Catheter placement system and needle tip shield

Abstract

A catheter placement assembly 100 with automatic guidewire disengagement may include a handle 170 and a seal housing 180 assembly defining the needle lumen 172 and the guidewire lumen 174. When the vascular system is accessed, the guidewire 130 advances through the handle guidewire lumen to the target location. The needle is pulled out proximal through the handle needle lumen with a first force. As the needle tip is retracted into the seal housing, the seal housing locks onto the needle tip. By applying a larger second force, the seal housing is biased to disengage the handle. The seal housing is held in place by a retaining arm 178 and / or a timing lock mechanism 190. The seal housing reduces needle stick injuries, allows the needle and seal housing assembly to be removed, and allows the catheter to advance on the guidewire without obstruction.

Description

Background Art

[0001] A central venous catheter (CVC) is generally introduced into a patient's body for placement by the Seldinger method and advanced within the patient's vascular structure. In the Seldinger method, many steps and medical devices (such as needles, surgical scalpels, guidewires, introducer sheaths, dilators, CVCs, etc.) are utilized. Although the Seldinger method is effective, many of the steps are time-consuming, handling a large number of medical devices is cumbersome, and all of these have the potential to cause trauma to the patient. In addition, since there are many medical devices that need to be replaced during the implementation of the Seldinger method, the possibility of contamination by contact is relatively high. Therefore, it is necessary to reduce the number of steps and medical devices involved in introducing a catheter into a patient's body and advancing a catheter such as a CVC within its vascular structure.

[0002] In the present application, a rapidly insertable central catheter (RICC) insertion assembly, an introducer needle assembly, and a method therefor for addressing the above are disclosed. In particular, the RICC insertion assembly, the introducer needle assembly, and the method include protection against needle stick accidents as described below.

Summary of the Invention

[0003] Disclosed herein is a catheter placement system comprising: a catheter; a needle supported by a needle hub and extending distally toward the needle tip, the needle defining a lumen; a guidewire; a seal housing including a tip shield movable 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 in the recess, the handle and the seal housing working together to define a handle needle lumen and a handle guidewire lumen; and a retainer configured to hold the seal housing in the recess when a first force is applied to the needle, and to deflect radially outward when a second force is applied, thereby allowing the seal housing to disengage the handle.

[0004] In some embodiments, the first force is less than the threshold force required to deflect the retaining force, and the second force is greater than or equal to the threshold force. In some embodiments, one or both of the first and second forces bias the needle in the proximal direction.

[0005] In some embodiments, the tip shield in the locked position prevents distal movement of the needle tip relative to the seal housing, and the tip shield is biased toward the locked position. In some embodiments, the seal housing further includes a slot extending between the outer surface of the seal housing and one or both of the handle needle lumen and the handle guidewire lumen, configured to allow a portion of the guidewire to pass through when the seal housing disengages the handle.

[0006] 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, and the handle guidewire lumen communicates with the handle needle lumen and extends therefrom at a certain angle.

[0007] In some embodiments, the seal housing is formed from a compliant material and includes a seal that defines a fluid-seal seal extending around the junction between the handle needle lumen and the handle guidewire lumen.

[0008] In some embodiments, the needle includes a guidewire opening that communicates with the needle lumen and is configured to align with the handle guidewire lumen when the needle hub engages with the proximal end of the handle.

[0009] In some embodiments, the needle further includes a slot extending between the guide wire opening and the needle tip. In some embodiments, the catheter is an RICC and further includes a blood flushing system coupled to a needle hub.

[0010] In some embodiments, the catheter placement system further includes a support pin located within the handle, which abuts against a portion of the guidewire to support it. The support pin causes the seal housing to automatically disengage from the guidewire when the seal housing is biased proximal.

[0011] In some embodiments, the tether is configured to allow the needle hub to be pulled out proximally to a predetermined distance (d), and the tether prevents further proximal movement toward the seal housing beyond the predetermined distance (d).

[0012] Also disclosed is a method for positioning a catheter, which includes forming an insertion site using a needle supported by a needle hub; advancing a guidewire to a target position through the handle guidewire lumen of the handle; and withdrawing the needle proximal through the handle needle lumen until its distal tip is located within the seal housing, the seal housing defining the junction between the handle needle lumen and the handle guidewire lumen; moving the tip shield to a locked position to prevent further distal movement of the needle tip relative to the seal housing; and biasing the needle proximal to deflect the retainer radially outward and disengage the seal housing from the handle.

[0013] In some embodiments, pulling the needle out proximal further includes applying a first proximal force, and biasing the needle proximal to deflect the retaining arm includes a second proximal force, the second proximal force being greater than the first proximal force and greater than or equal to a threshold force required to deflect the retaining arm.

[0014] In some embodiments, the seal housing is slidably engaged within a recess defined by a handle, and a retainer, when a first proximal force is applied, abuts against a portion of the seal housing to hold it within the recess.

[0015] In some embodiments, the step of biasing the needle proximal involves biasing a portion of the guidewire positioned within the handle guidewire lumen through a slot extending between the handle guidewire lumen and the outer surface of the seal housing.

[0016] 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).

[0017] Also disclosed is a catheter placement system comprising: a needle defining a needle lumen extending between a needle hub and a needle tip; a guidewire; a seal 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 within the recess, wherein the handle and the seal housing cooperate to define a handle needle lumen and a handle guidewire lumen; a tip shield movable between an unlocked position and a locked position; and a timing lock located within the seal housing and movable between a first position and a second position, wherein in the first position the timing lock is configured to prevent movement of the seal housing relative to the handle, and in the second position the timing lock is configured to allow the seal housing to slidably relative to the handle.

[0018] In some embodiments, the timing lock is biased toward a second position and held in the first position by a portion of the needle located in the distal part of the handle needle lumen. In some embodiments, the timing lock is configured to move from a first position to a second position when the needle tip is positioned within the seal housing.

[0019] In some embodiments, the timing lock in the second position allows the needle and seal housing assembly to disengage from the guide wire and handle assembly.

[0020] In some embodiments, the catheter placement system further includes a support pin, which is coupled to a handle and configured to support a guidewire when the seal housing slides proximal to the handle. The support pin causes the seal housing to automatically disengage from the guidewire when the seal housing is biased proximal.

[0021] A more detailed description of the present disclosure is provided by reference to specific embodiments of the present disclosure shown in the accompanying drawings. It will be understood that these drawings show only typical embodiments of the invention and, accordingly, are not to be considered as limiting the scope of the invention. Exemplary embodiments of the invention will be described and explained with further specificity and detail through the use of the accompanying drawings.

Brief Description of the Drawings

[0022] [Figure 1A] A perspective view of a catheter placement system in a deployed configuration according to an embodiment disclosed herein is shown. [Figure 1B] A plan view of a catheter placement system in a folded configuration ready for use according to an embodiment disclosed herein is shown. [Figure 2] A side view of the catheter of the catheter placement system of FIG. 1A in a deployed configuration according to an embodiment disclosed herein is shown. [Figure 3A] A close-up detail of the distal portion of the catheter of FIG. 2 according to an embodiment disclosed herein is shown. [Figure 3B] A cross-sectional view of the catheter of FIG. 3A according to an embodiment disclosed herein is shown. [Figure 3C] A cross-sectional view of the catheter of FIG. 3A according to an embodiment disclosed herein is shown. [Figure 4A] A perspective view of a handle, needle, and guide wire assembly according to an embodiment disclosed herein is shown. [Figure 4B] A longitudinal cross-sectional view of a handle, needle, and guide wire assembly according to an embodiment disclosed herein is shown. [Figure 5A] A perspective view of a needle and seal housing assembly disengaged from a guide wire and handle assembly according to an embodiment disclosed herein is shown. [Figure 5B]A longitudinal cross-sectional view of a needle and seal housing assembly disengaged from a guide wire and handle assembly, according to embodiments disclosed herein, is shown. [Figure 6A] An exemplary method of use for a catheter placement system including a handle having a tip shield mechanism, according to embodiments disclosed herein, is shown. [Figure 6B] An exemplary method of use for a catheter placement system including a handle having a tip shield mechanism, according to embodiments disclosed herein, is shown. [Figure 6C] An exemplary method of use for a catheter placement system including a handle having a tip shield mechanism, according to embodiments disclosed herein, is shown. [Figure 6D] An exemplary method of use for a catheter placement system including a handle having a tip shield mechanism, according to embodiments disclosed herein, is shown. [Figure 7A] An exemplary method of use for a catheter placement system including a timing lock mechanism, according to embodiments disclosed herein, is shown. [Figure 7B] An exemplary method of use for a catheter placement system including a timing lock mechanism, according to embodiments disclosed herein, is shown. [Figure 7C] An exemplary method of use for a catheter placement system including a timing lock mechanism, according to embodiments disclosed herein, is shown.

BEST MODE FOR CARRYING OUT THE INVENTION

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

[0024] With regard to the terminology used herein, it should be understood that the terms are for the purpose of describing certain specific embodiments and do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., 1st, 2nd, 3rd, etc.) are generally used to distinguish or identify different features or steps within a group of multiple features or processes and do not provide a sequential or numerical limitation. For example, the "1st," "2nd," and "3rd" features or steps do not necessarily have to appear in that order, and a particular embodiment containing such features or steps does not necessarily have to be limited to three features or steps. In addition, unless otherwise specified, any of the aforementioned features or steps may further include one or more features or steps. Labels such as "left," "right," "up," "down," "front," and "back" are used for convenience and do not, for example, imply a specific fixed position, orientation, or direction. Instead, such notations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "one," "one," and "the aforementioned" also include plural references unless explicitly indicated in the context.

[0025] In the following description, the terms “or” and “and / or” as used herein shall be construed to mean comprehensively or any one or any combination thereof. For example, “A, B or C” or “A, B and / or C” means “i.e., A only, B only, C only, A and B, A and C, B and C, and any of A, B and C.” Exceptions to this definition arise only if the combination of elements, components, functions, processes, or actions is in any way essentially mutually exclusive.

[0026] With respect to “proximal,” for example, the “proximal portion” or “proximal section” of a catheter disclosed herein includes the portion or section of the catheter that is intended to be near the clinician when the catheter is used on a patient. Similarly, for example, the “proximal length” of a catheter includes the length of the catheter that is intended to be near the clinician when the catheter is used on a patient. For example, the “proximal end” of a needle includes the end of the catheter that is intended to be near the clinician when the catheter is used on a patient. The proximal portion, proximal section, or proximal length of a catheter may include the proximal end of the catheter, but it is not required that the proximal portion, proximal section, or proximal length of a catheter include the proximal end of the catheter. That is, unless otherwise suggested by the context, the proximal portion, proximal section, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0027] Regarding "distal," for example, the "distal portion" or "distal section" of a catheter includes the portion or section of the catheter that is intended to be near or within the patient when the catheter is used in a patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter that is intended to be near or within the patient when the catheter is used in a patient. For example, the "distal end" of a needle includes the end of the catheter that is intended to be near or within the patient when the catheter is used in a patient. The distal portion, distal section, or distal length of a catheter may include the distal end of the catheter, but it does not have to include the distal end of the catheter. That is, unless suggested by the context, the distal portion, distal section, or distal length of a catheter is not the terminal portion or terminal length of the catheter.

[0028] In the description of the embodiment, as shown in Figure 1A, the longitudinal axis extends substantially parallel to the axial length of the catheter. The transverse axis extends perpendicular to the longitudinal axis, and the transverse axis extends perpendicular to both the longitudinal and transverse axes. The horizontal plane may be defined by the transverse and longitudinal axes. The vertical plane extends perpendicular to the horizontal plane.

[0029] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art. Figures 1A and 1B show a catheter placement system (system) 100, which generally includes a needle 120, a guidewire 130, a blood flush system 140, a catheter 150, and a handle 170, the handle 170 being simplified for illustrative purposes. (See Figures 4A and 5A for further details of the handle 170.) Figure 1A shows the system 100 in its non-folding configuration, and Figure 1B shows a plan view of the system 100 in its folded configuration, ready for use. In one embodiment, the catheter placement system 100 is a RICC placement system 100 configured to place a Rapidly Insertable Central Catheter (RICC) 150. However, it will be understood that other catheter placement systems configured to place other types of catheters are also conceivable. Exemplary catheters 150 include peripheral venous (PIV) catheters, peripherally inserted central venous catheters (PICCs), central venous catheters (CVCs), midline catheters, dialysis catheters, single-lumen catheters, and multi-lumen catheters.

[0030] In one embodiment, the catheter 150 generally includes a catheter body 152 supported at its proximal end by a catheter hub (hub) 160. The hub 160 includes one or more extension legs 162 extending proximal from the hub 160, and includes a fluid coupling device such as a Luer lock 164 located at the proximal end of one of the one or more extension legs 162. The Luer lock 164 is configured to connect the extension leg 162 to a medical fluid line, syringe, etc. Each of the one or more extension legs 162 can be in fluid communication with the lumen of the catheter 152. For example, a first extension leg 162A is in fluid communication with the proximal lumen 114A, a second extension leg 162B is in fluid communication with the intermediate lumen 114B, and a third extension leg 162C is in fluid communication with the distal lumen 114C. The catheter body 152 includes a distally located access section 154, a proximally located catheter section 156, and an expansion section 158 located between them. The access section 154 defines a single lumen and has a first outer diameter, while the catheter section 156 defines two or more lumens and has a second diameter greater than the first diameter. The expansion section 158, located between the access section 154 and the catheter section 156, defines a tapered outer shape extending from the first diameter of the access section 154 to the second diameter of the catheter section 156. The guidewire 130 extends through the lumen of the catheter 150 from the proximal end of the extension leg 162 to the distal end of the access section 154.

[0031] Figure 2 shows further details of an exemplary catheter 150 of system 100. In one embodiment, different sections of the catheter 150 are required to exhibit different mechanical properties because they are required to perform different functions. For example, the access section 154 and the expansion section 158 provide mechanical properties that are more rigid than those of the catheter section 156, or include a harder durometer material. Thus, the access section 154 and the expansion section 158 can withstand greater axial forces without twisting or crushing as these sections are biased distally to form and expand the insertion site. The catheter section 156 is formed of a softer durometer hardness material, or a more compliant material, to facilitate passage through the catheter section 156 through winding vascular pathways.

[0032] Figures 3A–3C show further details of the distal portion of the catheter 150, including the access section 154, the catheter section 156, and the expansion section 158. In one embodiment, the catheter section 156 includes a proximal lumen 114A terminating at a proximal lumen opening 116A and an intermediate lumen 114B terminating at an intermediate lumen opening 116B. In one embodiment, each of the proximal lumen aperture 116A and the intermediate lumen aperture 116B extends through the side wall of the catheter section 156. In one embodiment, each of the proximal lumen aperture 116A and the intermediate lumen aperture 116B is located proximal to the expansion section 158. In one embodiment, the proximal lumen aperture 116A is located proximal to the intermediate lumen aperture 116B. In one embodiment, the proximal lumen aperture 116A and the intermediate lumen aperture 116B are positioned equidistant from the distal tip of the catheter 150.

[0033] Figure 3B shows a cross-sectional view of the catheter body 152 at point "A" in Figure 3A. As shown, the access section 154 defines a single lumen and a relatively smaller outer diameter. In one embodiment, the proximal portion of the access section 154 is received within the distal portion of the expansion section 158. The distal lumen 114C of the catheter 150 extends to the distal tip 118 of the catheter 150 and communicates with the distal lumen opening 116C. Figure 3C shows a cross-sectional view of the catheter section 156 at point "B" in Figure 3A, showing the proximal lumen 114A, the intermediate lumen 114B, and the distal lumen 114C.

[0034] Details relating to the catheter body, the distal tip of the catheter, and the method for forming the catheter body and the distal tip of the catheter can be found in U.S. Patent No. 11,890,429, U.S. Patent Publication No. 2022 / 0001138, U.S. Patent Publication No. 2023 / 0126869, U.S. Patent Publication No. 2023 / 0132903, U.S. Patent Publication No. 2023 / 0233796, U.S. Patent Publication No. 2023 / 0233800, U.S. Patent Publication No. 2024 / 0091501, and U.S. Patent Application No. 18 / 076,169, each incorporated in whole by reference. Further details relating to the catheter material can be found, for example, in international application PCT / US2024 / 011269, filed on 11 January 2024, which is incorporated herein by reference in its entirety.

[0035] Further details of the catheter placement system 100 according to the embodiments described herein can be found, for example, in U.S. Patent No. 11,517,719, U.S. Patent No. 10,376,Specifications No. 675, U.S. Patent Application Publication No. 2019 / 0255294, U.S. Patent Application Publication No. 2021 / 0069471, U.S. Patent Application Publication No. 2021 / 0113809, U.S. Patent Application Publication No. 2021 / 0113810, U.S. Patent Application Publication No. 2021 / 0121667, U.S. Patent Application Publication No. 2021 / 0121661, U.S. Patent Application Publication No. 2021 / 0228843, U.S. Patent Application Publication No. 2021 / 0283381, U.S. Patent Application Publication No. 2021 / 0322729, United States U.S. Patent Application Publication No. 2021 / 0361915, U.S. Patent Application Publication No. 2021 / 0330941, U.S. Patent Application Publication No. 2021 / 0330942, U.S. Patent Application Publication No. 2021 / 0402149, U.S. Patent Application Publication No. 2021 / 0402142, U.S. Patent Application Publication No. 2022 / 0032013, U.S. Patent Application Publication No. 2021 / 0402153, U.S. Patent Application Publication No. 2021 / 0379336, U.S. Patent Application Publication No. 2021 / 0283368, U.S. Patent Application Publication No. 202 Specifications 2 / 0062528, U.S. Patent Application Publication No. 2022 / 0032014, U.S. Patent Application Publication No. 2022 / 0126064, U.S. Patent Application Publication No. 2022 / 0193378, U.S. Patent Application Publication No. 2022 / 0176081, U.S. Patent Application Publication No. 2022 / 0193376, U.S. Patent Application Publication No. 2022 / 0193377, U.S. Patent Application Publication No. 2022 / 0152368, U.S. Patent Application Publication No. 2022 / 0176082, U.S. Patent Application Publication No. 2022 / 0193379 These can be found in the specifications, U.S. Patent Application Publication No. 2022 / 0296862, U.S. Patent Application Publication No. 2022 / 0323723, U.S. Patent Application Publication No. 2022 / 0370762, U.S. Patent Application Publication No. 2022 / 0362524, U.S. Patent Application Publication No. 2023 / 0043989, U.S. Patent Application Publication No. 2023 / 0041261, U.S. Patent Application Publication No. 2023 / 0039733, and U.S. Patent Application Publication No. 2023 / 0042898, each incorporated in whole by reference.

[0036] Figures 4A and 4B show further details of the handle 170 of system 100. Figure 4A shows a perspective view of the handle 170, including a guide wire 130 extending through it and a needle 120 supported by a needle hub 122 in a retracted position. Figure 4B shows a longitudinal section of the handle 170 of Figure 4A. In one embodiment, the needle 120 further includes a guide wire opening 128 that defines a needle lumen 126, extends through the wall of the needle 120, and communicates with the needle lumen 126.

[0037] In one embodiment, the handle 170 defines a recess 176 that extends distally from the proximal end of the handle 170 and is configured to receive a seal housing 180. When the seal housing 180 is positioned within the recess 176, it cooperates with the handle 170 to define the handle needle lumen 172 and the handle guidewire lumen 174. The seal housing 180 is slidably engaged with the recess 176 so that it can be removed proximal to the recess 176, as described in more detail herein.

[0038] In one embodiment, the handle 170 and the seal housing 180 cooperate to define a handle needle lumen 172, which extends between the distal and proximal ends of the handle 170 and is configured to receive a portion of the needle 120 through it. The needle 120 is slidably engaged with the handle needle lumen 172 between a distal position (e.g., Figures 6A and 6B) and a proximal position (e.g., Figure 4B). The handle 170 and seal housing 180 assembly further defines a handle guidewire lumen 174, which communicates with the handle needle lumen 172 at a joint 166 and extends proximal therefrom at a certain angle. In one embodiment, with the needle 120 positioned distally, the needle guidewire opening 128 aligns with the joint 166. The guidewire 130 passes through the handle guidewire lumen 174 and the needle guidewire opening 128, extending into the needle lumen 126, and extending from the distal end of the needle tip 124 and / or the distal end of the handle needle lumen 172.

[0039] In one embodiment, the handle 170 further includes a support pin 168 that extends laterally and is positioned below a portion of the guide wire 130. The support pin 168 is positioned above the uppermost surface of the seal housing 180. Thus, the support pin 168 does not obstruct the path of the seal housing 180 when it is retracted from the recess 176. The support pin 168 is configured to support a portion of the guide wire 130 when the seal housing 180 is biased in the proximal direction.

[0040] In one embodiment, the seal housing 180 is formed from a compliant material and further includes a seal 182 that forms a seal extending around a joint 166 in which the handle guidewire lumen 174 communicates with the handle needle lumen 172. The seal 182 is formed from a polymer, elastomer, rubber, silicone rubber, self-sealing silicone, and the like. Thus, when one or both of the needle 120 and the guidewire 130 are withdrawn from the seal 182, the seal 182 self-seals to provide a fluid-sealing seal, preventing any fluid contained therein from leaking out.

[0041] In one embodiment, the seal housing 180 further includes a tip shield mechanism (tip shield) 188 configured to move 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 against the seal housing 180 through the handle needle lumen 172. 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 held in the unlocked position by the presence of a portion of the needle 120 at the distal end of the handle needle lumen 172. When the needle tip 124 is retracted into the seal housing 180 and thereby removed from the distal portion of the handle needle lumen 172, the tip shield 188 is able to move toward the locked position, preventing the needle tip 124 from extending distally from the seal housing 180.

[0042] In one embodiment, the system 100 further includes a tether 192 extending between the needle hub 122 and the seal housing 180. The tether 192 may be attached to one or both of the needle hub 122 and the seal housing 180 using adhesives, welding, ultrasonic welding, joints, mechanical attachments (e.g., eyelets that engage with projections or hooks), or a combination thereof. The tether 192 may be formed from an organic or synthetic flexible material having relatively high tensile strength. Exemplary materials may include metals, alloys, plastics, polymers, composites, wires, ropes, strings, tapes, or a combination thereof. As shown, the tether 192 includes a pleated material with one or more openings, allowing the needle 120 to extend through it. However, this is not intended to be limiting.

[0043] The tether 192 can transition between a folded position (Figure 6A) and an extended position (Figures 4A, 5A). The tether 192 is configured to allow the needle hub 122 to move proximal to the seal housing 180 up to a predetermined distance (d). When the needle hub 122 reaches the predetermined distance (d) from the seal housing 180, the tether is fully extended and in the taught position (Figure 5A), preventing any further proximal movement of the needle tip 124 and needle 120 relative to the seal housing 180. Note 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). Furthermore, with the needle hub 122 at distance (d), the needle tip 124 is located within the seal housing 180 in a position that allows the tip shield 188 to transition to the locked position, preventing any distal movement of the needle 120 relative to the seal housing 180. Accordingly, the needle tip 124 is locked within the seal housing 180 with the tip shield 188 preventing any distal movement and the tether 192 preventing 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.

[0044] In one embodiment, the handle 170 includes a retaining arm 178 that extends into a recess 176 and is configured to hold the seal housing 180 within the recess 176. The retaining arm 178 is supported by a flexible portion of the handle 170. Thus, when the seal housing 180 is biased proximal using a first force, the retaining arm 178 prevents proximal movement of the seal housing 180 until a second force greater than or equal to a threshold force is applied. When the proximal force exceeds the threshold force, the retaining arm 178 deflects radially outward with respect to the central longitudinal axis 70. When the retaining arm 178 is deflected outward, the seal housing 180 can slide proximal and disengage the handle 170.

[0045] Figures 5A and 5B show further details of the seal housing 180 and needle 120 assembly disengaged from the handle 170 and guidewire 130 assembly. Figure 5A is a perspective view, and Figure 5B is a longitudinal section view. In one embodiment, a first force is applied proximal to the needle 120, pulling the needle 120 through the handle needle lumen 172, causing the tether 192 to unfold and transition from a folded configuration to an unfolded configuration. As the needle hub 122 approaches a predetermined distance (d) from the seal housing 180, the needle tip 124 is retracted into the seal housing 180. Just before the needle hub 122 reaches the predetermined distance (d), the needle tip 124 is pulled proximal to the tip shield 188, allowing the tip shield 188 to transition to a locked position. The needle tip 124 is then locked into the seal housing 180, and optionally into the seal 182, with further distal movement prevented by the tip shield 188. With the needle hub 122 at a predetermined distance (d) and the tether 192 fully extended, the user can apply a second force proximal to the needle 120 and seal housing 180 assembly. The second force may be greater than the threshold force and deflect the retaining arm 178 radially outward, allowing the seal housing 180 to slide distally out of the recess 176 and disengage the handle 170. The seal housing 180 locks around the needle tip 124, and therefore, once the needle 120 is disengaged from the handle 170, the seal housing 180 prevents a needle-stick injury. For further details on how the seal housing 180 locks around the needle tip 124, see the needle-stick injury (NSI) protection mechanism described in International Application PCT / US2024 / 011269, filed January 11, 2024, which is incorporated in whole by reference herein.

[0046] In one embodiment, the seal housing 180 extends longitudinally along a vertical plane and includes a slot 184 that communicates the outer surface of the seal housing 180 with the handle guidewire lumen 174. When a second force is applied and the seal housing 180 is biased proximal to the handle 170, a portion of the guidewire 130 positioned within the handle guidewire lumen 174 automatically disengages the handle guidewire lumen 174, passes through the slot 184, and disengages the seal housing 180. It should be noted that the support pin 168 supports the portion of the guidewire 130 as it is biased through the slot 184, reducing any movement or twisting of the guidewire 130. Thus, when the seal housing 180 disengages the handle 170, the guidewire 130 automatically disengages from the seal housing 180, otherwise, optionally, it remains in place within the handle 170, within the patient's blood vessel if the distal end of the guidewire is positioned within the patient's blood vessel.

[0047] Figures 6A to 6D illustrate an exemplary use of system 100. As shown in Figure 6A, the needle 120 is in the distal position with the needle hub 122 engaged with the proximal end of the handle 170. The tether 192 is in the folded position, positioned between the needle hub 122 and the seal housing 180. A portion of the guidewire 130 extends through the handle guidewire lumen 174 and through the seal 182 into the handle needle lumen 172. Note that 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), the needle 120 includes a guidewire opening 128 that aligns with the handle guidewire lumen 174. Thus, the guidewire 130 extends from the handle guidewire lumen 174 through the guidewire opening 128 of the needle 120 into the needle lumen 126, which is located in the distal portion of the handle needle lumen 172.

[0048] First, the user advances the needle tip 124 to form an insertion site and access the blood vessel. Next, the guidewire 130 is advanced into the blood vessel through the needle lumen 126 to secure the insertion site. As shown in Figure 6B, a first proximal force is applied to the needle hub 122, biasing the needle 120 proximal to the seal housing 180. Friction between the needle 120 and the seal housing 180, and between related structures (e.g., the seal 182, the inner surface of the handle needle lumen 172, etc.), can cause the seal housing 180 to be biased proximal until it engages with the retainer 178. The first force is below the threshold force required to deflect the retainer 178, and therefore the retainer holds the seal housing 180 within the recess 176 of the handle 170, while allowing the needle 120 and needle hub 122 to continue sliding proximal. In one embodiment, the needle 120 includes a slot extending from a guidewire opening 128 of the needle 120 to its distal tip 124, allowing the guidewire 130 to disengage the needle 120 when the needle 120 is withdrawn proximal. In one embodiment, the needle 120 further includes a tearable sheath disposed on its outer surface and configured to reduce leakage of any fluid through the slot from the needle lumen 126. Further details and embodiments of the slotted needle can be found in U.S. Patent Application No. 17 / 970005 filed October 20, 2022, and U.S. Patent Application No. 17 / 971182 filed October 21, 2022, each of which is incorporated in whole by reference in this application.

[0049] As shown in Figure 6C, the needle 120 is retracted proximal to the seal housing 180, and the tether 192 moves from a folded configuration to an unfolded configuration until the needle hub 122 is at a predetermined distance (d) from the seal housing 180. At that point, the needle tip 124 is positioned within the seal housing 180, preventing further movement of the needle 120 relative to the seal housing 180, as described herein, for example, by the tip shield 188 and the tether 192 extending between the seal housing 180 and the needle hub 122. With the needle tip 124 positioned as shown in Figure 6C, the tether 192 is extended and taught to prevent any further proximal movement between the needle 120 and the seal housing 180. In one embodiment, when the needle tip 124 is retracted 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 located at the distal end of the handle needle lumen 172. When the needle tip 124 is retracted into the seal housing, the tip shield 188 is released and moves toward the locked position. In the locked position, the tip shield 188 engages with the needle 120 and locks the seal housing to the needle tip 124.

[0050] With the needle tip 124 inside the seal housing 180, a second force is applied to the needle 120, biasing the needle 120 and the seal housing 180 proximal. The second force is greater than the first force and greater than the threshold force required to deflect the retaining arm 178 radially outward. Thus, as shown in Figure 6D, the seal housing 180, with the needle tip 124 positioned inside it, slides proximal, disengaging the handle 170. When the seal housing 180 is biased proximal to disengage the handle 170, the portion of the guidewire 130 positioned inside the handle guidewire lumen 174 is biased through the slot 184 to disengage the seal housing 180 without withdrawing the guidewire 130 from the vascular system.

[0051] Advantageously, the support pin 168 stabilizes the guidewire 130 when the portion of the guidewire 130 is biased through the slot 184, thereby reducing twisting or movement of the guidewire 130. Thus, the guidewire 130 automatically disengages from the seal housing 180 when the needle 120 is removed from the vascular system and disengaged from the handle 170. Advantageously, the guidewire 130 is isolated from the seal housing 180 while the user controls and operates the handle 170, allowing for better control throughout the process.

[0052] Advantageously, the needle 120, tether 192, seal housing 180, needle hub 122, and blood flush system 140 assembly can be disengaged from the handle 170, guidewire 130, and catheter 150 assembly once vascular access is achieved, mitigating any obstruction to the advancement of the catheter 150 over the guidewire 130. Advantageously, the seal housing 180 surrounds the needle tip 124, preventing any needle stick injury once the needle 120 is disengaged from the handle 170.

[0053] In one embodiment, the threshold force required to disengage the seal housing 180 from the handle 170 may be significantly greater than the first force required to disengage the needle hub 122 from the handle 170 and pull the needle 120 proximal. Advantageously, this ensures that the seal housing 180 does not disengage the handle 170 until the needle tip 124 is positioned within the seal housing 180 and the tip shield 188 is deployed to the locked position, thereby reducing needle stick injuries. Furthermore, 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 via the tether 192.

[0054] As shown in Figures 7A to 7C, in one embodiment, the handle 170 includes a timing lock 190. Note that the timing lock 190 may replace or add to the retaining arm 178. The timing lock 190 is configured to move between a locked position and an unlocked position and is biased toward the unlocked position. In the locked position, the timing lock 190 is configured to fix the seal housing 180 in a recess 176 of the handle 170. In the unlocked position, the timing lock 190 allows the seal housing 180 to slide proximally relative to the handle 170.

[0055] In one embodiment, the timing lock 190 is located distally within the seal housing 180 and is aligned with the distal portion of the handle needle lumen 172. As shown in Figure 7A, when a portion of the needle 120 is positioned within the distal portion of the handle needle lumen 172, the needle 120 holds the timing lock 190 in the locked position.

[0056] As shown in Figures 7B and 7C, when the needle 120 is pulled out in the proximal direction, the needle tip 124 passes through the timing lock 190 and enters the seal housing 180. Thus, when the needle tip 124 is proximal to the timing lock 190 and inside the seal housing 180, the timing lock 190 moves to the unlocked position, allowing the needle 120 and seal housing 180 assembly to disengage the handle 170, as described herein.

[0057] In one embodiment, the timing lock 190 is operably coupled to the tip shield 188. Thus, in the first position, the tip shield 188 is unlocked, allowing the needle 120 to slide against the seal housing 180, and the timing lock 190 is locked, preventing the seal housing 180 from sliding against the handle 170. When the needle tip 124 is retracted into the seal housing 180, the tip shield 188 / timing lock 190 assembly is released and moves toward the second position. In one embodiment, the tip shield 188 / timing lock 190 assembly is biased toward the second position. In the second position, the tip shield 188 is locked, preventing any distal movement of the needle 120 against the seal housing 180, and the timing lock 190 is unlocked, allowing the seal housing 180 to slide against 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 tip shield 188 may be the same mechanism. In one embodiment, the timing lock 190 and the tip shield 188 may be separate mechanisms operating in parallel. In one embodiment, the timing lock 190 and the tip shield 188 may be separate mechanisms operating independently of each other and may 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 the handle 170 regardless of how much proximal force is 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.

Claims

1. A catheter placement system, Catheter and, A needle supported by a needle hub and extending distally to the needle tip, wherein the needle defines a lumen, Guide wire and A seal housing including a tip shield that can move between a locked position and an unlocked position, A tether extending between the needle hub and the seal housing, A handle having a defined recess and configured to slidably receive a seal housing within the recess, wherein the handle and the seal housing cooperate to define a handle needle lumen and a handle guide wire lumen, A stopper is configured such that when a first force is applied to the needle, the seal housing is held in the recess, and when a second force is applied, the seal housing is deflected radially outward so that it can disengage the handle. A catheter placement system including a catheter.

2. The catheter placement system according to claim 1, wherein the first force is less than the threshold force required to deflect the return stopper, and the second force is greater than or equal to the threshold force.

3. The catheter placement system according to claim 1 or 2, wherein one or both of the first force and the second force bias the needle in a proximal direction.

4. The catheter placement system according to any one of claims 1 to 3, wherein the tip shield in the locked position prevents distal movement of the needle tip relative to the seal housing, and the tip shield is biased toward the locked position.

5. The catheter placement system according to any one of claims 1 to 4, further comprising a slot extending between the outer surface of the seal housing and one or both of the handle needle lumen and the handle guidewire lumen, configured to allow a portion of the guidewire to pass through when the seal housing disengages the handle.

6. The catheter placement system according to any one of claims 1 to 5, wherein the handle needle lumen extends between the distal and proximal ends of the handle and the seal housing assembly and is configured to slidably receive a portion of the needle within the handle needle lumen, and the handle guidewire lumen communicates with the handle needle lumen and extends therefrom at a certain angle.

7. The catheter placement system according to claim 6, wherein the seal housing is formed from a compliant material and includes a seal that defines a fluid-seal seal extending around the junction between the handle needle lumen and the handle guidewire lumen.

8. The catheter placement system according to claim 7, comprising a guidewire opening, wherein the needle is in communication with the needle lumen and is configured to align with the handle guidewire lumen when the needle hub engages with the proximal end of the handle.

9. The catheter placement system according to claim 8, wherein the needle further includes a slot extending between the guidewire opening and the tip of the needle.

10. The catheter placement system according to any one of claims 1 to 9, wherein the catheter is a rapid insertion type central venous catheter, and further comprises a blood flushing system coupled to the needle hub.

11. A catheter placement system according to any one of claims 1 to 10 further includes a support pin disposed within the handle and in contact with a portion of the guide wire to support the guide wire, wherein the support pin causes the seal housing to automatically disengage the seal housing from the guide wire when the seal housing is biased in the proximal direction.

12. The catheter placement system according to any one of claims 1 to 11, wherein the tether is configured to allow the needle hub to be withdrawn proximally to a predetermined distance (d), and the tether prevents further proximal movement of the seal housing beyond the predetermined distance (d).

13. A catheter placement system, A needle that defines the needle lumen extending between the needle hub and the needle tip, Guide wire and Seal housing and A tether extending between the needle hub and the seal housing, A handle having a defined recess, configured to slidably receive the seal housing within the recess, wherein the handle and the seal housing cooperate to define the handle needle lumen and the handle guide wire lumen, A tip shield that can be moved between the unlocked position and the locked position, A timing lock disposed within the seal housing and movable between a first position and a second position, wherein in the first position the timing lock is configured to prevent movement of the seal housing relative to the handle, and in the second position the timing lock is configured so that the seal housing is slidable relative to the handle, and A catheter placement system including a catheter.

14. The catheter placement system according to claim 13, wherein the timing lock is biased toward the second position and is held in the first position by a portion of the needle positioned in the distal portion of the handle needle lumen.

15. The catheter placement system according to claim 13 or 14, wherein the timing lock is configured to move from a first position to a second position when the needle tip is positioned within the seal housing.

16. The catheter placement system according to any one of claims 13 to 15, wherein the timing lock in the second position allows the needle and the seal housing assembly to be disengaged from the guide wire and the handle assembly.

17. A catheter placement system according to any one of claims 13 to 16, further comprising a support pin coupled to the handle and configured to support the guide wire when the seal housing slides proximal to the handle, wherein the support pin causes the seal housing to automatically disengage the guide wire when the seal housing is biased proximal.

Images