Intravenous catheter device with integrated extension tube

The present invention relates to peripheral intravenous catheters, and in particular to an integrated peripheral intravenous catheter having a low profile securement platform, a needle hub having an interior compartment and further comprising a paddle grip, and an extension tube coupled to the catheter and stored within the interior compartment of the needle hub prior to catheterization.

BACKGROUND OF THE INVENTION

In medicine, an intravenous is a catheter placed into a peripheral vein in order to administer medications or fluids to a patient in need. An intravenous catheter may also be used to draw blood.

The catheter is introduced into the patient's vein by an introducer needle that is positioned within the lumen of the catheter, such that a sharpened tip of the needle is exposed beyond the distal tip of the catheter. The sharpened tip punctures the skin and vein of the patient to provide a pathway through which the distal tip of the catheter may be advanced. Once the catheter tip is placed into the vein, the needle tip is withdrawn into the catheter; a technique commonly referred to as “hooding”. The catheter and needle are then advanced into the vein to a desired depth, after which the needle is entirely removed from the catheter. The catheter is then secured to the patient's skin by an adhesive strip or wrapping.

Generally a catheter is coupled to a catheter adapter having a blood control device, such as a valve or septum. As such, blood flowing through the catheter is retained within the catheter adapter until the blood control device is actuated or otherwise manipulated to permit flow through the catheter and catheter adapter.

An extension tube generally comprises a flexible section of tubing having a first end that is configured to compatibly couple to a catheter or catheter adapter, and further comprises a second end that may be accessed directly by a syringe or needle, or may be further coupled to an intravenous bag by a section of intravenous tubing. As a common practice, an extension tube is coupled to the catheter adapter following placement of the catheter. In some instances, a clinician may be required to manually occlude the patient's vein and/or the catheter while simultaneously attaching an extension tube thereto. In other instances, a clinician must take care to immobilize the catheter and/or catheter adapter while attaching the extension tube to prevent accidental removal of the inserted catheter. Further, in many instances a clinician is required to sterilize the mating ends of the catheter adapter and the extension tube prior to making the connection, thus adding an additional step to the procedure.

Thus, although methods and devices currently exist for accessing the vasculature of a patient via a catheter and an extension tube, challenges still remain. Accordingly, the features of the present invention address and overcome these challenges.

BRIEF SUMMARY OF THE INVENTION

The present invention relates to peripheral intravenous catheters, and in particular to an integrated peripheral intravenous catheter having a low profile securement platform, a needle hub having an interior compartment and further comprising a paddle grip, and an extension tube coupled to the catheter and stored within the interior compartment of the needle hub prior to insertion of the catheter.

Some implementations of the present invention comprise an intravenous catheter device having a catheter adapter having a proximal end, a distal end, and a lumen interposed therebetween. The catheter adapter further comprises a securement platform that is constructed of a soft, pliable or flexible material, such as a soft polymer. In some instances, the securement platform comprises a soft, polymer material comprising a Shore A durometer hardness of from approximately 15 to 100. In some instances, the soft, polymer material comprises a durometer hardness of from approximately 30 Shore A to approximately 90 Shore D. In some instances, the soft, polymer material comprises a durometer hardness of from approximately 50 Shore A to approximately 90 Shore D. In some instances, the distal end of the catheter adapter comprises an intravenous catheter in fluid communication with the lumen. Further, the proximal end of the catheter adapter comprises an extension tube that is also in fluid communication with the lumen. In some instances, securement platform may further comprise a hard or rigid plastic polymer material.

Some implementations of the present invention further comprise a needle hub comprising a rigid material, such as a hard plastic material. The needle hub comprises an open end, a closed end, and a compartment interposed therebetween. The closed end is configured to receive a terminal end of the extension tube, and the open end is configured to receive the proximal end of the catheter adapter, wherein the extension tube is stored within the compartment. In some instances, the extension tube is wound around an outer surface of the needle hub. In some instances, the closed end further comprises a flashback chamber in fluid communication with an interior lumen of the introducer needle.

In some instances, the needle hub further comprises a paddle grip positioned in proximity to the open end and arranged to overlap the securement platform, thereby permitting the user to pinch the paddle grip and securement platform between their thumb and index finger during the process of catheterization. In some instances, the overlapping arrangement of the paddle grip and the securement platform permits the user to hood the tip end of the needle by adjusting their grip to move the securement platform and paddle grip in opposite directions.

The needle hub further comprises an introducer needle having a base end, a tip end, and a body extending therebetween. The base end of the needle is securely attached to the closed end of the needle hub. When assembled, the body of the needle extends outwardly from the closed end, through the proximal end, the lumen, the distal end, and the intravenous catheter, such that the tip end of the needle is exposed beyond a terminal end of the intravenous catheter.

Some implementations of the present invention are further configured such that the body of the introducer needle passes through an interior of the extension tube when the intravenous catheter device is assembled. In some instances, the extension tube is wound around the body of the introducer needle within the compartment.

In some instances, the proximal end of the catheter adapter, and/or the terminal end of the extension tube further comprises a blood control device, such as a valve, a self-sealing polymer, a luer adapter, or a septum. In some instances, the blood control valve comprises a passageway through which the body of the introducer needle passes. In some instances, the blood control device is a single-use device. In other instances, the blood control device is a multi-use device.

Some implementations of the present invention further comprise an extension tube having an access port that is coupled to a sidewall surface of the extension tube, and extending outwardly therefrom. For these embodiments, the needle hub further comprises an access slot extending proximally from the open end to a position that is in proximity to the closed end, whereby the access port passes through the access slot and is located externally to the compartment of the needle hub with the intravenous catheter device is assembled. In some instances, the open end of the needle hub further comprises a notch having a width and depth that is configured to receive and support a proximal edge of the securement platform of the catheter adapter.

Some implementations of the present invention further comprise one or more features designed to capture and shield the tip end of the introducer needle following catheterization of the patient. For example, in some instances the proximal end of the extension tube further comprises a needle shield or safety mechanism that is selectively coupled thereto and through which the body of the introducer needle passes when the device is assembled. Upon removal of the introducer needle from the extension tube, a needle feature, such as a ferrule or notch, actuates the safety mechanism to selectively disengage the safety mechanism from the terminal end of the extension tube. Once released, the safety mechanism captures the tip end of the needle, thereby preventing unintended exposure to the tip end of the needle.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to peripheral intravenous catheters, and in particular to an integrated peripheral intravenous catheter having a low profile securement platform, a needle hub having an interior compartment and further comprising a paddle grip, and an extension tube coupled to the catheter and stored within the interior compartment of the needle hub prior to insertion of the catheter.

Some implementations of the present invention comprise an intravenous catheter device having a catheter adapter having a proximal end, a distal end, and a lumen interposed therebetween. The catheter adapter further comprises a securement platform that is constructed of a soft, pliable or flexible material, such as a soft polymer. In some instances, the securement platform comprises a soft, polymer material comprising a Shore A durometer hardness of from approximately 15 to 100. In some instances, the soft, polymer material comprises a durometer hardness of from approximately 30 Shore A to approximately 90 Shore D. In some instances, the soft, polymer material comprises a durometer hardness of from approximately 50 Shore A to approximately 90 Shore D. In some instances, the distal end of the catheter adapter comprises an intravenous catheter in fluid communication with the lumen. Further, the proximal end of the catheter adapter comprises an extension tube that is also in fluid communication with the lumen. In some instances, securement platform may further comprise a hard or rigid plastic polymer material.

Some implementations of the present invention further comprise a needle hub comprising a rigid material, such as a hard plastic material. The needle hub comprises an open end, a closed end, and a compartment interposed therebetween. The closed end is configured to receive a terminal end of the extension tube, and the open end is configured to receive the proximal end of the catheter adapter, wherein the extension tube is stored within the compartment. In some instances, the extension tube is wound around an outer surface of the needle hub. In some instances, the closed end further comprises a flashback chamber in fluid communication with an interior lumen of the introducer needle.

In some instances, the needle hub further comprises a paddle grip positioned in proximity to the open end and arranged to overlap the securement platform, thereby permitting the user to pinch the paddle grip and securement platform between their thumb and index finger during the process of catheterization. In some instances, the overlapping arrangement of the paddle grip and the securement platform permits the user to hood the tip end of the needle by adjusting their grip to move the securement platform and paddle grip in opposite directions.

The needle hub further comprises an introducer needle having a base end, a tip end, and a body extending therebetween. The base end of the needle is securely attached to the closed end of the needle hub. When assembled, the body of the needle extends outwardly from the closed end, through the proximal end, the lumen, the distal end, and the intravenous catheter, such that the tip end of the needle is exposed beyond a terminal end of the intravenous catheter.

Some implementations of the present invention are further configured such that the body of the introducer needle passes through an interior of the extension tube when the intravenous catheter device is assembled. In some instances, the extension tube is wound around the body of the introducer needle within the compartment.

In some instances, the proximal end of the catheter adapter, and/or the terminal end of the extension tube further comprises a blood control device, such as a valve, a self-sealing polymer, a luer adapter, or a septum. In some instances, the blood control valve comprises a passageway through which the body of the introducer needle passes. In some instances, the blood control device is a single-use device. In other instances, the blood control device is a multi-use device.

Some implementations of the present invention further comprise an extension tube having an access port that is coupled to a sidewall surface of the extension tube, and extending outwardly therefrom. For these embodiments, the needle hub further comprises an access slot extending proximally from the open end to a position that is in proximity to the closed end, whereby the access port passes through the access slot and is located externally to the compartment of the needle hub with the intravenous catheter device is assembled. In some instances, the open end of the needle hub further comprises a notch having a width and depth that is configured to receive and support a proximal edge of the securement platform of the catheter adapter.

Some implementations of the present invention further comprise one or more features designed to capture and shield the tip end of the introducer needle following catheterization of the patient. For example, in some instances the proximal end of the extension tube further comprises a needle shield or safety mechanism that is selectively coupled thereto and through which the body of the introducer needle passes when the device is assembled. Upon removal of the introducer needle from the extension tube, a needle feature, such as a ferrule or notch, actuates the safety mechanism to selectively disengage the safety mechanism from the terminal end of the extension tube. Once released, the safety mechanism captures the tip end of the needle, thereby preventing unintended exposure to the tip end of the needle.

With reference toFIGS. 1 and 2, perspective top and cross-sectioned views of an assembled intravenous catheter device10are illustrated. In some embodiments, catheter device10comprises a catheter adapter20having a proximal end22, a distal end24, and a lumen26extending therebetween. Distal end24further comprises an intravenous catheter30having a gauge configured to access the peripheral vascular system.

Catheter adapter20further comprises one or more securement platforms40. In some embodiments, securement platforms40comprise a soft, pliable polymer material that may easily conform to the contours of the patient's body in proximity to the catheter insertion site, thus providing a low profile securement platform. In some instances, securement platforms40comprise a soft polymer material having a Shore A durometer hardness of from approximately 15 to 100, from approximately 20 to 80, from approximately 30 to 70, from approximately 40 to 60, from approximately 45 to 55, or approximately 50. In some instances, a soft, polymer material comprises a Shore A durometer hardness of less than 15. In some instances, a soft, polymer material comprises a Shore A durometer hardness of greater than 100. In some instances, both catheter adapter20and securement platform40comprise a soft, pliable polymer material.

Proximal end22of catheter adapter20further comprises an extension tube50having a first end52coupled to proximal end22, and further comprises a distal end54having a blood control device56. In some instances, extension tube50and catheter30comprise a single, monolithic structure or component. In other instances, extension tube50and catheter30are separate devices or components that are each independently coupled to lumen26, such that extension tube50, catheter30, and lumen26are in fluid communication. In some instances, lumen26further comprises a blood control device, such as a one-way valve or septum (not shown).

In some embodiments, the septum may have a “low friction” or “low drag” design configured to provide relatively low resistance to withdrawal of an introducer needle70proximally through the septum, which occurs as the catheter device10transitions from an insertion configuration to a fluid delivery configuration. The resistance to withdrawal of the needle70through the septum may be sufficiently low that the clinician can relatively easily move the catheter device10from the insertion configuration to the fluid delivery configuration with only a single hand. In some embodiments, the resistance to withdrawal may be, on average, less than about 50 gf.

In some instances, a proximal end of catheter adapter20is extended proximally (not shown) to provide extension tube50. Thus, the proximal end of catheter30terminates within the lumen26of catheter adapter20, and extension tube50extends outwardly from catheter adapter20, wherein catheter30, lumen26, and extension tube50are in fluid communication. In some instances, a portion of securement platform40is extended (not shown) to provide extension tube50.

In some embodiments, blood control device56comprises a luer adapter configured to compatibly receive a luer connector coupled to a length of intravenous tubing, or provide access via a needle or syringe. In some instances blood control device56further comprises a valve, the septum, and/or a self-healing polymer that permits selective access to the interior lumen of extension tube50. In some instances, blood control device56comprises a single-use valve. In other instances, blood control device56comprises a multi-use valve. Blood control device56may further comprise a septum actuator configured for use with a single-use or multi-use valve. When not accessed, blood control device56retains fluids within catheter30, catheter adapter20, and extension tube50.

Catheter device10further comprises a needle hub60. Needle hub60comprises a closed end62, an open end64, and a compartment66interposed therebetween. Closed end62is the proximal-most end of catheter device10and is configured to receive a terminal end54of extension tube50. Open end64is located opposite of closed end62and is configured to compatibly receive proximal end22of catheter adapter20. In some instances, compartment66comprises a length sufficient to receive the entire length of extension tube50. For example, in one embodiment compartment66comprises a length from approximately 0.5 inches to approximately 8 inches, from approximately 1 inch to approximately 7.5 inches, from approximately 2 inches to approximately 7 inches, from approximately 3 inches to approximately 6 inches, from approximately 4 inches to approximately 5 inches, or approximately 4.5 inches. In one embodiment, compartment66is approximately 4 inches.

Catheter device10further comprises the introducer needle70. Introducer needle70comprises a hollow metal or rigid plastic cannula having a base end72that is securely attached to closed end62within compartment66. Needle70further comprises a sharpened tip end74that is opposite base end72. The body76of needle70has a length that is greater than the combined lengths of catheter adapter20, catheter30, and needle hub60, when assembled, such that tip end74is exposed distally beyond a terminal end32of catheter30. As such, tip end74is exposed and capable of providing access through the patient's skin to introduce catheter30into the patient's vein.

In some embodiments, introducer needle70is threaded through extension tube50, lumen26, and catheter30prior to catheterization. In this way, introducer needle70aligns and coordinates the relative positions of each of the various components.

Various embodiments of the present invention further comprise a safety mechanism80configured to secure the sharpened, distal tip74of the introducer needle70following removal and separation of the needle hub60from the catheter adapter20. A safety mechanism may include any compatible device known in the art. In some instances, the safety mechanism is configured to interact with a needle feature, such as a ferrule, notch, crimp or bump on the cannula. The crimp or bump formed in the cannula cause a slight out of round configuration that can be used to activate a safety mechanism. In some instance, the safety mechanism comprises an arm or lever that is actuated to capture the needle tip within the mechanism and prevent the tip from emerging prior to safe disposal.

The safety mechanism is attached to the body of the needle and is capable of sliding along the length thereof. In some instances, an initial or assembled position of the safety mechanism is located in proximity to the base or proximal end of the needle adapter prior to catheterization. For some configurations, the assembled position of the safety mechanism is between the proximal end of the needle hub and the proximal end of the catheter adapter or securement platform, wherein the safety mechanism does not overlap the catheter adapter or securement platform. In some instances, a portion of the safety mechanism is positioned within the catheter adapter, with the balance of the safety mechanism being positioned external to the catheter adapter, such as within the needle hub. In some embodiments, a portion of the catheter adapter or securement platform is extended proximally to provide a housing in which at least a portion of the safety mechanism is house. In some instance, the entire safety mechanism is housed within the housing of the catheter adapter or securement platform prior to catheterization.

In some embodiments, the assembled position of the safety mechanism positions the proximal end of the catheter adapter between the distal end of the safety mechanism and a distal end of a paddle grip of the needle hub. In some instances, the assembled position of the safety mechanism positions the proximal end of the catheter adapter between the distal end of the safety mechanism and a proximal end of a paddle grip of the needle hub. In some instances, a portion of the safety mechanism overlaps a portion of a paddle grip of the needle hub. In some embodiments, at least some portion of at least one of the catheter adapter and the paddle grip overlaps at least some portion of the safety mechanism. In some embodiments, no portion of the catheter adapter or paddle grip overlaps any portion of the safety mechanism.

In some embodiments, a defeatable mechanical connection is provided between the safety mechanism and at least one other component of the intravenous catheter device. In some embodiments, a distal end of the safety mechanism is selectively coupled to a proximal end of the catheter adapter. In one embodiment, the safety mechanism interlocks internally to the proximal end of the catheter adapter. In one embodiment, the safety mechanism interlocks externally to the proximal end of the catheter adapter. In some embodiments, a distal end of the safety mechanism is selectively coupled to a proximal end of the securement platform. In some embodiments, a surface of the safety mechanism is selectively coupled to at least one surface of at least one of the catheter adapter, a blood control valve, an extension tube, and the securement platform. In some instances, the mechanical connection is defeated upon securement of the needle tip within the safety mechanism.

In some embodiments, catheter device10comprises a safety mechanism80through with body76of needle70is threaded, and which is interposedly positioned between terminal end54and closed end62. Following catheterization and withdrawal of needle70from extension tube50, a needle feature78interacts with safety mechanism80to trap tip end74therein, thereby preventing accidental exposure to tip end74. Any combination of known needle feature and safety mechanism may be used within the scope of the present invention.

Needle hub60further comprises a paddle grip68positioned in proximity to open end64and arranged to overlap a portion of securement platform40when catheter device10is assembled. In some embodiments, paddle grip68comprises a rigid plastic material. The overlapped arrangement of securement platform40and paddle grip68permits a user to hold catheter device10by pinching the overlapped features or components. In one embodiment, a user pinches the overlapping paddle grip68and securement platform40in order to insert the catheter into a patient. Once tip end74and terminal end32are inserted within the patient's vein, the user may hood tip end74by adjusting their grip to move paddle grip68in a proximal direction90while either maintaining the position of securement platform40, or by simultaneously moving securement platform40in a distal direction92.

Once tip end74is hooded, the user may further advance catheter30into the patient's vein to a final insertion depth. In some instances, catheter30comprises a clear or translucent material through which the user can see, and which provides primary blood flashback to indicate proper insertion of catheter30. In some instances, catheter adapter20and/or needle hub60further comprise a clear or translucent material for purposes of blood flashback observation. In some embodiments, needle feature78comprises a notch which permits blood within the hollow interior of needle70to flow between the outer surface of needle70and the interior of catheter30.

In some embodiments, base end72of needle70is coupled to a secondary flashback chamber (not shown) that is in fluid communication with tip end74and the hollow interior of needle70. For example, closed end62may further be modified to include a secondary flashback chamber. As such, blood may flow through the hollow interior of needle70and further flow into the secondary flashback chamber to further indicate proper insertion of catheter30prior to separating needle hub60and needle70from catheter adapter20, catheter30, and extension tube50.

As illustrated inFIGS. 1B and 1C, in some embodiments, the securement platform40may be nested in the paddle grip68in the assembled position or insertion configuration. In further detail, in some embodiments, the paddle grip68may include a peripheral ridge69disposed along an outer edge of the paddle grip68. In some embodiments, the peripheral ridge69may define a boundary of a distal recess71of the paddle grip40. In some embodiments, the securement platform40may be disposed within the distal recess71in the insertion configuration. In some embodiments, a curvature of an outer edge of the securement platform40may correspond to a curvature of an inner edge of the peripheral ridge69such that the securement platform40fits within the distal recess71in the insertion configuration.

In some embodiments, the peripheral ridge69may act as a pull feature. In some embodiments, the peripheral ridge69may be positioned such that a digit can easily contact an apex and/or a distal side of the peripheral ridge69to apply proximal pressure on the paddle grip68. In some embodiments, the peripheral ridge69may be disposed outward of an outer edge of the securement platform40when the intravenous catheter device10is in the insertion configuration such that the peripheral ridge69may be contacted by the digit even when the securement platform40is positioned to overlie the paddle grip68.

Referring now toFIG. 3, an exploded, cross-sectioned view of catheter device10is shown. In some embodiments, open end64of needle hub60further comprises a notch61having a width and depth sufficient to receive and support a proximal edge42of securement platform40. In some instances, notch61comprises a depth sufficient to achieve an overlapped arrangement of securement platform40and paddle grip68when proximal edge42is fully inserted within notch61. In some instances, with width of notch61is slightly greater than the thickness of securement platform40, such that securement platform40may easily slide within notch61, and notch61maintains the axial position of catheter adapter20within open end64, and further provides a buttressing support to the soft, pliable material of securement platform40.

Referring now toFIGS. 4 and 5, some embodiments of the present invention further comprise an access port58comprising a first end51coupled to, and in fluid communication with extension tube50, and further comprising a second end53extending outwardly from extension tube50and comprising a blood control device57. Access port58may comprise any structure or length within the teachings of the present invention. In some embodiments, access port58extends outwardly from the side or sidewall of extension tube50at an angle to resemble a y-port. In some instances, access port58extends outwardly in a proximal direction. In other instances, access port58extends outwardly in a distal direction. In some instances, access port58is used to pre-prime extension tube50and catheter30prior to catheterization.

Blood control device57may comprise any structure, shape or feature within the teachings of the present invention, or as is commonly known and practiced in the art. Further, blood control device57may be coupled to any secondary intravenous device, including but not limited to, intravenous extension tubing, a syringe, a needle, a cap, a secondary flash chamber, a y-port adapter, a vial, an IV bag, a valve, and a clamp.

Unlike blood control device56, blood control device57is located outside compartment66, and therefore may include features that may be incapable of being stored within compartment66. For example, in one embodiment blood control device57comprises a y-port. In one embodiment, blood control device57comprises one or features in common with blood control device56, as discussed previously. Access port58may further comprise one or more features that may be incompatible for storage within compartment66. For example, in one embodiment access port58comprises a roller clamp, a pinch clamp, or a similar device to control fluid flow therethrough.

In some instances, access port58is directly coupled to blood control device56. In some embodiments, access port58extends from catheter adapter20. In some embodiments, catheter device10comprises a first access port coupled to and extending from catheter adapter20(not shown), and further comprises a second access port58that is coupled to extension tube50or blood control device56.

In some embodiments, needle hub60further comprises an access slot63extending proximally from open end64to closed end62to accommodate access port58. Access slot63generally comprises a length selected to correspond to the position of access port58when catheter device10is assembled. Access port63further comprises a width that is slightly larger than the outer diameter of access port63, whereby access port63is able to free slide within access slot63.

As illustrated inFIG. 4B, in some embodiments, the securement platform40may be nested in the paddle grip68in the assembled or insertion configuration, similar to the nesting of the securement platform40in the paddle grip68, illustrated inFIG. 1B.

Referring now toFIGS. 6A-6C, some embodiments of the present invention further comprise a catheter device100having an elongated extension tube150, wherein the length of extension tube150is greater than the length of compartment166. In some instances, the excess length of extension tube150is wrapped around body76of needle70to accommodate storage within compartment166prior to catheterization. Following catheterization, extension tube150is unwound from needle70as needle70and needle hub160are separated and removed from catheter adapter120.

In some embodiments, catheter adapter120comprises a lumen126having a distal end124and a proximal end122. Distal end124comprises intravenous catheter30, as discussed previously. In some embodiments, proximal end122comprises a first surface to which first end152of extension tube150is coupled and in fluid communication with lumen126. First end152is coupled to proximal end122at an off-center position, such as in proximity to the perimeter edge of proximal end122.

Proximal end122further comprises a second surface through which needle70passes. In some instances, the second surface of proximal end122is the axial center of proximal end122. In some embodiments, second surface of proximal end122comprises a blood control device, such as septum or self-healing polymer through which needle70is passed. Upon removal of needle70from proximal end122, the blood control device prevents fluid from passing through the second surface of proximal end122, thereby directing fluid flow through extension tube150at the first surface of proximal end122.

Similarly, blood control device156comprises a first aperture151to which is secured the distal end154of extension tube150. In some instances, first aperture151is located at an off-center position, such as in proximity to the perimeter edge of blood control device156. Blood control device156further comprises a second aperture153through which needle70passes. In some instances, second aperture153is located at the axial center of blood control device156. Upon catheterization, blood control device156retains fluid within extension tube150until further accessed by a secondary intravenous device, such as a luer connector, a syringe, a needle, or other device.

In some embodiments, needle hub160comprises a pair of truncated paddle grips168having slots that receive the proximal edges of securement platforms140. In some instances, the dimensions and shape of paddle grips168and securement platforms140are configured to accommodate catheterization by pinching these elements between the user's thumb and index finger. In some embodiments, each of the securement platforms140may be nested in one of the paddle grips168in the assembled position or insertion configuration, similar to the nesting of the securement platform40in the paddle grip68, illustrated inFIGS. 1B and 4B.

In some instances, the small gauge and extended length of introducer needle70may result in undesirable flexing or bending of needle70during catheterization. Accordingly, in some embodiments catheter device200comprises a sleeved needle configuration, as shown inFIG. 7. In some instances, catheter30comprises a second cannula250having an inner diameter that is configured to receive the outer diameter of needle70. Second cannula250may comprise a truncated length and be securely fixed within the interior lumen or fluid pathway of catheter30. In some instances, second cannula250is fixed within the portion of catheter30that is located within catheter adapter220. Second cannula250therefore acts as a sheath for the portion of needle70located within catheter adapter220. In some instances, second cannula250supports and stiffens needle70against undesired flexing or bending.

In some instances, catheter device200comprises a tapered introducer needle (not shown), wherein the base and middle portions of the tapered needle comprises a gauge and thickness that is greater than the gauge of the distal end and tip portion of the needle. The tapered configuration imparts greater stiffness to the proximal and middle portions of the needle, which serve to stiffen the distal and tip portions of the needle, thereby reducing undesired flexing or bending of the needle during catheterization. Further still, in some embodiments catheter device200comprises an introducer needle having base and middle portions comprising a first gauge, and distal and tip portions comprising a second gauge, wherein the first gauge is greater than the second gauge, and the first gauge imparts stiffness to the second gauge.

In some embodiments, a particular catheter device, such as, for example, the catheter device of any of theFIGS. 1-7, may include a needle safety mechanism. The safety mechanism may include any safety mechanism configured to secure a sharpened, distal tip of an introducer needle when the needle is withdrawn from a catheter of the particular catheter device, preventing accidental needle sticks.

The safety mechanism may be coupled with the particular catheter device in any number of ways. In some embodiments, the safety mechanism may include an internal interlock in which the safety mechanism is coupled with an internal surface of a catheter adapter. Coupling may include threading, fitting, snapping, connecting, attaching, fastening, clipping, hooking, or any other suitable means of coupling. Non-limiting examples of safety mechanisms that include an internal interlock are provided in: U.S. Pat. No. 8,496,623, titled BI-DIRECTIONAL CANNULA FEATURE CAPTURE MECHANISM, filed Mar. 2, 2009; U.S. Pat. No. 9,399,120, titled BI-DIRECTIONAL CANNULA FEATURE CAPTURE MECHANISM, filed Jul. 11, 2013; U.S. Patent Application No. 62/314,262, titled CANNULA CAPTURE MECHANISM, filed Mar. 28, 2016, each of which is herein incorporated by reference in its entirety. In some embodiments, the safety mechanism may include a clip disposed within the catheter adapter, a non-limiting example of which is provided in U.S. Pat. No. 6,117,108, titled SPRING CLIP SAFETY IV CATHETER, filed Jun. 12, 1998, which is herein incorporated by reference in its entirety.

In some embodiments, the safety mechanism may include an external interlock in which the safety mechanism is coupled with an external surface of the catheter adapter. In some embodiments, the safety mechanism may be coupled with an external surface of the catheter adapter and an internal and/or external surface of a needle hub. Coupling may include threading, fitting, snapping, connecting, attaching, fastening, clipping, hooking, or any other suitable means of coupling. Non-limiting examples of safety mechanisms that include an external interlock are provided in U.S. patent application Ser. No. 14/295,953, titled PORTED IV CATHETER HAVING EXTERNAL NEEDLE SHIELD AND INTERNAL BLOOD CONTROL SEPTUM, filed Jun. 4, 2014, which is herein incorporated by reference in its entirety. In some embodiments, the safety mechanism may include a V-clip or a similar clip. A non-limiting example of a V-clip is provided in U.S. patent application Ser. No. 14/295,953, titled PORTED IV CATHETER HAVING EXTERNAL NEEDLE SHIELD AND INTERNAL BLOOD CONTROL SEPTUM, filed Jun. 4, 2014, which is herein incorporated by reference in its entirety. The V-clip may selectively retain a portion of the catheter adapter.

In some embodiments, a defeatable mechanical connection is provided between the safety mechanism and at least one other component of the IV catheter system. In some instances, the mechanical connection is defeated upon securement of the distal tip of the needle within the safety mechanism. In some embodiments, a surface of the safety mechanism is selectively coupled to one or more of the following: the catheter adapter, a blood control valve, an extension tube, and one or more paddle grips.

In some embodiments, the safety mechanism may include a safety barrel, which may be spring-loaded. For example, the safety barrel may be spring loaded as in the BD™ Insyte® Autoguard™ BC shielded protective IV catheter. In some embodiments, the safety mechanism may be passively and/or actively activated. In some embodiments, the safety mechanism may be configured to interact with a needle feature, such as a ferrule, notch, crimp or bump on the needle. In some embodiments, the safety mechanism may include an arm or lever that may be actuated to capture the distal tip within the safety mechanism and prevent the tip from emerging prior to safe disposal. In some embodiments, the safety mechanism may be attached to a body of the needle and may be capable of sliding along the length thereof.

In some embodiments, in an assembled position prior to catheterization, the safety mechanism may be disposed between the catheter adapter and the needle hub. In some embodiments, the catheter adapter and the needle hub may be spaced apart by at least a portion of the safety mechanism in the assembled position prior to catheterization. In some embodiments, in the assembled position prior to catheterization, a proximal end of the catheter adapter may be disposed between a distal end of the safety mechanism and a distal end of a grip of the needle hub, such as, for example, a paddle grip. In some embodiments, in the assembled position prior to catheterization, the proximal end of the catheter adapter body may be disposed between the distal end of the safety mechanism and a proximal end of the grip of the needle hub. In some embodiments, a portion of the safety mechanism may overlap with a portion of the grip of the needle hub. In some embodiments, at least a portion of at least one of the catheter adapter and the grip overlaps at least some portion of the safety mechanism. In some embodiments, no portion of the catheter adapter body or the grip overlaps any portion of the safety mechanism.