Blood collection device and methods of use

Abstract

A blood collection device comprising a coupler having a protrusion configured to engage a catheter, the coupler positioned at the distal end of a handle. An extension port is positioned adjacent to the distal end of the handle, the extension port configured to couple to a vacutainer assembly. A slider with a body disposed within an interior of the handle and an arm extending through an axial slot extending along a length of the handle, the slider body having a lumen extending through from a distal end of the slider body to a flow path opening along a length of the slider body, the slider configured to move axially along a length of the handle. A cannula extending from a distal end of the slider body. The cannula can comprise a lumen extending from a distal end into the slider body. Also a movable seal coupled to slider body, the movable seal configured to seal the slider lumen against the handle interior.

Description

BLOOD COLLECTION DEVICE AND METHODS OF USECROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of US Provisional Patent Application No. 63 / 587,438, titled “BLOOD COLLECTION DEVICE AND METHODS OF USE,” and filed on October 2, 2023, which is incorporated by reference herein in its entirety.INCORPORATION BY REFERENCE

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.BACKGROUND

[0003] Accessing a patient’s vasculature with a catheter provides a convenient and minimally intrusive opportunity for blood draws and administration of medications. Often extended periods of catheter placement can be associated with occlusions developing at or near the distal end of the catheter in the vessel which impede the ability for effective blood draws. Existing occlusions, vascular tortuosity, and vascular valves are additional examples of conditions and situations that restrict or complicate accessing the vessel via a catheter.

[0004] Establishing or re-establishing vascular access in these situations is challenging considering the small dimensions of the placed catheter, coupling to the catheter, and providing a sufficient flow rate for the blood from the vessel to a vacutainer assembly.

[0005] For these reasons, it would be desirable to provide improved methods, systems, and devices for blood draws through catheters and catheter assemblies. It would be particularly desirable to provide simplified deployment systems and assemblies configured to be utilized and manipulated in a straightforward, intuitive manner to establish or re-establish blood flow and collection through placed catheters. At least some of these objectives will be met by the various embodiments that follow.SUMMARY OF THE DISCLOSURE

[0006] Described herein are blood collection devices and methods of use.

[0007] In general, a blood collection device can comprise a handle having a proximal end, a distal end, an interior portion with an elongated slot providing access to the interior portion; a coupler on the handle distal end with a protrusion, the coupler shaped to engage anexterior portion of a catheter hub. An extension port positioned adjacent to the distal end of the handle having a first end in communication with the handle interior portion and a second end configured to couple to a vacutainer assembly; a slider having a body with a pair of alignment features on an exterior surface of the body and an arm extending from the body wherein the slider is disposed within the interior portion of the handle with the arm extending through and moveable relative to the elongated slot; a slider lumen extending from a distal end of the slider body to a flow path opening along a portion of a sidewall the slider body; and a cannula having a proximal end and a distal end and a lumen extending from the distal end to the proximal end wherein the cannula lumen proximal end is coupled to the slider body so that the cannula lumen is in fluid communication with the flow path opening.

[0008] In this and other examples described herein may further comprise one or more of the following. The slider body, cannula, and coupler protrusion may be axially aligned with a central axis of the handle. The coupler protrusion may be adapted to open at least one valve in a proximal face of a catheter hub so that in use, the cannula can be extended through a catheter coupled to the catheter hub into a blood vessel.

[0009] In some examples, a length of slider movement along the elongated slot may be configured to advance the cannula distally a first distance without creating a fluid pathway through an attached catheter and then further distally a second distance that creates a fluid pathway through the attached catheter.

[0010] In some examples, the coupler may be configured to releasably engage a proximal end of the catheter hub. The releasable engagement may be provided by axial movement of the device to a proximal face of the catheter hub. The releasable engagement may be provided by rotational movement of the handle onto the catheter hub. The releasable engagement may be provided by at least one deformable component, spring loaded component, or a magnetic component positioned on the coupler and configured to engage the catheter hub. The releasable engagement may be provided by a level, latch, button or release feature on the handle, on the hub or a combination of the handle and the hub.

[0011] In this and other examples described herein may further comprise one or more of the following. The protrusion comprises a tapered male luer proximal segment and an elongate extension distal to the male luer proximal segment. The elongate extension may be positionable adjacent to a proximal end of a catheter lumen extending from the catheter hub. The blood draw device can further comprise a seal sized and shaped to fit into the handle along the elongate slot to close off access to the interior portion, the seal having an angled slit along a length shaped to allow sliding movement of the slider arm. The seal may further comprise a perimeter adapted to engage the opening of the elongated slot. The angled slitadapted to reseal along the length of the angled slit distal to the slider arm and along the length of the angled slit proximal to the slider arm.

[0012] In this and other examples described herein may further comprise one or more of the following. The device may further comprise a ratchet assembly with a first ratchet element positioned on an interior of the handle and a second ratchet feature positioned on the slider body, the second ratchet feature configured to engage the first ratchet feature when the slider is advanced distally within the handle. The first ratchet feature may comprise a plurality of teeth along a length of the ratchet feature, wherein the plurality of teeth corresponds to a length of cannula deployment when the second ratchet feature is in communication with the first ratchet feature. The first ratchet feature may have length configured to provide tactile indication of the slider body relative to the extension port.

[0013] In this and other examples described herein may further comprise one or more of the following. The blood draw device may further comprise a tube seal disposed within the interior portion of the handle having a sealing portion wherein the slider arm and tube seal are adapted and configured to releasably seal and reseal at the sealing portion of the tube seal along the elongated slot as the slider is moved along the tube seal. The slider body comprising a raised perimeter around the flow path opening adapted to seal the flow path opening until the flow path opening is in fluid communication with the extension port on the handle. The raised flow path opening perimeter extends outward to contact an interior surface of the tube seal. The slider may further comprise a forward facing edge angled and adapted to advance through the sealing portion of the tube seal.

[0014] In this and other examples described herein may further comprise one or more of the following. The device may further comprise a visual or a tactile indicator along a surface of the handle adjacent to the elongate slot configured to indicate a length of cannula deployment, a relative position of the slider or the cannula with respect to a catheter hub coupled to the proximal end of the handle, or a relative position of the flow path opening on the slider body with respect to the extension port on the handle. The visual or tactile indicator may be a tactile indicator is a ratchet system formed by an interaction between a ratchet element on the slider and a cooperating ratchet element along the elongated slot of the handle. A first ratchet element comprises a plurality of teeth along a length of the ratchet feature, wherein the plurality of teeth correspond to a length of cannula deployment when the second ratchet feature is in communication with the first ratchet feature. A second ratchet element may have a length configured to provide tactile indication of the cannula distal end to a distal most end of a catheter lumen coupled to the proximal end of the handle. A third ratchet element may have a length configured to provide tactile indication of the cannula distal endto a full cannula extension length for an indicated catheter lumen length of a catheter coupled to the proximal end of the slider.

[0015] In some examples, the device may be configured to be used with more than one length of catheter, and the slider flow path opening has a distal end and proximal end extending along a length of the slider body, wherein the flow path opening is adapted to be fluidly coupled to the extension port at any position between the flow path opening distal end and proximal end.

[0016] In general, a method of drawing blood through a catheter can comprise the steps of engaging a catheter hub with a distal end of a blood draw device handle such that engaging the catheter hub with a distal end of a blood draw device aligns a blood draw cannula lumen extending from a slider through the distal end of the blood draw device handle and along the central longitudinal axis of a catheter extending from the catheter hub into a patient blood vessel; Advancing the slider body distally along the handle towards a side port in the handle without introducing a distal most end of the cannula into the patient blood vessel; continuing advancing the slider body distally along the handle to align a portion of a slider fluid path into fluid communication with the side port; and continuing advancing the slider body distally along the handle until the distal most end of the cannula lumen is in fluid communication with the patient blood vessel.

[0017] In this and other examples described herein may further comprise one or more of the following. The step of engaging the catheter hub with a distal end of the blood draw device comprises inserting a distal protrusion of the blood draw device through a proximal end of the catheter hub. The method may further comprise establishing fluid communication between the patient blood vessel and a side port of the blood draw device handle only after the distal most end of the cannula extends beyond the distal end of the catheter in the patient’s blood vessel. The method may further comprise adjusting a position of the distal most end of the cannula lumen to establish the fluid communication with the patient blood vessel.

[0018] In general, a method of coupling a coupler of a blood draw device to an indwelling catheter hub can comprise the steps of aligning a coupler at the distal end of a blood draw device with a proximal end of a catheter hub; and advancing the coupler over the exterior of the catheter hub until the catheter hub is docked with the coupler; and positioning a protrusion of the blood draw device within the catheter hub and adjacent to a proximal end of a catheter lumen extending from the catheter hub.

[0019] In this and other examples described herein may further comprise one or more of the following. The method may further comprise the step of locking the catheter hub to thecoupler wherein a protruding feature of the catheter hub is positioned within a disengagement mechanism. The catheter hub may be releasable from the coupler when a disengagement button of the disengagement mechanism is depressed causing a distal end of the disengagement mechanism to lift away from interference with the protruding feature of the catheter hub. The method may further comprise the step of distally biasing the catheter hub with an interior surface of the disengagement mechanism when the depression button is depressed.

[0020] In general, a blood collection device may comprise a coupler having a protrusion that can be configured to engage a catheter, the coupler can be positioned at the distal end of a handle, an extension port may be positioned adjacent to the distal end of the handle, the extension port can be configured to couple to a vacutainer assembly, a slider can have a body disposed within an interior of the handle and an arm extending through an axial slot along a length of the handle, the slider body can have a lumen extending through from a distal end of the slider body to a flow path opening along a length of the slider body, the slider can be configured to move axially along a length of the handle, a cannula that may extend from a distal end of the slider body, the cannula can comprise a lumen extending from a distal end into the slider body, and a movable seal coupled to slider body, the movable seal can be configured to seal the slider lumen against the handle interior.

[0021] In this and other examples described herein may further comprise one or more of the following: The slider body, cannula, and coupler protrusion can be axially aligned with a central axis of the handle. The coupler protrusion can be adapted to open at least one valve in a proximal face of a catheter hub so that in use, the cannula can extend through a catheter extending from the catheter hub into a blood vessel. The slider can be configured to advance the cannula distally through the catheter into the vessel. A ratchet assembly with a first ratchet element positioned on an interior of the handle and a second ratchet feature positioned on the slider body, the second ratchet feature can be configured to engage the first ratchet feature when the slider is advanced distally within the handle. The first ratchet feature can comprise a plurality of teeth along a length of the ratchet feature, wherein the plurality of teeth can correspond to a length of cannula deployment when the second ratchet feature is in communication with the first ratchet feature. The first ratchet feature can have a length configured to provide tactile indication of the slider body relative to the extension port. The device can be configured to be used with more than one length of catheter, and the slider flow path opening has a distal end and proximal end extending along a length of the slider body, wherein the flow path opening is adapted to be fluidly coupled to the extension port at any position between the flow path opening distal end and proximal end. An axial slot sealconfigured to seal an interior of the handle, the axial slot seal having a sealable slit configured to facilitate movement of the slider through the handle. The coupler can comprise one or more alignment features configured to align a catheter hub coupled to the device. The coupler can be configured to releasably engage a catheter hub. The releasable engagement can be provided by axial movement of the device to a proximal face of the catheter hub. The releasable engagement can be provided by rotational movement of the handle onto the catheter hub. The releasable engagement can be provided by at least one deformable component, spring loaded component, or a magnetic component positioned on the coupler and configured to engage the catheter hub. The releasable engagement can be provided by a level, latch, button or release feature on the handle, on the hub or a combination of the handle and the hub.

[0022] In general, a blood collection device comprises a coupler having a protrusion configured to engage a catheter, the coupler positioned at the distal end of a handle. An extension port positioned adjacent to the distal end of the handle; the extension port configured to couple to a vacutainer assembly. A slider having a body disposed within an interior of the handle and an arm extending through an axial slot extending along a length of the handle, the slider body having a lumen extending through from a distal end of the slider body to a flow path opening along a length of the slider body. A cannula extending from a distal end of the slider body, the cannula comprising a lumen extending from a distal end into the slider body. A tube seal disposed within the interior of the handle, wherein the slider is configured to move axially through an interior of the tube seal.

[0023] In general, a method of drawing blood through a catheter may comprise the steps including engaging a catheter hub with a distal end of a blood draw device handle wherein the engaging step aligns a blood draw cannula lumen extending from a slider through the distal end of the blood draw device handle and along the central longitudinal axis of a catheter extending from the catheter hub into a patient blood vessel. Then, advancing the slider body with a moveable side port in communication with the proximal most end of the cannula lumen along a handle towards the catheter hub. Then, moving a distal most end portion of the blood draw catheter beyond a distal most end portion of the catheter and into the patient blood vessel. Then, establishing fluid communication between the patient blood vessel and a side port of the blood draw device handle only after the distal most end of the cannula extends beyond the distal end of the catheter in the patient’s blood vessel.

[0024] In general, a method of drawing blood through a catheter may comprise the steps of engaging a catheter hub with a distal end of the blood draw devices described herein, wherein the engaging step aligns a blood draw cannula lumen extending from a slider throughthe distal end of the blood draw device handle and along the central longitudinal axis of a catheter extending from the catheter hub into a patient blood vessel. Then, advancing the slider body with a moveable side port in communication with the proximal most end of the cannula lumen along a handle towards the catheter hub. Then, moving a distal most end portion of the blood draw catheter beyond a distal most end portion of the catheter and into the patient blood vessel. Then, establishing fluid communication between the patient blood vessel and a side port of the blood draw device handle only after the distal most end of the cannula extends beyond the distal end of the catheter in the patient’s blood vessel. All the methods and apparatuses described herein, in any combination, are herein contemplated and can be used to achieve the benefits as described herein.

[0025] In general, a blood collection device can comprise a handle having a proximal end, a distal end, an interior space, a slot along a surface of the handle providing access to the interior space and a blood collection side port in communication with the interior space; a slider having a body, an aperture, a side port wherein fluid communication between the side port and the aperture is through the body; and a blood draw cannula having a proximal end, a distal end, a length from the proximal end to the distal end wherein the cannula proximal end is coupled to the slider aperture, wherein when the distal end of the handle is coupled to a proximal portion of a vascular access catheter hub, the length of the blood draw cannula is configured to extend beyond the distal most end of a vascular catheter when the slider is positioned along the slot in a position that allows fluid communication from the blood collection catheter distal end to the blood collection side port.

[0026] In this and other examples described herein may further comprise one or more of the following. A seal between the slider side port and the housing interior space. The seal may be on the slider about the side port adapted and configured to remain in sealed relation to the handle interior during slider movement. A blood collection device may further comprise a plurality of stabilizing mounts arranged on an exterior surface of the slider positioned to maintain the seal in apposition with the handle interior while moving the slider along the slot. A blood collection device may further comprise a seal coupled to the housing so as to close off the housing interior. A blood collection device may further comprise a tubular seal within the interior of the handle the tubular seal can be adapted and configured to releasably seal the slot in response to movement of the slider along the slot. The slider side port may remain in sealed relation to the tubular seal until movement of the slider along the slot establishes fluid communication between the blood collection catheter distal end and the blood collection side port. The distal end of the handle can be adapted and configured for releasable engagement with a proximal portion of the vascular catheter hub so as to provide axial alignment betweena lumen of the vascular catheter and the blood collection cannula. The distal end of the handle can be adapted and configured to open one or more valves or closures in the proximal portion of vascular catheter hub. Methods of drawing blood as described or claimed herein further performed using a blood collection device as described or claimed herein.BRIEF DESCRIPTION OF THE DRAWINGS

[0027] A better understanding of the features and advantages of the methods and apparatuses described herein will be obtained by reference to the following detailed description that sets forth illustrative embodiments, and the accompanying drawings of which:

[0028] FIG. 1 A shows an example of a blood collection device from a proximal perspective with a vacutainer assembly in communication with the extension set port of the blood collection device handle. In this configuration, the slider is in the stowed position proximally within the blood collection device handle and the male luer is locatable at the distal end of the blood collection device handle.

[0029] FIG. IB shows another example of the blood collection device from the previous figure in a perspective view and coupled with a catheter assembly as it may be during use.

[0030] FIG. 2 shows a proximal perspective view of the distal end of the blood collection device with the male luer partially hidden to highlight the cannula extending from the distal end of the handle through the male luer but not extending past the male luer protrusion as it may be in a stowed or ready -to-use configuration.

[0031] FIG. 3 shows yet anther detailed perspective view of the distal end of the handle and male luer coupled thereto. Similar to the previous figure, the position of the cannula distal segment is seen in the stowed position as it is not extending beyond the male luer protrusion in this ready-to-use configuration. Also shown here is an example of a disengagement button on the top and the protrusion feature on the distal end. The male luer is transparent to show the cannula extending through the male luer but not out of the distal end.

[0032] FIGS. 4A to 4E show an example of a male luer in various views to highlight the coupling features configured to engage the distal end of a blood collection device handle as well as the proximal configuration adapted to couple with a catheter assembly including an example of a catheter assembly disengagement mechanism.

[0033] FIG. 4F to 41 also show an example of a male luer configured to couple with the distal end of a blood collection device handle and a catheter assembly via the proximal end of the male luer with friction style engagement features, as described herein This example of amale luer is shown in different views to illustrate the configuration to facilitate engagement with a catheter assembly during use of the blood collection device.

[0034] FIG. 5 shows a perspective view of the blood collection device from a proximal end with expanded details of the male luer and distal handle portion with the catheter hub docked. This wireframe view shows details of the ratchet system of this single-catheter length blood collection device. The cannular is similarly in a non-deployed configuration as the slide plunger as not engaged the ratchet system and the cannula distal end is still within the male luer protrusion feature.

[0035] FIG. 6 shows a detailed perspective view of the distal end of a blood collection device as it may be coupled to a catheter assembly.

[0036] FIG. 7 shows an expanded view of the distal end of a blood collection device as illustrated in the previous figure with additional detail of examples for coupling between the male luer and the blood collection device handle as well as coupling of the male luer proximal side to a catheter assembly.

[0037] FIG. 8 shows yet another detailed view of the distal end of the blood collection device from the proximal perspective with the catheter assembly coupled to the male luer.

[0038] FIG. 9A and 9B show perspective views from the proximal side in FIG. 9A and the distal side FIG. 9B of a catheter hub of a catheter assembly that may be used in combination with the blood collection devices described herein.

[0039] FIG. 10 shows an example of a distal segment of a blood collection device in a side elevation view with details of the ratchet system and male luer configurations at the distal end of the handle.

[0040] FIGS. 11 A to 1 ID show examples of a movable seal alone in FIG. 11 A and coupled with a slider in a movable seal configuration used in some examples of blood collection devices described herein.

[0041] FIG. 12 shows a side elevation view of select elements of a blood collection device including a coupled catheter assembly, male luer, and slider coupled to the cannula with the handle removed to highlight an exemplary flow path, as described herein.

[0042] FIG. 13 shows an example of a slider in the stowed position proximally within the blood collection device handle as a cross section to highlight the internal flow path from the proximal end of the cannula and through the slider, which is sealed in the proximal position and the lumen is discontinuous relative to the vacutainer assembly.

[0043] FIG. 14 illustrates a proximal perspective view of the blood collection device handle with the slider again in the proximal and stowed position to highlight the slider slotalong the handle configure to guide the slider from the proximal position through distal advancement when in use.

[0044] FIG. 15 shows a side elevation view from the distal end of a blood collection device with the male luer removed to highlight the slider lumen and alignment features of the slider configured to facilitate alignment and positioning of the slider within the blood collection device handle.

[0045] FIGS. 16A and 16B show perspective views of the slider within the handle from the proximal side with the cross section taken more distally in in FIG. 16B compared to FIG. 16A to show yet further detail of the interior of the slider and the slider opening in sealed communication within the blood collection device handle.

[0046] FIG. 17 shows an example of a blood collection device handle distal end with a detailed side elevation view to highlight the ratchet system features and the positioning of the extension set port extending from the blood collection device handle.

[0047] FIGS. 18A to 18C illustrate a top plan view, side elevation view, and cross section view, respectively, of an example of a slider seal couplable to the device handle and configured to facilitate the positioning and seal of slider and interior of the blood collection device handle.

[0048] FIG. 19 shows a side elevation view of a blood collection device example configured to be used with multiple different catheter lengths as a single blood collection device. The slider is in the proximal and stowed position with an elongated plunger body and flow path opening configured to facilitate establishing a flow path through multiple different catheter lengths, as needed during use.

[0049] FIG. 20 shows the blood collection device of the previous figures in a perspective view from the proximal side to highlight the slider slot and arrangement of the slider relative to the male luer and extension set port.

[0050] FIGS. 21A, 21B and 21C show examples of a movable seal alone and coupled with a slider configured to multiple-catheter length use with an elongated plunger body coupled to the slider seal. The flow path opening of the slider seal is aligned with the flow path opening of the slider plunger body with annular features configured to contact the interior of the handle for sealing and positioning the slider within the blood collection device handle.

[0051] FIG. 22 shows yet another example of a multiple length slider positioned in the proximal end of the handle in the stowed position. This detailed view highlights the ratchet system features of the slider that can be configured to engage the ratchet system of the blood collection device handle.

[0052] FIG. 23 shows a perspective view of the slider from the previous figure with the slider seal coupled thereto and the blood collection device handle translucent to highlight the arrangement of the slider seal features and slider alignment elements.

[0053] FIG. 24 shows a cross-section side elevation view of a blood collection device configured for multiple-catheter length use with the slider advanced from the proximal position to the distal portion of the handle and engaged with the ratchet system. The crosssection view highlights an example of a flow path through the slider plunger body.

[0054] FIG. 25A and 25B show additional examples of the blood collection device from the previous figure with the slider advanced yet further distal within the handle in FIG. 25A and at a distal most advancement in FIG. 25B to highlight the different lengths and ratchet system engagement for the slider positioning during use.

[0055] FIGS. 26A to 26C show additional details of the blood collection device from the previous figure with the side elevation view of the entire device coupled to a catheter assembly in FIG. 26A and the details side elevation views of the slider in the proximal position within the blood collection device handle.

[0056] FIG. 27 shows an example of a multiple length blood collection device configuration adapted to be used with different length catheters by a single blood collection device. In this perspective view, the slider is advanced such that the cannula is extending from the distal end of a 2.30” catheter.

[0057] FIG. 28 is a cross-section view of the previous figure to highlight the arrangement of the flow path as established by the distal positioning of the slider in the handle. In this configuration, the slider is distally advanced to be in fluid communication with the extension set and vacutainer assembly.

[0058] FIG. 29 shows another example of the blood collection device from the previous figure used with a 1.75” catheter length and the slider is positioned proximal relative to the blood collection device example used with a 2.30” catheter, while maintaining fluid communication with the extension set port and vacutainer assembly.

[0059] FIG. 30 shows the cross section of the previous figure with the slide plunger continuing to maintain fluid communication with the extension port with yet a smaller catheter length.

[0060] FIG. 31 shows a cross section from the distal side similar to previous figures and particularly of the device in the previous figure to accommodate a 1.50” catheter. This cross section view again allows the flow path from the cannula extending beyond the catheter to be seen as fluidly coupled with the vacutainer assembly through the slider plunger body and the extension set port.

[0061] FIG. 32 shows the blood collection device of the previous figure now coupled to a 1.30” catheter length. The slider can be seen in a more proximal position within the slider slot of the blood collection device handle, and still maintains fluid communication with the vacutainer assembly.

[0062] FIG. 33 shows the cross-section view of the previous figure to highlight the maintenance of the fluid communication from the cannula through the slider plunger body to the vacutainer assembly via the extension set port.

[0063] FIG. 34 shows yet an additional example of the blood collection device from the previous figure now coupled with a 1.00” catheter and maintaining a fluid communication. Here, the cannula extends beyond the catheter distal tip and the slider is positioned yet more proximal relative to longer catheter lengths, yet still maintains the fluid communication and flow path to the vacutainer assembly.

[0064] FIG. 35 shows the cross section of the blood collection device from the previous figure to highlight the flow path is still being maintained from the proximal position of the slider plunger so long as the flow path opening is still in communication with the extension set port.

[0065] FIG. 36 shows the blood collection device of the previous figure with the slider in the proximal most position and stowed such that the flow path opening of the slider is no longer in fluid communication with the extension set port and the flow path is not established as the flow path opening is sealed against the interior of the blood collection device handle.

[0066] FIG. 37 shows a cross section of the previous blood collection device and slide plunger position. It is readily visible that the flow path of the cannula and slide plunger body is not aligned with the extension port. In this position, the flow path of the cannula and slide plunger may be sealed or air locked. The ratchet system is visible.

[0067] FIG. 38 shows a side elevation view example of a blood collection device having a tube seal configuration where the slider is now adapted to move from the proximal end of the blood collection device to the distal end or a distal position with the tube seal inside of the blood collection device handle maintained in a static position.

[0068] FIG. 39 shows a cross section of a blood collection device with the slide plunger is a proximal / stowed position in the handle. The cannula extends distally from the slider through the interior of the tube seal and through the male luer protrusion in a ready -to-use configuration.

[0069] FIG. 40 shows a side elevation detailed view of the slide plunger with axial opening configured to communicate with the extension set port. A raised perimeter around the axial opening can be configured to contact the interior surface of the tube seal. An uppertab can be engaged by the user for axial displacement of the slide plunger through the handle. The tab is separated from the slide plunger body by a slide arm that extends though the slit of the tube seal similar to the arm extending through the sterile barrier.

[0070] FIG. 41 shows a perspective view of the tube seal alone from a distal side. Of note, the slide plunger has been removed, but an example of the tube seal slit being raised where the slide arm would pass through is still included in this view. This example shows how the tube seal slit can remain sealed from the proximal side of the slide arm to the proximal end of the tube seal and on the distal side of the slide arm extending through the tube seal slit.

[0071] FIG. 42 shows a side elevation view of select components for a blood collection device with details of tube seal with slide plunger in distal position within the tube seal and the cannula extending distally from the slider plunger.

[0072] FIGS. 43 A, 43B and 43C show cross sectional views of a tube seal example at various positions along the length of the tube seal to highlight an opening in FIG. 43A configured to facilitate the slider arm passing therethrough as well as details for the tube seal slit and extension port opening.

[0073] FIG. 44 a distal perspective view of the slider with a cross section highlighting the flow path opening of the slider plunger sealed against the interior surface of the tube seal as the slider is advanced through the blood collection device handle.

[0074] FIG. 45 shows a detailed cross section of the slide plunger in a distal position of the handle and docked in the proximal end of the male luer such that the flow path through the slide plunger and continuing through the extension set port of the handle is visible.

[0075] FIG. 46 shows a side elevation view of a catheter assembly example with an integrated extension port configured to couple with an extension set and alignment features for coupling to the male luer of a blood collection device, as described herein.

[0076] FIG. 47 shows a perspective view of an example of a blood collection device from the proximal side.

[0077] FIG. 48 shows another perspective view of the distal portion of a blood collection device from the proximal side as it is approaching a catheter assembly before use as the male protrusion is aligned with the catheter assembly ready to insert into the catheter hub through a seal.

[0078] FIG. 49 shows a cross section of the FIG. 48 with details of a flow path from the distal end of the catheter through the lumen of the male luer positioned in the catheter hub.

[0079] FIG. 50 shows a cross section of a blood collection device coupled to a catheter assembly with details of the flow path established as the cannula is extending beyond thecatheter and the slider body is in fluid communication with the extension set port of the blood collection device handle.

[0080] FIG. 51 shows expanded details of the distal portion of the blood collection device including the male luer and catheter assembly as it may be docked to the blood collection device during use.

[0081] FIG. 52 shows a is a detailed cross section view from a distal side perspective of the distal portion of the handle and proximal end of catheter hub docked in the male luer with engagement features of the male luer coupled with corresponding features of the catheter hub.

[0082] FIGS. 53A and 53B show a cross-section perspective view from the proximal side in a transition of the disengagement button on the male luer.

[0083] FIG. 54 shows a cross section of both the blood collection device coupled to a catheter assembly catheter assembly such that the flow path from can be seen not in fluid communication with the extension set port as the slider plunger is in the stowed position within the proximal end of the blood collection device handle. The arrangement of the male luer and catheter assembly are also highlighted as the male luer approaches the catheter assembly for coupling during use.

[0084] FIG. 55 shows the blood collection device and catheter assembly of the previous figure in a perspective view from the proximal side with the slide plunger in the stowed position and arm extending through the proximal opening of the tube seal. The blood collection device is shown aligned with the catheter hub ready for insertion.

[0085] FIG. 56 shows another cross section of the blood collection device now docked with the catheter assembly. In this configuration, the male luer has penetrated the catheter hub seal and the cannula is ready to be extended via distal advancement of the slide plunger through the tube seal slit / handle slot. Although both extension sets (e g., of the catheter assembly and the handle) are shown, when the blood collection device is docked to the catheter assembly, the extension set of the catheter assembly is sealed whereby a flow of fluid will be directed through the cannula, slide plunger body to the extension set of the handle.

[0086] FIG. 57 shows a perspective view of the cross-section example and configuration of the blood collection device from the previous figure. Here this may be a single-catheter length configuration for a set catheter length. The male luer is coupled to the distal end of the handle and is an intermediate element between the distal end of the handle and the catheter assembly that is shown docked to the blood collection device in this view. The slide plunger is in the stowed position and cannula has not been advanced through the catheter assembly.

[0087] FIG. 58 shows a cross section of a blood collection device in a deployed configuration. In this example, the blood collection device may be a single-catheter lengthconfiguration for a set catheter length (e.g., 1.30”). The flow path is visible and has been established or completed from the distal end of the cannula extended beyond the distal end of the catheter. The cannula would be within the vessel and flow through the cannula through the slide plunger body (e.g., manifold) that is now in communication with the tube seal opening and extension port of the handle to the vacutainer assembly.

[0088] FIG. 59 shows the complete blood collection device of the previous figure where the cannula has been extended as the slide plunger is in the distal most position within the slot and tube seal slit. In particular, the slide arm is now extending through the distal opening axially aligned with the tube seal slit. The opening is accommodating he slide arm while the remaining length of the tube seal slit is sealed proximally from the slide plunger.

[0089] FIG. 60 shows additional advancement features of the single-catheter length configuration for the blood collection devices described herein. This additional advancement is an incremental transition of the slide plunger after it has been distally advanced. For example, when the cannula is deployed into the vessel and the slide plunger is correspondingly in the distal portion of the tube seal slit / handle slot, an optional additional advancement is possible to overcome any obstruction or occlusion contacted by the distal end of the cannula when deployed. In some examples, vascular valves may otherwise prevent the cannula from restabling a flow through the blood collection device. The additional advancement feature and configuration can allow deployment of the cannula beyond the obstruction even after the distal end of the cannula has been extended beyond the catheter. The ratchet system may therefore have a first deployed setting and a second obstruction clearance setting for the added advancement even in a single-catheter length device configuration.

[0090] FIG. 61 shows a cross section of the blood collection device from a proximal perspective and in a multiple-catheter length configuration coupled with a 1.00” catheter and the slider is in an advanced position to establish a flow path from the cannula to the vacutainer assembly via the extension set port on the blood collection device handle.

[0091] FIG. 62 shows the blood collection device from the previous figure in a perspective view from the proximal end to highlight the position of the slider within the tube seal slit.

[0092] FIG. 63 shows the blood collection device of the previous figure with the slide plunger advanced further than the previous figure to accommodate a 1.30” catheter length.

[0093] FIG. 64 shows the perspective view of the complete blood collection device of the previous section still coupled to the 1.30” catheter with the slide arm is shown extendingthrough the tube slit and handle slot generally between the tube seal proximal opening and tube seal distal opening.

[0094] FIG. 65 shows the blood collection device of the previous figure now adapted to accommodate the 1.50” catheter coupled to the male luer and the slider has been advanced further distally within the handle to accommodate the longer catheter length and maintain the flow path to the vacutainer assembly.

[0095] FIG. 66 shows the proximal perspective of the blood collection device from the previous figure.

[0096] FIG. 67 shows anther perspective view of the blood collection device of the previous figure with the slider advanced further still to accommodate now a 1.75” catheter length with continued flow path and fluid coupling to the extension set port of the device handle.

[0097] FIG. 68 shows the complete perspective view of the blood collection device from the previous figure adapted to accommodate the 1.75” catheter length with the same blood collection device.

[0098] FIG. 69 shows a cross section view from a proximal perspective of the blood collection device from the previous figure now coupled to a 2.30” catheter and the slider advanced to a distal most position within the device handle and docked to the proximal side of the male luer to accommodate the extended catheter length and maintain the flow path to the vacutainer assembly.

[0099] FIG. 70 shows the blood collection device of the previous figure from the proximal perspective with details of the slide arm extending through the tube seal distal opening as well as the tube seal slit in a sealed configuration along the entire length of the slit from the proximal opening to the distal opening.

[0100] FIG. 71 is a side elevation view example of a blood collection device having a tube seal configuration and examples of an alignment or positioning feature positioned on the exterior of the handle allowing for an indication of position and alignment of the slider relative to the extension set port of the handle.DETAILED DESCRIPTION

[0101] FIG. 1 A shows an example of a blood collection device from a proximal perspective with a vacutainer assembly in communication with the extension set port of the blood collection device handle. In this configuration, the slider is in the stowed position proximally within the blood collection device handle and the male luer is locatable at the distal end of the blood collection device handle. In this perspective view of the peripheral IVocclusion clearing device 100. The device body (e g., handle) 105 has a slot 115 axially positioned along a length of the handle 105 to accommodate a movement of a slider 110 during use. In this view, the slider 110 is positioned near the handle proximal end 107 with the slot 115 extending distally on the handle 105 towards the handle distal end 106. A male luer 125 is coupled to the handle distal end 106 with a catheter assembly including catheter hub 130 and catheter 131 in communication with the device 100. An extension set with vacutainer assembly is operably coupled to the device 100 at the extension set port 135 with extension tubing 137 extending from the port 135 to the extension set luer 138. The vacutainer coupler 139 is attached to the extension set luer 138 and a clamp 136 is provided in operable communication with the extension tubing 137.

[0102] This view illustrates an example of a blood collection device 100 in a ready -to-use configuration with the slider 110 is fully retracted to the handle proximal end 107 within the slot 115. The cannula 120 is in communication with the slider 110 and stowed within the handle 105. For example, the cannula is not extended beyond the distal end of the catheter, and a flow path is not established between the cannula 120, slider 110, and extension set port 135 in this view.

[0103] FIG. IB shows another example of the blood collection device from FIG. 1 A in a perspective view and coupled with a catheter assembly as it may be during use. shows a perspective view of a peripheral IV occlusion clearing device 100. The device body (e.g., handle) 105 has a slot 115 axially positioned along a length of the handle 105 to accommodate the movement of a slider 110 during use. In this view, the slider 110 is positioned near the handle proximal end 107 with the slot 115 extending distally on the handle 105 towards the handle distal end 106. A male luer 125 is coupled to the handle distal end 106 with a catheter assembly including catheter hub 130 and catheter 131 in communication with the device 100. An extension set with vacutainer assembly is operably coupled to the device 100 at the extension set port 135 with extension tubing 137 extending from the port 135 to the extension set luer 138. The vacutainer coupler 139 is attached to the extension set luer 138 and a clamp 136 is provided in operable communication with the extension tubing 137.

[0104] This view illustrates an example of the blood collection device 100 in a ready -to- use configuration with the slider 110 is fully retracted to the handle proximal end 107 within the slot 115. The cannula 120 is in communication with the slider 110 and stowed within the handle 105. For example, the cannula is not extended beyond the distal end of the catheter 131, and a flow path is not established between the cannula 120, slider 110, and extension set port 135 in this view.

[0105] In this example, the device 100 comprises a vacutainer assembly with a vacutainer 140 coupled to a luer 139 and tubing 137 coupled to the extension set port 135 of the handle 105. A clamp 136 may be disposed on the tubing 137 to control flow of fluids through the tubing 137.

[0106] In some examples, the devices described herein are configured to engage the proximal end or end of a catheter (e.g., catheter hub) to facilitate a blood draw through the catheter from the proximal end of the hub. The distal end of the devices described herein can have a coupling mechanism (e.g., male luer 125) adapted to couple with the catheter including a protrusion or other feature configured to be positioned within the catheter hub and direct or support the passage of the cannula through the in-dwelling catheter into the vessel for the blood draw. In any example, the arrangement of the device relative to the proximal end of the catheter can provide a direct flow path of blood through the cannula to the vacutainer when the cannula is deployed into the vessel as it may be during use.

[0107] FIG. 2 shows a perspective view of the distal end of the blood collection device with the male luer transparent to highlight the cannula extending from the distal end of the handle through the male luer but not extending past the male luer protrusion as it may be in a stowed or ready-to-use configuration. The male luer 125 is coupled to the distal end of the handle 106 with the cannula 120 extending through the male luer protrusion 270 in a stowed configuration as the distal end of the cannula 120 is not extending beyond the male luer protrusion 270 distal end. The slide seal is removed from the slider slot 115, and the slider is not shown as it would be positioned in the proximal position of the handle 105 in the stowed or ready-to-use configuration. This male luer may be configured to engage a catheter or catheter assembly (e.g., catheter hub of a catheter assembly) in a releasable engagement. For example, catheter coupling element 265b may be configured to engage a corresponding element on a catheter hub (not shown).

[0108] FIG. 3 shows yet another detailed perspective view of the distal end of the handle and male luer coupled thereto, as shown in FIG. 2. Referring to FIG. 3, the position of the cannula distal segment is seen in the stowed position as it is not extending beyond the male luer protrusion 270 in this ready-to-use configuration. Also shown here are examples of engagement capabilities of the male luer 125 to the handle 105 at the proximal end of the male luer 125 and a catheter to the distal end of the male luer 125. This detailed view also provides an example of the protrusion distal end 271 configured to complement and support insertion of the male luer into a catheter hub.

[0109] As described herein, the male luer (e g., coupling mechanism) may be positioned at a distal end of the handle. In some examples, the male luer may be integrated with thehandle. For example, the male luer may be a segment or portion of the handle. Referring to FIG. 3, the protrusion 270 extends out from the handle and is illustrated as extending beyond a region of the male luer configured to receive or otherwise contact a catheter hub. The protrusion 270 can be adapted to be positioned within the catheter (e.g., catheter hub or extension set) after being advanced through the proximal end of the catheter hub. The protrusion may be advanced into the catheter through one or more valves (e.g., blood control valves) positioned therein. For example, the protrusion may be advanced into the catheter and traverse a valve in the catheter to position the lumen through the protrusion in proximity to the proximal end of the catheter lumen allowing the cannula to be advanced from the device, through the protrusion, and through the catheter lumen. In some examples, the devices described herein may be configured to couple with a catheter placed in vasculature of a patient. For example, a catheter placed in a blood vessel for drawing patient samples, providing medications, fluids, interventional techniques, etc. In some examples, a handle of the device may have a distal end adapted to couple the device the catheter. In some examples, an additional element such as a male luer may be coupled to the distal end of the handle of a device and the male luer may be adapted to couple the device with a catheter assembly.

[0110] In any example described herein, the coupling mechanism (e.g., male luer) may be adapted to engage the proximal end of a catheter hub or an in-dwelling catheter. The cannula, and male luer protrusion may be axially aligned such that the male luer can align a lumen therethrough with the catheter lumen to provide a path for the cannula to be advanced through the catheter and into the blood vessel.[OHl] FIGS. 4A to 4E show an example of a male luer in various views to highlight the coupling features configured to engage the distal end of a blood collection device handle as well as the proximal configuration adapted to couple with a catheter assembly including an example of a catheter assembly disengagement mechanism. As illustrated, details of the male luer are provided in these various views. Referring to FIG. 4A, male luer 125 is shown in a side elevation view alone (e.g., without the device handle). The distal end of the male luer may include the male luer protrusion 270 and the distal end of the male luer protrusion 270a. In this example, the male luer protrusion distal end 270a is shown with a tapered geometry. In some examples, attributes of the male luer protrusion distal end 270a may be configured to be complementary to the interior of a catheter hub. For example, a corresponding taper inside a catheter hub may facilitate a sealed engagement between the catheter assembly and the device.

[0112] The disengagement button 265 can be configured to facilitate the separation of the male luer from the catheter hub. For example, activating the disengagement button maycontact a catheter hub and bias the catheter assembly away from the device. In some examples, the proximal side of the male luer 125 may be configured to receive the handle. In FIG. 4A, the male luer 125 comprises a docking portion 270c configured to receive a distal end of the slider when it is advanced to a distal most position in the handle of a device.

[0113] FIG. 4B shows the male luer 125 from the proximal side highlighting the male luer lumen 270b. In some examples, the lumen 270b is configured to receive the cannula extending therethrough during use. For example, the cannula may pass through lumen 270b and through the catheter assembly into a vessel during use. From this view, an example of alignment features 285 are shown and may be adapted to align a catheter assembly when coupling the handle to the catheter hub. These alignment features 285 may be configured to align the catheter hub in an appropriate orientation for docking and coupling with the handle. Also shown in this view are examples of raised features 280 that may be configured to support handling of the device during use. For example, one or more raised feature 285 may be locatable on the male luer to support grip and manipulation of the device during use.

[0114] In FIG. 4C, male luer 125 is shown from a distal perspective and oriented to show handle coupling feature 290 on the proximal section of the male luer body. These features 290 may correspond to elements on the distal end of a handle configured to engage features 290 and support coupling of the male luer to the device handle. In some examples, the male luer may be incorporated or integrated with the handle. In some examples, the male luer may be coupled to or affixed to the distal end of a handle via engagement elements 290, or other form of coupling between the handle and the male luer. Similarly, FIG. 4D illustrates another distal perspective view to highlight additional exemplary elements of a disengagement mechanism including the disengagement button 265 and catheter engagement feature 290 as another element of a disengagement mechanism of the male luer. This catheter engagement feature may be adapted to receive a corresponding element of a catheter hub for a positive engagement and locking the catheter to the device, when in use.

[0115] Referring to FIG. 4D, in some examples, the male luers (e.g., coupling mechanisms) of devices described herein may comprise a protrusion having a proximal segment and a distal extension. As illustrated here, the male luer comprises a proximal luer segment 270c and a distal extension segment 270d. The proximal segment may be configured to complement a standard female luer configuration of a catheter hub or other port. For example, a proximal luer segment may be a standard ISO luer taper or configuration to be used with a standard catheter hub. In some examples, the proximal segment of the male luers described herein may have a tapered geometry with a decreasing cross-sectional geometry as you move distally along a length of the proximal luer segment. In some examples, the distalextension segments of a male luer may have a constant diameter along a length of the extension segment. For example, as illustrated in FIG. 4D, the distal extension segment 270d is generally cylindrical until the tapered distal end 270a. In some examples, the distal end may be configured to have a geometry that is complementary to the interior geometry of a catheter hub, such that when the blood draw device is coupled to a catheter, the male luer may be positionable within the catheter hub and extend adjacent or substantially adjacent to the proximal end of a catheter lumen. In some examples, the position of the distal end of a male luer (e.g., coupling mechanism) may provide for a reduced distance between the male luer distal end and the catheter proximal end such that when the cannula of the blood draw device is deployed, it reduces or eliminates the distance between the male luer and the catheter lumen for the cannula to be deployed.

[0116] FIG. 4E shows the male luer 125 from FIG. 4A-4D in a cross-section view to illustrate the transition of the luer segments with a proximal segment 270c having a conical geometry from the base 270e to the proximal segment distal end 270f. As shown, the proximal segment can be configured as a standard male luer adapted to engage or couple with catheter hubs, ports, etc. The distal segment 270b may be considered an extension from the proximal segment 270c adapted to be inserted and positioned within the catheter hub and extend towards the proximal end of the catheter lumen. In some examples, the extension of distal segment 270d can provide additional support for the cannula and reduce the distance or gap from the distal end 270 to the proximal end of a catheter lumen. For example, the cannular can be extended or deployed out of the handle 105 through the proximal segment 270c and through the distal segment or extension 270d out of the distal tip 270b then through the catheter lumen (not shown).

[0117] FIG. 4F to 41 also show an example of a male luer 125a configured to couple with the distal end of a blood collection device handle and a catheter assembly via the proximal end of the male luer with friction style engagement features, as described herein. This example of a male luer 125a is shown in different views to illustrate the configuration to facilitate engagement with a catheter assembly during use of the blood collection device. In this example of the male luer 125a comprises an example for a friction fit engagement with a catheter hub at the distal side of the male luer. In some examples, a friction-fit engagement may still comprise a male luer protrusion 281 extending from the distal end of the male luer 125a. Here, some examples of a friction-fit engagement may include one or more detent engagement features 283 and 282 for facilitate communication with the proximal end of a catheter hub docked therein. In some examples, male luers described herein may have alignment features corresponding to alignment of a catheter for coupling with the device. Insome examples, as illustrated in FIGS. 4F to 41, there may not be alignment features as the device may be configured to engage any catheter regardless of alignment features or particular coupling elements on the catheter. For example, when coupling the device to a catheter, the device may be aligned with a catheter and the male luer may be advanced onto the proximal end of the catheter (e.g., catheter hub) until the device is in operable communication with the catheter and a flow path can then be established.

[0118] Referring to FIG. 4G, this elevation view from the proximal end highlights a similar lumen 288 through the center of the male luer including the male luer protrusion 281. Also shown is the interior distal wall 287 of the male luer 125a where the catheter proximal end may be in communication with to provide a sealed engagement between the catheter and the device in use. Manipulation support features 286 shown in FIGs. 4H and 41 are also illustrated. In some examples, male luer described herein may have one or more manipulation support features to support handling and manipulation of the device in use.

[0119] In any example described herein, the male luer may comprise the proximal luer segment (e.g., 270c in FIG. 4D) with or without a distal extension (e.g., 270d in FIG. 4D). In some examples, the male luers described herein may comprise a protrusion that can have a consistent cross-sectional geometry along a length of the protrusion. In ay example described herein, the geometry, dimensions, or other features of the male luers may be configured to complement, engage with, or otherwise support the insertion and positioning of the male luer within the catheter hub.

[0120] FIG. 5 shows a perspective view of the blood collection device from a proximal end with expanded details of the male luer 125 and distal handle portion with the catheter hub 130 docked. This view shows details of the ratchet system 250 of this single-catheter length blood collection device. The cannula 120 is similarly in a non-deployed configuration as the slide plunger as not engaged the ratchet system 250 and the cannula distal end is still within the male luer protrusion 270. In this example, the cannula 120 is axially aligned with the catheter 131 with the cannula distal end positioned proximal to the catheter opening 131b ready to be advanced through the cannula 131.

[0121] The details of the example in FIG. 5 also provide the communication between the male luer protrusion distal end and the interior of the catheter hub 130b. In this example, the catheter hub interior 13 lb is a similar tapered shape to receive the male luer protrusion distal end when coupled.

[0122] FIG. 6 shows a detailed perspective view of the distal end of a blood collection device as it may be coupled to a catheter assembly 129 including the catheter 131 and catheter hub 130. shows a detailed perspective view of the distal end of a device 100 with amale luer 125 coupled to the handle distal end 106. Further, details of the catheter assembly 129 engagement with the male luer 125 are visible wherein the catheter hub 130 is docked to the male luer 125 and catheter alignment feature 132 is seated in a corresponding feature of the male luer 125. Elements are shown here in a transparent manner to further illustrate the cannula 120 extending along a central axis of the device in the stowed configuration. For example, the cannula 120 is not visible beyond the catheter 131 as it has yet to be advanced. This view also shows a ratchet system 150 of the handle. The ratchet system is configured to engage the slider when advanced distally in the handle.

[0123] FIG. 7 shows an expanded view of the distal end of a blood collection device of FIG. 6 with additional detail of examples for coupling between the male luer 125 and the blood collection device handle 105 as well as coupling of the male luer distal side to a catheter hub 130. For example, the engagement features 127 at the distal end of the handle 105 are configured to couple with corresponding engagement feature 126 of the male luer. In some examples, the male luer may be coupled to the handle with the communication between engagement features 127 and 126, as shown. The communication between the handle 105 and the male luer 125 may be maintained by any manner such as adhesive, threaded engagement, quick disconnect engagement mechanisms, integration of the male luer as a segment of the handle, etc. or a combination thereof. The extension set port 135 is shown extending from the handle 105 and the slider is not visible in this detailed view highlighting discontinuity of a flow path in this read-to-use configuration. For example, the cannula 120 is still positioned axially within the handle 105, but the cannula lumen is sealed as the slider is not in fluid communication with the extension set port 135.

[0124] FIG. 8 shows yet another detailed view of the distal end of the blood collection device in FIG. 6 and FIG. 7 from the proximal perspective with the catheter assembly coupled to the male luer 125. This expanded view shows the disengagement mechanism of the male luer 125 including the disengagement button 265 and the catheter coupling feature 290 in operable communication with corresponding catheter docking element 305 / The distal end 265a of the disengagement mechanism can be configured to lift and release the coupling of features 290 and 305 when the disengagement button 265 is actuated.

[0125] Examples of catheter alignment can be seen in FIG. 8 with alignment elements 295 of the catheter hub 130 adapted to communicate with alignment features 285 of the male luer 125. In some examples, alignment element 295 may comprise a first side 300a and a second side 300b that may exclusively communicate with corresponding sides of the alignment features 285 of the male luer 125.

[0126] FIG. 9A and 9B show perspective views from the proximal side in FIG. 9A and the distal side FIG. 9B of a catheter hub 130 of a catheter assembly alone with additional features such as the catheter, valves, seals, stabilizing features, etc. that have been removed to highlight the features of the hub. For example, the catheter hub 130 may be more complete in examples illustrated in FIG. 29, 56, etc. This catheter hub 130 may be used in combination with the blood collection devices as part of a catheter or catheter assembly. In some examples, the catheter hub 130 may be a standard catheter. In some examples, catheters and catheter hubs described herein may comprise one or more features that are adapted to facilitate communication with male luers described herein. Referring to FIG. 9A, alignment elements 300 are shown with a first side 300a and second side 300b. In some examples, the first side may extend further away from the catheter hub surface than side 300b. In some examples, the second side 300b may extend further away from the catheter hub surface. In some examples, both sides 300a and side 300b may be generally coplanar. Where side 300a or 300b are not coplanar, alignment of the catheter hub for docking with the devices described herein may be accomplished when the catheter hub is aligned in a single orientation. In some examples, the catheter hub alignment elements may allow for coupling with corresponding alignment features 285 of a male luer in more than one orientation. For example, the catheter hub may align in a single orientation as the alignment elements 300 may be configured to only engage the corresponding alignment features 285 of a male luer. In other examples, the device may be adapted to rotate and engage the catheter hub in any orientation.

[0127] Gather hubs described herein may also comprise locking features 305 configured to engage the disengagement mechanism of the male luer or devise described herein. These additional locking features may be configured to facilitate a positive engagement between the device and the catheter assembly. Also, in FIG. 9A and 9B, the catheter is not shown. However, the distal hub opening 310 is shown where the catheter may extend from or be coupled to. On the proximal end a catheter hub proximal surface 300c may be configured to communicate with the distal interior surface of the male luer when docked.

[0128] FIG. 10 shows an example of a distal segment of a blood collection device in a side elevation view with details of the ratchet system and male luer configurations at the distal end of the handle, blood collection devices described herein may comprise a ratchet system 250 configured to engage the slider when it is advanced distally in the handle 105. The ratchet system 250 may have a series of teeth 250a, 250b, and 250c. For example, tooth 250a is positioned at a distal end of the ratchet system 250 and may provide an indicator for the distal positioning of the slider when advanced in the handle 105. Similarly, tooth 250b ispositioned at the proximal side of the ratchet system 250 and may provide an indication of initial contact between the ratchet system 250 and the slider (not shown). In some examples, the distance between the proximal side and distal side o the ratch system may include one or more additional teeth (e.g., 250c). The number and configuration of the ratchet system teeth may be configured to provide an indicator of the position of a slider and the length of cannula 120 advancement when in use. For example, the proximal side of the ratchet system 250 may indicate a first length of cannula advancement. Then, as the slider is advanced yet further distally, additional ratchet system teeth may indicate extended lengths of deployment.

[0129] In some examples, the ratchet systems described herein may indicate the length of cannula advancement. In some examples, the devices described herein may be adapted to be used with a single length catheter. In some examples, a single device may be adapted to be used with multiple different catheter lengths. For example, a single device may have a cannula, slider, ratchet system, handle length, etc. or a combination thereof configured to be used with a 1.75” catheter. In some examples, a single device may have a cannula, slider, ratchet system, handle length, etc. or a combination thereof configured to be used with multiple different catheter lengths. For example, a device adapted to be used with multiple catheter lengths may be configured to advance the slider and cannula to a first position associated with a first catheter length (e.g., a 1.00” catheter). If needed, the same device may be configured to advance the slider and cannula further distally within the handle to extend the cannula through a longer catheter (e.g., 1.30” catheter). Accordingly, the ratchet system may provide audible, tactile, or other feedback to a user to indicate the length of cannula deployment.

[0130] In some examples, catheter lengths may be any length. For example, catheter lengths may include 1.00”, 1.30”, 1.50”, 1.75”, 2.30” or more or less or any length therebetween. Accordingly, the device adapted to be used with any catheter length may comprise an extended handle length, cannula length, etc. with a slider adapted to be advanced to multiple positions distally within the handle corresponding to the different catheter lengths. The cannulas described herein may have a length from a proximal end extending out of the slider body to a distal end. In some examples, cannula lengths may be less than 1” to more than 5” or any length therebetween. For example, where a device is configured for use with a single length catheter, the cannula length may be 3”, 3.5”, 4”, 4.5” or more or less or any length therebetween. Another example where the device is configured for use with multiple different catheter lengths, the cannula may have a length of 4”, 4.5”, 5”, 5.5” or more or less or any length therebetween.

[0131] FIG. 10 also provides a sufficiently transparent handle to show the extension set port 135 with a lumen extending from an interior opening 135a to an exterior opening 135b. The interior opening 135a of the extension set port may be open to the interior of the handle and configured to communicate with a flow path opening of a slider when the slider is distally advanced during use. For example, a flow path may comprise a lumen from the distal end of the cannula to a vacutainer or specimen collection device. In some examples, this flow path lumen is discontinuous until the slider is advanced to be in communication with the extension set port.

[0132] FIGS. 11 A to 1 ID show examples of a movable seal alone in FIG. 11 A and coupled with a slider in a movable seal configuration used in some examples of blood collection devices described herein. In some examples, devices described herein may comprise a slidable seal or a seal adapted to move with the slider when it is advanced or retracted during use. In some examples, the slider may be configured to move within a seal such that the seal is fixed in position within the handle of a device. Referring to FIG.11 A an example of a slider seal 155 is illustrated alone or uncoupled from the slider 110. In some examples, the slider seal 155 is configured to engage a slider (e.g., slider 110) and provide a seal against an interior surface of the handle.

[0133] This example of the slider seal 155 shows raised annular features positioned circumferentially positioned around the slider seal 155. These circumferential seal features 128 can be configured to support alignment of the slider 110 inside the handle. For example, each circumferential seal feature 128 may extend outward from the seal body to contact the interior surface of the handle to support alignment of the slider 110 in the handle as well as support a seal of the flow path from the cannula through the slider flow path opening until the opening is aligned with the extension set port. The seal shown in FIG. 11 A also comprises an axal seal feature 157 around the perimeter of the seal flow path opening 156. this axial seal feature 157 can be configured to contact the interior surface of the handle in a sealing engagement to maintain closure of the flow path until the seal flow path opening (e.g., and slider flow path opening) are aligned with the extension set port when the slider is advanced distally in the handle.

[0134] FIG. 1 IB shows the slider seal 155 in communication with the slider 110. Here, the seal flow path opening 156 is aligned with the slider flow path opening and the axial seal feature is accordingly aligned with the perimeter of the slider flow path opening. Both the seal flow path opening 156 and slider flow path opening provide the proximal end of the flow path extending distally through the cannula 120. Referring to FIG.1 ID, the slider 110 is shown with the slider seal 155 in position at the handle proximal end 107. Thecircumferential seal features are in contact with the interior of the handle to support the alignment of the slider 100 and the cannula 120 axially positioned within the handle. This segmented view of the handle proximal end highlights the discontinuity of the flow path as the slider flow path opening and seal flow path opening are not aligned with the extension set port. In some examples, additional alignment features of the slider can be configured to align the slider 110 in the handle. Referring to FIG.1 ID, distal slider alignment features 112 may be configured to extend outward from the slider body towards the interior surface of the handle. For example, these distal slider alignment features may contact or be sufficiently adjacent to the interior surface of the handle to prevent unintentional displacement (e.g., misalignment) of the slider 110 in the handle. Similarly, proximal slider alignment features 111 can be configured to support the alignment and position of the slider 110 in the handle.

[0135] FIGS. 1 IB to 11C also show slider tooth 151 extending from the slider 110. In this example, the slider 110 may be configured to operate with a single catheter length or multiple-catheter lengths. For example, the single tooth 151 may be configured to engage the ratchet system 250 of the handle and provide tactile and / or audible feedback of the slider position when it is advanced distally within the handle. FIG. 11C, variations in the geometry of the seal features (e.g., the circumferential seal features 158) are shown where the exterior surface of the circumferential seal feature 158 is pointed as opposed to the rounded example 157. In some examples, the rounded circumferential seal features 157 may provide increased surface area contact with the interior surface of the handle. In some examples, the points geometry of axial seal features 158 may provide for a wiper-style seal 158 with less surface area contact with the interior of the handle. In some examples, the wiper-style seals 158 may be configured to contact the interior surface and bend or flex while maintaining contact with the handle interior surface as the slider is advanced or retracted within the handle.

[0136] FIG. 1 ID details of the slider including the slider arm 113 and slider tab 114 as illustrated in FIGS. 1 IB and 11C in position within the handle proximal end 107. The slider arm 113 is visible as it extends through the slider slot to the slider tab 114. The slider tab 114 can be configured to be engaged by a user to advance or retract the slider 110 when in use.

[0137] In some examples, sealing as facilitated by the slider seal 155 can be adapted to prevent unintentional flow of fluid through the cannula until fluid communication is established between the slider flow path opening and the extension set port. For example, the interior or lumen of the cannula including the interior of the slider may be locked with a fluid (e.g., biocompatible fluid such as a saline). The fluid lock of the partial flow path including the cannula and slider may be advanced into the vessel on insertion (e g., distal slider advancement). The fluid lock may provide for a simplified blood draw as the initial flow ofblood from the vessel through the cannula, slider and into the vacutainer may not be contaminated with the biocompatible fluid. Accordingly, the fluid lock may reduce or eliminate the need to discard the initial specimen (e.g., blood) drawn.

[0138] FIG. 12 shows a side elevation view of select elements of a blood collection device including a coupled catheter assembly, male luer, and slider coupled to the cannula with the handle removed to highlight an exemplary flow path, as described herein. With the handle removed, an example of alignment between the cannula 120, slider 110, male luer 125, and catheter assembly can be seen. As illustrated, the slider 110 is in a proximal position with the cannula 120 not extended beyond the catheter distal tip 131a. For example, cannula length 120a would be disposed within the handle and available to be advanced through the catheter into a vessel during use. The slider may be advanced distally (e.g., towards the male luer 125) causing the length 120a to extend through the catheter hub 130, catheter 131 and out of the distal end 131a to reestablish blood flow, clear occlusions at the catheter distal tip 131a, and / or establish a flow of blood from the vessel through the cannula 120.

[0139] FIG. 13 shows an example of a slider 110 in the stowed position proximally within the blood collection device handle 105 as a cross section to highlight the internal flow path from the proximal end of the cannula 120 and through the slider 110, which is sealed in the proximal position and the lumen is discontinuous relative to the vacutainer assembly (not shown). This cross-section view shows a channel or flow path region 195 inside the slider body. The flow path opening 156 is open through the slider 110 into the flow path region 195. In this example, with the slider 110 in the proximal position within the housing, the flow path is discontinuous as the flow path opening 156 is sealed against the interior of the handle 105 and not in fluid communication with a vacutainer (e.g., via an extension set port). Whether the interior of the slider 110 and cannula 120 are fluid lock or air locked, a flow of blood may not be initiated as long as the flow path opening 156 is sealed against the interior of the handle as a constant pressure inside the slider and cannula may be constant until the slider flow path opening 156 is in communication with the extension set port.

[0140] FIG. 14 illustrates a proximal perspective view of the blood collection device handle with the slider 110 again in the proximal and stowed position to highlight the slider slot 115 along the handle 105 configured to guide the slider 110 from the proximal position through distal advancement when in use. Similar to FIG. 13, the flow path may be sealed and discontinuous with the slider 110 in the proximal position, as shown in FIG. 14. Details of the ratchet system 150 near the proximal end of the handle interior are provided and ready to accept the slider 110 when it is advanced to a deployed configuration.

[0141] FIG. 15 shows a side elevation view from the distal end of a blood collection device from FIG. 14 with the male luer removed to highlight the slider lumen 180 and slider alignment features 112 configured to facilitate alignment and positioning of the slider 110 within the blood collection device handle 105. In this example, a ratchet system channel 175 is shown superior to the slider 110 inside the handle 105. This ratchet system channel can be adapted to receive the slider teeth 151 as the slider is advanced from a proximal position to a distal position.

[0142] A slider slot seal 190 is also visible in this cross-section view. The slider slot seal can be configured to cover or enclose the slider slot while allowing the slider 110 to be advanced or retracted through the handle 105 and slider slot 115 with minimal opening of the slider slot seal 190. For example, the slider slot seal may be closed along a length of the slider slot seal 190 except for the opening necessary to facilitate the slider arm 113 passing through the slider seal slot 190.

[0143] In some examples, alignment features of sliders described herein may support axial alignment and prevent unintentional buckling or misalignment of the slider and cannula during advancement and deployment in use. Additional alignment elements such as the ratchet system alignment channel (e.g., 175) can also support the path available for the slider through the handle. In some examples, it may be beneficial to provide additional support for the slider in this manner to prevent the cannula from buckling when it is advanced into a vessel and possibly contacting obstructions or occlusions in the vasculature. Another feature of the devices described herein may be minimizing the interior volume of the handle. For example, the interior diameter of a handle may be minimized by the slider and seal configurations to support slider alignment and prevent buckling, kinking, or unintentional non-linear displacement of the cannula during advancement and use.

[0144] FIGS. 16A and 16B show perspective views of the slider within the handle from the proximal side with the cross section taken more distally in in FIG. 16B compared to FIG. 16A to show yet further detail of the interior of the slider and the slider opening in sealed communication within the blood collection device handle. As described in FIG. 15, the slider slot seal 190 may be open only around the slider arm 113. For example, the slider slot seal 190 may be sealed along its length from a proximal end to a distal end with a sealable slit configured to allow the slider arm 113 to extend therethrough while maintaining a seal along the remainder of the slider slot seal distally from the slider arm 113 and proximally from the slider slot arm 113. The details shown in FIG. 16A and 16B provide cross section views showing a first side 215e and 215f of the slider slot seal slit 215d as the portion of the slider slot seal contacting the slider arm 113 is only open around the slider arm 113.

[0145] FIG. 17 shows an example of a blood collection device from FIG. 16 with expanded views of the handle distal end in a top-down view to highlight the ratchet system 250 features and the positioning of the extension set port 135 extending from the blood collection device handle. A distal portion of the slider slot seal can also be seen with the slider not shown and in the proximal position in the slider slot 115.

[0146] In some examples, the slider slot seal may be coupled to a device handle described herein. For example, the slider slot seal may be adapted to cover the slider slot of a handle and provide a sealed interior while allowing the slider arm to extend therethrough between the slider tab and slider plunger (e.g., slider body). The slider slot seal may have one or more features to facilitate transition of the slider from a proximal or stowed position to a distal or deployed position.

[0147] FIGS. 18A to 18C illustrate a top plan view, side elevation view, and cross section view, respectively, of an example of a slider seal 215 couplable to the device handle and configured to facilitate the positioning and seal of slider 110 and interior of the blood collection device handle 105. Referring to FIG. 18A, the slider seal 215 is shown in its entirety from a proximal end to distal end locatable in the proximal end and distal end, respectively, of the slider slot of a handle. The slider slot seal 215 can comprise a slit 215a extending along a length of the seal 215. In this example, the proximal end has an opening 215c configured to accommodate the slider in a stowed position. For example, opening 215c may be configured to accommodate the slider arm extending therethrough without pressure on the slider seal slit 215a. In some examples, a slider may be advanced distally along the slider slot seal 215 from the proximal opening 215c and though the slit 215a towards the distal end.

[0148] In FIG. 18B, a view of the slider from the distal end is shown to highlight an example of the slit 215a. In this example, the slit 215a is angled. The angle slit 215 may be adapted to allow the slider arm to extend therethrough while maintaining a seal along the slider slot seal 215 for the remainder of the seal length distal from the slider and proximal from the slider arm. In some examples, the slit 215 may be at any angle. In some examples, the angled characteristic of the slit 215a may be configured to prevent the canula from bending and extending through the slider slot seal 215. For example, considering the view in FIG. 18B, if a cannula were to bend or buckle within the handle interior, it can contact the interior surface of the slider slot seal 215 and the angle of the slit can be adapted to prevent the cannula from bending through the seal. For example, the cannula may be prevented from buckling by the slider slot seal 215.

[0149] FIG. 18C shows a cross section of a segment of the device with the slider 110 inside the handle and the slider slot seal 215 coupled to the handle. In this view, the interior of the handle 105 is generally cylindrical. The handle interior circumference can include combination of the interior surface of the handle and the interior surface of the slider slot seal 215.

[0150] FIG. 19 shows a side elevation view of a blood collection device 200 example configured to be used with multiple different catheter lengths as a single blood collection device 200. The slider 170 is in the proximal and stowed position with an elongated plunger body and flow path opening 195 configured to facilitate establishing a flow path through multiple different catheter lengths, as needed during use. The length of the slider body 170a (e.g., plunger) is extended compared to slider 110 with multiple ratchet teeth 167 and the extended length of the flow path opening 195 can all be adapted to accommodate a fluid communication with the extension set port 135 when the slider 170 is advanced through different lengths of an associated catheter in use. The cannula 120 may also be extended relative to the single catheter length device configuration to allow for extension beyond the device and beyond a distal tip of a catheter into the vessel.

[0151] FIG. 20 shows the blood collection device from FIG. 19 in a perspective view from the proximal side to highlight the slider slot 116 and arrangement of the slider 170 relative to the male luer 125 and extension set port 135. In some examples, the male luer of the extended multiple-catheter length device 200 may be interchangeable with the singlecatheter length device (e.g., device 100). Accordingly, in the example illustrated by FIG. 20, the male protrusion is shown at a distal end of the device 200 with the cannula 120 stowed and not extending out from the distal end of the device in this stowed configuration. As previously shown, extension set port 135, tubing 137 and luer 138 may be adapted to couple with the vacutainer during use.

[0152] The extended configuration of the slider 170 for use in a multiple-catheter length device can have additional elements and features to support alignment, displacement, and fluid coupling with the vacutainer during use. FIGS. 21A, 21B and 21C show examples of a movable seal 160 and associated configurations with slider 170 for use with a multiplecatheter length device 200. Accordingly, the length of the slider, cannula, handle, and slider slot may contribute to the capacity of a device to accommodate a single catheter length or multiple catheter lengths. FIGS. 21 A, 2 IB and 21 C highlight the extended length of the seal to accommodate coupling with an extended length of a slider 170. The slider seal 160 comprises a plurality of axial seal features 162 including the proximal axial seal feature 162a and distal axial seal feature 162b. In some examples, the axial seal features positionedbetween the proximal and distal axial seal features may be a discontinuous toroid as they may extend around a portion of the seal circumference not including the seal flow path opening 163. The slider seal 160 is also shown with a plurality of ratchet feature openings along a length of the seal configured to accommodate slider teeth 167 extending therethrough. The extended flow path openings of both the slider seal 160 and the slider 170 allow for extended travel of the slider 170 with a maintained fluid communication to the extension set port, when advanced distally in the handle to accommodate multiple different catheter lengths in a single device.

[0153] FIG. 21B shows a side view of the slider seal 160 coupled with the slider 170. Here again, the seal flow path opening and the slider flow path opening are aligned with the axial seal feature 161 aligned with a perimeter of the slider flow path opening. Circumferential seal features 162 are arranged along a length of the seal 160 to support the slider alignment and positioning within the handle and the slider teeth 167 are shown extending through the ratchet feature openings 165 of the seal 160. each of the plurality of slider teeth 167 can be configured to correspond to a known catheter length in this multilength catheter configuration.

[0154] Referring to FIG. 21A, the seal flow path opening 163 has a length and perimeter configured to communicate with the slider flow path opening. The length of the seal 160 is long enough to provide an extended flow path opening 163 allowing a fluid communication in a deployed configuration when the flow path opening 163 is in communication with an extension set port (not shown) from the distal end to the proximal end of the flow path opening. Annular elements 162 are positioned along a length of the seal and configured to support alignment and seal of the slider 170 in the handle. The number of annular elements 162 may be one or more between a proximal annular element 162a to a distal annular element 162b. The extended seal 160 also provide for additional openings 165 configured to facilitate the ratchet teeth 167 of the slider 170 to extend therethrough. Axial seal feature 161 is also positioned around the perimeter of the flow path opening 162 and configured to seal the interior of the slider body and interior of the flow path including the cannula 120 and slider 170.

[0155] FIGS. 21B and 21C show the seal 160 coupled to the slider 170. This again is an example of a movable seal configuration where the annular elements 162 and axial element 161 maintain a seal inside the handle as well as provide support for the slider alignment and transition from a stowed configuration to a deployed configuration. Referring to FIG. 21C, an additional example of the seal 160 is provided with wiper-style seal features 166a, 166b, 166, and 161a. These wiper-style seal features may provide additional support for displacement ofthe slider in the handle. For example, the surface area contact between a wiper-style seal feature may facilitate transition of the slider from a proximal position to a distal position in the handle during use.

[0156] Sliders described herein having a flow path opening such as flow path opening 163 in FIG. 21C or flow path opening 156 in FIG. 11C may have a length from the distal end of the flow path opening to the proximal end of the flow path opening to accommodate a fluid coupling between the flow path opening and the extension port of a handle when the cannula is in a deployed configuration. The length of the flow path opening in the slider body can provide for a length of cannula deployment while maintaining a fluid coupling or fluid communication with the handle extension port for more than a single length of cannula deployment. For example, fluid communication or a flow path may be established when the distal end of a slider flow path opening is aligned with the handle extension port and the fluid communication is maintained through additional slider advancement as the slider flow path opening remains in alignment with the extension port along the length of the flow path opening. In some examples, the length of a slider flow path opening may be less than .1” to greater than 2” or any length therebetween. For example, the sliders illustrated in FIG. 1 IB to 1 ID may have a flow path opening 156 with a length of .15”, .16”, .17”, .18”, .19”, .20”, .21”, .22”, .23”, .24”, ,25”.26”, .27”. .28”, .29”, .30”, or more or less or any length therebetween. Other examples of sliders such as those illustrated in FIG. 2 IB and 21C may be configured to accommodate multiple lengths of catheter and the flow path opening 163 may have a length of 1”, 1.1”, 1.15”, 1.2”, 1.25”, 1.3”, 1.35”, 1.4”, 1.45”, 1.5”, 1.55”, 1.6”, 1.65”, 1.7”, 1.75”, 1.8”, 1.85”, 1.9”, 1.95”, 2” or more or less or any length therebetween.

[0157] In some examples, the length of the slider flow path opening may correspond to a deployment length of the cannula associated with an established flow path. For example, where the length of a slider body flow path is 1.5”, fluid communication or a flow path can be established and maintained through 1.5” of cannula deployment.

[0158] FIG. 22 shows a multiple length slider 170 positioned in the proximal end of the handle 205 in the stowed position. This detailed view is shown with the seal removed to highlight features of the slider 170 in position within the handle. FIG. 23, provides the additional detail of the slider 170 with the seal. Referring to FIG. 22, the ratchet system features of the slider are shown as they may be configured to engage the ratchet system of the blood collection device handle. As previously described, alignment features such as 172 can be configured to contact an interior surface of the handle and support proper position and alignment of the slider 170 within the handle 205. In this view, the arrangement of the ratchet teeth 167 can be seen. The position of teeth 167 may correspond to known lengths ofdeployment for the cannula 120 as may be associated with a catheter length. For example, the distal most teeth may indicate initial deployment of the cannula 120 from the distal end of the device 200 for a catheter length of 1.00” with proximal teeth associated with longer catheters as the proximal teeth would contact the ratchet system of the handle 205 when the slider 170 and cannula are advanced to an extended deployment length to accommodate longer catheter lengths. The flow path opening 195 is visible here having a length from a proximal end to a distal end of the flow path opening 195. In some examples, the slider is in fluid communication with the vacutainer assembly when the slow path opening 195 is in communication with the extension set port (not shown). Accordingly, the communication between the flow path opening 195 and the extension set port allows for a consistent fluid communication along the entire length of the flow path opening 195. For example, the length of the flow path opening 195 may extend along a length of the slider body correspondingly to accommodate to different catheter lengths with a single device. In FIG. 22, the slider 170 has channels 168 that can be configured to accept a portion of annular elements of the slider seal 160. These channels 168 can be configured to support communication between the slider seal 160 and the slider 170 to prevent the slider seal from becoming dislodged or displaced from the slider 170.

[0159] FIG. 23 shows a perspective view of the slider 170 shown in FIG. 22 with the slider seal 160 coupled thereto and the blood collection device handle 205 translucent to highlight the arrangement of the slider seal features 160 and 162. The slider ratchet teeth 167 can also be seen extending through the seal 160. The slider 170 has a slider arm 171 extending from the plunger to the slider tab 173 that can be engaged by a user to advance the slider distally within the handle 205.

[0160] In some examples, the blood collecting devices described herein may provide flow path from a blood vessel, through the cannula, through the slider body, through an extension port on the handle, and on to a vacutainer. As illustrated, the sliders (e.g., slider bodies) described herein may have an opening larger than the aperture or opening at the extension port of the handle. For example, in FIG. 23, the opening 195 may have a length to allow for fluid communication and creation of the flow path for multiple catheter lengths as the fluid communication is maintained between the slider body opening and the extension port. In some examples, the flow path can preferentially be directed through the extension port and tube to the vacutainer based on a pressure differential (e.g., lower pressure) provided by the vacutainer. For example, although a slide body opening may be larger than an extension port aperture, the seal of the slider to the handle interior or tube seal can prevent blood flowing anywhere other than the flow path.

[0161] FIG. 24 shows a cross-section side elevation view of a blood collection device 200 configured for multiple-catheter length use with the slider 170 advanced from the proximal position to the distal portion of the handle 205 and engaged with the ratchet system 250. The cross-section view highlights an example of a flow path through the slider plunger. The cannula 120 is extending distally from the slider 170 and through the male luer 125. The proximal end of the cannula is in communication with the slider interior and slider flow path opening 195. In this example, the slider 170 has been advanced to contact the ratchet system 250 at least with the first distal teeth 167. Again, the distal advancement of the slider 170 deploys the cannula 120 and the ratchet system 250 can communicate with the slider teeth 167 to indicate a length of deployment that can help identify the length of cannula deployed.

[0162] FIG. 25A and 25B show additional examples of the blood collection device 200 from FIG. 24 with the slider 170 advanced yet further distally within the handle. Notably FIG. 25 A shows the slider 170 advanced more distal relative to FIG. 24, and FIG. 25B shows the slider 170 in the distal most position and the distal end of the slider is in communication with (e.g., docked) to the proximal end of the male luer 125. Referring to FIG. 25 A, the distal slider tooth 163a is contacting the proximal end of the ratchet system 250. Then, in FIG. 25B, the distal slider tooth 167a is no longer in communication with the ratchet system 250 as it has been advanced distally beyond the ratchet system 250 allowing proximal teeth 167 to be in contact with the ratchet system 250.

[0163] FIGS. 26A to 26C provide additional details of the slider and handle arrangement as described in FIG. 21 A to 21C. Here, the entire device 200 is shown in FIG. 26A to illustrate the slider 170 in the proximal and stowed position in the handle 205. The slider teeth 167 are proximal to the ratchet system 250 and the flow path opening 195 is not in communication with the extension set port 135. Accordingly, this may be the ready-to-use configuration (e.g., stowed configuration) as the cannula 120 is entirely within the device 200. FIG. 26B and 26C highlight details of the slider 170 with the proximal section of device 200 from FIG. 26A showing the slider 170 and flow path opening 195 sealed against the interior of the handle 205. Similarly, FIG. 26C removed the handle to show the slider 170 and movable slider seal 160 with wiper-style seal features 166. The slider arm 173 is configured to extend through the handle and may be adapted to open a segment or portion of the slider slot seal (not shown).

[0164] The movable seal configuration of devices (e.g., device 100 and device 100) may be used by advancing the slider from a proximal position in the handle to a distal position such that the cannula extending from the slider is deployed into a vessel. For example, the slider distal advancement can advance the distal end of a cannula beyond a coupled catheterassembly and into the vessel to establish a flow of blood from the vessel, through the cannula, through the slider, and into a vacutainer assembly in communication with the device.

[0165] FIGs. 27 to 37 illustrate examples of a sequence for the devices described herein during use. These figures highlight the position of the slider and arrangement of the different components as the slider is advanced for a single catheter length device or a multiple catheter length device configuration.

[0166] FIG. 27 shows an example of a blood collection device 200 adapted for use with different catheter lengths for a single device 200. In this perspective view, the slider 170 is advanced such that the cannula 120 is extending from the distal end of a 2.30” catheter 400. In this position, the slider 170 is advanced to a distal most position. The vacutainer assembly 415 would be in fluid communication with the slider 170 as the flow path opening 195 would be in communication with the extension set port allowing for a completed flow path as the length 405 of the cannula beyond the catheter would be within the vessel to establish a blood flow.

[0167] FIG. 28 is a cross-section view of the device in FIG. 27 highlight the arrangement of the flow path as established by the distal positioning of the slider 170 in the handle 205. In this configuration, the slider 170 is distally advanced to be in fluid communication with the extension set and vacutainer assembly. In this cross-section view, the distal end of the slider can be seen in communication with the proximal end of the slider. The flow path is completed including the cannula 120 extending beyond catheter 400 and into a vessel such that fluid can flow from the vessel through the cannula and through the slider into the vacutainer assembly. In this distal most position, the slider flow path opening 195 is in communication with the extension set port at a proximal end of the flow path opening.

[0168] FIG. 29 and 30 shows another example of the blood collection device from figure 27 used with a 1.75” catheter 401 and the slider 170 is positioned proximal relative to the blood collection device 200 example shown in FIGS. 27 and 28, while maintaining fluid communication with the extension set port 135 and vacutainer assembly 415. The length 410b shows additional room for distal advancement of the slider 170. Yet, the flow path opening 195 is still in fluid communication with the extension set port 135 now between the proximal and distal ends of the flow path opening 195. The deployed cannula length 420 may be adaptable for a catheter length. For example, it may be longer or shorter as needed and controlled by positioning of the slider 170. Also shown is the slider slot seal 215. Referring to FIG. 30 the cross section of FIG. 29 is shown with the slide plunger continuing to maintain fluid communication with the extension port with yet a smaller catheter length.

[0169] FIG. 31 to FIG. 37 provide further examples of different distal advancement and positioning of a slider 170 within the blood collection device 200 including examples of different distances remaining distal of the slider 170 for continued advancement. The length of the cannula 120 extending beyond the catheter shown in these figures may be adaptable. For example, the length of the cannula deployed in each example may be extended or retracted as needed to address occlusions, obstructions, or vessel tortuosity and establish a flow through the flow path including the cannula, slider, extension set port and vacutainer assembly. Referring to FIG. 31, the cross-section view shows an example of the slider position adapted to accommodate a 1.50” catheter 402. Referring to FIG. 32 the device 200 is shown in an arrangement to accommodate a 1.30” catheter 403. Referring to FIG. 33 shows the cross-section view of the device in FIG. 32 and highlights the fluid communication relationship between the flow path opening 195 and the extension set port 135 as the extension set port 135 is in communication with the flow path opening 195 closer to the distal end of the flow path opening 195. Referring to FIG. 34, the device 200 is now coupled with a 1.00” catheter 404. Here, the cannula extends beyond the catheter with deployed length 120d that may be increased as remaining length 410e can accommodate additional distal advancement of the slider 170. For example, with a shorter catheter length, the multiple catheter length device configuration may be capable of deploying the cannula further beyond the catheter distal tip, as needed during use. Referring to FIG. 35 the cross section of the blood collection device in FIG. 34 is shown with notable position of the extension set port 135 in communication with the distal end of the flow path opening 195. For example, if the slider 170 were retracted proximally from this position, the flow path would not longer be continuous and the flow path opening 195 would be sealed against the interior of the handle 205.

[0170] FIG. 36 and 37 show the blood collection device 200 of FIGs. 27 to 35 with the slider 170 in the proximal most position and stowed. For example, in a ready -to-use configuration. Here, the flow path opening 195 of the slider 170 is not in fluid communication with the extension set port 135 and the flow path is not established as the flow path opening is sealed against the interior of the blood collection device handle. For example, the lumen including the cannula 120, slider 170, and extension port 135 to vacutainer assembly 415 is discontinuous. Referring to FIG. 37 the ratchet system 250 is visible and disengaged from the slider 170.

[0171] In some examples, the blood collection devices described herein may comprise a tube seal. Compared to configurations with a movable seal coupled to the slider, a tube seal may be in a static position within the handle and provide seal of the flow path and interior ofthe handle without moving. For example, the slider may move through the tube seal or relative to the tube seal while the tube seal remains in position within the handle.

[0172] FIG. 38 shows a side elevation view of a blood collection device 500 with a tube seal configuration where the slider 506 is now adapted to move from the proximal end of the blood collection device 500 to the distal end or a distal position with the tube seal 510 inside of the blood collection device handle 505 maintained in a static position. The device 500 can comprise a male luer 520 having a male luer protrusion 521 at the distal end of the handle 505. As illustrated in FIG. 38, the tube seal 510 extends through the interior of the handle 505 from a proximal end towards a distal end of the handle and / or proximal end of the male luer 520. The slider 506 is shown here in the proximal position in a stowed or ready-to-use configuration. The vacutainer assembly including the vacutainer 535, luer 530, tubing 516 are in communication with the extension set port 515 of the handle 505. The cannula 525 extends through the center of the tube seal and through the male luer 520 including the male luer protrusion 521.

[0173] In some examples, devices described herein having a static positioned tube seal may be configured for use with a single catheter length or configured for use with many catheter lengths in a single device.

[0174] FIG. 39 shows a cross section of a blood collection device 500 of FIG. 38 with the slider 506 in a proximal / stowed position in the handle 505. The cannula 525 is shown extending through a central axis of the device 500 from the slider 506 through the interior of the tube seal 510 and through the male luer protrusion in a ready-to-use configuration. The cross section reveals the tube seal 510 forming the interior of the device. The slider 506 can have an exterior surface in contact with the interior surface of the tube seal 510. The tube seal 510 and slider 506 can be configured to facilitate movement of the slider 506 within the handle 505 while the tube seal 510 remains in place. In FIG. 39, the tube seal 510 is shown extending to the distal end of the handle and may contact an interior surface of the handle distal end or may be configured to contact the proximal end of the male luer 520. Also shown by this cross-section view is the flow path opening or interior of the slider 506a. In the proximal position (as shown), the flow path opening 506a may not be in communication with the extension set port.

[0175] The male luer 520 can have a disengagement mechanism configured to separate a catheter hub from being docked to the device 500 in use. The disengagement button 522 can be depressed to lift the distal end of the disengagement mechanism and unlock the catheter coupled to the device. For example, a catheter hub may be docked and in communication with the device with one or more locking features engaged to disengagement feature 523 thatmay be released when the disengagement button 522 is actuated. The male luer interior 520a may be configured to accommodate a catheter hub or portion of a catheter when the device 500 is in use. Additionally, and as described herein, male luers (e.g., male luer 500) may be coupled to the handle 505 and can be locked to the handle with coupling features 520b configured to lock the male luer to the handle 505.

[0176] FIG. 40 shows a side elevation detailed view of the slider 506. Considering devices with a tube seal configuration, the slider arm 580 can have a proximal side 508a with an angle or other configuration adapted to open a slit in the tube seal when advanced distally through the handle. The slider tab 507 can have one or more engagement features 507a to support user contact when the slider is advanced and manipulated during use. The flow path opening 506a now has a raised perimeter 509a configured to contact an interior surface of the tube seal in the handle. The raised perimeter 509a can be adapted to seal the flow path opening 506a against the tube seal to maintain a seal of the flow path including the cannula lumen and interior of the slider 506.

[0177] In some examples, the slider 506 has alignment features 509b and may have additional alignment features arranged on the exterior of the slider 506 to support alignment and position of the slider in the tube seal as it is advanced or retracted during use. Alignment features 509b may also support the axial alignment of the cannula 525 extending from the distal end of the slider 506.

[0178] The tube seal may provide a complete seal of the interior of the handle taking the place of the handle interior and slider slot seal of examples as illustrated in FIG. 18C. Accordingly, the tube seal may also be configured to further reduce the interior dimensions and add further support to prevent cannula buckling or slider misalignment.

[0179] FIG. 41 shows a distal perspective view of the tube seal 510 without additional device elements. Notably, the slider has been removed, but an example of the tube seal slit raised at segment 510d remains where the slide arm would pass through. The tube seal slit 510c can remain sealed from the proximal side of the slide arm to the proximal end of the tube seal 510b and on the distal side of the slide arm extending through the tube seal slit. In this example, the proximal end of the tube seal 510 includes an opening 513 configured to retain and accommodate the slider in the proximal (e.g., stowed or ready-to-use) configuration and maintaining a seal along the remainder of the distal length of the tube seal slit 510c. The tube seal, similar to the slider slot seal can be adapted to maintain and support a sterile environment for the interior of the devices described herein.

[0180] In some examples, distal ends of the tube seal 510 may comprise additional features configured to accommodate the distal end of the handle, male luer, extension setport, etc. As illustrated in FIG. 41, the tube seal includes an extension port opening 514 configured to align with the extension set port of the handle. The extension port opening 514 of the tube seal may not be required with a tube seal configuration to allow for a flow of blood from a vessel when the cannula is deployed. For example, a completed flow path may now include the cannula extending into a vessel, the slider interior, extension port opening, extension port, and tubing to vacutainer.

[0181] FIG. 42 shows a side elevation view of the slider 506 in the tube seal 510. Here, the slider 506 is positioned near a distal end 510a of the tube seal with the cannula extending through a center of the tube seal. Although the handle and remaining device components are not shown, the length of the tube seal 510 proximal to the slider 506 show the slider 506 in a distal position. The slider arm 508 is extending through the tube seal slit 510c with the proximal side of the slider arm 508a lifting or opening the tube seal slit 510c.

[0182] In some examples, the slider can be configured to slide through the tube seal from a proximal end to a distal end. For example, the slider may be configured to transition from a proximal position to a distal position in the tube seal during use and corresponding to the deployment length needed for the cannula based on the catheter length.

[0183] FIGS. 43 A, 43B and 43C show cross sectional views of a tube seal 510 at various positions along the length of the tube seal 510. Referring to FIG. 43 A, the cross section is through the tube seal 510 at the extension port opening 514 and happens to align with the opening 510d as if the slider were extending therethrough. In FIG. 43B, the cross section is taken further distal in the tube seal compared to FIG. 43 A with the tube seal slit 512 shown. As described herein, the tube seal slit may be angled to support retention of the cannula and slider within the tube seal. In some examples, the tube seal slit may be a sealable slit configured to open only when motivated by a slider arm extending therethrough while maintaining a seal along the remaining length of the slit both distal to and proximal to the slider arm extending therethrough. In FIG. 43C, yet another cross section at a proximal position of the tube seal 510 is shown with the tube seal slit 510c still visible. The extension set opening 514 is faintly shown for relative position and arrangement to the tube seal slit 510c. For example, the tube seal slit 510c maybe positioned along a length of the tube seal 510 along the top of the seal, while the extension set opening 514 may be at a different position on the perimeter of the tube seal.

[0184] FIG. 44 a distal perspective view of the slider 506 in the tube seal 510 and the tube seal in the handle 505. This cross section reveals the interior of the slider 506a as an example of the flow path through the slider 506. The slider arm 508 is extending through the tube seal 510 and through the slider slot of the handle. Alignment features 509b aresupporting the alignment of the slider 506 in the tube seal and the raised perimeter 509a is in contact with the tube seal interior. It can be appreciated from this view that the slider 506 is adapted to move through the tube seal 510 such that the tube seal does not move when the slider moves therethrough.

[0185] FIG. 45 shows a detailed cross section of a perspective view at the distal end of the handle and proximal end of the male luer. In this view, the slider 506 is in the distal most position and in communication with the proximal end of the male luer 520. The cannula 525 is extending through the center of the male luer 520 with a potential flow path established including the cannula 525, slider interior 506a, extension set opening 514 through the tube seal 510 at the extension set port 515. The flow path continues through the extension set port lumen 515b and on to the vacutainer assembly (not shown). Additional details of the engagement elements 505a are shown at the distal end of the handle. These engagement features may be configured to provide improved engagement and manipulation for a user during use.

[0186] In some examples, devices described herein are configured to couple with a catheter. For example, the male luer or handle distal end described herein may be configured to couple with a catheter, catheter hub, catheter assembly, etc. In some examples, the male luer may be adapted to couple with the catheter assembly via an engagement mechanism including features of the catheter hub and corresponding features configured to receive the catheter hub in the male luer. In some examples, the male luer may be adapted to facilitate a friction fit with a catheter (e.g., catheter hub). In some examples, the catheter hub may be adapted to couple with a male luer of a device described herein.

[0187] Referring still to FIG. 45, of note is the interior geometry of the slider at 506a. The proximal end of the cannula 525a is positioned at a distal end of the flow path through the slider interior 506a. and then to the vacutainer via the extension port 515. In any example described herein, the interior geometry of the slider can be adapted to reduce the amount (e.g., severity) of deflection of blood flowing therethrough. For example, in IG. 45, the interior geometry of the slider 506 is a generally curved flow path that provides a gentle or gradual change in direction for blood flowing from the canula 525 to the extension port 515. This interior geometry for the flow path through the slider can be adapted to reduce insult to cells traveling in the blood flow by reducing the impact of the cells on interior surfaces of flow path components (e.g., cannula, slider / slider plunger / extension port, etc.). Accordingly, the quality of cells in the drawn sample will improve due to a reduction in hemolysis.

[0188] FIG. 46 shows a side elevation view of a catheter assembly configured to couple with a blood collection device described herein. The catheter assembly 550 may have acatheter hub 555 with a proximal end 506 and a catheter 570 extending from a distal end of the catheter hub. Stabilizing features 565 can provide stability and placement support for the catheter assembly when positioned in the patient. In some examples, the catheter hub may comprise an extension set including an extension port 559 coupled to tubing 575 that extends from the catheter hub extension port 559 to a luer 585. A clamp 580 may be provided to control a flow through the catheter assembly extension set.

[0189] Additional features of the catheter hub may support engagement with a male luer of a device described herein. For example, as shown in FIG. 46, the catheter hub 555 may include one or more alignment features 557 configured to align the catheter assembly and blood collection device when coupling during use. A locking feature 556 is also positioned on the catheter hub 555 and can be configured to support a connection with a male luer of a device described herein. Catheter hub tab 558 may also be positioned on the catheter hub 555 and can be configured to support manipulation of the catheter during use. This tab 558 may also be configured to engage tape or other element configured to retain the catheter in position when placed and inserted into a patient’s vasculature.

[0190] As illustrated in FIG. 46, the catheter distal tip 571 may be adapted for use with an intravascular access device during placement of the catheter assembly 550. For example, the catheter distal tip 571 may have one or more features such as a notch configured to couple with a distal end of a guide element that can facilitate the insertion and placement of the catheter assembly 550 during insertion and placement int eh patient’s vasculature.

[0191] In some examples, the catheter hub proximal end 560 may be configured to receive the protrusion from a male luer described herein. For example, the distal end of the catheter hub 560 may comprise a seal or septum configured to allow for an intravascular access device (e.g., needle, guidewire, catheter, etc. to pass through the seal and through the catheter 570. The seal may also be adapted to allow for passage of the male luer protrusions described herein to pass through the and into the catheter hub for blood collection, administration of medications, fluids, or interventional procedures without having to use the extension set of the catheter hub.

[0192] FIG. 47 to FIG. 49 show a sequence of the device 500 as it interacts and engages the catheter assembly 550. Referring to FIG. 47, the device 500 is aligned with the catheter assembly 550 such that the male luer 520 and male luer protrusion 521 are axially aligned with the catheter hub 550 with the male luer protrusion 560 approaching the seal at the catheter hub proximal end 560. The cannula 525 is still stowed within the device 500 through the center of the tube seal 510 as the device is ready to engage the catheter assembly. FIG. 48 now shows the device 500 coupled to the catheter assembly 550. The catheter hub 555 iscoupled with the male luer 520 with the disengagement mechanism 590 locked to the corresponding features of the catheter hub 555. The cross-section view in FIG. 49 shows the coupled device of FIG. 48 with the male luer protrusion 521 in the catheter hub interior and contacting the distal interior surface 555a. In some examples the male luer 521 may be configured to close the catheter assembly extension port when inserted. In some examples, the male luer protrusion may be positionable inside the catheter hub without closing the catheter hub extension set 559.

[0193] FIG. 50 shows a cross section of the blood collection device 500 from FIGS. 47 to 49 with the slider 506 in a distally advanced position within the handle 505 and tube seal 510. The cannula 525 is now deployed and extending beyond catheter 570 to establish a flow path including the cannula 525, slider 506, slider flow pat opening 506a, tube seal extension set opening 514, extension set interior opening 515a to the tubing 516 and vacutainer (not show).

[0194] Notably, the slider 506 is not advanced to the distal most position as the distal end of the slider is not in communication with the proximal end of the male luer 520. In some examples, the devices described herein may be configured to be used with a single catheter length. However, distal advancement of a slider may provide for deployment of the cannula beyond a catheter distal end with a remaining space or length of additional distal advancement. For example, the slider of a single catheter length device may be advanced and the cannula deployed. If blood flow is not initially established in this position, the slider may be advanced yet further still to overcome an occlusion or obstruction (e.g., vascular valve) even with a single-length configuration.

[0195] FIGS. 51 to 53B show cross section detailed views of engagement examples between a male luer and catheter assembly 550.Referring to FIG. 51, the distal portion of the handle 505 including the male luer 520 and catheter assembly 550 are shown in a cross section of a side view.

[0196] In some examples, the male luer 520 has disengagement mechanism 590 including the disengagement button 595, disengagement distal end 600, opening 556 and internal disengagement feature with proximal side 595a and distal sider 595b. The catheter assembly 555 is coupled to the male luer 520 with the catheter hub 555 inside the male luer and the male luer protrusion 521 extending into the catheter hub interior. The catheter hub proximal surface 555b is in contact with the disengagement feature 595a. The button 5959 has not been depressed and accordingly the catheter hub 555 is locked or docket to the male luer 520. Locking feature 556 is positioned in the opening of the male luer disengagement mechanism 590. The slider 506 is shown in a distal position within the tube seal 510 and the cannula is deployed through the catheter assembly 555.

[0197] FIG. 52 shows similar detail of FIG. 51 including the seal 561 (e.g., catheter hub valve) in the distal position of the catheter hub 555 with the male luer protrusion 521 extending therethrough. The tube seal 510 can be seen extending all the way to the distal end of the handle interior. The cannula is still shown though the device 500 but not extending beyond the male luer 520 as the slider may be in a proximal position and ready -to-use configuration.

[0198] In this view, the male luer is shown with an example of a protrusion 521 having a generally cylindrical body extending from the blood draw device to the distal end positioned adjacent to the catheter lumen proximal end 570c. In this configuration, the positioning of the protrusion distal end proximal and adjacent to the catheter lumen proximal end reduces the distance between the protrusion and the catheter lumen, thereby reducing or eliminating any unsupported distance the cannula may be required to travel when being deployed from the blood draw device through the catheter lumen.

[0199] FIGS. 53A and 53B show a sequence of disengagement of the catheter assembly 550 from the device 500 (e.g., male luer 520). The catheter assembly is coupled in FIG. 53A, then the disengagement button 595 is depressed causing the distal end 600 of the disengagement mechanism to lift and release the catheter hub locking feature 556. In some examples, the catheter assembly may be pulled away from the device. In some examples, and illustrated in FIG. 53B, the interior disengagement feature proximal surface 595a can be adapted to bias the catheter hub 555 away from the device when the button 595 is depressed. For example, the proximal surface of the interior disengagement feature 595a may be angled such that when the button is depressed, the angle is adapted to push or force the catheter hub away from an engaged configuration with the device. In this example, the disengagement button 595 can unlock and displace the catheter hub in a single action.

[0200] Referring to FIG. 53B, arrows 700-703 indicate an example of a disengagement sequence for separating a catheter hub from a blood draw device. Here, the disengagement button 595 is depressed causing the disengagement mechanism distal end 600 to lift above the catheter hub locking feature 556 while biasing the catheter hub 555 distally away from the blood draw device male luer 520 (e.g., coupling mechanism). In this exemplary sequence, arrow 700 shows a step of depressing the disengagement button 595. Then the proximal end of the catheter hub 555 is contacted by the interior disengagement feature 595a. Contacting the proximal end of the catheter provides a distally biasing force to advance the catheter hub away from the male luer 520. Depressing the disengagement button also causes the distal end of the disengagement feature to lift away from catheter hub exterior allowing the catheter hub locking feature to be free of the interferences of the disengagement mechanism, as shown atarrow 701. Then, advancing the catheter hub 555 as shown at arrow 702 and withdrawing or otherwise separating the male luer as indicated in arrow 703 support the disengagement of the blood draw device from the catheter hub, which can remain in the patient.

[0201] In some examples, the interior disengagement feature 595a can be configured to complement the circular perimeter of the catheter hub proximal end allowing for increased contact between the interior disengagement feature 595a and the catheter hub 555 when the disengagement button 595 is depressed. For example, the interior disengagement feature 595a may comprise a curve geometry complementary to the arc of the circumference of the catheter hub proximal end such that when the button 595 is depressed, the interior disengagement feature 595a is substantially in communication and contacting the catheter hub proximal end.

[0202] In some examples, the catheter hub lock 556 may extend out from the catheter hub to a height of less than .015” to more than .030” to support the interference engagement with the luer when it is docked or locked there to. For example, the catheter hub lock 556 may have a height of .022” on the distal face contacting or otherwise engaged with the disengagement feature of the male luer. Accordingly, depression of the disengagement button 595 can cause the distal end 600 to lift away from the catheter at least a distance larger than the catheter hub lock 556 allowing the catheter hub to be distally advanced or disengaged from the blood draw device.

[0203] In any example described herein, a seal or valve (e.g., seal 561) can be a blood control valve positioned in a catheter hub to maintain a fluid seal within the catheter assembly. The devices described herein can be adapted to engage and draw blood while maintaining a coaxial alignment of the cannula, plunger (e.g., slider / slider plunger) and protrusion of the coupling mechanism (e.g., male lure). Accessing the catheter, with the devices described herein, from the proximal end provides a direct flow path through the cannula to the plunger and then to the vacutainer through the extension port on the handle when the slider is advanced to be in fluid communication with the extension set port on the handle. This simplified and direct flow path can reduce or eliminate damage to cells flowing through the flow path as there are fewer turns, angles, or other features of the flow path (e g., including the cannula, plunger, extension set to vacutainer). By reducing the need for blood flow to change direction or traverse angles in the flow path, hemolysis is reduced or eliminated thereby preserving the quality of cells in the sample drawn by the device. For example, when blood flows through a path including dramatic angles and / or several directional changes, the cells may become damaged on contact with interior surface of the flow path. The devices described herein, including the capacity to couple with the proximalend of the catheter hub, provide a more direct flow path with fewer turns or angles compared to devices that require access to the catheter via an extension port on the catheter hub. Referring to FIG. 54, the axial alignment of the male protrusion, cannula, catheter lumen, and plunger provide a direct path for blood flow through the cannula lumen to the plunger where it is then directed to the vacutainer through the tubing and extension port on the handle.

[0204] The devices described herein, including devices with movable seals or nonmoving tube seal configurations may be used with a single predetermined catheter length or with many different catheter lengths using a single device. As described herein, variations in the length of the handle, cannula, slider, ratchet system, seals, tube seals, male luer, etc. can support for the variation between a single catheter length device or a device adapted to be used with multiple catheter lengths. FIGS. 54 to FIG. 70 show examples of the device in use for both the single length configuration and multiple catheter length configurations of a device having a tube seal.

[0205] FIG. 54 and 55 show an example of a device 500 adapted for use with a single catheter length as it is approaching a catheter assembly 550. Referring to FIG. 54, the device can be configured to work with predetermined catheter length 570a. The slider 506 is in the stowed or ready -to-use configuration in the proximal end of the handle 505 and tube seal 510. The cross section reveals the cannula 525 stowed within the device as the male luer is axially aligned with the catheter hub 555. Catheter hub seal 560 can be seen in FIG. 55 ready to receive the male luer protrusion 521 therethrough.

[0206] FIG. 56 and 57 show the device 500 of FIG. 54 now coupled to the catheter assembly 550. The slider 506 is still in the proximal position ready to be deployed and deploy the cannula 525 through the catheter assembly 550. The cross section shown in FIG. 57 reveals the discontinuous flow path as the slider flow path opening is not in communication with the extension port. The view in FIG. 56 also illustrates and example of the position of the male luer within the catheter hub when the blood draw device is engaged or coupled with the catheter as it may be during use. In some examples, described herein, the male luer may extend past the extension port on the catheter hub. Accordingly, the devices described herein can be configured to engage the catheter assembly (e.g., catheter hub) from the proximal end of the catheter and support a blood draw through the catheter hub rather than requiring additional configuration for vascular access through the extension port of the catheter. In some examples, the capacity for the device to perform a blood draw in this manner can reduce or prevent hemolysis by reducing the tortuosity of a flow path for the blood to travel from the blood vessel to the vacutainer.

[0207] FIGS. 58 and 59 show the device 500 of FIG. 54 now with the slider 506 advanced distally into the deployed configuration whereby the cannula 525 is deployed and extending beyond the distal end of catheter 570. The slider 506 has been advanced adjacent to the extension port 515 with the majority of the tube seal 510 now extending proximal from the slider 506. For example, the slider 506 has been advanced distally through the tube seal 510 while the tube seal has remained in a static position inside the device handle 505. The cross section shown by FIG. 58 illustrates the completed flow path including the cannula 525 extended beyond the catheter 570 and the slider interior and flow path opening 506a in fluid communication with the tube seal extension opening 514 then the extension port 515 to the tubing 516 and vacutainer assembly.

[0208] FIG. 60 shows additional advancement capacity of the single-catheter length configuration for the device 500. This additional advancement is an incremental transition of the slider 506 after it has been distally advanced. For example, when the cannula 525 is deployed into the vessel and the slider 506 is correspondingly in the distal portion of the tube seal 510, an optional additional advancement is possible to overcome any obstruction or occlusion contacted by the distal end of the cannula 525 when deployed. In some examples, vascular valves may otherwise prevent the cannula 525 from restabling a flow through the device 500. The additional advancement feature and configuration can allow deployment of the cannula 525 beyond the obstruction even after the distal end of the cannula has been extended beyond the catheter 570. In some examples, the ratchet system may have a first deployed setting and a second obstruction clearance setting for the added advancement even in a single-catheter length device configuration.

[0209] FIGS. 61 to 70 illustrate a sequence of different positions for a device with a tube seal 510 and configured to be used with multiple catheter lengths. As described herein, the slider 606 is now extended with a flow path opening 606a having a distal end 606b and a proximal end 606c. The length of the flow path opening 606a can be adapted to maintain fluid communication with a tube seal extension set opening and extension port with different catheter lengths. As shown in FIG. 61, the device 600 is coupled to a catheter assembly having a 1.00” catheter 625. The flow path is established as the slider 606 is advanced and the cannula 625 extends beyond the catheter 625. The extension port 615 is in fluid communication with the distal end of the flow path opening 606b. For example, the shortest length of catheter accommodated by a device may be associated with the length of the slider flow path opening. FIG. 62 shows the device from FIG. 61 from a proximal perspective with the slider positioned between the distal end and proximal end of the handle 605. The tube seal 610 extends through the interior of the handle and sealing the interior of the handle from theflow of blood through the flow path that is established with the vacutainer assembly. Similarly, FIGS. 63 and 64 show the device 600 of FIG. 61 now coupled to a 1.30” catheter. In the cross-section view in FIG. 63, the slider is advanced distally relative to the example shown in FIG. 61. The flow path is maintained as the flow path opening 606a is still in communication with the extension set 615. Now, the extension port is aligned with the slider flow path opening 606a between the distal and proximal ends of the flow path opening and shows the capacity for additional distal advancement as well as additional proximal retraction that would maintain the flow path.

[0210] FIGS. 65 and 67 show the multiple catheter length device coupled to a 1.50” catheter. The cross-section view shown in FIG. 65 highlights the advanced slider 606 with the fluid communication to the extension port 615 now positioned near a middle section of the flow path opening 606a. The cannula extends beyond the catheter distal end and there is capacity for additional distal advancement or proximal retraction of the slider and cannula as needed to promote, establish, and maintain the flow path for blood from the vessel. Similarly, FIG. 68 shows the device of FIGS. 61 to 66 now in a position configured to accommodate a 1.75” catheter. Notably, the slider 606 is advanced yet further from FIGS. 65 and 66 with the fluid communication between the slider flow path opening 606a and the extension port 615 maintained although the extension port 615 is now aligned with the proximal side of the flow path opening 606a.

[0211] Finally, FIGS. 69 and 70 show the device coupled to a 2.30” catheter and the slider 606 advanced to a distal most position. The extension set port 615 is now in fluid communication with the flow path and flow path opening 606a near the proximal end of the opening 606a. The cross section illustrated in FIG. 69 shows the distal end of the slider 606 in communication with the distal end of the handle 605 and proximal end of the male luer 520.

[0212] In some examples, the handle may provide additional features for indication of the deployment position and length of the cannula as the slider is advanced along the handle. An example is shown in FIG. 71 where a tactile feature such as a ratchet system 1008 is provided on the exterior surface of the handle 1005. The slider 1006 is shown with an extension 1007 extending towards the handle exterior surface from the upper portion of the slider 1009. The slider extension 1007 can be configured to contact or engage the ratchet system 1008 to provide a tactile indication of the slider position on the handle 1005 and the corresponding position or alignment of the slider body opening (e.g., 163 as illustrated in FIGS. 21A-21C) relative to the handle extension port 1015. In this example, the user can advance the slider and when the extension 1007 contacts the ratchet system 1008, this can indicate that the sliderbody opening is now aligned with the extension port and a flow-path has been established through the cannula and to the vacutainer. In any example, the tactile positioning and alignment features of the handle can provide an indication of the slider position relative to the extension port. For example, where a handle comprises an interior tube seal, the slider may still engage the positioning features on the exterior of the handle to indicate when the slider body opening is in fluid communication with the handle. Some other illustrative examples of positioning features may include active features such as the ratchet system and active engagement with the slider. Additionally, or alternatively, positioning features may provide a passive tactile indication of the slider body alignment with the extension port by markers or other indicators on the handle exterior to indicate a relative position of the slider by to the handle extension port.

[0213] The devices described herein can improve blood collection procedures including establishing blood flow for collection or re-establishing blood flow through a catheter that is blocked or otherwise occluded. The devices may be configured for use with a single catheter length or use with multiple catheter lengths. The catheters may be a standard catheter or may be catheters described herein adapted to couple to the devices described herein. For example, the catheters may be adapted to couple to a male luer or distal end of devices described herein during use. The improved coupling and function of the blood collection devices can reduce injury to a patient and improve the collection of fluid samples through various extension sets and ports. The simplified devices described herein can provide for movable seal configurations or tube seal configurations with improved collection techniques for blood draws.

[0214] In still other alternative embodiments, an intravascular catheter and guide placement structure may be adapted and configured specifically for use with a blood collection device or method described herein. In one aspect, the catheter, the hub, or the lumen of an indwelling catheter may be modified for use with an embodiment of a guide element and a vascular access device. In still other embodiments, aspects of the guide element and the vascular access device may be adapted and configured for use with a vascular catheter described herein. In particular, a distal portion of the vascular access device may be adapted for ready coupling and uncoupling to a proximal aspect of the catheter hub, including passage through one or more valves or other structures based on specific configuration of the intravascular catheter. Still further, a portion of the catheter lumen may be adapted or modified or reshaped so as to accommodate one or both or a combination of a vascular access needle and guide element. In one particular aspect, the catheter lumen is modified to have a conformal shape configured for integral positioning and alignment with adistal portion of a guide element. In other aspects, the vascular access device will have a distal end adapted to open one or more or any closure structure in a proximal aspect of the catheter hub of the catheter to be delivered using the vascular access device. Additionally, or optionally, a proximal portion of the catheter hub may be adapted and configured for releasable engagement with either or both of the distal end of a blood collection device or a vascular access device. Releasable engagement includes, by way of example and not limitation, push to connect, twist to connect, friction fit, spring loaded sliding or twisting action, engagement of one or more alignment features or a coupling device that may releasable connect from any orientation between the catheter hub and the handle of the blood collection device or the vascular access device. In additional aspects, the blood collection device, intravascular catheter, catheter hub, vascular access device, guide element or needle of the vascular access device may include aspects, features, characteristics or combinations taken from any or all in any combination of the following commonly owned applications: International Application No. PCT7US2021 / 054046, entitled “Intravascular Catheter With Integrated Guide Structure,” filed October 7, 2021; International Application No. PCT / US2023 / 065556, entitled “Intravascular Catheter With Integrated Guide Structure,” filed on April 7, 2023; International Application No. PCT7US2023 / 074699, entitled Guide Element for Intravascular Access Device,” filed on September 20, 2023; U.S. Provisional Patent Application No. 63 / 387,688, entitled “Hypodermic Needles and Methods of Manufacture,” filed December 15, 2022; U.S. Provisional Patent Application No. 63 / 477,378, entitled “Intravascular Access Device,” filed December 27, 2022; U.S. Provisional Patent Application No. 63 / 482,901, entitled “Guide Element for Intravascular Access,” filed February 2, 2023, each of which is incorporated by reference herein in its entirety for all purposes.

[0215] It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein and may be used to achieve the benefits described herein.

[0216] The process parameters and sequence of steps described and / or illustrated herein are given by way of example only and can be varied as desired. For example, while the steps illustrated and / or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order illustrated or discussed. The various example methods described and / or illustrated herein may also omit one or more of the steps described or illustrated herein or include additional steps in addition to those disclosed.

[0217] When a feature or element is herein referred to as being "on" another feature or element, it can be directly on the other feature or element or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being "connected", "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being "directly connected", "directly attached" or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.

[0218] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and / or "comprising," when used in this specification, specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ".

[0219] Spatially relative terms, such as "under", "below", "lower", "over", "upper" and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as "under" or "beneath" other elements or features would then be oriented "over" the other elements or features. Thus, the exemplary term "under" can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms "upwardly", "downwardly", "vertical", "horizontal" and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

[0220] Although the terms “first” and “second” may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Thus, a first feature / element discussed below could be termed a second feature / element, and similarly, a second feature / element discussed below could be termed a first feature / element without departing from the teachings of the present invention.

[0221] Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0222] In general, any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and / or steps may alternatively be exclusive, and may be expressed as “consisting of’ or alternatively “consisting essentially of’ the various components, steps, sub-components or sub-steps.

[0223] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word "about" or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and / or position to indicate that the value and / or position described is within a reasonable expected range of values and / or positions. For example, a numeric value may have a value that is + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value "10" is disclosed, then "about 10" is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that "less than or equal to" the value, "greater than or equal to the value" and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value "X" is disclosed the "less than or equal to X" as well as "greater than or equal to X" (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, andranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0224] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.

[0225] The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

Claims

CLAIMSWhat is claimed is:

1. A blood collection device comprising:A handle having a proximal end, a distal end, an interior portion with an elongated slot providing access to the interior portion; a coupler on the handle distal end with a protrusion, the coupler shaped to engage an exterior portion of a catheter hub; an extension port positioned adjacent to the distal end of the handle having a first end in communication with the handle interior portion and a second end configured to couple to a vacutainer assembly; a slider having a body with a pair of alignment features on an exterior surface of the body and an arm extending from the body wherein the slider is disposed within the interior portion of the handle with the arm extending through and moveable relative to the elongated slot; a slider lumen extending from a distal end of the slider body to a flow path opening along a portion of a sidewall the slider body; a cannula having a proximal end and a distal end and a lumen extending from the distal end to the proximal end wherein the cannula lumen proximal end is coupled to the slider body so that the cannula lumen is in fluid communication with the flow path opening.

2. The device of claim 1, wherein the slider body, cannula, and coupler protrusion are axially aligned with a central axis of the handle.

3. The device of claim 1, wherein the coupler protrusion is adapted to open at least one valve in a proximal face of a catheter hub so that in use, the cannula can be extended through a catheter coupled to the catheter hub into a blood vessel.

4. The device of claim 3, wherein a length of slider movement along the elongated slot is configured to advance the cannula distally a first distance without creating a fluid pathway through an attached catheter and then further distally a second distance that creates a fluid pathway through the attached catheter.

5. The device of claim 1, wherein the coupler is configured to releasably engage a proximal end of the catheter hub.

6. The device of claim 5, wherein the releasable engagement is provided by axial movement of the device to a proximal face of the catheter hub.

7. The device of claim 5, wherein the releasable engagement is provided by rotational movement of the handle onto the catheter hub.

8. The device of claim 5, wherein the releasable engagement is provided by at least one deformable component, spring loaded component, or a magnetic component positioned on the coupler and configured to engage the catheter hub.

9. The device of claim 5, Wherein the releasable engagement is provided by a level, latch, button or release feature on the handle, on the hub or a combination of the handle and the hub.

10. The device of claim 1, wherein the protrusion comprises a tapered male luer proximal segment and an elongate extension distal to the male luer proximal segment.

11. The device of claim 10, wherein the elongate extension is positionable adj acent to a proximal end of a catheter lumen extending from the catheter hub.

12. The device of any of claims 1-11, further comprising: a seal sized and shaped to fit into the handle along the elongate slot to close off access to the interior portion, the seal having an angled slit along a length shaped to allow sliding movement of the slider arm.

13. The device of claim 12, the seal further comprising a perimeter adapted to engage the opening of the elongated slot.

14. The device of claim 12, the angled slit adapted to reseal along the length of the angled slit distal to the slider arm and along the length of the angled slit proximal to the slider arm.

15. The device of any one of claim 12, or claim 13, or claim 14, further comprising: a ratchet assembly with a first ratchet element positioned on an interior of the handle and a secondratchet feature positioned on the slider body, the second ratchet feature configured to engage the first ratchet feature when the slider is advanced distally within the handle.

16. The device of claim 15, wherein the first ratchet feature comprises a plurality of teeth along a length of the ratchet feature, wherein the plurality of teeth corresponds to a length of cannula deployment when the second ratchet feature is in communication with the first ratchet feature.

17. The device of claim 16, wherein the first ratchet feature has a length configured to provide tactile indication of the slider body relative to the extension port.

18. The device of any of claims 1 to claim 11, further comprising a tube seal disposed within the interior portion of the handle having a sealing portion wherein the slider arm and tube seal are adapted and configured to releasably seal and reseal at the sealing portion of the tube seal along the elongated slot as the slider is moved along the tube seal.

19. The device of claim 18, the slider body comprising a raised perimeter around the flow path opening adapted to seal the flow path opening until the flow path opening is in fluid communication with the extension port on the handle.

20. The device of claim 19, where the raised flow path opening perimeter extends outward to contact an interior surface of the tube seal.

21. The device of claim 1 , the slider comprising a forward facing edge angled and adapted to advance through the sealing portion of the tube seal.

22. The device of one of claim 12, or claim 18, or claim 19, or claim 20, or claim 21, further comprising: a visual or a tactile indicator along a surface of the handle adjacent to the elongate slot configured to indicate a length of cannula deployment, a relative position of the slider or the cannula with respect to a catheter hub coupled to the proximal end of the handle, or a relative position of the flow path opening on the slider body with respect to the extension port on the handle.

23. The device of claim 22, wherein the visual or tactile indicator is a tactile indicator is a ratchet system formed by an interaction between a ratchet element on the slider and a cooperating ratchet element along the elongated slot of the handle.

24. The device of claim 23, wherein a first ratchet element comprises a plurality of teeth along a length of the ratchet feature, wherein the plurality of teeth correspond to a length of cannula deployment when the second ratchet feature is in communication with the first ratchet feature.

25. The device of claim 24, wherein a second ratchet element has a length configured to provide tactile indication of the cannula distal end to a distal most end of a catheter lumen coupled to the proximal end of the handle.

26. The device of claim 25, wherein a third ratchet element has a length configured to provide tactile indication of the cannula distal end to a full cannula extension length for an indicated catheter lumen length of a catheter coupled to the proximal end of the slider.

27. The device of one of claims 1-14, or claim 15, or claim 16, or claim 17, or claim 18, or one of claim 19, to claim 21, or claim 22, or any one of claim 23 to claim 26, wherein the device is configured to be used with more than one length of catheter, and the slider flow path opening has a distal end and proximal end extending along a length of the slider body, wherein the flow path opening is adapted to be fluidly coupled to the extension port at any position between the flow path opening distal end and proximal end.

28. A method of drawing blood through a catheter, the method comprising the steps of: engaging a catheter hub with a distal end of a blood draw device handle wherein the engaging step aligns a blood draw cannula lumen extending from a slider through the distal end of the blood draw device handle and along the central longitudinal axis of a catheter extending from the catheter hub into a patient blood vessel; advancing the slider body distally along the handle towards a side port in the handle without introducing a distal most end of the cannula into the patient blood vessel; continuing advancing the slider body distally along the handle to align a portion of a slider fluid path into fluid communication with the side port; and continuing advancing the slider body distally along the handle until the distal most end of the cannula lumen is in fluid communication with the patient blood vessel.

29. The method of claim 28, wherein the step of engaging the catheter hub with a distal end of the blood draw device comprises inserting a distal protrusion of the blood draw device through a proximal end of the catheter hub.

30. The method of claim 28, further comprising establishing fluid communication between the patient blood vessel and a side port of the blood draw device handle only after the distal most end of the cannula extends beyond the distal end of the catheter in the patient’s blood vessel.

31. The method of claim 28, further comprising adjusting a position of the distal most end of the cannula lumen to establish the fluid communication with the patient blood vessel.

32. A method of coupling a coupler of a blood draw device to an indwelling catheter hub, comprising: aligning a coupler at the distal end of a blood draw device with a proximal end of a catheter hub; advancing the coupler over the exterior of the catheter hub until the catheter hub is docked with the coupler; and positioning a protrusion of the blood draw device within the catheter hub and adjacent to a proximal end of a catheter lumen extending from the catheter hub.

33. The method of claim 32, further comprising locking the catheter hub to the coupler wherein a protruding feature of the catheter hub is positioned within a disengagement mechanism.

34. The method of claim 33, wherein the catheter hub is releasable from the coupler when a disengagement button of the disengagement mechanism is depressed causing a distal end of the disengagement mechanism to lift away from interference with the protruding feature of the catheter hub.

35. The method of claim 34, further comprising distally biasing the catheter hub with an interior surface of the disengagement mechanism when the depression button is depressed.

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