Catheter placement system

Abstract

Disclosed herein are catheter placement systems. The catheter placement systems can include a needle, a catheter (e.g., a rapid insertion central catheter), one or more guide wires, and a reinforcement system configured to place the catheter while containing the patient-contacting portions of the catheter placement system in a sterile environment. Advantageously, the catheter placement systems can provide all of the tools necessary to access the vasculature, dilate the insertion site, and place the catheter within a single device, mitigating the need for repeated insertion of multiple tools and reducing the risk of introducing pathogens. Furthermore, the total time required to place the catheter is reduced, thereby reducing patient downtime and improving patient outcomes.

Description

[0001] Priority

[0002] This application claims priority to U.S. Provisional Application No. 63 / 106,792, filed October 28, 2020, the entire contents of which are incorporated herein by reference. TECHNICAL FIELD

[0003] The present application relates to the field of medical devices, and more particularly to a catheter placement system. SUMMARY

[0004] Embodiments disclosed herein relate to a catheter placement system having a stiffening system and methods related thereto. The catheter placement system can include a needle, a catheter (e.g., rapid insertion central catheter), one or more guide wires, and a stiffening system configured to place the catheter while containing the patient-contacting portion of the catheter placement system in a sterile environment. Advantageously, the catheter placement system can provide access to the vasculature, dilate the insertion site, and place the catheter within a single device, mitigating the need for multiple tools to be repeatedly inserted and reducing the risk of introducing pathogens, among other things. Further, the total time required to place the catheter is reduced, thereby reducing patient downtime and improving patient outcomes. Advantageously, the stiffening system can support the catheter or portions thereof disposed outside of the patient. The stiffening system can remain outside of the body when placing the catheter, and allow for more rigid materials to support the catheter.

[0005] Disclosed herein is a catheter placement system comprising: a housing defining an internal cavity and configured to maintain a sterile environment therein; a catheter defining a first lumen and including a first section, a second section, and a transition section disposed therebetween, one or both of the transition section and the second section being disposed in the sterile environment defined by the housing; and a stiffening system including a first stylet defining a stylet lumen and extending proximally into a proximal portion of the first lumen.

[0006] In some embodiments, the catheter placement system further includes a needle extending through a first side port of the catheter into a distal portion of the first lumen, a distal portion of the needle and a distal portion of the first section extending from a distal end of the housing. In some embodiments, the catheter placement system further includes a needle retraction assembly configured to withdraw the needle proximally from the first lumen and dispose the needle in a position within the internal cavity that is offset from an axis of the first lumen.

[0007] In some embodiments, the catheter placement system further includes a first guidewire advancement assembly configured to advance the first guidewire through the first side port of the catheter and through the distal portion of the first inner lumen. In some embodiments, the catheter placement system further includes a second guidewire assembly including a roller actuator configured to rotate and advance the second guidewire through the first inner lumen. In some embodiments, the reinforcement system includes a second stylet extending proximally into a proximal portion of the second inner lumen of the catheter, the second stylet including a stylet guidewire extending distally from the second stylet into the second segment of the catheter.

[0008] In some embodiments, the second inner lumen is in communication with a distal opening disposed in a sidewall of the second segment, a distal portion of the stylet guidewire is configured to selectively occlude the distal opening. In some embodiments, the catheter placement system further includes a catheter advancement assembly configured to advance the catheter distally and configured to separate the top half of the housing from the bottom half of the housing when advanced to a distal position. In some embodiments, the catheter placement system further includes a manifold including a flush hub in fluid communication with the stylet lumen, the manifold configured to support the reinforcement system. In some embodiments, the catheter placement system further includes a blood flash indicator disposed within the internal cavity and in fluid communication with the lumen of the needle.

[0009] A method of placing a catheter is also disclosed, including: providing a catheter placement system having a housing defining a sterile field and including a needle, a catheter defining a first catheter lumen, and a reinforcement system including a stylet having a stylet lumen and in fluid communication with the first catheter lumen; flushing the first catheter lumen by passing a fluid through the stylet lumen; accessing a vasculature of a patient by creating an insertion site with the needle; advancing a first segment of the catheter through the insertion site; withdrawing the needle from the lumen of the first segment; dilating the insertion site by advancing a transition segment of the catheter through the insertion site; advancing a second segment of the catheter into the vasculature; and withdrawing the reinforcement system from the first catheter lumen.

[0010] In some embodiments, the catheter includes a first segment disposed at a distal end, a transition segment extending proximally from the first segment, a second segment extending proximally from the transition segment, a hub disposed at a proximal end of the second segment, and an extension set extending proximally from the hub, the extension set including a first extension leg in fluid communication with the first catheter lumen. In some embodiments, the method further includes advancing one of the first guidewire or the second guidewire through a portion of the first inner lumen into the vasculature of the patient. In some embodiments, advancing the second segment of the catheter into the vasculature further includes separating the top half of the housing from the bottom half of the housing.

[0011] In some embodiments, the method further includes disengaging the catheter from the catheter placement system by pushing the catheter between the top half of the housing and the bottom half of the housing. In some embodiments, the method further includes a manifold having a flush hub and configured to provide fluid communication between the flush hub and the inner lumen of the needle. In some embodiments, the method further includes sliding the manifold proximally relative to the housing to withdraw the stiffening system from the first catheter lumen.

[0012] In some embodiments, the method further includes actuating a backflow actuator to provide fluid communication between the inner lumen of the needle and an internal cavity of the backflow indicator. In some embodiments, a vacuum is disposed within the internal cavity of the backflow indicator to draw fluid flow proximally through the needle lumen. BRIEF DESCRIPTION OF DRAWINGS

[0013] A more particular description of the disclosure will be presented in reference to specific embodiments thereof, as illustrated in the accompanying drawings. It should be understood that these drawings are only illustrative and are not necessarily drawn to scale. The example embodiments of the present disclosure will be described and explained with additional specificity and details by the use of the accompanying drawings in which:

[0014] Figures 1A-1B A perspective view of a catheter placement system according to embodiments disclosed herein is shown.

[0015] Figure 1C A side view of a catheter placement system according to embodiments disclosed herein is shown, with the outer housing removed for ease of illustration. Figure 1A

[0016] Figures 2A-2B A cross-sectional schematic view of a catheter according to embodiments disclosed herein is shown.

[0017] Figure 2C A close-up view of a distal portion of a catheter according to embodiments disclosed herein is shown.

[0018] Figures 3A-3C A side view of a needle insertion assembly according to embodiments disclosed herein is shown.

[0019] Figures 4A-4B A perspective view of a needle insertion assembly according to embodiments disclosed herein is shown.

[0020] Figure 5 A perspective view of a guidewire advancement assembly according to embodiments disclosed herein is shown.

[0021] Figures 6A-6I Steps in an exemplary method of use of a catheter placement system according to embodiments disclosed herein are shown.

[0022] ​Figures 7A-7D Steps in an exemplary method of use of a catheter placement system according to embodiments disclosed herein are shown, with the housing removed for ease of illustration. DETAILED DESCRIPTION

[0023] Before some particular embodiments are disclosed in more detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the particular embodiments disclosed herein can have features that can be readily separated from the particular embodiments and optionally combined with or substituted for features of any of the many other embodiments disclosed herein.

[0024] With respect to the terms used herein, it should also be understood that these terms are used to describe some particular embodiments for the purpose of aiding in understanding the concepts provided herein and are not limiting of the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are used merely to identify different features or steps in a group of features or steps and are not intended to impose an order or a numbering on the features or steps unless specifically indicated. For example, a “first,” “second,” and “third” feature or step need not necessarily appear in that order and a particular embodiment including such features or steps need not necessarily limit the features or steps to three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Rather, such terms are used to reflect, for example, relative location, orientation, or direction. The singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.

[0025] With respect to “proximal,” “proximal portion,” or “proximal end portion” of, for example, a catheter disclosed herein, it includes a portion of the catheter that is intended to be proximate to a clinician when the catheter is used on a patient. Likewise, “proximal length” of, for example, a catheter includes a length of the catheter that is intended to be proximate to a clinician when the catheter is used on a patient. For example, “proximal end” of a catheter includes an end of the catheter that is intended to be proximate to a clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter; however, the proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context suggests otherwise, the proximal portion, proximal end portion, or proximal length of a catheter is not the distal portion or distal length of the catheter.

[0026] The term "distal," "distal portion," or "distal part" of a catheter, as disclosed herein, includes the portion of the catheter intended to be close to or within the patient when used in a patient. Similarly, the term "distal length" of a catheter includes the length of the catheter intended to be close to or within the patient when used in a patient. For example, the term "distal end" of a catheter includes the tip of the catheter intended to be close to or within the patient when used in a patient. A distal portion, distal part, or distal length of a catheter may include the distal end of the catheter; however, a distal portion, distal part, or distal length of a catheter does not necessarily need to include the distal end of the catheter. That is, unless the context otherwise suggests, a distal portion, distal part, or distal length of a catheter is not the distal portion or distal length of the catheter.

[0027] In the following description, the terms “or” and “and / or” as used herein shall be interpreted as inclusive or referring to any one or any combination thereof. As an example, “A, B or C” or “A, B and / or C” means “any one of the following A, B, C; A and B; A and C; B and C; A, B and C”. Exceptions to this definition will only occur if a combination of elements, components, functions, steps, or actions is inherently mutually exclusive in some way.

[0028] like Figure 1A 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. A horizontal plane is defined by the longitudinal and lateral axes, and a vertical plane extends perpendicular to this horizontal plane.

[0029] 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.

[0030] The disclosed text generally relates to a catheter placement system (“System”) 100, including an enhanced system, and related methods thereof. In one embodiment, the catheter placement system 100 can be used to place a catheter, such as a rapid insertion central catheter (“RICC”) 190, 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 venous (PIV) catheters, peripherally inserted central catheters (PICC), central venous catheters (CVC), dialysis catheters, drainage catheters, etc., without limitation.

[0031] Figures 1A-1C An exemplary embodiment of a catheter placement system (“System”) 100 is shown. Figure 1A A perspective view of system 100 is shown before the catheter (e.g., catheter 190) is deployed. Figure 1BA perspective view of the system 100 is shown after the catheter 190 has been placed. Figure 1C A side view of the internal components of the system 100 is shown, with the external housings 110, 120 removed for ease of explanation.

[0032] The system 100 generally includes one or more external housings, such as a splittable catheter housing (“catheter housing”) 110 and a guidewire housing 120 coupled to a proximal end thereof. The system 100 also includes a needle 140, a catheter 190 such as a rapid insertion central catheter (RICC), an extension set 180, one or more guidewires 150, 160, and a reinforcement system 184, a portion of which can be disposed within an internal cavity defined by the one or more external housings 110, 120.

[0033] In one embodiment, the catheter 190 can include one or more segments configured to exhibit different mechanical properties. For example, the catheter 190 can include a first segment 130 disposed distally and a second segment 170 disposed proximally. The catheter 190 can also include a transition segment 136 disposed therebetween, as described in greater detail herein. Further, the system 100 can include a first guidewire 150 and a second guidewire 160, as described in greater detail herein.

[0034] The catheter housing 110 and the guidewire housing 120 can cooperate to define an elongated, cylindrical shape including a tapered distal portion and a substantially circular cross-sectional shape. However, it should be understood that other elongated profiles and cross-sectional shapes can also be contemplated, including triangular, square, hexagonal, polygonal, or combinations thereof. In one embodiment, a portion of the catheter housing 110 and / or the guidewire housing 120 can define a faceted surface to provide a gripping surface and facilitate manipulation of the system 100. In one embodiment, the catheter housing 110 and / or the guidewire housing 120 can include a protrusion 118 configured to provide an abutment surface for a user to facilitate manipulation of the system 100. In one embodiment, the catheter housing 110 and / or the guidewire housing 120 can be formed of a rigid or semi-rigid material, including a metal, an alloy, a polymer, a plastic, a thermoplastic, an elastomer, a rubber, a silicone rubber, a composite material, or combinations thereof, among others.

[0035] In one embodiment, the outer surface of the catheter housing 110 or the guidewire housing 120 includes a compliant material having an increased coefficient of friction, an elastomer, silicone rubber, or the like to provide a comfortable gripping surface and facilitate gripping and manipulation of the system 100. In one embodiment, the catheter housing 110 or the guidewire housing 120 or a portion thereof can be formed of a translucent or transparent material to allow a user to view structures, components, catheters, guidewires, extension sets, elongated medical devices, or the like disposed therein. As used herein, an "elongated medical device" can include the catheter 190 or a portion thereof, such as the first segment 130 or the second segment 170, the needle 140, the first guidewire 150, the second guidewire 160, one or more advancement assemblies, or combinations thereof, or the like.

[0036] In one embodiment, the catheter housing 110 can include a top housing piece 110A and a bottom housing piece 110B that releasably join along a horizontal plane. The top housing piece 110A and the bottom housing piece 110B are configured to selectively detach and disengage from the catheter 190 once the catheter 190 is placed within the vasculature 90 of a patient. In one embodiment, the housing pieces 110A, 110B can join along a longitudinal vertical plane to provide a left housing piece 110A and a right housing piece 110B or along a plane that is angled relative to the horizontal or vertical plane.

[0037] In one embodiment, the guidewire housing 120 can extend from the proximal end of the catheter housing 110 and define an internal cavity that communicates with the internal cavity of the catheter housing 110. In one embodiment, the guidewire housing 120 or a portion thereof can be formed of a transparent material to allow a user to view the catheter 190, a portion of the blood flash indicator 122 or an elongated medical device, or the like disposed therein.

[0038] The system 100 can also include an extension set manifold ("manifold") 182 disposed at the proximal end of the guidewire housing 120 and configured to slide proximally along the longitudinal axis between a distal position ( Figure 1A ) and a proximal position ( Figure 1B ). The manifold 182 can support a strengthening system 184 including one or more stylets 186 or stylet guidewires 188. The manifold 182 can include one or more tabs, wings, or protrusions configured to provide increased grip to a user to slide the manifold 182 to the proximal position and remove the strengthening system 184 from the catheter 190. The manifold 182 can include a flexible membrane barrier 114 extending between the distal end of the extension set manifold 182 and the proximal end of the guidewire housing 120 and annularly about the longitudinal axis.

[0039] In one embodiment, the barrier 114 can be formed from a thin polymer film or similar flexible material and can be configured to collapse to allow the manifold 182 to transition between the distal and proximal positions. In one embodiment, the barrier 114 or a portion thereof can be transparent to allow a user to view one or more components disposed therein, an elongated medical device, etc.

[0040] In one embodiment, the catheter housing 110, the guidewire housing 120, and / or one or more barriers (e.g., the barrier 114) can define an internal cavity configured to receive one or more elongated medical devices, a pusher assembly, etc. therein. Advantageously, the internal cavity can maintain the elongated medical devices, etc. within a sterile environment, allowing a user to manipulate the system 100 without having to directly contact the elongated medical devices. This maintains the elongated medical devices, etc. within a sterile environment and mitigates the introduction of pathogens or similar infection-causing agents.

[0041] In one embodiment, one or more flexible film barriers can be disposed within the internal cavity of the system 100 to contain one or more elongated medical devices within a sterile environment. For example, as shown in FIG. 1, a first sterile barrier 114 can include a portion of the extension set 180 and the catheter 190. A second sterile barrier 116 can include the first guidewire 150 and the needle 140 in a retracted state. These and other combinations of sterile barriers and elongated medical devices are also contemplated. Figure 1C

[0042] As shown in FIG. 1, the catheter placement system 100 can include a needle pusher assembly 144, a catheter pusher assembly 174, a first guidewire pusher assembly 154, and a second guidewire pusher assembly 164. In one embodiment, the system 100 can include a rapid insertion central catheter ("RICC") 190. The catheter 190 can be disposed within an internal cavity formed by the catheter housing 110 and the guidewire housing 120. The catheter 190 can be coupled with the catheter pusher assembly 174, and both the catheter 190 and the catheter pusher assembly 174 can slide along a longitudinal axis relative to the catheter housing 110 or the guidewire housing 120. Figure 1C

[0043] The catheter pusher assembly 174 can be coupled with a catheter actuator 172 disposed on an outer surface of the catheter housing 110. Transitioning the catheter actuator 172 between a proximal position (FIG. 1) and a distal position (FIG. 2) can transition the catheter pusher assembly 174 and the catheter 190 between a retracted position and an extended position. In use, a user can manipulate the catheter actuator 172 to advance the catheter 190 or similar catheter device into the vasculature 90. Figure 1A Figure 1B

[0044] Figures 2A-2B ​​​​Further details of an exemplary catheter 190 are shown. The catheter 190 can include a first section 130 disposed at a distal end of the catheter 190 and a second section 170 disposed proximally. In one embodiment, the catheter 190 can also include a transition section 136 disposed between the first section 130 and the second section 170.

[0045] In one embodiment, the catheter 190 can also include a hub 192 disposed at a proximal end of the second section 170. The catheter 190 can also include an extension set 180 extending proximally from the hub 192 and including one or more extension legs each in communication with an inner lumen of the catheter 190. For example, a first extension leg 180A can be in communication with a first inner lumen 194A, a second extension leg 180B can be in communication with a second inner lumen 194B, and a third extension leg 180C can be in communication with a third inner lumen 194C. Each extension leg can include a connector, such as a luer lock or the like, disposed at a proximal end thereof. The connector can be configured to couple the extension leg with a syringe, a medical fluid line, or the like to provide fluid communication with the inner lumen.

[0046] In one embodiment, each inner lumen 194 can be in communication with a distal opening 196. For example, the first inner lumen 194A can extend from the first extension leg 180A, through the hub 192, the second section 170, and the transition section 136, to a first distal opening 196A disposed at a distal tip of the first section 130. In one embodiment, one of the second inner lumen 194B or the third inner lumen 194C can extend from the second extension leg 180B or the third extension leg 180C, respectively, through the hub 192 to the second section 170 and in communication with a respective second distal opening 196B or third distal opening 196C disposed in a sidewall of the second section 170. In one embodiment, one of the distal openings 196A, 196B, 196C can be disposed in the transition section 136.

[0047] In one embodiment, the catheter 190 can include one or more side entries ("side ports") 132 extending through a sidewall of one of the first section 130, the transition section 136, or the second section 170 and in communication with one of the first inner lumen 194A, the second inner lumen 194B, or the third inner lumen 194C. For example, the first section 130 can include a first side port 132A. The needle 140 or the first guidewire 150 can extend through the first side port 132A and through a distal portion of the first inner lumen 194A, through the first distal opening 196A, to extend distally of the distal tip of the catheter 190.

[0048] In one embodiment, the first section 130 can define a relatively smaller diameter than the second section 170. In one embodiment, the first section 130 can define a relatively more rigid, more elastic, or stiffer durometer than the second section 170. As such, one or both of the first section 130 and the transition section 136 can provide greater columnar strength relative to the second section 170. In one embodiment, the first section 130 can define a single lumen and define a diameter similar to that of a peripheral intravenous (PIV) catheter. In one embodiment, the second section 170 can define two or more lumens and define a diameter similar to that of a central venous catheter (CVC). The first section 130 can also include a tapered tip that tapers from the diameter of the first section 130 to the diameter of the needle 140 distally to facilitate insertion of the first section 130 through an access site formed by the needle 140. In one embodiment, the transition section 136 can define a tapered or truncated conical shape that extends from the diameter of the first section 130 to the diameter of the second section 170.

[0049] Advantageously, the first section 130 can more easily access the vasculature due to the relatively smaller diameter. Furthermore, if an incorrect blood vessel is accessed, it is easier to remove the first section 130 and close the access site due to the smaller size of the access site. If the correct blood vessel is accessed, the catheter 190 can be pushed distally such that the transition section 136 is pushed through the access site to expand the access site from the diameter of the first section 130 to the diameter of the second section 170. As the catheter 190 is pushed into the vasculature 90, the reinforcement system 184 can support a portion of the catheter 190, such as the second section 170, the hub 192, or the extension set 180, among others. In one embodiment, the catheter 190 or some sections thereof can be formed from plastic, polymer, elastomer, urethane, polyether ether ketone (PEEK), fluorinated ethylene propylene (FEP), or similar suitable materials. Advantageously, the reinforcement system 184 can be formed from a rigid or elastic material and can support the catheter 190 or some sections thereof that remain outside the patient as the catheter 190 is advanced into the vasculature. The catheter 190 can be advanced while the reinforcement system 184 remains stationary, allowing the reinforcement system to support the portions of the catheter 190 that remain outside the patient. Alternatively, the reinforcement system 184 can be withdrawn proximally to completely remove the reinforcement system 184 from the catheter 190. Since a portion of the reinforcement system 184, such as the stylet 186, remains outside the patient, it can be formed from a more rigid material and provide greater columnar support to the catheter 190.

[0050] Figure 2BAn exemplary catheter 190 is shown that includes a needle 140 and a first guidewire 150 that enters the lumen of the first section 130 (i.e., the distal portion of the first lumen 194A) through a first side port 132A that extends through the sidewall of the catheter 190. The catheter 190 can also include a second guidewire 160 that enters the first lumen 194A of the second section 170 of the catheter 190 through a second side port 132B. In one embodiment, the second guidewire 160 can enter the first lumen 194A through the first extension leg 180A. Once the needle 140 and the first guidewire 150 are removed, the second guidewire 160 can be advanced through the first lumen 194A, through the first distal opening 196A into the vasculature 90 to facilitate advancement of the second section 170 into the vasculature 90.

[0051] The catheter placement system 100 can also include a reinforcement system 184 that includes one or more support stylets ("stylets") 186 that extend distally from the manifold 182. In one embodiment, the stylets 186 can also include a guidewire 188 that extends from the distal end thereof. As described herein, the stylets 186 remain outside the patient and can be formed of a substantially rigid or elastic material. The stylet guidewire 188 can be formed of a relatively more flexible material or exhibit more flexible properties relative to the stylets 186. In this manner, the reinforcement system 184 can provide additional support or reinforcement properties to the catheter 190 during placement. In one embodiment, one of the stylets 186 and optionally the stylet guidewire 188 remains stationary relative to the system 100 as the catheter 190 is advanced distally. In this manner, the reinforcement system 184 is passively withdrawn from the catheter 190 as the catheter 190 is placed, at least the stylets 186 and optionally the stylet guidewire 188 remain outside the patient and support the portion of the catheter 190 that remains outside the patient. In this manner, the reinforcement system 184 can exhibit more rigid mechanical properties and can provide increased columnar support during placement. The reinforcement system 184 can be removed proximally during placement or after the catheter 190 has been placed.

[0052] In one embodiment, the reinforcement system 184 can include a first stylet 186A that extends distally into the lumen of the first extension leg 180A (i.e., the proximal portion of the first lumen 194A), a second stylet 186B that extends distally into the lumen of the second extension leg 180B, and a third stylet 186C that extends distally into the lumen of the third extension leg 180C. Further, in one embodiment, one of the second stylet 186B or the third stylet 186C can include a guidewire 188 that extends distally therefrom through the lumen 194 of the hub 192 and the second section 170.

[0053] In one embodiment, as Figure 2CAs shown, as the second section 170 is advanced toward a target location within the vasculature 90, a distal portion of the stylet guidewire 188 can occlude the distal opening 196 to prevent fluid from entering the inner lumen 194. It is noted that the second guidewire 160 can extend through the first inner lumen 194A and can be configured to occlude the first opening 196A to similarly prevent fluid from entering the first inner lumen 194A as the second section 170 is advanced toward a target location within the vasculature 90.

[0054] In one embodiment, the one or more support stylets 186 can define a stylet lumen that is in fluid communication with the inner lumen of the flush hub 106. Fluid can be introduced at the flush hub 106 and pass through the manifold 182, through the inner lumens of the support stylets 186, and into the inner lumen 194 of the catheter 190 to flush the catheter 190 and clear any gas from the catheter 190 prior to placement.

[0055] With continued reference to Figures 1A-1C In one embodiment, the catheter placement system 100 can include a needle 140 coupled to a needle retraction assembly 144 disposed within an interior cavity of the catheter housing 110. The needle 140 and the needle retraction assembly 144 can be slidably engaged with the catheter housing 110 and can be changed between an extended position Figure 1A ) and a retracted position Figure 1B ). The needle retraction assembly 144 can be coupled with a needle actuator 142 disposed on an outer surface of the catheter housing 110. Changing the needle actuator 142 between a distal position Figure 1A ) and a proximal position Figure 1B ) can change the needle assembly 144 and the needle 140 between the extended position and the retracted position. In use, a user can manipulate the needle actuator 142 and retract the needle 140 into the catheter housing 110. Advantageously, the system 100 retains the needle 140 within the catheter housing 110 after use, mitigating accidental needle stick injuries or contamination from fluids disposed on the needle 140 (e.g., blood).

[0056] Figures 3A-3C Further details of the needle retraction assembly 144 are shown. The needle 140 can extend through the first side port 132A and can be disposed within an inner lumen of the first section 130. A proximal end of the needle 140 can be coupled to the needle retraction assembly 144 that is coupled with the needle retraction actuator 142. As Figures 3A-3B shown, proximally retracting the needle retraction actuator 142 can proximally retract the needle 140 through the side port 132A, removing the needle 140 from the first inner lumen 194A.

[0057] In one embodiment, as Figures 3A-3B and Figures 4A-4BAs shown, the needle retraction actuator 142 can be slidably engaged with the needle retraction assembly 144 along the transverse axis. In this way, as the needle 140 is retracted proximally, the needle 140 can move laterally upward, away from the central axis of the first lumen 194A. Advantageously, the lateral movement of the needle 140 can allow for unobstructed passage of another elongated medical device, such as the second guidewire 160, to advance through the first lumen 194A.

[0058] In one embodiment, as shown in FIG. 1, the system 100 can further include a side port obturator 134 slidably engaged with the system 100 along the transverse axis and can be configured to close the side port 132, such as the first side port 132A, once the needle 140 is removed from the side port 132. The side port obturator 134 can be biased toward a closed position such that once the needle 140 is fully removed from the side port 132, the side port obturator 134 changes to the closed position. Figures 3B-3C Advantageously, the side port obturator 134 can prevent any fluid from leaking out of the first lumen 194A when the needle 140 is removed. Figure 3C

[0059] With continued reference to FIG. 1, the guidewire housing 120 can include one or more guidewire advancement assemblies. In one embodiment, the guidewire housing 120 can include a first guidewire 150 coupled to a first guidewire advancement assembly 154. The first guidewire 150 and the first guidewire advancement assembly 154 can be slidably engaged with the guidewire housing 120. The first guidewire advancement assembly 154 can transition between a proximal position and a distal position. The first guidewire advancement assembly 154 can be coupled with a first guidewire actuator 152 disposed on an outer surface of the guidewire housing 120. Changing the first guidewire actuator 152 between the proximal position and the distal position can change the first guidewire advancement assembly 154 and the first guidewire 150 between a retracted position and an extended position. In use, a user can manipulate the first guidewire actuator 152 to advance the first guidewire 150 into the vasculature 90, as described in greater detail herein. Figures 1A-1C In one embodiment, the guidewire housing 120 can further include a second guidewire 160 coupled to a second guidewire advancement assembly 164 and slidably or rotatably engaged with the guidewire housing 120. The second guidewire advancement assembly 164 can change the second guidewire 160 between a retracted position and an extended position. The second guidewire advancement assembly 164 can be coupled with a second guidewire actuator 162 disposed on an outer surface of the guidewire housing 120. In one embodiment, the second guidewire actuator 162 can be a roller rotatably coupled with the guidewire housing 120. A portion of the roller can extend through a sidewall of the guidewire housing 120. Rotating the second guidewire actuator 162 can extend or retract the second guidewire 160 along the longitudinal axis.

[0060]

[0061] ​​Figure 5 Further details of the roller actuator 162 of the second guidewire advancement assembly 164 are shown. The second guidewire actuator 162 can be coupled with one or more gears, wheels, or similar mechanisms configured to grip or compress the second guidewire 160 therebetween and convert rotational motion of the second guidewire actuator 162 into longitudinal motion of the guidewire 160.

[0062] With continued reference to Figures 1A-1C In one embodiment, the catheter placement system 100 can also include a flashback indicator 122. The flashback indicator 122 can include a tube or similar structure formed of a transparent material and can be disposed within the guidewire housing 120. As described above, the guidewire housing 120 can be made of a transparent material so that a user can observe the flashback indicator 122 disposed therein.

[0063] In one embodiment, the flashback indicator 122 can define an internal cavity configured to maintain a vacuum therein. The flashback indicator 122 can be in fluid communication with the lumen of the needle 140 through a communication tube 124 or similar structure. When the distal tip of the needle 140 enters the vasculature 90 of a patient, fluid (e.g., blood) can flow proximally into the flashback indicator 122 for observation by a user. In one embodiment, a vacuum disposed within the flashback indicator 122 can draw fluid (e.g., blood) proximally through the needle lumen and into the flashback indicator 122. A user can then observe the color or pulsatile flow characteristics to confirm vascular access. In one embodiment, the system 100 can include a flashback actuator 126. Actuation of the flashback actuator 126 can open a valve or similar structure to place the vacuum disposed within the flashback indicator 122 in fluid communication with the needle lumen to draw fluid proximally through the needle lumen. In one embodiment, the flashback indicator 122 can also include a pump configured to be actuated by a user to create a vacuum within the flashback indicator 122. For example, repeated actuation of the flashback actuator 126 can actuate the pump and create a vacuum within the flashback indicator 122 to draw fluid proximally through the needle lumen.

[0064] In one embodiment, the system 100 also includes a cap 108 configured to couple with the distal end of the catheter housing 110 and cover the distal portion of the needle 140 or one of the first segments 130 of the catheter 190. The cap 108 can mitigate accidental needle stick injuries during storage or transport and maintain the needle 140 or the like in a sterile environment.

[0065] In one exemplary method of use, as Figures 6A-6I shown, a catheter placement system 100 is provided as described herein. First, as Figure 6AAs shown, a user can couple a syringe or medical fluid line to a flushing bushing 106 disposed proximally at the catheter placement system 100. The flushing bushing 106 extends from the proximal surface of the manifold 182, as illustrated. The manifold 182 provides fluid communication between the flushing bushing 106 and one or more needles 186 partially disposed within an extension leg of the extension kit 180. Flushing fluid through the manifold 182, the needles 186, and into the lumen 194 of the catheter 190 purges any air from the catheter 190, preparing it for placement within the vascular system 90. The catheter placement system cap 108 is removable from the catheter housing 110.

[0066] like Figures 6A-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 the components for placing the catheter 190, namely, the needle 140, blood return indicator 122, catheter 190, first guidewire 150, second guidewire 160, reinforcement system 184, etc., all contained in a single sterile unit. This keeps all components that might be exposed to the patient in a sterile environment, and in contrast to existing procedures that require repeated insertion of multiple components, posing a risk of introducing pathogens, etc. Furthermore, the catheter placement system 100 maintains a barrier between the user and the components that come into contact with the patient, thereby reducing exposure to the patient's blood.

[0067] like Figure 6B As shown, when the needle tip 141 enters the vascular system 90, blood flow can flow proximally through the needle lumen to the return blood indicator 122. In one embodiment, a clinician can actuate the return blood actuator 126 and provide fluid communication between the vacuum disposed within the return blood indicator 122 and the needle lumen. Optionally, actuation or repeated actuation of the return blood actuator 126 can create a vacuum within the return blood indicator 122. The vacuum can draw blood through the needle lumen and into the return blood indicator 122. The user can then observe the color and pulsating flow characteristics of the fluid disposed within the return blood indicator 122 to confirm the correct vascular pathway. For example, bright red or strong pulsating flow indicates arterial entry, while dark red and low pulsating flow indicates venous entry. Optionally, the user can compress the flexible return blood indicator tube 122 to guide blood flow therein. As shown in the figure, both the blood return indicator 122 and the guidewire housing 120 in which the blood return indicator 122 is disposed may include transparent material to allow the user to observe the blood flow therein.

[0068] In one embodiment, after confirming correct vascular access, the user can actuate the first guidewire actuator 152 to advance the first guidewire 150 through the needle lumen and into the patient's vascular system 90 until the distal end of the first guidewire 150 extends distal to the needle tip 141 within the vascular system 90. In one embodiment, as the needle enters the vascular system, the distal end of the first segment 130 may advance into the vascular system along with the needle 140. The distal end of the first segment 130 may be positioned on and tightly fitted to the outer surface of the needle 140 to prevent the propulsion of fluid, blood, or tissue between the needle 140 and the first segment 130 as the needle enters the vascular system.

[0069] like Figure 6C As shown, with the first segment 130 of catheter 190 positioned within the vascular system 90, a clinician can actuate needle retraction actuator 142 to retract needle 140 into catheter housing 110. Advantageously, needle 140 may be contained within catheter housing 110 to mitigate accidental needlestick injury and prevent contamination from fluid disposed thereon. In one embodiment, a clinician can actuate first guidewire actuator 152 to retract first guidewire 150 into catheter housing 110. Advantageously, when needle 140 is retracted, first guidewire 150 may provide columnar support to the first segment 130. In one embodiment, after needle 140 retraction, catheter placement system 100 may advance distally to further advance the first segment 130 into vascular system 90. As system 100 advances distally, first guidewire 150 may provide columnar support to the first segment 130. Once the first segment 130 has been advanced into the vascular system, the first guidewire 150 can be retracted. In one embodiment, the needle 140 and the first guidewire 150 can be retracted simultaneously.

[0070] like Figure 6D As shown, in one embodiment, a clinician can actuate the catheter actuator 172 from a first position to a second position to further advance the first segment 130 of the catheter 190 into the vascular system 90. As illustrated, the catheter housing 110 may include a first notch 176A disposed in the first position, a second notch 176B disposed in the second position, and a third notch 176C disposed in the third position. Each notch 176 may be configured to capture the catheter actuator 172 as it slides through the notch 176 to provide some resistance to further longitudinal movement. Thus, the notch 176 may provide tactile feedback to the user to indicate when the catheter actuator 172 is positioned in one of the first, second, or third positions. As described herein, the reinforcement system 184 remains stationary relative to the housings 110, 120 as the catheter 190 advances distally. Thus, the reinforcement system is passively removed from the catheter 190 as the catheter 190 advances.

[0071] like Figure 6E As shown, in one embodiment, a clinician can actuate the second guidewire actuator 162 to advance the second guidewire 160 through the first segment 130 of the catheter 190 and into the vascular system 90. The distal end of the second guidewire 160 can be advanced distally from the distal end of the first segment 130 to a target location within the vascular system 90. In one embodiment, the manifold 182 can be proximally pushed to disengage from the proximal end of the guidewire housing 120, and the reinforcement system 184 can be retracted proximally. As described above, the foldable membrane barrier 114 extending between the manifold 182 and the guidewire housing 120 can retain the reinforcement system 184 within a sterile environment within the internal lumen of the catheter placement system 100.

[0072] like Figure 6F As shown, in one embodiment, the catheter actuator 172 can be advanced distally from a second position at the second notch 176B to a third position at the third notch 176C to advance the transition section 136 and the second section 170 into the vascular system 90. The transition section 136 can expand the insertion site to allow the second section 170 into the vascular system 90.

[0073] like Figure 6G As shown, in one embodiment, with the catheter actuator 172 positioned in the third position, the catheter advancement assembly 174 engages a cam structure disposed on the inner surface of the catheter housing 110 and is configured to separate the top catheter housing member 110A from the bottom catheter housing member 110B. Furthermore, the manifold 182 can be completely retracted proximally to completely disengage the reinforcement system 184 from the catheter 190.

[0074] like Figure 6H As shown, in one embodiment, a clinician can actuate the second guidewire actuator 162 to retract the second guidewire 160 from the catheter 190 and into the guidewire housing 120. Furthermore, the top housing member 110A and the bottom housing member 110B can be further separated by the clinician to allow the bushing 192 and the extension kit 180 to be removed from the catheter housing 110.

[0075] like Figure 6I As shown, in one embodiment, with the catheter 190 placed at a target location within the vascular system 90, the catheter housing 110 can disengage the catheter 190 and the extension kit 180. The catheter 190 can then be stabilized near the insertion site, and a syringe or medical fluid line can be coupled to the extension kit.

[0076] Figures 7A-7D The movement of internal components of the catheter placement system 100 is shown, with the outer casing removed for ease of explanation. In one embodiment, as... Figure 7AThe needle tip 141 is shown advanced into the vasculature 90 to allow blood to flow to the flashback indicator 122 through the communication tube 124 that provides fluid communication between the needle lumen and the flashback indicator 122. Figure 7B The first guidewire actuator 152 is shown advanced to advance the first guidewire 150 through the lumen of the needle 140 and into the vasculature 90. Figure 7C The needle actuator 142 is shown withdrawn to withdraw the needle 140 from the lumen of the first section 130. Figure 7D The first guidewire actuator 152 is shown withdrawn proximally to withdraw the first guidewire 150.

[0077] While certain specific embodiments have been disclosed herein, and while the specific embodiments have been disclosed in some detail for the purposes of illustration and by way of example, it is contemplated that additional adaptations and / or modifications will readily occur to those skilled in the art. Therefore, it is the intent that the scope of the concepts provided herein be limited only by the claims that follow.

Claims

1. A catheter placement system, characterized by, including: a housing defining an internal cavity and configured to maintain a sterile environment therein; a catheter defining a first inner lumen and including a first section, a second section, and a transition section disposed between the first section and the second section, one or both of the transition section and the second section being disposed within the sterile environment defined by the housing; and a reinforcement system including a first stylet defining a stylet lumen and extending proximally into a proximal portion of the first inner lumen, wherein the reinforcement system includes a second stylet extending proximally into a proximal portion of a second inner lumen of the catheter, the second stylet including a stylet guidewire extending distally from the second stylet into the second section of the catheter.

2. The catheter placement system of claim 1, wherein, further including a needle extending through a first side port of the catheter into a distal portion of the first inner lumen, a distal portion of the needle and a distal portion of the first section extending from a distal end of the housing.

3. The catheter placement system of claim 2, wherein, further including a needle retraction assembly configured to retract the needle proximally from the first inner lumen and dispose the needle in a position within the internal cavity that is offset from an axis of the first inner lumen.

4. The catheter placement system of claim 2, wherein, further including a first guidewire advancement assembly configured to advance a first guidewire through the first side port of the catheter and through the distal portion of the first inner lumen.

5. The catheter placement system of claim 4, wherein, further including a second guidewire advancement assembly including a roller actuator configured to rotate and advance a second guidewire through the first inner lumen.

6. The catheter placement system of claim 1, wherein, the second inner lumen being in communication with a distal opening disposed in a sidewall of the second section, a distal portion of the stylet guidewire being configured to selectively occlude the distal opening.

7. The catheter placement system of claim 1, wherein, further including a catheter advancement assembly configured to advance the catheter distally and configured to separate a top half of the housing from a bottom half of the housing when advanced to a distal position.

8. The catheter placement system of claim 1, wherein, further including a manifold including a flush hub in fluid communication with the stylet lumen, the manifold being configured to support the reinforcement system.

9. The catheter placement system of claim 2, wherein, further including a backflow indicator disposed within the internal cavity and in fluid communication with an inner lumen of the needle.

10. A catheter placement system characterized by, including: a housing defining an internal cavity and configured to maintain a sterile environment therein; a catheter defining a first inner lumen and including a first section, a second section, and a transition section disposed between the first section and the second section, one or both of the transition section and the second section being disposed within the sterile environment defined by the housing; a reinforcement system including a first stylet defining a stylet lumen and extending proximally into a proximal portion of the first inner lumen; a needle extending through a first side port of the catheter into a distal portion of the first inner lumen, a distal portion of the needle and a distal portion of the first section extending from a distal end of the housing; a first guidewire advancement assembly configured to advance a first guidewire through the first side port of the catheter and through the distal portion of the first inner lumen; and a second guidewire advancement assembly including a roller actuator configured to rotate and advance a second guidewire through the first inner lumen. a second guidewire advancement assembly including a roller actuator configured to rotate and advance a second guidewire through the first inner lumen.

11. The catheter placement system of claim 10, wherein, a needle retraction assembly configured to withdraw the needle proximally from the first inner lumen and dispose the needle in a position within the internal cavity that is offset from an axis of the first inner lumen.

12. The catheter placement system of claim 10, wherein, a catheter advancement assembly configured to advance the catheter distally and configured to separate a top half of the housing from a bottom half of the housing when advanced to a distal position.

13. The catheter placement system of claim 10, wherein, a manifold including a flush hub in fluid communication with the inner needle lumen, the manifold configured to support the reinforcement system.

14. The catheter placement system of claim 10, wherein, a backflow indicator disposed within the internal cavity and in fluid communication with the inner lumen of the needle.

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