Patent Description:
A common type of catheter is an over-the-needle peripheral intravenous ("IV") catheter. As its name implies, the over-the-needle catheter may be mounted over an introducer needle having a sharp distal tip. The catheter and the introducer needle may be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter with the bevel of the needle facing up away from skin of the patient. The catheter and introducer needle are generally inserted at a shallow angle through the skin into vasculature of the patient.

Blood withdrawal using a peripheral IV catheter may be difficult for several reasons, particularly when an indwelling time of the catheter is more than one day. For example, when the catheter is left inserted in the patient for a prolonged period of time, the catheter or vein may be more susceptible to narrowing, collapse, kinking, blockage by debris (e.g., fibrin or platelet clots), and adhering of a tip of the catheter to the vasculature. Due to this, catheters may often be used for acquiring a blood sample at a time of catheter placement but are much less frequently used for acquiring a blood sample during the catheter dwell period. Therefore, when a blood sample is required, an additional needle stick is needed to provide vein access for blood collection, which may be painful for the patient and result in higher material costs. Accordingly, there is a need for catheter systems and methods that facilitate placement of blood sample instruments, such as, for example, catheters and probes, in the vasculature of the patient without additional needle sticks.

<CIT> discloses an intravascular insertion apparatus having a guide member internally associated with a syringe, which can be advanced and retracted by actuation of the thumb of the hand, which holds the syringe.

The subject matter of the invention is defined by each of independent claims <NUM>, <NUM> and <NUM>.

The present invention relates generally to a syringe-based delivery device for delivering a vascular access instrument into a catheter assembly and/or vasculature of a patient. The delivery device includes a syringe having a barrel and a plunger movable within the barrel. The delivery device includes a guide feature disposed within the barrel and movable with the plunger. The guide feature includes a channel, which is generally U-shaped. In some embodiments, the guide feature and channel may be oriented in various ways within the barrel. For example, the channel may be horizontally or vertically oriented within the barrel.

The delivery device includes an instrument disposed within the barrel and extending through through the channel. In response to depression of the plunger the guide feature moves in the distal direction a first distance, the instrument moves through the channel, and a first end of the instrument is advanced in the distal direction a second distance, which may be greater than the first distance. In some embodiments, the second distance may be at least two times the first distance.

In some embodiments, the first end of the instrument may be advanced in the distal direction beyond a distal end of the syringe in response to the plunger being partially and/or fully depressed within the barrel in the distal direction. In some embodiments, a second end of the instrument may be fixed. In some embodiments, the second end of the instrument may be fixed within the barrel. In some embodiments, a catheter adapter of the catheter assembly may be coupled to the syringe.

In some embodiments, a needleless connector may be disposed between the syringe and the catheter adapter and may connect the syringe to the catheter adapter. In further detail, in some embodiments, a distal end of the needleless connector may be coupled to the catheter adapter of the catheter assembly, and a proximal end of the needleless connector may be coupled to the syringe. In some embodiments, the distal end of the syringe may include connector, which may be configured to couple to a proximal end of the catheter adapter and/or the needleless connector. In some embodiments, an interface adapter may be disposed between the syringe and the catheter adapter and may connect the syringe to the catheter adapter. In some embodiments, the second end of the instrument may be fixed within the interface adapter. In some embodiments, the barrel may include a liquid, such as, for example, saline or another suitable flushing liquid. In some embodiments, the liquid may completely fill the barrel. In some embodiments, in response to depression of the plunger, the liquid may exit a distal opening of the syringe. In some embodiments, a diameter of the distal opening of the syringe may be greater than an outer diameter of the instrument. In some embodiments, in response to depression of the plunger, the liquid may flow around the instrument and into and/or through the catheter assembly.

In some embodiments, the barrel may not include the liquid, but the syringe may be used to deliver the instrument to the catheter assembly. In these and other embodiments, the distal opening of the syringe may include a septum to create a seal between the distal opening of the syringe and the instrument, and the barrel or a stopper may include a vent for air escape during when advancing the plunger.

In some embodiments, the instrument may include a probe (which may include a sensor), a light tube for disinfection, or another suitable instrument. In some embodiments, the instrument may include a catheter. In these and other embodiments, the syringe may include extension tubing, which may extend outwardly from a distal portion of the syringe. In some embodiments, the second end of the instrument may be coupled to the extension tubing. In some embodiments, blood collected from the patient may flow from the second end of the instrument into the extension tubing.

In some embodiments, a guidewire may be disposed within the instrument. In some embodiments, in response to depression of the plunger within the barrel in the distal direction, the guidewire and the instrument may move through the channel. In some embodiments, in response to depression of the plunger within the barrel in the distal direction, a first end of the guidewire may be advanced in the distal direction. In some embodiments, in response to depression of the plunger, the guide feature may be moved in the distal direction a first distance, the first end of the guidewire may be advanced in the distal direction a second distance. In some embodiments, the second distance may be greater than the first distance. In some embodiments, the second distance may be at least two times the first distance.

In some embodiments, the first end of the guidewire may be advanced in the distal direction beyond the distal end of the syringe in response to the plunger being partially and/or fully depressed. In some embodiments, the second end of the guidewire may be fixed. For example, the second end of the guidewire may be fixed within the barrel or the interface adapter.

In some embodiments, the delivery device may include support tubing, which may extend from and be coupled to the guide feature. In some embodiments, in response to depression of the plunger, the guide feature may be moved in the distal direction a first distance, the instrument may move through the support tubing, a first end of the instrument may be advanced in the distal direction a second distance, and a first end of the support tubing may be advanced in the distal direction the first distance. In these embodiments, the second distance may be greater than the first distance.

In some embodiments, the delivery device may allow the instrument to access the vasculature of a patient through another vascular access device, such as, for example, a catheter assembly, which may be inserted into the vasculature of the patient. In some embodiments, when the instrument is introduced into the catheter assembly via the delivery device, the instrument may access a fluid pathway of the catheter assembly and/or the instrument may extend through the catheter assembly and access the vasculature of the patient. In some embodiments, the catheter assembly may include the catheter adapter and another catheter, which may extend distally from the catheter adapter. In some embodiments, a proximal end of the other catheter may be secured within the catheter adapter.

The instrument is coupled to the plunger and movable along the plunger to an advanced position. The instrument extends distally into the barrel. The distal end of the instrument is configured to be advanced distal to the distal end of the syringe.

In some embodiments, the plunger may include a rib. In some embodiments, the instrument may be coupled to the rib and movable along the rib. In some embodiments, the plunger may include a slot. In these and other embodiments, the instrument may be disposed within the barrel and coupled to an advancement tab movable along the slot. In some embodiments, the plunger may include the stopper. In some embodiments, in response to the plunger moving to the advanced position, the instrument may move through the stopper.

In some embodiments, the syringe may include an outer barrel, an inner barrel, an elongated body movable within the inner barrel, and a plunger head disposed within the inner barrel. In some embodiments, a distal end of the elongated body may couple to the plunger head. In some embodiments, in response to the coupling of the elongated body to the plunger head, the elongated body and the plunger head may be configured to distally advance together to expel liquid from the inner barrel through the distal opening of the syringe.

In some embodiments, an instrument may extend from the distal end of the elongated body and through the plunger head. In some embodiments, in response to advancement of the elongated body in the distal direction within the inner barrel, the distal end of the instrument may be advanced in the distal direction. In some embodiments, in response to the coupling of the elongated body to the plunger head, the elongated body and the plunger head may be configured to proximally retract together to expel liquid from the inner barrel into the outer barrel.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive of the invention, as claimed. It should be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. It should also be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural changes may be made as long as all fall within the scope of the claims defining the invention. The following detailed description is, therefore, not to be taken in a limiting sense.

Referring now to <FIG>, a delivery device <NUM> includes a syringe <NUM> having a barrel <NUM> and a plunger <NUM> movable within the barrel <NUM>. <FIG> illustrate the barrel <NUM> of the syringe <NUM> in a proximal position, according to some embodiments. The delivery device <NUM> includes a guide feature <NUM>, which is disposed within the barrel <NUM> and movable with the plunger <NUM>. The guide feature <NUM> includes a channel <NUM>, which is generally U-shaped. In other embodiments, a portion <NUM> of the channel <NUM> may be removed and the channel <NUM> may include a generally semi-circular shape.

In some embodiments, a distal end of the plunger <NUM> may include a stopper <NUM>, which may include rubber or another suitable material. In some embodiments, the guide feature <NUM> may be movable with the plunger <NUM>. For example, the guide feature <NUM> may be coupled to the stopper <NUM> and may move proximally and/or distally with the plunger <NUM>. As another example, the stopper <NUM> may include the guide feature <NUM>, and the guide feature <NUM> may move proximally and distally with the plunger <NUM>. In further detail, in some embodiments, the channel <NUM> may be disposed within the stopper <NUM>. In some embodiments, in response to movement of the plunger <NUM> proximally, the guide feature <NUM> may be moved proximally and the instrument <NUM> may be retracted or withdrawn proximally.

The delivery device <NUM> includes an instrument <NUM>, which is disposed within the barrel <NUM> and extends through the channel <NUM>. In some embodiments, the instrument <NUM> may include a probe (which may include a sensor), a light tube for disinfection, or another suitable instrument. In some embodiments, the instrument <NUM> may include a catheter. In these and other embodiments, the syringe <NUM> may include extension tubing <NUM>, which may extend outwardly from a distal portion of the syringe <NUM>, such as, for example, the barrel <NUM>. In some embodiments, a distal end of the barrel <NUM> may be proximate the distal connector <NUM>. In some embodiments, the barrel <NUM> may include a uniform inner diameter.

In some embodiments, a blood collection device <NUM> may be coupled to the extension tubing <NUM>. In some embodiments, the blood collection device <NUM> may include a vacuum tube, test tube, or syringe. In some embodiments, the blood collection device may include an adapter, which may be configured to hold a test tube, as illustrated, for example, in <FIG>.

In some embodiments, a first end <NUM> of the instrument <NUM> may be advanced in the distal direction beyond a distal opening <NUM> of the syringe <NUM> in response to the plunger <NUM> being partially and/or fully depressed within the barrel <NUM> in the distal direction. In some embodiments, a second end <NUM> of the instrument <NUM> may be fixed. In some embodiments, the second end <NUM> of the instrument <NUM> may be fixed within the barrel <NUM> or the distal connector <NUM>. In some embodiments, the second end <NUM> of the instrument <NUM> may be coupled to the extension tubing <NUM> such that blood collected from the patient via a catheter assembly <NUM> may flow from the second end <NUM> of the instrument <NUM> into the extension tubing <NUM>. In some embodiments, the first end <NUM> of the instrument <NUM> may be blunt and/or tapered.

In some embodiments, a catheter adapter <NUM> of the catheter assembly <NUM> may be coupled to the syringe <NUM>. In further detail, in some embodiments, a distal end <NUM> of the syringe <NUM> may include a distal connector <NUM>, which may be configured to couple to a proximal end of the catheter adapter <NUM>. In some embodiments, the distal connector <NUM> may include a luer adapter, such as a slip or thread male or female luer adapter, or another suitable connector.

In some embodiments, a needleless connector may connect the syringe <NUM> to the catheter adapter <NUM>. In further detail, in some embodiments, the distal connector <NUM> may be configured to couple to a proximal end of the needleless connector. In some embodiments, a distal end of the needleless connector may be coupled to the proximal end of the catheter adapter <NUM>. In some embodiments, the needleless connector may include a luer adapter, such as a male or female luer adapter, or any other suitable connector. In some embodiments, the needleless connector may include a pro re nata ("PRN") connector. In some embodiments, the needleless connector may include a SMARTSITE™ Needle-Free Connector available from Becton, Dickinson and Company, a Q-SYTE™ Luer Activated Split Septum available from Becton, Dickinson and Company, an INTERLINK™ Needlefree System available from Baxter, or another other suitable needleless connector.

In some embodiments, the catheter assembly <NUM> may include a catheter <NUM>, which may be secured within the catheter adapter <NUM> and may extend distally from the catheter adapter <NUM>. In some embodiments, the catheter <NUM> may include a peripheral intravenous catheter, which may be indwelling within vasculature of the patient. In some embodiments, the catheter adapter <NUM> may be integrated, having an integrated extension tube (not illustrated), or non-integrated.

In some embodiments, the delivery device <NUM> may allow the instrument <NUM> to access the vasculature of a patient through the catheter <NUM>, which may be inserted into the vasculature of the patient. In some embodiments, when the instrument <NUM> is introduced into the catheter assembly via the delivery device <NUM>, the instrument may access a fluid pathway of the catheter assembly <NUM> and/or the instrument <NUM> may extend through the catheter assembly <NUM> and access the vasculature of the patient.

In some embodiments, the catheter assembly <NUM> may include a needle hub coupled to the proximal end of the catheter adapter <NUM> and an introducer needle extending distally from the needle hub (not illustrated). In some embodiments, the needle hub and the introducer needle may be removed from the catheter assembly <NUM> in response to placement of the catheter <NUM> within vasculature of the patient, and the delivery device <NUM> may be coupled to the proximal end of the catheter adapter <NUM> after the needle hub and introducer needle are removed.

In some embodiments, the guide feature <NUM> and the channel <NUM> may be oriented in various ways and angles within the barrel <NUM>. For example, the channel <NUM> may be generally horizontally or vertically oriented within the barrel <NUM> when the delivery device <NUM> is coupled with the catheter adapter <NUM> positioned for insertion into a patient.

In some embodiments, the barrel <NUM> may include a liquid <NUM>, such as, for example, saline or another suitable flushing liquid. In some embodiments, the liquid <NUM> may completely fill the barrel <NUM>. In some embodiments, the liquid <NUM> may be used to flush all or a portion of the catheter assembly <NUM>, as will be explained in further detail.

In some embodiments, a guidewire <NUM> may be disposed within the instrument <NUM>. In some embodiments, a first end <NUM> of the guidewire <NUM> may be advanced in the distal direction beyond the distal end of the syringe <NUM> in response to the plunger <NUM> being partially and/or fully depressed. In some embodiments, a second end <NUM> of the guidewire <NUM> may be fixed. For example, the second end <NUM> of the guidewire <NUM> may be fixed within the barrel <NUM>.

In some embodiments, the guidewire <NUM> may be used to facilitate placement of the instrument <NUM> within the vasculature of the patient, which may result in less vein-related trauma. In some embodiments, the guidewire <NUM> may support the instrument <NUM>, such as a catheter, during advancement to prevent collapse or buckling of the instrument <NUM> as it advances through a second catheter (such as, for example, the catheter <NUM>, illustrated in <FIG>). In some embodiments, the guidewire <NUM> may support the instrument <NUM> along all or a portion of the instrument <NUM> to improve structural reliability, provide adequate blood collection fill time performance, maintain acceptable blood hemolysis risks, and minimize a risk of kinking of the instrument <NUM>. In some embodiments, the guidewire <NUM> and the instrument <NUM> may be enclosed within the delivery device <NUM> upon completion of blood sampling. It is understood that in some embodiments, the delivery device <NUM> may not include the guidewire <NUM>.

Referring now to <FIG>, in some embodiments, the channel <NUM> may contact and support the instrument <NUM>. In some embodiments, a shape of the channel <NUM> may be configured to decrease a risk of kinking or bending of the instrument <NUM> as the instrument <NUM> moves through the channel. In some embodiments, an outer diameter of the guidewire <NUM> may be less than an inner diameter of the instrument <NUM> such that fluid may easily flow through the instrument <NUM>. In some embodiments, a curvature of the U-shape may vary depending on, for example, on a bend radius of a material from which the instrument <NUM> is constructed. In some embodiments, the curvature of the U-shape may be configured to prevent kinking of or damage to the instrument <NUM>. In some embodiments, the channel <NUM> may include one or more protrusions <NUM>, such as, for example, a lip or a detent, which may facilitate securement of the instrument <NUM> within the channel <NUM>.

Referring now to <FIG>, as an alternative to the guide feature configuration illustrated in <FIG> in which the guide feature <NUM> only partially spans a lumen of the barrel <NUM>, in some embodiments, the guide feature <NUM> may span an entirety of the lumen of the barrel <NUM>. In further detail, in some embodiments, the guide feature <NUM> may contact an entirety of an inner surface of the barrel at a cross-section of the barrel, as illustrated, for example, in <FIG>.

Referring now to <FIG>, in some embodiments, as opposed to being horizontally oriented, as illustrated, for example, in <FIG>, the channel <NUM> may be vertically oriented within the syringe <NUM>, as illustrated, for example, in <FIG>. In some embodiments, the guide feature <NUM> may span an entirety of the lumen of the barrel <NUM> and contact an entirety of an inner surface of the barrel at a cross-section of the barrel, as illustrated, for example, in <FIG>. In other embodiments, the guide feature <NUM> may only partially span the lumen of the barrel <NUM>.

Referring now to <FIG>, the plunger <NUM> may be depressed or moved in a distal direction from the proximal position. In response to depression of the plunger <NUM>, the guide feature <NUM> is moved in the distal direction a first distance, the instrument <NUM> moves through the channel <NUM>, and a first end <NUM> of the instrument <NUM> is advanced in the distal direction a second distance, which may be greater than the first distance. In some embodiments, the second distance may be at least two times the first distance ("a <NUM>:<NUM> advancement ratio") due to the U-shape of the channel <NUM>. In some embodiments, the delivery device <NUM> and the <NUM>:<NUM> advancement ratio (or another advancement ratio where the second distance is greater than the first distance) between the guide feature <NUM> and the first end <NUM> of the instrument <NUM> may provide reliability and structural support as the instrument <NUM> is distally advanced, while also providing an instrument <NUM> with long reach.

In some embodiments, in response to depression of the plunger <NUM>, the liquid <NUM> may exit the distal opening <NUM> of the syringe <NUM>. In some embodiments, a diameter of the distal opening <NUM> of the syringe <NUM> may be greater than an outer diameter of the instrument <NUM>. In some embodiments, in response to depression of the plunger <NUM>, the liquid <NUM> may flow around the instrument <NUM> and into and/or through the catheter assembly <NUM>.

In some embodiments, the instrument <NUM> may include the guidewire <NUM> and/or a multi-diameter catheter, such as described, for example, in <CIT>, entitled "MULTI-DIAMETER CATHETER AND RELATED DEVICES AND METHODS In some embodiments, the multi-diameter catheter may allow improved blood flow rates during blood collection. In some embodiments, the distal end of the guidewire <NUM> may be disposed proximal to a transition of the multi-diameter catheter to allow fluid to flow in an annular space between an outer surface of the guidewire <NUM> and an inner surface of the multi-diameter catheter.

In some embodiments, in response to depression of the plunger <NUM> within the barrel <NUM> in the distal direction, the guidewire <NUM> may move through the channel <NUM> within the instrument <NUM>, and the first end <NUM> of the guidewire <NUM> may be advanced in the distal direction. In response to depression of the plunger <NUM>, the guide feature <NUM> is moved in the distal direction a first distance, the first end <NUM> of the guidewire <NUM> may be, in some embodiments, advanced in the distal direction a second distance. In some embodiments, the second distance may be greater than the first distance. In some embodiments, the second distance may be at least two times the first distance.

Referring back to <FIG>, in some embodiments, a distal end <NUM> of the catheter <NUM> may include one or more flow holes <NUM> extending through a wall of the catheter <NUM>. In some embodiments, the liquid <NUM> may flow out of the flow holes <NUM> in response to depression of the plunger <NUM>.

Referring now to <FIG>, in some embodiments, the delivery device <NUM> may include support tubing <NUM>, which may extend from the guide feature <NUM>. In some embodiments, the support tubing <NUM> may be secured to the guide feature <NUM>. In response to depression of the plunger <NUM>, the guide feature <NUM> is moved in the distal direction a first distance, the instrument <NUM> may move, in some embodiments, through the support tubing <NUM>, and a first end <NUM> of the support tubing <NUM> may be advanced in the distal direction the first distance. In some embodiments, the support tubing <NUM> may include a uniform inner diameter and/or uniform outer diameter along all or a portion of a length of the support tubing <NUM>.

In some embodiments, when the delivery device <NUM> includes the support tubing <NUM>, the instrument <NUM> may include a catheter constructed of a softer material than polyimide, which may be less damaging to the vein wall. In these and other embodiments, the instrument <NUM> may include a tube constructed of one or more of polyurethane, silicon, thermoplastic elastomer ("TPE"), thermoplastic polyurethane ("TPU"), and another suitable compliant material.

In some embodiments, the support tubing <NUM> may include a larger inner diameter than an outer diameter of the instrument <NUM> such that the instrument <NUM> may easily move through the support tubing <NUM>. In some embodiments, the support tubing <NUM> may provide support to the first end <NUM> or the free end of the instrument <NUM>. In some embodiments, in response to depression of the plunger <NUM> and movement of the guide feature <NUM> the first distance, the first end <NUM> of the support tubing <NUM> may be advanced in the distal direction a distance equal to the first distance (a "<NUM>:<NUM> advancement ratio"), while the first end <NUM> of the instrument <NUM> may be advanced a distance greater than that of the first distance, such as for example, twice the first distance ("a <NUM>:<NUM> advancement ratio"). In some embodiments, the differing advancement ratios of the guide feature <NUM> with respect to the first end <NUM> and the guide feature <NUM> with respect to the support tubing <NUM> may result in the support tubing <NUM> not advancing distally beyond a portion of the instrument <NUM>, and the portion of the instrument <NUM> advancing distally through the catheter assembly <NUM> and into the vasculature. In these and other embodiments, the portion of the instrument <NUM> may have a decreased outer diameter or the instrument <NUM> may include a uniform diameter along all or a portion of a length of the instrument <NUM>.

In some embodiments, given the <NUM>:<NUM> advancement ratio (or another advancement ratio where the second distance is greater than the first distance) between the guide feature <NUM> and the first end <NUM> of the instrument <NUM> and the <NUM>:<NUM> advancement ratio between the guide feature <NUM> and the first end <NUM> of the support tubing <NUM>, the first end <NUM> of the instrument <NUM> may exit the first end <NUM> of the support tubing <NUM>. In some embodiments, the first end <NUM> of the instrument <NUM> may exit the first end <NUM> of the support tubing <NUM> to facilitate entry of the instrument <NUM> into a portion of the catheter assembly <NUM> that may be too narrow for the support tubing <NUM> to enter.

In some embodiments, the delivery device <NUM> may facilitate a timed or delayed exit of the instrument <NUM> from the support tubing <NUM>. In further detail, in some embodiments, the first end <NUM> of the instrument <NUM> may be shortened so that it is positioned even with or proximal to the first end <NUM> of the support tubing <NUM> when the guide feature <NUM> is fully retracted, as illustrated, for example, in <FIG>.

Referring now to <FIG>, another delivery device <NUM> is illustrated, according to some embodiments. In some embodiments, the delivery device <NUM> may include or correspond to the delivery device <NUM>, discussed with respect to <FIG>. In further detail, in some embodiments, the delivery device <NUM> may include one or more features of the delivery device <NUM> and/or the delivery device <NUM> may include one or more features of the delivery device <NUM>.

In some embodiments, the second end <NUM> of the instrument <NUM> may be fixed within an interface adapter <NUM>, which may connect the delivery device <NUM> to a proximal end of the needleless connector or a proximal end of a catheter adapter, such as, for example, the catheter adapter <NUM> discussed with respect to <FIG>. In some embodiments, the needleless connector may be disposed between the interface adapter <NUM> and the catheter adapter and may connect the interface adapter <NUM> to the catheter adapter. In some embodiments, a proximal end <NUM> of the interface adapter <NUM> may be configured to couple with the distal connector <NUM> of the delivery device <NUM>. In some embodiments, the proximal end <NUM> may include a luer adapter, such as a slip or thread male or female luer adapter, or another suitable connector. In some embodiments, the proximal end <NUM> of the interface adapter <NUM> may be removably or non-removably coupled to the distal connector <NUM>. In some embodiments, a distal end <NUM> of the interface adapter <NUM> may include a luer adapter, such as a slip or thread male or female luer adapter, or another suitable connector, which may be configured to couple the proximal end of the needleless connector or the proximal end of the catheter adapter.

In some embodiments, the interface adapter <NUM> may include a side port <NUM>, which may include a luer adapter, such as a slip or thread male or female luer adapter, or another suitable connector. In some embodiments, the delivery device <NUM> may include a first cap and/or a second cap (not illustrated). The first cap may be coupled to and seal the distal opening <NUM> of the syringe <NUM> in some embodiments where the instrument <NUM> is fully contained within the syringe <NUM> when the plunger <NUM> is in the proximal position. The first cap may be coupled to and seal the distal end of the interface adapter <NUM> in some embodiments where the first end of the instrument <NUM> is fixed within the interface adapter <NUM>. In some embodiments, the second cap may seal the side port <NUM>. In some embodiments, the first cap may be removable to allow connection of the delivery device <NUM> to the interface adapter <NUM> and/or the second cap may be removable to allow coupling of a blood collection device to the side port <NUM>, for example.

In some embodiments, the blood collection device, such as, for example, the blood collection device <NUM> of <FIG> and <FIG>, may be coupled to the luer adapter of the side port <NUM> to collect blood from the patient. In some embodiments, the blood collection device may include a syringe, a blood collection tube, or another suitable device. In some embodiments, extension tubing <NUM> may be coupled to the side port <NUM> and may extend from the side port <NUM>. In some embodiments, a proximal end of the extension tubing <NUM> may be coupled to the blood collection device.

In some embodiments, the side port <NUM> may include a cavity <NUM> that may be sealed off from a lumen <NUM> of the interface adapter <NUM>, which may prevent blood or other fluid from leaking into the lumen <NUM>. In some embodiments, the cavity <NUM> may be sealed off from the lumen <NUM> by a wall <NUM>, through which the second end <NUM> of the instrument <NUM> and/or the second end <NUM> of the guidewire <NUM> (not illustrated in <FIG>) may extend. In some embodiments, the guidewire <NUM>, illustrated, for example, in <FIG> and <FIG>, may be disposed within the instrument <NUM> and may operate in a similar fashion as discussed with respect to <FIG> and <FIG>.

Referring now to <FIG>, in some embodiments, the delivery device <NUM> may include the support tubing <NUM>, which may extend from the guide feature <NUM>. In some embodiments, the support tubing <NUM> may be secured to the guide feature <NUM>. In response to depression of the plunger <NUM>, as illustrated, for example, in <FIG>, the guide feature <NUM> is moved in the distal direction a first distance, the instrument <NUM> may move, in some embodiments, through the support tubing <NUM>, and a first end <NUM> of the support tubing <NUM> may be advanced in the distal direction the first distance. In some embodiments, the support tubing <NUM> may include a uniform inner diameter and/or uniform outer diameter along all of a portion of a length of the support tubing <NUM>.

Referring now to <FIG>, another example delivery device <NUM> is illustrated, according to a second aspect of the invention.

The instrument <NUM> is coupled to the plunger <NUM> and is movable along the plunger <NUM> in the distal direction to an advanced position. In some embodiments, the instrument <NUM> may also be moved proximally along the plunger <NUM> to retract the instrument <NUM>. In these and other embodiments, the instrument <NUM> may move independently of the plunger. In some embodiments, the instrument <NUM> may extend distally into the barrel <NUM>. A distal end <NUM> of the instrument <NUM> is configured to be advanced distal to the distal opening <NUM> of the syringe <NUM>, as illustrated, for example in <FIG>.

In some embodiments, the plunger <NUM> may include at least one rib <NUM>. In some embodiments, the instrument <NUM> may be coupled to the rib <NUM> and movable along the rib <NUM>. In some embodiments, the instrument <NUM> may be coupled to the rib <NUM> via an advancement tab <NUM>, which may extend over the rib <NUM>, as illustrated in <FIG>, for example. In some embodiments, the plunger <NUM> may include a stopper <NUM>, which may include rubber or another suitable material. In some embodiments, in response to the plunger <NUM> moving to the advanced position, the instrument <NUM> may move through the stopper <NUM>.

As illustrated in <FIG>, in some embodiments, a positioning feature <NUM> may include a proximal end coupled to the advancement tab <NUM>, which may be coupled to the instrument <NUM> and configured to move the instrument <NUM> proximally and/or distally. In some embodiments, the positioning feature <NUM> may be rigid. In some embodiments, a distal end <NUM> of the positioning feature <NUM> may contact an upper surface of the syringe <NUM> to prevent distal movement of the advancement tab <NUM> and the instrument <NUM>. In some embodiments, the distal end <NUM> of the positioning feature <NUM> may be free floating, and may contact the upper surface of the syringe <NUM> in response to movement of the advancement tab <NUM> and the instrument <NUM> in the distal direction. In some embodiments, the distal end <NUM> of the positioning feature <NUM> may be attached or selectively attached to the syringe <NUM>. In some embodiments, the positioning feature <NUM> may secure a position of the instrument <NUM> when the delivery device <NUM> is packaged and/or prior to use.

In some embodiments, in response to depression of the plunger <NUM>, the liquid <NUM> may flow out of the distal opening <NUM> of the syringe <NUM>. In some embodiments, the distal end <NUM> of the syringe <NUM> may include a luer adapter, such as a slip or thread male or female luer adapter, or another suitable connector. In some embodiments, the syringe <NUM> may be coupled to a proximal end of the catheter adapter <NUM> of the catheter assembly <NUM> (illustrated, for example, in <FIG> and <FIG>), and the instrument <NUM> may be advanced in the distal direction such that the instrument <NUM> is disposed in a fluid pathway of the catheter assembly <NUM> and/or advanced beyond the distal end <NUM> of the catheter <NUM>.

In some embodiments, a method of operating the delivery device <NUM> may include coupling the delivery device <NUM> to the proximal end of the catheter adapter <NUM>, which may include an indwelling catheter <NUM>. In some embodiments, the instrument <NUM> may then be advanced in the distal direction. In some embodiments, the plunger <NUM> may be depressed such that the liquid <NUM> flows around the instrument <NUM> and through the catheter <NUM> to flush the catheter <NUM> and the catheter assembly <NUM>.

In some embodiments, the barrel <NUM> and/or the plunger <NUM> may include one or more markings <NUM>, which may provide a visual and/or tactile indication to the user of a position of the instrument. In further detail, in some embodiments, the markings <NUM> may indicate a distance that the instrument <NUM> is advanced and/or retracted. In some embodiments, the barrel <NUM> and/or the plunger <NUM> may be transparent. It is understood that the barrel <NUM> and/or the plunger <NUM> of other embodiments may include the markings.

Referring now to <FIG>, in some embodiments, the plunger <NUM> of the delivery device <NUM> may include a slot <NUM>. In these and other embodiments, the instrument <NUM> may be disposed within the barrel <NUM> and coupled to an advancement tab <NUM> movable along the slot <NUM>. In some embodiments, the advancement tab <NUM> may be coupled to the instrument <NUM> and configured to move the instrument <NUM> proximally and/or distally.

Referring now to <FIG>, another example delivery device <NUM> is illustrated, according to a third aspect of the invention.

In some embodiments, the syringe <NUM> includes an outer barrel <NUM>, an inner barrel <NUM>, an elongated body <NUM> movable within the inner barrel <NUM>, and a plunger head <NUM> disposed within the inner barrel <NUM>. The elongated body <NUM> when advanced from a proximal position, illustrated, for example, in <FIG>, in a distal direction, and a distal end <NUM> of the elongated body <NUM> couples to the plunger head <NUM>, as illustrated, for example, in <FIG>. In response to the elongated body <NUM> being advanced from the proximal position in the distal direction to couple to the plunger head <NUM>, some of the liquid <NUM> is expelled from the inner barrel <NUM>. In response to the coupling of the elongated body <NUM> to the plunger head <NUM>, the elongated body <NUM> and the plunger head <NUM> are configured to distally advance together to expel the liquid <NUM> from the inner barrel <NUM> through the distal opening <NUM> of the syringe <NUM>, as illustrated, for example, in <FIG>. In some embodiments, when the elongated body <NUM> and the plunger head <NUM> are coupled together they may form a unitary plunger <NUM>.

The instrument <NUM> extends from the distal end <NUM> of the elongated body <NUM> and through the plunger head <NUM>. In response to advancement of the elongated body <NUM> in the distal direction within the inner barrel <NUM>, the distal end <NUM> of the instrument <NUM> is advanced in the distal direction. In some embodiments, in response to the coupling of the elongated body <NUM> to the plunger head <NUM>, the elongated body <NUM> and the plunger head <NUM> may be configured to proximally retract together to expel the liquid <NUM> from the inner barrel <NUM> into the outer barrel <NUM>, as illustrated, for example, in <FIG>. In some embodiments, the elongated body <NUM> may be coupled to the plunger head <NUM> in various ways, such as, for example, a snap-fit, an interference fit, threading, a barbed fitting, etc. <FIG> illustrate a barbed fitting, for example.

In some embodiments, one or more one-way valves <NUM> may be disposed between the inner barrel <NUM> and the outer barrel <NUM>, and the liquid <NUM> may flow through the one-way valves from the inner barrel <NUM> to the outer barrel <NUM> in response to retraction of the elongated body <NUM> and the plunger head <NUM> coupled together. In some embodiments, a distal end of the inner barrel <NUM> and/or a distal end of the outer barrel <NUM> may include a septum <NUM>. In some embodiments, the delivery device <NUM> may include a venting element to prevent a vacuum from being formed as the plunger is retracted proximally. In some embodiments, the venting element may provide venting to a portion of the inner barrel <NUM> distal to the plunger head <NUM> and may prevent a vacuum from being formed as the elongated body <NUM> and the plunger head <NUM> are retracted proximally.

In some embodiments, a proximal end of the outer barrel <NUM> may include a seal <NUM> proximate an opening in the outer barrel <NUM> through which the elongated body <NUM> may extend. In some embodiments, the seal <NUM> may prevent fluid leakage from the proximal end of the outer barrel <NUM>.

In some embodiments, the outer barrel <NUM> may include multiple pieces, which may be coupled together. In further detail, in some embodiments, the outer barrel <NUM> may include a first piece and a second piece, which may be coupled together via welding, adhesive, pins, a press-fit, or another suitable means. In some embodiments, the outer barrel <NUM> may be monolithically formed as a single unit.

In some embodiments, the inner barrel <NUM> may be fixed within the outer barrel <NUM> via one or more retaining features. In further detail, in some embodiments, one or more retaining features of the inner barrel <NUM> may be engaged in a mechanical fit (such as, for example, a snap fit, a press fit, or another suitable fit) with one or more retaining features of the outer barrel <NUM>. In some embodiments, the retaining features may include ribs <NUM> that may extend from the inner barrel <NUM> to the outer barrel <NUM>. Example ribs <NUM> are illustrated in <FIG>. In some embodiments, the ribs <NUM> may be rigid or semi-rigid. In some embodiments, the retaining features may be annular and may extend around a circumference of the inner barrel <NUM>. In these and other embodiments, the retaining features may include apertures and/or valves which may open in response to fluid pressure, allowing fluid to pass. In some embodiments, fluid may flow around the retaining features.

As mentioned, in some embodiments, the elongated body <NUM> may be coupled to the plunger head <NUM> in various ways, such as, for example, a snap-fit, an interference fit, threading, a barbed fitting, etc. <FIG> illustrates each of the elongated body <NUM> and the plunger head <NUM> including one or more threads, according to some embodiments. In some embodiments, the elongated body <NUM> is threaded to the plunger head <NUM>. In some embodiments, after the user threads the elongated body <NUM> to the plunger head <NUM>, the elongated body <NUM> and the plunger head <NUM> may be distally advanced together to expel the liquid <NUM> from the inner barrel <NUM> through the distal opening <NUM> of the syringe <NUM> and advance the instrument <NUM>. In some embodiments, in response to the threading of the elongated body <NUM> to the plunger head <NUM>, the elongated body <NUM> and the plunger head <NUM> may be configured to proximally retract together to expel the liquid <NUM> from the inner barrel <NUM> into the outer barrel <NUM> and retract the instrument <NUM>. In some embodiments, in response to the elongated body <NUM> and the plunger head <NUM> being partially or fully retracted in the proximal direction, the user may unthread the elongated body <NUM> may be unthreaded from the plunger head <NUM> such that the elongated body <NUM> and the instrument <NUM> may be removed from the delivery device <NUM>.

Referring now to <FIG>, another delivery device <NUM> is illustrated, according to a third aspect of the invention.

The syringe <NUM> of the delivery device <NUM> includes an outer barrel <NUM>, an inner barrel <NUM> containing the liquid <NUM> and movable within the outer barrel <NUM> between a proximal position and a distal position, a plunger <NUM> depressible within the inner barrel <NUM>, and may include a first valve <NUM> disposed between the outer barrel <NUM> and the inner barrel <NUM>. In some embodiments, the inner barrel <NUM> may be pre-filled with the liquid <NUM>, as illustrated, for example, in <FIG> illustrates the delivery device <NUM> in an initial position, or upon removing the delivery device <NUM> from a package, according to some embodiments.

In some embodiments, the plunger <NUM> may include a second valve <NUM> configured to allow the liquid <NUM> to flow from the inner barrel <NUM> to the outer barrel <NUM> in a distal direction in response to depression of the plunger <NUM> within the inner barrel <NUM>, as illustrated, for example, in <FIG>. In some embodiments, the first valve <NUM> may be closed when the inner barrel <NUM> is in the distal position and during depression of the plunger <NUM>, as illustrated, for example, in <FIG>. In some embodiments, in response to retraction of the plunger <NUM> in a proximal direction, the first valve <NUM> may open and the liquid <NUM> may flow through the distal opening <NUM> of the syringe <NUM>, as illustrated, for example, in <FIG>. In some embodiments, the delivery device <NUM> may include multiple first valves <NUM> and/or multiple second valves <NUM>, as illustrated, for example in <FIG>.

The instrument <NUM> extends through the plunger <NUM>. In response to the depression of the plunger <NUM>, the distal end <NUM> of the instrument <NUM> is advanced in a distal direction. In some embodiments, the distal end <NUM> of the syringe <NUM> may include a distal connector <NUM>, such as, for example, a slip or thread male or female luer adapter, or another suitable connector. In some embodiments, the distal end <NUM> of the instrument <NUM> may be blunt and/or tapered. In some embodiments, the distal connector <NUM> may be configured to couple to a proximal end of a catheter adapter. In some embodiments, the syringe <NUM> may be coupled to a proximal end of the catheter adapter <NUM> of the catheter assembly <NUM> (illustrated, for example, in <FIG> and <FIG>), and the plunger <NUM> may be depressed to advance the instrument <NUM> in the distal direction such that the instrument <NUM> is disposed in a fluid pathway of the catheter assembly <NUM> and/or advanced beyond the distal end <NUM> of the catheter <NUM>.

Not claimed but also disclosed is a method of operating the delivery device <NUM> that may include coupling the delivery device <NUM> to the proximal end of the catheter adapter <NUM>. The plunger <NUM> may be depressed to advance the instrument <NUM> in the distal direction, which may also cause the liquid <NUM> to flow from the inner barrel <NUM> through the first valve <NUM> into the outer barrel <NUM>. Depressing the plunger <NUM> may also move the inner barrel <NUM> to the distal position, closing the second valve <NUM>. The plunger <NUM> may then be retracted or moved proximally, at least partially retracting the instrument <NUM> in the proximal direction. In some embodiments, proximal movement of the plunger <NUM> may also move the inner barrel <NUM> proximally, opening the second valve <NUM>. As the plunger is moved proximally, the liquid <NUM> disposed within the outer barrel <NUM> may exit the distal opening <NUM> of the syringe <NUM> and may flush the catheter assembly <NUM>.

In some embodiments, an inner surface of the outer barrel <NUM> may include a stop or catch that may prevent the inner barrel <NUM> from moving proximally beyond the proximal position. In some embodiments, a proximal end of the outer barrel <NUM> may include a seal <NUM> proximate an opening in the outer barrel <NUM> through which the plunger <NUM> may extend. In some embodiments, the seal <NUM> may prevent fluid leakage from the proximal end of the outer barrel <NUM>.

In some embodiments, the inner barrel <NUM> may be fixed within the outer barrel <NUM> via one or more retaining features. In further detail, in some embodiments, one or more retaining features of the inner barrel <NUM> may be engaged in a mechanical fit (such as, for example, a snap fit, a press fit, or another suitable fit) with one or more retaining features of the outer barrel <NUM>. In some embodiments, the retaining features may include one or more ribs <NUM> (illustrated, for example, in <FIG>), which may extend from the inner barrel <NUM> to the outer barrel <NUM>. In some embodiments, the ribs <NUM> may be rigid or semi-rigid. In some embodiments, the retaining features may be annular and may extend around a circumference of the inner barrel <NUM>. In these and other embodiments, the retaining features may include apertures and/or valves which may open in response to fluid pressure, allowing fluid to pass. In some embodiments, fluid may flow around the retaining features.

In some embodiments, a proximal end of the inner barrel <NUM> may include one or more retaining features <NUM>. In some embodiments, the proximal end of the inner barrel <NUM> may include a single annular retaining feature <NUM>. In some embodiments, the retaining features <NUM> may contact the plunger <NUM> to prevent proximal movement of the plunger <NUM>. In some embodiments, the distal opening <NUM> may include an anti-reflux valve, which may prevent blood reflux from entering the delivery device <NUM>.

In some embodiments, the plunger <NUM> may include a connector <NUM>. In some embodiments, the connector <NUM> may include a luer adapter, such as a slip or thread male or female luer adapter, or another suitable connector. In some embodiments, a channel <NUM> may extend from the connector <NUM> through a distal end of the plunger <NUM>. In some embodiments, the connector <NUM> may be disposed within the plunger <NUM>. In some embodiments, the connector <NUM> may be disposed distal to a proximal end <NUM> of the plunger <NUM>.

In some embodiments, the instrument <NUM> may extend from a distal end <NUM> of the plunger <NUM>. In some embodiments, the channel <NUM> may provide a fluid pathway for fluid infusion and/or blood withdrawal. In some embodiments, a blood collection device or a fluid infusion device may be coupled to the connector <NUM>. In some embodiments, a distal end of an extension tube may be coupled to the connector <NUM>. In some embodiments, a proximal end of the extension tube <NUM> may be coupled to the blood collection device or the infusion device. In some embodiments, the extension tube <NUM> may be in fluid communication with the channel <NUM> to provide a fluid pathway for fluid infusion and/or blood withdrawal.

In some embodiments, the distal end <NUM> of the syringe <NUM> may include a distal connector <NUM>, such as, for example, a slip or thread male or female luer adapter, or another suitable connector. In some embodiments, the distal connector <NUM> may be configured to couple to a proximal end of a catheter adapter. In some embodiments, the syringe <NUM> may be coupled to a proximal end of the catheter adapter <NUM> of the catheter assembly <NUM> (illustrated, for example, in <FIG> and 2A-2B), and the plunger <NUM> may be depressed to advance the instrument <NUM> in the distal direction such that the instrument <NUM> is disposed in a fluid pathway of the catheter assembly <NUM> and/or advanced beyond the distal end <NUM> of the catheter <NUM>.

Referring now to <FIG>, in some embodiments, a distal end of an extension tube <NUM> may be integrated into the plunger <NUM>. In some embodiments, a proximal end of the extension tube <NUM> may be coupled to a blood collection device or an infusion device. In some embodiments, the extension tube <NUM> may be in fluid communication with the channel <NUM> to provide a fluid pathway for fluid infusion and/or blood withdrawal.

Referring now to <FIG>, an example method <NUM> is illustrated (not claimed). The method <NUM> may begin at block <NUM>. In block <NUM>, a delivery device may be coupled to a catheter adapter. The delivery device may include or correspond to the delivery device of one or more of <FIG>. The delivery device may be coupled to the catheter adapter via a needleless connector and/or an interface connector, such as the interface adapter <NUM> of <FIG>, for example.

Block <NUM> may be followed by block <NUM>. At block <NUM>, the catheter adapter may be flushed with a liquid, such as, for example, saline or another suitable flushing liquid, while an instrument of the delivery device is advanced distally. The instrument of the delivery device may be advanced distally into the vasculature of the patient. The instrument may include or correspond to the instrument <NUM> of one or more of <FIG>. The catheter adapter may be flushed with the liquid and the instrument may be advanced distally by depressing a plunger of the delivery device.

Block <NUM> may be followed by block <NUM>. In block <NUM>, a blood sample may be collected using the delivery device. The blood sample may be collected in a blood collection device coupled to the delivery device.

Block <NUM> may be followed by block <NUM>. In block <NUM>, the instrument may be retracted proximally. A distal end of the instrument may be disposed within the delivery device or the interface adapter when the instrument is retracted proximally.

Claim 1:
A delivery device (<NUM>, <NUM>) for delivering an instrument (<NUM>) into a catheter assembly (<NUM>), comprising:
a syringe (<NUM>) having a barrel (<NUM>) and a plunger (<NUM>) movable within the barrel;
characterized by
a guide feature (<NUM>) disposed within the barrel and movable with the plunger, wherein the guide feature comprises a channel (<NUM>), wherein the channel is generally U-shaped; and
an instrument (<NUM>) disposed within the barrel and extending through the channel, wherein in response to depression of the plunger, the guide feature moves in a distal direction, the instrument moves through the channel, and a first end (<NUM>) of the instrument is advanced in the distal direction, wherein a second end (<NUM>) of the instrument is fixed.