VASCULAR ACCESS DEVICE AND RELATED SYSTEMS AND METHODS
Patent Information
- Authority / Receiving Office
- MX · MX
- Patent Type
- Patents
- Current Assignee / Owner
- BECTON DICKINSON & CO
- Filing Date
- 2022-09-23
- Publication Date
- 2026-05-19
AI Technical Summary
Catheters used for extended periods in patients face issues such as narrowing, collapse, twisting, blockage by debris, and tip adhesion, making blood sampling difficult and requiring additional needle sticks, which are painful and costly.
A vascular access device with a housing that protects an instrument, such as a guide needle, which can be advanced through a catheter to clear obstructions, featuring a locking mechanism and a flexible extension tube for needle-free blood collection and fluid infusion, maintaining a closed fluid path and reducing shear stress.
Enables efficient, pain-free blood collection and fluid infusion by clearing catheter obstructions, maintaining a closed system, and reducing shear stress, thus minimizing patient discomfort and material costs.
Smart Images

Figure MX434160B0
Abstract
Description
VASCULAR ACCESS DEVICE AND RELATED SYSTEMS AND METHODS BACKGROUND Catheters are commonly used for various infusion therapies. For example, catheters can be used to infuse fluids, such as normal saline, various medications, and total parenteral nutrition, into a patient. Catheters can also be used to draw blood from the patient to obtain a blood sample. A common type of catheter is a peripheral intravenous (IV) over-the-needle catheter. As the name implies, the over-the-needle catheter is mounted on an introducer needle with a sharp distal tip. The catheter and introducer needle are assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter, with the bevel of the needle facing upward and away from the patient's skin. The catheter and introducer needle are typically inserted at a shallow angle, through the skin, into the patient's vasculature. To verify proper placement of the introducer needle and / or catheter in the blood vessel, a physician typically confirms that blood flows back into a return chamber of the catheter assembly. Once needle placement has been confirmed, the physician can temporarily occlude flow in the vasculature and withdraw the needle, leaving the catheter in place for future blood draws, fluid infusions, or catheter access. Blood collection or infusion using a catheter can be difficult for several reasons, particularly when the catheter remains in the patient for more than a day. For example, when a catheter is left in place for an extended period, it can be more susceptible to narrowing, collapse, twisting, blockage by debris (e.g., fibrin or platelet clots), and adhesion of the catheter tip to the vasculature. Because of this, catheters are often used to obtain a blood sample at the time of catheter placement, although they are used much less frequently to obtain a blood sample during the catheter's dwell time. Therefore, when a blood sample is desired, an additional needle puncture is used to provide access to the vein for blood collection, which can be painful for the patient and result in higher material costs. The subject matter claimed in this document is not limited to implementations that resolve some disadvantage or that operate only in environments such as those described above. iviA / a / zuzz / uii oou Rather, this background information is provided only to illustrate an area of technology as an example where some of the implementations described in this document can be put into practice. BRIEF DESCRIPTION OF THE INVENTION This disclosure generally relates to a vascular access device that can accommodate an instrument such as, for example, a guidewire, probe, or intravenous catheter, as well as related systems and methods. In some embodiments, the vascular access device can deliver the instrument through an existing peripheral intravascular catheter for blood collection, fluid delivery, patient or device monitoring, or other clinical needs. In some embodiments, the instrument can be inserted into the catheter to overcome complications that may impede fluid flow, such as a thrombus or fibrin sheath accumulated at the catheter tip, valves, venous collapse, or other obstructions. The instrument can be forced through by pushing such occlusions to clear a pathway for fluid flow into or out of the vein. In some embodiments, the vascular access device may include a housing comprising 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 and an advanced position. The 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 it. The fluid seal may maintain a closed fluid pathway. A proximal end of the instrument can be engaged with the advance tongue. In response to the movement of the advance tongue from the retracted to the advanced position, the distal tip of the instrument can advance beyond the distal end of the housing. In some embodiments, the housing may be substantially rigid. In some embodiments, the distal end of the housing may comprise a coupling element, such as a Luer adapter, for coupling to a catheter assembly. In other embodiments, the coupling element may comprise a cannula and multiple lever-locking arms for coupling to a 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 movement of the advancing tongue in a distal direction beyond the retracted position. In some embodiments, the locking element may include a push element or a cam element to automatically lock the coupling element in response to movement of the advancing tongue in a distal direction beyond the retracted position. In some embodiments, such as when the coupling element includes the cannula and the plurality of lever-lock arms, the locking element may be positioned between the housing and the plurality of lever-lock arms when the instrument is in the advanced position. This may prevent the plurality of lever-lock arms from being pressed and thus prevent the catheter assembly from being released from the housing. When the instrument is in the retracted position, the locking element may be positioned proximal to the lever-lock arms, allowing the lever-lock arms to be pressed and thus releasing the catheter assembly from the housing. In some embodiments, the vascular access device may include a T-adapter or Y-adapter attached to the distal end of the housing for connection to the catheter assembly. In some embodiments, an extension tube may extend from the T-adapter or Y-adapter, and a blood collection line may extend through the extension tube and be used to obtain a blood sample. The instrument may be a guide needle. In some embodiments, the extension tube may extend from the housing between the distal end of the housing and a distal end of the slot. In other embodiments, the extension tube may extend from the housing between the proximal end of the housing and a proximal end of the slot. A blood collection line may be extended through the extension tube and used to obtain a blood sample. In some embodiments, the vascular access device may include a stop feature to automatically maintain a position of the advancement tongue relative to the groove. In some embodiments, the stop feature may be coupled to the advancement tongue and may interact with a feature of the housing. The stop feature may therefore obstruct the linear movement of the instrument between the retracted and advanced positions. In other embodiments, the stop feature may be coupled to the housing and interact with the advancement tongue to obstruct the linear movement of the instrument. In some embodiments, a method for providing vascular access may include attaching the vascular access device to the 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 groove. A lead tab can be configured to move linearly along the slot between a retracted position and an advanced position. 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 the advance tongue. In response to the movement of the advance tongue from the retracted to the advanced position, the distal tip of the instrument may advance beyond the distal end of the housing. In some embodiments, attaching the vascular access device to the catheter assembly may include attaching the housing to the catheter assembly. In some embodiments, the method may further include moving the advancement tab linearly along the groove from the retracted to the advanced position. In response to the movement of the advancement tab to the advanced position, the distal tip of the instrument may extend beyond the distal end of the housing. 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 can be actuated in response to movement of the advancement tab in a distal direction beyond the retracted position. In some embodiments, a position of the advancement tab relative to the groove can be automatically maintained. In some embodiments, a force can be applied to the advancement tab to release this position. It should be understood that both the preceding general description and the following detailed description are illustrative, not restrictive, examples of the invention as claimed. It should be understood that the various embodiments are not limited to the arrangements and instruments illustrated in the drawings. It should also be understood that the embodiments may be combined or that other embodiments may be used, and that structural changes, unless otherwise claimed, may be made without departing from the scope of the various embodiments of the present invention. The following detailed description should therefore not be interpreted in a limiting manner. BRIEF DESCRIPTION OF THE VARIOUS VIEWS OF THE DRAWINGS The example realizations will be described and explained in additional specificity and detail through the use of the accompanying drawings, in which: Figure 1A is a top perspective view of an example of a vascular access device, illustrating an example of an instrument in a retracted position according to some embodiments; Figure 1B is a cross-sectional view of the vascular access device in Figure 1A; Figure 2A is a top perspective view of the vascular access device of Figure 1A, illustrating the instrument in an advanced position according to some embodiments; Figure 2B is a cross-sectional view of the vascular access device of Figure 1A, illustrating the instrument in the advanced position according to some embodiments; Figure 3 is a partial exploded view of the vascular access device and an example of an adapter according to some embodiments; Figure 4 is a cross-sectional view of the vascular access device and adapter of Figure 3; Figure 5 is an exploded view of another example of a vascular access device according to some embodiments; Figure 6 is a cross-sectional view of the vascular access device of Figure 5 and another example of an adapter according to some embodiments; Figure 7 is a top perspective view of another example of a vascular access device illustrating a fluid pathway extending from a proximal end of the housing according to some embodiments; Figure 8 is a cross-sectional view of the vascular access device of Figure 7 and another example of an adapter according to some embodiments; Figure 9A is a top perspective view of an example of a housing that includes a locking element in an unlocked position according to some embodiments; Figure 9B is a cross-sectional view of the housing and locking element of Figure 9A; Figure 10A is a top perspective view of another example of a housing that includes a locking element in a locked position according to some embodiments; Figure 10B is a cross-sectional view of the housing and locking element of Figure 10A; Figure 11 is a cross-sectional view of an example of a housing configured to advance an instrument twice the distance traveled by the advance tongue iviA / a / zuzz / uiioj» according to some embodiments; Figure 12 is a cross-sectional view of an example of a housing that includes a guide element according to some embodiments; Figure 13 is a cross-sectional view of the vascular access device configured for one-handed operation according to some embodiments; Figure 14 is a top perspective view of an example of a feed tongue configured for one-handed operation according to some embodiments; Figure 15A is a cross-sectional view of an example of a Luer adapter according to some embodiments; Figure 15B is a cross-sectional view of another example of a Luer adapter according to some embodiments; Figure 15C is a cross-sectional view of another example of a Luer adapter according to some embodiments; Figure 16A is a perspective view of an example of a lever lock containing an extension tube according to some embodiments; Figure 16B is a cross-sectional view of the lever lock of Figure 16A; Figure 17 is a cross-sectional view of an example of a lead tongue and stop feature according to some embodiments; Figure 18 is a cross-sectional view of an example of a vascular access device configured to advance an instrument three times the distance traveled by the advancing tongue according to some embodiments; Figure 19 is a top perspective view of the vascular access device in Figure 18; Figure 20 is a perspective view of an example of a housing attached to a blood collection adapter according to some embodiments; and Figure 21 is a perspective view of an example of a vascular access device that has a flexible joint according to some embodiments. DETAILED DESCRIPTION As used in this descriptive report, the term distal refers to a direction away from the clinician who would place the device in contact with a patient, and closer to the patient. The term proximal refers to a direction closer to the clinician who would place the device in contact with a patient, and farther from the patient. Thus, for example, the end of a catheter that first touches the patient's body is the distal end, while the opposite end of the catheter is the proximal end. With reference to Figures 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 blood collection, fluid delivery, patient or device monitoring, or other clinical needs, for example. An example of a catheter assembly is illustrated in Figure 21. In some embodiments, the catheter may include a peripheral intravenous 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 the patient's vasculature and may remain within the vasculature. In some embodiments, instrument 102 can be advanced through a fluid pathway of the catheter and catheter assembly so that a distal tip 118 of instrument 102 is positioned in the patient's vasculature distal to a distal tip of the catheter. In some embodiments, during operation, a clinician can deploy instrument 102 to clear any occlusions in the catheter or vasculature (e.g., a thrombus or fibrin accumulation at the catheter tip, a collapsed vein, valves, etc.) to create a clear pathway for fluid flow. In some embodiments, the instrument 102 may be housed within a casing 104, configured to protect the instrument 102 from damage and / or contamination from the surrounding external environment. In some embodiments, the casing may be rigid or semi-rigid. In some embodiments, the casing 104 may be made of one or more of the following suitable materials: stainless steel, aluminum, polycarbonate, metal, ceramic, plastic, and other materials. In some embodiments, the casing 104 may include a proximal end 106, a distal end 108, a groove 110, and an advance tab 112. In some embodiments, the groove 110 may extend parallel to a longitudinal axis of the casing 104. In some embodiments, as discussed in more detail below, the distal end 108 of the casing 104 may be coupled to a coupling element 122, such as a Luer connector, for connection to the catheter assembly, for example. In some embodiments, instrument 102 may include, for example, a guide needle, another catheter, a probe, or another suitable instrument. In some embodiments, instrument 102 may include several openings and / or sensors. In some embodiments, instrument 102 may include elements of both a probe and a catheter. In some embodiments, the openings and / or sensors may be arranged toward the distal tip 118 of instrument 102. In some embodiments, the openings may serve 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, microbes, placement of an implantable stent, the stabilization feature of the catheter tip in a vein, or another device, etc. In some embodiments, the advance tab 112 may be configured to move linearly along the groove 110 between a retracted position 114 and an advanced 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 groove 110 may cause the instrument 102 to move in the same direction as the advance tab 112 with respect to the housing 104. In some embodiments, the clinician may squeeze or grasp the advance tab 112 to move the instrument 102 between the retracted position 114 and the advanced position 116.As described in more detail below, in some embodiments, a distance traveled by the instrument 102 with respect to the housing 104 may be proportional to the distance traveled by the lead tongue 112 with respect to the slot 110, and may include any ratio. In some embodiments, as illustrated in Figures 2A and 2B, movement of the advancement tab 112 from the retracted position 114 to the advanced position 116 can cause a distal tip 118 of the instrument 102 to advance beyond the distal end 108 of the housing 104. In some embodiments, movement of the advancement tab 112 to the advanced position 116 can introduce the instrument 102 into the catheter assembly, for example. In some embodiments, in response to the introduction of the instrument 102 into the catheter assembly, the instrument 102 can access a fluid pathway of the catheter assembly and / or the vasculature of a patient. In some embodiments, the catheter of the catheter assembly, with a significant dwell time within the vasculature, may be susceptible to narrowing, collapse, twisting, blockage by debris (e.g., fibrin or platelet clots), and adhesion of the catheter tip to the vasculature. Thus, blood collection using the catheter may be difficult. In some embodiments, the instrument 102 may include a guide needle or another catheter with a smaller diameter than the catheter of the catheter assembly to provide access to the patient's vasculature without additional needle punctures. In some embodiments, the guide needle may clear the way for blood collection. Thus, in some embodiments, the vascular access device 100 may be used for needle-free blood collection and / or fluid infusion. In some embodiments, the advance tab 112 can be moved along the groove 110 from the advanced position 116 to the retracted position 114 to withdraw or retract at least a portion of the instrument 102 into the housing 104. With reference to Figures 3-8, in some embodiments, an extension tube 126 can be coupled to the vascular access device 100. The extension tube 126 can be used for blood collection and / or fluid infusion, can be infused into or withdrawn from a patient vein, and can be oriented in any of several ways. As illustrated in Figures 5-6, in some embodiments, the extension tube 126 can extend directly from the housing 104. In some embodiments, the coupling element 122 can include a lever lock 130, for example. In some embodiments, the coupling element 122 can include a Luer connector, such as a male or female Luer connector. In some embodiments, the extension tube 126 can extend from the housing 104 between the distal end 108 of the housing 104 or the lever lock 130 and a distal end of the slot 110. As illustrated in these and other embodiments, a fluid seal 131 may be provided in 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, for example, when the extension tube 126 extends from the proximal end 106 of the housing 104, the fluid seal 131 may be provided in 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 include silicone, rubber, an elastomer, or other suitable material. In some embodiments, the fluid seal 131 may include an opening, slit, or the like to accommodate the instrument 102 through it. As illustrated in Figures 3-4, in some embodiments it may be advantageous to route a fluid pathway of a vascular access system through an adapter 124, such as a T-adapter or a Y-adapter, attached to the housing 104. In some embodiments, the extension tube 126 can be extended from the adapter 124 so that the fluid pathway, such as a blood collection pathway, can be routed through the extension tube 126 instead of through the housing 104. In these and other embodiments, such as when the fluid pathway is used to obtain a blood sample, for example, an internal diameter and length of the extension tube 126 can be selected to balance the shear stress along a length of the fluid pathway, thereby reducing hemolysis of the blood. As illustrated in Figures 7-8, in some embodiments, the extension tube 126 can extend from the proximal end 106 of the housing 104. In some embodiments, the extension tube 126 can extend from the housing 104 from the proximal end 106 of the housing 104 proximal to a proximal end of the groove 110. In some embodiments, a proximal end of the extension tube 126 can include a connector 300, which can include a Luer connector or other suitable connector, coupled thereto. In some embodiments, the connector 300 can be attached to a blood collection device, such as, for example, a VACUTAINER® or a VACUTAINER® LUER-LOK™, marketed by Becton Dickinson and Company of Franklin Lakes, New Jersey. In some embodiments, the connector 300 can be attached to an infusion device. In some embodiments, the vascular access system fluid path can extend through the catheter assembly and / or adapter 124. In some embodiments, the vascular access system fluid path can extend through all or part of housing 104. In some embodiments, the length L of the 126 extension tube can be selected based on one or more of the following: a particular catheter gauge, a particular catheter assembly configuration, or a clinical setting. In some embodiments, the 126 extension tube may include an inner diameter D. The fluid flow in a fluid path through the extension tube 126, which is tubular, can be analyzed using Poiseuille's equation: „ _ - πΰ4ΔΡ ΔΡ — Kf — ---- — - 128μZ Rf where ΔR is a change in pressure gradient along the length of the fluid path, D and L are the internal diameter and length, respectively, of the fluid path, μ is the viscosity of a fluid, and Rf = is the fluid resistance. Since μ is the fluid viscosity and is not part of the geometry of the extension tube, a geometric factor Gf is defined such that Rf (the fluid resistance) is Rf = where Gf In some embodiments, the extension tube 126 may have multiple sections with lengths (L1, L2, L3) and internal diameters (D1, D2, D3), the geometric factor then being: fDI4' D24' D34 In some embodiments, the extension tube 126 may have an internal diameter that varies along the length of the extension tube 126, the geometric factor then being: Q = dl fJo In some embodiments, the extension tube 126 may have a non-circular cross-section or a complex internal diameter profile. The geometric factor can be determined by measuring the flow rate (Q) at a given pressure (ΔP) with a fluid of known viscosity (μ): „ _ πΔR (jf-128μ<2 The Gf value of the 126 extension tube can be selected to reduce the maximum shear stress of each catheter size to be equal to or less than the maximum shear stress of a BD VACUTAINER® UltraTouch™ 21G pulsatile blood collection set (marketed by Becton, Dickinson & Company of Franklin Lakes, New Jersey), which was previously considered the gold standard for blood collection. In some embodiments, the Gf value of the 126 extension tube can be selected to reduce the maximum shear stress of each catheter size to be equal to or less than the maximum shear stress of a BD VACUTAINER® UltraTouch™ 25G pulsatile blood collection set (marketed by Becton, Dickinson & Company of Franklin Lakes, New Jersey). In some embodiments, the vascular access system fluid pathway, which may include one or more blood collection devices, extension tube 126, adapter 124, and catheter assembly, may include the entire blood collection pathway through which blood flows after leaving the vasculature and into or through the blood collection device during blood collection. The system geometric factor (GfS) for the vascular access system fluid pathway can be determined similarly to the Gf value for extension tube 126 described above. In some embodiments, the system geometric factor (Gts) with instrument 102 in the advanced position may be equal to or greater than 0.448E+06 (1 / cm3) (7.34E+06 (1 / in3)). In some embodiments, GfS may include another value.In some embodiments, the geometric factor of the Gfs system with instrument 102 in the advanced position may be 0.448E+06 (1 / cm3) (7.34E+06 (1 / in3)) plus or minus 10 percent, plus or minus 25 percent, plus or minus 50 percent, or plus or minus 75 percent. In some embodiments, Gts may include another value, which can be selected based on the catheter gauge and / or length. In some embodiments, the instrument 102 housed in the casing 104 can be kept in a fluid-free environment and protected from contamination and environmental hazards until use. Advantageously, in some embodiments, the extension tube 126 can also allow for the maintenance of a closed system and aseptic technique, while reducing disturbance or detachment of the catheter and / or catheter fixation dressing. In some embodiments, the distal end 108 of the housing 104 may include the lever lock 130 for coupling 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 128a, 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 a longitudinal axis of the housing 104. In some embodiments, the lever lock arms 128a, b may be separated from each other and, in some embodiments, may be positioned substantially opposite each other with respect to the cannula 132. In some embodiments, during operation, the cannula 132 can penetrate a Luer connector of the catheter assembly to access the fluid pathway of the catheter assembly. In some embodiments, the proximal ends of the lever-lock arms 128a, b can be pushed inward toward the longitudinal axis of the housing 104 to engage or otherwise couple with the Luer connector. In this way, the lever-lock arms 128a, b can automatically secure the cannula 132 to the Luer connector. In some embodiments, the Luer connector of the catheter assembly can include one or more recesses configured to receive one or more protrusions of the lever-lock arms 128a, b. In some embodiments, the lever-lock arms 128a, b can engage with the protrusions of the lever-lock arms 128a, b to secure the housing 104 to the catheter assembly. With reference now to Figures 15A-15C, in some embodiments, the coupling element 122 may include a Luer connector, such as, for example, a male Luer connector, for connection to the catheter assembly. In some embodiments, the Luer connector may include a Luer locking connector 1500, which may include internal threads 1502 for engaging with the corresponding threads of a Luer connector of the catheter assembly. In some embodiments, the Luer locking connector 1500 may further include a cannula 132 for insertion into the Luer connector of the catheter assembly. In some embodiments, the coupling element 122, such as the lever lock 130 (see, for example, Figures 1-11) or the Luer lock connector 1500, can be fixed to the housing 104. In other embodiments, the coupling element 122 can be coupled to the housing 104 and can be configured to rotate to any clockwise position with respect to it. With reference to Figures 16A and 16B, in some embodiments, the coupling element 122, such as the lever lock 130 (see, for example, Figures 1-11) or the Luer lock connector 1500 (see, for example, Figure 15), the coupling element 122 may be monolithically formed with the housing 104 as a single unit. With reference to Figures 9A-B and 10A-B, 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 discussed above, the coupling element 122 may include the cannula 132 and the lever-lock arms 128a, b for coupling to a 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 integrated with or coupled to an elongated extension member 904 disposed within the housing 104 and extending along a length or part of the length thereof. In some embodiments, in response to the instrument 102 being in the advanced position 116, the locking member 902 can be arranged in a locked position between the housing 104 and the lever-lock arms 128a, b. In this position, the locking member 902 can prevent the lever-lock arms 128a, b from being pressed, thereby preventing the catheter assembly from being released from the housing 104. In response to the instrument 102 being in the retracted position 114, the locking member 902 can be arranged proximal to the lever-lock arms 128a, b in an unlocked position, allowing the lever-lock arms 128a, b to be pressed and thus releasing the catheter assembly from the housing 104. In some embodiments, the locking element 900 may include a push element, such as a spring, or a cam element, such as a cam and roller, disposed within the housing 104 and automatically actuated in response to movement of the advance tab 112 in a distal direction beyond the retracted position 114. The push element or the cam element may automatically activate the locking element 900 to lock the coupling element 122 and thereby prevent the catheter assembly from disengaging from the housing 104. Specifically, in some embodiments, the elongated extension member 904 can be held proximally so that the locking member 902 is in an unlocked position when the advance tab 112 is in the retracted position 114. As soon as the advance tab 112 is moved distally to advance the instrument 102 into the catheter, the locking member 902 can be released. The push element or the cam element can then push the locking member 902 in a distal direction to engage the lever-lock arms 128a, b in the locked position. Similarly, when the advance tab 112 is actuated to retract the instrument 102, a final movement in a proximal direction may pull the locking member 902 against the push element or the cam element, thereby unlocking the lever lock arms 128a, b. This may prevent a user from removing the instrument 102 from the catheter assembly when the advance tab 112 is in any position except its most proximal and retracted position 114. Of course, as someone skilled in the art will recognize, the self-locking mechanism can be reversed so that the push element or the cam element pulls the locking member 902 to disengage the lock and pushes the locking member 902 to engage it in order to secure the catheter assembly to the housing 104. In some embodiments, the self-locking mechanism can be activated when the movement of the advance tab 112 begins or ends. In some embodiments, the locking member 902 can rotate inward and outward from a locked position instead of sliding forward and backward. With reference to Figures 13, 14, and 17, in some embodiments, a position of the advancement tab 112 can be controlled before, during, and after the use of the instrument 102. In some embodiments, the vascular access device 100 can include a stop feature 1300 to automatically maintain a position of the advancement tab 112 relative to the groove 110. In some embodiments, the stop feature 1300 can be coupled to the advancement tab 112 and can interact with a feature of the housing 104. The stop feature 1300 can therefore obstruct the linear movement of the instrument 102 between the retracted position 114 and the advanced position 116. In other embodiments, the stop feature 1300 can be coupled to the housing 104 and interact with the advancement tab 112 to obstruct movement. linear of instrument 102. In some embodiments, the stop feature 1300 can provide engineered friction between the lead tongue 112 and the housing 104 such that movement of the lead tongue 112 requires an applied force. In the absence of such an applied force, the lead tongue 112 can maintain its linear position along the groove 110. In some embodiments, the stop feature 1300 can apply friction along the entire length of the groove 110. In some embodiments, the stop feature 1300 may comprise a simple interference fit between the lead tongue 112 and the housing 104, and may utilize the material modulus of the lead tongue 112 as a spring for control. For example, in some embodiments, both the lead tongue 112 and the housing 104 may have substantially elliptical cross-sections. The lead tongue 112 may be configured to rotate relative to the housing 104, thereby locking a position of the lead tongue 112. In some embodiments, the stop feature 1300 may be an integral cantilevered part of the lead tongue 112 or the housing 104 that acts as a spring. In other embodiments, the stop feature 1300 may include a separate spring member attached to the lead tongue 112 to apply friction as the lead tongue 112 slides against the housing 104, or vice versa. In some embodiments, the surface finish and / or materials used for the lead tongue 112 and / or the housing 104, in addition to the spring force, may be selected to optimize the friction between the two. In some embodiments, the stop feature 1300 may substantially correspond to the distal and / or proximal ends 108, 106 of the groove 110 or the housing 104, thus corresponding to the advanced and / or retracted positions 116, 114 of the instrument 102. In some embodiments, the stop feature 1300 may include one or more retainers or other features integrated into or coupled to the distal and / or proximal ends 108, 106 of the groove 110 or the housing 104. In some embodiments, the retainers may interact mechanically or magnetically with the advance tab 112 to hold the advance tab 112 in the advanced and / or retracted positions 116, 114. In this way, the instrument 102 may be held in a fully retracted or fully inserted position. Of course, one or more retainers can be implemented in any position along the groove 110 or housing 104 to hold the lead tab 112 in any of those positions.In some embodiments, one or more retainers may be implemented in addition to another 1300 stop feature. With reference now to Figure 17, in some embodiments, the stop feature 1300 may include a spring-loaded latch 1700 integrated into or coupled to the feed tongue 112. The spring-loaded latch 1700 can automatically engage with a recess 1702 provided in the housing 104 as the feed tongue 112 moves linearly along the groove 110. The feed tongue 112 can be selectively pressed to release the spring-loaded latch 1700 from the recess 1702. Releasing the spring-loaded latch 1700 in this manner allows the feed tongue 112 to slide in a linear direction along the groove 110 to advance or retract the instrument 102. In some embodiments, the recess 1702 can be integrated into the housing. 104 at any desired position or distance along slot 110 or housing 104. With reference now to Figures 11 and 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. As illustrated in Figure 11, for example, the advance tab 112 can be configured to advance the instrument 102 a distance greater than, such as twice, the distance traveled by the advance tab 112 when joining a proximal end 120 of the instrument 102 to the distal end 108 of the housing 104, looking in the proximal direction. In some embodiments, the instrument 102 can be U-shaped by means of the advance tab 112 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 instrument 102 to advance the instrument 102 and can pull the U-shaped portion of the instrument 102 to retract the instrument 102.Instrument 102 can slide along the feed tongue 112 as it moves. In this way, the feed tongue 112 can act as a pulley to move instrument 102 a distance twice that traveled by the feed tongue 112. With reference now to Figures 18-19, in some embodiments, one or more additional bends may be incorporated into the instrument 102 before joining the proximal end 120 to the advancement tongue 112. This may allow the advancement tongue 112 to further increase the distance traveled by the instrument 102 relative to the distance traveled by the advancement tongue 112 by a factor equal to the number of bends or U-turns. In some embodiments, the factor may be equal to the number of bends or U-turns in the instrument 102 plus one. For example, zero curves may correspond to a 1x advance between instrument 102 and advance tab 112, 1 curve may correspond to a 2x advance between instrument 102 and advance tab 112, 2 curves may correspond to a 3x advance between instrument 102 and advance tab 112, etc.Configuring instrument 102 and feed tab 112 in this manner, however, can cause instrument 102 to bend during insertion. Therefore, some embodiments may include guides or restraints to support instrument 102 and prevent bending. For example, with reference to Figure 12, some embodiments may include a guide element 1204 disposed in the housing 104 to constrain the instrument 102. In some embodiments, the guide element 1204 may be disposed within a bore 1206 of the housing 104 containing the instrument 102. In some embodiments, the guide element 1204 may be coupled to the feed tongue 112 via a connecting member 1202. In some embodiments, the connecting member 1202 may be configured to substantially occupy a tortuous path 1200 between the bore 1206 and the slot 110. The connecting member 1202 can thus occlude the tortuous path 1200 and prevent contamination that could otherwise enter the slot 110 and reach the instrument 102. In other embodiments, the connecting member 1202 can occupy a direct path between the slot 110 and the hole 1206 and / or the instrument 102. In some embodiments, such as when the feed tongue 112 moves the instrument 102 a distance twice that traveled by the feed tongue 112, for example, the guide element 1204 may occupy a space between the U-shaped portions of the instrument 102. In this way, the instrument 102 can be restricted on three sides, thus preventing movement of the instrument 102 in those three directions. To prevent bending in the fourth direction, some embodiments may include a guard to selectively protect the open area in the fourth direction. In some embodiments, the guard may be selectively withdrawn to advance the instrument 102 through it. In other embodiments, the instrument 102 may include a slight curve or incline that causes the instrument 102 to tend away from the open side or area and instead tend toward a wall or restricted area. Advantageously, configuring the advancement tab 112 to advance the instrument 102 beyond the distance traveled by the advancement tab 112 can facilitate a compact housing 104 with reduced dimensions and a shorter groove 110. In other words, the distance the advancement tab 112 must travel to advance and retract the instrument 102 can be reduced, thus requiring a more compact vascular access device 100. As a result, the vascular access device 100 can be operated with one hand. Indeed, as illustrated in Figures 13 and 14, some embodiments of the vascular access device 100 can be operated by moving a single finger, including the thumb, while holding the vascular access device 100 in the same hand. Some embodiments of the vascular access device 100 that allow one-handed operation may include an advancement collar grip 1302 or a center grip 1303. As illustrated, the advancement collar grip 1302 or the center grip 1303 can allow one-handed advancement of the advancement tongue 112 with the clinician or user holding the housing 104 with the thumb and middle finger. The advancement collar grip 1302 or the center grip 1303 can be moved with the index finger, for example. With reference now to Figures 20-21, in some embodiments, the housing 104 may include one or more markings 2000 or measurements, which can visually indicate to a physician or other user the insertion depth of the instrument 102. In some embodiments, the markings 2000 may be a scale 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 scale 2002 may be fixed for use with a specific catheter configuration and length. In some embodiments, the markings 2000 may include a table to indicate the position for different catheter configurations and lengths. In some embodiments, the scale 2002 may be a sliding scale 2002 and / or an indicator 2004 that can be adjusted depending on the catheter configuration and length. In some embodiments, the 2000 markings may indicate at what distance to insert and / or remove one or more different instruments 102, such as different types of catheters, for example. In some embodiments, the 2000 markings may indicate one or more of the following: the advanced position 116 of instrument 102, the retracted position 114 of instrument 102, and various positions between the advanced position 116 and the retracted position 114 of instrument 102. Some embodiments may include a cone to indicate alignment between the catheter tip and the distal tip 118 of instrument 102. In some embodiments, additional cones may indicate specific distances beyond the catheter tip traveled by the distal tip 118 of instrument 102. In some embodiments, the distance between the 2000 marks can be adjusted if the vascular access device 100 includes an instrument 102 and an advancement tab configuration 112 that has a multiplying effect on the distance traveled by the instrument 102 with respect to the advancement tab 112. Of course, the multiplier can be any number or ratio known to those skilled in the art. With reference now to Figure 20, in some embodiments a blood collection adapter 2006 can be attached to the vascular access device 100. For example, in some embodiments, the blood collection adapter 2006 can be directly attached to the extension tube 126. In other embodiments, the blood collection adapter 2006 can be attached to the vascular access device 100 via a Luer connection, for example, to allow selective removal of the blood collection adapter 2006 and replacement with another device, such as a syringe. With reference now to Figure 21, in some embodiments, a flexible joint 2100 can be incorporated between the lever lock 130 or other coupling element 122 and the housing 104. The flexible joint 2100 can provide flexibility between the catheter connection and the housing 104. In some embodiments, the flexible joint 2100 can include a short piece of tubing or a ball joint coupled to the housing 104 and / or the lever lock 130 or other coupling element 122. All examples and conditional language listed herein are for pedagogical purposes to assist the reader in understanding the invention and the concepts contributed by the inventor to further the technique, and should be considered without limitation to such specifically listed examples and conditions. Although embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and alterations may be made without departing from the spirit and scope of the invention.
Claims
1. A vascular access device, comprising: a housing, comprising a proximal end, a distal end, a groove, and an advancement tongue configured to move linearly along the groove between a retracted position and an advanced position; and an instrument disposed within the housing, the instrument comprising a proximal end and a distal tip, wherein the proximal end of the instrument is coupled to the advancement tongue, wherein, in response to the movement of the advancement tongue from the retracted position to the advanced position, the distal tip of the instrument advances beyond the distal end of the housing.
2. The vascular access device of claim 1, wherein the instrument comprises a guide needle, catheter, or 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 distal end of the housing comprises a coupling element for coupling to a catheter assembly.
5. The vascular access device of claim 4, wherein the coupling element comprises a Luer adapter.
6. The vascular access device of claim 4, wherein the coupling element comprises a cannula and a plurality of lever-lock arms configured to couple to a catheter assembly.
7. The vascular access device of claim 4, further comprising a locking element disposed within the housing to lock the coupling element in order to prevent the catheter assembly from disengaging from the housing, in response to movement of the advancement tab in a distal direction beyond the retracted position.
8. The vascular access device of claim 7, wherein the locking element comprises a push element or a cam element for automatically locking the coupler element in response to movement of the advance tongue in a distal direction beyond the retracted position.
9. The vascular access device of claim 7, 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 the plurality of lever-lock arms from being pressed and the catheter assembly from being released from the housing.
10. The vascular access device of claim 1, further comprising: a T-adapter or Y-adapter coupled to the distal end of the housing for coupling to a catheter assembly; and an extension tube extending from the T-adapter or Y-adapter, wherein a blood collection pathway extends through the extension tube, and wherein the instrument comprises a guide needle.
11. The vascular access device of claim 1, further comprising an extension tube extending from the housing between the distal end of the housing and a distal end of the slot, wherein a blood collection pathway extends through the extension tube, and wherein the instrument comprises a guide needle.
12. The vascular access device of claim 1, further comprising an extension tube extending from the housing between the proximal end of the housing and a proximal end of the slot, wherein a blood collection pathway extends through the extension tube, and wherein the instrument comprises a guide needle.
13. The vascular access device of claim 1, further comprising a stop feature for automatically maintaining a position of the advance tongue relative to the groove.
14. The vascular access device of claim 13, wherein the stop feature is coupled to the advance tongue and interacts with a feature of the housing to obstruct linear movement of the instrument between the retracted and advanced positions.
15. The vascular access device of claim 13, wherein the stop feature is coupled to the housing and interacts with the advance tongue to obstruct linear movement of the instrument between the retracted and advanced positions.
16. 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 pathway.
17. A method comprising: coupling a vascular access device to a catheter assembly, the catheter assembly comprising a catheter adapter including a proximal end, a distal end, and a catheter extending from the distal end, wherein the vascular access device comprises: a housing comprising 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; and an instrument disposed within the housing, the instrument comprising a proximal end and a distal tip, wherein the proximal end of the instrument is coupled to the advancement tab, wherein, in response to the movement of the advancement tab from the retracted position to the advanced position, the distal tip of the instrument advances beyond the distal end of the housing;wherein attaching the vascular access device to the catheter assembly comprises attaching the housing to the catheter assembly; and moving the advance tab linearly along the groove from the retracted position to the advanced position, wherein, in response to the movement of the advance tab to the advanced position, the distal tip of the instrument extends beyond the distal end of the housing.
18. The method of claim 17, further comprising actuating a locking element to secure the vascular access device to the catheter assembly in response to movement of the advancement tab in a distal direction beyond the retracted position.
19. The method of claim 17, wherein the movement of the lead tongue comprises automatically maintaining a position of the lead tongue with respect to the groove.
20. The method of claim 19, wherein the movement of the advance tongue comprises applying a force to the advance tongue to release the position.