Vascular Access Devices and Related Systems and Methods

Abstract

A vascular access device for delivering instruments is provided. A vascular access device may include a housing and an instrument disposed within the housing. The housing may include a proximal end, a distal end, a groove, and an advancement tab. The advancement tab may be configured to move linearly along the groove between a retracted position and an advanced position. The proximal end of the instrument may be coupled to the advancement tab such that, in response to movement of the advancement tab from the retracted position to the advanced position, a distal tip of the instrument is advanced beyond the distal end of the housing and into a patient's catheter assembly and / or vasculature.

Description

[Technical Field]

[0001] FIELD OF THE INVENTION The present invention relates to vascular access devices, including instruments such as catheters. [Background technology]

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

[0003] A common type of catheter is the over-the-needle peripheral intravenous ("IV") catheter. As the name suggests, an over-the-needle catheter may be mounted over an introducer needle having a sharpened distal end. The catheter and introducer needle may be assembled such that the distal end of the introducer needle extends beyond the distal end of the catheter, with the bevel of the needle facing up and away from the patient's skin. The catheter and introducer needle are generally inserted at a shallow angle through the patient's skin and into the vasculature.

[0004] To confirm proper placement of the introducer needle and / or catheter within the blood vessel, the clinician typically checks for blood "backflow" within the flashback chamber of the catheter assembly. Once needle placement is confirmed, the clinician may temporarily block flow through the vasculature and remove the needle, leaving the catheter in place for future blood draws, infusions, or probe access.

[0005] Blood collection or infusion using a catheter can be difficult for several reasons, especially when the catheter remains in place in the patient for more than a day. For example, when a catheter remains inserted in a patient for an extended period of time, the catheter may become susceptible to stenosis, collapse, kinking, blockage by debris (e.g., fibrin or platelet clots), and adhesion of the catheter tip to the vasculature. For this reason, catheters are often used to collect blood samples at the time of catheter placement but much less frequently to collect blood samples during the catheterization period. Therefore, when a blood sample is needed, an additional needle puncture is used to access the vein for collection, which can be painful for the patient and result in higher material costs.

[0006] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is provided only to illustrate one example technology area where some implementations described herein may be practiced. Summary of the Invention [Means for solving the problem]

[0007] The present disclosure generally relates to vascular access devices, which may house instruments such as guidewires, probes, or intravenous catheters, and related systems and methods. In some embodiments, the vascular access device may deliver an instrument through an existing peripheral intravascular catheter for blood withdrawal, fluid delivery, patient or device monitoring, or another clinical need. In some embodiments, the instrument may be introduced into the catheter to overcome complications that may impede fluid flow, such as a thrombus or fibrin sheath buildup at the catheter tip, a collapsed valve, a vein, or another obstruction. The instrument may displace such obstructions to clear a path for fluid flow into or out of the vein.

[0008] In some embodiments, the vascular access device may include a housing with a proximal end, a distal end, a groove, and an advancement tab. The advancement tab may be configured to move linearly along the groove between a retracted position and an advanced position. An instrument may be disposed within the housing and thereby protected from damage or contamination from 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 pathway.

[0009] The proximal end of the instrument may be coupled to the advancement tab, and in response to movement of the advancement tab from a retracted position to an advanced position, the distal tip of the instrument may be advanced 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 coupling element, such as a luer adapter, for coupling to the catheter assembly. In another embodiment, the coupling element may comprise a cannula and a plurality of lever lock arms that couple to the catheter assembly. Some embodiments may include a locking element disposed within the housing to prevent disengagement of the catheter assembly from the housing. The locking element may be activated in response to the advancement tab moving distally beyond the retracted position. In some embodiments, the locking element may include a biasing element or cam element that automatically locks the coupling element in response to the advancement tab being moved distally beyond the retracted position.

[0011] In some embodiments, such as when the coupling element includes a cannula and multiple lever lock arms, a locking element may be disposed between the housing and the multiple lever lock arms in response to the device being in the advanced position, which may prevent depression of the multiple lever lock arms and thus prevent the catheter assembly from being released from the housing. In response to the device being in the retracted position, a locking element may be disposed proximal to the lever lock arms, thereby allowing the lever lock arms to be depressed to release the catheter assembly from the housing.

[0012] In some embodiments, the vascular access device may include a T-adapter or Y-adapter coupled to a distal end of a housing that couples to the catheter assembly. In some embodiments, an extension tube extends from the T-adapter or Y-adapter, and a blood collection line extends through the extension tube and can be used to obtain a blood sample. The instrument may be a guidewire.

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

[0014] In some embodiments, the vascular access device may include a stop mechanism that automatically maintains the position of the advancement tab relative to the groove. In some embodiments, the stop mechanism may be coupled to the advancement tab and may interact with a feature on the housing. The stop mechanism may thus prevent linear movement of the instrument between the retracted and advanced positions. In another embodiment, the stop mechanism may be coupled to the housing and interact with the advancement tab to prevent linear movement of the instrument.

[0015] In some embodiments, a method of providing vascular access may include coupling a vascular access device to a catheter assembly. The catheter assembly may include a catheter adapter including a proximal end, a distal end, and a catheter extending from the distal end. The vascular access device may include a housing with a proximal end, a distal end, and a groove. The advancement tab may be configured to move linearly along the groove between a retracted position and an advanced position.

[0016] In some embodiments, an instrument may be disposed within the housing. The instrument may include a proximal end and a distal tip. The proximal end of the instrument may be coupled to an advancement tab. In response to movement of the advancement tab from a retracted position to an advanced position, the distal tip of the instrument may be advanced beyond the distal end of the housing.

[0017] In some embodiments, coupling the vascular access device to the catheter assembly may include coupling a housing to the catheter assembly. In some embodiments, the method may further include moving the advancement tab linearly along the groove from a retracted position to an advanced position. In response to moving the advancement tab to the advanced position, the distal tip of the instrument 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 the advancement tab moving distally past the retracted position. In some embodiments, the position of the advancement tab may be automatically maintained relative to the groove. In some embodiments, application of a force to the advancement tab may release the position.

[0019] It is to be understood that both the foregoing general description and the following detailed description are examples and explanations only and are not intended to limit the invention, as claimed. It is to be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. It is also to be understood that the embodiments may be combined or alternative embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the present invention, unless otherwise claimed. Therefore, the following detailed description is not to be taken in a limiting sense. [Brief explanation of the drawings]

[0020] Exemplary embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which: FIG. [Figure 1A] FIG. 1 is a top perspective view of an exemplary vascular access device showing an exemplary instrument in a retracted position, according to some embodiments. [Figure 1B] 1B is a cross-sectional view of the vascular access device of FIG. 1A. [Figure 2A] 1B is a top perspective view of the vascular access device of FIG. 1A showing the instrument in an advanced position, according to some embodiments. [Figure 2B] 1B is a cross-sectional view of the vascular access device of FIG. 1A showing an instrument in an advanced position, according to some embodiments. [Figure 3] FIG. 1 is a partial exploded view of a vascular access device and an exemplary adapter, according to some embodiments. [Figure 4] 4 is a cross-sectional view of the vascular access device and adapter of FIG. 3. [Figure 5] FIG. 10 is an exploded view of another exemplary vascular access device, according to some embodiments. [Figure 6] 6 is a cross-sectional view of the vascular access device of FIG. 5 and another exemplary adapter, according to some embodiments. [Figure 7]FIG. 10 is a top perspective view of another exemplary vascular access device showing a fluid pathway extending from the proximal end of the housing, according to some embodiments. [Figure 8] 8 is a cross-sectional view of the vascular access device of FIG. 7 and another exemplary adapter, according to some embodiments. [Figure 9A] FIG. 1 is a top perspective view of an exemplary housing including a locking element in an unlocked position, according to some embodiments. [Figure 9B] FIG. 9B is a cross-sectional view of the housing and locking element of FIG. 9A. [Figure 10A] FIG. 10 is a top perspective view of another exemplary housing including a locking element in a locked position, according to some embodiments. [Figure 10B] FIG. 10B is a cross-sectional view of the housing and locking element of FIG. 10A. [Figure 11] FIG. 10 is a cross-sectional view of an exemplary housing configured to advance the instrument twice the travel distance provided by the advancement tab, according to some embodiments. [Figure 12] 1 is a cross-sectional view of an exemplary housing including a guide element, according to some embodiments. [Figure 13] 1A-1C are cross-sectional views of an exemplary vascular access device configured for single-handed operation, according to some embodiments. [Figure 14] FIG. 10 is a top perspective view of an exemplary advancement tab configured for one-handed operation, according to some embodiments. [Figure 15A] 1 is a cross-sectional view of an exemplary luer adapter, according to some embodiments. [Figure 15B] FIG. 10 is a cross-sectional view of another exemplary luer adapter, according to some embodiments. [Figure 15C] FIG. 10 is a cross-sectional view of another exemplary luer adapter, according to some embodiments. [Figure 16A] 12A-12C are perspective views of an exemplary lever lock housing an extension tube, according to some embodiments. [Figure 16B] FIG. 16B is a cross-sectional view of the lever lock of FIG. 16A. [Figure 17] FIG. 10 is a cross-sectional view of an example of an advancement tab and stop mechanism, according to some embodiments. [Figure 18] 10A-10C are cross-sectional views of an exemplary vascular access device configured to advance an instrument three times the travel distance of an advancement tab, according to some embodiments. [Figure 19] FIG. 19 is a top perspective view of the vascular access device of FIG. 18. [Figure 20] FIG. 1 is a perspective view of an exemplary housing attached to a blood collection adapter, according to some embodiments. [Figure 21] FIG. 1 is a perspective view of an exemplary vascular access device having a flexible joint, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0021] As used herein, the term "distal" refers to a direction closer to the patient, away from the clinician who will place the device in contact with the patient. The term "proximal" refers to a direction farther away from the patient, closer to the clinician who will place the device in contact with the patient. Thus, for example, the end of a catheter that first contacts the patient's body is the distal end, while the opposite end of the catheter is the proximal end of the catheter.

[0022] 1A and 1B, in some embodiments, a vascular access device 100 may be configured to deliver an instrument 102 through a catheter of a catheter assembly, for example, for blood withdrawal, fluid delivery, patient or device monitoring, or another clinical need. An exemplary catheter assembly is shown in FIG. 21. In some embodiments, the catheter may include a peripheral IV catheter, a peripherally inserted central catheter, or a midline catheter. In some embodiments, the catheter through which the instrument 102 is delivered may have been previously inserted into and remain within the patient's vasculature.

[0023] In some embodiments, the instrument 102 may be advanced through the fluid path of the catheter and catheter assembly such that the distal tip 118 of the instrument 102 is positioned within the patient's vasculature distal to the distal tip of the catheter. In some embodiments, during a procedure, a clinician may deploy the instrument 102 to push aside any obstructions within the catheter or vasculature (e.g., a thrombus or fibrin buildup at the catheter tip, a collapsed vein, a valve, etc.) to create a clear path for fluid flow.

[0024] In some embodiments, the instrument 102 may be disposed within a housing 104 configured to protect the instrument 102 from damage and / or contamination from the surrounding external environment. In some embodiments, the housing may be rigid or semi-rigid. In some embodiments, the housing 104 may be made from 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 groove 110, and an advancement tab 112. In some embodiments, the groove 110 may extend parallel to a longitudinal axis of the housing 104. In some embodiments, the distal end 108 of the housing 104 may be coupled to a coupling element 122, such as a Luer connector, for example, to connect to a catheter assembly, as discussed in more detail below.

[0025] In some embodiments, the instrument 102 may include, for example, a guidewire, another catheter, a probe, or another suitable instrument. In some embodiments, the instrument 102 may include various apertures and / or sensors. In some embodiments, the instrument 102 may include both probe and catheter elements. In some embodiments, the apertures and / or sensors may be positioned toward the distal tip 118 of the instrument 102. In some embodiments, the apertures may function as fluid inlets and / or outlets. In some embodiments, the sensors may measure one or more parameters and / or detect one or more elements related to, for example, diagnostic information, blood chemistry, pressure, flow rate, drug identification, microorganisms, placement of an implantable stent, intravenous catheter tip stabilization mechanism, or another device.

[0026] In some embodiments, the advancement tab 112 may be configured to move linearly along the groove 110 between the retracted position 114 and the advanced position 116. In some embodiments, the advancement tab 112 may be coupled to the proximal end 120 of the instrument 102 such that moving the advancement tab 112 linearly along the groove 110 moves the instrument 102 relative to the housing 104 in the same direction as the advancement tab 112. In some embodiments, a clinician may move the instrument 102 between the retracted position 114 and the advanced position 116 by pinching or squeezing the advancement tab 112. 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 advancement tab 112 relative to the groove 110, and may include any ratio.

[0027] 2A and 2B, movement of the advancement tab 112 from the retracted position 114 to the advanced position 116 may advance the distal tip 118 of the instrument 102 beyond the distal end 108 of the housing 104. In some embodiments, moving the advancement tab 112 to the advanced position 116 may, for example, introduce the instrument 102 into a catheter assembly. In some embodiments, in response to the instrument 102 being introduced into the catheter assembly, the instrument 102 may access a fluid pathway of the catheter assembly and / or the patient's vasculature.

[0028] In some embodiments, catheters of a catheter assembly that have a significant dwell time within the vasculature may be susceptible to stenosis by debris (e.g., fibrin or platelet clots), collapse, kinking, occlusion, and adhesion of the catheter tip to the vasculature. Thus, drawing blood using the catheter may be difficult. In some embodiments, the instrument 102 may include a guidewire or another catheter that has a smaller diameter than the diameter of the catheter of the catheter assembly, thereby providing access to the patient's vasculature without an additional needle stick. In some embodiments, the guidewire may clear a pathway for collecting a blood sample. Thus, in some embodiments, the vascular access device 100 may be used for needleless blood draws and / or infusions.

[0029] In some embodiments, the advancement tab 112 may be moved along the groove 110 from an advanced position 116 to a retracted position 114 to cause at least a portion of the instrument 102 to be lowered or retracted into the housing 104 .

[0030] 3-8, in some embodiments, an extension tube 126 may be coupled to the vascular access device 100. The extension tube 126 may be used for blood collection and / or transfusion, which may be infused into or withdrawn from a patient's vein, and may be oriented in any of a variety of ways. As shown in FIGS. 5-6, in some embodiments, the extension tube 126 may extend directly from the housing 104. In some embodiments, the coupling element 122 may include, for example, a lever lock 130. In some embodiments, the coupling 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 the lever lock 130 and the distal end of the groove 110.

[0031] 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 be advanced and / or retracted from the distal end 108 while maintaining a closed fluid path. In other embodiments, such as when the dilator 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 movement of the instrument 102 therethrough while maintaining a closed fluid path. In some embodiments, the fluid seal 131 may comprise silicone, rubber, an elastomer, or another suitable material. In some embodiments, the fluid seal 131 may include an opening, slit, etc. for accommodating the instrument 102 therethrough.

[0032] 3-4 , in some embodiments, it may be advantageous to direct a fluid pathway of a vascular access system through an adapter 124, such as a T-adapter or Y-adapter, coupled to the housing 104. In some embodiments, an extension tube 126 extends from the adapter 124, such that a fluid pathway, such as a blood draw pathway, may be directed through the extension tube 126 rather than through the housing 104. In these or other embodiments, such as when the fluid pathway is used to obtain a blood sample, for example, the inner diameter and length of the extension tube 126 may be selected to balance shear stresses across the length of the fluid pathway, thereby reducing blood hemolysis.

[0033] 7-8 , in some embodiments, the dilation tube 126 may extend from the proximal end 106 of the housing 104. In some embodiments, the dilation tube 126 may extend from the proximal end 106 of the housing 104 proximal to the proximal end of the groove 110. In some embodiments, the proximal end of the dilation tube 126 may include a connector 300, which may include a luer connector or another suitable connector coupled thereto.

[0034] In some embodiments, connector 300 may be coupled to a blood collection device, such as, for example, a VACUTAINER® or VACUTAINER® LUER-LOK™, available from Becton Dickinson and Company, Franklin Lakes, New Jersey. 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 a portion of housing 104.

[0035] In some embodiments, the length L of the dilation tube 126 may be selected based on one or more of a particular catheter gauge, a particular catheter assembly configuration, or a clinical device. In some embodiments, the dilation tube 126 may include an inner diameter D.

[0036] Fluid flow within the fluid path through the tubular dilation tube 126 can be analyzed using the Poiseuille equation: TIFF0007741089000001.tif28136 where ΔP is the change in pressure gradient over the length of the fluid path, D and L are the inner diameter and length of the fluid path, respectively, μ is the viscosity of the fluid, and R f =128μL / πD 4 is the fluid resistance. μ is the viscosity of the fluid and is not part of the geometry of the expansion tube, so the geometric coefficient G f is R f (fluid resistance) is R f =(128μ / π)×G f where G f =L / D 4 is.

[0037] In some embodiments, the dilation tube 126 may have multiple sections with lengths (L1, L2, L3) and inner diameters (D1, D2, D3), with geometric factors as follows: TIFF0007741089000002.tif30136 In some embodiments, the dilation tube 126 may have an inner diameter that varies over the length of the dilation tube 126, where the geometric factor is: In some embodiments, the dilation tube 126 may have a non-circular cross-section or a complex inner diameter profile. The geometric coefficient may then be determined by measuring the flow rate (Q) at a given pressure (ΔP) using a fluid of known viscosity (μ), as follows: TIFF0007741089000004.tif37136

[0038] Extension tube 126G f The values ​​are selected to reduce the maximum shear stress for each catheter gauge and may be less than or equal to the maximum shear stress of the BD 21G VACUTAINER® UltraTouch™ push-button blood collection set (available from Becton Dickinson & Company, Franklin Lakes, NJ), previously considered the gold standard for blood collection. f The values ​​were selected to reduce the maximum shear stress for each catheter gauge, allowing it to be equal to or less than the maximum shear stress of the BD 25G VACUTAINER® UltraTouch™ Push-Button Blood Collection Set (available from Becton Dickinson & Company, Franklin Lakes, New Jersey).

[0039] In some embodiments, the fluid path of the vascular access system, which may include one or more of the blood collection device, the extension tube 126, the adapter 124, and the catheter assembly, may include the entire blood collection path through which blood flows into or through the blood collection device after exiting the vascular system during blood collection. fs is the G of the aforementioned expansion tube 126. f In some embodiments, the system geometric coefficient G for the device 102 in the advanced position may be determined in a similar manner to the value fs is 7.34E+06(1 / in 3 ) or more. In some embodiments, G fs may include other values. In some embodiments, the system geometric coefficient G for the instrument 102 in the advanced position fs is 7.34E+06(1 / in 3 ) may be plus or minus 10 percent, plus or minus 25 percent, plus or minus 50 percent, or plus or minus 75 percent. In some embodiments, G fs may include other values ​​and may be selected based on the gauge and / or length of the catheter.

[0040] In some embodiments, the instrument 102 disposed within the housing 104 may be maintained in a non-fluid environment and protected from contamination and environmental hazards until use. Advantageously, in some embodiments, the extension tube 126 may also allow for the maintenance of a closed system and aseptic technique while reducing obstruction or dislodgement of the catheter and / or catheter securement dressing.

[0041] In some embodiments, the distal end 108 of the housing 104 may include a lever lock 130 that couples the housing 104 to the catheter assembly. The lever lock 130 may include a cannula 132 and at least two of the lever lock arms 128 a, b. 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 128 a, b may be spaced apart from one another, and in some embodiments, may be located substantially opposite one another with respect to the cannula 132.

[0042] In some embodiments, during surgery, the cannula 132 may penetrate a luer connector of the catheter assembly to access the fluid path of the catheter assembly. In some embodiments, the proximal ends of the lever lock arms 128 a, b may be biased inward toward the longitudinal axis of the housing 104 to snap onto or otherwise couple to the luer connector. In this manner, the lever lock arms 128 a, b 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 lock arms 128 a, b. In some embodiments, the lever lock arms 128 a, b may engage the protrusions of the lever lock arms 128 a, b to secure the housing 104 to the catheter assembly.

[0043] 15A-15C, in some embodiments, the coupling element 122 may include a luer connector, such as, for example, a male luer connector, that connects to a catheter assembly. In some embodiments, the luer connector may include a luer lock connector 1500, which may include internal threads 1502 that engage with corresponding threads on the luer connector of the catheter assembly. In some embodiments, the luer lock connector 1500 may further include a cannula 132 that penetrates or is inserted into the luer connector of the catheter assembly.

[0044] In some embodiments, coupling element 122, such as lever lock 130 (see, e.g., FIGS. 1-11) or luer lock connector 1500, may be secured to housing 104. In other embodiments, coupling element 122 may be coupled to housing 104 and configured to rotate to any clock position relative thereto.

[0045] 16A and 16B, in some embodiments, a coupling element 122, such as a lever lock 130 (see, e.g., FIGS. 1-11) or a luer lock connector 1500 (see, e.g., FIG. 15), can be monolithically formed with the housing 104 as a single unit.

[0046] 9A-B and 10A-B, some embodiments may include a locking element 900 that selectively or automatically secures the housing 104 to the catheter assembly while the device 102 is advanced through the catheter. In some embodiments, as described above, the coupling element 122 may include the cannula 132 and lever lock arms 128a, b that couple 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 lock arms 128a, b. The locking member 902 may be integral with or coupled to an elongated extension member 904 that is disposed within the housing 104 and extends along all or part of its length.

[0047] In some embodiments, in response to the instrument 102 being in the advanced position 116, the locking member 902 may be disposed in a locked position between the housing 104 and the lever lock arms 128a,b. In this position, the locking member 902 may prevent the lever lock arms 128a,b from being depressed, thereby preventing release of the catheter assembly from the housing 104. In response to the instrument 102 being in the retracted position 114, the locking member 902 may be disposed proximal to the lever lock arms 128a,b in an unlocked position, whereby the lever lock arms 128a,b may depress, thereby releasing, the catheter assembly from the housing 104.

[0048] In some embodiments, locking element 900 may include a biasing element, such as a spring, or a camming element, such as a cam and follower, that is disposed within housing 104 and automatically activated in response to distal movement of advancement tab 112 beyond retracted position 114. The biasing element or camming element may automatically activate locking element 900 to lock coupling element 122, thereby preventing disengagement of the catheter assembly from housing 104.

[0049] Notably, in some embodiments, the elongate expansion member 904 may be held proximally such that the locking member 902 is in an unlocked position when the advancement tab 112 is in the retracted position 114. The locking member 902 may be released once the advancement tab 112 is moved distally to advance the device 102 into the catheter. A biasing or camming element may then urge the locking member 902 distally, engaging the lever lock arms 128 a,b into the locked position.

[0050] Similarly, when the advancement tab 112 is actuated to retract the instrument 102, the final movement in the proximal direction may pull the locking member 902 against the biasing or camming element, thus unlocking the lever lock arms 128 a,b. This may prevent the user from removing the instrument 102 from the catheter assembly when the advancement tab 112 is in any position except its proximal-most and retracted positions 114.

[0051] Of course, as one skilled in the art will appreciate, the automatic locking mechanism may be reversed, causing a biasing member or cam element to pull the locking member 902 to disengage the lock and then push the locking member 902 into an engaged state to secure the catheter assembly to the housing 104. In some embodiments, the automatic locking mechanism may be activated when the movement of the advancement tab 112 begins or ends. In some embodiments, the locking member 902 may rotate in and out of a locked position rather than sliding forward and backward.

[0052] 13, 14, and 17, in some embodiments, the position of the advancement tab 112 may be controlled before, during, and after use of the instrument 102. In some embodiments, the vascular access device 100 may include a stop mechanism 1300 that automatically maintains the position of the advancement tab 112 relative to the groove 110. In some embodiments, the stop mechanism 1300 may be coupled to the advancement tab 112 and may interact with a feature of the housing 104. The stop mechanism 1300 may thus prevent linear movement of the instrument 102 between the retracted position 114 and the advanced position 116. In another embodiment, the stop mechanism 1300 may be coupled to the housing 104 and interact with the advancement tab 112 to prevent linear movement of the instrument 102.

[0053] In some embodiments, the stop mechanism 1300 may provide designed friction between the advancement tab 112 and the housing 104 such that movement of the advancement tab 112 requires the application of a force. In the absence of the application of such a force, the advancement tab 112 may maintain its linear position along the groove 110. In some embodiments, the stop mechanism 1300 may apply friction along the entire length of the groove 110.

[0054] In some embodiments, the stop mechanism 1300 may include a simple interference between the advancement tab 112 and the housing 104 and may use the tensile stress of the advancement tab 112 material as a spring for control. For example, in some embodiments, both the advancement tab 112 and the housing 104 may have a substantially oval cross-section. The advancement tab 112 may be configured to rotate relative to the housing 104, thereby locking the position of the advancement tab 112.

[0055] In some embodiments, the stop mechanism 1300 may be a cantilever beam integral to the advancement tab 112 or the housing 104 that acts as a spring. In another embodiment, the stop mechanism 1300 may include a separate spring member attached to the advancement tab 112 that provides friction as the advancement tab 112 slides against or against the housing 104. In some embodiments, in addition to the spring force, the surface finish and / or materials used for the advancement tab 112 and / or the housing 104 may be selected to optimize friction between the two.

[0056] In some embodiments, the stop mechanism 1300 may substantially correspond to the groove 110 or the distal end 108 and / or proximal end 106 of the housing 104, and thus may correspond to the advanced position 116 and / or retracted position 114 of the instrument 102. In some embodiments, the stop mechanism 1300 may include one or more detents or other features integral with or coupled to the groove 110 or the distal end 108 and / or proximal end 106 of the housing 104. In some embodiments, the detents may mechanically or magnetically interact with the advancement tab 112 to retain the advancement tab 112 in the advanced position 116 and / or retracted position 114. In this manner, the instrument 102 may be maintained in a fully retracted or fully inserted position. Of course, one or more detents may be implemented anywhere along the groove 110 or housing 104 to maintain the advancement tab 112 in any such position. In some embodiments, one or more detents may be implemented in addition to another stop mechanism 1300.

[0057] 17 , in some embodiments, the stop mechanism 1300 may include a spring-loaded catch 1700 integrated with or coupled to the advancement tab 112. The spring-loaded catch 1700 may automatically engage a recess 1702 disposed within the housing 104 as the advancement tab 112 moves linearly along the groove 110. The advancement tab 112 may be selectively depressed to release the spring-loaded catch 1700 from the recess 1702. The spring-loaded catch 1700 may thus be released to allow the advancement tab 112 to slide linearly along the groove 110, thereby advancing or removing the instrument 102. In some embodiments, the recess 1702 may be integrated within the housing 104 at any desired position or distance along the groove 110 or the housing 104.

[0058] 11 and 18-19, in some embodiments, the advancement tab 112 may be configured to advance the instrument 102 a greater distance than the advancement tab 112 itself would travel. As shown in FIG. 11, for example, the advancement tab 112 may be configured to advance the instrument 102 a greater distance, e.g., twice the distance, than the distance traveled by the advancement tab 112, by attaching the proximal end 120 of the instrument 102 to the distal end 108 of the housing 104, which faces proximally. In some embodiments, the instrument 102 may form a "U-shaped" turn through the advancement tab 112 to exit the housing 104 at the distal end 108. In some embodiments, the advancement tab 112 may push the "U-shaped" portion of the instrument 102 to advance the instrument 102 and may pull the "U-shaped" portion of the instrument 102 to retract the instrument 102. The instrument 102 may slide through the advancement tab 112 as it moves. In this manner, the advancement tab 112 may act as a pulley to move the instrument 102 a distance twice as far as the advancement tab 112 moves it.

[0059] 18-19 , in some embodiments, one or more additional bends may be incorporated into the instrument 102 prior to attaching the proximal end 120 to the advancement tab 112. This may allow the advancement tab 112 to further increase the distance traveled by the instrument 102 relative to the distance traveled by the advancement tab 112 by a factor equal to the number of bends or “U-shaped” turns. In some embodiments, the factor may be equal to the number of bends or “U-shaped” turns that the instrument 102 has plus one. For example, no bends may correspond to one advancement between the instrument 102 and the advancement tab 112, one bend may correspond to two advancements between the instrument 102 and the advancement tab 112, two bends may correspond to three advancements between the instrument 102 and the advancement tab 112, etc. However, configuring the instrument 102 and the advancement tab 112 in this manner may cause the instrument 102 to buckle during insertion. Therefore, some embodiments may include guides or restraints to support the device 102 to prevent buckling.

[0060] For example, with reference to FIG. 12 , some embodiments may include a guide element 1204 disposed within the housing 104 to restrain the instrument 102. In some embodiments, the guide element 1204 may be disposed within a bore 1206 in the housing 104 that accommodates the instrument 102. In some embodiments, the guide element 1204 may be coupled to the advancement tab 112 via a connector member 1202. In some embodiments, the connector member 1202 may be configured to substantially occupy the tortuous path 1200 between the bore 1206 and the groove 110. The connector member 1202 may thereby occupy the tortuous path 1200 and prevent contamination that would otherwise enter the groove 110 and reach the instrument 102. In another embodiment, the connector member 1202 may occupy a straight path between the groove 110 and the bore 1206 and / or the instrument 102.

[0061] In some embodiments, the guide element 1204 may occupy the space between portions of the instrument 102 that form a "U" shape, such as when the advancement tab 112 moves the instrument 102 twice as far as the advancement tab 112 moves it. In this manner, the instrument 102 may be constrained on three sides, thereby preventing movement of the instrument 102 in these three directions. To prevent buckling in a fourth direction, some embodiments may include a blocking element to selectively block the open area in the fourth direction. In some embodiments, the blocking element may be selectively removed to allow the instrument 102 to advance therethrough. In other embodiments, the instrument 102 may include small bends or deflections that direct the instrument 102 away from the open area or side and instead into a wall or constrained area.

[0062] Advantageously, configuring the advancement tab 112 to advance the instrument 102 greater than the distance traveled by the advancement tab 112 may facilitate a compact housing 104 having reduced dimensions and a reduced length of the groove 110. In other words, the distance that the advancement tab 112 must travel to advance and retract the instrument 102 is reduced, which may require a vascular access device 100 with a more compact design. The vascular access device 100 may be operated with one hand as a result.

[0063] 13 and 14, some embodiments of the vascular access device 100 may be operated by moving a single finger or thumb while holding the vascular access device 100 in the same hand. Some embodiments of the vascular access device 100 that allow for one-handed operation may include a collar advancement grip 1302 or a center grip 1303. As shown, the collar advancement grip 1302 or center grip 1303 may allow the advancement tab 112 to be advanced one-handed by a clinician or user holding the housing 104 with their thumb and middle finger. The collar advancement grip 1302 or center grip 1303 may be translated by, for example, the index finger.

[0064] 20-21 , in some embodiments, the housing 104 may include one or more markings 2000 or dimensions that may visually indicate to a clinician or another user the insertion depth of the instrument 102. In some embodiments, the markings 2000 may be a scale 2002 on the side of the housing 104 that may align with an indicator 2004 on the advancement tab 112. In some embodiments, the scale 2002 may be affixed for use with a particular catheter setting and length. In some embodiments, the markings 2000 may include a table indicating positions for different catheter settings and lengths. In some embodiments, the scale 2002 may be a sliding scale 2002 and / or indicator 2004 that is adjustable depending on the catheter setting and length.

[0065] In some embodiments, the markings 2000 may indicate how far to insert and / or withdraw one or more different instruments 102, such as, for example, different types of catheters. In some embodiments, the markings 2000 may indicate one or more of the advanced position 116 of the instrument 102, the retracted position 114 of the instrument 102, and various positions between the advanced position 116 and the retracted position 114 of the instrument 102. Some embodiments may include an icon indicating alignment between the catheter tip and the distal tip 118 of the instrument 102. In some embodiments, an additional icon may indicate a particular distance traveled by the distal tip 118 of the instrument 102 beyond the catheter tip.

[0066] In some embodiments, the distance between the markings 2000 may be adjusted when the vascular access device 100 includes an instrument 102 and advancement tab 112 configuration that has a multiplier effect on the distance traveled by the instrument 102 relative to the advancement tab 112. Of course, the multiplier may be any number or ratio known to one of skill in the art.

[0067] 20 , in some embodiments, the blood draw adapter 2006 may be secured to the vascular access device 100. For example, in some embodiments, the blood draw adapter 2006 may be directly joined to the extension tube 126. In another embodiment, the blood draw adapter 2006 may be coupled to the vascular access device 100 via a luer connection, thereby allowing the blood draw adapter 2006 to be selectively removed and replaced with another device, such as a syringe, for example.

[0068] 21 , in some embodiments, a flexible joint 2100 may be incorporated between the lever lock 130 or another coupling element 122 and the housing 104. The flexible joint 2100 may provide flexibility between the attachment to the catheter and the housing 104. In some embodiments, the flexible joint 2100 may include a piece of tubing or a ball and socket coupled to the housing 104 and / or lever lock 130, or another coupling element 122.

[0069] All examples and conditional language listed herein are intended for educational purposes to aid the reader in understanding the invention and the concepts contributed by the inventors to furthering the art, and should not be construed as being limited to such specifically described examples and conditions. Although embodiments of the invention have been described in detail, it should be understood that various changes, substitutions, and alterations can be made thereto without departing from the spirit and scope of the invention. [Explanation of symbols]

[0070] 100 Vascular Access Devices 102 Equipment 104 Housing 106 Proximal end 108 Distal end 110 Groove 112 Forward Tab 114 Retract position 116 Forward position 118 Distal Tip

Claims

1. 1. A vascular access device comprising: a housing having a proximal end, a distal end, a groove, and an advancement tab configured to move linearly along the groove between a retracted position and an advanced position; the distal end of the housing includes a coupling element for coupling to a catheter assembly; an instrument disposed within the housing, the instrument having a proximal end and a distal tip, the proximal end of the instrument coupled to the advancement tab, and in response to movement of the advancement tab from the retracted position to the advanced position, the distal tip of the instrument is advanced beyond the distal end of the housing; a locking element disposed within the housing that locks the coupling element to prevent disengagement of the catheter assembly from the housing in response to the advancement tab being moved distally beyond the retracted position; 1. A vascular access device comprising:

2. The vascular access device of claim 1 , wherein the instrument comprises a guidewire, a catheter, or a probe.

3. The vascular access device of claim 1 , wherein the housing is substantially rigid.

4. The vascular access device of claim 1 , wherein the coupling element comprises a luer adapter.

5. The vascular access device of claim 1 , wherein the coupling element comprises a cannula and a plurality of lever lock arms configured to couple to a catheter assembly.

6. 10. The vascular access device of claim 1, wherein the locking element comprises a biasing or camming element that automatically locks the coupling element in response to the advancement tab being moved distally beyond the retracted position.

7. 2. The vascular access device of claim 1, wherein the coupling element comprises a cannula and a plurality of lever lock arms configured to couple to a catheter assembly, and wherein, in response to the instrument being in the advanced position, the locking element is disposed between the housing and the plurality of lever lock arms to prevent depression of the plurality of lever lock arms to release the catheter assembly from the housing.

8. a T- or Y-adapter coupled to the distal end of the housing for coupling to a catheter assembly; an extension tube extending from the T adapter or the Y adapter, a blood collection path extending through the extension tube, and the device comprising a guidewire; and The vascular access device of claim 1 , further comprising:

9. 10. The vascular access device of claim 1, further comprising an extension tube extending from the housing between the distal end of the housing and the distal end of the groove, a blood collection path extending through the extension tube, and the instrument comprising a guidewire.

10. 10. The vascular access device of claim 1, further comprising an extension tube extending from the housing between the proximal end of the housing and the proximal end of the groove, a blood collection path extending through the extension tube, and the instrument comprising a guidewire.

11. The vascular access device of claim 1 , further comprising a stop mechanism that automatically maintains the position of the advancement tab relative to the groove.

12. 12. The vascular access device of claim 11, wherein the stop mechanism is coupled to the advancement tab and interacts with a feature on the housing to prevent linear movement of the instrument between the retracted and advanced positions.

13. 12. The vascular access device of claim 11, wherein the stop mechanism is coupled to the housing and interacts with the advancement tab to prevent linear movement of the instrument between the retracted and advanced positions.

14. The vascular access device of claim 1 , further comprising a fluid seal disposed within the distal end of the housing to maintain a closed fluid path.

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