( Figure 4B This allows the gripped expander 150 within the housing 110 to be pushed distally. The user can then release the proximal flexible section 112B and move the pleated section 114 from its collapsed configuration. Figure 4B ) transforms into an extended configuration ( Figure 4C Optionally, as the pleated section 114 transitions from a collapsed configuration to an extended configuration, the user can compress the distal flexible section 112A to grip the expander 150 in a distal position to prevent retrograde movement of the expander 150 during the transition. As will be understood, the user can repeat the process as needed to continue advancing the expander 150 in the proximal direction.

[0040] Similarly, to retract the elongated medical device proximally, the user can compress the distal flexible segment 112A to grasp a portion of the dilator 150 disposed therein. The user can then change the pleated segment 114 from an extended configuration to a collapsed configuration. The user can release the portion of the dilator 150 adjacent to the distal flexible segment 112A and deform the proximal flexible segment 112B to grasp a second portion of the dilator 150. The user can then change the pleated segment 114 from a collapsed configuration to an extended configuration to retract the dilator 150 proximally. The user can repeat the process as needed to continue retracting the dilator 150 proximally. As will be understood, the dilator 150 is an exemplary elongated medical device, and the dilator 150, guidewire 160, catheter 170, combinations thereof, etc., can be advanced distally or retracted proximally as described herein. As will be understood, although a compressible flexible segment 112 is shown, one or more orifice flexible segments (e.g., Figures 3A to 3C It can also be used to replace one or more compressible flexible sections 112, and still fall within the scope of the invention.

[0041] Continue to refer to Figure 1 System 100 may include a needle 140 supported by a needle bushing 142, the bushing being coupled to the distal end of a needle housing 130. The needle 140 may define a needle lumen 144 and, in one embodiment, includes a needle sheath 146 disposed on its outer surface. In one embodiment, the sheath 146 may be a peripherally inserted venous (PIV) catheter, which may define a smaller outer diameter than catheter 170. The sheath 146 may remain in the insertion site when changing one or more of the needle 140, dilator 150, guidewire 160, or catheter 170. In one embodiment, the sheath 146 may be configured to support a first and second half of the needle 140 to define the needle lumen 144, as described in more detail herein. In one embodiment, the sheath 146 may be formed of a plastic, polymer, elastomer, polyurethane, or similar suitable material.

[0042] In one embodiment, system 100 may further include a dilator 150 disposed within catheter housing 110. The dilator 150 may be supported by a dilator bushing 152 and define a dilator lumen 154. In one embodiment, the dilator 150 may comprise a plastic, polymer, polyetheretherketone (PEEK) material, or fluorinated ethylene propylene (FEP) material, or a similar suitable material. In one embodiment, the dilator 150 may be supported by a dilator propulsion assembly (not shown) configured to facilitate manipulation of the dilator 150 within catheter housing 110 via either a flexible section 112 or a pleated section 114, as described herein.

[0043] In one embodiment, catheter 170 may be disposed within catheter housing 110 and may be supported by catheter bushing 172. Catheter 170 may be configured to fit through dilator lumen 154. Catheter bushing 172 may be configured to be manipulated by a user via one or more flexible sections 112 to advance or retract catheter 170, as described herein. In one embodiment, catheter 170 may be supported by a catheter advancement assembly (not shown) configured to facilitate manipulation of catheter 170 within catheter housing 110 via one of flexible sections 112 or pleated sections 114, as described herein. In one embodiment, catheter 170 may comprise plastic, polymer, polyetheretherketone (PEEK) material, or fluorinated ethylene propylene (FEP) material, or similar suitable material.

[0044] In one embodiment, the guidewire housing 120 may extend proximally from the catheter housing 110 and define an internal chamber communicating with an internal cavity of the catheter housing 110. The guidewire housing 120 may be configured to receive a portion of a 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 160 disposed therein. In one embodiment, the guidewire housing 120 is formed of a flexible plastic, polymer, elastomer, etc. The user may compress a portion of the guidewire housing 120 disposed proximally to the guidewire 160 to block the internal cavity of the guidewire housing 120. Then, as described herein, the user may slide the blocking portion of the guidewire housing 120 distally in a “wavy” manner to push the guidewire 160 distally forward of the blocking portion.

[0045] In one embodiment, the guidewire housing 120 is formed of a thin film or similar collapsible barrier. A user can grasp the guidewire 160 by compressing the exterior of the guidewire housing 120. The user can then advance the guidewire 160 distally into the catheter housing 110. The portion of the guidewire housing 120 disposed distal to the grasped portion of the guidewire 160 is collapsible to allow distal advancement of the guidewire 160. In one embodiment, the guidewire housing 120 may be formed of a transparent material to allow the user to observe a portion of the guidewire 160 disposed therein. In one embodiment, the guidewire 160 may extend from the guidewire housing 120 through one or a portion of a catheter 170, dilator 150, needle 140 disposed within the catheter housing 110.

[0046] In one embodiment, system 100 may further include a blood return indicator 122. The blood return indicator 122 may include a tube or similar structure formed of a flexible, transparent material and may extend proximally from the catheter housing 110. The blood return indicator 122 may define an internal chamber. In one embodiment, the internal chamber may be configured to maintain a vacuum therein. The blood return indicator 122 is in fluid communication with the lumen of needle 140 via a connecting tube 124. When the distal tip of needle 140 enters the patient's vascular system, fluid (e.g., blood) may flow proximally into the blood return indicator 122 for observation by the user. In one embodiment, a vacuum disposed within the blood return indicator 122 may draw fluid (e.g., blood) proximally through the connecting tube 124 and into the blood return indicator 122. The user can then observe color or pulsating flow characteristics to confirm correct vascular access.

[0047] In one embodiment, system 100 further includes a cap 108 configured to releasably engage the distal end of one of catheter housing 110 or needle housing 130 and cover the distal portion of one or more of needle 140, needle sheath 146, or dilator 150. Cap 108 mitigates accidental needlestick injuries during storage or transport and maintains needle 140, needle sheath 146, dilator 150, etc., in a sterile environment. System 100 may also include a connector assembly 180 configured to engage the proximal end of catheter 170. Connector assembly 180 may include a connector bushing 182 and one or more extension legs 184 configured to provide fluid communication with one or more lumens of catheter 170.

[0048] Figures 5A to 5D Details of the needle 140 and the detachable needle housing 130 are further shown. The needle housing 130 may include a connector 132 configured to releasably connect the needle housing 130 to the catheter housing 110. The needle housing 130 may also include one or more stabilizing wings (“wings”) 134, such as a right stabilizing wing 134A and a left stabilizing wing 134B. The wings 134 may extend laterally from the needle housing 130 and define an extended lower surface configured to engage the patient’s skin surface and mitigate rotational movement about a longitudinal axis. Optionally, the wings 134 may include one or more holes configured to engage strips, tapes, dressings, bandages, or similar fixation devices to secure the needle housing 130 to the patient’s skin surface. In one embodiment, the surface of the needle housing 130 may include an adhesive layer disposed thereon and configured to secure the needle housing 130 to the patient’s skin surface. Alternatively, strips, tapes, dressings, bandages, adhesive layers, etc., may provide a sterile barrier between the catheter placement system 100 and the insertion site.

[0049] The needle housing 130 may also include a needle retraction mechanism 190. The needle retraction mechanism 190 may include one or more levers, gear mechanisms, ratchet mechanisms, sector gears, over-run slip clutches, etc., configured to engage with the needle bushing 142 and retract the needle 140 proximally into one of the needle housing 130 or the catheter housing 110, thereby leaving the sheath 146 within the insertion site to maintain the insertion site open. In one embodiment, a guidewire 160 may be advanced through the needle lumen 144 to maintain the insertion site open, and one or both of the needle 140 and the sheath 146 may be retracted into the needle housing 130, as described herein.

[0050] In one embodiment, the needle retraction mechanism 190 may be configured to disassemble the needle 140 along a longitudinal axis and coil the needle 140 onto itself. The needle 140 can then be stored within the needle housing 130. Disassembling and storing the needle 140 in this manner allows the needle to be radially displaced outward from the central longitudinal axis 80 and provides an unobstructed passage for the distal advancement of one or more elongated medical devices therebetween.

[0051] like Figures 5C to 5F As shown, in one embodiment, one of the needles 140 or the sheath 146 may include a longitudinally extending rupture line 148. As used herein, a "rupture line" may include a laser-cut line, a perforation, a groove, a notch, etc., configured to facilitate separation along it. Figures 5C to 5D As shown, in one embodiment, the needle 140 may include a single rupture line 148 extending longitudinally through one side of the needle 140. The needle 140 may be split along this rupture line 148 to form a first side edge 148A and a second side edge 148B. The cylindrical shape of the longitudinally extending needle 140 may then be transformed into a planar shape extending along an axis from the first side edge 148A to the second side edge 148B. The needle 140 may then curl itself up along an axis extending perpendicular to the longitudinal axis and recede into the needle housing 130.

[0052] In one embodiment, the needle retraction mechanism 190 may be configured to split the needle 140 along two tear lines 148 to divide the needle 140 into a first portion 140A and a second portion 140B. In one embodiment, as Figure 5E As shown, the needle 140 can be formed as two longitudinally extending separate portions 140A and 140B, which cooperate to form a needle cavity 144 and are held in place by a needle sheath 146. Then, a needle retraction mechanism 190 breaks the needle sheath 146 to separate the needle portions 140A and 140B. Figure 5F As shown, each of the needle portions 140A and 140B can then be transformed from a semi-cylindrical shape to a planar shape before it is rolled up along an axis extending perpendicular to the longitudinal axis.

[0053] In one implementation scheme, such as Figure 5B As shown, the needle retraction mechanism 190 may include one or more levers 192, which are hinged to the needle housing 130 and configured to rotate in a horizontal plane. However, it will be understood that the one or more levers 192 may also rotate in a vertical plane or along a plane extending at an angle between the horizontal and vertical planes. Rotating the one or more levers 192 may disassemble the needle bushing 142 and retract the needle 140 proximally into the needle housing 130. In one embodiment, a single rotation of the lever 192 may disassemble and fully retract the needle 140. In one embodiment, the needle retraction mechanism 190 may include a ratchet mechanism configured to allow one or more rotations of the lever 192 to disassemble and fully retract the needle 140. In one embodiment, the retraction mechanism 190 may link a first retraction lever 192A and a second retraction lever 192B such that actuating one of the first retraction lever 192A or the second retraction lever 192B may cause rotation of both retraction levers 192A and 192B. In one embodiment, the needle retraction mechanism 190 may further include a biasing member to bias the rod toward the starting position, such as... Figure 5A As shown. The user can then actuate lever 192 from the starting position to the actuated position. Releasing retractable lever 192 then allows the biasing member to return retractable lever 192 from the actuated position to the starting position.

[0054] Figures 6A to 6J An exemplary method of use for the catheter placement system 100 as described herein is shown. First, as... Figure 6A As shown, the user can rinse the connector assembly 180 and cover its ends, placing it to one side. The catheter placement system cap 108 can be removed from the needle housing 130 to expose the needle 140. Figures 6A to 6B As shown, the user can grasp the catheter housing 110 and push the needle tip 141 into the patient's vascular system 90. It is important to note that the catheter placement system 100 provides all components for placing the catheter 170—the needle 140, blood return indicator 122, PIV sheath 146, dilator 150, guidewire 160, and the catheter 170 itself (e.g., a CVC catheter)—all housed within a single sterile unit. This keeps all components potentially exposed to the patient's vascular system 90 in a sterile environment, contrasting with existing procedures that require multiple components, exposing multiple parts and introducing the risk of infection at each stage. Furthermore, the catheter placement system 100 maintains a barrier between the user and exposure to the patient's blood, a barrier that also protects the user from potential exposure.

[0055] like Figure 6BAs shown, when the needle tip 141 enters the vascular system 90, blood flow can proceed proximally through the needle lumen 144. In one embodiment, vacuum-drawn blood arranged within a blood return indicator 122 flows through the connecting tube 124 and enters the blood return indicator 122. The user can then observe the color and pulsating characteristics of the fluid arranged within the blood return indicator 122 to confirm the correct vascular access. For example, bright red or strong pulsating flow indicates arterial access, while dark red and low pulsating flow indicates venous access. Optionally, the user can compress the flexible blood return indicator tube to guide blood flow therein.

[0056] like Figure 6C As shown, with vascular access confirmed, the blood return indicator 122 can be pushed proximally to disengage it from the proximal end of the catheter housing 110. A portion of the connecting tube 124 is also withdrawn from the catheter housing 110, which in turn withdraws the distal end of the connecting tube 124, disengaging it from the needle lumen 144. The blood return indicator 122 can then be removed and discarded, or it can be secured to the outer surface of the catheter housing 110 using a clamp or similar suitable device.

[0057] When the connecting tube 124 disengages from the needle lumen 144, one of the catheter 170 or the dilator 150 may be advanced slightly such that the distal tip of the dilator 150 can engage the proximal end of the needle lumen 144. Figure 6D As shown, the distal tip 171 of the catheter 170 engages the proximal end of the dilator 150. Thus, the catheter 170, dilator 150, and needle 140 cooperate to provide a continuous path for advancing the guidewire 160 into the patient's vascular system 90.

[0058] In one embodiment, the catheter housing 110 includes a locking mechanism 126 configured to engage and lock a guidewire 160 extending therethrough 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 place to prevent it from being pulled into the patient's vascular system 90. In one embodiment, the guidewire 160 may advance through the catheter 170, through the dilator 150, and through the needle 140 until the distal tip 161 of the guidewire advances distal to the distal tip 141 of the needle. In one embodiment, the guidewire tip 161 may be advanced to a target location within the patient's vascular system 90. In one embodiment, the guidewire lock 126 may include a rotary locking mechanism or a push-button locking mechanism.

[0059] like Figure 6EAs shown, as the guidewire tip 161 is advanced into the patient's vascular system 90, the needle 140 can be withdrawn to make way, thereby allowing the dilator 150 to advance. In one embodiment, the dilator 150 and catheter 170 can be slightly withdrawn to disengage the dilator tip 151 from the needle lumen 144. The user can then manipulate the needle retraction levers 192A, 192B to retract the needle 140 proximally.

[0060] Actuating these needle retraction levers 192A, 192B retracts the needle bushing 142 and the needle 140, and separates the needle into two separate portions 140A, 140B. Each portion 140A, 140B can then roll itself up within the needle housing 130 to retract the needle 140 away from the central longitudinal axis 80, thereby allowing one or more elongated medical devices to pass axially therebetween. As described herein, the needle retraction mechanism 190 may include biasing members, ratchet mechanisms, etc., to provide mechanical advantages and facilitate the separation and removal of the needle 140.

[0061] In one embodiment, the sheath 146 can be disassembled and rolled up together with the needle 140. In one embodiment, the needle 140 is formed by two separate halves 140A and 140B, which are held together by the sheath 146. Thus, removal of the needle 140 involves disassembling the sheath 146 along the longitudinal axis and rolling up the first half of the sheath with the first half 140A of the needle and the second half of the sheath with the second half 140B of the needle. In one embodiment, the needle is withdrawn, disassembled, and rolled up, leaving the sheath 146 in place within the insertion site to maintain the patency of the blood vessel entry site.

[0062] like Figure 6F As shown, with the needle 140 withdrawn and retracted into the needle housing 130, the dilator 150 can be advanced distally over the guidewire 160 and optionally over the sheath 146 into the patient's vascular system 90 to dilate the vascular access site. As described herein, the dilator 150 can be advanced by manipulating the dilator bushing 152 through the flexible sections 112A, 112B and / or the pleated section 114. In one embodiment, the dilator bushing 152 may be coupled to the distal end of a dilator advancement assembly (not shown) extending 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.

[0063] like Figure 6GAs shown, after the insertion site is dilated, the dilator 150 can be retracted proximally by manipulating the dilator bushing 152 through the distal flexible section 112A, or by manipulating the dilator advance assembly, as described herein. When the dilator 150 is pushed proximally into the catheter housing 110, the dilator 150 can be pushed past the dilator disassembler 158. Figure 6D As shown, the splitter 158 may include a wedge-shaped distal tip configured to split the dilator 150 along a longitudinal axis when the dilator 150 is pushed proximally thereon. In one embodiment, the dilator 150 may also include a rupture line 148 to facilitate splitting the dilator 150 into two halves. In one embodiment, the splitter 158 can be pushed distally by manipulating the splitter arm 156 through the proximal flexible section 112B. The two dilator halves may be radially displaced outward relative to the central axis to allow one of the catheter 170 or guidewire 160 to pass longitudinally therebetween.

[0064] like Figure 6H As shown, catheter 170 can be advanced distally over guidewire 160 until the distal tip enters the patient's vascular system 90. Guidewire 160 can then be unlocked using guidewire lock 126 and withdrawn into catheter housing 110 and guidewire housing 120. Guidewire 160 can then be locked in place using guidewire lock 126 once the distal tip 161 of the guidewire is positioned within catheter housing 110.

[0065] like Figure 6I As shown, the catheter housing 110, in which the dilator 150, splitter 158, and guidewire 160 are arranged, can be removed from and discarded from the needle housing 130. In one embodiment, the catheter housing 110 can be removed by rotating it about a central longitudinal axis 80. With the catheter housing 110 removed from the needle housing 130, the needle housing 130 can be divided into two separate halves 130A, 130B along the longitudinal axis. Each half 130A, 130B can then be separated perpendicular to the longitudinal axis to detach from the catheter bushing 172. In one embodiment, the needle housing 130 may include a rupture line 138 extending longitudinally and configured to facilitate separation of the first half 130A from the second half 130B of the needle housing. In one embodiment, the connector 132 between the catheter housing 110 and the needle housing 130 can be configured to divide the needle housing 130 into two halves when the catheter housing 110 is rotated. For example, the distal end of the catheter housing 110 may include a cam lobe structure that engages the needle housing 130 when the catheter housing 110 rotates about its longitudinal axis. The cam lobe provides mechanical advantages to facilitate the disengagement of the needle housing 130.

[0066] like Figure 6JAs shown, with the catheter housing 110 and needle housing 130 detached from the catheter 170, the connector assembly 180 can be coupled to the catheter bushing 172. Each of one or more extension legs 184 is in fluid communication with the lumen of the catheter 170. In one embodiment, the connector assembly 180 can be coupled to the catheter bushing 172 via interference fit, push-in fit, snap-fit ​​fit, threaded engagement, bayonet fit, etc.

[0067] While certain specific embodiments have been disclosed herein, and while these specific embodiments have been disclosed in considerable detail, they are not intended to limit the scope of the concepts provided herein. Other adaptations and / or modifications will be apparent to those skilled in the art, and these adaptations and / or modifications are also covered in a broader sense. Therefore, changes may be made to the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A catheter placement system for inserting an elongated medical device into a patient's vascular system, characterized in that, The catheter placement system includes: The catheter housing defines the longitudinal axis; A catheter, disposed within the internal cavity of the catheter housing, the catheter housing surrounding a portion of the catheter about the longitudinal axis; and A needle housing, the proximal end of which is releasably coupled to the distal end of the catheter housing to allow dissociation of the needle housing from the catheter housing, the needle housing comprising: A needle having a beveled tip, the needle extending distally from the needle housing and having a first rupture line extending along the top side of the needle, the first rupture line being configured to allow the needle to separate thereal; and A needle retraction mechanism is configured to retract the needle proximally into the needle housing before advancing the catheter distally into the needle housing, the needle housing surrounding a portion of the needle and a portion of both the needle and the needle retraction mechanism about a longitudinal axis, wherein the needle retraction mechanism includes one or more lever, gear, or ratchet mechanisms coupled to a needle bushing of the needle and configured to retract the needle proximally into the needle housing by transforming the needle into a planar shape and coiling the planar needle about an axis extending perpendicular to the longitudinal axis.

2. The catheter placement system according to claim 1, characterized in that, The needle housing also includes a needle retraction rod, which is hinged to the needle housing and configured to actuate the needle retraction mechanism to retract the needle proximally.

3. The catheter placement system according to claim 1, characterized in that, The needle includes a sheath disposed on its outer surface, and one of the needle or the sheath includes a rupture line.

4. The catheter placement system according to claim 1, characterized in that, It also includes dilators and guidewires.

5. The catheter placement system according to claim 4, characterized in that, One of the expander or the conduit comprises a polyetheretherketone material or a fluorinated ethylene propylene material.

6. The catheter placement system according to claim 4, characterized in that, It also includes a dilator wedge splitter disposed within the catheter housing and configured to split the dilator along the longitudinal axis.

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

8. The catheter placement system according to claim 1, characterized in that, The catheter housing includes a hole extending through the sidewall of the catheter housing and includes a flexible membrane barrier disposed thereon.

9. The catheter placement system according to claim 1, characterized in that, The conduit housing includes a pleated section that can be converted between an extended configuration and a collapsed configuration along the longitudinal axis.

10. The catheter placement system according to claim 1, characterized in that, The catheter housing is configured to rotate about the longitudinal axis to remove from the needle housing and disassemble the needle housing along the longitudinal axis.

11. The catheter placement system according to claim 1, characterized in that, The catheter housing includes a blood return indicator that is releasably coupled to the proximal end of the catheter housing.

12. The catheter placement system according to claim 1, characterized in that, The catheter housing includes a guidewire housing that extends from the proximal end of the catheter housing and is configured to receive a portion of the guidewire therein.

13. The catheter placement system according to claim 12, characterized in that, A portion of either the catheter housing or the guidewire housing comprises a transparent material.

14. The catheter placement system according to claim 1, characterized in that, The needle also includes a second rupture line extending along the bottom side of the needle opposite to the first rupture line, the needle being configured to separate into a first needle portion and a second needle portion along the first rupture line and the second rupture line.

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