Systems for accessing a patient's vascular system

Abstract

A system for accessing a patient's vascular system, comprising: a tube including a wall defining an outer surface and an inner cavity having a proximal end and a distal end; a guidewire that can be deployed by sliding distally from a retracted position in which the guidewire is in the inner cavity to a deployed position in which the guidewire extends beyond the distal end; and at least one element selected from the group consisting of: a retracting mechanism that can be actuated to retract the guidewire from the deployed position to the retracted position; and a protective cover that can be actuated to extend distally from the distal end of the tube to cover the guidewire in the deployed position. The present system can reduce trauma to the vein and overcome obstructions such as thrombi, valves, and / or fibrin sheaths in or around a vascular access device or vein that might otherwise prevent blood aspiration.

Description

Technical Field

[0001] The present disclosure relates to access devices with blood exposure protection and related methods. More particularly, the present disclosure relates to a system for accessing a patient's vascular system. Background Art

[0002] Many different vascular access devices (VADs) are used to provide access to a patient's vascular system, for example, to infuse blood, aspirate blood, deliver medications, deliver nutrients, or monitor the patient's blood conditions. In many cases, it is desirable to perform more than one of these functions, either sequentially or simultaneously, for a given patient. Many vascular access devices include a catheter line that is connected to a patient's vein via a cannula. Unfortunately, with many existing systems, this requires connecting a new vascular access device, resulting in another needle insertion for the patient.

[0003] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as described above. Rather, this background is merely provided to illustrate one example technology area where some implementations described herein may be practiced. Summary of the invention

[0004] The present disclosure generally relates to a system for accessing a patient's vascular system. In some embodiments, a vascular access device delivery device can deliver a probe needle-free to a patient's vascular system by utilizing an existing vascular access device (VAD) for blood collection, fluid delivery, patient or device monitoring, or other clinical needs to reduce trauma to the vein and overcome obstructions such as thrombi, valves, and / or fibrin sheaths in or around the vascular access device or vein that might otherwise prevent blood aspiration.

[0005] In some embodiments, the system can have: a tube having a wall defining an outer surface and an inner cavity with a proximal end and a distal end; and a guidewire that can be deployed by sliding distally from a retracted position in the inner cavity where the guidewire is located to a deployment position where the guidewire extends beyond the distal end. In some embodiments, the system can have a retracting mechanism that can be used to retract the guidewire from the deployment position to the retracted position, or a protective cover that can be used to extend distally from the distal end of the tube to cover the guidewire in the deployment position.

[0006] In some embodiments, the proximal end may be capable of being connected to a source of pressurized fluid. In some embodiments, the guidewire may be capable of being deployed in response to pressure proximal to the lumen from the source of pressurized fluid. In some embodiments, the system may have an expansion kit for a vascular access device. In some embodiments, the distal end may have a blunt tip cannula configured to cooperate with a needleless access connector of a vascular access device. In some embodiments, the system may include a cap configured to cover the blunt tip cannula before attaching the blunt tip cannula to the vascular access device.

[0007] In some embodiments, system may include a retraction mechanism that may be slidably coupled to an outer surface. In some embodiments, the retraction mechanism may be coupled to a guide wire so that the guide wire is retracted from a deployment position to a retraction position toward the motion of the proximal end. In some embodiments, the guide wire may have a distal portion with an elongated shape and a proximal portion with a coupling feature. In some embodiments, the coupling feature may include a cross-sectional shape that expands relative to the distal portion. In some embodiments, the retraction mechanism may be coupled to the coupling feature by the wall.

[0008] In some embodiments, the coupling feature may include one or more of the following: a wedge, one or more rounded ridges, one or more fins, one or more splines, one or more longitudinal ribs, and one or more anti-rotation features. In some embodiments, the retraction mechanism may compress the wall into contact with the coupling feature so that the wall causes the coupling feature to move proximally in response to proximal movement of the retraction mechanism.

[0009] In some embodiments, the retraction mechanism may include one or more of: one or more wheels that engage the outer surface to compress the tube, one or more ball bearings that engage the outer surface to compress the tube, and one or more manually compressible walls that can bend toward the tube. In some embodiments, the retraction mechanism may include one or more of: one or more magnets that magnetically engage the coupling feature, one or more springs coupled to the coupling feature, and a tether secured to the coupling feature.

[0010] In some embodiments, the system may include a spring that forces the guidewire to be deployed from the retracted position to the deployed position. In some embodiments, the system may include a protective cover. In some embodiments, the system may include an absorbent component that is positioned to remove blood from the guidewire after the guidewire is deployed.

[0011] In certain embodiments, guide wire can comprise a spring with variable pitch and / or can comprise an auxiliary tube with an endopore, by which blood can be drawn from the vascular system. In certain embodiments, the proximal end can be connected to a pressurized fluid source. In certain embodiments, guide wire can be deployed in response to the pressure from the pressurized fluid source, the proximal side of the inner chamber. In certain embodiments, guide wire can be an auxiliary tube. In certain embodiments, guide wire can have a valve, which closes during guide wire deployment and opens during drawing blood from the vascular system. In certain embodiments, at least one of guide wire and pipe can have a capture mechanism that guide wire is maintained at the deployment position.

[0012] In some embodiments, a method for accessing a patient's vascular system may include placing a tube near the vascular system. In some embodiments, the tube may have an outer surface and an inner cavity with a proximal end and a distal end. In some embodiments, the method may include deploying the guidewire by sliding the guidewire distally from the retraction position in the inner cavity where the guidewire extends beyond the distal end. In some embodiments, the method may include performing one or more of the following steps: retracting the guidewire from the deployment position to the retraction position by sliding the retraction mechanism slidably connected to the outer surface proximally; and extending the protective cover to extend distally from the distal end of the tube to cover the guidewire in the deployment position.

[0013] In some embodiments, the method may include moving the retraction mechanism to a predetermined position before the guide wire is deployed so that during the guide wire deployment, the retraction mechanism limits the range of proximal motion of the guide wire. In some embodiments, the method may include removing blood from the guide wire using an absorbent component after the guide wire is deployed. In some embodiments, the method may include connecting the proximal end to a pressurized fluid source before the guide wire is deployed.

[0014] In some embodiments, the guide wire may include a valve and an auxiliary tube with an inner hole. In some embodiments, the deployment of the guide wire may include responding to the pressure from the pressurized fluid source, the proximal side of the inner cavity and deploying the guide wire when the valve is closed to prevent fluid from flowing through the inner hole. In some embodiments, the method may include opening the valve to allow fluid to flow through the inner hole after the deployment of the guide wire, and drawing blood through the inner hole.

[0015] According to some embodiments, a system for accessing a patient's vascular system may include: a tube having a wall defining an outer surface and an inner cavity with a proximal end and a distal end; and a guidewire, which can be deployed by sliding distally from a retracted position in which the guidewire is located in the inner cavity to a deployment position in which the guidewire extends beyond the distal end. In some embodiments, the guidewire may have a distal portion with an elongated shape and a proximal portion with a coupling feature having a cross-sectional shape that is enlarged relative to the distal portion. In some embodiments, the system may include a retraction mechanism that can be actuated to retract the guidewire from the deployment position to the retraction position. In some embodiments, the proximal end may be capable of being connected to a pressurized fluid source. In some embodiments, the guidewire may be deployed in response to pressure from the pressurized fluid source proximal to the inner cavity. In some embodiments, the system may be an expansion kit for a vascular access device. In some embodiments, the distal end may have a blunt cannula configured to cooperate with a needleless access connector of a vascular access device.

[0016] The objects and advantages of these embodiments will be achieved at least by the elements, features and combinations particularly pointed out in this disclosure.It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive of the invention as claimed. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which:

[0018] Figure 1 is a perspective view of a system for accessing a patient's vascular system, according to some embodiments.

[0019] Figure 2A , 2B and 2C are respectively in the pre-deployment position, the deployed position, and the retracted position according to some embodiments Figure 1 A front cross-sectional view of the system.

[0020] Figure 3 is an elevation view of a system for accessing a patient's vascular system, according to some embodiments.

[0021] Figure 4A and 4B According to some embodiments, they can be respectively used to connect Figure 3 and Figure 1 Front view of the smooth wheel and ridged wheel of the system.

[0022] Figure 5A , 5B 5C are front views of a system for accessing a patient's vascular system in a pre-compression state, a compressed state, and a compressed state, respectively, according to some embodiments.

[0023] Figure 6 is an elevation view of a system for accessing a patient's vascular system, according to some embodiments.

[0024] Fig. 7A , 7B 7C are perspective, front cross-sectional, and side cross-sectional views, respectively, of a system for accessing a patient's vascular system according to some embodiments.

[0025] Fig. 8A and 8B are elevational and schematic cross-sectional views of a system for accessing a patient's vascular system, according to some embodiments.

[0026] Fig. 9 is a perspective view of a system for accessing a patient's vascular system, according to some embodiments.

[0027] Fig. 10A and 10Brespectively before deployment and after retrieval according to some embodiments Fig. 9 Front view of the system.

[0028] Fig.11A , 11B 11C are front cross-sectional views of a system for accessing a patient's vascular system before deployment, after deployment and before retrieval, and after retrieval, respectively, according to some embodiments.

[0029] Fig. 12A , 12B 12C are front schematic deployed, front deployed, and front retracted views, respectively, of a system for accessing a patient's vascular system according to some embodiments.

[0030] Fig.13 is a schematic elevation view of a system for accessing a patient's vascular system, according to some embodiments.

[0031] Fig.14A and 14B According to some embodiments Fig.13 Schematic front and perspective views of the system.

[0032] Fig.15A and 15B Schematic illustration of an elevation view of a system for accessing a patient's vascular system in a deployed position and in a retracted position, respectively, according to some embodiments.

[0033] Fig. 15C and 15D is an elevational view of a distal end of a system for accessing a patient's vascular system in a retracted configuration with a protective cover respectively attached to and detached from a vascular access device, according to some embodiments.

[0034] Fig.16A and 16B is an elevational, partial cross-sectional view of a system for accessing a patient's vascular system, according to some embodiments.

[0035] Fig. 16C is an elevational view of a distal end of a system for accessing a patient's vascular system, according to some embodiments.

[0036] Fig.17A , 17B 17C are front views of coupling features according to some embodiments.

[0037] Fig.18A , 18B 18C are front / side views of coupling features according to some embodiments.

[0038] Fig.19A and 19Bis a front / side view of a coupling feature according to some embodiments.

[0039] Fig.19C and 19D 2 are front and side views, respectively, of a distal end of a coupling feature according to some embodiments.

[0040] Fig.19E and 19F are side and front views, respectively, of a coupling feature according to some embodiments.

[0041] Figure 19G is a side view of a coupling feature according to some embodiments.

[0042] Fig. 20A , 20B , 20C and 20D are front / side views of coupling features according to some embodiments.

[0043] Fig.21 is a front view of a coupling feature according to some embodiments.

[0044] Fig. 22 is a front view of a coupling feature according to some embodiments.

[0045] Fig.23 is an elevation view of a system for accessing a patient's vascular system, according to some embodiments.

[0046] Fig.24 According to some embodiments Fig.23 A front cross-sectional view of the connection features of the system.

[0047] Fig.25A is an elevational, cross-sectional view of a proximal portion of a system for accessing a patient's vasculature, according to some embodiments.

[0048] Fig.25B and 25C is an elevational cross-sectional view of a proximal portion of a system for accessing a patient's vasculature with a guidewire in an unlocked position and a locked position, respectively, according to some embodiments.

[0049] Fig.25D and 25E is an elevational cross-sectional view of a proximal portion of a system for accessing a patient's vasculature with a guidewire in an unlocked position and a locked position, respectively, according to some embodiments.

[0050] Fig.26A and 26B According to some embodiments, Figure 1 A perspective view of the components of a system.

[0051] Fig.27A , 27B27A and 27B are a front view, a front cross-sectional view, and a front cross-sectional view, respectively, of a cap according to some embodiments. DETAILED DESCRIPTION

[0052] Reference now Figure 1 , Figure 1 1 is a perspective view of a system 100 for accessing a patient's vascular system according to some embodiments. In some embodiments, the system 100 can have a proximal end 102 and a distal end 104. In some embodiments, the system 100 can further have: a tube 110; a guidewire 112 received within the tube 110 such that the guidewire 112 can be deployed distally from the tube 110; and a retrieval mechanism 114 that facilitates the retrieval of the guidewire 112 distally into the tube 110.

[0053] In some embodiments, system 100 may include an expansion kit for a vascular access device (VAD, not shown) and may be designed to work in conjunction with the vascular access device to enable one or more actions to be performed in the patient's vascular system while utilizing the access provided by the vascular access device. Such actions may include, but are not limited to, monitoring the vascular system, drawing blood or other fluids, injecting blood or other fluids into the vascular system, and / or the like. In some embodiments, guidewire 112 may be deployed into the vascular system via existing vascular access device components (e.g., a catheter and cannula already placed in a patient's vein (not shown)) to provide access through the vein to the patient's vascular system.

[0054] Thus, in some embodiments, the system 100 can be arranged in series with other vascular access device components. In some embodiments, the proximal end 102 and the distal end 104 can have features that facilitate such series connection. More specifically, the proximal end 102 can have a Luer connector 120 that connects the proximal end 102 to the tube 110, the Luer connector having a male component 122 and a female component 124. In some embodiments, the proximal end 102 can also have a proximal connector 126 that can be connected to a pressurized fluid source (e.g., a syringe filled with saline solution) or the like. In some embodiments, the proximal connector 126 can be optionally permanently fixed to the male component 122 to prevent accidental or intentional removal by a user, such as by bonding, adhesives, RF welding, and / or the like.

[0055] Similarly, in some embodiments, the distal end 104 can have a Luer connector 130 that connects the distal end 104 to the tube 110, the Luer connector having a male component 132 and a female component 134. In some embodiments, the distal end 104 can also have a distal connector 136 that is designed to interface with an existing vascular access device. In some embodiments, the distal connector 136 can be a blunt-tipped cannula or the like that fits within an existing female receiver in a vascular access device. In some embodiments, the distal connector 136 can be optionally permanently secured to the female component 134 to prevent accidental or intentional removal by a user, such as by bonding, adhesives, RF welding, and / or the like.

[0056] In some embodiments, distal end 104 may further have a clip 138 that holds distal end 104 coupled to the vascular access device until the user wishes to remove it. In some embodiments, clip 138 is optional; in other embodiments, another Luer connection or a different type of permanent connection may be used. Similarly, in other embodiments, proximal connector 126 may be replaced with various alternatives and / or enhanced with a clip or other retention device if desired.

[0057] Although the embodiments disclosed herein generally utilize a distal connector 136 in the form of a blunt cannula and a clip, all of these solutions can also be applied to male Luer connectors potentially with a rotational or fixed locking mechanism. They can also be applied to Luer-type male connectors without a rotational locking mechanism but with a clip (e.g., clip 138).

[0058] In some embodiments, tube 110 can have a wall 139 defining a proximal end 140, a distal end 142, and an outer surface 144. In some embodiments, guidewire 112 can be deployed into the patient's vascular system through a vascular access device. In some embodiments, deployment can require sliding guidewire 112 distally so that guidewire 112 slides from a retracted position, in which guidewire 112 is entirely contained within tube 110, to a deployed position, in which guidewire 112 protrudes distally beyond distal end 142 of tube 110 and protrudes into the patient's vascular system through the vascular access device.

[0059] In some embodiments, the guidewire 112 may have a proximal end 150 and a distal end 152. In some embodiments, in the retracted configuration, the proximal end 150 of the guidewire 112 may be located within the proximal end 140 of the tube 110, and the distal end 152 of the guidewire 112 may be located within the distal end 142 of the tube 110. In some embodiments, the male component 122 may have a generally flexible configuration that enables the guidewire 112 to bend around the tube 110, the vascular access device, and / or the patient's vascular system. Therefore, in some embodiments, the guidewire 112 may be generally constructed as a wire, a spring, or a combination of a wire and a spring, etc. In some alternative embodiments that will be described later, suction may be performed through the guidewire. In such embodiments, the guidewire may be optionally constructed as a tube through which suction may be performed. Alternatively, suction may be performed around the guidewire 112 through the tube 110. Suction may be achieved using devices such as LLAD and vacuum containers or syringes.

[0060] In some embodiments, the system 100 can be flushed with a high viscosity fluid to increase the resistance between the fluid and the tube 110 or the guide wire 112, thereby facilitating deployment. In some embodiments, the guide wire optionally has a variable pitch along its length. For example, the pitch of the guide wire 112 located upstream of the catheter end can allow more blood to flow, thereby providing an increased flow rate. In some embodiments, the guide wire 112 can have a smaller pitch near the end of the catheter to prevent blood clots from entering the device, but still allow blood to flow through the device. In some embodiments, the guide wire may or may not have a wire passing through the center for increasing rigidity for easy insertion.

[0061] Alternatively or additionally, in some embodiments, the guidewire 112 can have a soft or hard tube that is punched into the vascular access device instead of a spring or wire. In some embodiments, the soft or hard tube can be colored to increase visibility. In some embodiments, the soft or hard tube can be used to create a closed path for blood flow and prevent contamination of the blood due to drug absorption in the vascular access device. In some embodiments, the inner diameter and length of the soft or hard tube can be optionally optimized to minimize shearing of red blood cells and thus reduce hemolysis.

[0062] In some embodiments, the fluid path extending through the system 100 can be optimized to reduce or minimize the maximum shear stress during blood draw to reduce hemolysis. In some embodiments, the length of the fluid path can be selected based on one or more of the following: the specifications of a particular catheter, a particular vascular access device configuration, or a clinical setting. In some embodiments, the fluid path can include a length L from the proximal end 102 to the distal end 104 (e.g., see Figure 2A ). In some embodiments, the fluid path may include an inner diameter D.

[0063] Fluid flow in a tubular fluid path therethrough can be analyzed using the Poiseuille equation:

[0064]

[0065] Where ΔP is the change in pressure gradient along the length of the fluid path, D and L are the inner diameter and length of the fluid path, respectively, and μ is the viscosity of the fluid. is the fluid resistance. Since μ is the viscosity of the fluid and not part of the extended tube geometry, the geometric factor G is defined as f , so that R f (fluid resistance) is in

[0066] In some embodiments, the fluid path is tubular and may have multiple segments of length (L1, L2, L3) and inner diameter (D1, D2, D3), then the geometry factor is:

[0067]

[0068] In some embodiments, the inner diameter of the fluid path may vary over the entire length of the fluid path, then the geometry factor is:

[0069]

[0070] In some embodiments, the fluid path may have a non-circular cross-section or may have a complex inner diameter profile. The geometric factor may be determined by measuring the flow rate (Q) at a given pressure (ΔP) using a fluid of known viscosity (μ):

[0071]

[0072] The G of the fluid path can be selected when the guidewire 112 is in the deployed position. f The maximum shear stress of each catheter size is reduced to equal or less than BD 21G UltraTouch TM The maximum shear stress of the push-button blood collection kit (available from Becton, Dickinson & Company, Franklin Lakes, NJ), which was previously considered the gold standard for blood draws. In some embodiments, the G of the fluid path can be selected f The maximum shear stress of each catheter size is reduced to equal or less than BD 25G UltraTouch TM Maximum shear stress of a button blood collection kit (available from Becton, Dickinson & Company, Franklin Lakes, NJ).

[0073] In some embodiments, LUER-LOK TM An access device ("LLAD") or another suitable blood collection device may be coupled to proximal end 102 to facilitate blood drawing. TM The access device can include a needle assembly that can include a needle configured to receive a blood collection container. In these and other embodiments, the blood collection container can include an evacuated blood collection tube. In some embodiments, all or a portion of the air in the blood collection container is removed so that the pressure within the blood collection container is lower than ambient pressure. In some embodiments, the fluid path can include one or more of the needle assembly, the system 100 with the guidewire 112 in the deployed position, and the vascular access device, and can include the entire blood collection path through which blood flows during blood collection.

[0074] System geometry factor G of the fluid path fs It can be determined in a similar manner as described above. In some embodiments, the system geometry factor G fs Can be equal to or greater than 7.34E+06(1 / in 3 ). In some embodiments, G fs Another value may be included. In some embodiments, the system geometry factor G fs It can be 7.34E+06(1 / in 3 ) ±10%, ±25%, ±50%, or ±75%. In some embodiments, G fs Another value may be included, which may be selected based on the gauge and / or length of the catheter.

[0075] In some embodiments, the guidewire 112 can have a coupling feature 154 that facilitates coupling of the guidewire 112 to the retrieval mechanism 114. As used herein, "coupling" refers to a permanent or temporary connection through which movement of the retrieval mechanism 114 can drive movement of the guidewire 112. In some embodiments, the coupling feature 154 can be located at any of a variety of locations along the guidewire 112. In some embodiments, as Figure 1 As shown, the coupling feature 154 can be located near the proximal end 150. In some embodiments, the coupling feature 154 can have a generally enlarged cross-sectional shape relative to the remainder of the guidewire 112 (more particularly, relative to the distal end 152 of the guidewire 112 and the intermediate portion of the guidewire 112 located between the proximal end 150 and the distal end 152). In some embodiments, the enlarged cross-sectional shape can enable the coupling feature 154 to be coupled to the retrieval mechanism 114 through the wall 139 of the tube 110.

[0076] In some embodiments, the retraction mechanism 114 can effectively pinch the tube 110 into a narrower cross-section that can be moved proximally and / or distally by sliding the retraction mechanism 114 along the outer surface 144 of the tube 110. In some embodiments, the narrower cross-section can cause the interior of the tube 110 to impact on the coupling feature 154, causing the coupling feature 154 to move proximally or distally with the retraction mechanism 114.

[0077] More specifically, in some embodiments, the retraction mechanism 114 can have a housing 160 and one or more wheels 162 carried by the housing 160. In some embodiments, the housing 160 can have a hole 164 in which the tube 110 is received so that the tube 110 extends through the housing 160. In some embodiments, the wheel 162 can be rotatably coupled to the housing 160 and can be positioned to press against the outer surface 144 of the tube 110 within the housing 160. In some embodiments, the retraction mechanism 114 can have two wheels 162 located on opposite sides of the housing 160. In alternative embodiments, the retraction mechanism can have more or less than two wheels. In some embodiments, there are many other alternative structures, as will be described in conjunction with subsequent embodiments.

[0078] Reference now Figure 2A , 2B and 2C, Figure 2A , 2B 2C and 2C are in the pre-deployment position, deployed position and retracted position respectively. Figure 1 In some embodiments, the user can start with the system 100 in a pre-deployment position, such as Figure 2A From the pre-deployment position, the user can deploy the guidewire 112 into the patient's vascular system to move the system 100 to the Figure 2B In some embodiments, in response to completion of treatment of the patient, the system 100 may be moved to the position of the patient by sliding the retraction mechanism 114 proximally. Figure 2C retracted position.

[0079] In some embodiments, during operation, when the system 100 is in Figure 2AIn the case of the pre-deployment position of the system 100, the user can connect the system 100 to an existing vascular access device, for example, by inserting the distal connector 136 into the female receiver of the existing vascular access device and securing the clip 138 to the vascular access device. In some embodiments, the user can also connect the system 100 to a pressurized fluid source such as a syringe by connecting the proximal connector 126 to the pressurized fluid source. In some embodiments, the pressurized fluid at the proximal end 102 of the system 100 can be pressed against the proximal surface (or multiple proximal surfaces) of the coupling feature 154 of the guidewire 112, thereby driving the guidewire 112 distally from the retracted position to the guidewire 112. Figure 2B This process may be referred to as "flushing." In some embodiments, saline solution may be injected into the vascular system, or in some embodiments, saline solution may be expelled from the system 100 near the proximal end 102 of the system 100 via a valve (not shown) or the like.

[0080] In some embodiments, Figure 2A In the pre-deployment position of the tube 110, the retraction mechanism 114 can be positioned near the distal end 142 of the tube 110 so that the retraction mechanism 114 does not interfere with the deployment of the guidewire 112. In some embodiments, the position of the retraction mechanism 114 can control the extent to which the guidewire 112 can be deployed. In some embodiments, the user can take advantage of this feature by sliding the retraction mechanism 114 along the tube 110 to a desired position before deploying the guidewire 112. For example, a longer vascular access device may require a larger movement to deploy the guidewire 112 so that the distal end 152 of the guidewire 112 reaches the patient's vascular system. Conversely, a shorter vascular access device can be deployed using a smaller movement. In addition, the user may wish to control how far the distal end 152 of the guidewire 112 extends into the patient's vascular system.

[0081] Therefore, in some embodiments, the user can optionally slide the retraction mechanism 114 to a position between the proximal end 140 and the distal end 142 of the tube 110 before deployment to cause such a shorter deployment to occur. In some embodiments, the retraction mechanism 114 can pinch the tube 110 within the housing 160 so that the coupling feature 154 of the guidewire 112 cannot move through the housing 160.

[0082] In some embodiments, Figure 2BIn the deployed position, the user can use the access provided by system 100 when guidewire 112 is deployed in the vascular system to perform one or more actions related to the patient's vascular system. In some embodiments, once the one or more actions are completed, the user may wish to remove system 100 from the vascular access device without moving system 100 back to the retracted position. Therefore, the user can slide retraction mechanism 114 back toward the proximal end 140 of tube 110. In some embodiments, the pinched portion of tube 110 located within housing 160 of retraction mechanism 114 can also move proximally, thereby pushing coupling feature 154 proximally. In some embodiments, guidewire 112 can therefore move proximally until guidewire 112 is once again contained within tube 110 and system 100 is in a retracted position. Figure 2C In some embodiments, the user can then disconnect the distal connector 136 from the vascular access device without exposing themselves to blood. In some embodiments, optionally, a valve (not shown) can be present near the distal end 104 of the system 100; the valve can be closed after the guidewire 112 is retracted.

[0083] Reference now Figure 3 , Figure 3 is a front view of a system 300 for accessing a patient's vascular system according to some embodiments. In some embodiments, the system 300 may have Figure 1 100, except that the system 300 has a retraction mechanism 314 with a modified design. In particular, in some embodiments, the retraction mechanism 314 can have a housing 360 with a gripping feature 366 that enhances the user's ability to grasp the housing 360 and slide the housing along the tube 110. In some embodiments, the gripping feature 366 can be a ridge, a depression, a surface texture (e.g., knurling), and / or any other feature that makes the housing 360 easier to grip and move. In some embodiments, the retraction mechanism 314 can further have a wheel 362 with a smooth edge rather than a ridged edge.

[0084] Reference now Figure 4A and 4B , Figure 4A and 4B According to some embodiments, they can be respectively used to connect Figure 3 and Figure 1 In some embodiments, the smooth edge 400 of the wheel 362 can make Figure 3 In some embodiments, the ridged edge 410 of the wheel 162 of the retracting mechanism 114 can make it easier for the user to grasp and rotate in order to cause the retracting mechanism 114 to slide along the Figure 1 The tube 110 in the embodiment slides.

[0085] In other embodiments, wheels such as wheel 162 or wheel 362 may be completely enclosed within the housing so that the user cannot see or touch them. This configuration may advantageously simplify the appearance of the device and eliminate potential pinch points.

[0086] Reference now Figure 5A , 5B and 5C, Figure 5A , 5B 5C are front views of a system 500 for accessing a patient's vascular system in a pre-compression state, a compressed state, and a compressed state, respectively, according to some embodiments. In some embodiments, the system 500 can be configured to be Figure 1 The system 100 is constructed in a similar manner, except that deployment and / or retrieval can be performed by manually compressing the tube 110.

[0087] More specifically, in some embodiments, the system 500 can have a guidewire 512, a retrieval mechanism 514, and a Figure 1 Similar tube 110. In some embodiments, the guidewire 512 can have a proximal end 550, a distal end 552, and a coupling feature 554 located near the proximal end 550. In some embodiments, the coupling feature 554 can protrude outward toward the interior of the tube 110 so that the tube 110 can be compressed to grasp the coupling feature 554 through the tube 110. In some embodiments, the retraction mechanism 514 can be configured as a compression ring that can be elastically compressed manually or by applying other compression forces (e.g., via a tool such as a crimper or the like) to grasp the outer surface 144 of the wall 139 of the tube 110.

[0088] like Figure 5A As shown, in some embodiments, the coupling feature 554 can be manually compressed in the direction indicated by arrow 570 so that the coupling feature grips the outer surface 144 of the wall 139 of the tube 110. Figure 5B System 500 is shown with some compression applied, according to some embodiments. Figure 5C System 500 is shown with full compression applied, according to some embodiments. In some embodiments, as indicated by arrow 580, retraction mechanism 514 can be moved along tube 110 to cause coupling feature 554 to move proximally or distally.

[0089] Thus, in some embodiments, the retraction mechanism 514 can be used as a deployment mechanism in addition to or as an alternative to the retraction mechanism. In some embodiments, rather than deploying the guidewire 512 by flushing the tube 110 with pressurized fluid, the guidewire 512 can be manually deployed using the retraction mechanism 514. In some embodiments, the guidewire 512 can then be manually retracted, also by squeezing the retraction mechanism 514 as indicated by arrow 570 using the retraction mechanism 514, and then sliding the retraction mechanism 514 proximally. In some embodiments, the guidewire 512 can alternatively be deployed by flushing and then retracted with the retraction mechanism 514.

[0090] Reference now Figure 6 , Figure 6 is a front view of a system 600 for accessing a patient's vascular system according to some embodiments. In some embodiments, the system 600 can be similar to Figure 1 The system 100 may be constructed in the same manner as described above, except that deployment and / or retrieval may be performed without the use of wheels such as wheel 162 or wheel 362.

[0091] More specifically, in some embodiments, the system 600 can have a guidewire 612, a retrieval mechanism 614, and a similar Figure 1 110. In some embodiments, the guide wire 612 can have a proximal end 650, a distal end (not shown), and a coupling feature 654 located near the proximal end 650. In some embodiments, the coupling feature 654 can protrude outward, but does not have to directly engage with the interior of the tube 110. Instead, in some embodiments, the retraction mechanism 614 can be constructed as a ring with an inwardly convex protrusion 670 that continuously presses inwardly against the outer surface 144 of the wall 139 of the tube 110. In some embodiments, the pinched inner diameter of the tube 110 may be too small to allow the coupling feature 654 to pass through it. Therefore, in some embodiments, the retraction mechanism 614 can be used to push the coupling feature 654 proximally or distally to deploy or retract the guide wire 612.

[0092] Reference now Fig. 7A , 7B and 7C, Fig. 7A , 7B 7C are perspective, front cross-sectional, and side cross-sectional views of a system for accessing a patient's vascular system according to another alternative embodiment. In some embodiments, system 700 may be similar to Figure 1 The system 100 is constructed in the same manner, except that deployment and / or retrieval can be facilitated through the use of ball bearings.

[0093] More specifically, in some embodiments, the system 700 can have a guidewire 712, a retrieval mechanism 714, and a Figure 1 Similar to tube 110. Guidewire 712 can have a proximal end 750, a distal end 752, and a coupling feature 754 positioned near proximal end 750. In some embodiments, retrieval mechanism 714 can have one or more ball bearings 770 that press against outer surface 144 of wall 139 of tube 110, thereby making the inner surface of tube 110 within retrieval mechanism 714 too small to allow coupling feature 754 to pass therethrough.

[0094] In some embodiments, the ball bearing 770 can rotate within a socket 780 formed in the interior of the retraction mechanism 714, which faces the outer surface 144 of the wall 139 of the tube 110. In some embodiments, the rotation of the ball bearing 770 can make it easier for the retraction mechanism 714 to slide along the tube 110. In some embodiments, the retraction mechanism 714 can also be rotatable in a manner similar to Figure 6 The system 600 functions in the manner of the system 600 and can be used to deploy or retrieve the guidewire 712. In some embodiments, the system 600 has three ball bearings that are radially symmetrically distributed about the axis of the retrieval mechanism; however, in other embodiments, there may be one, two, or more than three ball bearings, and they may be arranged in various symmetrical and asymmetrical configurations.

[0095] Reference now Fig. 8A and 8B , Fig. 8A and 8B 800 and 880 are schematic cross-sectional views of the front view for accessing the vascular system of a patient according to some embodiments. In some embodiments, both system 800 and system 880 can be similar to Figure 1 The system 100 is constructed in the same manner, except that deployment and / or retrieval can be performed through the use of magnetism.

[0096] More specifically, in some embodiments, the system 800 can have a guidewire 812, a retrieval mechanism 814, and a similar Figure 1 110. In some embodiments, the guidewire 812 can have a proximal end 850, a distal end 852, and a coupling feature 854 located near the proximal end 650. In some embodiments, the coupling feature 854 can be magnetic or can be made of a magnetic material such as a ferromagnetic material. In some embodiments, the retrieval mechanism 814 can also be magnetic or can be made of a magnetic material such as a ferromagnetic material, and the magnetic material is selected so that there is an attractive or repulsive force between the coupling feature 854 and the retrieval mechanism 814. In some embodiments, the retrieval mechanism 814 can wrap around the tube 110 or can simply be slidably coupled to one side of the tube 110 as shown.

[0097] Reference now Fig. 8A , Fig. 8A The system 800 is depicted in a pre-deployment position. In some embodiments, when the guidewire 812 is deployed, the guidewire can move distally (i.e., Fig. 8A 812, thereby driving the coupling feature 854 close to the retraction mechanism 814. Then, in order to retract the guide wire 812, the coupling feature 854 can be moved proximally (i.e., Fig. 8A In some embodiments, the repulsive force between the retraction mechanism 814 and the coupling feature 854 can cause the retraction mechanism 814 to push the coupling feature 854 proximally in front of it. In some embodiments, the attractive force between the retraction mechanism 814 and the coupling feature 854 can cause the retraction mechanism 814 to pull the coupling feature 854 proximally behind it. In some embodiments, in either case, by virtue of the magnetic coupling between the coupling feature 854 and the retraction mechanism 814, the proximal movement of the retraction mechanism 814 can cause the guidewire 812 to move proximally to the retracted position.

[0098] It is noteworthy that in some embodiments, both the retraction mechanism 814 and the coupling feature 854 can be magnetized so that they have relative polarities that provide the desired attraction or repulsion. However, in some embodiments, only one of the retraction mechanism 814 and the coupling feature 854 is magnetized; the other can simply provide a low magnetic resistance path for the magnetic field generated by the other, thereby causing an attraction between the two. In some embodiments, if desired, the retraction mechanism 814 can be used to deploy the guidewire 812 in addition to or as an alternative to retracting the guidewire 812.

[0099] In some embodiments, Figure 8B The system 880 of the present invention is similar. However, in some embodiments, the retraction mechanism 884 of the system 880 can have an annular shape that surrounds or substantially surrounds the tube 110. In some embodiments, the tube 110 can be connected to a magnetic hub 890 at the distal end 142 of the tube, which attracts the retraction mechanism 884 to keep it in place until the retraction of the guidewire 812 is about to be performed. Therefore, in some embodiments, one or both of the magnetic hub 890 and the retraction mechanism 884 can be magnetic. In some embodiments, one can be formed of a magnetic material such as a ferromagnetic material. In some embodiments, the system 880 can further have a spacer 892, which is located between the retraction mechanism 884 and the magnetic hub 890 to facilitate the separation of the retraction mechanism 884 from the magnetic hub 890 when it is time to retract the guidewire 812.

[0100] Reference now Fig. 9 , Fig. 9 is a perspective view of a system 900 for accessing a patient's vascular system according to some embodiments. In some embodiments, the system 900 can be similar to Figure 1The system 100 is constructed in the same manner, except that the retraction can be driven by a spring.

[0101] More specifically, in some embodiments, the system 900 can have a retraction mechanism 914 and a similar Figure 1 The tube 110 and the guidewire 112. In some embodiments, the retraction mechanism 914 may include a housing 960 having a button 962 coupled to a spring 964 that is maintained in a compressed state until retraction is performed.

[0102] Reference now Fig. 10A and 10B , Fig. 10A and 10B According to some embodiments Fig. 9 A front view of the system before deployment and after retraction. In some embodiments, before deployment, such as Fig. 10A As shown, spring 964 is located within housing 960. In some embodiments, when retraction is desired, the user can press button 962 to release a capture member (not shown) within housing 960 to release spring 964, thereby allowing spring 964 to extend distally and push coupling feature 154 in a distal direction. In some embodiments, spring 964 can have an inner diameter sufficient to slide over distal end 152 of guidewire 112, but small enough so that spring 964 cannot pass over coupling feature 154. Thus, in some embodiments, the expansion of spring 964 pushes coupling feature 154 and thus guidewire 112 to move distally to Fig. 10B Shown in retracted position.

[0103] Reference now Fig.11A , 11B and 11C, Fig.11A , 11B 11C are front cross-sectional views of a system 1100 for accessing a patient's vascular system before deployment, after deployment and before retrieval, and after retrieval, respectively, according to some embodiments. In some embodiments, the system 1100 may be similar to Fig. 9 System 900, but with springs for driving both deployment and retraction.

[0104] More specifically, in some embodiments, the system 1100 can have a retraction mechanism 1114 and a deployment mechanism 1116 and Figure 1 Similar tube 110 and guide wire 112. In some embodiments, each of the retraction mechanism 1114 and the deployment mechanism 1116 may include a spring that is Fig.11AIn some embodiments, the retraction mechanism 1114 may include a spring 1160 and the deployment mechanism 1116 may include a spring 1170. In some embodiments, the spring 1160 of the retraction mechanism 1114 may be located within the tubular housing 1180 and the spring 1170 of the deployment mechanism 1116 may be located outside of the tubular housing 1180 and substantially surround the tubular housing.

[0105] In some embodiments, both the retraction mechanism 1114 and the deployment mechanism 1116 can further include: a catch (not shown) that holds the associated spring in a compressed state until retraction or deployment, respectively; and a button, lever, or other user control (not shown) that can release the catch to initiate retraction or deployment, respectively. Thus, the user can actuate the appropriate control to initiate deployment or retraction.

[0106] In some embodiments, initially, both spring 1160 and spring 1170 may be in a compressed state, such as Fig.11A In some embodiments, when the user begins deployment, the spring 1170 may be allowed to expand, thereby pushing the tubular housing 1180 and the guidewire 112 distally. In some embodiments, the tubular housing 1180 may stop moving near the distal end 142 of the tube 110, as shown. Fig. 11B as in the deployment structure of .

[0107] In some embodiments, when the user begins to retract, the spring 1160 can be allowed to expand, thereby pushing the guidewire 112 proximally. In some embodiments, the tubular housing 1180 can remain in place. Thus, in some embodiments, the system 1100 can reach Fig. 11C A retracted configuration in which springs 1160 and 1170 are both extended and relatively relaxed.

[0108] Reference now Fig. 12A , 12B and 12C, Fig. 12A , 12B 12C are front schematic deployment diagrams, front deployment diagrams, and front retraction diagrams of system 1200 for accessing a patient's vascular system according to some embodiments. In some embodiments, system 1200 may be similar to Figure 1 The system 100 has a tether for performing the retrieval.

[0109] More specifically, in some embodiments, Fig. 12A As shown, system 1200 may have Figure 1Tube 110 and guidewire 112 are shown, along with a retrieval mechanism 1214 that includes a tether 1270. In some embodiments, the tether can be secured to the coupling feature 154 of the guidewire 112 and can extend proximally from the coupling feature 154 and away from the system 1200 so that a user can pull on the free end of the tether 1270 to retract the guidewire 112 from the deployed position to the retracted position.

[0110] like Fig. 12B As shown, in some embodiments, system 1200 can include a housing 1280 located proximal to tube 110 through which the free end of tether 1270 exits and through which the user can access the free end of the tether. In some embodiments, the free end can have a grip 1290, such as a ball or knob, that can be easily grasped and pulled by hand. Fig. 12B In the deployed position, grip 1290 can be located proximate to housing 1280 with little or no portion of tether 1270 exposed between housing 1280 and grip 1290. In some embodiments, pulling grip 1290 can pull guidewire 112 to the retracted position as grip 1290 moves away from housing 1280, thereby exposing more of tether 1270 outside of housing 1280.

[0111] like Fig. 12C As shown, in some embodiments, a spring 1294 can be coupled to the guidewire 112 to hold the guidewire 112 in a deployed position until the user pulls the tether 1270 proximally. Thus, the user can optionally pull against the force of the spring 1294 to retract the guidewire 112.

[0112] Reference now Fig.13 , Fig.13 is a schematic front view of a system 1300 for accessing a patient's vascular system according to some embodiments. In some embodiments, the system 1300 may be similar to Fig. 12A , 12B 12C with a tether for performing retrieval. However, in some embodiments, system 1300 may also include a rotating reel 1370 that receives and reels the tether during retrieval. Rotating reel 1370 may be manually operated (e.g., via a crank or the like), or may be driven by a spring, motor, or other device.

[0113] Reference now Fig.14A and 14B , Fig.14A and 14B According to some embodiments Fig.13 A front schematic and perspective view of system 1300 is provided. Fig.14AAn optional use of electricity delivered by wire 1470 to power a motor (not shown) in rotating winding member 1370 is shown in accordance with some embodiments. In some embodiments, rotating winding member 1370 can have a main shaft (not shown) around which the proximal end of tether 1270 is wound; the main shaft can be rotated in the direction indicated by arrow 1374 to retract tether 1270 and pull guidewire 112 to a retracted position.

[0114] Fig. 14B The rotating winding member 1370 is shown in more detail according to some embodiments. In some embodiments, the rotating winding member 1370 may include: a housing 1480 to receive the tether 1270; a motor compartment 1490 that stores an electric motor, spring or other drive; and an aspiration port 1494 that can be connected to a fluid container. In some embodiments, blood and / or other liquids can be drawn from the tube 110 through the rotating winding member 1370 and drawn out of the system 1300 through the aspiration port 1494. Other rotating winding mechanisms that can be used in conjunction with such embodiments are shown and described in U.S. patent application serial number 16 / 388,650, entitled "INSTRUMENT DEVLIERY DEVICE HAVING AROTARY ELEMENT," filed on April 18, 2019, which is incorporated herein by reference.

[0115] Reference now Fig.15A and 15B , Fig.15A and 15B 1 is a schematic elevation view of a system 1500 for accessing a patient's vascular system in a deployed position and a retracted position, respectively, according to some embodiments. In some embodiments, in addition to or as an alternative to retracting the guidewire into the tube, the system can have a protective cover that extends to cover the guidewire in the deployed configuration. In some embodiments, such a protective cover can contain blood and / or other fluids from the surgical site, thereby helping the physician avoid exposure to potential pathogens.

[0116] More specifically, in some embodiments, system 1500 may have a configuration similar to Figure 1The system 1500 may include a tube 110 and a guidewire 112 of the system 100. However, in some embodiments, the system 1500 may not include a retrieval mechanism, but may have a protective cover 1514 that can extend distally from the distal end 142 of the tube 110 to cover the guidewire 112 after the guidewire 112 is deployed. In some embodiments, the protective cover 1514 may include an extendable member 1560 and a collar 1562 at the distal end of the extendable member 1560. In some embodiments, the extendable member 1560 has an accordion structure or a similar structure that allows the extendable member 1560 to effectively extend along its axis. In some embodiments, the collar 1562 can help provide a fluid seal when the guidewire 112 is deployed within the patient's vascular system and / or when the system 1500 is removed from the vascular access device.

[0117] Fig.15A The system 1500 is shown in a deployed position according to some embodiments, wherein the extendable member 1560 is in a compressed configuration to allow the guidewire 112 to protrude beyond the loop 1562. In some embodiments, during the performance of one or more actions requiring access to the vascular system, the exposed portion of the guidewire 112 can be located within the vascular access device and / or the patient's vascular system (not shown). In some embodiments, after the action is completed, rather than retracting the guidewire 112 into the tube 110, the guidewire 112 can remain deployed relative to the tube 110, but the extendable member 1560 can be extended to cover the guidewire 112 so that the guidewire 112 is contained within the protective cover 1514, as shown. Fig. 15B shown. Fig.15A and 15B is a schematic diagram omitting details of system 1500 according to some embodiments, some of which will be described in Fig. 15C and 15D Shown in.

[0118] Fig. 15C and 15D is an elevational view of the distal end of system 1580 for accessing a patient's vascular system in a retracted state with protective cover 1590 attached to and detached from the vascular access device, respectively, according to some embodiments. In some embodiments, system 1580 may be configured to Fig.15A and 15B1500, except that system 1580 has a protective cover 1590 with a collar 1592 having a coupling feature 1594 that can be used to removably couple the distal end of protective cover 1590 to another device (e.g., vascular access device 1596) to form a fluid-tight seal. In some embodiments, coupling feature 1594 can take the form of, for example, a pair of arms that extend proximally and curve inwardly to slide into corresponding slots 1599 in vascular access device 1596. In some embodiments, various detents, locking features, and / or other devices (not shown) can be used to ensure that the pair of arms remain engaged within slots 1599 until intentionally removed by a user.

[0119] In some embodiments, Fig. 15C In the sealed configuration, blood and / or other fluids can be retained within the protective cover. In some embodiments, when system 1500 is to be decoupled from vascular access device 1596, system 1500 can be oriented with protective cover 1590 facing upward to ensure that any fluid captured within protective cover 1590 does not leak out of protective cover 1590. Then, in some embodiments, the arm can be decoupled from vascular access device 1596, such as Fig.15D Then, in some embodiments, if desired, a cap or other sealable feature (not shown) can be coupled to coupling feature 1594 to seal protective cover 1590 to contain otherwise exposed portions of guidewire 112 and associated fluids to prevent leakage of the fluids during subsequent storage, transport, and / or disposal.

[0120] Reference now Fig.16A and 16B , Fig.16A and 16B 1 is a partial cross-sectional view of a system 1600 for accessing a patient's vascular system according to some embodiments. In some embodiments, instead of retracting the guidewire 112 and covering the guidewire 112 with a protective cover, a cleaning module can be used to clean blood and / or other fluids from the guidewire 112. In some embodiments, the cleaning module can slide along the guidewire 112 to absorb and remove fluids using a scraper effect.

[0121] Fig.16AThe distal end and cleaning module 1670 of the system 1600 according to some embodiments are shown, which can be used to clean the guide wire 112 instead of retracting or covering the guide wire 112. In some embodiments, the cleaning module 1670 can be designed to absorb and remove fluid. In particular, in some embodiments, the cleaning module 1670 can have a housing 1672 and a cap 1674, both of which can be cannulated to receive the guide wire 112. In some embodiments, the interior of the housing 1672 can define an absorbent member 1676 (e.g., a pad) and a fluid removal member 1678, which can be a rubber seal or other structure designed to slide along the surface of the guide wire 112 and prevent blood from leaving the interior of the housing 1672. In some embodiments, the absorbent member 1676 can be positioned adjacent to the fluid removal member 1678 so that the fluid captured by the fluid removal member 1678 is naturally directed to the absorbent member 1676. In some embodiments, the cap 1674 can be optionally removed before cleaning.

[0122] In some embodiments, the cleaning module 1670 can be advanced away from the distal connector 136 of the system 1600 and can initially interface with the distal connector 136, which can be a blunt-tipped cannula or the like. Fig. 16B Shown is how such interfacing occurs according to some embodiments.

[0123] In some embodiments, the retraction of the guidewire 112 and the cleaning of the guidewire 112 may be performed together; these two steps are not necessarily mutually exclusive. In particular, rather than advancing the cleaning module 1670 away from the distal connector 136, the cleaning module 1670 may be initially positioned proximal to the distal connector 136, and the guidewire 112 may be retracted through the cleaning module 1670 to clean the guidewire 112 as the guidewire 112 passes through the cleaning module 1670. In some embodiments, the guidewire 112 may be retracted completely through the cleaning module 1670, or may be retracted only until the distal end 152 of the guidewire 112 is located within the cleaning module 1670. Then, in some embodiments, the cleaning module 1670 may remain in place on the distal connector 136 and may be disposed of with the rest of the system 1600 after use.

[0124] Fig. 16C is an elevational view of a distal end of a system 1680 for accessing a patient's vascular system, according to some embodiments. Fig.16A and Fig. 16BAs in system 1600 of the present invention, system 1680 can have a cleaning module 1690 that cleans guidewire 112 in addition to or as an alternative to retracting guidewire 112 and / or covering guidewire 112 after use. In some embodiments, cleaning module 1690 can have a housing 1692 and a fluid removal member 1698 that can use a scraper effect. In some embodiments, housing 1692 can be part of a Luer connector on the proximal end of a vascular access device, or can be a separate component connected to the proximal end of a vascular access device.

[0125] As previously mentioned, in some embodiments, the coupling feature can serve multiple functions. In some embodiments, the coupling feature is connected to a retraction mechanism. In some embodiments, the coupling feature receives fluid pressure and moves the guide wire in response to the fluid pressure. In some embodiments, the coupling feature can be used as a motion stop to limit the deployment and / or retraction of the guide wire. Various coupling features can be used in conjunction with the present disclosure.

[0126] According to various embodiments, the coupling feature may have a tapered exterior or one or more rounded ridges to improve the ability to round corners when it is deployed or punched into position. In some embodiments, the coupling feature may have fins to help it travel along the pipeline. In some embodiments, the coupling feature may have a window therein to allow fluid to flow around it. In some embodiments, the coupling feature may be attached to a guide wire and / or pipeline by interference fit, adhesive or both. In some embodiments, a tapered pipeline may also be used so that the large outer diameter end is used as its own coupling feature. In some embodiments, the coupling feature may be colored to increase visibility. In some embodiments, longitudinal ribs may be molded on the outer surface of the coupling feature to keep the coupling feature correctly oriented (i.e., parallel to pipe 110) so that the coupling feature moves straight forward during deployment. Alternatively, in some embodiments, the longitudinal ribs may have relative characteristics to prevent the coupling feature from rotating.

[0127] Reference now Fig.17A , 17B and 17C, Fig.17A , 17B 17C are front views of coupling feature 1700, coupling feature 1740, and coupling feature 1780, respectively, according to some embodiments. As shown, in some embodiments, coupling feature 1700 can have a simple "wedge" shape with a frustoconical surface 1710. In some embodiments, coupling feature 1740 can also have a wedge shape with a proximal ridge 1750 that interfaces with the interior of tube 110 to form a seal. In some embodiments, coupling feature 1780 can have a wedge shape with a pair of ridges 1790 to facilitate retention of a spring or other component of the retraction mechanism.

[0128] Reference now Fig.18A , 18B and 18C, Fig.18A , 18B 18C are front / side views of coupling feature 1800, coupling feature 1840, and coupling feature 1880, respectively, according to some embodiments. As shown, in some embodiments, coupling feature 1800 can have a wedge shape similar to coupling feature 1700, with a frustoconical surface 1810 having a greater diameter taper. In some embodiments, coupling feature 1840 can have a generally cylindrical shape with a cylindrical surface 1850. In some embodiments, coupling feature 1880 can have a stepped cylindrical shape with a first cylindrical surface 1890 having a first diameter and a second cylindrical surface 1894 having a smaller second diameter.

[0129] Reference now Fig.19A and 19B , Fig.19A and 19B 1900 and the front / side view of the coupling feature 1910 according to some embodiments. In some embodiments, the coupling feature 1900 can have a generally spherical surface 1902 with a boss 1904 for connecting to the rest of the guide wire or to another element. In some embodiments, the coupling feature 1910 can have a spline surface 1912 with a groove 1914 that allows fluid to be transmitted around the coupling feature 1910 (e.g., between the coupling feature 1910 and the inner wall of the tube 110).

[0130] Fig.19C and 19D 1920 are front and side views, respectively, of the distal end of the coupling feature 1920 according to some embodiments. As shown, in some embodiments, the coupling feature 1920 can have a generally cylindrical surface 1922 with two ridges 1924 protruding outward to engage the inner surface of the tube 110. In some embodiments, each ridge 1924 can have notches 1926 spaced around its periphery to allow fluid to flow between the ridge 1924 and the inner surface of the tube 110. In some embodiments, the coupling feature 1920 can further have a hole 1928 through which a fluid can flow, for example, for injecting a fluid into a patient's vascular system or for aspirating blood from the vascular system.

[0131] Fig.19E and 19F1930 . As shown, in some embodiments, the coupling feature 1930 can have a set of splines 1932 that define a generally frustoconical outer surface 1934 that abuts a smaller cylindrical portion 1936. In some embodiments, the splines 1932 can help keep the coupling feature 1930 properly oriented within the tube 110 and also facilitate fluid flow around the coupling feature 1930.

[0132] Figure 19G 1940 is a side view of a coupling feature 1940 according to some embodiments. In some embodiments, coupling feature 1940 can have a more organic shape defining a complex surface 1942. In some embodiments, complex surface 1942 can optionally include splines, as in other embodiments.

[0133] Reference now Fig. 20A , 20B , 20C and 20D, Fig. 20A , 20B , 20C and 20D are front / side views of coupling feature 2000, coupling feature 2010, coupling feature 2020 and coupling feature 2030 according to some embodiments. In some embodiments, coupling feature 2000 has a generally parabolic surface 2002, while coupling feature 2010 has a non-axisymmetric crescent-shaped member 2012 and engages the inner surface of tube 110 with the end 2014 of crescent-shaped member 2012. In some embodiments, coupling feature 2020 and coupling feature 2030 both have a disc-shaped member 2022 with a hole 2024 that allows fluid to flow through disc-shaped member 2022. In some embodiments, coupling feature 2020 is fixed to a helical guidewire portion 2026, while coupling feature 2030 is fixed to a straight guidewire portion 2036.

[0134] Now refer to Fig.21 , Fig.21 is a front view of a coupling feature 2100 according to some embodiments. In some embodiments, coupling feature 2100 can have a wedge shape with splines 2110 that allow fluid to flow through the coupling feature therebetween in the direction of arrows 2120.

[0135] Reference now Fig. 22 , Fig. 222200, each fin having a crescent shape. In some embodiments, the first fin 2210 and the second fin 2220 can be separated from each other by a thin flexible member 2230, which is bent to allow a certain degree of relative rotation between the first fin 2210 and the second fin 2220, thereby accommodating the bend in the inner surface of the tube 110. In some embodiments, the crescent shape can help provide a seal against the inner wall of the tube 110 and help capture the hydraulic force to provide reliable deployment in response to the rush pressure. In some embodiments, the small hole 2240 passing through the first fin 2210 and the second fin 2220 can help provide some lubrication and / or fluid passing therethrough. In some embodiments, the inner hole 2250 can enable blood and / or other fluids to be drawn from the patient's vascular system.

[0136] Reference now Fig.23 , Fig.23 23 is a front view of a system 2300 for accessing a patient's vascular system according to some embodiments. In some embodiments, the system 2300 may have: a tube 110 having a proximal end 140 and a distal end 142; and a guidewire 2312 having a proximal end 2350 and a distal end 2352. In some embodiments, a coupling feature 2354 near the proximal end 2350 may couple the guidewire 2312 to a retrieval mechanism (not shown), such as any of the retrieval mechanisms previously described herein. Alternatively, in some embodiments, the system 2300 may not have a retrieval mechanism, but may function in conjunction with a protective cover and / or a cleaning module disclosed herein.

[0137] Reference now Fig.24 , Fig.24 According to some embodiments Fig.23 13. The front cross-sectional view of the proximal portion of the system 2300 of FIG. As shown, in some embodiments, the coupling feature 2354 can have two ridges 2400 extending outward to contact the inner surface of the wall 139 of the tube 110. In some embodiments, the presence of multiple ridges 2400 can help the coupling feature 2354 to bend around the bend in the tube 110. In some embodiments, the guide wire 2312 can have a hole 2410 extending over its entire length to allow fluid to be drawn from the patient's vascular system through the guide wire 2312. In some embodiments, the coupling feature 2354 can further have a valve 2420, which is closed in response to positive pressure near the coupling feature 2354 (such as when the guide wire 2312 is to be deployed by flushing) and opened in response to positive pressure from the vascular system as shown to allow suction.

[0138] In some embodiments, various capture mechanisms may be used to prevent, for example, Fig.23 and Fig.24 Premature withdrawal of a guidewire such as guidewire 2312. Figures 25A to 25E Various examples are shown and described.

[0139] Fig.25A is a front cross-sectional view of a proximal portion of a system 2500 for accessing a patient's vascular system, according to some embodiments. In some embodiments, the system 2500 has Fig.23 and 24 A guidewire 231 and a tube 2510 having a modified construction designed to incorporate a capture member to lock the guidewire 2312 in a deployed position until retrieval is desired.

[0140] In particular, in some embodiments, the tube 2510 can have a wall 2539 defining an inner surface 2545. In some embodiments, the inner surface 2545 can be shaped to provide a stop 2560 and a locking wing 2570. In some embodiments, the stop 2560 can be sized to receive the adjacent edge of any one of the ridges 2400 to provide one or two stable resting positions for the guidewire 2312. In some embodiments, the locking wing 2570 can lie flat on the rest of the inner surface 2545 as the coupling feature 2354 moves distally through the tube 2510, but can be biased to pivot to the interior of the tube 2510 after one of the ridges 2400 passes through it. Thus, in some embodiments, the locking wing 2570 can prevent the guidewire 2312 from moving proximally until the user desires.

[0141] In some embodiments, the guidewire 2312 may be pushed proximally by applying sufficient force to overcome the restraining force of the locking wings 2570 so that the locking wings 2570 bend back proximally. Then, one or both of the ridges 2400 may be able to return proximally past the locking wings 2570. In an alternative embodiment, a user-actuated release mechanism may be connected to the locking wings 2570 to enable the user to disengage the locking wings 2570 to facilitate the retraction of the guidewire 2312.

[0142] Fig.25B and 25C is a front view of a proximal portion of a system 2580 for accessing a patient's vascular system, with guidewire 2312 in an unlocked position and a locked position, respectively, according to some embodiments. In some embodiments, system 2580 also includes Fig.23 and 24 The invention also provides a guide wire 2312 of the present invention and has a tube 2582 with a modified structure. In some embodiments, the tube 2582 has a wall 2584 with an inner surface 2586.

[0143] In some embodiments, the inner surface 2586 defines a stopper 2587 and a locking wing 2588, which may have an annular configuration. In some embodiments, the stopper 2587 and the locking wing 2588 may be arranged in a manner similar to that of a stopper 2587 and a locking wing 2588. Fig.25A The corresponding portion of the system 2500 of 2582 functions in a substantially similar manner. However, in some embodiments, the stopper 2587 can be larger and can extend a full circle around the coupling feature 2354, thereby providing a more secure fixation. Additionally, in some embodiments, the inner surface 2586 of the wall 2584 of the tube 2582 can also define a reduced diameter portion 2589 of the tube proximal to the stopper 2587, where the tube 2582 is too narrow to receive the coupling feature 2354. This can provide an additional hard stop to limit the proximal travel of the guidewire 2312.

[0144] Fig.25D and 25E 25 is a front view of a proximal portion of a system 2590 for accessing a patient's vascular system, with a guidewire 2512 in an unlocked position and a locked position, respectively, according to some embodiments. In some embodiments, the guidewire 2512 may be similar to Fig.23 and 24 In some embodiments, the system 2590 can further include a tube 2592 having a modified structure. In some embodiments, the tube 2592 includes a wall 2594 having an inner surface 2596.

[0145] In some embodiments, the inner surface 2596 defines a stop 2597, which can have an annular configuration. However, in some embodiments, the inner surface 2596 may not define a locking wing. Instead, in some embodiments, the locking wing 2598 can be positioned on the coupling feature 2554 of the guidewire 2512. Rather than locking with the ridge 2400 of the coupling feature 2554, in some embodiments, the locking wing 2598 can lock with the stop 2597, such as Fig.25E In some embodiments, the inner surface 2596 of the wall 2594 of the tube 2592 can also define a reduced diameter portion 2599 of the tube proximal to the stop 2597 where the tube 2592 is too narrow to receive the coupling feature 2554 .

[0146] The various systems of the present disclosure may be inserted through various vascular access devices, including but not limited to straight catheters and integrated catheters. Infusions, blood draws, or other vascular access may be performed through the system itself, an integrated PIVC extension kit, an extension kit for a blunt cannula device, or a separate extension kit (e.g., a T-connector).

[0147] Reference now Fig.26A and 26B , Fig.26A and26B According to some embodiments, Figure 1 100. More particularly, Fig.26A An assembly 2600 is shown having the system 100 , a first vascular access device 2610 coupled to the distal connector 136 of the system 100 , and a syringe 2620 coupled to the proximal connector 126 of the system 100 . Fig.26B An assembly 2650 is shown having the system 100, a second vascular access device 2660 that is configured differently than the first vascular access device 2610 and coupled to the distal connector 136 of the system 100, and a syringe 2620 coupled to the proximal connector 126 of the system 100. Fig.26A and 26B System 100 is shown in FIG. 1 , but in some embodiments, any other system disclosed herein may be used in conjunction with first vascular access device 2610, second vascular access device 2660, syringe 2620, or any other vascular access device or pressurized fluid source known in the art.

[0148] Reference now Fig.27A , 27B and 27C, Fig.27A , 27B 27C are a front view, a front cross-sectional view, and a front cross-sectional view of cap 2700, cap 2720, and cap 2740, respectively, according to some embodiments. In some embodiments, cap 2700, cap 2720, and cap 2740 are shown in Figure 1 The invention is preferably used on the system 100 of the present invention, but may also be used in combination with any other system disclosed herein.

[0149] In some embodiments, the cap 2700 may have ridges 2710 that serve as gripping features to facilitate removal of the cap 2700 from the distal connector 136. In some embodiments, the caps 2720 and 2740 may have solid distal ends 2730 and 2750, respectively, that keep the distal end 152 of the guidewire 112 from sliding proximally out of the caps 2720 or 2740 during transport and infusion. In alternative embodiments, the caps may have other features, such as vents in the sidewalls or distal walls.

[0150] All examples and conditional language recorded herein are intended for teaching purposes to help readers understand the present invention and the concepts contributed by the inventors to further develop the art, and should be interpreted as not being limited to these specific recorded examples and conditions. Although various embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions and modifications may be made thereto without departing from the spirit and scope of the present invention.

Claims

1. A system for accessing a patient's vascular system, the system for accessing a patient's vascular system comprising: a tube comprising a wall defining an outer surface and an inner lumen having a proximal end and a distal end, wherein the proximal end is connectable to a source of pressurized fluid; a guidewire deployable by sliding distally from a retracted position in which the guidewire is within the lumen to a deployed position in which the guidewire extends beyond the distal end, wherein the guidewire is deployable distally in response to pressure provided to the lumen from the source of pressurized fluid; and At least one element selected from the group consisting of: a retrieval mechanism actuatable to retract the guidewire from the deployed position to the retracted position; and A protective cover is actuatable to extend distally from the distal end of the tube to cover the guidewire in the deployed position.

2. The system for accessing a patient's vascular system according to claim 1, characterized in that: The system for accessing a patient's vascular system includes an expansion kit for a vascular access device (VAD); and The distal end includes a blunt-tipped cannula configured to mate with a needleless access connector of the vascular access device.

3. The system for accessing a patient's vascular system according to claim 2, characterized in that: The system for accessing a patient's vascular system also includes a cap configured to cover the blunt tip cannula prior to attaching the blunt tip cannula to the vascular access device.

4. The system for accessing a patient's vascular system according to claim 1, characterized in that: said at least one element comprises said retraction mechanism; and The retraction mechanism is slidably coupled to the outer surface and to the guidewire such that movement of the retraction mechanism toward the proximal end retracts the guidewire from the deployed position to the retracted position.

5. The system for accessing a patient's vascular system according to claim 1, characterized in that: said at least one element comprising said retraction mechanism; The guide wire comprises: a distal portion having an elongated shape; and a proximal portion having a coupling feature having an enlarged cross-sectional shape relative to the distal portion; and The retraction mechanism is coupled to the coupling feature through the wall.

6. The system for accessing a patient's vascular system according to claim 5, characterized in that: The connection feature includes at least one option selected from the group consisting of: wedge-shaped; one or more rounded ridges; one or more fins; one or more splines; one or more longitudinal ribs; and One or more anti-rotation features.

7. The system for accessing a patient's vascular system according to claim 5, characterized in that: The retraction mechanism compresses the wall into contact with the coupling feature such that the wall urges the coupling feature to move proximally in response to proximal movement of the retraction mechanism.

8. The system for accessing a patient's vascular system according to claim 7, characterized in that: The retraction mechanism includes at least one option selected from the group consisting of: one or more wheels engaging the outer surface to compress the tube; one or more ball bearings engaged with the outer surface to compress the tube; and One or more manually compressible walls capable of deflecting toward the tube.

9. The system for accessing a patient's vascular system according to claim 5, characterized in that: said at least one element comprises said retraction mechanism; and The retraction mechanism includes at least one option selected from the group consisting of: one or more magnets that magnetically engage the coupling feature; one or more springs coupled to the coupling feature; and A tether secured to the coupling feature.

10. The system for accessing a patient's vascular system according to claim 1, characterized in that: The system for accessing a patient's vascular system also includes a spring that urges the guidewire to deploy from the retracted position to the deployed position.

11. The system for accessing a patient's vascular system according to claim 1, characterized in that: The at least one element comprises the protective cover; and The system for accessing a patient's vascular system also includes an absorbent component positioned to remove blood from the guidewire after deployment of the guidewire.

12. The system for accessing a patient's vascular system according to claim 1, characterized in that: The guidewire comprises at least one option selected from the group consisting of: including a variable pitch spring; and An auxiliary tube includes an inner hole through which blood can be drawn from the vascular system.

13. The system for accessing a patient's vascular system according to claim 12, characterized in that: The guidewire includes the auxiliary tube; and The guidewire further includes a valve that is closed during deployment of the guidewire and opened during aspiration of blood from the vascular system.

14. The system for accessing a patient's vascular system according to claim 13, characterized in that: At least one of the guidewire and the tube further includes a capture mechanism that retains the guidewire in the deployed position.

15. A system for accessing a patient's vascular system, the system for accessing a patient's vascular system comprising: a tube comprising a wall defining an outer surface and an inner lumen having a proximal end and a distal end; A guidewire deployable by sliding distally from a retracted position of the guidewire within the lumen to a deployed position in which the guidewire extends beyond the distal end, the guidewire comprising: a distal portion having an elongated shape; and a proximal portion having a coupling feature having an enlarged cross-sectional shape relative to the distal portion; and a retrieval mechanism actuatable to retract the guidewire from the deployed position to the retracted position; in: The proximal end is connectable to a source of pressurized fluid; the guidewire being deployable in response to pressure from the source of pressurized fluid proximal to the lumen; The system for accessing a patient's vascular system includes an expansion kit for a vascular access device (VAD); and The distal end includes a blunt-tipped cannula configured to mate with a needleless access connector of the vascular access device.

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