Splittable needle and dilation catheter placement device

Abstract

To provide a catheter placement system including a splittable needle and a dilator.SOLUTION: The system 100 can include a housing 110 having one or more flexible portions and a corrugated portion 114. A user can grasp the elongate medical device 150 using the flexible portion and transition the corrugated portion of the housing between the extended configuration and the collapsed configuration to bias the elongate medical device proximally or distally. The system also includes a needle retraction mechanism configured to split the needle 140 along a longitudinal axis and wind up another portion to allow one or more elongate medical devices to pass between the portions.SELECTED DRAWING: Figure 1

Description

Summary of the Invention

[0001] 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 crimped section. A user can use the flexible section to grasp an elongated medical device and transition the crimped section of the housing between an extended configuration and a collapsed configuration to bias the elongated medical device proximally or distally. The housing further includes a needle retraction mechanism configured to split the needle along the longitudinal axis and retract another section to allow one or more elongated medical devices to pass therebetween. The system includes a dilator splitter configured to separate the dilator along the longitudinal axis and radially displace a section of the dilator to allow one or more elongated medical devices to pass therebetween. Advantageously, the system maintains the elongated medical device in a sterile environment while mitigating the introduction of pathogens and the like.

[0002] Disclosed herein is a catheter placement system including a catheter housing defining a longitudinal axis, an elongated medical device disposed within an interior cavity of the catheter housing, and a needle housing including a needle extending distally from the needle housing, the needle housing releasably coupled to a distal end of the catheter housing, the needle housing including a needle retraction mechanism configured to split the needle along the longitudinal axis and to retract the needle into the needle housing.

[0003] In some embodiments, the needle housing includes a needle retraction lever hinged to the needle housing and configured to activate a gear mechanism disposed within the needle retraction mechanism. In some embodiments, the needle retraction mechanism is configured to wind 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 outer surface of the needle, and one of the needle and the sheath includes a break line. In some embodiments, the elongate medical device includes one of a dilator, a catheter, and a guidewire. In some embodiments, one of the dilator and the catheter includes one of a polyetheretherketone (PEEK) material and a fluorinated ethylene propylene (FEP) material. In some embodiments, the catheter housing includes a flexible portion configured to elastically deform along an axis extending perpendicular to the longitudinal axis.

[0004] In some embodiments, the catheter housing includes an opening extending through a sidewall of the catheter housing, the opening including a flexible film barrier disposed over the opening. In some embodiments, the catheter housing includes a pleat capable of transitioning along a longitudinal axis between an extended configuration and a collapsed configuration. In some embodiments, the catheter housing is configured to rotate about a longitudinal axis to detach from the needle housing and split the needle housing along the longitudinal axis. In some embodiments, the catheter placement system further includes a dilator wedge splitter disposed within the catheter housing and configured to split a dilator along the longitudinal axis. In some embodiments, the catheter housing includes a blood flush indicator releasably coupled to a proximal end of the catheter housing. In some embodiments, the catheter housing includes a guidewire housing extending from a proximal end of the catheter housing, the guidewire housing configured to receive a portion of the guidewire therein. In some embodiments, a portion of one of the housing and the guidewire housing includes a transparent material.

[0005] Also disclosed is a method of placing a catheter, the method comprising providing a catheter placement system including a catheter housing including a flexible section and a crimped section, an elongated medical device, a portion of the elongated medical device disposed within the catheter housing, and a needle housing including a needle releasably coupled to a distal end of the catheter housing and extending from the distal end, accessing a patient's vasculature, deforming the flexible section to grasp the portion of the elongated medical device disposed beneath the flexible section, transitioning the crimped section between an extended configuration and a collapsed configuration, releasing the flexible section to release the portion of the elongated medical device, and transitioning the crimped section between a predetermined configuration and an extended configuration.

[0006] In some embodiments, the elongate medical device comprises one of a dilator, a catheter, and a guidewire. In some embodiments, the method includes compressing a blood flush indicator to pump fluid flow through the needle to confirm vascular access. In some embodiments, the method further includes deforming a distal flexible section to grip a first portion of the elongate medical device, transitioning the pleats from the extended configuration to the collapsed configuration, deforming a proximal flexible section to grip a second portion of the elongate medical device, releasing the first flexible section, and transitioning the pleats from the collapsed configuration to the extended configuration to retract the elongate medical device proximally.

[0007] In some embodiments, the method further includes retracting 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 hingedly connected 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 winding up 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 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, and a bayonet fit.

[0008] A more particular description of the present disclosure will be made by reference to specific embodiments that are illustrated in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and are not to be considered limiting of its scope. Exemplary embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief explanation of the drawings]

[0009] [Figure 1]1 shows a perspective view of a catheter placement system according to an embodiment disclosed herein. [Figure 2A] 1 shows a side cross-sectional view of a catheter placement system according to an embodiment disclosed herein. [Figure 2B] 1 shows a side cross-sectional view of a catheter placement system according to an embodiment disclosed herein. [Figure 3A] 1 shows a side cross-sectional view of a catheter placement system according to an embodiment disclosed herein. [Figure 3B] 1 shows a side cross-sectional view of a catheter placement system according to an embodiment disclosed herein. [Figure 3C] 1 shows a side cross-sectional view of a catheter placement system according to an embodiment disclosed herein. [Figure 4A] 1 shows a side cross-sectional view of a catheter placement system according to an embodiment disclosed herein. [Figure 4B] 1 shows a side cross-sectional view of a catheter placement system according to an embodiment disclosed herein. [Figure 4C] 1 shows a side cross-sectional view of a catheter placement system according to an embodiment disclosed herein. [Figure 5A] FIG. 1 shows a perspective view of a needle housing of a catheter placement system according to an embodiment disclosed herein. [Figure 5B] FIG. 1 shows a perspective view of a needle housing of a catheter placement system according to an embodiment disclosed herein. [Figure 5C] 1 shows a side cross-sectional view of a needle and sheath of a catheter placement system according to an embodiment disclosed herein. [Figure 5D] FIG. 1 illustrates a perspective view of a needle of a catheter placement system in a coiled state according to an embodiment disclosed herein. [Figure 5E] 1 shows a side cross-sectional view of a needle and sheath of a catheter placement system according to an embodiment disclosed herein. [Figure 5F] FIG. 1 illustrates a perspective view of a needle of a catheter placement system in a coiled state according to an embodiment disclosed herein. [Figure 6A]1 illustrates various steps in an exemplary method of using a catheter placement system according to embodiments disclosed herein. [Figure 6B] 1 illustrates various steps in an exemplary method of using a catheter placement system according to embodiments disclosed herein. [Figure 6C] 1 illustrates various steps in an exemplary method of using a catheter placement system according to embodiments disclosed herein. [Figure 6D] 1 illustrates various steps in an exemplary method of using a catheter placement system according to embodiments disclosed herein. [Figure 6E] 1 illustrates various steps in an exemplary method of using a catheter placement system according to embodiments disclosed herein. [Figure 6F] 1 illustrates various steps in an exemplary method of using a catheter placement system according to embodiments disclosed herein. [Figure 6G] 1 illustrates various steps in an exemplary method of using a catheter placement system according to embodiments disclosed herein. [Figure 6H] 1 illustrates various steps in an exemplary method of using a catheter placement system according to embodiments disclosed herein. [Figure 6I] 1 illustrates various steps in an exemplary method of using a catheter placement system according to embodiments disclosed herein. [Figure 6J] 1 illustrates various steps in an exemplary method of using a catheter placement system according to embodiments disclosed herein. DETAILED DESCRIPTION OF THE INVENTION

[0010] Before some specific embodiments are disclosed in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein can have features that can be readily separated from the specific embodiment and, optionally, combined with or substituted for features of any of the other numerous embodiments disclosed herein.

[0011] Regarding the terms used herein, it should also be understood that the terms are intended to describe certain specific embodiments and do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps and do not provide sequential or numerical limitations. For example, "first," "second," and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Labels such as "left," "right," "top," "bottom," "front," "back," etc. are used for convenience and do not imply, for example, a particular fixed position, orientation, or direction. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "one," "one," and "said" also include plural references unless the context clearly dictates otherwise.

[0012] With respect to "proximal," for example, the "proximal portion" or "proximal end portion" of a needle disclosed herein includes the portion of the needle intended to be near the clinician when the needle is used on a patient. Similarly, for example, the "proximal length" of a needle includes the length of the needle intended to be near the clinician when the needle is used on a patient. For example, the "proximal end" of a needle includes the end of the needle intended to be near the clinician when the needle is used on a patient. The proximal portion, proximal end portion, or proximal length of a needle can include the proximal end of the needle, but the proximal portion, proximal end portion, or proximal length of a needle need not include the proximal end of the needle. That is, unless the context suggests otherwise, the proximal portion, proximal end portion, or proximal length of a needle is not the terminal portion or terminal length of the needle.

[0013] With respect to "distal," for example, the "distal portion" or "distal end portion" of a needle disclosed herein includes the portion of the needle intended to be near or within a patient when the needle is used with a patient. Similarly, for example, the "distal length" of a needle includes the length of the needle intended to be near or within a patient when the needle is used with a patient. For example, the "distal end" of a needle includes the end of the needle intended to be near a clinician or within a patient when the needle is used with a patient. The distal portion, distal end portion, or distal length of a needle can include the distal end of the needle, but the distal portion, distal end portion, or distal length of a needle need not include the distal end of the needle. That is, unless the context suggests otherwise, the distal portion, distal end portion, or distal length of a needle is not the terminal portion or terminal length of the needle.

[0014] 1A, to aid in describing the embodiments described herein, a longitudinal axis extends generally parallel to the axial length of the needle 140. A lateral axis extends perpendicular to the longitudinal axis, and a transverse axis extends perpendicular to both the longitudinal and lateral axes. A horizontal plane is defined by the longitudinal and transverse axes. A vertical plane can extend perpendicular to the horizontal plane.

[0015] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. The present disclosure relates generally to a catheter placement system 100 including a splittable needle and dilator, and related methods. As used herein, the catheter placement system 100 may be used to place a central venous catheter (CVC) to access a patient's vasculature. However, it will be understood that the embodiments disclosed herein may be used to place various catheters, cannulas, single-lumen catheters, multi-lumen catheters, intravenous (IV) catheters, peripherally inserted central catheters (PICCs), rapid insertion central catheters (RICCs), dialysis catheters, drainage catheters, and the like, without limitation.

[0016] FIG. 1 illustrates an exemplary embodiment of a catheter placement system (system) 100 generally including a catheter housing 110 and a splittable needle housing 130 releasably coupled to the distal end of the catheter housing 110. The system 100 further includes a needle 140, a dilator 150, a guidewire 160, and a catheter 170. The catheter housing 110 defines a substantially elongated cylindrical shape, including a circular cross-sectional shape. However, it will be understood that other elongated cross-sectional shapes are also contemplated, including triangular, square, hexagonal, polygonal, or combinations thereof. In one embodiment, a portion of the catheter housing 110 can define a polygonal cross-sectional shape to provide a gripping surface and facilitate rotation of the catheter housing 110.

[0017] In one embodiment, the catheter housing 110 can be formed from a rigid or semi-rigid material including a metal, alloy, polymer, plastic, thermoplastic, elastomer, rubber, silicone rubber, combinations thereof, etc. In one embodiment, the exterior surface of the catheter housing 110 comprises a flexible material, elastomer, etc. to provide a comfortable gripping surface and to facilitate manipulation of the system 100. In one embodiment, the catheter housing 110 can be formed from a translucent or transparent material to allow a user to observe structures, components, or elongated medical devices disposed within the catheter housing 110.

[0018] In one embodiment, the catheter housing 110 can include a barrier 116 extending on an exterior surface of the catheter housing 110. The barrier 116 can extend from the needle housing 130 located at the distal end to the proximal end of the catheter housing 110 and can extend annularly around the longitudinal axis of the catheter housing 110. In one embodiment, the barrier 116 can be formed from a thin polymer film or similar flexible material configured to allow a user to manipulate the catheter housing 110 or one of the elongated medical devices disposed within the catheter housing 110. As used herein, an "elongated medical device" can include one or more of the needle 140, dilator 150, catheter 170, guidewire 160, or one or more advancement assemblies configured to manipulate one of the needle 140, dilator 150, catheter 170, guidewire 160, combinations thereof, etc. In one embodiment, the barrier 116 or a portion of the barrier 116 may be transparent to allow a user to observe the catheter housing 110 or one of the elongated medical devices disposed within the catheter housing 110.

[0019] In one embodiment, the catheter housing 110 can include one or more flexible sections 112, such as 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 is elastically deformable along an axis perpendicular to the longitudinal axis of the system 100. The flexible section 112 can include a portion of the wall of the catheter housing 110 that defines a more flexible mechanical property. In one embodiment, as shown in FIG. 1A , the flexible section 112 can include a portion of a sidewall of the catheter housing 110, such as the top sidewall. In one embodiment, the flexible section 112 can include a first portion of the sidewall and a second portion of the sidewall disposed opposite the first portion across the central longitudinal axis 80, such as a first and second portion laterally if the flexible section includes a left and right portion, a first and second portion transversely if the flexible section includes a top and bottom portion, or a first and second portion laterally and transversely if the flexible section includes a combination thereof. In one embodiment, the flexible portion 112 can include a portion of a sidewall that extends annularly about the longitudinal axis.

[0020] In one embodiment, the flexible segment 112 can comprise a material that is different from the material of the catheter housing 110. In one embodiment, the flexible segment 112 can define a wall thickness that is different from the wall thickness of the material of the catheter housing 110. In one embodiment, the flexible segment 112 can be elastically deformed by a user to grasp or manipulate an elongated medical device or advancement assembly disposed within the catheter housing 110.

[0021] 2A, a user can deform a portion of the flexible section 112 to constrict an internal cavity of the catheter housing 110 located below the flexible section 112. The constricted section can be located distal or proximal to an elongated medical device (e.g., a dilator 150) located within the catheter housing 110 or the end of an advancement assembly coupled to the elongated medical device. The deformed section can constrict the inner diameter of the catheter housing 110 to a diameter smaller than the outer diameter of the elongated medical device 150.

[0022] 2B, the user can then slide the deformed portion along the longitudinal axis of the flexible section 112 in a "wave" motion. In other words, the user can contract the adjacent portion of the flexible section 112 along the longitudinal axis of the flexible section 112. Thus, the elongate medical device 150 can be urged through the interior cavity of the catheter housing 110 just in front of the deformed portion.

[0023] In one embodiment, the flexible segment 112 may have more transparent properties than the catheter housing 110 to allow a user to view an elongated medical device disposed beneath the flexible segment 112. Advantageously, a user can manipulate an elongated medical device disposed within the catheter housing 110 without having to directly contact the elongated medical device, thereby maintaining the elongated medical device in a sealed environment and mitigating the introduction of pathogens or similar infectious agents.

[0024] In one embodiment, the flexible section 112 can include an opening extending through the sidewall of the catheter housing 110. For example, as shown in Figures 3A-3C, in one embodiment, the opening flexible section 112 can include a flexible barrier 116 disposed above the opening flexible section 112 to maintain a sterile environment. As shown in Figure 3B, a user can compress a portion of the barrier 116 through one or more of the flexible section openings 112 to grasp an elongated medical device (e.g., a dilator 150) disposed within the catheter housing 110. As shown in Figure 3C, the user can then slide the grasped portion longitudinally to advance the elongated medical device proximally or withdraw it distally through the catheter housing 110. Advantageously, the opening flexible section 112, together with the barrier 116 disposed above the opening flexible section 112, can enable a user to manipulate an elongated medical device disposed within the catheter housing 110 while maintaining a sterile barrier therebetween.

[0025] In one embodiment, the catheter housing 110 can include a pleat 114. As used herein, a "pleat" can include a portion of the catheter housing that is stretched or folded along the longitudinal axis. In one embodiment, the pleat 114 can include one or more folded pleats that are stretched or folded along the longitudinal axis to allow the catheter housing 110 to transition between an extended configuration and a folded configuration. However, it should be understood that other configurations of the catheter housing 110 that are configured to stretch or fold along the longitudinal axis, such as telescoping sections, sliding sections, folding sections, and combinations thereof, are also contemplated within the scope of the present invention.

[0026] 4A-4C show cross-sectional views of a catheter housing 110 including a distal flexible section 112A, a proximal flexible section 112B, a pleated section 114, and an elongated medical device, such as a dilator 150, disposed within the catheter housing 110. In an exemplary method of use, a user can compress the proximal flexible section 112B to grasp a portion of the dilator 150 disposed within the proximal flexible section 112B. The user can transition the pleated section 114 from an extended configuration (FIG. 4A) to a folded configuration (FIG. 4B). Thus, the dilator 150 grasped within the housing 110 can be advanced distally. The user can release the proximal flexible section 112B to transition the pleated section 114 from the folded configuration (FIG. 4B) to the extended configuration (FIG. 4C). Optionally, the user can compress the distal flexible section 112A to grip the dilator 150 in a distal position to prevent retrograde movement of the dilator 150 during the transition of the pleats 114 from the collapsed configuration to the extended configuration. It will be appreciated that the user can repeat the above procedure as needed to continue advancing the dilator 150 proximally.

[0027] In a similar manner, the user can compress the proximal flexible section 112A to grasp the portion of the dilator 150 disposed within the proximal flexible section 112A. The user can then transition the pleats 114 from an extended configuration to a collapsed configuration. The user can release the portion of the dilator 150 disposed adjacent the distal flexible section 112A and deform the proximal flexible section 112B to grasp a second portion of the dilator 150. The user can then transition the pleats 114 from an extended configuration to a collapsed configuration to retract the dilator 150 proximally. The user can repeat the above procedure as necessary to continue to retract the dilator 150 proximally. As will be appreciated, the dilator 150 is an exemplary elongate medical device, and the dilator 150, guidewire 160, catheter 170, combinations thereof, and the like can be advanced distally or retracted proximally as described herein. It will be appreciated that although compressible flexible portions 112 are shown, one or more aperture flexible portions 112 (e.g., Figures 3A-3C) may also be used in place of one or more compressible flexible portions 112 and still be within the scope of the present invention.

[0028] Continuing to refer to FIG. 1 , system 100 may include a needle 140 supported by a needle hub 142 coupled to the distal end of needle housing 130. Needle 140 may define a needle lumen 144 and, in one embodiment, may include a needle sheath 146 disposed on its outer surface. In one embodiment, sheath 146 may be a peripherally inserted venous (PIV) catheter that may define a smaller outer diameter than catheter 170. Sheath 146 may maintain access to the insertion site when one or more of needle 140, dilator 150, guidewire 160, and catheter 170 are exchanged. In one embodiment, sheath 146 may be configured to support first and second halves of needle 140 and define needle lumen 140, as described in more detail herein. In one embodiment, sheath 146 may be formed from a plastic, polymer, elastomer, urethane, or similar suitable material.

[0029] In one embodiment, the system 100 can further include a dilator 150 disposed within the catheter housing 110. The dilator 150 can be supported by a dilator hub 152 and define a dilator lumen 154. In one embodiment, the dilator 150 can comprise a plastic, polymer, polyetheretherketone (PEEK) material, or fluorinated ethylene propylene (FEP) material, or a similar suitable material. In one embodiment, the dilator 150 can be supported by one of the flexible portion 112 and the crimped portion 114, as described herein, by a dilator advancement assembly (not shown) configured to facilitate manipulation of the dilator 150 within the catheter housing 110.

[0030] In one embodiment, the catheter 170 may be disposed within the catheter housing 110 and supported by a catheter hub 172. The catheter 170 may be configured to fit through the dilator lumen 154. The catheter hub 172 may be configured to be manipulated by a user via one or more of the flexible sections 112 to advance or retract the catheter 170, as described herein. In one embodiment, the catheter 170 may be supported by one of the flexible sections 112 and the corrugated section 114, as described herein, with a dilator advancement assembly (not shown) configured to facilitate manipulation of the catheter 170 within the catheter housing 110. In one embodiment, the catheter 170 may comprise a plastic, polymer, polyetheretherketone (PEEK) material, or fluorinated ethylene propylene (FEP) material, or a similar suitable material.

[0031] In one embodiment, guidewire housing 120 can extend from the proximal end of catheter housing 110 and define an internal cavity in communication with the internal cavity of catheter housing 110. Guidewire housing 120 can be configured to receive a portion of guidewire 160 disposed therein. In one embodiment, guidewire housing 120 can be formed from a flexible material, allowing a user to manipulate guidewire 170 disposed therein. In one embodiment, guidewire housing 120 can be formed from a flexible plastic, polymer, elastomer, or the like. A user can compress a portion of guidewire housing 120 disposed proximal to the proximal end of guidewire 160 to occlude the internal cavity of guidewire housing 120. The user can then slide the occluding portion of guidewire housing 120 distally in a “wave” manner, as described herein, to urge guidewire 160 distally, ahead of the occlusion portion.

[0032] In one embodiment, guidewire housing 120 is formed from a thin film or similar foldable barrier. A user can grasp guidewire 160 by compressing the outer portion of guidewire housing 120. The user can then urge guidewire 160 distally into catheter housing 110. A portion of guidewire housing 120 distal to the grasped portion of guidewire 160 can be folded to allow guidewire 160 to be advanced distally. In one embodiment, guidewire housing 120 can be formed from a transparent material to allow a user to observe a portion of guidewire 170 disposed within guidewire housing 120. In one embodiment, guidewire 170 can extend from guidewire housing 120 through one of catheter 170, dilator 150, needle 140, and portions thereof disposed within catheter housing 110.

[0033] In one embodiment, system 100 may further include a blood flush indicator 122. Blood flush indicator 122 may comprise a tube or similar structure formed from a flexible, transparent material and may extend from the proximal end of catheter body 110. Blood flush indicator 122 may define an internal cavity. In one embodiment, the internal cavity may be configured to maintain a vacuum therein. Blood flush indicator 122 may be in fluid communication with the lumen of needle 140 via connecting tube 124. When the distal tip of needle 140 accesses the patient's vasculature, fluid (e.g., blood) may flow proximally into blood flush indicator 122 for observation by a user. In one embodiment, a vacuum provided within blood flush indicator 122 may draw fluid (e.g., blood) proximally through connecting tube 124 and into blood flush indicator 122. A user may then observe color or pulsatile flow characteristics to confirm proper vascular access.

[0034] In one embodiment, the system 100 further includes a cap 108 configured to releasably engage the distal end of one of the catheter housing 110 and the needle housing 130 and configured to cover a distal portion of one or more of the needle 140, the needle sheath 146, and the dilator 150. The cap 108 can reduce accidental needle stick injuries during storage or transport and maintain a sterile environment for the needle 140, the needle sheath 146, the dilator 150, etc. The system 100 can further include a connector set 180 configured to engage the proximal end of the catheter 170. The connector set 180 can include a connector hub 182 and one or more extension legs 184 configured to provide fluid communication with one or more lumens of the catheter 170.

[0035] 5A-5D show the needle 140 and the splittable needle housing 130 in further detail. The needle housing 130 may include a coupler 132 configured to releasably couple the needle housing 130 to the catheter housing 110. The needle housing 130 may further include one or more stabilizing wings (wings) 134, e.g., 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 enlarged undersurface configured to engage a patient's skin surface and to reduce rotational movement about the longitudinal axis. Optionally, the wings 134 may include one or more apertures configured to engage a strap, tape, dressing, bandage, or similar securement device to facilitate securing 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. Optionally, straps, tapes, dressings, bandages, adhesive layers, etc. can provide a sterile barrier between the catheter placement system 100 and the insertion site.

[0036] The needle housing 130 can further include a needle retraction mechanism 190. The needle retraction mechanism 190 can include one or more levers, gear mechanisms, ratchet mechanisms, sector gears, overrun slip clutches, etc. configured to couple with the needle hub 142 and retract the needle 140 proximally into one of the needle housing 130 and the catheter housing 110 while leaving the sheath 146 within the insertion site to maintain insertion site patency. In one embodiment, the guidewire 160 can be advanced through the needle lumen 144 to maintain insertion site patency, and one or both of the needle 140 and the sheath 146 can be retracted into the needle housing 130 as described herein.

[0037] In one embodiment, needle retraction mechanism 190 may be configured to split needle 140 along the longitudinal axis and to coil needle 140 onto itself. Needle 140 may then be retracted within needle housing 130. Splitting and retracting needle 140 in this manner displaces the needle radially outward from central longitudinal axis 80, providing a clear passageway for one or more elongated medical devices to be advanced distally therebetween.

[0038] As shown in FIGS. 5C-5F , in one embodiment, one of the needle 140 and the sheath 146 can include a longitudinally extending fracture line 148. As used herein, a “fracture line” can include a laser cut line, perforations, grooves, split lines, etc. configured to facilitate separation therealong. As shown in FIGS. 5C-5F , in one embodiment, the needle 140 can include a single fracture line 148 extending longitudinally through one side of the needle 140. The needle 140 can be split along this fracture line 148 to form a first side edge 148A and a second side edge 148B. The longitudinally extending cylindrical shape of the needle 140 can then transition to a planar shape extending along an axis from the first side edge 148A to the second side edge 148A. The needle 140 can then be rolled up on itself along an axis extending perpendicular to the longitudinal axis and isolated within the needle housing 130.

[0039] In one embodiment, the needle retraction mechanism 190 can be configured to split the needle 140 along two break lines 148 to separate the needle 140 into a first portion 140A and a second portion 140B. In one embodiment, as shown in FIG. 5E, the needle 140 can be formed as two separate longitudinally extending portions 140A, 140B that cooperate to form a needle lumen 144 and are held in place by a needle sheath 146. The needle retraction mechanism 190 then breaks the needle sheath 146, separating the needle portions 140A, 140B. As shown in FIG. 5F, each of the needle portions 140A, 140B can then transition from a semi-cylindrical shape to a planar shape before rolling up onto itself along an axis extending perpendicular to the longitudinal axis.

[0040] 5B, the needle retraction mechanism 190 may include one or more levers 192 hinged to the needle housing 130 and configured to rotate through a horizontal plane. However, it will be understood that the one or more levers 192 may rotate through a vertical plane or along a plane extending at an angle therebetween. Rotating the one or more levers 192 can split the needle hub 142 and retract the needle 140 proximally into the needle housing 130. In one embodiment, a single rotation of the lever 192 can split and fully retract the needle 140. In one embodiment, the needle retraction mechanism 190 may include a ratchet mechanism configured such that one or more rotations of the lever 192 can split and fully retract the needle 140. In one embodiment, the retraction mechanism 190 can couple the first retraction lever 192A and the second retraction lever 192B such that actuation of one of the first retraction lever 192A and the second retraction lever 192B rotates both retraction levers 192A, 192B. In one embodiment, the needle retraction mechanism 190 can further include a biasing member that biases the lever toward a start position, as shown, for example, in FIG. 5A . A user can then actuate the lever 192 from the start position to an actuated position. Releasing the needle retraction lever 192 can then cause the biasing member to transition the needle retraction lever 192 from the actuated position to the start position.

[0041] 6A-6J illustrate an exemplary method of using the catheter placement system 100 described herein. First, as shown in FIG. 6A, a user can flush the connector set 180 and remove and set to one side the end cap of the connector set 180. The catheter placement system cap 108 can be removed from the needle housing 130 to expose the needle 140. As shown in FIGS. 6A-6B, a user can grasp the catheter housing 110 and urge the needle tip 141 into the patient's vasculature 90. It is important to note that the catheter placement system 100 provides all of the components for placing the catheter 170, namely, the needle 140, blood flush indicator 122, PIV sheath 146, dilator 150, guidewire 160, as well as the catheter 170 itself (e.g., a CVC catheter), housed within a single sterile unit. This maintains all components within a sterile environment that may be exposed to the patient's vasculature 90, in contrast to existing procedures that require multiple exposed components and risk introducing infection at every step. Additionally, the catheter placement system 100 protects the user from potential exposure by maintaining a barrier to the user's exposure to the patient's blood.

[0042] As shown in FIG. 6B , once needle tip 141 accesses vasculature 90, blood can flow proximally through needle lumen 144. In one embodiment, a vacuum created within blood flush indicator 122 can draw blood through connecting tube 124 and into blood flush indicator 122. The user can then observe the color and pulsatile flow characteristics of the blood within blood flush indicator 122 to confirm proper vascular access. For example, a bright red color or strong pulsatile flow can indicate arterial access, while a dark red color and low pulsatile flow can indicate venous access. Optionally, the user can compress flexible blood flush indicator tube 122 to induce blood flow into flexible blood flush indicator tube 122.

[0043] 6C, once vascular access is confirmed, the blood flush indicator 122 can be urged proximally to disengage the blood flush indicator 122 from the proximal end of the catheter housing 110. A portion of the communicating tube 124 is also withdrawn from the catheter housing 110, thereby withdrawing the distal end of the communicating tube 124 and disengaging the communicating tube 124 from the needle lumen 144. The blood flush indicator 122 can then be removed and discarded, or secured to the outer surface of the catheter housing 110 using a clip or similar suitable means.

[0044] With the communicating tube 124 disengaged from the needle lumen 144, one of the catheter 170 and the dilator 150 can be advanced slightly so that the distal tip of the dilator 150 can engage the proximal end of the needle lumen 144. As shown in FIG. 6D , the distal tip 171 of the catheter 170 engages the proximal end of the dilator 150. Thus, the catheter 170, the dilator 150, and the needle 140 cooperate to provide a continuous pathway for the guidewire 160 to be advanced into the patient's vasculature 90.

[0045] In one embodiment, the catheter housing 110 includes a locking mechanism 126 configured to engage a guidewire 160 extending therethrough and lock the guidewire 160 relative to the catheter housing 110. A user can unlock the guidewire 160, advance a portion of the guidewire 160, and then lock the guidewire 160 in place to prevent the guidewire from being retracted into the patient's vasculature 90. In one embodiment, the guidewire 160 can be advanced through the catheter 170, through the dilator 150, and through the needle 140 until the guidewire distal tip 161 is advanced distal to the needle distal tip 141. In one embodiment, the guidewire tip 161 can be advanced to a target location within the patient's vasculature 90. In one embodiment, the guidewire lock 126 can include either a rotational locking mechanism or a push-button locking mechanism.

[0046] 6E, with the guidewire tip 161 advanced into the patient's vasculature 90, the needle 140 can be withdrawn from the path to allow the dilator 150 to advance. In one embodiment, the dilator 150 and catheter 170 can be slightly retracted to disengage the dilator tip 151 from the needle lumen 144. The user can then operate the needle retraction levers 192A, 192B to retract the needle 140 proximally.

[0047] Actuation of the needle retraction levers 192A, 192B can retract the needle hub 142 and needle 140, separating them into two separate sections 140A, 140B. Each section 140A, 140B can then be rolled up upon itself within the needle housing 130 to allow one or more elongated medical devices to pass axially therebetween to isolate the needle 140 away from the central longitudinal axis 80. As described herein, the needle retraction mechanism 190 can include a biasing member, a ratchet mechanism, or the like to provide mechanical advantage and facilitate separation and removal of the needle 140.

[0048] In one embodiment, the sheath 146 may be split and rolled up along with the needle 140. In one embodiment, the needle 140 is formed from two separate halves 140A, 140B that are held together by the sheath 146. Thus, removal of the needle 140 involves splitting the sheath 146 along the longitudinal axis and rolling up the first half of the sheath with the first half of the needle 140A and the second half of the sheath with the second half of the needle 140B. In one embodiment, the needle is withdrawn, split, and rolled up, and the sheath 146 is left in place within the insertion site to maintain patency of the vascular access site.

[0049] With the needle 140 withdrawn and isolated within the needle housing 130, as shown in FIG. 6F , the dilator 150 can be advanced distally over the guidewire 160, and optionally over the sheath 146, into the patient's vasculature 90 to dilate the vascular access site. The dilator 150 can be advanced by manipulating the dilator hub 152 through the flexible segments 112A, 112B and / or the crimped segments 114, as described herein. In one embodiment, the dilator hub 152 can be coupled to the distal end of a dilator advancement assembly (not shown) that extends proximally through the catheter housing 110. The user can then manipulate the dilator advancement assembly to advance or retract the dilator hub 150 through the flexible segments 112A, 112B and / or the crimped segments 114, as described herein.

[0050] As shown in FIG. 6G, with the insertion site dilated, the dilator 150 can be proximally withdrawn by manipulating the dilator hub 152 through the distal flexible section 112A or by manipulating the dilator advancement assembly, as described herein. When the dilator 150 is urged proximally into the catheter housing 110, the dilator 150 can be biased onto the dilator splitter 158. As shown in FIG. 6D, the splitter 158 can include a wedge-shaped distal tip configured to split the dilator 150 along the longitudinal axis when the dilator 150 is urged proximally onto the splitter 158. In one embodiment, the dilator 150 can further include a break line 148 to facilitate separation of the dilator 150 into two halves. In one embodiment, the splitter 158 can be urged distally by manipulating the splitter arms 156 through the proximal flexible section 112B. The two dilator halves can be displaced radially outward relative to the central axis to allow one of the catheter 170 and the guidewire 160 to pass longitudinally between the two dilator halves.

[0051] 6H, catheter 170 can be advanced distally over guidewire 160 until its distal tip enters the patient's vasculature 90. Guidewire 170 can then be unlocked using guidewire lock 126, and guidewire 170 can be withdrawn into catheter housing 110 and guidewire housing 120. Once the distal tip of guidewire 161 is positioned within catheter housing 110, guidewire lock 126 can be used to lock guidewire 160 in place.

[0052] As shown in FIG. 6I, the catheter housing 110, with the dilator 150, splitter 158, and guidewire 160 disposed therein, can be removed from the needle housing 130 and discarded. In one embodiment, the catheter housing 110 can be removed by rotating the catheter housing 110 about the central longitudinal axis 80. With the catheter housing 110 removed from the needle housing 130, the needle housing 130 can be split along the longitudinal axis into two separate halves 130A, 130B. The halves 130A, 130B can then be separated perpendicular to the longitudinal axis to disengage the catheter hub 172. In one embodiment, the needle housing 130 can include a longitudinally extending break line 138 configured to facilitate separation of the first needle housing half 130A from the second needle housing half 130B. In one embodiment, the connection 132 between the catheter housing 110 and the needle housing 130 can be configured to separate the needle housing 130 into two halves as the catheter housing 110 is rotated. For example, the distal end of the catheter housing 110 can include a cam lobe structure that engages the needle housing 130 as the catheter housing 110 rotates about its longitudinal axis. The cam lobe can provide a mechanical advantage to facilitate separation of the needle housing 130.

[0053] 6J, with the catheter housing 110 and needle housing 130 disengaged from the catheter 170, the connector set 180 can be coupled to the catheter hub 172. Each of the one or more extension legs 184 can be in fluid communication with a lumen of the catheter 170. In one embodiment, the connector set 180 can be coupled to the catheter hub 172 with an interference fit, a push fit, a snap fit, a threaded engagement, a bayonet fit, or the like.

[0054] Some specific embodiments have been disclosed herein, and while those specific embodiments have been disclosed in some detail, those specific embodiments are not intended to limit the scope of the concepts provided herein. Further adaptations and / or modifications may become apparent to those skilled in the art, and the broader aspects encompass those adaptations and / or modifications as well. Thus, departures from the specific embodiments disclosed herein may be made without departing from the scope of the concepts provided herein.

Claims

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

2. 10. The catheter placement system of claim 1, wherein the needle housing includes a needle retraction lever hingedly connected to the needle housing and configured to actuate a gear mechanism disposed within the needle retraction mechanism.

3. The catheter placement system of claim 1 or 2, wherein the needle retraction mechanism is configured to wind up a portion of the needle about an axis extending perpendicular to the longitudinal axis.

4. The catheter placement system of claim 1 , wherein the needle includes a sheath disposed on an outer surface of the needle, and one of the needle and the sheath includes a break line.

5. The catheter placement system of claim 1 , wherein the elongated medical device comprises one of a dilator, a catheter, and a guidewire.

6. 6. The catheter placement system of claim 5, wherein one of the dilator and the catheter comprises one of a polyetheretherketone (PEEK) material and a fluorinated ethylene propylene (FEP) material.

7. 7. The catheter placement system of claim 5, further comprising a dilator wedge splitter disposed within the catheter housing and configured to split the dilator along the longitudinal axis.

8. The catheter placement system according to claim 1 , wherein the catheter housing includes a flexible portion configured to elastically deform along an axis extending perpendicular to the longitudinal axis.

9. 9. The catheter placement system of claim 1, wherein the catheter housing includes an opening extending through a sidewall of the catheter housing, the opening including a flexible film barrier disposed over the opening.

10. 10. The catheter placement system of claim 1, wherein the catheter housing includes a pleat portion that is transitionable along the longitudinal axis between an extended configuration and a collapsed configuration.

11. 11. The catheter placement system of claim 1, wherein the catheter housing is configured to rotate about the longitudinal axis to detach from the needle housing and split the needle housing along the longitudinal axis.

12. 12. The catheter placement system of claim 1, wherein the catheter housing includes a blood flush indicator releasably coupled to a proximal end of the catheter housing.

13. 13. The catheter placement system of claim 5, wherein the catheter housing includes a guidewire housing extending from a proximal end of the catheter housing, the guidewire housing configured to receive a portion of a guidewire therein.

14. The catheter placement system of claim 13 , wherein a portion of one of the housing and the guidewire housing comprises a transparent material.

Images