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 application claims the benefit of US Provisional Patent Application No. 63 / 588,685, titled “BLOOD COLLECTION DEVICE AND METHODS OF USE,” filed October 6, 2023, incorporated by reference herein in its entirety.INCORPORATION BY REFERENCE

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

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

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

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

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

[0007] In general, a blood collection device may comprise a handle having a first side and a second side wherein when coupled together form a closed proximal end, a distalsegment with an open distal end, an extension port positioned adjacent to the distal segment and an interior portion between the open distal end, the closed proximal end and in communication with the extension port. An elongate opening can be positioned along a length of the handle first side wherein the interior portion may be accessible through the elongate opening, a coupler having a proximal end and a distal end, a protrusion on the coupler distal end. The coupler proximal end can be adapted and configured to couple to the distal segment. A one-piece tube seal having a cylindrical body with an open distal end, an open or a closed proximal end and a seal arm wherein the one-piece tube seal is sized and shaped to fit within the interior portion. A sealing segment can be positioned along a length of the one-piece tube seal positioned to align with the elongate opening when the one-piece tube seal is within the interior portion. A slider body having a distal end and a proximal end, a slider arm extending from the body wherein when the slider body is within the one piece tube seal the slider arm protrudes through the sealing segment. A slider body lumen extending from the slider body distal end to a flow path opening along a length of the slider body. A cannula having a proximal end and a distal end and a cannula lumen extending from the cannula proximal end to the cannula distal end, the cannula proximal end is coupled to the slider body distal end so that the cannula lumen is in fluid communication with the slider body lumen.

[0008] This and any other embodiment described herein may further comprise one or more of the following. The handle first side and handle second side may be held together while the coupler proximal end is coupled to the distal segment. The extension port may be adapted and configured to couple to a vacutainer assembly. The slider body, cannula, and coupler protrusion may be axially aligned with a central axis of the handle. The coupler protrusion may be adapted to open at least one valve in a proximal face of a catheter hub so that in use, the cannula can be extended through a catheter extending from the catheter hub into a blood vessel. The slider may be configured to advance the cannula distally through the catheter into the vessel.

[0009] In some examples, the device (e.g., blood draw device) may further comprise a ratchet assembly positioned along a portion of the elongate opening of the handle first side and adapted to releasably engage with the slider arm. The device may further comprise a ratchet assembly with one or more ratchet features positioned along a length of an inner surface of the elongate opening adjacent an exterior surface of the handle first side. Engagement of the ratchet assembly with the slider arm corresponds to a length of cannula deployment or communication with the slider fluid pathway or a catheter length. The rachet assembly or one or more ratchet features is configured to provide a tactile indication or avisual indication of the slider body position relative to the extension port or the cannula distal end.

[0010] This and any other embodiment described herein may further comprise one or more of the following. The slider flow path opening may have a length wherein the distal movement of the slider will advance the cannula distal end beyond a distal most end of a catheter engaged to the coupler distal end. The slider flow path length may be sized for catheters having a length of .75” to 2.5”. The slider flow path length may be between .15” and 2”.

[0011] In some examples, when the slider is in an initial position adjacent to the proximal end of the one-piece tube seal and first advanced distally towards the coupler the cannula distal end is not in contact with a lumen of a catheter engaged with the coupler and the slider fluid port is not in fluid communication with the extension port. When the slider is further advanced distally towards the coupler the cannula lumen may be in fluid communication with the side port. When the slider is further advanced distally the cannula distal end is beyond a distal most end of a catheter engaged to the coupler distal end.

[0012] This and any other embodiment described herein may further comprise one or more of the following. The sealing segment may further comprise an axial slit along a length of the one-piece tube seal configured to seal an interior of the handle, wherein the slider arm and sealing segment are adapted and configured to releasably seal and reseal the sealing segment of the one-piece tube seal along the elongated slot as the slider is moved along the one-piece tube seal. The coupler proximal end may further comprise one or more locking features to engage the handle first side and the handle second side to secure the handle first part to the handle second part.

[0013] In some examples, the coupler distal end may be configured to releasably engage a proximal face of a catheter hub. The releasable engagement may be provided by axial movement of the coupler distal end onto a proximal end of the catheter hub. The releasable engagement may be provided by a friction fit between the protrusion and a valve in the catheter hub and a detent within an interior surface of the coupler distal end. The coupler distal end may comprise a detent around an interior surface adapted and configured to receive an exterior surface feature on the catheter hub. When the coupler proximal end is engaged to the distal segment and the one-piece tube seal may be within the interior portion the open distal end of the one-piece tube seal is adjacent the coupler proximal end.

[0014] In general, a blood collection device may comprise a coupler having a protrusion configured to engage a proximal face of a catheter hub, the coupler positioned at the distal end of a handle. A handle extension port positioned adjacent to the distal end of the handle;the extension port configured to couple to a vacutainer assembly. A slider having a body disposed within an interior of the handle and an arm extending through an axial slot extending along a length of the handle, the slider body having a lumen extending through from a distal end of the slider body to a flow path opening along a length of the slider body. A cannula extending from a distal end of the slider body, the cannula comprising a lumen extending from a distal end into the slider body. A one-piece tube seal disposed within the interior of the handle, wherein the one-piece tube seal having a cylindrical body along a length of the handle and a seal arm sized for the extension port wherein the slider is configured to move axially through an interior of the one-piece tube seal.

[0015] This and any other embodiment described herein may further comprise one or more of the following. The slider body, cannula, and coupler protrusion may be axially aligned with a central axis of the handle. The coupler protrusion may be adapted to open at least one valve in a proximal face of a catheter hub so that in use, the cannula can be extended through a catheter extending from the catheter hub into a blood vessel. The slider may be configured to advance the cannula distally through the catheter into the vessel until the flow path opening is in alignment with the extension port of the one-piece tube seal.

[0016] In some examples, the device may further comprise a ratchet assembly with a first ratchet element positioned on an interior of the axial slot and a second ratchet feature positioned on the slider arm, the second ratchet feature configured to engage the first ratchet feature when the slider is advanced distally within the handle. The first ratchet element may further comprise a plurality of teeth along a length of the ratchet feature, wherein the plurality of teeth correspond to a length of cannula deployment when the second ratchet feature is in communication with the first ratchet feature. The first ratchet element may have a length configured to provide tactile indication of the slider body relative to the extension port.

[0017] In some examples, the device may be configured to be used with more than one length of catheter, and the slider flow path opening has a distal end and proximal end extending along a length of the slider body, wherein the flow path opening is adapted to be fluidly coupled to the extension port at any position between the flow path opening distal end and proximal end.

[0018] This and any other embodiment described herein may further comprise one or more of the following. The device may further comprise an axial slot seal configured to seal an interior of the handle, the axial slot seal having a sealable slit configured to facilitate movement of the slider through the handle. The coupler protrusion may further comprise a male luer proximal segment and an extension segment distal to the male luer proximal segment, the extension segment configured to be positioned adjacent to a proximal end of acatheter extending distally from the catheter hub. The coupler may be configured to releasably engage the catheter hub.The releasable engagement may be provided by axial movement of the device to a proximal face of the catheter hub. The releasable engagement may be provided by rotational movement of the handle onto the catheter hub. The releasable engagement may be provided by at least one deformable component, spring loaded component, or a magnetic component positioned on the coupler and configured to engage the catheter hub. The handle may comprise a first side and a second side, wherein the handle first side is attached to the handle second side by one or more attachment features and the coupler is configured to receive a distal end of the handle first side and handle second side.

[0019] In general, a method of assembling a blood draw device for drawing blood from a blood vessel may comprise the steps of providing a tube seal with a seal arm extending outward and adjacent to a distal end of the tube seal. Positioning a slider body in an interior of the tube seal, where a slider arm extends out of an angled slit extending along a length of the tube seal and a cannula extending through the tube seal from the distal end of the slider body, wherein a lumen extends through the cannula and to a flow path opening along a length of the slider body. Positioning the tube seal between a first handle portion and a second handle portion, wherein the first handle portion comprises a first extension port segment and an axial slot along a length of the first handle portion, and wherein the second handle portion comprises a second extension port segment configured to align with the first extension port segment. Positioning a proximal side of a coupler over the distal end of the first handle portion and the second handle portion to retain communication between the first handle portion and the second handle portion, wherein the coupler has a lumen axially aligned with the tube seal and the cannula, wherein the cannula distal end is positioned in the coupler lumen and configured to be deployed therefrom.

[0020] In general, a method of drawing blood through a catheter may comprise the steps of engaging a catheter hub with a distal end of the blood draw device described herein, wherein the engaging step aligns a blood draw cannula lumen extending from a slider through the distal end of the blood draw device handle and along the central longitudinal axis of a catheter extending from the catheter hub into a patient blood vessel. Advancing the slider body with a moveable side port through a tube seal until the slider body is in communication with the proximal most end of the cannula lumen along a handle towards the catheter hub. Moving a distal most end portion of the blood draw catheter beyond a distal most end portion of the catheter and into the patient blood vessel. Establishing fluid communication between the patient blood vessel and a side port of the blood draw device handle only after the distalmost end of the cannula extends beyond the distal end of the catheter in the patient’s blood vessel.

[0021] In general, a blood collection device may comprise a handle comprising a first part adapted to couple with a second part, the handle having a proximal end, a distal end, an interior space, a slot along a surface of the handle providing access to the interior space and a blood collection side port in communication with the interior space. A slider having a body, an aperture, a side port wherein fluid communication between the side port and the aperture is through the body. A blood draw cannula having a proximal end, a distal end, a length from the proximal end to the distal end wherein the cannula proximal end is coupled to the slider aperture. When the distal end of the handle is coupled to a proximal portion of a vascular access catheter hub, the length of the blood draw cannula may be configured to extend beyond the distal most end of a vascular catheter when the slider is positioned along the slot in a position that allows fluid communication from the blood collection catheter distal end to the blood collection side port.

[0022] This and any other embodiment described herein may further comprise one or more of the following. A distal end of the handle first part and handle second part may be adapted to form a distal handle segment with a reduced diameter adapted to insert into the proximal side of a coupler, the coupler adapted to lock the handle first side and handle second side to one another. The seal may form the interior of the handle and has a bifurcation adapted to extend and seal the blood collection side port. The blood collection device may further comprise a plurality of stabilizing mounts arranged on an exterior surface of the slider positioned to maintain the seal in apposition with the handle interior while moving the slider along the slot. The seal may be coupled to the interior of the handle so as to close off the handle interior. The slider side port may remain in sealed relation to the tubular seal until movement of the slider along the slot establishes fluid communication between the blood collection catheter distal end and the seal bifurcation in the handle side port. The distal end of the handle may be adapted and configured for releasable engagement with a proximal portion of the vascular catheter hub so as to provide axial alignment between a lumen of the vascular catheter and the blood collection cannula. The distal end of the handle may be adapted and configured to open one or more valves or closures in the proximal portion of vascular catheter hub.

[0023] In general, a blood collection device for use with an indwelling catheter, may comprise a housing having a first portion and a second portion. A side port in the housing can be formed when the first portion is coupled to the second portion. A slot in a surface of the first portion providing access to a housing interior volume formed when the first portion iscoupled to the second portion, a distal end piece adapted and configured to be coupled on, in or within a distal end of the housing when the first portion is coupled to the second portion.

[0024] This and any other embodiment described herein may further comprise one or more of the following. The blood collection device may further comprise a slider sized and positioned to have a body within the housing interior volume and an arm that extends through the slot and a blood collection cannula coupled to the slider and adapted and configured to advance through the distal end piece when the slider is advanced along the slot. The slider may further comprise a side port in communication with the first portion of the blood collection device wherein when the slider is advanced to a distal position in the slot the blood collection cannula distal end is beyond the distal end piece and the slider side port is at least partially aligned with the housing side port.

[0025] In general, a blood collection device may comprise a handle having a proximal end and a distal end and defining an interior volume. A coupling feature on the distal end of the handle with an aperture in communication with the interior volume. An axial slot along the handle providing communication to the interior volume from outside of the handle. A side port in the handle with a coupling member sized for engagement with a fluid handling accessory. A unitary sealing member within the handle having a resealable axial seal for temporary, resealable opening of the axial slot, a distal end portion to seal the aperture and a side portion having an outer dimension adapted and configured for placement within the side port and interior dimension for sealed coupling to the fluid handling accessory.

[0026] This and any other embodiment described herein may further comprise one or more of the following. The blood collection device may further comprise a slider sized and positioned to have a body within the housing interior volume and an arm that extends through the slot and a blood collection cannula coupled to the slider and adapted and configured to advance through the coupling feature when the slider is advanced along the slot. The slider further comprising a side port in communication with the distal end of the blood collection device wherein when the slider may be advanced to a distal position in the slot the blood collection cannula distal end is beyond the coupling feature and the slider side port is at least partially aligned with the housing side port.

[0027] In general, an intravascular catheter may comprise a catheter body having a proximal end and a distal end defining an interior volume. A tube extending from the catheter body having a lumen in communication the interior volume wherein a distal end portion of the tube is adapted and configured for integrated use with a guide element. A first seal on a proximal most portion of the catheter body and a second seal within the interior volume andadjacent to the first seal. A side port in the catheter body defining a lumen in communication with only the interior volume, the lumen and the second seal.

[0028] This and any other embodiment described herein may further comprise one or more of the following. The device may further comprise a base coupled to the catheter body. The device may further comprise at least one feature on the catheter body or the side port to facilitate coupling with a fluid handling accessory.

[0029] In general, a fluid coupler for use with an intravascular catheter may comprise a distal end adapted and configured to releasably couple to an opening in fluid communication with a catheter body. An extension housing with a proximal end and a distal end defining an interior volume in communication with the distal end. A first seal on a proximal most portion of the housing and a second seal within the interior volume and adjacent to the first seal. A side port in the extension housing defining a lumen in communication with only the interior volume, the opening in fluid communication with the catheter and the second seal.

[0030] In general, a blood collection device may comprise a handle having a first side couplable to a second side with an axial slot along a length of the first handle side; a coupler having a protrusion configured to engage a catheter, the coupler adapted to receive a distal segment of the handle first side and handle second side; a tube seal within the handle having a seal arm positionable within an extension port extending outward from the handle, the extension port positioned adjacent to the distal end of the handle, and configured to couple to a vacutainer assembly; a slider having a body disposed within an interior of the tube seal and an arm extending through an axial slot extending along a length of the handle, the slider body having a lumen extending through from a distal end of the slider body to a flow path opening along a length of the slider body, the slider configured to move axially along a length of the handle; and a cannula extending from a distal end of the slider body, the cannula comprising a lumen extending from a distal end into the slider body.

[0031] This and any other embodiment described herein may further comprise one or more of the following. The slider body, cannula, and coupler protrusion may be axially aligned with a central axis of the handle. The coupler protrusion may be adapted to open at least one valve in a proximal face of a catheter hub so that in use, the cannula can be extended through a catheter extending from the catheter hub into a blood vessel. The slider is configured to advance the cannula distally through the catheter into the vessel. The device may further comprise a ratchet assembly positioned on the axial slot of the handle and adapted to communicate with the slider arm extending therethrough. The ratchet assembly comprises a plurality of teeth along a length of one or more ratchet features positioned along a length of the axial slot, wherein a plurality of teeth correspond to a length of cannuladeployment when the ratchet feature may be in communication with the slider arm. The one or more ratchet features have a length configured to provide tactile indication of the slider body relative to the extension port. The device may be configured to be used with more than one length of catheter, and the slider flow path opening has a distal end and proximal end extending along a length of the slider body, wherein the flow path opening may be adapted to be fluidly coupled to the extension port at any position between the flow path opening distal end and proximal end. The device may further comprise an axial slit along a length of the tube seal configured to seal an interior of the handle and facilitate movement of the slider through the handle. The coupler comprises one or more locking features configured to engage the first handle part and second handle part to lock the first handle part to the second handle part. The coupler may be configured to releasably engage a valve positioned at a proximal end of a catheter hub. The releasable engagement may be provided by axial movement of the device to a proximal face of the catheter hub. The releasable engagement may be provided by a friction fit between the valve and a detent within the distal end of the coupler. The releasable engagement may be provided by at least one deformable component, spring loaded component, or a magnetic component positioned on the coupler and configured to engage the catheter hub. The releasable engagement may be provided by a level, latch, button or release feature on the handle, on the hub or a combination of the handle and the hub.

[0032] In general, a blood collection device may comprise a coupler having a protrusion configured to engage a catheter, the coupler positioned at the distal end of a handle; a handle extension port positioned adjacent to the distal end of the handle, the extension port configured to couple to a vacutainer assembly; a slider having a body disposed within an interior of the handle and an arm extending through an axial slot extending along a length of the handle, the slider body having a lumen extending through from a distal end of the slider body to a flow path opening along a length of the slider body; a cannula extending from a distal end of the slider body, the cannula comprising a lumen extending from a distal end into the slider body; and a tube seal disposed within the interior of the handle, wherein the tube seal has an extension port positionable within the handle extension port, wherein the slider is configured to move axially through an interior of the tube seal.

[0033] This and any other embodiment described herein may further comprise one or more of the following. The slider body, cannula, and coupler protrusion may be axially aligned with a central axis of the handle. The coupler protrusion may be adapted to open at least one valve in a proximal face of a catheter hub so that in use, the cannula can be extended through a catheter extending from the catheter hub into a blood vessel. The slider may be configured to advance the cannula distally through the catheter into the vessel. Thedevice may further comprise a ratchet assembly with a first ratchet element positioned on an interior of the axial slot and a second ratchet feature positioned on the slider arm, the second ratchet feature configured to engage the first ratchet feature when the slider is advanced distally within the handle. The first ratchet feature comprises a plurality of teeth along a length of the ratchet feature, wherein the plurality of teeth correspond to a length of cannula deployment when the second ratchet feature is in communication with the first ratchet feature. The first ratchet feature has a length configured to provide tactile indication of the slider body relative to the extension port. The device can be configured to be used with more than one length of catheter, and the slider flow path opening has a distal end and proximal end extending along a length of the slider body, wherein the flow path opening may be adapted to be fluidly coupled to the extension port at any position between the flow path opening distal end and proximal end.

[0034] The device may further comprise an axial slot seal configured to seal an interior of the handle, the axial slot seal having a sealable slit configured to facilitate movement of the slider through the handle. The coupler comprises one or more alignment features configured to align a catheter hub coupled to the device. The coupler may be configured to releasably engage a catheter hub. The releasable engagement may be provided by axial movement of the device to a proximal face of the catheter hub. The releasable engagement may be provided by rotational movement of the handle onto the catheter hub. The releasable engagement may be provided by at least one deformable component, spring loaded component, or a magnetic component positioned on the coupler and configured to engage the catheter hub. The handle may comprise a first side and a second side, wherein the handle first side may be attached to the handle second side by one or more attachment features and the coupler may be configured to receive a distal end of the handle first side and handle second side.

[0035] In general, a method of drawing blood through a catheter may 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 slider through the distal end of the blood draw device handle and along the central longitudinal axis of a catheter extending from the catheter hub into a patient blood vessel; advancing the slider body through a tube seal extending through the interior of the handle until a flow path opening of the slider may be in communication with an extension port segment of the tube seal positioned within an extension port of the handle; moving a distal most end portion of the blood draw catheter beyond a distal most end portion of the catheter and into the patient blood vessel; and establishing fluid communication between the patient blood vessel and acollection assembly coupled to the blood draw device handle only after the distal most end of the cannula extends beyond the distal end of the catheter in the patient’s blood vessel.

[0036] In general, a method of drawing blood through a catheter may comprise the steps of engaging a catheter hub with a distal end of the blood draw device described herein, wherein the engaging step aligns a blood draw cannula lumen extending from a slider through the distal end of the blood draw device handle and along the central longitudinal axis of a catheter extending from the catheter hub into a patient blood vessel; advancing the slider body with a moveable side port through a tube seal until the slider body may be in communication with the proximal most end of the cannula lumen along a handle towards the catheter hub; moving a distal most end portion of the blood draw catheter beyond a distal most end portion of the catheter and into the patient blood vessel; establishing fluid communication between the patient blood vessel and a side port of the blood draw device handle only after the distal most end of the cannula extends beyond the distal end of the catheter in the patient’s blood vessel.

[0037] In general, a blood collection device may comprise a handle comprising a first part adapted to couple with a second part, the handle having a proximal end, a distal end, an interior space, a slot along a surface of the handle providing access to the interior space and a blood collection side port in communication with the interior space; a slider having a body, an aperture, a side port wherein fluid communication between the side port and the aperture may be through the body; and a blood draw cannula having a proximal end, a distal end, a length from the proximal end to the distal end wherein the cannula proximal end may be coupled to the slider aperture. In some examples, when the distal end of the handle may be coupled to a proximal portion of a vascular access catheter hub, the length of the blood draw cannula may be configured to extend beyond the distal most end of a vascular catheter when the slider may be positioned along the slot in a position that allows fluid communication from the blood collection catheter distal end to the blood collection side port.

[0038] This and any other embodiment described herein may further comprise one or more of the following. A distal end of the handle first part and handle second part may be adapted to form a distal handle segment with a reduced diameter adapted to insert into the proximal side of a coupler, the coupler adapted to lock the handle first side and handle second side to one another. The seal can form the interior of the handle and may have a bifurcation adapted to extend and seal the blood collection side port. The blood collection device may further comprise a plurality of stabilizing mounts arranged on an exterior surface of the slider positioned to maintain the seal in apposition with the handle interior while moving the slider along the slot. The seal may be coupled to the interior of the handle so as to close off thehandle interior. The slider side port remains in sealed relation to the tubular seal until movement of the slider along the slot establishes fluid communication between the blood collection catheter distal end and the seal bifurcation in the handle side port. The distal end of the handle can be adapted and configured for releasable engagement with a proximal portion of the vascular catheter hub so as to provide axial alignment between a lumen of the vascular catheter and the blood collection cannula. The distal end of the handle can be adapted and configured to open one or more valves or closures in the proximal portion of vascular catheter hub. The method of drawing blood may be performed using a blood collection device as described and claimed herein.

[0039] In general, a blood collection device for use with an indwelling catheter may comprise a housing having a first portion and a second portion; a side port in the housing formed when the first portion may be coupled to the second portion; a slot in a surface of the first portion providing access to a housing interior volume formed when the first portion may be coupled to the second portion; and a distal end piece adapted and configured to be coupled on, in or within a distal end of the housing when the first portion may be coupled to the second portion.

[0040] In this and any other embodiment described herein may further comprise one or more of the following. A slider sized and positioned to have a body within the housing interior volume and an arm that extends through the slot and a blood collection cannula coupled to the slider and adapted and configured to advance through the distal end piece when the slider may be advanced along the slot. The slider may further comprise a side port in communication with the first portion of the blood collection device wherein when the slider may be advanced to a distal position in the slot the blood collection cannula distal end may be beyond the distal end piece and the slider side port may be at least partially aligned with the housing side port.

[0041] In general, a blood collection device may comprise a handle having a proximal end and a distal end and defining an interior volume; a coupling feature on the distal end of the handle with an aperture in communication with the interior volume; an axial slot along the handle providing communication to the interior volume from outside of the handle; a side port in the handle with a coupling member sized for engagement with a fluid handling accessory; and a unitary sealing member within the handle having a resealable axial seal for temporary, resealable opening of the axial slot, a distal end portion to seal the aperture and a side portion having an outer dimension adapted and configured for placement within the side port and interior dimension for sealed coupling to the fluid handling assessor.

[0042] This and other embodiments described herein may further comprise one or more of the following. The device may further comprise a slider sized and positioned to have a body within the housing interior volume and an arm that extends through the slot and a blood collection cannula coupled to the slider and adapted and configured to advance through the coupling feature when the slider may be advanced along the slot. The blood collection device may further comprise a side port in communication with the distal end of the blood collection device wherein when the slider may be advanced to a distal position in the slot the blood collection cannula distal end may be beyond the coupling feature and the slider side port may be at least partially aligned with the housing side port.

[0043] In general, an intravascular catheter may comprise a catheter body having a proximal end and a distal end defining an interior volume; a tube extending from the catheter body having a lumen in communication the interior volume wherein a distal end portion of the tube may be adapted and configured for integrated use with a guide element; a first seal on a proximal most portion of the catheter body and a second seal within the interior volume and adjacent to the first seal; and a side port in the catheter body defining a lumen in communication with only the interior volume, the lumen and the second seal. The device may further comprise a base coupled to the catheter body. The device may further comprise at least one feature on the catheter body or the side port to facilitate coupling with a fluid handling accessory.

[0044] In general, a fluid coupler for use with an intravascular catheter may comprise a distal end adapted and configured to releasably couple to an opening in fluid communication with a catheter body; an extension housing having a proximal end and a distal end defining an interior volume in communication with the distal end; a first seal on a proximal most portion of the housing and a second seal within the interior volume and adjacent to the first seal; and a side port in the extension housing defining a lumen in communication with only the interior volume, the opening in fluid communication with the catheter and the second seal.BRIEF DESCRIPTION OF THE DRAWINGS

[0045] 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:

[0046] FIG. l is a perspective view of a blood collection device having a two-part housing and an integral housing seal. The integral housing seal includes a proximal end, a distal end, a resealable slot seal and a Y-seal for a housing side-port connection. The Y-sealhas an arm extending into and along a connection adapted for use with a blood collection assembly. The distal end of the two-part handle may be secured with a distal end piece adapted for releasable connection to a catheter hub.

[0047] FIG. 2 is a cross section view of the blood collection device of FIG. 1. Details of a ratchet system along the slot are visible in this view. Not visible in this view are the complementary ratchet element on the slider arm positioned to engage the teeth positions within the slider slot.

[0048] FIG. 3 is an exploded view of the blood collection device of FIG. 1. Details are shown of elements comprising the device including a first part and second part of the handle, tube seal, coupler, slider and cannula.

[0049] FIG. 4 shows the blood collection device of FIG 1 in a side elevation view from the opposite side shown in FIG. 1 highlighting connection features between the first side and second side of the handle. The slider is positioned in the proximal end of the handle in the stowed position ready to be deployed. In this example, the blood collection device is configured to be used with a variety of catheter lengths as the slider has an elongated body positioned within the handle to facilitate fluid communication with the vacutainer assembly during advancement through several positions.

[0050] FIG. 5 is a side view of a slider having a side port configured for use with a single catheter length. The arm may be further modified for use with the slot mounted rachet system (see slider of FIG. 6).

[0051] FIG. 6 is a side view of a slider having a side port configured for use with a multiple different length catheter lumens. The arm connecting the slider body to the tab contains one or more features positioned for engagement with the slot ratchet system. The arm includes an angled and contoured shaped section configured to engage with the slot seal portion of the tube seal.

[0052] FIG. 7A is a perspective view of the handle one-piece tube seal with Y-connector and slot seal.

[0053] FIG. 7B is a cross section view of the tube seal of FIG. 7A from the distal end taken along section H-H illustrating the detail of the ”Y”-style connector for use with tubing of a blood collection assembly.

[0054] FIG. 7C is a perspective view of another embodiment of the handle tube seal having a closed or sealed proximal end.

[0055] FIG. 7D is a cross-section view of the tube seal from FIG. 7C from the distal end taken along section Z-Z highlighting the example of a closed proximal end seen through the tube seal from the distal side.

[0056] FIG. 7E is a side elevation view of the tube seal from FIG. 7A.

[0057] FIG. 8 is a left side, perspective and section view of a slider within a portion of the tube seal positioned within the handle interior. The arm of the handle is in position to engage with the slot ratchet system shown in FIG. 2. The raised seal portion of the tube seal is configured to seal around the slider arm.

[0058] FIG. 9 is a perspective view of an exemplary sealed catheter hub having side port, tubing, fluid connection and closure clip. The proximal end of the catheter hub is accessible via one or more seals.

[0059] FIG. 10 shows a sealed catheter hub of FIG. 9 in an exploded view including interior seal configured to be positioned inside of the catheter hub and coupling seal configured to couple with the blood collection device handle.

[0060] FIG. 11 is an exemplary orientation of the catheter of FIG. 10 when in use in a patient as an in-dwelling catheter. A blood collection device of FIG. 1 is shown in a position to engage with the proximal end of the catheter hub.

[0061] FIG. 12 is a perspective view of the blood collection device engaged with the proximal end of the catheter hub. Once engaged, the blood collection catheter is in axial alignment with the lumen of the catheter.

[0062] FIG. 13 is a top perspective section view of the engaged blood collection device and catheter shown in FIG. 12. In this view the distal end and full circumference portion of the tube seal can be seen in position against the distal end piece. The full circumference sealing portion is placed about the shaped proximal opening of the distal end. The shaped proximal opening is sized and shaped to engage with the distal most end of the slider body. The Y-tube portion of the tubular seal is also shown within the handle side port. A collection tube with clip is in positioned in the Y-tube.

[0063] FIGS. 14A and 14B are additional section views of the blood collection device and catheter of FIG. 12. Added details of tube seal and male luer engagement with the closed system. Also visible in FIG. 14B is the shape of the distal end of the slider and the correspondence with the proximal opening of the distal end piece.

[0064] FIGS. 14C to 14F are detailed views of the coupler from FIGS. 14A and 14B.

[0065] FIG. 14G is an alternative embodiment of the coupler with a protruding feature configured to engage a catheter hub including an extension distally positioned to a male luer at the distal end of the coupler.

[0066] FIG. 15A is a section view of the coupled blood collection device and catheter hub of FIG. 9 with the slider advanced to a position where the slider side portion has established initial fluid communication with the Y-seal and attached tube.

[0067] FIG. 15B is the blood collection device of FIG. 13 with the slider advanced to a distal most position. The distal end of the slider is seated into the shaped proximal opening of the distal end piece and the proximal most end of the slider side port is aligned with the Y- seal. In this configuration the distal end of the blood collection cannula may be at a maximum extended length beyond the distal end of the catheter lumen and still be in fluid communication with the handle side port and Y-seal.

[0068] FIGS. 16A and 16B are perspective and cross section views respectively of an extension set for use with a conventional catheter assembly. A conventional catheter assembly has a proximal opening that is an unsealed fluid connection. Normally capped off then not in use. The extension set has a distal end for engagement with a proximal portion of the catheter hub and a proximal portion for sealed engagement with a distal end portion of a blood collection handle. A locking collar is used to retain the extension set in place during use.

[0069] FIG. 17 is a perspective view of an embodiment of a blood collection device in position to engage with a proximal portion of an extension set and conventional catheter of FIG. 16 A.

[0070] FIG. 18 is a perspective and section view of the components in FIG. 17.

[0071] FIG. 19 is a perspective view of an embodiment of a blood collection device engaged with a proximal portion of an extension set and conventional catheter of FIG. 16 A. The blood collection device is shown in an initial or ready to draw sample position. A vacutainer is coupled to the handle side port and the slider is in the proximal most position in the handle slot. The distal most end of the blood collection cannula is still within the housing interior portion. As a result, fluid communication from the distal end of the catheter lumen to the vacutainer has not been established.

[0072] FIG. 20 is a perspective and section view of the components in FIG. 19. The engagement of the distal end of the blood collection device with the proximal end of the extension set is visible in this view. The distal end of the blood collection device is configured for releasable engagement with the proximal end of the extension set as well as to open any valves within the extension set housing.DETAILED DESCRIPTION

[0073] 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 an elongate opening (e.g., slot) froma 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.

[0074] FIG. 1 is a perspective view of an exemplary blood collection device 100 having a two-part housing 105 and an integral housing seal 110. The integral housing seal 110 (e.g., Y-seal) includes a proximal end, a distal end, a resealable slot seal and a Y-seal (e.g., bifurcation) for a housing side-port connection 130. The Y-seal has an arm extending into and along a connection adapted for use with a blood collection assembly. The distal end of the two-part handle may be secured with a coupler 135 adapted for releasable connection to a catheter hub.

[0075] The coupler 135 may include a protruding feature 140 with a lumen extending therethrough adapted to allow the cannula to extend from the distal end of the housing. The protruding feature 140 can be configured to extend into a catheter hub and facilitate deployment of the cannula 120 through the catheter into the vessel during use. The two-part housing 105 has a slot 108 extending from a proximal end of the housing 105 to a distal position near the side port connection 130. A slider 250 is shown in a proximal position within the slot 108 in FIG. 1 at the end of the housing 105 opposite ratchet elements 125. A vacutainer assembly 150 adapted to receive fluids, when flowing through the tubing 145, is in communication with the side port 130. The two parts of the housing 105 are coupled together with housing attachment features 126 locatable at one or more positions where the two parts of the housing contact one another.

[0076] FIG. 2 is a cross section view of the blood collection device of FIG. 1. Details of a ratchet system 125 along the slot 108 are visible in this view. Not visible in this view are the complementary ratchet element on the slider arm positioned to engage the teeth positions within the slider slot. The ratchet system 125 is shown with a distal ratchet element 125a and a proximal ratchet element 125b. As described herein, the ratchet system can be configured to communicate with the slider in an advanced position within the handle slot. The communication between the ratchet system and the slider can be adapted to provide feedback on the position of the slider distal placement and corresponding length of cannula deployment through the catheter. For example, the slider may contact proximal ratchet element 125a and on initial contact (e.g., communication between the slider and the ratchet system) the cannulamay be at, near, proximal to, aligned with, etc. the distal tip of the catheter. Then, additional advancement of the slider through the slot and ratchet elements may indicate further deployment of the cannula such as a length of cannula extending beyond the catheter distal tip within the vessel.

[0077] In some examples, the ratchet system includes ratchet elements (e.g., 125a / 125b) locatable on an interior surface of the housing slot. For example, the ratchet elements 125a and 125b may be positioned on or around the slot perimeter between an exterior surface and interior surface of the housing. In some examples, positioning of the ratchet system elements on the housing may be adapted to communicate with corresponding ratchet elements positions on the slider (e.g., slider arm) as it is extending through the housing slot.

[0078] The cross-section view of FIG. 2 also illustrates an exemplary position of the Y- seal 110 through the housing 105. In some examples, the distal end of the Y-seal 110 may be adjacent to a proximal face of the coupler 135. The axial alignment of the cannula 120 and the slider body within the Y-seal 110 is visible through the coupler protrusion feature 140. The coupler 135 is shown coupled to the distal end of the handle 105 at the distal face of the handle 105a. The proximal side of the coupler 135 can be adapted to receive a portion of the handle distal end therein.

[0079] FIG. 3 is an exploded view of the blood collection device of FIG. 1. Details are shown of elements comprising the device 100 including a first part 106 and second part 107 of the handle 105, tube seal (e.g., Y-seal) 110, coupler 135, slider 250 and cannula 120. The tube seal including the bifurcated arm 112 adapted to extend into the side port 130 is shown. An opening 113 near the tube seal proximal end 110a can be configured to facilitate a position of the slider 250 when in a stowed position. The opening 113 may allow the slider arm to extend therethrough without opening the tube seal slit 111. The tube seal slit 111 extends from the tube seal proximal end 110a towards the distal end 110b. In some examples, the tube seal slit 111 may extend along a length of the tube seal corresponding to the length of the slider slot 108. The segment of the tube seal 110 distal to the tube seal slit 111 is shown as a continuous tube without a slit. In some examples, the slit may extend to any apposition between the proximal end 110a and distal end 110b, including extending along the entire length of the tube seal 110.

[0080] The two-part handle 105 is shown in FIG. 3 including a first part 106 and a second part 107. Both the first and second part include a distal end with a smaller diameter than the remaining proximal length. For example, the first part distal end 106a and the second part distal end 107a can be configured to couple with one another and insert into the coupler proximal side 136. In some examples, the coupler provides a locking mechanism for the two-part handle configuration to support the connection between the first part 106 and second part 107. For example, the coupler 135 can be adapted to lock and support an engagement between first part 106 and second part 107 by receiving the combined distal segment (e.g., 106a and 107a). As illustrated in the exploded view of FIG. 3, assembly of the device can include aligning the first handle part 106 and the second handle part 107 with the tube seal 110. Aligning the tube seal 110 with the first handle part 106 may also include aligning the tube seal slit 111 with the slot 108 such that the slider arm may be initially positioned through opening 113 with the cannula 120 extending from the slider 250 and through the interior of the tube seal 111. Further aligning of the first handle part 106, second handle part 107 and the tube seal 110 can include positioning the tube seal bifurcation 112 extending out of the tube seal 110 at an angle and adapted to provide a seal through the side port 130 of the completed handle. Aligning the tube seal bifurcation 112 can include aligning the bifurcation portion of the tube seal 112 between the two portions of the handle extension port 130. For example, the first handle part having first side port segment 130a that is aligned with an upper portion of the tube seal bifurcation 112 and the second handle part having second side port segment 130b correspondingly aligned with the bottom of the tube seal bifurcation 112. When the handle parts and the tube seal features are aligned, the first handle part and second handle part can be locked together with handle attachment features.

[0081] Handle attachment features 126 are shown separated to include attachment features 126a and corresponding attachment features 126b of the second part 107. Each attachment feature of a handle part may be aligned with one another and adapted to connect the first part and second part of the handle 105. In some examples, the handle parts (e.g., 106 and 107) may each have a half or portion of the side port 130. For example, the first part is shown in FIG. 2 with side port segment 130a with the second part 130b extending from the second handle part 107. Accordingly, when the handle parts are coupled with each other, the side port segments couple to form a completed side port 130. The tube seal 110 may be adapted to complement the interior of the handle parts when they are coupled together. As illustrated in FIG. 2, the bifurcation 112 is positioned at the side port 130 of the handle and when the handle parts are connected, the tube seal 110 can form the interior surface of the handle 105. Continuing with an example of assembling the device, after the first handle part 106 and the second handle part 107 have been locked together, the handle distal end 107 (comprising first distal end 107a and second distal end 107b) can be inserted into the coupler proximal end 136 to support and maintain the communication between the first handle part 106 and the second handle part 107.

[0082] FIG. 4 shows the blood collection device of FIG 1 in a side elevation view from the opposite side shown in FIG. 1 highlighting connection features 126 between the first side 106 and second side 107 of the handle 105. The slider 250 is positioned in the proximal end of the handle in the stowed position ready to be deployed. In this example, the blood collection device 100 is configured to be used with a variety of catheter lengths as the slider has an elongated body positioned within the handle to facilitate fluid communication with the vacutainer assembly during advancement through several positions.

[0083] In some examples, the blood collection devices described herein may be adapted for use with a single catheter length. In some examples, the blood collection devices described herein may be adapted for use with multiple catheter lengths. As shown in FIG. 5, a side view of a slider 115 having a flow path opening 215 configured for use with a single catheter length. The flow path opening length 216 may allow for fluid communication with the handle side port 130 from the distal end of the flow path opening 215a to the proximal end of the flow path opening. 215b. For example, when the slider 115 is advanced distally through the slider slot 108, the flow path opening 215 may come into fluid communication with the side port 130 and remain in fluid communication through additional advancement corresponding to the length of the flow path opening 215. In some examples, the sliders described herein may be adapted to be distally advanced within the handle 105 until the slider arm contacts the distal end of the slider slot. In some examples, the sliders described herein may be adapted to be advanced distally through the slider slot until the slider body distal end (e.g., 220) contacts or docks with the proximal face of the coupler 135. The slider tab 200 is separated from the slider body by a slider arm 210. An angled segment 211 can be configured to open the tube seal slit 111 as the slider is advanced during use. Also visible here is ratchet feature 212 of the slider that can contact and otherwise engage the ratchet system 125 of the handle 105.

[0084] Alignment features 225 can be positioned at the proximal end of the slider body as illustrated in FIG. 5. Additional alignment features may be positioned elsewhere on the slider body and configured to contact the interior of the tube seal for axial alignment of the slider and cannula. The flow path opening 215 is shown with an elevated perimeter 217 also configured to support alignment and seal of the flow path extending through the interior of the slider and through the cannula 120.

[0085] In both FIG. 5 and FIG. 6 of slider 115 and slider 250, respectively, the slider flow path may comprise a slider lumen extending from an interior of the slider body and through the distal end of the slider body. As illustrated throughout, the cannula proximal end may be positioned in the slider lumen extending between the distal end of the slider and the sliderbody interior such that the cannula is in fluid communication with the flow path opening along the slider body.

[0086] FIG. 6 is a side view of a slider 250 having a flow path opening 270 configured for use with multiple catheters of different lengths. The arm 265 connecting the slider body to the tab contains one or more features 266 positioned for engagement with the slot ratchet system. The arm 265 includes an angled and contoured leading edge section configured to engage with the tube seal slit 111. The leading edge of the slider arm can be configured to unseal the tube seal slit 111 as the slider 250 is advanced through the handle slot, while allowing for the tube seal slit 111 to reseal behind or proximal to the slider arm 265. The capacity of the slider arm to unseal and the tube slit to reseal may be the same whether the slider is configured to use with multiple catheter lengths (e.g., slider 250) or the slide is configured to use with a single length catheter (e.g., slider 115).

[0087] This slider 250 has a flow path opening with an extended length 275 from the distal end 275a to the proximal end 275b. The elongated length of the flow path opening can be configured to provide and maintain a fluid communication with the handle side port 130 for a longer length of cannula deployment (e.g., distal slider advancement) during use. Similar slider elements such as the alignment features 290 and raised flow path opening perimeter 280 can be adapted to provide the same alignment and seal support whether the slider is adapted for a single catheter length (e.g., FIG. 5) or multiple catheter lengths as shown in FIG. 6. The tab in both sliders 115 and 250 include engagement features 260 arranged on the tab portion adapted to support user engagement during use.

[0088] FIG. 7A is a perspective view of the handle tube seal 110. FIG. 7B is a cross section view of the tube seal of FIG. 7 A from the proximal end taken along section H-H. FIG. 7B illustrates the detail of the ”Y”-style connector for use with tubing of a blood collection assembly. Referring to FIG. 7A, the distal portion 110b is shown as a continuous and complete cylinder without the tube seal slit 111. The tube seal slit 111 extends from the proximal opening 113 distally to a position adjacent to the bifurcation 112 for the side port connector 130. An example of the tube seal slit separation to accommodate the slider arm when in a position distal to the opening 113. The tube seal slit 111 is sealed along the length except where the slider arm may be extending through. For illustrative purposes, region 114 shows the tube seal slit 111 opens with a first side 114a and a second side 114b raised against the slider arm. This example shows how the seal slit 111 may react as the slider arm moves through the slit 111. In this view, the slider has been removed for clarity. The cross-section shown in FIG. 7B highlight an example of the tube seal slit 111 shown at an angle with first side 114a and second side 114b of the slit in communication with each other as if the cross-section is taken from a position of the tube seal slit 111 not where the slider arm is. The tube seal slit 111 angle may be adapted to prevent inadvertent buckling of the cannula extending through the tube seal 110. For example, if the cannula 120 bends within the handle, the tube seal slit 111 may prevent the cannula from bending through the slit 111. Also visible are details of the bifurcation 112 comprising a lumen extending from an interior opening 112b to an exterior opening 112a. The exterior opening 112 may be adapted to couple with a tube to a vacutainer or collection assembly when coupled to the side port 130 of the handle. The interior opening 112b may be configured to fluidly communicate with the flow path opening of a slider when the slider is advanced to a distal position within the handle and the cannula is in a deployed configuration.

[0089] In some examples, the proximal end of the tube seal may be closed or otherwise sealed. For example, the tube seals described herein may be in contact with the entire interior surface of the handle, including the interior surface of the handle proximal end. FIG. 7C and 7D provide similar details to the examples illustrated in FIG. 7A and 7B, respectively. Here, the tube seal 110 also have slit 111, opening 113, bifurcation (e.g., seal arm) 112, now with a proximal end 110a being sealed. Referring to FIG. 7D, the tube seal proximal end interior surface 1 lOal can be seen through the tube seal from the distal end as FIG. 7D is oriented to expose the interior of the tube seal from the cross section of FIG. 7C taken along Z-Z. In some examples, the sliders described herein, may be in a proximal most position within the tube seal and adjacent to the tube seal proximal end interior surface 1 lOal before they are advanced to deploy the cannula. In some examples, the tube seal provides a sealed interior of the device and provide a seal around the slider side port (e.g., flow path opening) until the slider is distally advanced to align the flow path opening with the interior opening 112b of the seal arm 112, which is in fluid communication with the extension set couple to the handle.

[0090] FIG. 7E shows the tube seal 110 from FIG. 7 A and 7B in a side elevation, now with the section 114 closed as it may be without the slider positioned in the slit 111. Here, the tube seal can be seen as a continuous piece with a body portion 110c being the elongate segment in communication with the interior surface of a handle, and a second body portion (e.g., seal arm) 1 lOd extending out from the body portion 110c. The seal arm 1 lOd has a lumen in communication with the lumen extending through the first body portion 110c. In some examples, the tube seal is a singular piece seal configured to contact the interior of the handle. For example, the first body portion 110c can be in communication with the first handle part (e.g., 106 in FIG. 3) and the second handle part (e.g., 107 in FIG. 3). The seal arm would then contact the interior of the extension port of both the first and second handle parts to provide a seal of the handle interior. In some examples, the angle 1 lOe, at which thesecond both portion 1 lOd extends from the first body portion 110c may be configured to reduce hemolysis for the blood flowing through the flow path opening of a slider in alignment with the interior aperture of the second body lumen. In some examples, and as described herein, the seal arm 1 lOd may also be referred to as the bifurcation (e.g., bifurcation 112 in FIG. 7A). The angle 1 lOe can be seen as an acute angle with the second body portion extending at an acute angle from the first body portion 110c.

[0091] In some examples, when the slider is distally advanced through the interior of the first body portion 110c of the tube seal 110, the flow path opening of a slider may remain sealed against the interior surface of the tube seal 110 (e.g., the interior of the first body portion 110c) until the flow path opening of the slider is aligned with the lumen of the second body part 1 lOd (e.g., the bifurcation 112) of the tube seal. The slit length I l la may provide for a length of travel for the slider arm to pass through the slit from opening 113 adjacent to the proximal end of the first body portion 110c.

[0092] FIG. 8 is a perspective and section view of a slider 250 within a portion of the tube seal 110 positioned within the handle interior. The arm of the slider 250 is in position to engage with the slot ratchet system (e.g., 125a and 125b) shown in FIG. 2. The raised seal portion (e.g., 114a and 114b) of the tube seal is configured to seal around the slider arm. Handle attachment features 126 are coupled with one another between the first handle part 106 and the second handle part 107. From this view, the axial alignment of the slider 250 can be seen as facilitated by alignment features 290 contacting the interior surface of the tube seal 110 within the handle 105 and the slider interior 270 is shown as a reservoir to receive a flow of blood from the cannula when deployed and when the slider flow path opening is in communication with the handle side port 130.

[0093] In some examples, the ratchet system 125 may comprise more than one ratchet feature in the slider slot 108. Here, a proximal ratchet feature 125a is in communication with the slider arm with the distal ratchet feature 125b distal still and adapted to receive the slider as it may be advanced beyond ratchet feature 125a as needed to sufficiently deploy the cannula during use for a particular catheter length and / or to extend or deploy beyond an occlusion in the vessel. The ratchet features 125a and 125b can be configured to engage the arm of a slider (e.g., slider 250 or slider 115) when the slider has been distally advanced in the handle slot. In some examples, the arrangement of the ratchet features may provide tactile indication of the deployment length, alignment of the slider flow path opening with the extension port of the tube seal / handle, etc. For example, ratchet features 125a are positioned proximal to ratchet features 125b and when the slider arm contacts the ratchet features 125a, the indication may refer to an initial position of the cannula distal end out of the catheter andin a blood vessel. Similarly, the contact of the slider arm with the proximal ratchet features (e.g., ratchet features 125a) may indicate a flow path has been established between the cannula distal end and the vacutainer as the slider flow path opening may have made initial communication with the side port at this position. Then, further advancement of the slider can relate to further advanced position of cannula deployment while the flow path is maintained and the slider flow path opening maintains fluid communication with the side port. In some examples, the distal most ratchet features on the interior surface of the slot (e.g., ratchet features 125b) may indicate that the slider has reached a distal most advancement position. For example, where the slider has been advanced in the slot to engage the distal ratchet features 125b, the indication may be that the slider flow path opening is now in fluid communication and a proximal end of the flow path opening such that the cannula has been deployed to a maximum length with the flow path being maintained.

[0094] In any example described herein, the slider flow path opening can provide a length of adaptable deployment for the cannula while the flow path is maintained. For example, when the distal end of the slider flow path is in alignment with the side port of the handle (e.g., the tube seal bifurcation), the flow path may be initially established, and blood can flow through the cannula out of the slider flow path opening and on to the vacutainer. The flow path can then be maintained through additional slider advancement until the proximal end of the slider flow path opening is in alignment with the side port of the handle (e.g., the tube seal bifurcation) such that any additional advancement may cause the slider flow path opening to not be aligned with handle side port such that the flow path is stopped, and the blood no longer flows out of the slider flow path opening. In some examples, the distal most position of the slider in the handle may also relate to the longest cannula deployment length. In some examples, after the blood draw is completed, and the slider is retracted proximally along the slot and tube seal slit, the flow path is similarly stopped when the distal end of the slider flow path opening is proximal to the handle side port and no longer in fluid communication with the extension set.

[0095] Referring still to FIG. 8, the ratchet features 125a and 125b are show in position on a surface 108a of the slot 108. In this example, the handle has an exterior surface, and an interior surface contacted by the tube seal. Through the slot, surface 108a extends between the exterior surface 105a and the interior surface. The surface 108a has a length sufficient to position the ratchet features thereon. In this example, the ratchet features are then extending in a direction towards the middle of the slot 108.

[0096] FIG. 9 is a perspective view of an exemplary sealed catheter hub 300 having side port 320, tubing 325, fluid connection 330 and clamp 335. The proximal end 345 of thecatheter hub is accessible via one or more seals (e.g., 340). The catheter 310 extends from a distal side of the hub 305 to a distal tip 310a. The stabilizing feature 350 may be adapted to stabilize the catheter assembly 300 when placed. Additional features such as engagement element 206 may be adapted to support movement and manipulation of the catheter assembly 300 during placement and may also provide an anchor for tape of adhesive to support placement and position when the catheter assembly 330 is in position within a patient.

[0097] FIG. 10 shows the sealed catheter hub of FIG. 9 in an exploded view including interior seal configured to be positioned inside of the catheter hub and coupling seal configured to couple with the blood collection device handle. Additional details of the catheter assembly 300 can be appreciated. The stabilizing feature 350 may comprise a lumen extending from 350a to 350b allowing the catheter 310 to extend from the hub 305 therethrough. The length of the catheter 310 may include the distance between the proximal end 310b coupled to the catheter hub 305 and the catheter distal tip 310a. As described herein, the catheter length may be considered when using a single-length catheter configured device or a device configured for use with multiple catheter lengths.

[0098] In some examples, catheter lengths may be any length. For example, catheter lengths may include 1.00”, 1.30”, 1.50”, 1.75”, 2.30” or more or less or any length therebetween. Accordingly, the device adapted to be used with any catheter length may comprise an extended handle length, cannula length, etc. with a slider adapted to be advanced to multiple positions distally within the handle corresponding to the different catheter lengths. The cannulas described herein may have a length from a proximal end extending out of the slider body to a distal end. In some examples, cannula lengths may be less than 1” to more than 5” or any length therebetween. For example, where a device is configured for use with a single length catheter, the cannula length may be 3”, 3.5”, 4”, 4.5” or more or less or any length therebetween. Another example where the device is configured for use with multiple different catheter lengths, the cannula may have a length of 4”, 4.5”, 5”, 5.5” or more or less or any length therebetween.

[0099] The catheter hub 305 may have a lumen extending through side port 320 and into an interior of the catheter hub. The catheter hub interior may be sealed at the proximal side with one or more valves. Here, a first valve 355 and second valve 340 are shown. The proximal valve 355 may be positioned proximal to valve 340 inside the catheter hub 305. The valves may be axially aligned and adapted to receive the protrusion feature 140 of the coupler 135 when a blood collection device is coupled to the catheter assembly. In some examples, the proximal valve 355 may be adapted to receive a portion of the distal valve 340 within a proximal side 355a. The distal valve 340 is shown with a raised annular feature 341 that canbe adapted to communicate with an interior detent of the coupler 135 when engaged to a blood collection device.

[0100] FIG. 11 is an exemplary orientation of the catheter of FIG. 9 when in use in a patient as an in-dwelling catheter. A blood collection device of FIG. 1 is shown in a position to engage with the proximal end of the catheter hub. As illustrated, the protrusion feature 140 is aligned and positioned to be inserted into the valve 340. For example, an axial alignment may be shared by the slider body, cannula 120, protrusion feature 140, valve 340 and the catheter 310. FIG. 12 shows the device now coupled with the catheter assembly 300. The protrusion feature 140 is no longer visible here as it is positioned within the catheter hub 305. The slide is also not visible as it is in a proximal position within the slider slot 108 and the cannula has yet to be deployed beyond the catheter 310.

[0101] In some examples, the extension clamp 335 of the catheter assembly and the clamp 336 of the extension set extending from the handle may be opened or closed based on the position and configuration of the handle relative to the catheter assembly during use. For example, and referring to FIG. 11, the handle 105 and coupler 135 are aligned with the catheter hub 305 as it may be if the catheter 310 were positioned in a patient (e.g., in a blood vessel). Accordingly, both clamp 335 of the catheter assembly and clamp 336 of the device may be closed to prevent fluid from flowing through the respective extension tubes. In some examples, when the device has been coupled to the catheter hub, one or more of the clamps may be opened to open fluid communication. In FIG. 12, the coupler 135 is engaged with the catheter hub 305. In this configuration, the device may be ready to control a flow of blood to a container. Here, although illustrated with both clamps 335 and 336 in an open configuration, blood may be permitted to flow through one extension tube, or both extension tubes. In some examples, when the device is coupled to the catheter assembly positioned in a blood vessel, clamp 336 may be opened to allow blood to flow through the flow path and into a vacutainer in fluid communication therewith. In some examples, the clamp 335 on the catheter assembly may be opened to allow for blood flow, infusion, flush, etc. The opening and closing of clamps 335 may be adapted to permit a flow of fluid through the respective tubes and into and / or out of a blood vessel.

[0102] FIG. 13 is a top perspective section view of the engaged blood collection device and catheter shown in FIG. 12. In this view the distal end and full circumference portion of the tube seal 110 can be seen in position against the distal end piece. The full circumference sealing portion is placed about the shaped proximal opening of the distal end. The shaped proximal opening is sized and shaped to engage with the distal most end of the slider body. The Y-tube portion (e.g., bifurcation) of the tubular seal 110 is also shown within the handleside port 130. A flow has yet to be established with the cannula as it is not deployed beyond the catheter. However, the flow path from the distal end of the catheter 310, through the protrusion feature 140 and to the side port 130 of the handle 105 can be seen. In some examples, the interior volume 305c of the catheter hub 305 may be minimized by the positioning of the proximal seal 355 and the protrusion feature 140. The closed catheter system 300 and catheter side port 320 may be closed off by the protrusion feature 140. In some examples, the catheter side port 320 may allow access to the vessel through the catheter for blood draws or administration of medications. However, in some examples, if the catheter side port 320 is closed off, any flow from the vessel may then be only through the device to the side port 130 of the handle 105.

[0103] FIG. 14A and 14B are additional section views of the blood collection device and catheter of FIG. 12. Added details of tube seal and male luer engagement with the closed system. Also visible in FIG. 14B is the shape of the distal end of the slider and the correspondence with the proximal opening of the distal end piece. In these detailed views, the reduction of dead space within the catheter hub interior 305c can be seen. The distal valve 355 can be configured to seal interior 305c whether the protrusion feature 140 extends therein or the catheter assembly 300 is separated from the device.

[0104] Also shown in these detailed cross sections are the coupling features including openings 135b and locking features of the first handle side 106c and the second handle side 107c. The coupling between the handle 105 and the coupler can be adapted to lock or retain the handle parts in communication with each other. For example, the couple and the attachment features 126 may facilitate the communication between the two handle parts.

[0105] In FIGS. 14A and 14B, the cannula 120 is shown extending from the device 100 through the catheter hub 305 as it may be during cannula deployment or in a deployed configuration. In particular, the distal end of the slider 385 is approaching the proximal face of the coupler 135a. The complementary geometry between the slider and the coupler may be adapted for docking between the slider and the coupler when the slider is in a distal most position during deployment of the cannula 120.

[0106] Also in FIG. 14A, additional details of the slider are shown with the slider lumen 270 extending from the interior of the slider 250 and in communication with the cannula proximal end 120a. This cross-section view exposes the slider lumen 270c extending from the slider body and in fluid communication with the slider flow path opening 270 (e.g., slider side port). As shown here, the cannula proximal end 120a is in the slider lumen 270c. In any example described herein, the cannula proximal end 120a may be positioned within the distalend of the slider, within the slider lumen, and / or extending out from the distal end of the slider body.

[0107] Referring to FIG. 14B, the distal tip 140a of the coupler 135 is positioned within the catheter hub 305 providing access through the valves 355 and 340 for the cannula 120 to extend from the blood draw device to the catheter 310. In some examples, the distal tip 140a may be configured to be positioned at the distal end of the catheter hub interior adjacent to the cannula proximal end 310a. For example, the distal tip 140a may have a tapered configuration to complement the interior geometry of the catheter hub 305. As illustrated in FIG. 14B, there may a distance or length between the distal tip 140a and the catheter proximal end 120a whereby the cannula 120 may be extended or deployed from the device across such distance to and through the catheter 310. In some examples, the interior geometry of the catheter hub (e.g., the conical distal interior) may provide additional support to guide the cannula to and through the catheter proximal end 310a.

[0108] FIG. 14C to 14F Provide additional detail of the coupler alone from FIG. 14A and 14B to highlight the coupler support of the handle assembly and the engagement with the catheter hub. In FIG. 14C, the profile view of the coupler 135 highlights an example of the distal tip 140a with a tapered or conical distal end which may be adapted to complement the interior of the catheter hub and the ability for the protruding feature 140 to traverse any valves positioned in the catheter hub. The openings 135b at the proximal side of the coupler body have been described throughout as being adapted to receive elements or features of the handle distal end to support a positive engagement of the handle with the coupler. The crosssection view of the coupler 135 in FIG. 14D, provides additional detail of the coupler lumen 140b where the distal end of the cannula 120 may be positioned in a stowed or ready-to-use configuration. The lumen 140b then provides a path for cannula deployment out of the coupler and through a catheter. In the coupler distal end, the cross section reveals the detent 137b configured to receive the catheter hub 305. This detent 137b is shown as a channel or depression extending circumferentially around the interior surface of the coupler, but may be any configuration adapted to receive a corresponding features of the catheter hub. For example, as illustrated in FIG. 14B, the catheter hub comprises a valve sealing the proximal face of the catheter hub with a raised feature 341 of the valve engaging the detent 137b of the coupler to provide a friction, snap, or interference with when the device is coupled to the catheter hub. In some examples, the catheter hub proximal face may be positioned within the coupler distal end 137 until the catheter proximal face engages the coupler distal face 137a. In some examples, the engagement between the coupler 135 and a catheter hub (e.g., 305)may be when the catheter hub is sufficiently inserted into the coupler distal end 137 and the coupler is in communication with the detent 137b.

[0109] At the coupler proximal end 136, the cross section view also reveals the coupler proximal face 136a configured to receive the distal most end of the handle (e.g., first handle part 106 and second handle part 107).

[0110] In FIG. 14E, further detail of the coupler proximal end 136 also shows a conical interior surface 136b axially aligned with the coupler lumen 140b. The conical geometry of the proximal surface 136b can be configured to complement the distal end of the slider body when the slider is advanced to a distal most portion in the handle. For example, the cannula may be positioned through the lumen 140b and when it is deployed distally from the handle, the slider is advanced to a distal most position that may include contact between the slider body and the conical proximal surface 136b. FIG. 14F provides further detail of the coupler distal side 137 again revealing the coupler distal face 137a and the protruding feature 140 extending distally therefrom. The exemplary details of the slider are shown as an example of how the device may be axially aligned then advanced onto a catheter hub proximal end.

[0111] FIG. 14G is another side elevation of a coupler that can be positioned on the distal end of the handle, as described herein. In this cross-section, another embodiment of the protruding feature is shown having a male luer portion 140c extending from the distal face of the coupler 135d with an extension 140d positioned distal to the male luer portion 140c and extending to the distal tip 140e. The lumen 140f is still extending through the protruding feature, as described herein from the proximal side of the coupler 135d to guide the cannula therethrough. In some examples, the male luer portion 140c may be configured to complement a standard female luer configuration of a catheter hub or other port. For example, a proximal luer segment may be a standard ISO luer taper or configuration to be used with a standard catheter hub. In some examples, the proximal segment of the coupler protruding features described herein may have a tapered geometry with a decreasing cross- sectional geometry as you move distally along a length of the proximal luer segment. In some examples, the distal extension portion 140d may have a constant diameter along a length of the extension segment. For example, as illustrated in FIG. 14G, the distal extension segment 140d is generally cylindrical until the tapered distal end 140e. In some examples, the distal end may be configured to have a geometry that is complementary to the interior geometry of a catheter hub, such that when the blood draw device is coupled to a catheter, the male luer may be positionable within the catheter hub and extend adjacent or substantially adjacent to the proximal end of a catheter lumen. In some examples, the position of the distal end of a coupler protruding feature (e.g., distal end 140e) may provide for a reduced distance betweenthe coupler distal end and the catheter proximal end such that when the cannula of the blood draw device is deployed, it reduces or eliminates the distance between the protruding feature and the catheter lumen for the cannula to be deployed.

[0112] FIG. 15A is a section view of the coupled blood collection device and catheter hub of FIG. 9 with the slider advanced to a position where the slider side portion has established initial fluid communication with the Y-seal and attached tube. In use, the devices described herein can establish or re-establish a flow of blood from a vessel when the cannular is deployed and the slider flow path opening is in communication with the interior opening of the tube seal bifurcation and the side port 130. FIG. 15B is the blood collection device of FIG. 13 with the slider advanced to a distal most position. The distal end of the slider is seated into the shaped proximal opening of the distal end piece and the proximal most end of the slider side port (e.g., flow path opening) is aligned with the Y-seal. In this configuration the distal end of the blood collection cannula may be at a maximum extended length beyond the distal end of the catheter lumen and still be in fluid communication with the handle side port and Y-seal. As shown in FIG. 15A and 15B, the slider 250 is advanced in a distal position of the handle 105. The slow path opening 270 is in communication with the extension port at the distal end of the flow path opening 275a. For example, this may be the initial fluid communication between the cannula distal end and a specimen collection assembly coupled to the handle side port 130. In FIG. 15B, details of the slider 250 and fluid communication with the side port 130 are shown with the slider 250 advanced further distally compared to FIG. 15 A. For example, the fluid communication between the slider 250 and the side port 130 is now near the proximal side of the flow path opening 270b. This may represent the distal most position of the slider to maintain a fluid coupling and flow path from the cannula through the slider and to the specimen collection assembly. Further, the distal end of the slider 285 is docked with the proximal face of the coupler at 135a showing a distal most position of the slider 250. Referring to FIG. 15 A, the cannula 120 can be seen extending beyond the catheter 310 to length 120c. Accordingly, the length of deployment from FIG. 15A may increase as the slider is advanced further (e.g., to the position in FIG. 15B).

[0113] FIG. 16A and 16B are perspective and cross section views respectively of an extension set for use with a conventional catheter assembly. A conventional catheter assembly has a proximal opening that is an unsealed fluid connection. Normally capped off then not in use. The extension set has a distal end for engagement with a proximal portion of the catheter hub and a proximal portion for sealed engagement with a distal end portion of a blood collection handle. A locking collar is used to retain the extension set in place during use. In some examples, a catheter assembly 400 may include an adapter 425 adapted tocouple with a standard catheter hub 415 to create a sealed system configured to be used with the devices described herein. The adapter 415 may include a locking collar 420 configured to maintain a connection between the adapter 425 and the catheter hub 415. The adapter may comprise or be adapted to engage valves 340 and 355 in a similar manner as described with catheter assembly 300. Also shown here, the extension tubing 435 extending from the adapter side port 430 form a closed system as provided by the adapter 420 when coupled to a standard catheter hub 415.

[0114] FIG. 17 to FIG. 20 show various views of a device 100 engaging a closed catheter assembly 400 with the adapter 420 coupled to a catheter hub. Referring to FIG. 17, a perspective view of an embodiment of a blood collection device 100 in position to engage with a proximal portion of an extension set and conventional catheter of FIG. 16 A. The alignment and function of device components operate as described herein now coupling with the valve 340 of the adapter 420. The axial alignment of the cannula 120 is still adapted to extend through the catheter 405. In FIG. 17, the device is approaching the catheter assembly 400 with the slider 250 positioned proximally within the handle 105 in a stowed and ready - to-use configuration. The cross section view of FIG. 18 shows the arrangement of the device 100 and the catheter assembly 400 shown in FIG. 17. Details of axial alignment can be seen, and the flow path is discontinuous as the cannula lumen and slider are not in fluid communication with the handle side port 130. The cannula 120 is also seen entirely within the device 100 ready to be deployed.

[0115] FIG. 19 is a perspective view of an embodiment of a blood collection device 100 engaged with a proximal portion of an extension set 420 and conventional catheter of FIG. 16A. The blood collection device 100 is shown in an initial or ready to draw sample position. A vacutainer 144 is coupled to the handle side port 130 and the slider 250 is in the proximal most position in the handle slot 108. The distal most end of the blood collection cannula 120 is still within the housing interior portion. As a result, fluid communication from the distal end of the catheter lumen 405 to the vacutainer 144 has not been established. Then, in FIG. 20 the perspective and section view of the components in FIG. 19 is shown to detail the arrangement of components as they may be ready to deploy and provide a fluid communication through the vessel to the vacutainer. However, the flow path is still sealed as the slider is not in a distal position within the handle to provide a fluid communication with the side port 130. . The engagement of the distal end of the blood collection device with the proximal end of the extension set is visible in this view. The distal end of the blood collection device is configured for releasable engagement with the proximal end of the extension set as well as to open any valves within the extension set housing.

[0116] In some examples, sliders described herein having a flow path opening such as flow path opening 215 and flow path opening 270 in FIG. 5 and FIG. 6 may have a length from the distal end of the flow path opening to the proximal end of the flow path opening to accommodate a fluid coupling between the flow path opening and the bifurcation of the tube seal (e.g., second body portion) when the cannula is in a deployed configuration. The length of the flow path opening in the slider body can provide for a length of cannula deployment while maintaining a fluid coupling or fluid communication with the handle extension port for more than a single length of cannula deployment. For example, fluid communication or a flow path may be established when the distal end of a slider flow path opening is aligned with the tube seal bifurcation and the fluid communication is maintained through additional slider advancement as the slider flow path opening remains in alignment with the tube seal bifurcation along the length of the flow path opening. In some examples, the length of a slider flow path opening may be less than .1” to greater than 2” or any length therebetween. For example, the sliders illustrated in FIG. 5 may have a flow path opening with a length of .15”, .16”, .17”, .18”, .19”, .20”, .21”, .22”, .23”, .24”, ,25” 26”, .27”. .28”, .29”, .30”, or more or less or any length therebetween. Other examples of sliders such as those illustrated in FIG. 6 may be configured to accommodate multiple lengths of catheter and the flow path opening may have a length of 1”, 1.1”, 1.15”, 1.2”, 1.25”, 1.3”, 1.35”, 1.4”, 1.45”, 1.5”, 1.55”, 1.6”, 1.65”, 1.7”, 1.75”, 1.8”, 1.85”, 1.9”, 1.95”, 2” or more or less or any length therebetween.

[0117] 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.

[0118] 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 guideelement 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 for releasable engagement with either or both of the distal end of a blood collection device or a vascular access device. Releasable engagement includes, by way of example and not limitation, push to connect, twist to connect, friction fit, spring loaded sliding or twisting action, engagement of one or more alignment features or a coupling device that may releasable connect from any orientation between the catheter hub and the handle of the blood collection device or the vascular access device.

[0119] 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.

[0120] 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 / 587,438entitled “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.

[0121] 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 International Application Number PCT / US24 / 49677 entitled “BLOOD COLLECTION DEVICE AND METHODS OF USE,” filed on October 2, 2024 (hereinafter, “ the ‘677 application”). The ‘677 application is incorporated herein by reference for all purposes.

[0122] 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.

[0123] 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.

[0124] 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, thefeatures 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.

[0125] 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 " / ".

[0126] 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.

[0127] 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.

[0128] 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, theterm “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0129] 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.

[0130] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word "about" or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and / or position to indicate that the value and / or position described is within a reasonable expected range of values and / or positions. For example, a numeric value may have a value that is + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value " 10" is disclosed, then "about 10" is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that "less than or equal to" the value, "greater than or equal to the value" and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value "X" is disclosed the "less than or equal to X" as well as "greater than or equal to X" (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, 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.

[0131] 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. Optionalfeatures 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.

[0132] The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

Claims

CLAIMSWhat is claimed is:

1. A blood collection device comprising: a handle having a first side and a second side wherein when coupled together form a closed proximal end, a distal segment with an open distal end, an extension port positioned adjacent to the distal segment and an interior portion between the open distal end, the closed proximal end and in communication with the extension port; an elongate opening along a length of the handle first side wherein the interior portion is accessible through the elongate opening; a coupler having a proximal end and a distal end; a protrusion on the coupler distal end; the coupler proximal end adapted and configured to couple to the distal segment; a one-piece tube seal having a cylindrical body with an open distal end, an open or closed proximal end and a seal arm wherein the one-piece tube seal is sized and shaped to fit within the interior portion; a sealing segment along a length of the one-piece tube seal positioned to align with the elongate opening when the one-piece tube seal is within the interior portion; a slider body having a distal end and a proximal end, a slider arm extending from the body wherein when the slider body is within the one piece tube seal the slider arm protrudes through the sealing segment; a slider body lumen extending from the slider body distal end to a flow path opening along a length of the slider body; and a cannula having a proximal end and a distal end and a cannula lumen extending from the cannula proximal end to the cannula distal end, the cannula proximal end is coupled to the slider body distal end so that the cannula lumen is in fluid communication with the slider body lumen.

2. The device of claim 1, wherein the handle first side and handle second side are held together while the coupler proximal end is coupled to the distal segment.

3. The device of claim 1, wherein the extension port is adapted and configured to couple to a vacutainer assembly.

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

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

6. The device of claim 3, wherein the slider is configured to advance the cannula distally through the catheter into the vessel.

7. The device of claim 1, further comprising a ratchet assembly positioned along a portion of the elongate opening of the handle first side and adapted to releasably engage with the slider arm.

8. The device of claim 1, further comprising a ratchet assembly with one or more ratchet features positioned along a length of an inner surface of the elongate opening adjacent an exterior surface of the handle first side.

9. The device of claim 7 or claim 8, wherein engagement of the ratchet assembly with the slider arm corresponds to a length of cannula deployment or communication with the slider fluid pathway or a catheter length.

10. The device of claim 7 or claim 8, wherein the rachet assembly or one or more ratchet features is configured to provide a tactile indication or a visual indication of the slider body position relative to the extension port or the cannula distal end.

11. The device of any of the above claims, wherein the slider flow path opening has a length wherein the distal movement of the slider will advance the cannula distal end beyond a distal most end of a catheter engaged to the coupler distal end.

12. The device of claim 11, wherein the slider flow path length is sized for catheters having a length of .75” to 2.5”.

13. The device of any of claims 1-10, wherein the slider flow path length is between .15” 2”.

14. The device of any of claim 1-10, wherein when the slider is in an initial position adjacent to the proximal end of the one-piece tube seal and first advanced distally towards the coupler the cannula distal end is not in contact with a lumen of a catheter engaged with the coupler and the slider fluid port is not in fluid communication with the extension port.

15. The device of claim 14, wherein when the slider is further advanced distally towards the coupler the cannula lumen is in fluid communication with the side port.

16. The device of claim 15, wherein when the slider is further advanced distally the cannula distal end is extended beyond a distal most end of a catheter engaged to the coupler distal end.

17. The device of claim 1, the sealing segment further comprising an axial slit along a length of the one-piece tube seal configured to seal an interior of the handle, wherein the slider arm and sealing segment are adapted and configured to releasably seal and reseal the sealing segment of the one-piece tube seal along the elongated slot as the slider is moved along the one-piece tube seal.

18. The device of claim 1, wherein the coupler proximal end further comprises one or more locking features to engage the handle first side and the handle second side to secure the handle first part to the handle second part.

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

20. The device of claim 19, wherein the releasable engagement is provided by axial movement of the coupler distal end onto a proximal end of the catheter hub.

21. The device of claim 19, wherein the releasable engagement is provided by a friction fit between the protrusion and a valve in the catheter hub and a detent within an interior surface of the coupler distal end.

22. The device of claim 19, wherein the coupler distal end comprises a detent around an interior surface adapted and configured to receive an exterior surface feature on the catheter hub.

23. The device of claim 1, wherein when the coupler proximal end is engaged to the distal segment and the one-piece tube seal is within the interior portion the open distal end of the one-piece tube seal is adjacent the coupler proximal end.

24. A blood collection device comprising: a coupler having a protrusion configured to engage a proximal face of a catheter hub, the coupler positioned at the distal end of a handle; a handle extension port positioned adjacent to the distal end of the handle; the extension port configured to couple to a vacutainer assembly; a slider having a body disposed within an interior of the handle and an arm extending through an axial slot extending along a length of the handle, the slider body having a lumen extending through from a distal end of the slider body to a flow path opening along a length of the slider body; a cannula extending from a distal end of the slider body, the cannula comprising a lumen extending from a distal end into the slider body; and a one-piece tube seal disposed within the interior of the handle, wherein the one-piece tube seal having a cylindrical body along a length of the handle and a seal arm sized for the extension port wherein the slider is configured to move axially through an interior of the one- piece tube seal.

25. The device of claim 24, wherein the slider body, cannula, and coupler protrusion are axially aligned with a central axis of the handle.

26. The device of claim 24, wherein the coupler protrusion is adapted to open at least one valve in a proximal face of a catheter hub so that in use, the cannula can be extended through a catheter extending from the catheter hub into a blood vessel.

27. The device of claim 26, wherein the slider is configured to advance the cannula distally through the catheter into the vessel until the flow path opening is in alignment with the extension port of the one-piece tube seal.

28. The device of claim 24, further comprising a ratchet assembly with a first ratchet element positioned on an interior of the axial slot and a second ratchet feature positioned on the sliderarm, the second ratchet feature configured to engage the first ratchet feature when the slider is advanced distally within the handle.

29. The device of claim 28, wherein the first ratchet element comprises a plurality of teeth along a length of the ratchet feature, wherein the plurality of teeth correspond to a length of cannula deployment when the second ratchet feature is in communication with the first ratchet feature.

30. The device of claim 28, wherein the first ratchet element has a length configured to provide tactile indication of the slider body relative to the extension port.

31. The device of claim 24 or claim 29, wherein the device is configured to be used with more than one length of catheter, and the slider flow path opening has a distal end and proximal end extending along a length of the slider body, wherein the flow path opening is adapted to be fluidly coupled to the extension port at any position between the flow path opening distal end and proximal end.

32. The device of claim 24, further comprising an axial slot seal configured to seal an interior of the handle, the axial slot seal having a sealable slit configured to facilitate movement of the slider through the handle.

33. The device of claim 24, wherein the coupler protrusion comprises a male luer proximal segment and an extension segment distal to the male luer proximal segment, the extension segment configured to be positioned adjacent to a proximal end of a catheter extending distally from the catheter hub.

34. The device of claim 24, wherein the coupler is configured to releasably engage the catheter hub.

35. The device of claim 34, wherein the releasable engagement is provided by axial movement of the device to a proximal face of the catheter hub.

36. The device of claim 34, wherein the releasable engagement is provided by rotational movement of the handle onto the catheter hub.

37. The device of claim 34, wherein the releasable engagement is provided by at least one deformable component, spring loaded component, or a magnetic component positioned on the coupler and configured to engage the catheter hub.

38. The device of any of claims 24 to 37, wherein the handle comprises a first side and a second side, wherein the handle first side is attached to the handle second side by one or more attachment features and the coupler is configured to receive a distal end of the handle first side and handle second side.

39. A method of assembling a blood draw device for drawing blood from a blood vessel, the method comprising the steps of: providing a tube seal with a seal arm extending outward and adjacent to a distal end of the tube seal; positioning a slider body in an interior of the tube seal, where a slider arm extends out of an angled slit extending along a length of the tube seal and a cannula extending through the tube seal from the distal end of the slider body, wherein a lumen extends through the cannula and to a flow path opening along a length of the slider body; positioning the tube seal between a first handle portion and a second handle portion, wherein the first handle portion comprises a first extension port segment and an axial slot along a length of the first handle portion, and wherein the second handle portion comprises a second extension port segment configured to align with the first extension port segment; positioning a proximal side of a coupler over the distal end of the first handle portion and the second handle portion to retain communication between the first handle portion and the second handle portion, wherein the coupler has a lumen axially aligned with the tube seal and the cannula, wherein the cannula distal end is positioned in the coupler lumen and configured to be deployed therefrom.

40. A method of drawing blood through a catheter, the method comprising the steps of: engaging a catheter hub with a distal end of the blood draw device of claim 1 or claim 24, wherein the engaging step aligns a blood draw cannula lumen extending from a slider through the distal end of the blood draw device handle and along the central longitudinal axis of a catheter extending from the catheter hub into a patient blood vessel; advancing the slider body with a moveable side port through a tube seal until the slider body is in communication with the proximal most end of the cannula lumen along a handle towards the catheter hub;moving a distal most end portion of the blood draw catheter beyond a distal most end portion of the catheter and into the patient blood vessel; establishing fluid communication between the patient blood vessel and a side port of the blood draw device handle only after the distal most end of the cannula extends beyond the distal end of the catheter in the patient’s blood vessel.

41. A blood collection device, comprising: a handle comprising a first part adapted to couple with a second part, the handle having a proximal end, a distal end, an interior space, a slot along a surface of the handle providing access to the interior space and a blood collection side port in communication with the interior space; a slider having a body, an aperture, a side port wherein fluid communication between the side port and the aperture is through the body; and a blood draw cannula having a proximal end, a distal end, a length from the proximal end to the distal end wherein the cannula proximal end is coupled to the slider aperture, wherein when the distal end of the handle is coupled to a proximal portion of a vascular access catheter hub, the length of the blood draw cannula is configured to extend beyond the distal most end of a vascular catheter when the slider is positioned along the slot in a position that allows fluid communication from the blood collection catheter distal end to the blood collection side port.

42. The blood collection device of claim 41, wherein a distal end of the handle first part and handle second part are adapted to form a distal handle segment with a reduced diameter adapted to insert into the proximal side of a coupler, the coupler adapted to lock the handle first side and handle second side to one another.

43. The blood collection device of claim 42, wherein the seal forms the interior of the handle and has a bifurcation adapted to extend and seal the blood collection side port.

44. The blood collection device of claim 43, further comprising a plurality of stabilizing mounts arranged on an exterior surface of the slider positioned to maintain the seal in apposition with the handle interior while moving the slider along the slot.

45. The blood collection device of claim 43, wherein the seal is coupled to the interior of the handle so as to close off the handle interior.

46. The blood collection device of claim 45, wherein the slider side port remains in sealed relation to the tubular seal until movement of the slider along the slot establishes fluid communication between the blood collection catheter distal end and the seal bifurcation in the handle side port.

47. The blood collection device of claims 41-46, wherein the distal end of the handle is adapted and configured for releasable engagement with a proximal portion of the vascular catheter hub so as to provide axial alignment between a lumen of the vascular catheter and the blood collection cannula.

48. The blood collection device of claim 47, wherein the distal end of the handle is adapted and configured to open one or more valves or closures in the proximal portion of vascular catheter hub.

49. The blood collection device of any of claims 41-48, further comprising one or more elements of any of claims 1-15.

50. The blood collection device of any of claims 41-49, further comprising one or more of the elements of any of claims 24-38.

51. The method of drawing blood according to either claim 39 or claim 40, further performed using a blood collection device of any of claims 49 or 50.

52. A blood collection device for use with an indwelling catheter, comprising: a housing having a first portion and a second portion; a side port in the housing formed when the first portion is coupled to the second portion; a slot in a surface of the first portion providing access to a housing interior volume formed when the first portion is coupled to the second portion; and a distal end piece adapted and configured to be coupled on, in or within a distal end of the housing when the first portion is coupled to the second portion.

53. The blood collection device of claim 52, further comprising:a slider sized and positioned to have a body within the housing interior volume and an arm that extends through the slot and a blood collection cannula coupled to the slider and adapted and configured to advance through the distal end piece when the slider is advanced along the slot.

54. The blood collection device of claim 53, the slider further comprising a side port in communication with the first portion of the blood collection device wherein when the slider is advanced to a distal position in the slot the blood collection cannula distal end is beyond the distal end piece and the slider side port is at least partially aligned with the housing side port.

55. A blood collection device, comprising: a handle having a proximal end and a distal end and defining an interior volume; a coupling feature on the distal end of the handle with an aperture in communication with the interior volume; an axial slot along the handle providing communication to the interior volume from outside of the handle; a side port in the handle with a coupling member sized for engagement with a fluid handling accessory; and a unitary sealing member within the handle having a resealable axial seal for temporary, resealable opening of the axial slot, a distal end portion to seal the aperture and a side portion having an outer dimension adapted and configured for placement within the side port and interior dimension for sealed coupling to the fluid handling assessor.

56. The blood collection device of claim 55, further comprising a slider sized and positioned to have a body within the housing interior volume and an arm that extends through the slot and a blood collection cannula coupled to the slider and adapted and configured to advance through the coupling feature when the slider is advanced along the slot.

57. The blood collection device of claim 56, the slider further comprising a side port in communication with the distal end of the blood collection device wherein when the slider is advanced to a distal position in the slot the blood collection cannula distal end is beyond the coupling feature and the slider side port is at least partially aligned with the housing side port.

58. An intravascular catheter, comprising:a catheter body having a proximal end and a distal end defining an interior volume; a tube extending from the catheter body having a lumen in communication the interior volume wherein a distal end portion of the tube is adapted and configured for integrated use with a guide element; a first seal on a proximal most portion of the catheter body and a second seal within the interior volume and adjacent to the first seal; and a side port in the catheter body defining a lumen in communication with only the interior volume, the lumen and the second seal.

59. The device of claim 58, further comprising a base coupled to the catheter body.

60. The device of claim 58, further comprising at least one feature on the catheter body or the side port to facilitate coupling with a fluid handling accessory.

61. A fluid coupler for use with an intravascular catheter, comprising: a distal end adapted and configured to releasably couple to an opening in fluid communication with a catheter body; an extension housing having a proximal end and a distal end defining an interior volume in communication with the distal end; a first seal on a proximal most portion of the housing and a second seal within the interior volume and adjacent to the first seal; and a side port in the extension housing defining a lumen in communication with only the interior volume, the opening in fluid communication with the catheter and the second seal.

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