Patent Description:
The catheter may include an over-the-needle peripheral intravenous ("IV") catheter. In this case, the 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 the introducer needle are generally inserted at a shallow angle through the skin into vasculature of the patient.

Blood withdrawal using the catheter may be difficult for several reasons, particularly when a dwell time of the catheter within the vasculature is more than one day. 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, the catheter is often used for acquiring a blood sample at a time of catheter placement, but the catheter is 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 often used to provide vein access for blood collection, which may be painful for the patient and result in higher material costs.

In some instances, in order to avoid the additional needle stick, a vascular access instrument may be used to access the vasculature of the patient via the catheter. The vascular access instrument may be inserted through the catheter and into the vasculature to extend a life of the catheter and allow blood withdrawal through the catheter without the additional needle stick.

<CIT> discloses a system for catheter insertion and blood flashback.

<CIT> discloses an intravenous catheter with a duckbill valve.

<CIT> discloses a system to compensate for compression forces in an intravascular device.

<CIT> discloses an IV catheter assembly.

<CIT> discloses an extravascular system in-line venting.

<CIT> discloses a system for phlebotomy through a peripheral IV-catheter.

According to the present invention there is provided a catheter system according to claim <NUM>.

In some embodiments, the septum may be coupled to a housing that extends out of the proximal end of the Y-adapter. In some embodiments, the Y-adapter may include a slot disposed around a portion of a circumference of the Y-adapter. In some embodiments, the slot may include a notch. In some embodiments, the housing may include a protrusion. In some embodiments, the protrusion may be disposed within the notch in response to the septum being in the prime position. In some embodiments, in response to the septum being moved from the prime position to the infusion position, the housing may be moved distally and the protrusion may slide along the slot.

In some embodiments, the lumen of the septum may be aligned with a longitudinal axis of the Y-adapter. In some embodiments, an outer surface of the proximal end of the septum may be non-circular and may correspond to a shape of an inner surface of the housing. In some embodiments, a length of the extension tube may be less than that of a BD NEXIVA™ Closed IV Catheter System or other catheter systems known in the art. In some embodiments, the length of the extension tube may be <NUM>-<NUM> inches, <NUM>-<NUM> inches, <NUM>-<NUM> inches, or another suitable length.

In some embodiments, the housing may be coupled to a needle assembly. In some embodiments, the needle assembly may include a body, a needle extending proximally from the body, and an elastomeric sheath coupled to the body and covering the needle. In some embodiments, the catheter system may include a blood collection tube holder coupled to the body of the needle assembly. In some embodiments, the body may be monolithically formed as a single unit with the housing.

In some embodiments, the catheter system may include a needle hub coupled to the proximal end of the catheter hub. In some embodiments, the needle hub may include a flashback chamber. In some embodiments, the catheter system may include an introducer needle extending distally from the needle hub and through the catheter.

In some embodiments, the catheter system may include another extension tube, which may include a distal end and a proximal end. In some embodiments, the distal end may be coupled to the second port of the Y-adapter. In some embodiments, the catheter system may include another Y-adapter coupled to the proximal end of the other extension tube. In some embodiments, the catheter system may include a needleless connector coupled to the second port.

In some embodiments, another septum may be disposed within the second port, and may be configured to pass air but not blood. In some embodiments, the needleless connector may be coupled to the second port of the Y-adapter. In some embodiments, the needleless connector may include a distal end and a proximal end, and the catheter system may include another extension tube coupled to the proximal end of the needleless access connector. In some embodiments, the catheter system may include another septum disposed within the first port of the Y-adapter. In some embodiments, the septum may be disposed in an open position in response to the needle assembly being coupled to the first port.

Referring now to <FIG>, a prior art catheter system <NUM> is illustrated. The prior art catheter system <NUM> includes a catheter hub <NUM> with a side port <NUM> and a long extension tube <NUM> extending from the side port <NUM>. A Y-adapter <NUM> is often disposed at a proximal end of the long extension tube <NUM>. A catheter <NUM> may extend from the catheter hub <NUM> and may be inserted into vasculature of a patient via an introducer needle <NUM>, which is removed from the prior art catheter system <NUM> after the catheter <NUM> is positioned within the vasculature. The prior art catheter system <NUM> with the catheter <NUM> positioned within the vasculature may be used for blood withdrawal or fluid infusion. The long extension tube <NUM> may create a tortuous blood flow path and lower blood pressure, slowing a blood collection time. Also, the Y-adapter <NUM> may retain blood or fluid and may not flush well.

Referring now to <FIG>, in some embodiments, a catheter system <NUM> may include a catheter hub <NUM>, which may include a distal end <NUM>, a proximal end <NUM>, a side port <NUM> disposed between the distal end <NUM> of the catheter hub <NUM> and the proximal end <NUM> of the catheter hub <NUM>, and a lumen <NUM> extending through the distal end <NUM> of the catheter hub <NUM> and the proximal end <NUM> of the catheter hub <NUM>. In some embodiments, the catheter system <NUM> may include a catheter <NUM> extending distally from the distal end <NUM> of the catheter hub <NUM>. In some embodiments, the catheter <NUM> may include a peripheral intravenous catheter, a peripherally-inserted central catheter, or a midline catheter. In some embodiments, a needle hub <NUM> may be removably coupled to the proximal end <NUM> of the catheter hub <NUM>. In some embodiments, an introducer needle <NUM> may extend from the needle hub <NUM> and through the catheter <NUM> in an insertion position to insert the catheter system <NUM> into the vasculature of the patient.

In some embodiments, the catheter system <NUM> may include a Y-adapter <NUM>, which may include a distal end <NUM>, a first port <NUM>, and a second port <NUM>. In some embodiments, the first port <NUM> and/or the second port <NUM> may include a luer adapter, such as, for example, a female luer adapter. In some embodiments, the catheter system <NUM> may include an extension tube <NUM>, which may include a distal end <NUM> integrated with the side port <NUM> and a proximal end <NUM> integrated with the distal end <NUM> of the Y-adapter <NUM>. In some embodiments, a clamp may be disposed on the extension tube <NUM>. In other embodiments, the extension tube <NUM> may not include the clamp.

In some embodiments, the Y-adapter <NUM> may reduce or eliminate dead space, where blood gets trapped during blood collection or fluid gets trapped during infusion. Further, the Y-adapter may provide air venting, which may facilitate blood collection. In some embodiments, a large angle between the first port <NUM> and the second port <NUM>, such as, for example <NUM>° or between <NUM>° and <NUM>°, may reduce the dead space. In some embodiments, a length of the first port <NUM> and/or the second port <NUM> may also be shortened to reduce the dead space. In some embodiments, the length of the first port <NUM> and/or the second port <NUM> may be <NUM>-<NUM> inches or another suitable length, which may reduce dead space and improve flushing.

In some embodiments, a septum <NUM> may be disposed within the second port <NUM>, and may be configured to pass air but not fluid, such as blood. For example, an outer surface of the septum <NUM> may include one or more grooves <NUM> and/or an inner surface of the second port <NUM> may include one or more grooves. In some embodiments, dimensions of the grooves <NUM> and/or the grooves of the inner surface may allow air but not fluid to pass.

In some embodiments, a needleless connector <NUM> may be coupled to the second port <NUM> of the Y-adapter <NUM>. In some embodiments, the needleless connector <NUM> may be coupled to the second port <NUM> after blood collection is complete. In some embodiments, the needleless connector <NUM> may include a first end <NUM> and a second end <NUM>, and the catheter system <NUM> may include another extension tube coupled to the second end <NUM> of the needleless connector <NUM>.

In some embodiments, the catheter system <NUM> may include another septum <NUM> disposed within the first port <NUM> of the Y-adapter <NUM>. In some embodiments, the other septum <NUM> may be disposed in an open position in response to a needle assembly <NUM> being coupled to the first port <NUM>, as illustrated, for example, in <FIG>. In some embodiments, the needle assembly <NUM> may include a body <NUM>, a needle <NUM> extending proximally from the body <NUM>, and an elastomeric sheath <NUM> coupled to the body <NUM> and covering the needle <NUM>. In some embodiments, the needle assembly <NUM> may include a luer adapter, such as, for example, a male luer adapter, which may be coupled to the first port <NUM>. In some embodiments, the luer adapter may be threaded (see, for example, <FIG>) or slip-fit (see, for example, <FIG>). In some embodiments, the needle assembly <NUM> may be pre-attached to the catheter system <NUM> in a kit. In some embodiments, the body <NUM> may be monolithically formed as a single unit with a housing, as illustrated, for example, in <FIG>. In some embodiments, the needle assembly <NUM> may be removed and replaced with a luer connector after blood collection is complete.

In some embodiments, the catheter system <NUM> may include a blood collection tube holder <NUM> coupled to the body <NUM> of the needle assembly <NUM>, as illustrated, for example, in <FIG>. In some embodiments, the blood collection tube holder <NUM> may be coupled to the body <NUM> of the needle assembly 68via one or more threads or another suitable means. In some embodiments, the blood collection tube holder <NUM> may be configured to receive a blood collection tube. In response to depression of the blood collection tube within the blood collection tube holder <NUM>, the needle <NUM> may pierce the elastomeric sheath <NUM> and a cap of the blood collection tube to provide fluid communication between the catheter system <NUM> and the blood collection tube.

In some embodiments, during blood collection, blood may flow proximally through the catheter <NUM>, the catheter hub <NUM>, the extension tube <NUM>, the Y-adapter <NUM>, and the needle assembly <NUM>. In some embodiments, blood collection may be done at insertion of the catheter <NUM> into the vasculature and/or later on after the catheter <NUM> has been dwelling within the vasculature due to the septum <NUM> being accessed by the needle assembly <NUM>. In some embodiments, the needleless connector <NUM> may prevent contamination prior to a later blood collection event after the catheter <NUM> has been inserted into the vasculature. In some embodiments, the needle assembly <NUM> further comprises a cap <NUM> disposed over the elastomeric sheath <NUM>, as illustrated, for example, in <FIG>, which may prevent contamination.

Referring now to <FIG>, a catheter system <NUM> may include the catheter hub <NUM>, which may include the distal end <NUM>, the proximal end <NUM>, the side port <NUM> disposed between the distal end <NUM> of the catheter hub <NUM> and the proximal end <NUM> of the catheter hub <NUM>, and the lumen <NUM> extending through the distal end <NUM> of the catheter hub <NUM> and the proximal end <NUM> of the catheter hub <NUM>. In some embodiments, the catheter system <NUM> may include the catheter <NUM> extending distally from the distal end <NUM> of the catheter hub <NUM>. In some embodiments, the catheter <NUM> may include a peripheral intravenous catheter, a peripherally-inserted central catheter, or a midline catheter. In some embodiments, the catheter system <NUM> may be similar or identical to the catheter system <NUM> in terms of one or more included features and/or operation.

In some embodiments, the needle hub <NUM> may be removably coupled to the proximal end <NUM> of the catheter hub <NUM>. In some embodiments, the introducer needle <NUM> may extend from the needle hub <NUM> and through the catheter <NUM> in the insertion position to insert the catheter system <NUM> into the vasculature of the patient.

In some embodiments, the catheter system <NUM> may include a Y-adapter <NUM>, which may include a distal end <NUM>, a first port <NUM>, and a second port <NUM>. In some embodiments, the first port <NUM> and/or the second port <NUM> may include a luer adapter, such as, for example, a female luer adapter. In some embodiments, the catheter system <NUM> may include the extension tube <NUM>, which may include the distal end <NUM> integrated with the side port <NUM> and the proximal end <NUM> integrated with the distal end <NUM> of the Y-adapter <NUM>. In some embodiments, a clamp may be disposed on the extension tube <NUM>. In other embodiments, the extension tube <NUM> may not include the clamp.

In some embodiments, the Y-adapter <NUM> may include a septum <NUM> disposed within the second port <NUM> of the Y-adapter <NUM>. In some embodiments, the septum <NUM> may include one or more of the following: a distal end <NUM>, a proximal end <NUM>, a lumen <NUM> extending through the distal end <NUM> of the septum <NUM>, a side opening <NUM> in fluid communication with the lumen <NUM> of the septum <NUM>, and a vent <NUM> extending from the proximal end <NUM> of the septum <NUM>. In some embodiments, the septum <NUM> may be movable between a prime position, illustrated, for example, in <FIG>, and an infusion position, illustrated, for example, in <FIG>. In some embodiments, in response to the septum <NUM> being in the prime position, the vent <NUM> may be aligned with the first port <NUM>.

In some embodiments, the catheter system <NUM> may include another extension tube <NUM>, which may include a distal end <NUM> and a proximal end <NUM>. In some embodiments, the distal end <NUM> may be coupled to the second port <NUM> of the Y-adapter <NUM>. In some embodiments, the catheter system <NUM> may include another Y-adapter <NUM> coupled to the proximal end <NUM> of the other extension tube <NUM>. In some embodiments, the catheter system <NUM> may include the needleless connector <NUM> coupled to the second port <NUM>. In some embodiments, one or more of the following: the other extension tube <NUM>, the other Y-adapter <NUM>, and the needleless connector <NUM> may be primed with a priming solution, such as, for example, saline, when the septum <NUM> is in the prime position. In some embodiments, the vent <NUM> may facilitate movement of air from the other extension tube <NUM> to an external environment. In some embodiments, in response to the septum <NUM> being in the prime position, air may flow through the vent <NUM> and into the external environment. In some embodiments, the vent <NUM> may extend proximal to a proximal end <NUM> of the Y-adapter <NUM> or there may be a small space between an inner surface of the Y-adapter <NUM> and an outer surface of the septum <NUM> proximal to the vent <NUM>, and the small space may allow air to pass to the external environment.

In some embodiments, in response to the septum <NUM> being in the infusion position, the side opening <NUM> may be aligned with the first port <NUM>. Thus, fluid may flow from the other extension tube <NUM> through the side opening <NUM>, out the distal end <NUM> of the septum <NUM>, through the extension tube <NUM>, and through the catheter hub <NUM> and the catheter <NUM> into the vasculature of the patient.

In some embodiments, the septum <NUM> may be coupled to a housing <NUM> that extends out of the proximal end <NUM> of the Y-adapter <NUM>. In some embodiments, the Y-adapter <NUM> may include a slot <NUM> disposed around a portion of a circumference of the Y-adapter <NUM>. In some embodiments, the slot <NUM> may include a notch <NUM>. In some embodiments, the housing <NUM> may include a protrusion <NUM>. In some embodiments, the protrusion <NUM> may be disposed within the notch <NUM> in response to the septum <NUM> being in the prime position. In some embodiments, the distal end of the housing <NUM> contacts a stepped surface of the septum <NUM> to facilitate movement of the septum <NUM> in response to movement of the housing <NUM>.

In some embodiments, the slot <NUM> may include another notch <NUM>. In some embodiments, the notch <NUM> and the other notch <NUM> may be disposed at opposing ends of the slot <NUM>. In some embodiments, in response to the septum <NUM> being moved from the prime position to the infusion position, the housing <NUM> may be moved distally and the protrusion <NUM> may slide along the slot <NUM>. In some embodiments, the protrusion <NUM> may be disposed within the other notch <NUM> in response to the septum <NUM> being in the infusion position.

In some embodiments, the lumen <NUM> of the septum <NUM> may be aligned with a longitudinal axis <NUM> of the Y-adapter. In some embodiments, an outer surface of the proximal end <NUM> of the septum <NUM> may be non-circular and may correspond to a shape of an inner surface of the housing <NUM>.

In some embodiments, the housing <NUM> may be coupled to the needle assembly <NUM>. In some embodiments, the needle assembly <NUM> may include the body <NUM>, the needle <NUM> extending proximally from the body <NUM>, and the elastomeric sheath <NUM> coupled to the body <NUM> and covering the needle <NUM>. In some embodiments, the catheter system <NUM> may include the blood collection tube holder coupled to the body of the needle assembly <NUM>, as illustrated, for example, in <FIG>. In some embodiments, the body <NUM> may be monolithically formed as a single unit with the housing <NUM>.

Claim 1:
A catheter system (<NUM>, <NUM>, <NUM>), comprising:
a catheter hub (<NUM>, <NUM>), comprising a distal end, a proximal end, a side port disposed between the distal end of the catheter hub (<NUM>, <NUM>) and the proximal end of the catheter hub (<NUM>, <NUM>), and a lumen (<NUM>, <NUM>) extending through the distal end of the catheter hub (<NUM>, <NUM>) and the proximal end of the catheter hub (<NUM>, <NUM>);
a catheter (<NUM>, <NUM>) extending distally from the distal end of the catheter hub (<NUM>, <NUM>);
a Y-adapter (<NUM>, <NUM>, <NUM>, <NUM>), comprising a distal end, a first port (<NUM>, <NUM>), and a second port (<NUM>, <NUM>);
an extension tube (<NUM>, <NUM>, <NUM>), comprising a distal end integrated with the side port and a proximal end integrated with the distal end of the Y-adapter (<NUM>, <NUM>, <NUM>, <NUM>); and
a septum (<NUM>, <NUM>, <NUM>) disposed within the second port (<NUM>, <NUM>) of the Y-adapter (<NUM>, <NUM>, <NUM>, <NUM>),
characterized in that
the septum (<NUM>, <NUM>, <NUM>) comprises a distal end, a proximal end, a lumen (<NUM>, <NUM>) extending through the distal end of the septum (<NUM>, <NUM>, <NUM>), a side opening (<NUM>) in fluid communication with the lumen (<NUM>, <NUM>) of the septum (<NUM>, <NUM>, <NUM>), and a vent (<NUM>) extending from the proximal end of the septum (<NUM>, <NUM>, <NUM>), wherein the septum (<NUM>, <NUM>, <NUM>) is movable between a prime position and an infusion position, wherein in response to the septum (<NUM>, <NUM>, <NUM>) being in the prime position the vent (<NUM>) is aligned with the first port (<NUM>, <NUM>), wherein in response to the septum (<NUM>, <NUM>, <NUM>) being in the infusion position, the side opening (<NUM>) is aligned with the first port (<NUM>, <NUM>).