Catheter placement system

Abstract

The utility model relates to a catheter placement system. A catheter placement assembly with automatic guidewire disengagement may include a handle and sealed housing assembly defining a needle lumen and a guidewire lumen. Upon entry into the vasculature, the guidewire is advanced through the handle guidewire lumen to a target location. The needle is proximally withdrawn with a first force through the handle needle lumen. The sealing housing locks to the needle tip when the needle tip is withdrawn into the sealing housing. Applying a greater second force urges the seal housing out of engagement with the handle. The sealed housing is held in place by a stop device and / or a timing lock mechanism. When the sealed housing is pushed proximally, the support pin holds the guidewire in place, causing the guidewire to automatically disengage from the sealed housing. The sealed housing mitigates needle stick injuries and allows the needle and sealed housing assembly to be removed, thereby allowing the catheter to be advanced unhindered on the guidewire.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 465,942, filed on May 12, 2023, which is incorporated by reference in its entirety into this application. Technical Field

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

[0004] A central venous catheter ("CVC") is typically introduced into a patient and advanced through the patient's vascular system to achieve placement using the Seldinger technique. The Seldinger technique utilizes multiple steps and medical devices (e.g., needles, scalpels, guidewires, introducer sheaths, dilators, CVCs, etc.). Although the Seldinger technique is effective, the multiple steps are time consuming, handling multiple medical devices is difficult, and both of the aforementioned can cause patient injury. In addition, since multiple medical devices need to be replaced during the Seldinger technique, there is a relatively high likelihood of contact contamination. Therefore, there is a need to reduce the multiple steps and medical devices involved in introducing a catheter (such as a CVC) into a patient and advancing the catheter through the patient's vascular system.

[0005] Disclosed herein are rapidly insertable central catheter ("RICC") insertion assemblies, introducer needle assemblies, and methods that address the aforementioned problems. Notably, such RICC insertion assemblies, introducer needle assemblies, and methods include needle stick protection, as described below. Utility Model Content

[0006] The present invention discloses a catheter placement system comprising: a catheter; a needle supported by a needle hub and extending distally to the needle tip, the needle defining an inner cavity; a guidewire; a sealing housing comprising a tip shield capable of transitioning between a locked position and an unlocked position; a tether extending between the needle hub and the sealing housing; a handle defining a recess and configured to slidably receive the sealing housing therein, wherein the handle and the sealing housing cooperate to define a handle needle inner cavity and a handle guidewire inner cavity; and a detent configured to retain the sealing housing in the recess when a first force is applied to the needle, and configured to deflect radially outward when a second force is applied to allow the sealing housing to disengage from the handle.

[0007] In some embodiments, the first force is less than a threshold force required to deflect the detent, and the second force is equal to or greater than the threshold force.

[0008] In some embodiments, one or both of the first force and the second force pushes the needle in a proximal direction.

[0009] In some embodiments, the tip shield in the locked position prevents distal movement of the tip of the needle relative to the seal housing, the tip shield being biased toward the locked position.

[0010] In some embodiments, the seal housing further comprises a slot extending between an outer surface of the seal housing and one or both of the handle needle lumen and the handle guidewire lumen and configured to allow a portion of the guidewire to pass therethrough when the seal housing is disengaged from the handle.

[0011] In some embodiments, the handle needle lumen extends between the distal and proximal ends of the handle and seal housing assembly and is configured to slidably receive a portion of the needle therein, and the handle guidewire lumen is connected to the handle needle lumen and extends from the handle needle lumen at a certain angle.

[0012] In some embodiments, the seal housing includes a seal formed of a compliant material and defining a fluid tight seal extending around a junction between the handle needle lumen and the handle guidewire lumen.

[0013] In some embodiments, the needle includes a guidewire bore that communicates with the needle lumen and is configured to align with the handle guidewire lumen when the needle hub engages the proximal end of the handle.

[0014] In some embodiments, the needle further comprises a slot extending between the guidewire hole and the needle tip.

[0015] In some embodiments, the catheter is a RICC and further includes a blood flash system coupled to the needle hub.

[0016] In some embodiments, the catheter placement system further comprises a support pin disposed in the handle and against a portion of the guidewire to support the guidewire. When the seal housing is pushed proximally, the support pin causes the guidewire to automatically disengage from the seal housing.

[0017] In some embodiments, the tether is configured to allow the needle hub to be withdrawn proximally up to a predetermined distance (d), wherein the tether prevents further proximal movement relative to the seal housing beyond the predetermined distance (d).

[0018] The present invention also discloses a method for placing a catheter, comprising: forming an insertion site using a needle supported by a needle hub; advancing a guidewire to a target location through a handle guidewire lumen of the handle; withdrawing the needle proximally through the handle needle lumen until the distal tip is located within a sealing housing, the sealing housing defining a junction between the handle needle lumen and the handle guidewire lumen; transitioning a tip shield to a locked position to prevent further distal movement of the needle tip relative to the sealing housing; and advancing the needle proximally to deflect a stop radially outward and disengage the sealing housing from the handle.

[0019] In some embodiments, withdrawing the needle proximally further comprises applying a first proximal force, and pushing the needle proximally to deflect the stop comprises a second proximal force greater than the first proximal force and equal to or greater than a threshold force required to deflect the stop.

[0020] In some embodiments, the seal housing is slidably engaged within a recess defined by the handle, and when the first proximal force is applied, the stop device abuts a portion of the seal housing to retain the seal housing within the recess.

[0021] In some embodiments, the step of proximally advancing the needle advances a portion of the guidewire disposed within the handle guidewire lumen through a slot extending between the handle guidewire lumen and an outer surface of the seal housing.

[0022] In some embodiments, the method further includes a tether extending between the needle hub and the seal housing and configured to prevent further proximal movement of the needle hub relative to the seal housing beyond a predetermined distance (d).

[0023] The present invention also discloses a catheter placement system comprising: a needle defining a needle lumen extending between a needle hub and a needle tip; a guidewire; a sealing housing; a tether extending between the needle hub and the sealing housing; a handle defining a recess and configured to slidably receive the sealing housing therein, wherein the handle and the sealing housing cooperate to define a handle needle lumen and a handle guidewire lumen; an end shield capable of transitioning between an unlocked position and a locked position; and a timing lock disposed within the sealing housing and capable of transitioning between a first position and a second position, wherein in the first position, the timing lock is configured to prevent movement of the sealing housing relative to the handle, and wherein in the second position, the timing lock is configured to allow the sealing housing to slide relative to the handle.

[0024] In some embodiments, the time lock is biased toward the second position and is retained in the first position by a portion of the needle being disposed in a distal portion of the handle needle lumen.

[0025] In some embodiments, the time lock is configured to transition from a first position to a second position when the needle tip is disposed within the sealed housing.

[0026] In some embodiments, the time lock in the second position allows the needle and seal housing assembly to be disengaged from the guidewire and handle assembly.

[0027] In some embodiments, the catheter placement system also includes a support pin, which is connected to the handle and is configured to support the guide wire when the seal housing slides proximally relative to the handle. When the seal housing is pushed proximally, the support pin automatically disengages the guide wire from the seal housing. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] A more specific description of the disclosure will be presented by reference to the specific embodiments of the disclosure shown in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the utility model and are therefore not to be considered as limiting the scope of the utility model. The exemplary embodiments of the utility model will be described and explained by using the accompanying drawings with additional particularity and detail.

[0029] Figure 1A A perspective view of a catheter placement system in a deployed configuration is shown according to embodiments disclosed herein.

[0030] Figure 1B A plan view of a catheter placement system in accordance with embodiments disclosed herein is shown in a collapsed configuration ready for use.

[0031] Figure 2 FIG. 1 shows an embodiment of the present disclosure in an expanded configuration. Figure 1A Side view of a catheter of the catheter placement system.

[0032] Figure 3A The embodiment disclosed herein is shown Figure 2 Close-up detail of the distal portion of the catheter.

[0033] Figure 3B and Figure 3C The embodiment disclosed herein is shown Figure 3A Cross-sectional view of a catheter.

[0034] Figure 4A Shown is a perspective view of a handle, needle, and guidewire assembly according to embodiments disclosed herein.

[0035] Figure 4B A longitudinal cross-sectional view of a handle, needle, and guidewire assembly according to embodiments disclosed herein is shown.

[0036] Figure 5A A perspective view of a needle and seal housing assembly disengaged from a guidewire and handle assembly is shown according to embodiments disclosed herein.

[0037] Figure 5BA longitudinal cross-sectional view of a needle and seal housing assembly disengaged from a guidewire and handle assembly is shown in accordance with embodiments disclosed herein.

[0038] FIG. 6A to FIG. 6D An exemplary method of using a catheter placement system including a handle with a tip shield mechanism according to embodiments disclosed herein is shown.

[0039] FIG. 7A to FIG. 7C An exemplary method of using a catheter placement system including a time lock mechanism according to embodiments disclosed herein is shown. DETAILED DESCRIPTION

[0040] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiments, and these features may be optionally combined with or replace the features of any of the many other embodiments disclosed herein.

[0041] About the terms used herein, it should also be understood that these terms are for the purpose of describing some specific embodiments, and these terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a set of features or steps, and do not provide sequence or numerical restrictions. For example, "first", "second" and "third" features or steps do not necessarily appear in this order, and the specific embodiments including such features or steps are not necessarily limited to these three features or steps. In addition, unless otherwise specified, any feature or step in the aforementioned features or steps and then can also include one or more features or steps. For convenience, using labels such as "left", "right", "top", "bottom", "front", "back", etc., these labels are not intended to imply, for example, any specific fixed position, orientation or direction. On the contrary, such labels are used to reflect, for example, relative position, orientation or direction. The singular forms of "a kind of", "one" and "the" include plural references, unless the context clearly specifies otherwise.

[0042] In the following description, the terms "or" and "and / or" as used herein should be interpreted as inclusive or meaning any one or any combination. As an example, "A, B or C" or "A, B and / or C" means "any of the following: A; B; C; A and B; A and C; B and C; A, B and C". An exception to this definition will only occur if the combination of elements, parts, functions, steps or actions are inherently mutually exclusive in some way.

[0043] With respect to "proximal", for example, a "proximal portion" or "proximal segment" of a catheter includes a portion or segment of the catheter that is intended to be placed near a clinician when the catheter is used for a patient. Similarly, for example, a "proximal length" of a catheter includes a length of the catheter that is intended to be placed near a clinician when the catheter is used for a patient. For example, the "proximal end" of a catheter includes the end of the catheter that is intended to be placed near a clinician when the catheter is used for a patient. The proximal portion, proximal segment, or proximal length of a catheter may include the proximal end of the catheter; however, the proximal portion, proximal segment, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context otherwise indicates, the proximal portion, proximal segment, or proximal length of a catheter is not the terminal portion or terminal length of a catheter.

[0044] With respect to "distal", for example, a "distal portion" or "distal segment" of a catheter includes a portion or segment of the catheter that is intended to be placed near or in the patient when the catheter is used in a patient. Similarly, for example, a "distal length" of a catheter includes a length of the catheter that is intended to be placed near or in the patient when the catheter is used in a patient. For example, the "distal end" of a catheter includes the end of the catheter that is intended to be placed near or in the patient when the catheter is used in a patient. The distal portion, distal segment, or distal length of a catheter may include the distal end of the catheter; however, the distal portion, distal segment, or distal length of a catheter does not need to include the distal end of the catheter. That is, unless the context otherwise indicates, the distal portion, distal segment, or distal length of a catheter is not the terminal portion or terminal length of a catheter.

[0045] To help describe the embodiments described herein, Figure 1A As shown, the longitudinal axis extends substantially parallel to the axial length of the catheter. The lateral axis extends perpendicular to the longitudinal axis, and the transverse axis extends perpendicular to both the longitudinal axis and the lateral axis. A horizontal plane can be defined by the lateral axis and the longitudinal axis. A vertical plane extends perpendicular to the horizontal plane.

[0046] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art.

[0047] Figure 1A to Figure 1B A catheter placement system ("system") 100 is shown, which generally includes a needle 120, a guidewire 130, a blood return system 140, a catheter 150, and a handle 170. For ease of illustration, the handle 170 is simplified (see FIG. 1 for additional details of the handle 170). Figure 4A and Figure 5A ). Figure 1A The system 100 is shown in a deployed configuration, while Figure 1BA plan view of the system 100 in a folded configuration ready for use is shown. In one embodiment, the catheter placement system 100 is a rapidly insertable central catheter (RICC) placement system 100 configured to place a RICC 150. However, it should be understood that other catheter placement systems configured to place other types of catheters can also be envisioned. Exemplary catheters 150 include peripheral intravenous (PIV) catheters, peripherally inserted central catheters (PICCs), central venous catheters (CVCs), midline catheters, dialysis catheters, single lumen catheters, multi-lumen catheters, etc.

[0048] In one embodiment, the catheter 150 generally includes a catheter body 152 supported at a proximal end by a catheter hub ("hub") 160. The hub 160 includes one or more extension legs 162 extending proximally therefrom, and includes a fluid coupling device, such as a Luer lock 164, disposed at the proximal end of one of the one or more extension legs 162. The Luer lock 164 is configured to couple the extension leg 162 to a medical fluid line, a syringe, or the like. Each of the one or more extension legs 162 is in fluid communication with the lumen of the catheter body 152. For example, a first extension leg 162A is in fluid communication with a proximal lumen 114A, a second extension leg 162B is in fluid communication with an intermediate lumen 114B, and a third extension leg 162C is in fluid communication with a distal lumen 114C. The catheter body 152 includes an entry segment 154 disposed distally, a catheter segment 156 disposed proximally, and an expansion segment 158 ​​disposed therebetween. The access segment 154 defines a single lumen and has a first outer diameter, and the catheter segment 156 defines two or more lumens and has a second diameter greater than the first diameter. The expansion segment 158 ​​disposed between the access segment 154 and the catheter segment 156 defines a tapered outer profile extending from the first diameter of the access segment 154 to the second diameter of the catheter segment 156. The guidewire 130 extends from the proximal end of the extension leg 162 through the lumen of the catheter 150 to the distal end of the access segment 154.

[0049] Figure 2 Other details of an exemplary catheter 150 of system 100 are shown. In one embodiment, different segments of catheter 150 need to perform different functions and therefore need to display different mechanical properties. For example, relative to catheter segment 156, entry segment 154 and expansion segment 158 ​​provide more rigid mechanical properties or include harder materials. Therefore, when entry segment 154 and expansion segment 158 ​​are pushed distally, these segments can withstand greater axial forces without kinking or collapsing, thereby forming and expanding the insertion site. Catheter segment 156 is formed by a softer or more compliant material in hardness, so that catheter segment 156 can pass smoothly through a tortuous vascular path.

[0050] FIG. 3A to FIG. 3CAdditional details of the distal portion of the catheter 150 are shown, the distal portion including the access segment 154, the catheter segment 156, and the expansion segment 158. In one embodiment, the catheter segment 156 includes a proximal lumen 114A terminating at a proximal lumen hole 116A and an intermediate lumen 114B terminating at an intermediate lumen hole 116B. In one embodiment, each of the proximal lumen holes 116A and the intermediate lumen holes 116B extend through the sidewall of the catheter segment 156. In one embodiment, each of the proximal lumen holes 116A and the intermediate lumen holes 116B are arranged proximal to the expansion segment 158. In one embodiment, the proximal lumen hole 116A is arranged proximal to the intermediate lumen hole 116B. In one embodiment, the proximal lumen hole 116A and the intermediate lumen hole 116B are arranged equidistant from the distal end of the catheter 150.

[0051] Figure 3B The catheter body 152 is shown in Figure 3A 3B-3B of FIG. As shown, the entry segment 154 defines a single lumen and a relatively small outer diameter. In one embodiment, the proximal portion of the entry segment 154 is received within the distal portion of the expansion segment 158. The distal lumen 114C of the catheter 150 extends to the distal tip 118 of the catheter 150 and is in communication with the distal lumen hole 116C. Figure 3C The catheter segment 156 is shown in Figure 3A 3C-3C of the cross-sectional view, showing the proximal inner cavity 114A, the middle inner cavity 114B and the distal inner cavity 114C.

[0052] Details regarding the catheter body, the distal tip of the catheter, and methods of forming the catheter body and distal tip of the catheter can be found in the following documents: U.S. Patent No. 11,890,429; U.S. Publication Nos.: US2022 / 0001138, US2023 / 0126869, US2023 / 0132903, US2023 / 0233796, US2023 / 0233800 and US2024 / 0091501; and U.S. Patent Application No. 18 / 076,169, each of which is incorporated by reference in its entirety into this application.

[0053] Additional details of the catheter placement system 100 according to the embodiments described herein can be found, for example, in the following documents: US11,517,719, US10,376,675, US2019 / 0255294, US2021 / 0069471, US2021 / 0113809, US2021 / 0113810, US2021 / 0121667, US2021 / 0121661, US2 021 / 0228843, US2021 / 0283381, US2021 / 0322729, US2021 / 0361915, US2021 / 0330941, US2021 / 0330942、US2021 / 0402149、US2021 / 0402142、US2022 / 0032013、US2021 / 0402153、US2021 / 037 9336, US2021 / 0283368, US2022 / 0062528, US2022 / 0032014, US2022 / 0126064, US2022 / 019337 8. US2022 / 0176081, US2022 / 0193376, US2022 / 0193377, US2022 / 0152368, US2022 / 0176082, U S2022 / 0193379, US2022 / 0296862, US2022 / 0323723, US2022 / 0370762, US2022 / 0362524, US2023 / 0043989, US2023 / 0041261, US2023 / 0039733, US2023 / 0042898, each of which is incorporated by reference in its entirety into this application.

[0054] FIG. 4A to FIG. 4B Additional details of handle 170 of system 100 are shown. Figure 4A A perspective view of the handle 170 is shown, including the guidewire 130 extending therethrough, and the needle 120 supported by the needle hub 122 in a retracted position. Figure 4B Shows Figure 4A 170 . In one embodiment, the needle 120 defines a needle lumen 126 and further includes a needle guidewire hole 128 extending through the wall of the needle 120 and communicating with the needle lumen 126 .

[0055] In one embodiment, the handle 170 defines a recess 176 extending distally from the proximal end of the handle 170 and configured to receive a seal housing 180 therein. With the seal housing 180 positioned within the recess 176, the seal housing 180 cooperates with the handle 170 to define a handle needle lumen 172 and a handle guidewire lumen 174. The seal housing 180 is slidably engaged with the recess 176 so that it can be removed proximally from the recess 176, as described in more detail herein.

[0056] In one embodiment, handle 170 and seal housing 180 cooperate to define a handle needle lumen 172 that extends between the distal and proximal ends of handle 170 and is configured to receive a portion of needle 120 therethrough. Needle 120 is located at a distal position (e.g., FIG. 6A to FIG. 6B ) and proximal locations (e.g. Figure 4B ) is slidably engaged with the handle needle lumen 172. The handle 170 and the sealing housing 180 assembly also define a handle guide wire lumen 174, which is in communication with the handle needle lumen 172 at the junction 166 and extends proximally from the handle needle lumen at a certain angle. In one embodiment, when the needle 120 is arranged in the distal position, the needle guide wire hole 128 is aligned with the junction 166. The guide wire 130 extends through the handle guide wire lumen 174, through the needle guide wire hole 128 and into the needle lumen 126, and extends from the distal end of the needle tip 124 and / or the distal end of the handle needle lumen 172.

[0057] In one embodiment, the handle 170 further includes a support pin 168 that extends laterally and is disposed below a portion of the guidewire 130. The support pin 168 is positioned above the topmost surface of the seal housing 180. Thus, when the seal housing 180 is retracted from the recess 176, the support pin 168 does not obstruct the path of the seal housing 180. The support pin 168 is configured to support a portion of the guidewire 130 when the seal housing 180 is pushed proximally.

[0058] In one embodiment, the seal housing 180 also includes a seal 182 formed of a compliant material and forming a seal extending around the junction 166 where the handle guidewire lumen 174 communicates with the handle needle lumen 172. The seal 182 is formed of a polymer, an elastomer, a rubber, a silicone rubber, a self-sealing silicone, etc. Thus, when one or both of the needle 120 and the guidewire 130 are withdrawn from the seal 182, the seal 182 self-seals, thereby providing a fluid tight seal and preventing any fluid disposed therein from escaping.

[0059] In one embodiment, the seal housing 180 also includes a tip shield mechanism ("tip shield") 188 configured to transition between a first position or unlocked position and a second position or locked position. In the unlocked position, the tip shield 188 allows the needle 120 to slide through the handle needle lumen 172 relative to the seal housing 180. In the locked position, the tip shield 188 extends between the needle tip 124 and the distal end of the seal housing 180 to prevent any distal movement of the needle 120 relative to the seal housing 180. In one embodiment, the tip shield 188 is biased toward the locked position and is maintained in the unlocked position by the presence of a portion of the needle 120 in the distal end of the handle needle lumen 172. When the needle tip 124 is withdrawn into the seal housing 180 and thereby removed from the distal portion of the handle needle lumen 172, the tip shield 188 is allowed to transition to the locked position, thereby preventing the needle tip 124 from extending distally from the seal housing 180.

[0060] In one embodiment, system 100 also includes a tether 192 extending between needle hub 122 and seal housing 180. Tether 192 can be coupled to one or both of needle hub 122 and seal housing 180 using adhesive, welding, ultrasonic welding, bonding, mechanical attachment (e.g., eyelet engagement protrusion or hook), combinations thereof, etc. Tether 192 can be formed by an organic or synthetic flexible material with a relatively high tensile strength. Exemplary materials can include metals, alloys, plastics, polymers, composite materials, wires, ropes, strings, bands, combinations thereof, etc. As shown, tether 192 includes a corrugated material that includes one or more holes to allow needle 120 to extend through it. However, this is not intended to be limiting.

[0061] The tether 192 can be in the folded position ( Fig. 6A ) and the expanded position ( Figure 4A , Figure 5A ). The tether 192 is configured to allow the needle hub 122 to move proximally relative to the seal housing 180 up to a predetermined distance (d). Once the needle hub 122 has reached the predetermined distance (d) from the seal housing 180, the tether is fully deployed and in a tensioned position ( Figure 5A), and any further proximal movement of the needle tip 124 and the needle 120 relative to the seal housing 180 is prevented. It is noted that the tensile strength of the tether 192 is configured to prevent any further movement of the needle hub 122 beyond the predetermined distance (d). In addition, with the needle hub 122 at the distance (d), the needle tip 124 is located in a position within the seal housing 180 that allows the tip shield 188 to transition to a locked position, thereby preventing any distal movement of the needle 120 relative to the seal housing 180. Thus, the needle tip 124 is locked within the seal housing 180, wherein the tip shield 188 prevents any distal movement, and the tether 192 prevents any proximal movement. The needle 120, seal housing, tether 192, and needle hub 122 assembly can then be removed from the handle 170, as described in more detail herein.

[0062] In one embodiment, the handle 170 includes a stop 178 that extends into the recess 176 and is configured to hold the seal housing 180 within the recess 176. The stop 178 is supported by a flexible portion of the handle 170. Thus, when the seal housing 180 is pushed proximally using a first force, the stop 178 prevents proximal movement of the seal housing 180 until a second force equal to or greater than a threshold force is applied. When the proximal force exceeds the threshold force, the stop 178 deflects radially outward relative to the central longitudinal axis 70. As the stop 178 deflects outward, the seal housing 180 can slide proximally and disengage from the handle 170.

[0063] FIG. 5A to FIG. 5B Additional details of the seal housing 180 and needle 120 assembly being disengaged from the handle 170 and guidewire 130 assembly are shown. Figure 5A A perspective view is shown and Figure 5BA longitudinal cross-sectional view is shown. In one embodiment, a first force is applied to the needle 120 in the proximal direction to withdraw the needle 120 through the handle needle lumen 172, and the tether 192 is deployed, thereby transitioning from a folded configuration to an expanded configuration. When the needle hub 122 approaches a predetermined distance (d) from the seal housing 180, the needle tip 124 is withdrawn into the seal housing 180. Just before the needle hub 122 reaches the predetermined distance (d), the needle tip 124 is withdrawn proximally of the tip shield 188, thereby allowing the tip shield 188 to transition to a locked position. The needle tip 124 is then locked in the seal housing 180 and optionally in the seal 182, wherein the tip shield 188 prevents further distal movement. With the needle hub 122 at the predetermined distance (d) and the tether 192 fully deployed, the user can apply a second force to the needle 120 and seal housing 180 assembly in the proximal direction. The second force is greater than the threshold force and can deflect the stop 178 radially outward, thereby allowing the seal housing 180 to slide distally out of the recess 176 and disengage from the handle 170. The seal housing 180 locks around the needle tip 124, and thus prevents needle stick injuries from occurring once the needle 120 is disengaged from the handle 170. For additional details on how the seal housing 180 locks around the needle tip 124, see the needle stick injury (NSI) protection mechanism described in PCT / US2024 / 011269 filed on January 11, 2024, which is incorporated by reference in its entirety into this application.

[0064] In one embodiment, the seal housing 180 includes a slot 184 extending longitudinally along a vertical plane and communicating between the outer surface of the seal housing 180 and the handle guidewire lumen 174. When the second force is applied and the seal housing 180 is pushed proximally relative to the handle 170, a portion of the guidewire 130 disposed within the handle guidewire lumen 174 automatically disengages from the handle guidewire lumen 174 and passes through the slot 184 to disengage from the seal housing 180. It is noted that when a portion of the guidewire 130 is pushed through the slot 184, the support pin 168 supports the portion of the guidewire 130 and mitigates any movement or kinking of the guidewire 130. Thus, when the seal housing 180 is disengaged from the handle 170, the guidewire 130 automatically disengages from the seal housing 180, but otherwise remains in place in the handle 170, and if the distal end of the guidewire is disposed in the patient's vasculature, the guidewire is optionally held in place in the patient's vasculature.

[0065] FIG. 6A to FIG. 6D An exemplary method of using the system 100 is shown. Fig. 6A170 . As shown, the needle 120 is in a distal position with the needle hub 122 engaged with the proximal end of the handle 170. The tether 192 is in a folded position disposed between the needle hub 122 and the seal housing 180. A portion of the guidewire 130 extends through the handle guidewire lumen 174, through the seal 182, and into the handle needle lumen 172. It is noted that the needle 120 includes a guidewire aperture 128 that is aligned with the handle guidewire lumen 174 when the needle 120 is in the distal position (i.e., when the needle hub 122 is engaged with the proximal end of the handle 170). Thus, the guidewire 130 extends from the handle guidewire lumen 174 through the guidewire aperture 128 of the needle 120 and into the needle lumen 126, which in turn is disposed within the distal portion of the handle needle lumen 172.

[0066] Initially, the user advances the needle tip 124 to form an insertion site and enter the vessel. Then, the guide wire 130 is advanced through the needle lumen 126 into the vessel to anchor the insertion site. Figure 6B As shown, a first proximal force is applied to the needle hub 122, thereby pushing the needle 120 proximally relative to the seal housing 180. Due to friction between the needle 120 and the seal housing 180 and associated structures (e.g., seal 182, the inner surface of the handle needle lumen 172, etc.), the seal housing 180 can be pushed proximally until the seal housing 180 engages the stop device 178. The first force is less than the threshold force required to deflect the stop device 178, and therefore, the stop device holds the seal housing 180 in the recess 176 of the handle 170 while allowing the needle 120 and the needle hub 122 to continue to slide proximally. In one embodiment, the needle 120 includes a slot extending from the guide wire hole 128 of the needle 120 to its distal end 124 to allow the guide wire 130 to disengage from the needle 120 when the needle 120 is withdrawn proximally. In one embodiment, the needle 120 further comprises a tearable sheath disposed on an outer surface thereof and configured to mitigate leakage of any fluid from the needle lumen 126 through the slot. Additional details and embodiments of the slotted needle can be found in U.S. Application Nos. 17 / 970,005, filed on October 20, 2022, and 17 / 971,182, filed on October 21, 2022, each of which is incorporated herein by reference in its entirety.

[0067] like Figure 6C As shown, needle 120 is withdrawn proximally relative to seal housing 180 and tether 192 is transformed from the folded configuration to the expanded configuration until needle hub 122 is at a predetermined distance (d) relative to seal housing 180. At this point, needle tip 124 is disposed within seal housing 180 and further movement of needle 120 relative to seal housing 180 is prevented, as described herein. For example, by tip shield 188 and tether 192 extending between seal housing 180 and needle hub 122. At needle tip 124 as described herein, tether 192 is extended between seal housing 180 and needle hub 122. Figure 6C In the case of the position shown, the tether 192 is tightened, thereby preventing any further proximal movement between the needle 120 and the seal housing 180. In one embodiment, when the needle tip 124 is withdrawn into the seal housing 180, the tip shield 188 is released. The tip shield 188 is biased toward the locked position and is held in the open position by a portion of the needle being disposed within the distal end of the handle needle lumen 172. When the needle tip 124 is withdrawn into the seal housing, the tip shield 188 is released and transitions to the locked position. In the locked position, the tip shield 188 engages the needle 120 and locks the seal housing to the needle tip 124.

[0068] When the needle tip 124 is within the seal housing 180, a second force is applied to the needle 120, thereby pushing the needle 120 and the seal housing 180 proximally. The second force is greater than the first force and greater than the threshold force required to deflect the stop 178 radially outward. Fig.6D As shown, the seal housing 180 in which the needle tip 124 is disposed slides proximally and disengages from the handle 170. When the seal housing 180 is pushed proximally to disengage from the handle 170, a portion of the guidewire 130 disposed within the handle guidewire lumen 174 is pushed through the slot 184 to disengage from the seal housing 180 without withdrawing the guidewire 130 from the vascular system.

[0069] Advantageously, the support pin 168 stabilizes the guidewire 130 as a portion of the guidewire 130 is pushed through the slot 184, thereby mitigating kinking or movement of the guidewire 130. Thus, when the needle 120 is removed from the vasculature and disengaged from the handle 170, the guidewire 130 automatically disengages from the seal housing 180. Advantageously, the guidewire 130 is separated from the seal housing 180 as the user controls and manipulates the handle 170, thereby allowing for greater control over the procedure.

[0070] Advantageously, once vascular access is achieved, the needle 120, tether 192, seal housing 180, needle hub 122, and blood return system 140 assembly may be disengaged from the handle 170, guidewire 130, and catheter 150 assembly, thereby alleviating any obstruction to advancement of the catheter 150 over the guidewire 130. Advantageously, the seal housing 180 encloses the needle tip 124, thereby preventing any needle stick injuries once the needle 120 is disengaged from the handle 170.

[0071] In one embodiment, the threshold force required to disengage the seal housing 180 from the handle 170 can be significantly greater than the first force required to disengage the needle hub 122 from the handle 170 and withdraw the needle 120 proximally. Advantageously, this ensures that the seal housing 180 is not disengaged from the handle 170 until the needle tip 124 is disposed within the seal housing 180 and the tip shield 188 is deployed to the locked position, thereby mitigating needle stick injuries. In addition, the tether 192 allows the user to apply a greater proximal force to the needle hub 122, which is then transmitted to the seal housing 180 through the tether 192.

[0072] like FIG. 7A to FIG. 7C As shown, in one embodiment, the handle 170 includes a time lock 190. It should be noted that the time lock 190 can be used as a replacement or supplement for the stop device 178. The time lock 190 is configured to transition between a locked position and an unlocked position and is biased toward the unlocked position. In the locked position, the time lock 190 is configured to fix the seal housing 180 in the recess 176 of the handle 170. In the unlocked position, the time lock 190 allows the seal housing 180 to slide proximally relative to the handle 170.

[0073] In one embodiment, the time lock 190 is disposed distally within the seal housing 180 and is aligned with the distal portion of the handle needle lumen 172. Fig. 7A As shown, when a portion of needle 120 is disposed within a distal portion of handle needle lumen 172, needle 120 maintains time lock 190 in the locked position.

[0074] like FIG. 7B to FIG. 7C As shown, as needle 120 is withdrawn proximally, needle tip 124 passes time lock 190 and enters seal housing 180. Thus, when needle tip 124 is proximal to time lock 190 and within seal housing 180, time lock 190 transitions to an unlocked position, thereby allowing needle 120 and seal housing 180 assembly to disengage from handle 170, as described herein.

[0075] In one embodiment, the timing lock 190 is operably connected to the end shield 188. Therefore, in the first position, the end shield 188 is unlocked, thereby allowing the needle 120 to slide relative to the seal housing 180, and the timing lock 190 is locked, thereby preventing the seal housing 180 from sliding relative to the handle 170. When the needle end 124 is withdrawn into the seal housing 180, the end shield 188 / timing lock 190 assembly is released and transformed toward the second position. In one embodiment, the end shield 188 / timing lock 190 assembly is biased toward the second position. In the second position, the end shield 188 is locked, thereby preventing the needle 120 from any distal movement relative to the seal housing 180, and the timing lock 190 is unlocked, thereby allowing the seal housing 180 to slide relative to the handle 170. The needle 120 and the seal housing 180 can be disengaged from the handle 170 and the guide wire 130 assembly, as described herein. In one embodiment, the timing lock 190 and the end shield 188 can be the same mechanism. In one embodiment, the timing lock 190 and the tip shield 188 can be separate mechanisms that operate simultaneously. In one embodiment, the timing lock 190 and the tip shield 188 can be separate mechanisms that operate independently of each other and can operate based on the movement and / or position of the needle 120. Advantageously, the timing lock 190 in the first position prevents the seal housing 180 from disengaging from the handle 170 regardless of the proximal force applied to the needle hub 122. Thus, the timing lock 190 can further mitigate premature disengagement of the seal housing 180 from the handle 170.

[0076] Although some specific embodiments have been disclosed herein, and although these specific embodiments have been disclosed in considerable detail, these specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations or modifications may be envisioned by those of ordinary skill in the art, and in broader aspects, these adaptations or modifications are also encompassed. Therefore, changes may be made to the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A catheter placement system, characterized in that: include: catheter; a needle supported by the needle hub and extending distally to a needle tip, the needle defining a needle lumen; Guidewire; a seal housing including a tip shield transitionable between a locked position and an unlocked position; a tether extending between the needle hub and the seal housing; a handle defining a recess and configured to slidably receive the seal housing therein, wherein the handle and the seal housing cooperate to define a handle needle lumen and a handle guidewire lumen; and A detent is configured to retain the seal housing within the recess when a first force is applied to the needle and is configured to deflect radially outward to allow the seal housing to disengage from the handle when a second force is applied.

2. The catheter placement system according to claim 1, characterized in that: The tip shield in the locked position prevents distal movement of the tip of the needle relative to the seal housing, the tip shield being biased toward the locked position.

3. The catheter placement system according to claim 1, characterized in that: The seal housing further includes a slot extending between an outer surface of the seal housing and one or both of the handle needle lumen and the handle guidewire lumen and configured to allow a portion of the guidewire to pass therethrough when the seal housing is disengaged from the handle.

4. The catheter placement system according to claim 1, characterized in that: The handle needle lumen extends between the distal and proximal ends of the handle and seal housing assembly and is configured to slidably receive a portion of the needle therein, and the handle guidewire lumen is in communication with and extends at an angle from the handle needle lumen.

5. The catheter placement system according to claim 4, characterized in that: The seal housing includes a seal formed of a compliant material and defining a fluid tight seal extending around a junction between the handle needle lumen and the handle guidewire lumen.

6. The catheter placement system according to claim 5, characterized in that: The needle includes a guidewire bore in communication with the needle lumen and configured to align with the handle guidewire lumen when the needle hub engages the proximal end of the handle.

7. The catheter placement system according to claim 6, characterized in that: The needle also includes a slot extending between the guidewire hole and the needle tip.

8. The catheter placement system according to claim 1, characterized in that: The catheter is a rapidly insertable central catheter and also includes a blood return system coupled to the needle hub.

9. The catheter placement system according to claim 1, characterized in that: Also included is a support pin disposed within the handle and abutting against a portion of the guidewire to support the guidewire, the support pin automatically disengaging the guidewire from the seal housing when the seal housing is pushed proximally.

10. The catheter placement system according to claim 1, characterized in that: The tether is configured to allow proximal withdrawal of the needle hub up to a predetermined distance (d), wherein the tether prevents further proximal movement relative to the seal housing beyond the predetermined distance (d).

11. A catheter placement system, characterized in that: include: a needle defining a needle lumen extending between the needle hub and the needle tip; Guidewire; Sealing housing; a tether extending between the needle hub and the seal housing; a handle defining a recess and configured to slidably receive the seal housing therein, wherein the handle and the seal housing cooperate to define a handle needle lumen and a handle guidewire lumen; a tip shield transitionable between an unlocked position and a locked position; and A timing lock is arranged in the sealed housing and can be transformed between a first position and a second position, wherein in the first position, the timing lock is configured to prevent movement of the sealed housing relative to the handle, and in the second position, the timing lock is configured to allow the sealed housing to slide relative to the handle.

12. The catheter placement system according to claim 11, characterized in that: The time lock is biased toward the second position and is retained in the first position by a portion of the needle being disposed within a distal portion of the handle needle lumen.

13. The catheter placement system according to claim 11, characterized in that: The time lock is configured to transition from the first position to the second position when the needle tip is disposed within the sealed housing.

14. The catheter placement system according to claim 11, characterized in that: The time lock in the second position allows the needle and seal housing assembly to disengage from the guidewire and handle assembly.

15. The catheter placement system according to claim 11, characterized in that: Also included is a support pin coupled to the handle and configured to support the guidewire when the seal housing slides proximally relative to the handle, and when the seal housing is pushed proximally, the support pin automatically disengages the guidewire from the seal housing.

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