Patent Description:
In order to verify proper placement of the introducer needle and/or catheter in the blood vessel, the user may confirm that there is "flashback" of blood into a flashback chamber associated with the needle assembly. Flashback generally entails the appearance of a small amount of blood, which is visible within the needle assembly or between the introducer needle and the catheter. Once proper placement of the distal tip of the catheter into the blood vessel is confirmed, the user may apply pressure to the blood vessel by pressing down on the skin over the blood vessel, distal to the introducer needle and the catheter. This finger pressure may momentarily occlude the vessel, reducing further blood flow through the introducer needle and the catheter.

The user may then withdraw the introducer needle from the catheter. The introducer needle may be withdrawn into a needle tip cover or needle cover that extends over the distal tip and prevents accidental needle sticks. In general, a needle tip cover may include a casing, sleeve, or other similar device that is designed to trap or capture the distal tip when the introducer needle is withdrawn from the catheter and the patient. After the introducer needle is withdrawn, the catheter may be left in place to provide intravenous access to the patient.

The separation of the introducer needle assembly from catheter portions of the catheter assembly presents numerous potential hazards to the users and others in the area. As indicated above, there is a risk of accidental needle sticks if the distal tip is not secured properly. Additionally, because the introducer needle has been in contact with blood in vasculature of the patient, blood may be present on an exterior of the introducer needle as well as inside a lumen of the introducer needle. As the introducer needle is withdrawn from the catheter, there is a risk that the blood will drip from the distal tip or come into contact with other surfaces to expose people and equipment to blood.

Additionally, it has been observed that withdrawing the introducer needle from a catheter assembly may impart energy to parts of the needle assembly. For instance, during withdrawal of the introducer, bending forces can be applied (either unintentionally or intentionally) to the introducer needle. The bending forces on the introducer needle may cause blood to splatter or spray from the introducer needle when the needle vibrates and shakes as it becomes free from the catheter assembly and releases stored energy. Accordingly, there is a need in the art for devices, systems, and methods that provide catheter assemblies with increased needle safety. <CIT> discloses an intravenous catheter device which includes a catheter adapter having a fluid chamber, and a needle adapter being slidably positioned within the fluid chamber. <CIT> discloses a catheter and introducer needle assembly including a catheter adapter at its proximal end having a hollow disposed therein. <CIT> discloses an insulin infusion system with a manual insertion device having a dual retraction spring configuration for automatic introducer needle retraction. <CIT> discloses an indwelling needle device.

The present invention relates generally to an intravenous catheter assembly. The catheter assembly may be used for infusion and/or blood collection. The catheter assembly includes a catheter adapter, which includes a distal end, a proximal end, and an inner surface forming a lumen. The lumen extends between the proximal end and the distal end of the catheter adapter.

The catheter assembly includes a cannula hub, which is configured to slide with respect to the catheter adapter from a distal, unlocked position to a proximal, locked position. In some embodiments, the cannula hub may include an inner portion and/or an outer portion. In some embodiments, the outer portion may at least partially surround the inner portion. In some embodiments, the inner portion may be disposed within the lumen of the catheter adapter.

In some embodiments, the inner portion may include a first interlock portion, and an inner surface of the catheter adapter may include a second interlock portion. In some embodiments, when the cannula hub is in the locked position, the first interlock portion and the second interlock portion may interlock or be coupled together, which may prevent movement of the cannula hub with respect to the catheter adapter. In some embodiments, when the cannula hub is in the unlocked position, the first interlock portion and the second interlock portion may be uncoupled, which may allow movement of the cannula hub with respect to the catheter adapter in a direction aligned with a longitudinal axis of the catheter adapter.

In some embodiments, the first interlock portion may include a receiving portion and the second interlock portion may include an engaging portion. Alternatively, in some embodiments, the first interlock portion may include the engaging portion and the second interlock portion may include the receiving portion. In some embodiments, the receiving portion may include one or more grooves, and the engaging portion may include one or more corresponding protrusions. In some embodiments, the engaging portion and the receiving portion may interlock or be coupled together when the cannula hub is in the locked position. In some embodiments, the cannula may be entirely disposed within the catheter adapter when the cannula hub is in the locked position.

The catheter assembly includes a cannula, which includes a distal tip. The cannula includes an elongated tubular shaft and an inner lumen formed by the elongated tubular shaft. The tubular shaft includes a notch, which may improve first stick success and allow observation of blood flashback. The cannula extends distally from the cannula hub. In further detail, in some embodiments, the cannula may extend distally from the inner portion of the cannula hub.

In some embodiments, the outer portion of the cannula hub may be generally cylindrical and/or disposed outside of the catheter adapter. In some embodiments, the outer portion may be configured to slide proximally along an outer surface of the catheter adapter until the cannula hub reaches the locked position. In some embodiments, in response to the outer portion of the cannula hub sliding proximally along the outer surface of the catheter adapter, the cannula may be withdrawn proximally into the catheter adapter. In some embodiments, the outer portion of the cannula hub may be configured to slide proximally to the locked position in which the cannula hub may be locked with respect to the catheter adapter, preventing removal of the cannula from the catheter assembly, reducing a risk of needle stick injury, and discouraging reuse of the catheter assembly. When the cannula hub is in the locked position, the distal tip is disposed within the catheter adapter, also reducing the risk of needle stick injury. In some embodiments, the outer portion of the cannula hub may include a grip, which may be configured to be gripped by a user when the catheter assembly is inserted into a blood vessel of a patient. In some embodiments, the cannula hub may be slid to the locked position as the user grips the grip and slides the outer portion of the cannula hub to the locked position.

In some embodiments, the catheter assembly may include a wedge, which may be funnel-shaped. In some embodiments, the wedge may be constructed of metal. In some embodiments, a catheter tube of the catheter assembly may be connected to the wedge. In some embodiments, the wedge may be configured to couple the catheter tube to the catheter adapter. In some embodiments, the wedge may be disposed in a distal portion of the lumen. In some embodiments, the wedge may be frictionally wedged into the distal portion of the lumen. In some embodiments, when the cannula hub is in the locked position, the distal tip of the cannula may be disposed within the wedge, which may prevent skiving of the catheter tube by the distal tip.

The catheter assembly includes a septum, which is disposed within the lumen of the catheter adapter. In some embodiments, the septum may be proximate and/or proximal to the wedge. When the cannula is withdrawn and the cannula hub is in the locked position, the notch is disposed within the septum, which prevents fluid from leaking out of the notch and/or into the lumen of the catheter adapter.

The catheter assembly includes a safety winged blood collection set. Hence, the catheter assembly includes a winged element, which is a coupled to the catheter adapter. The winged element includes one or more wings, which may extend outwardly from the catheter adapter and may be secured to skin of a patient. When the cannula hub is in the unlocked position, a distal end of the cannula hub is disposed proximate the winged element. In some embodiments, the winged element may act as a stop for the cannula hub, contacting the cannula hub and preventing the cannula hub from sliding beyond the winged element. In some embodiments, the catheter tube may improve comfort of a patient when the catheter assembly having the winged element is inserted into the blood vessel of the patient.

In order that the manner in which the above-recited and other features and advantages of the invention will be readily understood, a more particular description of the catheter assembly with cannula safety mechanism briefly described above will be rendered by reference to specific embodiments thereof, which are illustrated in the appended Figures. Understanding that these Figures depict only typical embodiments and are not, therefore, to be considered to be limiting of its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying Figures in which:.

The presently preferred embodiments of the described invention will be best understood by reference to <FIG>, wherein like parts are designated by like numerals throughout. It will be readily understood that the components of the present invention, as generally described and illustrated in <FIG> in the present disclosure, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of the embodiments of the catheter assembly, and associated devices, systems, and methods, is not intended to limit the scope of the invention, as claimed, but is merely representative of some embodiments of the invention.

The present disclosure relates generally to a catheter assembly. Referring now to <FIG>, the catheter assembly <NUM> includes a catheter adapter <NUM>, which includes a distal end <NUM>, a proximal end <NUM>, and an inner surface <NUM> forming a lumen. The lumen extends between the proximal end <NUM> and the distal end <NUM> of the catheter adapter <NUM>.

The catheter assembly <NUM> includes a cannula hub <NUM>, which is configured to slide with respect to the catheter adapter <NUM> from a distal, unlocked position, illustrated in <FIG>, to a proximal, locked position, illustrated in <FIG>. In some embodiments, the cannula hub <NUM> may include an inner portion <NUM> and/or an outer portion <NUM>. In some embodiments, the inner portion <NUM> may be at least partially disposed within the lumen of the catheter adapter <NUM>.

In some embodiments, the inner portion <NUM> of the cannula hub <NUM> may include a first interlock portion, and the inner surface <NUM> of the catheter adapter <NUM> may include a second interlock portion. In some embodiments, when the cannula hub <NUM> is in the unlocked position, the first interlock portion and the second interlock portion may be uncoupled, which may allow movement of the cannula hub <NUM> with respect to the catheter adapter <NUM> in a direction aligned with a longitudinal axis <NUM> of the catheter adapter <NUM>. In some embodiments, the first interlock portion may include one or more grooves <NUM>, and the second interlock portion may include one or more corresponding protrusions <NUM>. Additionally or alternatively, in some embodiments, the first interlock portion may include one or more protrusions <NUM> and the second interlock portion may include one or more grooves <NUM>.

In some embodiments, the catheter assembly <NUM> may include a wedge <NUM>, which may be funnel-shaped. In some embodiments, a catheter tube <NUM> of the catheter assembly <NUM> may be coupled with the wedge <NUM>. For example, a neck portion of the wedge <NUM> may be inserted into a proximal end of the catheter tube <NUM> in a friction or interference fit. In some embodiments, the wedge <NUM> and the catheter tube <NUM> may be integrally formed. In some embodiments, the wedge <NUM> may be configured to couple the catheter tube <NUM> to the catheter adapter <NUM>. In some embodiments, the wedge <NUM> may be frictionally wedged into a distal portion of the lumen.

The catheter assembly <NUM> includes a cannula <NUM>, which may be an introducer needle. In some embodiments, the cannula <NUM> may include a sharp distal tip <NUM>. In some embodiments, the wedge <NUM> may be constructed of metal, plastic, or another rigid material to prevent skiving of the catheter tube <NUM> by the distal tip <NUM>. In some embodiments, the cannula <NUM> includes an elongated tubular shaft and an inner lumen formed by the elongated tubular shaft. The tubular shaft includes a notch <NUM>, which may improve first stick success. The cannula <NUM> extends distally from the cannula hub <NUM>. In further detail, in some embodiments, the cannula <NUM> may be coupled to and extend distally from the inner portion <NUM> of the cannula hub <NUM>. In some embodiments, a fluid pathway of the catheter assembly <NUM> may extend through the inner portion <NUM> of the cannula hub <NUM> and the cannula <NUM>. In some embodiments, the inner portion <NUM> may be coupled with tubing (not illustrated), which may be part of the fluid pathway.

The catheter assembly <NUM> includes a septum <NUM>, which is disposed within the lumen of the catheter adapter <NUM>. In some embodiments, the septum <NUM> may be proximal to the wedge <NUM>. In some embodiments, the septum <NUM> may be proximate to and contacting the wedge <NUM>, which may facilitate alignment with the notch <NUM> when the cannula hub <NUM> is in the locked position. In some embodiments, the septum <NUM> may include one or more slits that may be pre-cut, or the septum <NUM> may be slit-less. In some embodiments, the septum <NUM> may be constructed of a resilient material. In some embodiments, the septum <NUM> may be constructed of silicon and/or polytetrafluoroethylene.

The catheter assembly <NUM> includes a winged element <NUM>, which is coupled to the catheter adapter <NUM>. In some embodiments, the winged element <NUM> may extend around an exterior of the catheter adapter <NUM>. The winged element <NUM> includes one or more wings <NUM>, which may extend outwardly from the catheter adapter <NUM>. When the cannula hub <NUM> is in the unlocked position, a distal end of the cannula hub <NUM> is disposed proximate the winged element <NUM>. In some embodiments, the winged element <NUM> may act as a stop for the cannula hub <NUM>, contacting the cannula hub <NUM> and preventing the cannula hub <NUM> from sliding distally beyond the winged element <NUM>. Additionally or alternatively, in some embodiments, one or more junctions <NUM> between the inner portion <NUM> and outer portion <NUM> may limit distal movement of the cannula hub <NUM>. In some embodiments, the catheter tube <NUM> may improve comfort of a patient when the catheter assembly <NUM> having the winged element <NUM> is inserted into the blood vessel of the patient.

Referring now to <FIG>, in some embodiments, when the cannula hub <NUM> is in the locked position, the first interlock portion and the second interlock portion may interlock or be coupled together, which may prevent movement of the cannula hub <NUM> with respect to the catheter adapter <NUM>. In some embodiments, the first interlock portion may include a receiving portion and the second interlock portion may include an engaging portion. Alternatively, in some embodiments, the first interlock portion may include the engaging portion and the second interlock portion may include the receiving portion. In some embodiments, the receiving portion may include one or more grooves <NUM>, and the engaging portion may include one or more protrusions <NUM> corresponding to the grooves <NUM>. In some embodiments, the engaging portion and the receiving portion may interlock or be coupled together when the cannula hub <NUM> is in the locked position. In some embodiments, the cannula <NUM> may be entirely disposed within the catheter adapter <NUM> when the cannula hub <NUM> is in the locked position.

In some embodiments, when the cannula hub <NUM> is in the locked position, illustrated in <FIG>, the distal tip <NUM> of the cannula <NUM> may be disposed within the wedge <NUM>, which may prevent skiving of the catheter tube <NUM> by the distal tip <NUM>. When the cannula <NUM> is withdrawn proximally into the catheter adapter <NUM> such that the cannula hub <NUM> is in the locked position, the notch <NUM> is disposed within the septum <NUM>, which Prevents fluid from leaking out of the notch <NUM> and/or into the lumen of the catheter adapter <NUM>. In some embodiments, the notch <NUM> may be in fluid communication with the fluid pathway such that fluid travelling through the fluid pathway may exit the cannula <NUM> through the notch <NUM> if the notch is not sealed or blocked by the septum <NUM>.

In some embodiments, a particular groove <NUM> may be configured to engage a particular protrusion <NUM> in the locked position. For example, the particular groove <NUM> may engage the particular protrusion <NUM> in a snap or interference fit. As illustrated in <FIG> and <FIG>, in some embodiments, the particular groove <NUM> may be formed between two protrusions <NUM> of the inner portion <NUM> of the cannula hub <NUM>, which may extend outwardly from an outer surface of the inner portion <NUM>. In some embodiments, the two protrusions <NUM> may contact the inner surface <NUM> of the catheter adapter <NUM>, which may support the inner portion <NUM> within the lumen. In some embodiments, the particular protrusion <NUM> may contact the outer surface of the inner portion <NUM>, which may support the inner portion <NUM> within the lumen. In some embodiments, an inner surface of the outer portion <NUM> may include the first interlock portion, and an outer surface of the catheter adapter <NUM> may include the second interlock portion.

In some embodiments, the outer portion <NUM> may at least partially surround the inner portion <NUM>. In some embodiments, the inner portion <NUM> may be at least partially disposed within the lumen of the catheter adapter <NUM>. In some embodiments, the outer portion <NUM> of the cannula hub <NUM> may be generally cylindrical and/or disposed outside of the catheter adapter <NUM>.

In some embodiments, the outer portion <NUM> may be configured to slide proximally along an outer surface of the catheter adapter <NUM> until the cannula hub <NUM> reaches the locked position. In some embodiments, in response to the outer portion <NUM> of the cannula hub <NUM> sliding proximally along the outer surface of the catheter adapter <NUM>, the cannula <NUM> may be withdrawn proximally into the catheter adapter <NUM>. In some embodiments, the outer portion <NUM> of the cannula hub <NUM> may be configured to slide proximally to the locked position in which the cannula hub <NUM> may be locked with respect to the catheter adapter <NUM>, preventing removal of the cannula <NUM> from the catheter assembly <NUM>, reducing a risk of needle stick injury, and discouraging reuse of the catheter assembly <NUM>. In some embodiments, when the cannula hub <NUM> is in the locked position, the distal tip <NUM> may be disposed within the catheter adapter <NUM>, also reducing the risk of needle stick injury. In some embodiments, the outer portion <NUM> of the cannula hub <NUM> may include a grip <NUM>, which may be configured to be gripped by a user when the catheter assembly <NUM> is inserted into a blood vessel of a patient. In some embodiments, the grip <NUM> may include one or more ribs or other protrusions to facilitate gripping.

In some embodiments, the cannula hub <NUM> may be slid to the locked position as the user grips the grip and slides the outer portion <NUM> of the cannula hub <NUM> to the locked position. In some embodiments, the locked position may be passively activated. In further detail, in some embodiments, the cannula hub <NUM> may slide to the locked position in a passive manner, requiring no additional steps other than those normally used in catheter introduction. In some embodiments, when the cannula hub <NUM> is in between the unlocked position and the locked position, the cannula hub <NUM> may freely move proximally or distally along the catheter adapter <NUM>, which may allow adjustment of the distal tip <NUM> such as, for example, during hooding of the cannula <NUM>.

Claim 1:
A catheter assembly (<NUM>), comprising:
a catheter adapter (<NUM>) comprising a distal end (<NUM>), a proximal end (<NUM>), and an inner surface (<NUM>) forming a lumen, wherein the lumen extends between the proximal end (<NUM>) and the distal end;
a cannula hub (<NUM>), wherein the cannula hub (<NUM>) is configured to slide with respect to the catheter adapter (<NUM>) from a distal, unlocked position to a proximal, locked position; and
a cannula (<NUM>) comprising a distal tip (<NUM>), an elongated tubular shaft, and an inner lumen formed by the tubular shaft, wherein the cannula extends distally from the cannula hub (<NUM>);
characterized in that
the tubular shaft comprises a notch (<NUM>);
the catheter assembly comprises a septum (<NUM>) disposed within the lumen,
wherein when the cannula hub is in the locked position, the notch is disposed within the septum thereby preventing fluid from leaking out of the notch into the lumen;
the catheter assembly comprises a winged element (<NUM>) coupled with the catheter adapter and comprising one or more wings (<NUM>), wherein when the cannula hub is in the unlocked position, a distal end of the cannula hub is disposed proximate the winged element.