Blood collection device and methods of use

Abstract

A blood collection device including a handle with a first side and a second side. An axial slot along the first side with a coupler adapted to receive the handle in a proximal side and a distal protrusion configured to engage a catheter. A tube seal with a seal arm in the handle such that the seal arm is within an extension port of the handle configured to couple to a vacutainer assembly. A slider including a body within tube seal and arm extending through the axial slot, a lumen extends through the slider body through forming a flow path through a cannula lumen extending from a distal end of the slider body, the flow path configured to direct a flow of blood from a vessel to the vacutainer assembly.

Description

BLOOD COLLECTION DEVICE AND METHODS OF USECROSS REFERENCE TO RELATED APPLICATIONS

[0001] This patent application claims priority to U.S. Provisional Patent Application No. 63 / 666,092, titled “BLOOD COLLECTION DEVICE AND METHODS OF USE,” filed June 28, 2024, which is incorporated by reference 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 drawings 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 impedes 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 phlebotomy, venipuncture or 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 various improved methods and devices for use in or providing improved outcomes during blood collection, venipuncture or phlebotomy procedures.

[0007] In general, a blood collection device can comprise a handle having an axial slot along a length of the handle between a proximal end and a distal end. A male luer can be positioned at the distal end of the handle and a coupler configured to engage a catheter assembly, wherein a distal end of the male luer extends distally beyond the coupler. A flow hub that can have a body disposed within an interior of the handle and an arm extending through the axial slot of the handle, the flow hub configured to be distally advanced along the axial slot. A cannula extending from a distal end of the flow hub body through a lumen of the male luer, the cannula can comprise a lumen extending from a distal end into the flow hub body. A vacutainer operably coupled to the flow hub arm and in communication with the cannula lumen.

[0008] This and any other example described herein may further comprise one or more of the following. In one embodiment of a blood collection device, the flow hub body, cannula, and male luer lumen can be axially aligned with a central axis of the handle. Optionally, the male luer can 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 extending from the catheter hub into a blood vessel. The device can further comprise a slider having a body positioned proximal to the flow hub body within the handle and configured to advance the flow hub distally to deploy the cannula through the catheter into the vessel. The device can further comprise a slider having a body positioned within the handle and an arm extending out of the axial slot, wherein the slider can be adapted to translate the flow hub distally within the slot. The vacutainer can be adapted to move with the flow hub. The flow hub can be in operable communication with the vacutainer when the flow hub lateral opening is aligned with a port extending out from the handle, and wherein the vacutainer is coupled to the port. The device can be configured to be used with more than one length of catheter, and a flow hub opening along a length of the flow hub body has a distal end and proximal end extending along a length of the flow hub body, wherein the flow hub opening is adapted to be fluidly coupled to an extension port of the handle at any position between the flow path opening distal end and proximal end. The device can further comprise a slot seal positioned in the handle slot, the slot seal having an axial slit along a length of the slot seal configured to seal an interior of the handle and facilitate movement of the flow hub through the handle. The coupler may comprise one or more engagement features configured to engage a catheter hub. The flow hub can comprise a lumen extending from the distal end of the flow hub body in contact with the cannula lumen through the flow hub arm. The vacutainer can be in communication with the lumen at the flow hub arm. A distal end of the slider can be insertable into the flow hub body. The flow hub body can be releasable engaged with the distal end of the slider body.The flow hub may comprise a tab extending out of the handle and configured to be contacted for proximal movement of the flow hub after blood has been drawn into the vacutainer.

[0009] In general, a blood collection device can comprise a handle having an axial slot extending along a length of the handle between the proximal end and the distal end. A male luer with a lumen extending through a protrusion at the distal side to a proximal end, wherein the male luer proximal end is configured to couple with the handle distal end. A coupler that can be circumferentially engaged to the handle distal end and around a portion of the male luer. A flow hub that can have a body positioned inside the handle and a port extending out of the axial slot, wherein a lumen extends through the flow hub from the flow hub port to a cannula extending from a distal end of the flow hub body, the cannula comprising a lumen extending from the flow hub lumen to a distal end of the cannula. A slider that can be in operable communication with the flow hub body and configured to be advanced within the axial slot to deploy the cannula distal end out from the male luer protrusion. A vacutainer assembly that may be in fluid communication with the flow hub lumen through the flow hub port.

[0010] This and any other example described herein may further comprise one or more of the following. The flow hub body, cannula, male luer lumen can be axially aligned with a central axis of the handle. The male luer 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 be extended through a catheter extending from the catheter hub into a blood vessel. The flow hub can be configured to be advanced distally with the vacutainer assembly along the axial slot to advance the cannula distally beyond the male luer protrusion. The device can further comprise alignment rails extending axially along an interior of the handle and configured to contact the flow hub body. The vacutainer assembly can be configured to be in fluid communication with a blood vessel when the cannula lumen is advanced through a catheter assembly and into the blood vessel. The vacutainer assembly can be configured to move with the flow hub.

[0011] 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 wherein the engaging step aligns a blood draw cannula lumen extending from a flow hub through the distal end of the blood draw device handle and along the central axis of a catheter extending from the catheter hub into a patient blood vessel. Advancing a collection assembly operably coupled to the flow hub through an axial slot of the blood draw device handle to advance the blood draw cannula through the catheter and into the vessel. Moving a distal end of the blood draw cannula beyond a distal most end portion of the catheter and into the patient blood vessel. Establishing fluid communication between the patient blood vessel and the collectionassembly after the distal most end of the cannula extends beyond the distal end of the catheter in the patient’s blood vessel.

[0012] In general, a blood collection device can comprise a handle having an axial slot along a length of the handle between a proximal end and a distal end. A coupler can be positioned at the distal end of the handle, the coupler configured to engage a catheter assembly. A flow hub can have a body disposed within an interior of the handle and an arm extending through the axial slot of the handle. A cannula that extends from a distal end of the flow hub body through a lumen of the male luer, the cannula comprising a lumen extending from a distal end into the flow hub body. A vacutainer can be coupled to the flow hub arm and in communication with the cannula lumen.

[0013] This and any other example described herein may further comprise one or more of the following. A fluid path can be selectively established through the cannula to the vacutainer when a distal tip of the cannula is extended distally beyond the coupler. The vacutainer can be configured to move with the flow hub. A fluid lumen can be continuous from the distal end of the cannula lumen to the vacutainer. The fluid lumen can be air-locked until the flow hub is distally advanced along the axial slot to extend the distal end of the cannula beyond the coupler. The vacutainer can be coupled directly to the flow hub. A tube extending between the flow hub and the vacutainer. A lumen extending through the flow hub from a proximal end of the cannula to the vacutainer. The flow hub can be configured to direct a flow of fluid from the cannula to the vacutainer. A seal positioned in the handle and configured to provide a fluid seal around the cannula within the handle interior.

[0014] This and any other example described herein may further comprise one or more of the following. The method may further comprise advancing the flow hub and blood collection assembly distally within the axial slot with a slider positioned proximal to the flow hub until the blood draw cannula distal end is positioned within the blood vessel. The method may further comprise drawing blood into the blood collection assembly before retracting the flow hub to a proximal position within the handle.BRIEF DESCRIPTION OF THE DRAWINGS

[0015] 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:

[0016] FIG. 1 A is a perspective view from a distal end of a blood collection device with a vacutainer assembly in fluid communication with a cannula positioned within a handle withthe slider and flow hub retracted in the proximal end of the handle as the device is in the stowed configuration ready to deploy the cannula out from the male luer at the distal end of the handle.

[0017] FIG. IB is a proximal perspective view of the blood collection device from FIG. 1A.

[0018] FIG. 2 is a detailed distal perspective view of a blood collection device showing the coupler and male luer positioned at the distal end of the housing and substantially transparent to illustrate the relative position of the cannula distal portion as it may be in a stowed configuration.

[0019] FIG. 3 is a detailed perspective view of a flow hub used with a blood collection device described herein with a body and distal protrusion configured to communicate with the proximal end of a cannula.

[0020] FIGS. 4A-4C illustrate a slider removed from a blood collection device described herein and shown in a side elevation view, distal perspective view, and proximal perspective view, respectively.

[0021] FIGS. 5 A and 5B are detailed proximal section views of the blood collection device in FIG. 1 A illustrating an arrangement of the slider, flow hub, and vacutainer assembly as they may be positioned when the slider is retracted in a stowed or read-to-use- configuration with the cannula proximal end withdrawn inside of the handle.

[0022] FIG. 6 illustrates an example of a blood collection device housing alone in a distal perspective view including a slot extending along a length of the handle from the proximal end of the distal end and configured to facilitate the distal and proximal translation of the slider and flow hub therethrough, when in use.

[0023] FIGS. 7 A and 7B show a cannula support member in the extended configuration in FIG. 7A and the compressed configuration in FIG. 7B as it may transition between the two configurations when the cannula is first in a retracted or stowed configuration, then when the cannula is deployed and the cannula support member is compressed as the slider is distally advanced in the handle slot.

[0024] FIG. 8 shows a male luer in a distal perspective view removed from the handle to illustrate details including the distal tip configured to penetrate an in-dwelling catheter, and a proximal protrusion locatable within the handle of a blood collection device and configured to support the cannula as it may extend therethrough.

[0025] FIGS. 9A-9F show various views of a coupling collar locatable at the distal end of a blood collection device handle with features to support the coupling or communication of a blood collection device with an in-dwelling catheter.

[0026] FIG. 10 shows another example of a blood collection device in a distal perspective view with an alternative coupling collar positioned at the distal end of the handle and the slider in the retracted or stowed position such that the vacutainer assembly, flow hub, and cannula are withdrawn to a proximal most position within the handle.

[0027] FIGS. 11 A and 1 IB show another example of a blood collection device handle or housing in a distal perspective view and a proximal perspective view, respectively, illustrating additional detail of the housing features including alignment features extending along an interior of the housing.

[0028] FIGS. 12A-12C illustrate embodiments of a slider used with a blood collection device described herein.

[0029] FIGS. 13A and 13B show a blood collection device including the slider from FIG. 12A-12C in a proximal position within the handle slot.

[0030] FIGS. 14A-14C show another embodiment of a flow hub removed from the blood collection device with an incorporated slider element locatable on the outside of the blood collection device handle and a body locatable within the device handle.

[0031] FIGS. 15A-15D are examples of a proximal cap configured to engage the proximal end of a flow hub and direct a flow of fluid from the cannula proximal end through the flow hub and to the vacutainer assembly in communication with the flow hub.

[0032] FIG. 16A shows an example of a blood collection device including the flow hub shown in FIG. 14A with the flow hub cap positioned at the proximal end of the flow hub as the flow hub and vacutainer assembly are in the retracted position in the handle slot as it may be in a stowed configuration.

[0033] FIG. 16B is a detailed section view of the proximal end of the blood collection device from FIG. 16A providing additional details of the flow hub and cap arrangement in the proximal end of the handle.

[0034] FIG. 16C is a proximal perspective view of the blood collection device from FIG. 16A illustrating additional details of the blood collection device proximal end with the cannula retracted such that the cannula distal end is positioned within the male luer at the distal end of the handle.

[0035] FIGS. 17A-17D illustrate various views of another slider embodiment, used with a blood collection device described herein, having a contact portion separated from the slider body such that the contact portion is configured to be positioned or accessible on the outside of the handle and the slider body being positionable within the handle interior.

[0036] FIGS. 18A and 18B illustrate another embodiment of a cannula support member positionable within the handle and configured to provide structural support to the cannula extending therethrough as well as reduce or prohibit contamination of the handle interior.

[0037] FIG. 19 shows a blood collection device in a proximal perspective view with the slider from FIG. 17A and the cannula support member in FIG. 18A in an extended configuration as the slider is withdrawn into the stowed position at the proximal end of the handle.

[0038] FIGS. 20 A and 20B show the blood collection device from FIG. 19 including a detailed proximal section and distal perspective view to further illustrate the arrangement of the slider and cannula support member in the stowed configuration.

[0039] FIG. 21 and FIG. 22 illustrate transition of the slider and flow hub from a proximal stowed configuration in FIG. 21 to a deployed configuration in FIG. 22 with the slider and flow hub advanced toward the distal end of the handle such that the cannula is deployed correspondingly based on the translation of the slider and flow hub as it may be extended through a catheter or other vascular access device to establish of re-establish a flow of blood from the vessel through the cannula and to the vacutainer assembly in communication with the flow hub.

[0040] FIGS. 23A-23C show another embodiment of a flow hub having a luer locatable outside of the handle and a body configured to be translated from a proximal position to a deployed or distal position when the slider is advanced or retracted within a blood collection device handle.

[0041] FIGS. 24A-24C show various views of another embodiment of a blood collection device handle including a slot extending along a length of the handle and alignment features extending along an interior surface of the housing to support alignment and positioning of the flow hub, cannula, slider, etc.

[0042] FIG. 25 A shows an example of a blood collection device in a side elevation view with the slider and vacutainer assembly in a proximal or stowed position within the handle.

[0043] FIGS. 25B and 25C show detailed section views of the blood collection device from FIG. 25A including a proximal portion in FIG. 25B and a distal position in FIG. 25C to illustrate additional details of the male luer and the flow hub assembly, respectively.

[0044] FIGS. 26A-26C show yet another example of a flow hub that can be used with a blood collection device, described herein, with a contact feature locatable outside of the handle and a body positionable within the handle configured to direct a flow of fluids through the distal end of the through the flow hub port fluidly coupled with a vacutainer assembly.

[0045] FIGS. 27A-27C illustrate various views of another example of a slider used with a blood collection device, described herein, with a contact feature positionable outside of the device handle through the slot and a body configured to contact and communicate with the proximal end of a flow hub.

[0046] FIG. 28 shows an example of a blood collection device with the flow hub from FIG. 26A and the slide from FIG. 27A now including an extension tube extending between the flow hub port and a vacutainer assembly with the slider and flow hub in the stowed configuration.

[0047] FIG. 29 shows a detailed proximal segment of the device from FIG. 28 to illustrate additional details of the extension set including the extension tub extending between the flow hub and the vacutainer assembly coupled thereto.

[0048] FIGS. 30A and 30B show yet further examples of flow hubs used with blood collection devices described herein having a first lumen extending through a proximal portion and a second lumen extending through the flow hub body to a luer or extension port configured to communicate with a vacutainer assembly.

[0049] FIG. 31 is a detailed view of a blood collection device proximal end with the flow hub from FIG. 30A showing how a vacutainer assembly may be in fluid communication with the cannula through a tube extending through the second lumen and through the first lumen to the proximal end of the cannula located at the distal end of the flow hub body.

[0050] FIGS. 32A-32D show yet further examples of a slider that may be used with a blood collection device described herein.

[0051] FIGS. 33A-33C illustrate various views of an additional example of a flow hub that may be used with a blood collection device described herein.

[0052] FIGS. 34A and 34B show the flow hub in FIG. 33A with a luer element couplable to the distal end of the second lumen through the flow hub body allowing for an alternative capability to communicate with a vacutainer assembly that can be coupled to the luer element.

[0053] FIGS. 35A and 35B show distal perspective views of an example of a blood collection device handle, alone, including a slot extending along a first length of the handle and a slit extending proximally from the slot, such that the slot and slit are configured to allow contact features of the slider and / or flow hub to extend out of the handle while facilitating the translation of a slider and / or flow hub from a proximal position to a distal position along the length of the handle slit and slot.

[0054] FIGS. 36A and 36B show a handle cap from a distal side and proximal side respectively.

[0055] FIG. 37 shows another example of a blood collection device including the flow hub of FIG. 33 A and handle cap positioned on the proximal opening of the handle to enclose the handle interior.

[0056] FIG. 38 is a detailed view of a proximal portion of the blood collection device from FIG. 37 providing additional detail of the flow hub, vacutainer assembly, and slider as they are positioned in a proximal end of the handle and the handle slit.

[0057] FIGS. 39A-39C show another example of a flow hub with a contacting portion configured to be positioned outside of the handle and facilitate the deployment and / or retraction of the cannula as the flow hub is distally or proximally translated within the handle.

[0058] FIG. 40 illustrates an example of a blood collection device with the flow hub in FIG. 39A at the proximal position within the handle as it may be in a stowed configuration without a separate slider feature as the contacting portion of the flow hub can be used to facilitate movement of the flow hub and vacutainer assembly to deploy or retract the cannula.

[0059] FIGS. 41 A and 41B show yet another example of a flow hub with a contacting portion and a lumen extending through a proximal end of the flow hub that is coupled to the proximal end of the cannula such that the cannula lumen continues through the flow hub and out of the lateral opening along the flow hub body.

[0060] FIGS. 42 A and 42B illustrate a seal configured to engage the exterior of the flow hub body from FIG. 41 A and provide a fluid seal against an interior surface of the handle such that fluids may flow through the cannula lumen, through the distal flow hub lumen and out of the lateral opening in the flow hub body until the flow hub is distally advanced to be in fluid communication with a port of the blood collection device handle.

[0061] FIG. 43 illustrates another example of a blood collection device handle, alone and in a distal perspective view showing the slot extending along a length of the blood collection device handle and a port having a lumen extending through the port an into the handle interior such that the flow hub may be advanced within the handle interior until the lateral opening is in communication with the port lumen to provide or establish a flow from the cannula, through the flow hub and out of the handle port to a vacutainer or other collection device in communication with the port.

[0062] FIGS. 44A-44C shows a handle slot seal that may be used with blood collection devices described herein and configured to seal or otherwise enclose the handle interior while facilitating the translation of the slider and / or flow between a proximal position and distal position during use.

[0063] FIG. 45 is another example of a blood collection device including the flow hub from FIG. 41 inside of a handle from FIG. 43 with an extension tube in communication with the handle port and a luer configured to engage a vacutainer assembly.

[0064] FIG. 46 is another view of the blood collection device from FIG. 45 with the flow hub still in the stowed or retracted position at the proximal end of the handle slot as it may be arranged before a flow path is established as the lateral opening of the flow hub is not in fluid communication with the handle port.

[0065] FIG. 47 is a detailed proximal perspective view of the proximal portion of the device from FIG. 46 to illustrate the relative position of the flow hub lateral opening proximal to the handle port such that fluid communication has yet to be established until the flow hub would be distally advanced through the seal slit to deploy the cannula and establish a flow path through the cannula to the extension set.

[0066] FIGS. 48A-48E show various views of male luer examples positionable at the distal end of the handle and configured to couple with, penetrate, and facilitate the deployment of the cannula of the blood collection device during use.

[0067] FIGS. 49A-49C show yet another example of a flow hub having a luer portion in fluid communication with a lumen extending through the hub body and out of the distal end where the cannula proximal end is configured to communicate with the flow hub proximal end and lumen extending therethrough.DETAILED DESCRIPTION

[0068] Blood collection devices described herein may have a cannula configured to extend through a catheter to provide a flow of blood from the vessel of a patient through the cannula or catheter. The cannula may be in communication with a slider configured to slide through a housing. A housing may include a handle with a slot from a proximal side to a distal side of the handle such that the slot can be configured to accommodate the slider movement between a proximal side and distal side of the handle. A tube seal can be positioned within the handle and configured to provide a seal for a lumen through the cannula and slider. The lumen may be discontinuous until the slider is advanced to be in fluid communication with a port on the handle. The seal can further extend into an interior of the port to provide a full seal of the slider path and fluid communication with the port.

[0069] FIG. 1 A is a perspective view from a distal end of a blood collection device 100 with an extendable cannula 120 positioned inside the handle 105. The device is illustrated with components and features being substantially transparent to reveal an exemplary internal configuration. The cannula 120 is in fluid communication with a vacutainer assembly 140configured to receive fluid (e.g., blood) from the cannula 120 when it is extended into a vessel. The vacutainer luer 135 is coupled to a flow hub port 114 extending from the flow hub 110 and positioned outside of the handle 105. A slider 115 is positioned proximal to the flow hub 110 as FIG. 1 A illustrates the device 100 in a stowed or ready -to-use configuration whereby the cannula 120 is not extending out of the male luer distal end 131 at the distal end of the handle 105. The male luer 130 can be configured to penetrate a septum or seal of a catheter and support the cannula 120 when it is extended out of the handle 105. A coupler 125 is also positioned at the distal end of the handle 105 and configured to engage a catheter (not shown). At the distal segment of the handle, a grip feature 106 is positioned to support user engagement with the device 100.

[0070] FIG. IB is the blood collection device 100 from FIG. 1 A shown from a proximal perspective view with the vacutainer assembly 140, flow hub 110 and slider 115 at a proximal position near the handle proximal end 105b. The handle 105 has a slot 107 extending along a length of the handle 105 and providing a path for displacement of the slider 115 and flow hub 110 when the cannula 120 is to be extended or retracted.

[0071] The slider 115 is generally configured to be distally advanced through the handle slot 107 and the cannula 120 will be extended or deployed from the male luer 130 correspondingly with the distally advancement of the flow hub 110 by the slider 115. As the vacutainer assembly 140 is coupled to the flow hub 110, the vacutainer assembly is also movable accordingly to the position of the flow hub 110. The cannula 120 is in communication with the flow hub 110 and a lumen extending through the cannula 120 is continued through the flow hub 110 then on to the vacutainer assembly 140 coupled thereto. Although FIG. 1 A and IB show the device in a stowed configuration with the flow hub 110 retracted in the handle slot 107, it is understood that the cannula 120 may be deployed to any length beyond the male luer 130 according to the advancement of the flow hub 110 and slider 115 to any positioned within the handle slot 107. For example, the slider 115 may be advanced from the illustrated proximal position in the slot 107 to a distal position adjacent to the coupler 125 at the distal end of the handle 105.

[0072] FIG. 2 is a detailed view of the distal segment of the device 100 with components shown transparent to highlight examples of their arrangement at the handle distal end and within the coupler 125a. The male luer 130 has a distal end 131 outside of the handle 105 and a proximal end positioned within the handle interior. In this example, the cannula 120 is extending through the interior of the handle 105 and through a cannula support member 150 having a distal end 152 engaged with the proximal end of the male luer 130. The coupler125a is shown here to maintain connection between the handle 105 and the male luer 130, aswell as to accept a portion of a catheter or other vascular access device wherein the male luer 130. may be inserted.

[0073] In this view, the cannula distal end 120a is within the male luer and ready to be deployed through a catheter into a vessel to establish a flow through the cannula lumen to the collection device (e.g., vacutainer assembly).

[0074] FIG. 3 shows an example of a flow hub 110 alone. The flow hub 110 is configured to direct a flow of fluid from the cannula coupled to the flow hub distal end 11 la to a vacutainer assembly coupled to the flow hub port 114. A lumen 112 extends through the flow hub distal end I l la and continues through the flow hub branch 113 and to the port lumen 114a then onto the vacutainer. The flow hub body I l l is positioned within the handle interior and the proximal side 11 lb is configured to contact or otherwise communicate with the slider during use. The flow hub branch 113 has a smaller diameter than the body 111 and is configured to extend through the handle slot (e.g., slot 107) to expose the flow hub port 114 on the exterior of the handle for connection to a vacutainer. The flow hub 110 can move within the handle between a proximal and distal position while the flow hub branch 113 is translated through the handle slot.

[0075] In some examples, flow hubs described herein are displaced by movement of a slider in communication therewith. FIG. 4A-4C illustrates a slider 115 removed from a blood collection device. The slider includes a portion inside the handle interior and a portion accessible outside of the handle interior. In this example, the slider 115 has a contact portion 116 separated from a slider body 117 by region 119. The space between the contacting portion 116 and the slider body 117 is configured to allow the thickness of the handle to be positioned therein while region 119 extends through the handle slot. At the slider distal end 118, there are one or more features than can be configured to insert into the proximal end of the flow hub. Here, a sloped or curved distal region 118a can be configured to be inserted into the flow hub and provide a portion of the flow path for blood from the cannula through the flow hub and into a vacutainer. In some examples, the curve or slope can be configured to reduce or eliminate hemolysis by providing a continuous flow path with minimal angles that may be contacted by cells traveling through the flow path from the cannula through the flow hub to the vacutainer.

[0076] FIGS. 5 A and 5B are detailed proximal section views of the blood collection device 100 to highlight an exemplary arrangement of the flow hub 110 and the slider 115 within the handle 105. As illustrated, the device is in the retracted configuration with the slider 115 at a proximal end of the handle 105b. The vacutainer assembly 140 is in communication with the flow hub port 114 with the lumen 113a extending through the flowhub branch 113 to the vacutainer luer 135. A proximal portion of the cannula 120 is shown in communication with the distal end of the flow hub 110. Although the cannula 120 is shown in the retracted position, this exemplary arrangement identifies the flow path through the cannula proximal end 120b through the flow hub lumen section 113b following proximal along the slider distal end 118 then through the flow hub lumen section 113a and out of the flow hub port 114 into the vacutainer assembly 140. Referring to FIG. 5B, the detailed view also shows the cannula support member proximal end 152 positioned over the distal end of the flow hub. Additionally, the contact between the slider distal end 118 and the flow hub proximal end can be appreciated. In fact, this example shows the distal slider portion 118 inserted into the flow hub body 111.

[0077] FIG. 6 shows an example of a blood collection device handle 105 alone. With the other elements removed from view, the slot 107 can be seen extending from a proximal end 107b to a distal end 107a. In some examples, the distal end of the slot may be open and configured to accept a proximal portion of the male luer when it is coupled to the handle 105. The length of the handle from distal end 105a to proximal end 105b provides a deployment length of the slider and flow hub, in use. This detailed view also shows an example of the grip feature 106 at the distal section of the handle 105 that can support user engagement in positioning and deploying the cannula.

[0078] As described in FIGS. 5 A and 5B, in some examples the cannula may be supported by a support member 150 configured to provide columnar support to prevent and reduce buckling or kinking of the cannula as it is deployed against possible occlusions or anatomical structures that otherwise blood or restrict blood flow through a catheter. FIGS. 7A and 7B show the cannula support member 150 in an extended position in FIG. 7A between a proximal end 141 and distal end 152. The configuration shown in FIG. 7A may relate to the position illustrated in FIG. 1 A with the flow hub and slider in a retracted position causing the cannula support member 150 to be extended and compressed or otherwise closer to the cannula exterior. The distal and proximal ends are shown in a tapered manner as they are configured to engage the distal end of the flow hub and proximal end of the male luer allowing the cannula to extend therethrough.

[0079] When the flow hub and slider are distally advanced, the cannula support member 150 can become compressed with a shortened length including a plurality of raised regions 154 and compressed regions 153. The compressed regions 153 have a smaller diameter and can be positioned adjacent to or encircling the cannula exterior to provide continued structural support from a retracted positioned all the way to a fully deployed or extended configuration for the length of cannula within the handle. The cannula support member 150has a lumen 150a extending through the length of the support member 150 where the cannula may be positioned.

[0080] FIG. 8 shows a male luer 130 in a distal perspective view alone. The male luer 130 is configured to penetrate a catheter hub or other vascular access device to allow a transition of the cannula from within the handle to extended into the vessel through the catheter. The male luer distal end 130 is generally tapered to facilitate improved insertion and a lumen 131 extends through the distal end 130a to the proximal end 130b where the cannula will be positioned through. Near the proximal end of the male luer 130, one or more engagement features 132 can be configured to align the male luer 130 with the handle distal end until the male luer is inserted up to collar 133.

[0081] Also, at the distal end of examples of devices described herein is a coupler 125 that can be positioned at the distal end of the handle and configured to support connection between the handle distal end and the male luer. Additionally, a coupler may be configured to support connection of the device to a catheter, in use. FIGS. 9A-9F show various view of a coupler 125, 15a, 125c (e.g., coupling collar locatable at the distal end of a blood collection device handle with features to support the coupling or communication of a blood collection device with an in-dwelling catheter. In the examples shown in FIGS. 9A and 9B, the coupler has a lumen 127 extending through the coupler body with a plurality of teeth 128 positioned around in interior surface of the lumen 127 and configured to contact and retain the catheter and / or the male luer on the distal end of the handle. In FIG. 9C to FIG. 9E, the coupler 125a similarly shows a lumen 127a with teeth 128a as well as an engagement channel 129 positioned circumferential with the lumen 127a that can be configured to engage the housing, male luer, and / or catheter inserted therein. Finally, FIG. 9F shows another example of a coupler 125c including a threaded engagement region 129c. In any example of a coupler, there may be one or more features adapted to couple the device to a catheter in use.

[0082] FIG. 10 shows another example of a blood collection device with the flow hub 110 and the slider 115 in a distal position and coupled to the vacutainer assembly 140 at the distal end, of the handle 205, there is an alternative coupler 125a over the male luer 130. As this is an example of the stowed configuration, the cannula 120 is retracted within the housing and the flow hub 110 is in a proximal position of the handle slot 107.

[0083] In some examples one or more variations of components of a blood collection device can provide alternative functions relating to a common action of deploying a cannula through a handle with an accompanying vacutainer assembly in fluid communication with the cannula lumen. FIG. 11 A and FIG. 1 IB show another example of a blood collection device handle 207 from FIG. 10 with other components removed to highlight the handle slot 207 andinterior alignment features 206 extending from a handle proximal end 205b to the handle distal end 205a. In this example, the distal end of the slot 207 is open to receive a male luer therein. The length of deployment can generally be defined by the length of the slot. In some examples, the coupler in communication with the handle distal end may cover a portion of the slot or may be configured to provide deployment of the flow hub along the entire length of the slot (e.g., slot 207). The alignment features 206 may be configured to reduce the amount of contact between the flow hub and the handle interior to reduce the amount of friction and any possible resistance as the flow hub and slider are advanced or retracted through the handle.

[0084] FIGS. 12A-12C show an example of a slider 215 that may be used with devices described herein. Similar to slider 115, slider 215 has a contacting portion 217 separated by slider arm 219 from the slider body 216. The slider distal position 218a and 218b are generally aligned with slider body 216 as they are also configured to be positioned within the handle interior. Referring to FIG. 12C, this distal view shows how the slider body 216 is geometrically advantageous to reduce the amount of contact within the handle and reduce the amount of friction or resistance as the slider 215 may be moved through the handle.

[0085] Slider arm 219 is now longer and curved between the contacting portion 217 and the slider body 216. Space 219a is provided to receive a portion of the handle such that the slider arm 219 extends out of the slit to orient the contacting portion 217 on a lateral side of the handle. This example of a slider may improve the user engagement and allow for improved manipulation with a single hand controlling the device and cannular deployment. The distal end 218a and 218b are illustrated similar to slider 115 with the flow path curve portion 218a and the distal region 218b that can be configured to be inserted into the proximal end of the flow hub.

[0086] FIGS. 13A and 13B show the blood collection device now including slider 215 at the proximal position of the handle 205 opposite the coupler 125a at the handle distal end. The cannula 120 is positioned within the handle 205 ready for deployment when the contacting portion 217 is distally advanced through slot 207 to advance the vacutainer assembly 140 coupled to the flow hub 110. As previously illustrated, the cannula support member 150 can be seen coupled to the distal end of the flow hub 110 with the cannula extending therethrough. In FIG. 13B, the view provides additional details of the slider arm 219 curved out of the slot 207 and around the handle body to position the contacting portion 217 on the outside lateral to the flow hub port 114.

[0087] In some examples, the flow hubs described herein may be translated within the slot of a handle by direct engagement with one or more areas of the flow hub, unlike other examples where a slider is contacted by a user, which subsequently translates movement to the flow hub. FIGS. 14A-14C show flow hub 210 now including a contacting portion 211 separated from the flow hub body by region 211a that can be configured to extend through the slot. Region 211a can have a smaller cross section adapted to extend through the slot of a handle while the flow hub body is retained inside the handle and the contacting portion is retained outside of the handle. The flow hub shown here includes a distal protrusion 212a and a proximal side 212b configured to receive a slider or cap, as illustrated in FIGS. 15A-15D. The flow hub branch 213 is still adapted to extend out of the handle through the handle slot to provide the flow hub port 214 for connection to a vacutainer assembly. A lumen 212c extends continuously through the flow hub body and out of the flow hub port 214. In some examples, the lumen 212c may be a continuous lumen from the flow hub distal end to the flow hub port 214. In some examples, the lumen 212c may still benefit from the support of a curved portion of a slider cap described below. The contacting region can be configured to translate the slider and vacutainer assembly along the handle slot when a user contacts portion 217 and moves it distally or proximally along the handle.

[0088] FIGS. 15A-15D are examples of a slider cap 315 configured to engage the proximal end of a flow hub (e.g., flow hub 210) and direct a flow of fluid from the cannula proximal end through the flow hub and to the vacutainer assembly in communication with the flow hub. Here, the slider cap 315 may be positioned entirely within the handle without a contacting portion as with other slider examples. Accordingly, the slider cap may be configured to provide support for a flow through the flow hub including the curved region 316a forming a portion of the flow path from the cannula to the vacutainer assembly coupled to the flow hub. In this example, portion 316a may be insertable into a flow hub and close or seal the distal end of the flow hub while providing an atraumatic curve to prevent or reduce hemolysis as blood flows through the cannula to the vacutainer assembly. In an example, the flow hub may have a collar region 317 or may have an enlarged region 320b as shown in FIG. 15D. In any example, the slider cap 315 or 3250 are configured to seal the flow path within and through the flow hub, the enlarged regions 317 or 320b can be configured to provide a fluid seal against the flow hub lumen.

[0089] FIGS. 16A to FIG. 16C show an example of a blood collection device including the flow hub 210 and slider cap 315 positioned at the proximal end of the flow hub 210 as the flow hub and vacutainer assembly 140 are in the retracted position in the handle slot 207 as it may be in a stowed configuration. Notably in these views, the slider cap 315 is positionedentirely within the handle 205 and the contacting portion 211 of the flow hub 210 is ready to be engaged for distal advancement to deploy the cannula 120 from the male luer 130. The vacutainer assembly 140 is coupled to the flow hub port 214 at an angle in this example to further reduce the impact of any curve or angle of the flow from the cannula through the flow hub 210, flow hub branch 213 and to the vacutainer assembly.

[0090] FIGS. 17A-17D show another example of a slider 415 that can be used with a blood collection device described herein. The slider 415 has a contacting portion 417 configured to be positioned outside of a device handle with the region or arm 419 configured to extend through a handle slot or slit and separating the contacting portion 417 from the slider body 416. At the slider distal end 415a, there may be one or more alignment features 415c that can align with a flow hub or the interior of the handle. The space 419a between the contacting portion 417 and the slider body 416 is configured to receive a portion of the handle. For example, the space 419a can be configured to receive the perimeter of the handle slot therein.

[0091] In some examples, the blood collection devices described herein may have cannula support members or handle interior seals that can further be configured to support the cannula in providing additional column strength, prevent or reduce kinking or buckling, and otherwise support distal advancement of the cannula through the blood collection device when it is distally advanced through a catheter and into a vessel. FIGS. 18A and 18B illustrate another embodiment of a cannula support member positionable within the handle and configured to provide structural support to the cannula extending therethrough. The cannula support member 250 is shown as a tubular member with a lumen extending through from a distal end 250a to a proximal end 250b where the cannula may extend through. The irregular surface of this cannula support member 250 example can be configured to provide a seal for the interior of the handle against contamination. For example, the cannular support member 250 may have a sufficiently large diameter to complement the interior diameter of the handle and cover the interior of the handle along the length of the slit distal to the flow hub or slider. The cannula support member 250 may be configured to transition between a compressed and extended state corresponding to the translation of the slider or flow hub within the handle.

[0092] FIG. 19 shows a blood collection device in a proximal perspective view with the slider 415 from FIG. 17A and the cannula support member 250 in FIG. 18A in an extended configuration as the slider 415 is withdrawn into the stowed position at the proximal end of the handle 205. The vacutainer assembly 140 is in communication with the flow hub 310 and connected to the flow hub port 313 at the distal end of a lumen extending through the flowhub 310 and cannula 120. Elements in this view are shown transparent to illustrate an example arrangement of the cannula support member 250 aligned through the handle 205 distal to the flow hub 310 and around the cannula 120. In this stowed configuration, the cannula support member is extended, as illustrated in FIG. 18 A. However, it can be appreciated that when a user would advance the slider 415 distally through the slot 207, the cannula support member 250 can compress around the cannula 120 as the cannula support member length is decreased.

[0093] FIGS. 20 A and 20B show the blood collection device from FIG. 19 including a detailed proximal section and distal perspective view to further illustrate the arrangement of the slider 415 in communication with the flow hub 310 adjacent to the handle proximal end 205b. The contacting portion 417 is accessible for a user to engage and push the slider 415 / flowhub310 assembly distally along the handle slot 207 to deploy the cannula 120 from the distal end of the male luer 130. Referring to FIG. 20A, the exemplary flow hub 310 includes a tab 311 that can provide additional manipulation capabilities. For example, the flow hub tab 311 may be used to retract or adjust the deployment length of the cannula 120, in use. Referring to FIG. 20A, the detailed view also shows the communication between the flow hub port 314 and the vacutainer luer 135 that is in fluid communication with the lumen extending through the flow hub port 314 to the proximal end of the cannula 120 and through the cannula lumen, and cannula support member in the stowed configuration. Referring to FIG. 20B, the coupler 125c is shown with the threaded engagement feature ready to be aligned with a catheter or other vascular access system as the male luer 130 provides support to traverse any seal thereby allowing the cannula to be deployed into a vessel. FIG. 20B shows the device in a stowed position at a proximal end of the slot 207 with an available deployment length to the distal end of the slot 207 when the slider 415 (e.g., contacting portion 417) is distally advanced against the flow hub 310.

[0094] FIG. 21 and FIG. 22 illustrate the transition of the slider and flow hub 310 from a proximal stowed configuration in FIG. 21 to a deployed configuration in FIG. 22 with the slider 415 and flow hub 310 advanced toward the distal end of the handle 205 such that the cannula 120 is deployed correspondingly based on the translation of the slider 415 and flow hub 310 as it may be extended through a catheter or other vascular access device to establish of re-establish a flow of blood from the vessel through the cannula 120 and to the vacutainer assembly 140 in communication with the flow hub 310. In this example, the cannula 120 is shown in a deployed configuration in FIG. 22 with the cannula distal end 120a extended beyond the male luer distal end 130a as the flow hub 310 with vacutainer assembly 140 in the distal most position of the handle slot 207. The vacutainer assembly 140, being coupled to theflow hub 310, moves accordingly with the flow hub 310. In some examples, as shown in FIG. 22, the slider 415 may be separatable from the proximal side of the flow hub 310. As shown in FIG. 22, the slider is in the opposite (e.g., proximal) end of the handle slot 207 while the flow hub 310 and vacutainer assembly remain in the distal position. Although the flow hub 310 is shown in a distal most position, it can be appreciated that the deployment length of the cannula may be any length corresponding to the distal advancement of the flow hub. For example, the cannula distal end 120a may be deployed or extended out from the device to any length from the proximal most position of the flow hub to the distal most position of the flow hub. In this example, the flow hub tab 311 can be used to retract or withdraw the flow hub 310, vacutainer assembly 140 and cannula 120 from a deployed configuration to a less deployed or withdrawn (e.g., stowed) configuration.

[0095] In some examples, the flow of blood may be established when the cannula is sufficiently deployed into the vessel. For example, when the cannula has been deployed through an occlusion or beyond an anatomical structure that may otherwise disrupt other forms of a blood draw. Accordingly, there may not be a flow path established from the cannula distal end through the lumen and into the vacutainer until the cannula distal end is in fluid contact with the interior of a vessel.

[0096] As shown in FIG. 21 and FIG. 22, the flow hub may have additional features such as the flow hub tab for independent translation or displacement from the slider. FIGS. 23 A- 23 C show detailed views of the flow hub 310 with the flow hub tab 311 configured to be contacted outside of the handle while the flow hub body 310a is positioned within the handle interior. Region 311a inferior to the flow hub tab 311 can be configured to extend through the slot while the tab 311 and the body 310a may not be able to pass through the handle slot. Referring to FIG. 23 A, from this proximal perspective, the lumen 314a through the flow hub port 314 is visible and adapted to extend through the flow hub 310 to the distal end 310b that is in operable communication with the cannula of a blood draw device described herein. At the proximal side of the flow hub body 310a, there is a recess portion or docking recess 310c configured to receive or communicate with the slider. In FIG. 22, the example showed the slider 415 positioned proximal in the handle slot 207 while the flow hub 310 was separated from the slider 415 and in the distal position of the handle. In that example, the slider 415 was docked at the flow hub docking recess 310c to advance the flow hub 310 and vacutainer assembly 140 until the slider 415 was the withdrawn proximally leaving the vacutainer 140 and the flow hub 310 in a deployed configuration by separating from the docking recess 310c. The flow hub tab 311 can then be used to retract and withdraw the cannula after the blood is drawn to the vacutainer assembly.

[0097] Referring to FIG. 23B, the distal view shows the lumen 310 through the flow hub distal end 310b that is also the distal end of the lumen 314a. In any example, the lumen extending through the flow hub can be continuous, discontinuous, or facilitated by one or more additional elements such as a tube that completes the lumen from the cannula proximal end to the vacutainer assembly. In the example shown in FIGS. 23A-23C, the flow path or lumen through the flow hub continues through the distal end 310b, through the flow hub body 310a, through the flow hub branch or arm 313 and finally open to the flow hub port 314 which is connectable to the vacutainer assembly. Referring to FIG. 23C, at the proximal end of the flow hub port 314 there is an example of a luer or threaded engagement 314b region configured to communicate with a vacutainer or vacutainer assembly (e.g., extension set).

[0098] Additional features of blood draw device components such as the handle can provide additional support and function for the position, arrangement, and capability of the blood draw device. FIGS. 24A-24C show another example of a blood collection device handle 305 including a slot 307 extending along a length of the handle 305 and alignment features extending along an interior surface of the handle 305 to support alignment and positioning of the flow hub, cannula, slider, etc. As shown here, the slot 307 extends from a proximal end 307b to an open distal end 307a that may be closed by the coupler in communication with the handle distal end to prevent the slider and flow hub from being advanced out of the distal end of the handle. Alignment rails 306 are also visible extending along the interior surface of the handle 305 from the handle proximal end 305b to the handle distal end 305a. Handle alignment rails (e.g., rails 306) can provide minimal contact with the slider, flow hub, or other component configured to move within the handle and reduce the amount of friction or resistance when transitioning between a stowed and deployed configuration.

[0099] FIG. 25 A shows an example of a blood collection device with handle 305 from FIG. 24 A in the stowed configuration with slider 515 proximally adjacent to the flow hub 310 in a proximal or retracted position in the handle slot 307. Accordingly, the cannula 120 is within the device and not extended beyond the male luer 130. In FIG. 25B, the coupler 125c is shown transparent to highlight additional examples of engagement and arrangement of the male luer 130 at the proximal end of the handle 305. The male luer has an alignment feature 132 configured to communicate with the opening at the distal end of the slot 307a. In some examples, the male luer may be affixed or incorporated into the distal end of the handle. The cannula 120 can be seen throughout FIGS. 25A-25C and an additional cannula support member 157 is positioned around the cannula 120. Coiled member 157 can be configured to provide further structural support for the cannula as well as provide a spring bias against theflow hub 310 to maintain a retracted configuration until force is applied by the slider 515 advancement against the spring bias of member 157. In some examples, the spring member 157 may be configured to provide a spring bias for supported or automatic retraction after a blood draw is complete.

[0100] Referring to FIG. 25C, additional details of the slider 515 arrangement relative to the flow hub 310 can be seen with the distal portion of the slider 515 inserted or docked in the slider docking recess 310c. This example of a slider includes the curved distal segment that may provide a portion of the flow path for blood flowing from the cannula lumen to the vacutainer assembly 140 during use. Alternatively, the lumen extending between the cannula distal end through the flow hub 310 and to the vacutainer assembly may be enclosed and the distal portion of the slider 515 may have a geometry to complement the proximal docking recess 310c of the flow hub 310. This lumen or flow path through the flow hub is configured to reduce or prevent hemolysis of blood flowing therethrough. As shown in FIG. 25C, the vacutainer luer 135 is coupled to the flow hub port 314 at an angle continuing the flow path through the flow hub branch 313 to the vacutainer.

[0101] In addition to the features of flow hubs described herein, the communication between the vacutainer assembly and flow hub may be with a flow hub port configured to mechanically engage the vacutainer luer. In some examples, the flu hub may communicate with the vacutainer assembly with one or more tubes in communication with a flow hub port. FIGS. 26A-26C shown another example of a flow hub 410 adapted to be used with a blood collection device, described herein. The flow hub 410 has a flow hub body 410a, again positionable within the handle interior and a flow hub distal end 410b configured to communicate with the cannula and, in some examples, communicate with a cannula support member. At the proximal side of the flow hub body 410a, there is a slider docking recess 410c configured to receive or otherwise communicate with a slider that can provide a force to distally advance the flow hub 410, vacutainer assembly, and cannula when transitioning to a deployed configuration. In this example, there is also a flow hub tab 411 similarly configured to contact by a user to adjust the position of the flow hub in the handle slot with or without the flow hub being in communication with the slider. The branch or arm 413 is adapted to extend out of the handle slot to communicate with the vacutainer assembly. Of note, in this example, the arm 413 is now the terminal end of the flow hub communication structure to fluidly couple with the vacutainer. In some examples, the flow hubs described herein may or may not have a luer engagement feature. The arm provides a proximal end of the lumen 413a extending between the flow hub arm 413 and the flow hub distal end 410b. For example, the lumen 412 may be considered a distal lumen segment that continues to the vacutainerassembly via lumen 413a. In any example, the transition between the first lumen segment 412 and second lumen segment 413a can be adapted to prevent or reduce hemolysis during blood flow through the cannula to the vacutainer.

[0102] Yet another example of a slider is illustrated in FIGS. 27A-27C. Similar to other examples, the slider 515 can be adapted to translate user engagement (e.g., distal advancement within the handle slot) to a flow hub positioned distal to the slider 515. The distal slider portion 518 includes a curved portion 518a that may form a portion of the lumen or flow path through the flow hub. Alternatively, the distal slider geometry (e.g., region 518a) may be complementary to the slider docking recess at the proximal side of a flow hub. The contacting portion 516 comprises one or more features to support the engagement between the user and the slider 515. In this example, directional support features may provide tactile indication for distal or proximal direction of translation for a user without requiring visual confirmation. Near the distal end of the slider 515, is an alignment feature 518c that may be adapted to communicate with the flow hub or with the handle interior to support alignment and communication between the flow hub when inside of the handle and contacting the slider 515. Referring to FIG. 27C, there is a proximal portion 518b of the distal region 518 of the slider 515 that may be configured to complement the interior geometry of the flow hub docking recess. Additionally, this region 518b may be configured to contact the flow hub and provide additional engagement between the slider 515 and a flow hub (e.g., additional friction engagement with docking recess). For example, the region 518b may allow the flow hub to be separately engaged with the slider while the distance between the contacting portion 516 and the slider body 517 (e.g., dimensions of region 519) may allow a user to apply downward pressure on the slider 515 while it is docked with the flow hub to maintain connect between the flow hub and slider when retracting while still allowing for selective separation between the flow hub and slider 515.

[0103] FIGS. 28 and 29 are provided to show another example of the blood draw device with slider 515 and flow hub 410. In this example, the vacutainer assembly 140 is in communication with the flow hub arm 413 by a length of tubing 145 extending from the vacutainer assembly to the arm 413 and continuing a lumen from the flow hub 413a to the vacutainer. In this example, the slider 515 is still adapted to advance the flow hub 410 with the vacutainer assembly 140 correspondingly advanceable with the flow hub. However, the tubing 145 can provide additional flexibility in the position of the vacutainer assembly while the cannula 120 is being advanced from the male luer 130 into a vessel. For example, the tubing 145 may be adapted to maintain the atraumatic flow path reducing or preventinghemolysis while allowing the vacutainer to be adjustably positionable during the blood draw procedure.

[0104] The tubing fluid connection between the vacutainer assembly and the cannula through the flow hub can provide added benefit of manipulation of a vacutainer assembly during a blood draw. Alternatively, the tubing may be a part of an extension set of a vacutainer assembly providing for added capability of coupling between the blood draw device and a vacutainer assembly. FIGS. 30A and 30B illustrate additional examples of a flow hub 510 now configured to receive a tub through the flow hub 510 to provide a continuous lumen from the distal end 510a through the flow path recess 510c and out of the flow hub port 514. The arm 513 is still extending between a flow hub port 514 with a lumen 514b extending through the port and to the flow hub recess 510c. A second lumen segment 512 then extends between the distal end 510a to the flow hub recess 510c. A tube (not shown) may then extend between the two flow hub lumen segments (e.g., 512 and 514b). This flow hub 510 also provides additional examples of a threaded engagement features 514a around the proximal opening of the flow hub port 514. At the proximal end of the flow hub body 510 is a protrusion or feature 510b that is now extending proximally from the flow hub 510 and configured to be locatable within the handle. This protrusion 510b may now be adapted to insert into the distal end of a slider for communication between the slider and flow hub 510. The protrusion 510b may provide additional alignment and stability of the communication or coupling between the slider and the flow hub 510. Similar to other flow hub examples, a tab 511 is provided on the top of the flow hub body 510 and adapted to contact from a user to move the flow hub and vacutainer assembly within the slot of a handle.

[0105] FIG. 31 is a detailed view of a blood collection device proximal end with the flow hub 510 from FIG. 30A showing how a vacutainer assembly 140 may be in fluid communication with the cannula 120 through a tube 145 extending from the vacutainer luer 135 to the proximal end of the cannula at the distal end of the flow hub 510. The tube 145 is shown extending completely through the flow hub lumen segments (e.g., 512 and 514a). The distal end of the slider 518 is contacting the proximal end of the flow hub 510, and although obscured, the proximal protrusion 510b is inserted into the distal end of the slider body 517.

[0106] As described above, some examples of a slider comprise a distal end configured to receive a portion of the flow hub. FIGS. 32A-32D show additional examples of a slider 615 including a distal end recess 618a at the distal portion 618 of the slider 615. The slider 615 may or may not include the alignment feature 618c also at the distal end. The distal recess 618a can be adapted to accommodate the proximal end or feature of a flow hub such that the communication and alignment between the flow hub and the slider is supported by theinsertion of a flow hub protrusion into recess 618a. The contact portion 616 of slider 615 is again configured to be positioned outside of the handle while the slider body 617 is positioned inside the handle and aligned with the flow hub and cannula. Separating region 618 is also configured to extend through a handle slot and maintain a position of the slider 615 in and on the handle.

[0107] In some examples, the slider protrusion is generally axially aligned with the slider body and the cannula. FIGS. 33A-33C illustrate various views of another example of a flow hub 610 including an elongated body 610a and a lumen recess 610b similar to the slider described in FIG. 30 A. The slider arm 613 terminates proximally with the opening of lumen segment 613a. At the distal end of the flow hub body 610a, a distal lumen segment 612 is also extending through the slider body 610a to the slider lumen recess 610b and may be configured to be in fluid communication with lumen segment 613a via a tube extending through the lumen recess 613b. Alternatively a tub may extend from the distal lumen segment 612 and on through the flow hub arm 613 to a vacutainer assembly. This flow hub example also includes flow hub tab 611 similarly adapted to be contacted by a user for translation of the flow hub 610 in a handle with or without being in communication with a slider.

[0108] In some examples, the flow hubs, sliders, or other components of a blood draw device may comprise alignment features that can be adapted to reduce friction between the component and the handle of a device. Referring still to FIG. 33A, alignment elements 610e can be configured to extend outward from the flow hub 610 and contact an interior surface of the handle to maintain axial alignment between the flow hub, cannula, slider, etc. within and extending though the handle.

[0109] FIGS. 34A and 34B add to details of a flow hub example where the arm 613 may be configured to couple with a flow hub port 614. Referring to FIG. 34A, the extension port 614 shows a lumen 614c extending between a first end 614a, configured to contact the flow hub arm 613, and a proximal opening 614b. Engagement features 614c can be configured to communicate with a vacutainer luer, if necessary. In this modular example, the flow hub 614 may be adaptable to operate with a vacutainer assembly directly coupled to the flow hub or with a vacutainer assembly in fluid communication with the cannula lumen including a tub extending through the flow hub body. In FIG. 34B, the profile also shows the alignment elements 610e and the proximal protrusion 610d all configured to promote alignment of the flow hub 610 and communication with the slider.

[0110] In some examples, the slider and / or flow hubs have a portion positioned within the handle interior a contact portion positioned outside of the handle through a slot or slit. The portion of the flow hub or slider that separates the contact portion from the body portioninside the handle may be further configured to be advanced against a sealable slit in the support surface of a handle. For example, the handle slots described herein may be a slot or a slit or a combination thereof. FIGS. 35A and 35B show distal perspective views of an example of a blood collection device handle 405, alone, including a slot 406 extending along a first length of the handle 405 and a slit 407 extending distally from the slot 406. The slot portion 406 can be configured to accommodate the portions of a flow hub and / or slider extending out of the handle interior. For example, the slot may allow for a stowed position of the flow hub and / or slider without unnecessary strain on the slit 407 until necessary (e.g., distal advancement to deploy the cannula). When the flow hub is advanced against the slit 407, the slit can be adapted to open around the flow hub extending out of the handle interior and seal behind the flow hub as it is advanced through the slit 407. In some examples, the handle slit can further seal the handle interior.

[0111] In any of the handle examples described herein, the proximal portion of the handle may be open to the handle interior (e.g., the handle is a tube with a lumen enclosed at the distal end with the male luer and the proximal end with a cap). In other examples, the handle proximal end may be closed to the handle interior. FIGS. 36A and 36B show a handle cap 401 with a distal surface 402 including recess 403 configured to receive a proximal perimeter of a handle where the proximal end of the handle is open. The cap 401 can allow for ease of manufacturing the handles and allow for subsequent sealing of the handle interior after placement and positioning of the flow hub, slider, etc. therein. As shown in FIG. 36B, the proximal side 404 of the cap 401 is closed or continuous to enclose the handle interior when the cap 401 is positioned thereon.

[0112] FIGS. 37 and 38 now show an example of the blood collection device using the slider 615 and flow hub 610 as well as cap 401 positioned on the proximal end of the handle 405. In this example, the vacutainer assembly 140 is in fluid communication with the cannula 120 (e.g., cannula lumen) by a tube 145 that extends from the vacutainer luer 135 to the flow hub arm 613 into the lumen segment 613a. Referring to the detailed view in FIG. 38, a second tube 145a extends between the flow hub lumen segments 613a and 612 across the lumen recess 613c to complete the flow path between the cannula proximal end 120b through the flow hub body 610a and on to the vacutainer assembly 140. In these examples, the handle 405 includes the slot portion 406 and the slit portion 407 positioned proximal to the flow hub tab 611. Accordingly, as the slider 615 and slider contact portion 616 are used to distally advance the flow hub 615 against the slit 407, the slit can open to accommodate the portions of the flow hub 610 and the slider 615 that extend from inside the handle to outside of the handle. As illustrated, the cap 401 at the proximal end of the handle seals the interior of thehandle while the slider and flow hub / vacutainer assembly are in the stowed position within the handle slot 407 at the handle proximal end.

[0113] Yet further examples of the flow hub may comprise features that allow for the flow hub to be used without a slider. FIGS. 39A-39C show another example of a flow hub now including a contacting portion 716 with a greater surface area than other examples (e.g., flow hub tabs) and configured to allow for distal and proximal movement of the flow hub without a slider. Accordingly, the overall dimensions of the blood draw device may be reduced as the slider may not be necessary in these examples allowing the overall length of the handle to be decreased. The flow hub 710 also has a body 710a with an elongated distal end including a distal lumen section 712 extending from the distal end 710b to the lumen recess 711. A proximal position of the flow hub body 710c can provide structural support along with the alignment features 710d to maintain both axial arrangement and alignment between the flow hub and the cannula within the handle. For example, when the contact portion is engaged by a user for distal or proximal movement, the flow hub will resist angular displacement of the distal end 710b and maintain axially alignment with the handle interior and the cannula. This example shows a flow hub arm 713 with a second lumen segment 713 extending between the lumen recess 711 and an opening at the proximal end of the arm 713 to receive or communicate with a vacutainer assembly.

[0114] FIG. 40 illustrates an example of a blood collection device with the flow hub 710 in FIG. 39A at the proximal position within the handle 405 as it may be in a stowed configuration without a separate slider feature as the flow hub contacting portion 716 can be used to facilitate movement of the flow hub 710 and vacutainer assembly 140 to deploy or retract the cannula 120. In this example, the slot 407 is shortened with the reduced length of the handle without the slider. Alignment features 710d are in contact with the handle interior and support the position of the flow hub 710 as well as reduced contact between the handle interior surface and the flow hub body 710a. The cannula 120 is in communication with the flow hub distal end 710b and the cannula lumen is in fluid communication with the vacutainer assembly 140 via tube 145 and tube segment 145a extending between the flow hub lumen 712 and lumen 713a. In some examples, the tube 145 may be configured to extend directly through the flow hub to communicate with the cannula. For example, the flow hub may therefore provide a routing for the tube between the cannula and the vacutainer assembly without the flow otherwise contacting the flow hub.

[0115] In any of the blood draw devices described herein, the vacutainer assembly coupling with the flow hub provides a significantly reduced length of flow between the cannula distal end and the vacutainer assembly. Accordingly, the flow rate from the vessel tothe vacutainer can be greatly improved with the reduction in length of the lumen. In some examples, the cannula may be required to have a diameter less than a catheter (e.g., indwelling catheter) as the devices herein can be adapted to establish or reestablish blood flow through the catheter. Accordingly, flow rate and hemolysis are of particular importance to the blood draw devices described herein. The configuration and arrangement of the lumens, flow hubs, slider, cannula, handle, etc. can be adapted to improve the flow rate and reduce hemolysis.

[0116] In some examples, the length of a device, and therefore the length of a lumen between the catheter distal end and a vacutainer may be further reduced when the flow hub is a plunger and the vacutainer is in fluid communication with the handle at a proximal end to minimize the length of a lumen between the vessel and the vacutainer. In some alternative examples, a blood draw device may have a vacutainer assembly in a fixed position on the handle as compared to the moving vacutainer assemblies described above coupled with a moving flow hub. For this, a flow hub may be a plunger adapted to advance a cannula in communication with the plunger distal end and a flow path opening along the plunger body configured to provide fluid communication with a fixed port on a handle when the plunger and cannula are sufficiently advanced out from the distal end of the device.

[0117] FIGS. 41A and 41B show an example of a flow hub as a plunger 810. The plunger 810 has a contacting element 616 separated from the plunger body 811 by an arm 819. The plunger body 811 has a length between a proximal end 811b and a distal end 811a. The distal end 811a can be configured to be in fluid communication with the cannula lumen as the cannula may be couple dot the plunger distal end 81 la. In this example of a plunger 810, there are additional features such as teeth 81 Id extending from the plunger body 811 and configured to engage the interior of a device handle either in a channel for alignment and / or a ratchet system configured to indicate position of the plunger 810 in the handle. Along a side of the plunger body 811 is an opening 812 extending along a length of the plunger body 811 from a distal end 812a to a proximal end 812b. The opening or flow path opening 812 can be configured to be in fluid communication with a vacutainer assembly attached to the handle and provide for adaptable deployment length of the cannula while maintaining fluid communication for a flow of blood through the cannula out of the flow path opening 812 and to the vacutainer assembly. As the plunger body 811 is positioned in the handle, alignment features 811c can support the alignment and reduce the contact or resistance between the plunger and the handle interior. Areas of reduced diameter around the plunger body 811 (e.g., 81 le) can be configured to engage a seal that may be used with the plunger to provide a fluidseal for the flow path opening to prevent the flow of blood outside of the flow path opening 812 and the vacutainer assembly, during use.

[0118] FIGS. 42 A and 42B how examples of the seal 820 that can be used with the plunger 810. The seal 812 extends from a proximal end 812b to a distal end 812a and comprises a plurality of annular elements 822 and 822a around the seal exterior. The annular elements 822 can provide sealing engagement between the seal 820 (and therefore plunger) and the handle interior. For example, each seal may provide a bulkhead seal preventing any flow of blood other than along the length of the plunger opening 812 and through the seal opening 821 with corresponding geometry and dimensions to the plunger opening 812. The elongated raised seal 822a is adapted to correspond to the plunger opening 812 and provides a seal around the flow path opening 812 while allowing for a continuous flow path when the plunger 810 is aligned with the vacutainer port on a handle.

[0119] Further adaptations of device handles are shown in FIG. 43 with the extension port 506 extending out of handle 505 with a lumen extending from the distal portion of the port 506 and into the handle interior. The handle 505 also comprises an enlarged slot 507 extending from a proximal end 507b. The perspective view from the distal end of the handle 505 also reveals a channel 508 positioned along a length of the handle and into the handle interior surface. Channel 508 may be configured to engage the teeth of a plunger 810 for alignment of the plunger through the handle 505. Additionally, or alternatively, a ratchet feature 509 may also be in position on the interior surface of the handle 505. The ratchet feature 509 may be configured to engage with teeth or corresponding ratchet elements on a plunger. The position of the ratchet feature 509 is adjacent to the port 506 and can be adapted to indicate when the plunger has been sufficiently advanced such that the flow path opening 812 is in fluid communication with the lumen extending through the port 506.Advantageously, a plunger may be advanceable from the handle proximal end 505b to the distal end 505a.

[0120] The larger slot 507 may be complemented by an additional handle seal illustrated in FIGS. 44A-44C. The seal 525 can be configured to enclose the handle interior by being positioned in the slot of a handle. The seal 525 is shown here with a slit 527 extending from a proximal area to a distal end 525a. Also shown at the proximal end of the seal 525 is an opening 526 adapted to accommodate the arm of a plunger extending from the plunger body within the handle (e.g., on one side of the seal 525) to the exterior of the handle. The slit 527 then extends from the opening 526 to the near the distal end of the seal 525a. The seal can be configured to seal the handle, promote alignment of the slider / plunger / flow hub.

[0121] FIG. 45 shows an example of a blood draw device including the handle 505 with the port 506 coupled to an extension tube 245 extending between the port 506 and a luer 235 configured to couple with a vacutainer assembly. Distal components such as the coupler 125c and male luer 130 are also shown for illustrative purposes and have been described throughout. The cannula 120 is extending from the plunger 810 and in the stowed configuration with the distal end in the male luer ready to be inserted in and through a catheter to access a blood vessel.

[0122] FIG. 46 shows the blood collection device from FIG. 45 now with the vacutainer assembly 140 in communication with the luer 235 and the extension tube 245 extending from the handle port 506. A clamp 243 is also provided and understood to control a flow of blood through the tube 245, in use. The plunger 810 is still in the proximal position in this stowed configuration. Accordingly, the flow path opening 812 is not in communication with the port 506. Therefore, the lumen is discontinuous from the distal end of the cannula to the blood collection device (e.g., vacutainer assembly). The teeth 81 Id and the alignment features 810c can also be seen here in position within the handle providing alignment support for the plunger 810. Accordingly, when the contact portion 816 is engaged by a user to advance the plunger 810 and deploy the cannula 120 from the distal end 130 of the device, the teeth 81 Id and alignment features 810c can prevent inadvertent rotation or flex of the plunger 810 when moved in the handle 505. The ratchet feature 509 is also shown here although not in contact with the plunger yet.

[0123] The detailed view of FIG. 47 reveals additional arrangement of the device shown in FIG. 46 with the flow path opening 812 of the plunger 810 aligned, but proximally positioned with the handle port 506. Accordingly, in this stowed configuration, there is no fluid communication and the lumen is discontinuous from the cannula 120 to the vacutainer assembly through the tube 245 in communication with the port 506. The handle 505 has the seal 825 positioned along the slot 507. From this view, it can be appreciated that the plunger 810 may be advanced using the contact portion 816 until the flow path opening 812 is in fluid alignment with the port 506. At that point, the lumen will be completed from the cannula to the tube 245 and vacutainer coupled to the luer 235. Additionally, the length of the flow path opening 812 allows for an initial fluid coupling between the cannula lumen and the vacutainer, which is maintained through further distal advancement of the plunger 812 until the plunger has been advanced to a maximum position distally in the handle 505 and the fluid communication may be disrupted is the flow path opening proximal end is advanced beyond the port 506. However, at any position of the plunger 810 while the flow path opening 812 is in fluid communication with the port, a flow of blood can continue to the vacutainer from thecannula 120. This allows for adaptability in the deployment length of the cannula. For example, the cannula 120 may be deployed to any length corresponding to the flow path opening 120. For example, the cannula 120 may be deployed from the distal end of the device to initiate a flow of blood when the flow path opening 812 is in fluid communication with the port 506. The user may then adjust the cannula deployment to account for any obstruction at the distal end of the cannula such as an obstruction or anatomic structure that may require additional or repetitive displacement in the deployment length of the cannula during use. The cannula 120 is in contact with the plunger distal end 811a and the lumen from the cannula continues through the plunger distal end 811a and through the plunger flow path opening 812. The seal 820 functions to maintain the alignment of the plunger 810 as well as prevent a flow of blood other than the flow path opening. For example, when the flow path opening is not in fluid alignment with the port 506, the seal can prevent any flow of blood from the cannula through the flow path opening to the interior of the handle. Additionally, the seal may also support an airlock or fluid clock within the plunger body and through the cannula lumen until the cannula is deployed into a vessel thereby eliminating an additional need to flush before drawing blood.

[0124] FIGS. 48A-48E show various views of male luers 230 and 330 examples that can be used with the device handles described herein. Referring to FIGS. 48A-48C, the male luer 230 has a distal portion 230a with a distal end opening to lumen distal end 233a that continues through the luer 230 to the proximal end 233b where the cannula can be configured to be locatable therethrough. The alignment feature 323 can be adapted to be positioned within the distal opening of a handle slot and provide further contact between the handle and the luer as well as align the luer 230 with the handle. Similar to luer 230, in FIGS. 48D and 48E, luer 330 also has a distal portion 330a and proximal end 330 with a lumen 333 extending therethrough and configured to accommodate the cannula as it extends through the male luer. Here, the luer 330 does not have an alignment feature and may be adapted for use with any of the handles described herein and including handles with a closed distal end (e.g., having a complete perimeter around the distal end).

[0125] FIGS. 49A-49C provide yet another example of a flow hub alternative embodiment now with the flow hub body 910a generally perpendicular to the flow hub arm 913 and the flow hub port 914. Similar to other flow hubs described herein, a coupling feature 915 is positioned at the distal end to the port 914 and configured to maintain a connection with a vacutainer assembly that can be in fluid communication with the lumen 914a extending through the flow hub port 914 and flow hub arm 913 to the flow hub distal end 910b. Referring to FIG. 49B, the proximal end of the flow hub body 910a includes recess910c that can be adapted to receive a slider distal end inserted therein. Of note, the lumen 912 can be seen extending through the flow hub body 910a from the distal end 910b through the proximal end. Accordingly, the sliders described herein may be configured to enclose this lumen and support a flow from the distal end 910b to the port 914. Alternatively, the sliders or flow hubs (e.g., 910) described herein may further comprise an accessible lumen through the slider and into the lumen 912 for an additional or alternative access point for blood flowing from a cannula through the flow hub.

[0126] 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.

[0127] 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. 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 a distal 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 forreleasable 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.

[0128] 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 Number PCT / US2021 / 054046 entitled “Intravascular Catheter With Integrated Guide Structure” filed 7 OCT 2021; International Application Number PCT / US2023 / 065556 entitled “Intravascular Catheter With Integrated Guide Structure” filed on 07 APR 2023; International Application Number PCT / US2023 / 074699 entitled Guide Element for Intravascular Access Device” filed on 20 SEP 2023; U.S. Provisional Patent Application 63 / 387,688 entitled “Hypodermic Needles and Methods of Manufacture” filed 15 DEC 2022; U.S. Provisional Patent Application 63 / 477,378 entitled “Intravascular Access Device” filed 27 DEC 2022; U.S. Provisional Patent Application 63 / 482,901 entitled “Guide Element for Intravascular Access” filed 02 FEB 2023, each of which is incorporated by reference herein in its entirety for all purposes.

[0129] In still other embodiments, aspects of the various alternatives described herein may include one or more features or variations taken from the methods and devices described in co-pending, commonly assigned U.S. Provisional Patent Application Ser. 63 / 587,438 entitled “Blood Collection Device and Methods of Use,” filed on October 2, 2023 (hereinafter, “ the ‘438 application”). In one exemplary embodiment, the slider and flow port embodiment of FIG. 5 may be used with a blood collection cannula having a range of different lengths so that the blood collection device may be paired with a catheter of a particular length as in FIGS. 54-60 of the ‘438 application. In yet another exemplary variation, the extension set described above with regard to FIGS. 16A-20 may be modified for use in the various embodiments of the ‘438 application. The ‘438 application is incorporated herein by reference for all purposes.

[0130] 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.

[0131] 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.

[0132] 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.

[0133] 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 " / ".

[0134] 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.

[0135] 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.

[0136] 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.

[0137] 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.

[0138] 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 alsounderstood 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, and ranges 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.

[0139] 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.

[0140] 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 an axial slot along a length of the handle between a proximal end and a distal end; a male luer positioned at the distal end of the handle and a coupler configured to engage a catheter assembly, wherein a distal end of the male luer extends distally beyond the coupler; a flow hub having a body disposed within an interior of the handle and an arm extending through the axial slot of the handle, the flow hub configured to be distally advanced along the axial slot; a cannula extending from a distal end of the flow hub body through a lumen of the male luer, the cannula comprising a lumen extending from a distal end into the flow hub body; and a vacutainer operably coupled to the flow hub arm and in communication with the cannula lumen.

2. The device of claim 1, wherein the flow hub body, cannula, and male luer lumen are axially aligned with a central axis of the handle.

3. The device of claim 1, wherein the male luer 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 extending from the catheter hub into a blood vessel.

4. The device of claim 3, further comprising a slider having a body positioned proximal to the flow hub body within the handle and configured to advance the flow hub distally to deploy the cannula through the catheter into the vessel.

5. The device of claim 1, further comprising a slider having a body positioned within the handle and an arm extending out of the axial slot, wherein the slider is adapted to translate the flow hub distally within the slot.

6. The device of claim 1, wherein the vacutainer is adapted to move with the flow hub.

7. The device of claim 1, wherein the flow hub is in operable communication with the vacutainer when the flow hub lateral opening is aligned with a port extending out from the handle, and wherein the vacutainer is coupled to the port.

8. The device of claim 1 or claim 7, wherein the device is configured to be used with more than one length of catheter, and a flow hub opening along a length of the flow hub body has a distal end and proximal end extending along a length of the flow hub body, wherein the flow hub opening is adapted to be fluidly coupled to an extension port of the handle at any position between the flow path opening distal end and proximal end.

9. The device of claim 1, further comprising slot seal positioned in the handle slot, the slot seal having an axial slit along a length of the slot seal configured to seal an interior of the handle and facilitate movement of the flow hub through the handle.

10. The device of claim 1, wherein the coupler comprises one or more engagement features configured to engage a catheter hub.

11. The device of claim 1, wherein the flow hub comprises a lumen extending from the distal end of the flow hub body in contact with the cannula lumen through the flow hub arm.

12. The device of claim 11, wherein the vacutainer is in communication with the lumen at the flow hub arm.

13. The device of claim 5, wherein a distal end of the slider is insertable into the flow hub body.

14. The device of claim 5, wherein the flow hub body is releasable engaged with the distal end of the slider body.

15. The device of claim 14, wherein the flow hub comprises a tab extending out of the handle and configured to be contacted for proximal movement of the flow hub after blood has been drawn into the vacutainer.

16. A blood collection device comprising: a handle having an axial slot extending along a length of the handle between the proximal end and the distal end; a male luer having a lumen extending through a protrusion at the distal side to a proximal end, wherein the male luer proximal end is configured to couple with the handle distal end; a coupler circumferentially engaged to the handle distal end and around a portion of the male luer; a flow hub having a body positioned inside the handle and a port extending out of the axial slot, wherein a lumen extends through the flow hub from the flow hub port to a cannula extending from a distal end of the flow hub body, the cannula comprising a lumen extending from the flow hub lumen to a distal end of the cannula; a slider in operable communication with the flow hub body and configured to be advanced within the axial slot to deploy the cannula distal end out from the male luer protrusion; and a vacutainer assembly in fluid communication with the flow hub lumen through the flow hub port.

17. The device of claim 16, wherein the flow hub body, cannula, male luer lumen are axially aligned with a central axis of the handle.

18. The device of claim 16, wherein the male luer 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 extending from the catheter hub into a blood vessel.

19. The device of claim 18, wherein the flow hub is configured to be advanced distally with the vacutainer assembly along the axial slot to advance the cannula distally beyond the male luer protrusion.

20. The device of claim 16, further comprising alignment rails extending axially along an interior of the handle and configured to contact the flow hub body.

21. The device of claim 17, wherein the vacutainer assembly is configured to be in fluid communication with a blood vessel when the cannula lumen is advanced through a catheter assembly and into the blood vessel.

22. The device of claim 18, wherein the vacutainer assembly is configured to move with the flow hub.

23. 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 flow hub through the distal end of the blood draw device handle and along the central axis of a catheter extending from the catheter hub into a patient blood vessel; advancing a collection assembly operably coupled to the flow hub through an axial slot of the blood draw device handle to advance the blood draw cannula through the catheter and into the vessel; moving a distal end of the blood draw cannula beyond a distal most end portion of the catheter and into the patient blood vessel; and establishing fluid communication between the patient blood vessel and the collection assembly after the distal most end of the cannula extends beyond the distal end of the catheter in the patient’s blood vessel.

24. The method of claim 23, further comprising advancing the flow hub and blood collection assembly distally within the axial slot with a slider positioned proximal to the flow hub until the blood draw cannula distal end is positioned within the blood vessel.

25. The method of claim 24, further comprising drawing blood into the blood collection assembly before retracting the flow hub to a proximal position within the handle.

26. A blood collection device comprising: a handle having an axial slot along a length of the handle between a proximal end and a distal end; a coupler positioned at the distal end of the handle, the coupler configured to engage a catheter assembly; a flow hub having a body disposed within an interior of the handle and an arm extending through the axial slot of the handle; a cannula extending from a distal end of the flow hub body through a lumen of the male luer, the cannula comprising a lumen extending from a distal end into the flow hub body; anda vacutainer coupled to the flow hub arm and in communication with the cannula lumen.

27. The blood collection device of claim 26, wherein a fluid path is selectively established through the cannula to the vacutainer when a distal tip of the cannula is extended distally beyond the coupler.

28. The blood collection device of claim 26, wherein the vacutainer is configured to move with the flow hub.

29. The blood collection device of claim 26, wherein a fluid lumen is continuous from the distal end of the cannula lumen to the vacutainer.

30. The blood collection device of claim 29, wherein the fluid lumen is air-locked until the flow hub is distally advanced along the axial slot to extend the distal end of the cannula beyond the coupler.

31. The blood collection device, of claim 26, wherein the vacutainer is coupled directly to the flow hub.

32. The blood collection device of claim 26, wherein a tube extends between the flow hub and the vacutainer.

33. The blood collection device of claim 26, wherein a lumen extends through the flow hub from a proximal end of the cannula to the vacutainer.

34. The blood collection device of claim 26, wherein the flow hub is configured to direct a flow of fluid from the cannula to the vacutainer.

35. The blood collection device of claim 26, further comprising a seal positioned in the handle and configured to provide a fluid seal around the cannula within the handle interior.

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