Vascular access devices and related systems and methods

Abstract

A vascular access device includes a housing and an instrument disposed within the housing. The housing can include a proximal end, a distal end, a slot, and an advancement tab. The advancement tab can be configured to move linearly along the slot between a retracted position and an advanced position. A proximal end of the instrument can be coupled to the advancement tab such that, in response to the advancement tab moving from the retracted position to the advanced position, a distal tip of the instrument can advance beyond the distal end of the housing into a catheter assembly and / or a vasculature of a patient.

Description

Technical Field

[0001] This disclosure relates to a vascular access device and related systems and methods. Background Technology

[0002] Catheters are commonly used for a variety of infusion therapies. For example, catheters can be used to infuse fluids such as saline solutions, various medications, and total parenteral nutrition into a patient. Catheters can also be used to draw blood from a patient to obtain blood samples.

[0003] A common type of catheter is the needle-type peripheral venous (“IV”) catheter. As the name suggests, a needle-type catheter can be mounted on a guide needle with a sharp distal end. The catheter and guide needle can be assembled such that the distal end of the guide needle extends beyond the distal end of the catheter, with the bevel of the guide needle facing upwards and away from the patient's skin. The catheter and guide needle are typically inserted into the patient's vascular system through the skin at a shallow angle.

[0004] To verify proper placement of the guide needle and / or catheter in a blood vessel, clinicians typically confirm the presence of a "flashback" of blood in the flashback lumen of the catheter assembly. Once needle placement has been confirmed, the clinician can temporarily block flow in the vascular system and remove the needle, leaving the catheter in place for future blood draws, fluid infusions, or probe insertion.

[0005] For several reasons, aspiration or infusion using a catheter can be difficult, especially when the catheter remains in the patient's body for more than a day. For example, when a catheter is inserted into the patient for an extended period, it is more likely to narrow, collapse, become kinked, become clogged with debris (e.g., fibrin or platelet clots), and the catheter tip may become attached to the vascular system. Therefore, catheters are typically used to collect blood samples during catheter placement, but rarely during catheter indwelling. Consequently, when blood samples are needed, the use of an additional needle to provide venous access for blood collection can be painful for the patient and result in higher material costs.

[0006] The subject matter claimed herein is not limited to embodiments that address any shortcomings or operate only in environments such as those described above. Rather, this background is provided merely to illustrate an exemplary technical field in which some of the implementations described herein can be practiced. Summary of the Invention

[0007] This disclosure generally relates to a vascular access device and related systems and methods that can accommodate devices such as guidewires, probes, or venous catheters. In some embodiments, the vascular access device can deliver the device via an existing peripheral intervascular catheter for blood collection, fluid delivery, patient or device monitoring, or other clinical needs. In some embodiments, the device can be introduced into the catheter to overcome complications that may prevent fluid flow, such as thrombus or fibrin sheath buildup at the catheter tip, valves, venous collapse, or other obstructions. The device can be pushed through these occlusions to clear the path of fluid inflow or outflow from the vein.

[0008] In some embodiments, the vascular access device may include a housing comprising a proximal end, a distal end, a slit, and an advance tab. The advance tab may be configured to move linearly along the slit between a retracted position and an advance position. The device may be housed within the housing to protect it from damage or contamination by the external environment. In some embodiments, the distal end of the housing may include a fluid seal disposed within the distal end of the housing. The fluid seal may maintain a closed fluid path.

[0009] The proximal end of the instrument can be attached to the advance tab. In response to the advance tab moving from the retracted position to the advance position, the distal end of the instrument can advance beyond the distal end of the housing.

[0010] In some embodiments, the housing may be substantially rigid. In some embodiments, the distal end of the housing may include a connector element, such as a Luer adapter, for coupling to a catheter assembly. In other embodiments, the connector element may include a cannula and a plurality of lever locking arms for coupling to the catheter assembly. Some embodiments may include a locking element disposed within the housing to prevent the catheter assembly from disengaging from the housing. The locking element may be actuated in response to distal movement of the advance tab beyond a retracted position. In some embodiments, the locking element may include a biasing element or a cam element to automatically lock the connector element in response to distal movement of the advance tab beyond a retracted position.

[0011] In some embodiments, such as those where the connector element includes a cannula and a plurality of lever locking arms, a locking element may be disposed between the housing and the plurality of lever locking arms in response to the instrument being in the forward position. This prevents the lever locking arms from being depressed and thus prevents the catheter assembly from being released from the housing. In response to the instrument being in the retracted position, the locking element may be disposed proximal to the lever locking arms, thereby allowing the lever locking arms to be depressed and thus releasing the catheter assembly from the housing.

[0012] In some embodiments, the vascular access device may include a T-adapter or a Y-adapter coupled to the distal end of the housing for connection to a catheter assembly. In some embodiments, an extension tube may extend from the T-adapter or Y-adapter, and a blood collection path may extend through the extension tube for obtaining a blood sample. The device may be a guidewire.

[0013] In some embodiments, the extension tube may extend from the housing between the distal end of the housing and the distal end of the slot. In other embodiments, the extension tube may extend from the housing between the proximal end of the housing and the proximal end of the slot. A blood collection path may extend through the extension tube and may be used to obtain blood samples.

[0014] In some embodiments, the vascular access device may include a stop feature for automatically maintaining the position of the advance tab relative to the slot. In some embodiments, the stop feature may be coupled to the advance tab and may interact with a feature of the housing. The stop feature can thus impede linear movement of the device between a retracted position and an advance position. In other embodiments, the stop feature may be coupled to the housing and interact with the advance tab to impede linear movement of the device.

[0015] In some embodiments, a method of providing vascular access or operating a vascular access device may include coupling the vascular access device to a catheter assembly. The catheter assembly may include a catheter adapter comprising a proximal end, a distal end, and a catheter extending from the distal end. The vascular access device may include a housing comprising a proximal end, a distal end, and a slot. An advance tab may be configured to move linearly along the slot between a retracted position and an advance position.

[0016] In some embodiments, the device may be disposed within a housing. The device may include a proximal end and a distal end. The proximal end of the device may be coupled to an advancing tab. In response to the advancing tab moving from a retracted position to an advancing position, the distal end of the device may advance beyond the distal end of the housing.

[0017] In some embodiments, coupling a vascular access device to a catheter assembly may include coupling a housing to the catheter assembly. In some embodiments, the method may further include linearly moving an advance tab along a slot from a retracted position to an advance position. In response to the advance tab moving to the advance position, the distal end of the device may extend beyond the distal end of the housing.

[0018] In some embodiments, the method may further include actuating a locking element to secure the vascular access device to the catheter assembly. The locking element may be actuated in response to distal movement of the advance tab beyond a retracted position. In some embodiments, the position of the advance tab relative to the slit may be automatically maintained. In some embodiments, a force may be applied to the advance tab to release the position.

[0019] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory, and are not intended to limit the claimed invention. It should be understood that the various embodiments are not limited to the configurations and means shown in the drawings. It should also be understood that these embodiments may be combined, other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the invention, unless so claimed. Therefore, the following detailed description should not be considered limiting. Attached Figure Description

[0020] The exemplary embodiments will be described and illustrated with additional features and details using the accompanying drawings, wherein:

[0021] Figure 1A This is a top perspective view of an exemplary vascular access device, showing an exemplary device in the retracted position according to some embodiments;

[0022] Figure 1B yes Figure 1A Cross-sectional view of the vascular access device.

[0023] Figure 2A yes Figure 1A The top perspective view of the vascular access device shows the device in the forward position according to some embodiments.

[0024] Figure 2B yes Figure 1A A cross-sectional view of a vascular access device, showing the device in the forward position according to some embodiments.

[0025] Figure 3 This is a partial exploded view of a vascular access device and an example adapter according to some embodiments.

[0026] Figure 4 yes Figure 3 Cross-sectional view of the vascular access device and adapter.

[0027] Figure 5 This is an exploded view of another exemplary vascular access device according to some embodiments.

[0028] Figure 6 This is another exemplary adapter according to some embodiments and Figure 5 Cross-sectional view of the vascular access device.

[0029] Figure 7 This is a top perspective view of another exemplary vascular access device according to some embodiments, showing a fluid path extending from the proximal end of the housing.

[0030] Figure 8 This is another exemplary adapter according to some embodiments and Figure 7 Cross-sectional view of the vascular access device.

[0031] Figure 9A This is a top perspective view of an exemplary housing according to some embodiments, the housing including a locking element in the unlocked position.

[0032] Figure 9B yes Figure 9A Cross-sectional view of the housing and locking element.

[0033] Figure 10A This is a top perspective view of another exemplary housing according to some embodiments, the housing including a locking element in a locked position.

[0034] Figure 10B yes Figure 10A Cross-sectional view of the housing and locking element.

[0035] Figure 11 This is a cross-sectional view of an exemplary housing according to some embodiments, the housing being configured to allow the instrument to advance twice the distance traveled by the advance tab.

[0036] Figure 12 This is a cross-sectional view of an exemplary housing including a guide element according to some embodiments.

[0037] Figure 13 This is a cross-sectional view of an exemplary vascular access device configured for one-handed operation according to some embodiments.

[0038] Figure 14 This is a top perspective view of an exemplary forward connector configured for one-handed operation according to some embodiments;

[0039] Figure 15A This is a cross-sectional view of an exemplary Luer adapter according to some embodiments.

[0040] Figure 15B This is a cross-sectional view of another exemplary Luer adapter according to some embodiments.

[0041] Figure 15C This is a cross-sectional view of another exemplary Luer adapter according to some embodiments.

[0042] Figure 16AThis is a perspective view of an exemplary rod lock including an extension tube according to some embodiments.

[0043] Figure 16B yes Figure 16A A cross-sectional view of the lever lock.

[0044] Figure 17 This is a cross-sectional view of an example of the forward tab and stop feature according to some embodiments.

[0045] Figure 18 This is a cross-sectional view of an exemplary vascular access device according to some embodiments, the vascular access device being configured to advance the instrument three times the distance traveled by the advance tab.

[0046] Figure 19 yes Figure 18 Top perspective view of the vascular access device.

[0047] Figure 20 This is a perspective view of an exemplary housing attached to a blood extraction adapter according to some embodiments.

[0048] Figure 21 This is a perspective view of an exemplary vascular access device with a flexible connector according to some embodiments. Detailed Implementation

[0049] As used in this specification, the term "distal" refers to the direction away from the clinician who will make contact with the patient and closer to the patient. The term "proximal" refers to the direction closer to the clinician who will make contact with the patient and further away from the patient. Thus, for example, the end of the catheter that first contacts the patient's body is the distal end, while the opposite end of the catheter is the proximal end.

[0050] Now for reference Figure 1A and Figure 1B In some embodiments, the vascular access device 100 may be configured as a catheter delivery device 102 via a catheter assembly for, for example, blood collection, fluid delivery, patient or device monitoring, or other clinical needs. Figure 21 An exemplary catheter assembly is illustrated. In some embodiments, the catheter may include a peripheral venous catheter, a peripherally inserted central catheter, or a midline catheter. In some embodiments, the catheter through which the device 102 delivers the catheter may have been pre-inserted into the patient's vascular system and may be left in place within the vascular system.

[0051] In some embodiments, the device 102 can advance through the fluid path of the catheter and catheter assembly such that the distal end 118 of the device 102 is positioned in the patient's vascular system distal to the distal end of the catheter. In some embodiments, during operation, a clinician may deploy the device 102 to push through any occlusions in the catheter or vascular system (e.g., thrombus or fibrin buildup at the catheter tip, venous collapse, valves, etc.) to establish a clean path for fluid flow.

[0052] In some embodiments, the device 102 may be housed within a housing 104 configured to protect the device 102 from damage and / or contamination by the surrounding external environment. In some embodiments, the housing may be rigid or semi-rigid. In some embodiments, the housing 104 may be made of one or more of stainless steel, aluminum, polycarbonate, metal, ceramic, plastic, and another suitable material. In some embodiments, the housing 104 may include a proximal end 106, a distal end 108, a slot 110, and a forward tab 112. In some embodiments, the slot 110 may extend parallel to the longitudinal axis of the housing 104. In some embodiments, as discussed in more detail below, for example, the distal end 108 of the housing 104 may be coupled to a connector element 122 (e.g., a Luer connector) for coupling to a catheter assembly.

[0053] In some embodiments, device 102 may include, for example, a guidewire, another catheter, a probe, or another suitable device. In some embodiments, device 102 may include various openings and / or sensors. In some embodiments, device 102 may include various elements of both probes and catheters. In some embodiments, the openings and / or sensors may be positioned toward the distal end 118 of device 102. In some embodiments, the openings may serve as fluid inlets and / or fluid outlets. In some embodiments, the sensors may measure one or more parameters and / or detect one or more elements relating to, for example, diagnostic information, blood chemistry, pressure, flow rate, drug recognition, microorganisms, placement of implantable stents, intravenous catheter tip stability characteristics, or other devices.

[0054] In some embodiments, the advance tab 112 may be configured to move linearly along the slot 110 between a retracted position 114 and an advance position 116. In some embodiments, the advance tab 112 may be coupled to a proximal end 120 of the instrument 102 such that linear movement of the advance tab 112 along the slot 110 causes the instrument 102 to move relative to the housing 104 in the same direction as the advance tab 112. In some embodiments, a clinician may pinch or grasp the advance tab 112 to move the instrument 102 between the retracted position 114 and the advance position 116. As described in more detail below, in some embodiments, the distance traveled by the instrument 102 relative to the housing 104 may be proportional to the distance traveled by the advance tab 112 relative to the slot 110, and may include any ratio.

[0055] In some embodiments, such as Figure 2A and Figure 2B As shown, movement of the advance tab 112 from the retracted position 114 to the advance position 116 can cause the distal end 118 of the device 102 to advance beyond the distal end 108 of the housing 104. For example, in some embodiments, moving the advance tab 112 to the advance position 116 can guide the device 102 into the catheter assembly. In some embodiments, in response to the device 102 being guided into the catheter assembly, the device 102 can enter the fluid pathway of the catheter assembly and / or the patient's vascular system.

[0056] In some embodiments, the catheters of the catheter assembly, when left in the vascular system for a considerable period, may easily become narrowed, collapsed, kinked, blocked by debris (e.g., fibrin or platelet clots), and the catheter tip may become attached to the vascular system. Therefore, aspirating blood using the catheter can be difficult. In some embodiments, device 102 may include a guidewire or another catheter with a diameter smaller than that of the catheters in the catheter assembly to provide access to the patient's vascular system without any additional needle insertion. In some embodiments, the guidewire may clean the path used for collecting blood samples. Therefore, in some embodiments, the vascular access device 100 can be used for needle-free blood collection and / or fluid infusion.

[0057] In some embodiments, the forward tab 112 can be moved along the slot 110 from the forward position 116 to the retraction position 114 to retract or withdraw at least a portion of the device 102 into the housing 104.

[0058] Now for reference Figure 3-8 In some embodiments, the extension tube 126 may be coupled to the vascular access device 100, and the extension tube 126 may be used for blood collection and / or fluid infusion. It can be infused into or withdrawn from a patient's vein in any of a variety of ways. Figure 5-6As shown, in some embodiments, the extension tube 126 may extend directly from the housing 104. In some embodiments, the connector element 122 may include, for example, a lever lock 130. In some embodiments, the connector element 122 may include a Luer connector, such as a male or female Luer connector. In some embodiments, the extension tube 126 may extend from the housing 104 between the distal end 108 of the housing 104 or between the lever lock 130 and the distal end of the slot 110.

[0059] As shown in these and other embodiments, a fluid seal 131 may be disposed at or within the distal end 108 of the housing 104 to allow the instrument 102 to advance and / or retract from the distal end 108 while maintaining a closed fluid path. In other embodiments, such as in an embodiment where the extension tube 126 extends from the proximal end 106 of the housing 104, the fluid seal 131 may be disposed at or within the proximal end 106 of the housing 104 to allow the instrument 102 to move through it while maintaining a closed fluid path. In some embodiments, the fluid seal 131 may comprise silicone, rubber, elastomer, or another suitable material. In some embodiments, the fluid seal 131 may comprise an orifice, slit, or the like to receive the instrument 102 passing through it.

[0060] like Figure 3-4 As shown, in some embodiments, it may be advantageous for the fluid path guiding the blood vessel into the system to pass through an adapter 124 (e.g., a T-adapter or a Y-adapter) coupled to the housing 104. In some embodiments, an extension tube 126 may extend from the adapter 124, such that a fluid path, such as a blood collection path, can be guided through the extension tube 126 instead of through the housing 104. In these and other embodiments, such as in embodiments where the fluid path is used to obtain a blood sample, the inner diameter and length of the extension tube 126 may be selected to balance shear stress over the entire length of the fluid path, thereby reducing hemolysis.

[0061] like Figure 7-8 As shown, in some embodiments, the extension tube 126 may extend from the proximal end 106 of the housing 104. In some embodiments, the extension tube 126 may extend from the proximal end 106 of the housing 104 located on the proximal side of the slot 110. In some embodiments, the proximal end of the extension tube 126 may include a connector 300 coupled thereto, which may include a Luer connector or another suitable connector.

[0062] In some embodiments, connector 300 may be coupled to a blood collection device, for example, that is available from Becton Dickinson and Company in Franklin Lake, New Jersey. or LUER-LOK TM In some embodiments, connector 300 may be coupled to an infusion device. In some embodiments, the fluid path of the vascular access system may extend through the catheter assembly and / or adapter 124. In some embodiments, the fluid path of the vascular access system may extend through all or part of the housing 104.

[0063] In some embodiments, the length L of the extension tube 126 may be selected based on one or more of the following: the specification of a particular catheter, the construction of a particular catheter assembly, or clinical settings. In some embodiments, the extension tube 126 may include an inner diameter D.

[0064] The Poiseuille equation can be used to analyze the fluid flow in the fluid path through the tubular extension tube 126:

[0065]

[0066] Where ΔP is the pressure gradient change 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. This is fluid resistance. Since μ is the viscosity of the fluid, and not part of the geometry of the extension tube, a geometry factor G is defined. f This makes R f (fluid resistance) is in

[0067] In some embodiments, the extension tube 126 may have multiple portions with lengths (L1, L2, L3) and inner diameters (D1, D2, D3), and the geometric factors are:

[0068]

[0069] In some embodiments, the extension tube 126 may have an inner diameter that varies along the length of the extension tube 126, with the geometric factor being:

[0070]

[0071] In some embodiments, the extension tube 126 may have a non-circular cross-section or a complex inner diameter profile. The geometric factors can then be determined by measuring the flow velocity (Q) at a given pressure (ΔP) using a fluid of known viscosity (μ).

[0072]

[0073] You can choose extension tube 126 G fValues ​​that reduce the maximum shear stress for each catheter specification to be equal to or less than BD 21G. UltraTouch TM The maximum shear stress of the button blood collection kit (available from Becton Dickinson & Company, Franklin Lake, New Jersey) was previously considered the gold standard for blood extraction. In some embodiments, the G of the extension tube 126 can be selected. f Values ​​that reduce the maximum shear stress of each catheter specification to be equal to or less than BD 25G. UltraTouch TM Maximum shear stress of the button blood collection kit (available from Becton Dickinson & Company, Franklin Lake, New Jersey).

[0074] In some embodiments, the fluid path of the vascular access system may include one or more of a blood collection device, an extension tube 126, an adapter 124, and a catheter assembly. This fluid path may include the flow of blood into the blood collection device after it has left the vascular system during blood collection, or the flow of blood through the entire blood collection path of the blood collection device. This can be achieved with the aforementioned extension tube 126. f The system geometry factor G for determining the fluid path in a similar manner to that used in vascular access systems is determined. fs In some embodiments, the system geometry factor G is determined when the device 102 is in the forward position. fs It 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 when the device 102 is in the forward position... fs It could be 7.34E+06(1 / in) 3 ±10%, ±25%, ±50%, or ±75%. In some embodiments, G fs Another value may be included, which can be selected based on the catheter's specifications and / or length.

[0075] In some embodiments, the device 102 disposed within the housing 104 can be kept in a non-fluid environment and protected from contamination and environmental hazards until use. Advantageously, in some embodiments, the extension tube 126 can also allow for maintaining a closed system and aseptic technique while reducing interference or displacement of the catheter and / or catheter fixation dressing.

[0076] In some embodiments, the distal end 108 of the housing 104 may include a lever lock 130 for engaging the housing 104 to the catheter assembly. The lever lock 130 may include at least two of lever lock arms 128a, 128b and a cannula 132. In some embodiments, the cannula 132 may be blunt. In some embodiments, the cannula 132 may extend from the distal end 108 of the housing 104 in a direction substantially aligned with the longitudinal axis of the housing 104. In some embodiments, the lever lock arms 128a, 128b may be spaced apart from each other, and in some embodiments, the lever lock arms 128a, 128b may be positioned substantially opposite each other relative to the cannula 132.

[0077] In some embodiments, during operation, the cannula 132 may penetrate the Luer connector of the catheter assembly to enter the fluid path of the catheter assembly. In some embodiments, the proximal ends of the lever locking arms 128a, 128b may be biased inward toward the longitudinal axis of the housing 104 to snap onto or otherwise engage with the Luer connector. In this way, the lever locking arms 128a, 128b may automatically secure the cannula 132 to the Luer connector. In some embodiments, the Luer connector of the catheter assembly may include one or more recesses configured to receive one or more protrusions of the lever locking arms 128a, 128b. In some embodiments, the lever locking arms 128a, 128b may engage the protrusions of the lever locking arms 128a, 128b to secure the housing 104 to the catheter assembly.

[0078] Now for reference Figures 15A-15C In some embodiments, connector element 122 may include a Luer connector, such as a male Luer connector, for connection to the catheter assembly. In some embodiments, the Luer connector may include a Luer lock connector 1500, which may include an internal thread 1502 for engaging a corresponding thread of the Luer connector of the catheter assembly. In some embodiments, the Luer lock connector 1500 may further include a cannula 132 for penetrating or inserting into the Luer connector of the catheter assembly.

[0079] In some embodiments, a connector element 122, such as a lever lock 130 (see, for example, Figures 1-11) or a Luer lock connector 1500, may be fixed to the housing 104. In other embodiments, the connector element 122 may be coupled to the housing 104 and configured to rotate relative to the housing to any clock position.

[0080] See Figure 16A and Figure 16B In some embodiments, connector elements 122, such as lever lock 130 (see, for example, Figures 1-11) or Luer lock connector 1500 (see, for example, Figure 15), can be integrally formed as a single unit with the housing 104.

[0081] Now for reference Figures 9A-9B and Figures 10A-10B Some embodiments may include a locking element 900 for selectively or automatically securing the housing 104 to the catheter assembly as the instrument 102 advances into the catheter. In some embodiments, as described above, the connector element 122 may include a cannula 132 and lever locking arms 128a, 128b for coupling to the catheter assembly. In these and other embodiments, the locking element 900 may include a locking member 902 configured to interact with the lever locking arms 128a, 128b. The locking member 902 may be integral with or coupled to an elongated extension member 904 disposed within the housing 104 and extending along its length or a portion thereof.

[0082] In some embodiments, in response to the device 102 being in the forward position 116, the locking member 902 may be positioned in a locked position between the housing 104 and the lever locking arms 128a, 128b. In this locked position, the locking member 902 may prevent the lever locking arms 128a, 128b from being depressed, and thus prevent the catheter assembly from being released from the housing 104. In response to the device 102 being in the retracted position 114, the locking member 902 may be positioned proximal to the lever locking arms 128a, 128b in the unlocked position, thereby allowing the lever locking arms 128a, 128b to be depressed and thus release the catheter assembly from the housing 104.

[0083] In some embodiments, the locking element 900 may include a biasing element (e.g., a spring) or a cam element (e.g., a cam and a follower) disposed within the housing 104 and automatically actuated in response to distal movement of the advance tab 112 beyond the retraction position 114. The biasing element or cam element may automatically activate the locking element 900 to lock the connector element 122, thereby preventing the conduit assembly from disengaging from the housing 104.

[0084] Specifically, in some embodiments, the elongated extension member 904 can be held proximally such that the locking member 902 is in the unlocked position when the advance tab 112 is in the retracted position 114. The locking member 902 can be released as the advance tab 112 moves distally to advance the instrument 102 into the catheter. A biasing element or cam element can then push the locking member 902 distally to engage the lever arms 128a, 128b in the locked position.

[0085] Similarly, when the advance tab 112 is actuated to retract the instrument 102, the final movement in the proximal direction can pull the locking member 902 against the biasing element or cam element, thereby unlocking the lever locking arms 128a, 128b. This prevents the user from removing the instrument 102 from the catheter assembly when the advance tab 112 is in any position other than its proximal retracted position 114.

[0086] Of course, as those skilled in the art will recognize, the automatic locking mechanism can be reversed, such that a biasing element or a cam element pulls the locking member 902 to release the lock and pushes the locking member 902 into engagement to secure the conduit assembly to the housing 104. In some embodiments, the automatic locking mechanism can be activated at the start or end of movement of the advancing tab 112. In some embodiments, the locking member 902 can screw into and out of the locked position, rather than sliding forward and backward.

[0087] Now for reference Figure 13 , 14 In some embodiments, the position of the advance patch 112 can be controlled before, during, and after use of the device 102. In some embodiments, the vascular access device 100 may include a stop feature 1300 for automatically maintaining the position of the advance patch 112 relative to the slot 110. In some embodiments, the stop feature 1300 may be coupled to the advance patch 112 and may interact with a feature of the housing 104. The stop feature 1300 may thus impede linear movement of the device 102 between a retracted position 114 and an advance position 116. In other embodiments, the stop feature 1300 may be coupled to the housing 104 and interact with the advance patch 112 to impede linear movement of the device 102.

[0088] In some embodiments, the stop feature 1300 may provide engineered friction between the advance tab 112 and the housing 104, such that movement of the advance tab 112 requires the application of force. Without the application of such force, the advance tab 112 may maintain its linear position along the slot 110. In some embodiments, the stop feature 1300 may apply friction along the entire length of the slot 110.

[0089] In some embodiments, the stop feature 1300 may include simple interference between the advance tab 112 and the housing 104, and the modulus of the material of the advance tab 112 may be used as a spring for control. For example, in some embodiments, both the advance tab 112 and the housing 104 may have a substantially elliptical cross-section. The advance tab 112 may be configured to rotate relative to the housing 104, thereby locking the position of the advance tab 112.

[0090] In some embodiments, the stop feature 1300 may be a cantilever integral with the advance tab 112 or the housing 104, which acts as a spring. In other embodiments, the stop feature 1300 may include a separate spring member attached to the advance tab 112 to apply friction as the advance tab 112 slides against the housing 104, or vice versa. In some embodiments, in addition to spring force, the surface finish and / or material of the advance tab 112 and / or housing 104 may be selected to optimize friction between them.

[0091] In some embodiments, the stop feature 1300 may substantially correspond to the distal end 108 and / or proximal end 106 of the housing 104 or slot 110, thereby corresponding to the advance position 116 and / or retraction position 114 of the instrument 102. In some embodiments, the stop feature 1300 may include one or more pawls or other features integral with or coupled to the distal end 108 and / or proximal end 106 of the housing 104 or slot 110. In some embodiments, the pawls may interact mechanically or magnetically with the advance tab 112 to hold the advance tab 112 in the advance position 116 and / or retraction position 114. In this way, the instrument 102 can be held in a fully retracted or fully inserted position. Of course, one or more pawls may be implemented at any location along the slot 110 or housing 104 to hold the advance tab 112 in any such position. In some embodiments, in addition to the stop feature 1300, one or more additional pawls may be implemented.

[0092] Now for reference Figure 17 In some embodiments, the stop feature 1300 may include a spring-loaded pawl 1700 integral with or coupled to the advance tab 112. As the advance tab 112 moves linearly along the slot 110, the spring-loaded pawl 1700 may automatically engage a recess 1702 provided in the housing 104. The advance tab 112 may be selectively depressed to release the spring-loaded pawl 1700 from the recess 1702. Releasing the spring-loaded pawl 1700 in this manner allows the advance tab 112 to slide linearly along the slot 110 to advance or remove the instrument 102. In some embodiments, the recess 1702 may be integrally formed in the housing 104 at any desired location or distance along the slot 110 or housing 104.

[0093] Now for reference Figure 11 and Figure 18-19 In some embodiments, the advance tab 112 can be configured to advance the instrument 102 further than the advance tab 112 itself travels. For example... Figure 11As shown, for example, by attaching the proximal end 120 of the device 102 to the distal end 108 of the housing 104 to face the proximal direction, the advance tab 112 can be configured to advance the device 102 a distance greater than the distance traveled by the advance tab 112, for example, twice the distance traveled by the advance tab 112. In some embodiments, the device 102 can pass through the advance tab 112 in a "U" shape and exit the housing 104 at the distal end 108. In some embodiments, the advance tab 112 can push the "U"-shaped portion of the device 102 to advance the device 102, and can pull the "U"-shaped portion of the device 102 to retract the device 102. The device 102 can slide through the advance tab 112 as it moves. In this way, the advance tab 112 can function as a pulley, causing the device 102 to move a distance twice the distance traveled by the advance tab 112.

[0094] Now for reference Figure 18-19 In some embodiments, one or more additional bends may be incorporated into the device 102 before the proximal end 120 is attached to the advance tab 112. This allows the advance tab 112 to further increase the distance traveled by the device 102 relative to the distance traveled by the advance tab 112 by a multiple equal to the number of bends or "U" turns. In some embodiments, this multiple may be equal to the number of bends or "U" turns in the device 102 plus one. For example, no bend may correspond to 1x advance between the device 102 and the advance tab 112, one bend may correspond to 2x advance between the device 102 and the advance tab 112, two bends may correspond to 3x advance between the device 102 and the advance tab 112, and so on. However, configuring the device 102 and the advance tab 112 in this way may cause the device 102 to bend during insertion. Therefore, some embodiments may include guides or restraints to support the device 102 to prevent bending.

[0095] For example, refer to Figure 12 Some embodiments may include a guide element 1204 disposed within the housing 104 to constrain the device 102. In some embodiments, the guide element 1204 may be disposed within an aperture 1206 of the housing 104 receiving the device 102. In some embodiments, the guide element 1204 may be coupled to the advance tab 112 via a connector member 1202. In some embodiments, the connector member 1202 may be configured to substantially occupy a tortuous path 1200 between the aperture 1206 and the slot 110. The connector member 1202 may thereby block the tortuous path 1200 and prevent contamination that might otherwise enter the slot 110 and reach the device 102. In other embodiments, the connector member 1202 may occupy a direct path between the slot 110 and the aperture 1206 and / or the device 102.

[0096] In some embodiments, such as in one where the advance tab 112 moves the device 102 twice the distance traveled by the advance tab 112, the guide element 1204 may occupy the space between the U-shaped portions of the device 102. In this way, the device 102 can be constrained on three sides, thereby preventing movement of the device 102 in those three directions. To prevent bending in a fourth direction, some embodiments may include a shielding element to selectively shield the open area in that fourth direction. In some embodiments, the shielding element may be selectively removed to allow the device 102 to pass through it. In other embodiments, the device 102 may include small bends or deflections to guide the device 102 away from the open area or open side and into a wall or constrained area.

[0097] Advantageously, the advance tab 112 is configured to allow the instrument 102 to advance a greater distance than the advance tab 112 itself travels. This allows for a more compact housing 104, resulting in a reduced size and a shorter slot 110 length. In other words, the distance the advance tab 112 must advance to advance and retract the instrument 102 can be reduced, thus necessitating a more compact design for the vascular access device 100. Consequently, the vascular access device 100 can be operated with only one hand.

[0098] In fact, such as Figure 13 and Figure 14 As shown, some embodiments of the vascular access device 100 can be operated by moving a single finger or thumb while simultaneously gripping the device with the same hand. Some embodiments of the vascular access device 100 that allow for one-handed operation may include a collar advance grip 1302 or a central grip 1303. As shown, the collar advance grip 1302 or the central grip 1303 allows for one-handed advancement of the advance tab 112 while the clinician or user grips the housing 104 with their thumb and middle finger. For example, the collar advance grip 1302 or the central grip 1303 can be translated with the index finger.

[0099] Now for reference Figure 20-21In some embodiments, the housing 104 may include one or more markings 2000 or measurements that visually indicate the insertion depth of the device 102 to a clinician or other user. In some embodiments, the markings 2000 may be scales 2002 on one side of the housing 104 that can be aligned with an indicator 2004 on the advance tab 112. In some embodiments, the scales 2002 may be fixed for use with a specific catheter setup and length. In some embodiments, the markings 2000 may include a table to indicate positions for different catheter setups and lengths. In some embodiments, the scales 2002 may be sliding scales 2002 and / or indicators 2004 that can be adjusted according to the catheter setup and length.

[0100] In some embodiments, for example, marker 2000 may indicate the distance of insertion and / or withdrawal of one or more different instruments 102 (e.g., catheters of different types). In some embodiments, marker 2000 may indicate one or more of the following: an advance position 116 of instrument 102, a retraction position 114 of instrument 102, and various positions between the advance position 116 and the retraction position 114 of instrument 102. Some embodiments may include icons to indicate alignment between the catheter tip and the distal tip 118 of instrument 102. In some embodiments, additional icons may indicate a specific distance traveled by the distal tip 118 of instrument 102 beyond the catheter tip.

[0101] In some embodiments, when the vascular access device 100 includes a device 102 and an advance patch 112 configuration that acts as a multiple of the distance traveled by the device 102 relative to the advance patch 112, the distance between the markers 2000 can be adjusted. Of course, the multiple can be any number or ratio known to those skilled in the art.

[0102] Now for reference Figure 20 In some embodiments, the blood extraction adapter 2006 may be secured to the vascular access device 100. For example, in some embodiments, the blood extraction adapter 2006 may be directly coupled to the extension tube 126. In other embodiments, the blood extraction adapter 2006 may be coupled to the vascular access device 100 via a Luer connector, for example, to allow the blood extraction adapter 2006 to be selectively removed and replaced by another device, such as a syringe.

[0103] Now for reference Figure 21In some embodiments, a flexible connector 2100 may be incorporated between the rod lock 130 or other connector element 122 and the housing 104. The flexible connector 2100 can provide flexibility for the attachment between the conduit and the housing 104. In some embodiments, the flexible connector 2100 may include a ball joint or a short tube that is coupled to the housing 104 and / or the rod lock 130 or other connector element 122.

[0104] All examples and conditional language described herein are intended for pedagogical purposes to aid the reader's understanding of the invention and the inventors' concepts for advancement in the field, and should be interpreted as not being limited to such specific examples and conditions. Although embodiments of the invention have been described in detail, it should be understood that various changes, substitutions, and modifications can be made therein without departing from the spirit and scope of the invention.

Claims

1. A vascular access device, comprising: A housing including a proximal end, a distal end, a slot, and an advance tab configured to move linearly along the slot between a retracted position and an advance position, wherein the distal end of the housing includes a connector element for connection to a catheter assembly. An instrument disposed within the housing, the instrument including a proximal end and a distal end, wherein the proximal end of the instrument is coupled to the advance tab, wherein in response to the advance tab moving from the retracted position to the advance position, the distal end of the instrument advances beyond the distal end of the housing; and A locking element is provided to lock the connector element in response to distal movement of the advancing tab beyond the retracted position, thereby preventing the conduit assembly from disengaging from the housing. The connector element includes a cannula and a plurality of lever locking arms configured to connect to the catheter assembly, wherein the locking element is configured to prevent the plurality of lever locking arms from being depressed to release the catheter assembly from the housing.

2. The vascular access device according to claim 1, wherein, The instruments include guidewires, catheters, or probes.

3. The vascular access device according to claim 1, wherein, The shell is substantially rigid.

4. The vascular access device according to claim 1, wherein, The connector element includes a Luer adapter.

5. The vascular access device according to claim 1, wherein, The locking element includes a biasing element or a cam element for automatically locking the connector element in response to the forward tab moving in the distal direction beyond the retraction position.

6. The vascular access device according to claim 1, wherein, In response to the instrument being in the forward position, the locking element is disposed between the housing and the plurality of lever locking arms to prevent the plurality of lever locking arms from being depressed and releasing the catheter assembly from the housing.

7. The vascular access device according to claim 1, wherein, The vascular access device also includes: A T-adaptor or a Y-adaptor is connected to the distal end of the housing, thereby connecting to the conduit assembly; and An extension tube extending from the T-adapter or Y-adapter, wherein a blood collection path extends through the extension tube, and the device includes a guidewire.

8. The vascular access device according to claim 1, wherein, The vascular access device further includes an extension tube extending from the housing between the distal end of the housing and the distal end of the slot, through which a blood collection path extends, and the device includes a guidewire.

9. The vascular access device according to claim 1, wherein, The vascular access device further includes an extension tube extending from the housing between the proximal end of the housing and the proximal end of the slot, through which a blood collection path extends, and the device includes a guidewire.

10. The vascular access device according to claim 1, wherein, The vascular access device also includes a stop feature for automatically maintaining the position of the advance tab relative to the slit.

11. The vascular access device according to claim 10, wherein, The stop feature is coupled to the forward tab and interacts with a feature of the housing to prevent linear movement of the instrument between the retracted position and the forward position.

12. The vascular access device according to claim 10, wherein, The stop feature is coupled to the housing and interacts with the forward tab to prevent linear movement of the instrument between the retracted position and the forward position.

13. The vascular access device according to claim 1, wherein, The vascular access device also includes a fluid seal disposed within the distal end of the housing to maintain a sealed fluid path.

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