Intravenous catheter assembly with cannula safety mechanism

A catheter assembly may include a catheter adapter that includes a distal end, a proximal end, and an inner surface forming a lumen. The lumen may extend between the proximal end and the distal end. The catheter assembly may also include a cannula and a cannula hub. The cannula hub may include an outer portion disposed outside of the catheter adapter and an inner portion disposed within the catheter adapter. The cannula may extend distally from the inner portion. In response to the outer portion sliding proximally along an outer surface of the catheter adapter, the cannula may be withdrawn proximally into the catheter adapter. The outer portion may be configured to slide proximally to a locked position in which the cannula hub is locked with respect to the catheter adapter, and a distal tip of the cannula is disposed within the catheter adapter.

RELATED APPLICATIONS

This application claims priority to Singapore Application Number 10201701920Q, filed Mar. 9, 2017, titled INTRAVENOUS CATHETER ASSEMBLY WITH CANNULA SAFETY MECHANISM, which is incorporated herein in its entirety.

BACKGROUND OF THE INVENTION

Intravenous (IV) catheter assemblies are among the various types of vascular access devices. Over-the-needle peripheral IV catheters are a common IV catheter configuration. As its name implies, an over-the-needle catheter may be mounted over an introducer needle having a sharp distal tip. The introducer needle may be a hypodermic needle coupled to a needle assembly to help guide the needle and to facilitate its cooperation with the catheter. At least the inner surface of the distal portion of the catheter tightly may engage an outer surface of the introducer needle to prevent peelback of the catheter and, thereby, facilitate insertion of the catheter into the blood vessel. 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. Moreover, the catheter and the introducer needle may be assembled so that, during insertion, the bevel of the introducer needle faces up, away from skin of a patient. The catheter and introducer needle may be inserted at a shallow angle through the skin into a blood vessel.

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.

BRIEF SUMMARY OF THE INVENTION

The present disclosure relates generally to an intravenous catheter assembly and associated devices, systems, and methods. In some embodiments, the catheter assembly may be used for infusion and/or blood collection. In some embodiments, the catheter assembly may include a catheter adapter, which may include a distal end, a proximal end, and an inner surface forming a lumen. In some embodiments, the lumen may extend between the proximal end and the distal end of the catheter adapter.

In some embodiments, the catheter assembly may include a cannula hub, which may be 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.

In some embodiments, the catheter assembly may include a cannula, which may include a distal tip. In some embodiments, the cannula may include an elongated tubular shaft and an inner lumen formed by the elongated tubular shaft. In some embodiments, the tubular shaft may include a notch, which may improve first stick success and allow observation of blood flashback. In some embodiments, the cannula may extend 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. In some embodiments, when the cannula hub is in the locked position, the distal tip may be 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.

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

In some embodiments, the catheter assembly may include a safety winged blood collection set. In these and other embodiments, the catheter assembly may include a winged element, which may be coupled to the catheter adapter. In some embodiments, the winged element may include one or more wings, which may extend outwardly from the catheter adapter and may be secured to skin of a patient. In some embodiments, when the cannula hub is in the unlocked position, a distal end of the cannula hub may be disposed proximate or abutting 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.

DETAILED DESCRIPTION OF THE INVENTION

The presently preferred embodiments of the described invention will be best understood by reference toFIGS. 1-5, 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 inFIGS. 1-5in 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 and associated devices, systems, and methods. Referring now toFIGS. 1-2, in some embodiments, the catheter assembly10may include a catheter adapter12, which may include a distal end14, a proximal end16, and an inner surface18forming a lumen. In some embodiments, the lumen may extend between the proximal end16and the distal end18of the catheter adapter12.

In some embodiments, the catheter assembly10may include a cannula hub20, which may be configured to slide with respect to the catheter adapter12from a distal, unlocked position, illustrated inFIGS. 1-2, to a proximal, locked position, illustrated inFIGS. 3-5. In some embodiments, the cannula hub20may include an inner portion22and/or an outer portion24. In some embodiments, the inner portion22may be at least partially disposed within the lumen of the catheter adapter12.

In some embodiments, the inner portion22of the cannula hub20may include a first interlock portion, and the inner surface18of the catheter adapter12may include a second interlock portion. In some embodiments, when the cannula hub20is in the unlocked position, the first interlock portion and the second interlock portion may be uncoupled, which may allow movement of the cannula hub20with respect to the catheter adapter12in a direction aligned with a longitudinal axis30of the catheter adapter12. In some embodiments, the first interlock portion may include one or more grooves26, and the second interlock portion may include one or more corresponding protrusions28. Additionally or alternatively, in some embodiments, the first interlock portion may include one or more protrusions28and the second interlock portion may include one or more grooves26.

In some embodiments, the catheter assembly10may include a wedge32, which may be funnel-shaped. In some embodiments, a catheter tube34of the catheter assembly10may be coupled with the wedge32. For example, a neck portion of the wedge32may be inserted into a proximal end of the catheter tube34in a friction or interference fit. In some embodiments, the wedge32and the catheter tube34may be integrally formed. In some embodiments, the wedge32may be configured to couple the catheter tube34to the catheter adapter12. In some embodiments, the wedge32may be frictionally wedged into a distal portion of the lumen.

In some embodiments, the catheter assembly10may include a cannula36, which may be an introducer needle. In some embodiments, the cannula36may include a sharp distal tip38. In some embodiments, the wedge32may be constructed of metal, plastic, or another rigid material to prevent skiving of the catheter tube34by the distal tip38. In some embodiments, the cannula36may include an elongated tubular shaft and an inner lumen formed by the elongated tubular shaft. In some embodiments, the tubular shaft may include a notch40, which may improve first stick success. In some embodiments, the cannula36may extend distally from the cannula hub20. In further detail, in some embodiments, the cannula36may be coupled to and extend distally from the inner portion22of the cannula hub20. In some embodiments, a fluid pathway of the catheter assembly10may extend through the inner portion22of the cannula hub20and the cannula36. In some embodiments, the inner portion22may be coupled with tubing (not illustrated), which may be part of the fluid pathway.

In some embodiments, the catheter assembly10may include a septum42, which may be disposed within the lumen of the catheter adapter12. In some embodiments, the septum42may be proximal to the wedge32. In some embodiments, the septum42may be proximate to and contacting the wedge32, which may facilitate alignment with the notch40when the cannula hub20is in the locked position. In some embodiments, the septum42may include one or more slits that may be pre-cut, or the septum42may be slit-less. In some embodiments, the septum42may be constructed of a resilient material. In some embodiments, the septum42may be constructed of silicon and/or polytetrafluoroethylene.

In some embodiments, the catheter assembly10may include a winged element44, which may be coupled to the catheter adapter12. In some embodiments, the winged element44may extend around an exterior of the catheter adapter12. In some embodiments, the winged element44may include one or more wings46, which may extend outwardly from the catheter adapter12. In some embodiments, when the cannula hub20is in the unlocked position, a distal end of the cannula hub20may be disposed proximate the winged element44. In some embodiments, the winged element44may act as a stop for the cannula hub20, contacting the cannula hub20and preventing the cannula hub20from sliding distally beyond the winged element44. Additionally or alternatively, in some embodiments, one or more junctions48between the inner portion22and outer portion24may limit distal movement of the cannula hub20. In some embodiments, the catheter tube34may improve comfort of a patient when the catheter assembly10having the winged element44is inserted into the blood vessel of the patient.

Referring now toFIGS. 3-5, in some embodiments, when the cannula hub20is 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 hub20with respect to the catheter adapter12. 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 grooves26, and the engaging portion may include one or more protrusions28corresponding to the grooves26. In some embodiments, the engaging portion and the receiving portion may interlock or be coupled together when the cannula hub20is in the locked position. In some embodiments, the cannula36may be entirely disposed within the catheter adapter12when the cannula hub20is in the locked position.

In some embodiments, when the cannula hub20is in the locked position, illustrated inFIGS. 3-5, the distal tip38of the cannula36may be disposed within the wedge32, which may prevent skiving of the catheter tube34by the distal tip38. In some embodiments, when the cannula36is withdrawn proximally into the catheter adapter12such that the cannula hub20is in the locked position, the notch40may be disposed within the septum42, which may prevent fluid from leaking out of the notch40and/or into the lumen of the catheter adapter12. In some embodiments, the notch40may be in fluid communication with the fluid pathway such that fluid travelling through the fluid pathway may exit the cannula36through the notch40if the notch is not sealed or blocked by the septum42.

In some embodiments, a particular groove26may be configured to engage a particular protrusion28in the locked position. For example, the particular groove26may engage the particular protrusion28in a snap or interference fit. As illustrated inFIGS. 1 and 3, in some embodiments, the particular groove26may be formed between two protrusions50of the inner portion22of the cannula hub20, which may extend outwardly from an outer surface of the inner portion22. In some embodiments, the two protrusions50may contact the inner surface18of the catheter adapter12, which may support the inner portion22within the lumen. In some embodiments, the particular protrusion28may contact the outer surface of the inner portion22, which may support the inner portion22within the lumen. In some embodiments, an inner surface of the outer portion24may include the first interlock portion, and an outer surface of the catheter adapter12may include the second interlock portion.

In some embodiments, the outer portion24may at least partially surround the inner portion22. In some embodiments, the inner portion22may be at least partially disposed within the lumen of the catheter adapter12. In some embodiments, the outer portion24of the cannula hub20may be generally cylindrical and/or disposed outside of the catheter adapter12.

In some embodiments, the outer portion24may be configured to slide proximally along an outer surface of the catheter adapter12until the cannula hub20reaches the locked position. In some embodiments, in response to the outer portion24of the cannula hub20sliding proximally along the outer surface of the catheter adapter12, the cannula36may be withdrawn proximally into the catheter adapter12. In some embodiments, the outer portion24of the cannula hub20may be configured to slide proximally to the locked position in which the cannula hub20may be locked with respect to the catheter adapter12, preventing removal of the cannula36from the catheter assembly12, reducing a risk of needle stick injury, and discouraging reuse of the catheter assembly12. In some embodiments, when the cannula hub20is in the locked position, the distal tip38may be disposed within the catheter adapter12, also reducing the risk of needle stick injury. In some embodiments, the outer portion24of the cannula hub20may include a grip52, which may be configured to be gripped by a user when the catheter assembly12is inserted into a blood vessel of a patient. In some embodiments, the grip52may include one or more ribs or other protrusions to facilitate gripping.

In some embodiments, the cannula hub20may be slid to the locked position as the user grips the grip and slides the outer portion24of the cannula hub20to the locked position. In some embodiments, the locked position may be passively activated. In further detail, in some embodiments, the cannula hub20may 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 hub20is in between the unlocked position and the locked position, the cannula hub20may freely move proximally or distally along the catheter adapter12, which may allow adjustment of the distal tip38such as, for example, during hooding of the cannula36.

The present invention may be embodied in other specific forms without departing from its structures, methods, or other essential characteristics as broadly described herein and claimed hereinafter. For example, it is understood that the catheter assembly10may include any number of interlock portions, which may include any variety of mechanisms capable of preventing movement between the catheter adapter12and the cannula hub20. As another example, the cannula hub20may include one or more adapters or connectors and/or may be coupled to tubing, which may allow another device to be connected to the catheter assembly10. The described embodiments and examples are to be considered in all respects only as illustrative, and not restrictive. The scope of the invention is, therefore, indicated by the appended claims, rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.