Patent Description:
A vascular access device may access a peripheral or central vasculature of a patient. A vascular access device may be indwelling for short term (days), moderate term (weeks), or long term (months to years). A vascular access device may be used for continuous infusion therapy or for intermittent therapy.

A common type vascular access device is an over-the-needle peripheral intravenous catheter (PIVC). As its name implies, the "over-the-needle" PIVC may be mounted over an introducer needle having a sharp distal tip. The sharp distal tip may be used to pierce skin and the vasculature of the patient. Insertion of the PIVC into the vasculature may follow the piercing of the vasculature by the needle. The needle and the PIVC are generally inserted at a shallow angle through the skin into the vasculature of the patient with a bevel of the needle facing away from the skin of the patient.

Placement of the PIVC within the vasculature is essential for blood withdrawal and fluid infusion and yet may be difficult to maintain. Patients often want or need to have a normal range of body motion while the PIVC is inserted. Also, external objects may apply external forces to the PIVC and thereby shift the PIVC's location within the vasculature. In some instances, the external forces may cause back-and-forth dynamic movement of a tip of the PIVC or a static shift in the tip from its location within the vasculature.

The PIVC assembly may be coupled with an extension set, which may allow coupling of an infusion or blood withdrawal device at a location removed from an insertion site of the PIVC. While the extension set may reduce a risk of disturbing the insertion site or dislodging the catheter from the vasculature of the patient, an extension set requires a priming protocol, wherein the extension tube must be filled with fluid to eliminate the air bubbles in a catheter system. The priming procedure is time consuming for a clinician. Further, a catheter having a lengthy extension tube has potential to get caught and accidentally dislodge the catheter or requires more securement that may feel bulky and uncomfortable to a patient. Lastly, a catheter with an extension tube requires a longer length to loop the tube for proper securement to minimize kinking. Therefore, a catheter system with an extendable extension tube would be beneficial to clinicians and patients requiring infusion therapy.

<CIT> shows an exemplary prior art catheter system. It comprises a catheter adapter having a distal end, a proximal end and a lumen extending therebetween. A catheter tube extends distally from the catheter adapter, an extension tube is coupled to the proximal end of the adapter. The extension tube is extendable and a locking mechanism is coupled to the extension tube and removably coupled to the proximal end of the catheter adapter. A needle hub is removably coupled to the proximal end of the catheter adapter. An introducer needle extends through the catheter tube, wherein a proximal end of the introducer needle is secured within the needle hub.

The present disclosure relates to catheter systems configured to facilitate catheter insertion success and eliminate or significantly reduce priming and also improve patient comfort related to catheter securement for longer indwell times. In further detail, the catheter system may reduce complications that may be associated with insertion of a catheter tube into a vein of a patient and/or improve the indwelling time of the catheter and looping of extension tubing. The catheter system may also eliminate or significantly reduce time associated with priming in order for clinicians to expedite PIVC setup.

A catheter system according to claim <NUM> is thus provided. It includes a catheter adapter having a distal end, a proximal end, and a lumen extending therebetween. The catheter system includes a catheter tube extending distally from the catheter adapter. The catheter system includes an extension tube coupled to the proximal end of the catheter adapter. The extension tube is extendable. The catheter system includes a locking mechanism coupled to the extension tube and removably coupled to the proximal end of the catheter adapter. The system includes a needle hub removably coupled to a proximal end of the extension tube and an introducer needle extending through the catheter tube. A proximal end of the introducer needle is secured within the needle hub.

In some embodiments, the extension tube may be corrugated. The extension tube may be flexible when extended, such that the extension tube may bend in various directions as required by the infusion therapy. Further, the extension tube may be resilient and retains shape when curved and may resist kinking.

The locking mechanism includes a lever having a lip disposed on a distal end of the locking mechanism that engages with a flange disposed on the proximal end of the catheter adapter. In response to a depression of a proximal end of the lever, the lip disengages from the flange of the catheter adapter. In some embodiments, the extension tube may be compressed when the locking mechanism is engaged and is extendable when the locking mechanism is disengaged. The introducer needle may be withdrawable through the extension tube when the extension tube is either compressed, extended, or while the extension tube is being extended.

In some embodiments, the catheter system may include a septum. The septum may be disposed within a proximal end of the extension tube. In other embodiments, the catheter system may include a luer connector coupled to the proximal end of the extension tube. A flash chamber may be disposed within the proximal end of the needle hub. In response to insertion of the catheter tube into the vein of the patient, blood may flow into the flash chamber. The flash chamber may include an air vent. In some embodiments, the flash chamber may extend in a proximal direction from the proximal end of the needle hub. The flash chamber may have a capacity between about <NUM> to about <NUM>. In some embodiments, the flash chamber may be transparent.

In some embodiments, the needle hub may include a paddle grip. Further, the catheter adapter may include at least one wing that extends outwardly from the catheter adapter. The at least one wing may include an upper surface and a lower surface. In some embodiments, the upper surface of the wing includes a grip and the lower surface of the wing includes a recess. The recess may couple with a grip on an upper surface of the paddle grip when a tip of the introducer needle is withdrawn within the catheter tube.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive of the embodiments of the present disclosure, as claimed. It should be understood that the various embodiments of the present disclosure are not limited to the arrangements and instrumentality shown in the drawings.

It should also be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural changes, unless so claimed, may be made without departing from the scope of the various embodiments of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense.

It is to be understood that the Figures are for purposes of illustrating the concepts of the present disclosure and may not be drawn to scale. Furthermore, the Figures illustrate exemplary embodiments and do not represent limitations to the scope of the present disclosure.

Exemplary embodiments of the present disclosure will be best understood by reference to the Figures, wherein like parts are designated by like numerals throughout. It will be readily understood that the components of the present disclosure, as generally described and illustrated in the Figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of the embodiments of the apparatus and systems, as represented in the Figures, is not intended to limit the scope of the present disclosure, as claimed, but is merely representative of exemplary embodiments of the present disclosure.

The present disclosure relates generally to a catheter system configured to facilitate catheter insertion success, eliminate or significantly reduce priming, and improve patient comfort related to catheter securement for longer indwell times. Referring now to <FIG>, an example catheter system <NUM> is illustrated, ready for insertion into a vein of a patient (not shown in <FIG>). The catheter system <NUM> includes a catheter adapter <NUM> and a catheter tube <NUM>. The catheter adapter <NUM> includes a distal end, a proximal end, and a lumen extending therebetween. The catheter tube <NUM> extends distally from the catheter adapter <NUM>.

The catheter system <NUM> includes a needle hub <NUM>. The proximal end of the catheter adapter is removably coupled to the needle hub <NUM>. The catheter system <NUM> may includes an introducer needle <NUM>. The introducer needle <NUM> extends through the catheter tube <NUM> and a proximal end of the introducer needle <NUM> may be secured within the needle hub <NUM>.

A flash chamber <NUM> may be disposed within and extend in a proximal direction from the proximal end of the needle hub <NUM>. In some embodiments, the flash chamber <NUM> may be transparent such that a clinician is able to verify that the catheter has been properly inserted into the vein of the patient. In some embodiments, the needle hub <NUM> further includes a paddle grip <NUM> to aid in the handling of the needle hub. The paddle grip <NUM> may extend outwardly from the needle hub <NUM> and in a distal direction.

Referring now to <FIG>, the catheter system <NUM> includes an extension tube <NUM> coupled to the proximal end of the catheter adapter <NUM>. The extension tube <NUM> is extendable and may be corrugated. The extendable and/or corrugated extension tube <NUM> may reduce or eliminate the need for priming of the catheter system <NUM> by reducing the internal fluid volume, such that external fluids are not required to prevent air bubbles forming in the catheter system <NUM>.

Referring now to <FIG>, the catheter system <NUM> includes a locking mechanism <NUM> coupled to the extension tube and removably coupled to the proximal end of the catheter adapter <NUM>. The locking mechanism <NUM> may be located on an upper surface of the catheter system <NUM>. The locking mechanism may include ridges to grip and also provide indication of proper locations to apply pressure to operate the locking mechanism <NUM>. The locking mechanism <NUM> may be engaged to maintain the extension tube <NUM> in a compressed state and disengaged for the extension tube <NUM> to be extended. The extension tube <NUM> includes a lever. The lever may be depressed on one end to disengage the locking mechanism <NUM>.

The locking mechanism <NUM> includes a lip disposed on a distal end of the lever to function as the locking mechanism <NUM>. The catheter adapter <NUM> includes a flange which may extend upward. The flange may include a flat, rigid plastic extending from the catheter adapter <NUM> so that the locking mechanism may engage with the flange disposed on the catheter adapter <NUM>. A user may apply pressure to a proximal end of the locking mechanism lever to raise the lip and disengage the lip from the flange.

In some embodiments, at least a portion of the proximal end of the catheter adapter <NUM>, the flash chamber <NUM>, and the extension tube <NUM> may nest within at least a portion within the needle hub <NUM>. The catheter adapter <NUM> and the extension tube <NUM> may be housed within the needle hub <NUM> prior to using the catheter adapter <NUM> on a patient and/or expanding the extension tube <NUM>. The compact design of the catheter system <NUM> may enable a user to insert the catheter tube <NUM> into a vein using a single hand.

In some embodiments, a proximal end of the catheter adapter <NUM> is slidably coupled to a distal end of the needle hub <NUM>. The extension tube <NUM> may be housed completely within the needle hub <NUM> while the extension tube <NUM> is compressed. In some embodiments, the locking mechanism may be configured to be a push-pull slider to extend and compress the extension tube <NUM> and/or separate the catheter adapter <NUM> and the extension tube <NUM> from the needle hub <NUM>. For example, a user may remove the catheter adapter <NUM> from the needle hub <NUM> by applying a force distally to the locking mechanism <NUM> to slide the extension tube <NUM> and the catheter adapter <NUM> from the needle hub <NUM>.

The locking mechanism <NUM> is coupled to a proximal end of the extension tube <NUM>. Thus, when the needle hub is separated from the extension tube <NUM>, the locking mechanism <NUM> remains coupled to the distal end of the extension tube. The needle hub may include a portion on an upper surface of the needle hub that is cutout, such that the locking mechanism <NUM> may slide distally to be removed and for the locking mechanism <NUM> to be accessible to a user.

In some embodiments, the flash chamber <NUM> may include an air vent <NUM>. The air vent <NUM> may be permeable to gases and impermeable to fluids. The air vent may be configured to remove gases from the flash chamber <NUM> as blood or other fluid enters the chamber. In some embodiments, the flash chamber <NUM> may be disposed within a proximal end of the needle hub. In response to insertion of the catheter tube <NUM> into the vein of the patient, blood may flow into the flash chamber <NUM> and provides an indication of successful placement of introducer needle <NUM> and/or the catheter tube <NUM> within the vein. In some embodiments, at least a portion of the flash chamber extends from the proximal end of the needle hub <NUM> and may be transparent. The flash chamber <NUM> may be transparent to provide a flashback indication of successful insertion into the vein of the patient.

Referring now to <FIG>, the catheter system <NUM> may include a septum <NUM>. The septum <NUM> may be disposed within a proximal end of the extension tube <NUM>. In some embodiments, the septum may be disposed within a septum holder <NUM> that is coupled to the extension tube <NUM>. The locking mechanism <NUM> may couple to the septum holder <NUM> to secure the locking mechanism <NUM> to the extension tube. In some embodiments, the septum may be a <NUM>-piece septum, <NUM>-piece septum, or any suitable septum.

In some embodiments, the introducer needle <NUM> may pierce the septum <NUM> to extend through the catheter tube <NUM>. Further, infusion devices may be coupled to the septum <NUM> to administer fluids to the patient. In some embodiments, a luer connector (not illustrated) may be coupled to the proximal end of the extension tube <NUM>. The extension tube <NUM> may be coupled to the catheter adapter and/or the septum holder <NUM> or luer connector by laser welding. The extension tube <NUM> may be coupled to the catheter adapter <NUM> and or the septum holder <NUM> by an adhesive.

Referring now to <FIG>, the extension tube <NUM> may be corrugated. The corrugated extension tube may be extendable and/or compressible and the extension tube <NUM> may be flexible when extended. The flexible extension tube may improve patient comfort and require less securement for long indwell times. In some embodiments, the introducer needle is withdrawable through the extension tube when the extension tube is compressed, extended, or while the extension tube is being extended.

A patient may have low blood pressure making the withdrawal of blood more difficult because the blood may not flow into the catheter adapter <NUM> without assistance. The clinician may expand the extension tube <NUM> while withdrawing the introducer needle <NUM> to create a negative pressure within the catheter system <NUM> and/or the extension tube <NUM> such that a vacuum effect draws blood from the vein. An expansion of the extension tube <NUM> may not be necessary to draw out blood and the introducer needle <NUM> may be withdrawn without expanding the extension tube <NUM>.

The introducer needle <NUM> may be withdrawn while the locking mechanism <NUM> is either engaged and/or disengaged. After the introducer needle <NUM> is withdrawn, the catheter adapter <NUM> and/or the extension tube <NUM> may be secured such that the distal end of the extension tube can be accessed for connecting other devices, sampling, and/or disinfecting the septum <NUM>. The extension tube may be compressed and the locking mechanism <NUM> engaged prior to securing the catheter adapter <NUM> to the skin of the patient or prior to removing the catheter adapter.

The extension tube <NUM> may be resilient and retain shape when curved. As an example, the extension tube <NUM> may be extended and bent such that the extension tube is L-shaped, U-shaped, V-shaped, or otherwise redirected. The extension tube <NUM> may be configured to retain the bent shape. The bent shape may improve patient comfort as the catheter system <NUM> is secured for a period of indwell. In some applications, the extension tube <NUM> may be bent to provide a more secure and/or convenient coupling to fluid sources such as IV fluids and/or medical devices.

In some embodiments, the extension tube <NUM> may be repositioned from a previously different shape. The extension tube <NUM> may be compressed after being positioned in a bent configuration. In some embodiments, patency of the catheter tube <NUM> and/or the extension tube <NUM> may be evaluated by extending or compressing the extension tube. Expanding or compressing the extension tube causes fluid to flow into our out of the catheter tube. A clinician may use the force required to expand or contract the extension tube to determine the presence of an obstruction. In some embodiments, the extension tube may be configured to resist kinking. The corrugation of the extension tube <NUM> may be bendable without kinking, while still flexing to bent shapes and/or redirecting the extension tube. The locking mechanism <NUM> may be reengaged after the extension tube <NUM> is compressed. In some embodiments, the compression of the extension tube <NUM> and/or the redirection of the extension tube may benefit the comfort of the patient by using less tape and/or securement material to secure the catheter adapter <NUM> or catheter system <NUM> for indwell.

Referring now to <FIG>, the needle hub <NUM> may include a paddle grip <NUM> that may include a raised feature <NUM> on the upper surface of the paddle grip. The raised feature <NUM> may include a bump and/or a nub to enhance grip. The raised feature may include a ridge or ridges and/or other grip feature that assists the user with gripping the paddle grip <NUM>. In some embodiments, the raised feature <NUM> may extend upward beyond the other grip feature of the paddle grip <NUM>.

In some embodiments, the catheter adapter <NUM> includes at least one wing <NUM> that extends outwardly from the catheter adapter. The wings may stabilize the catheter adapter and simplify insertion of the catheter. In some embodiments, the catheter adapter <NUM> includes two wings extending from the catheter adapter. The wings may be constructed of flexible material. When the catheter adapter <NUM> is coupled to and/or nested within the needle hub <NUM>, the at least one wing <NUM> of the catheter adapter may be situated on top of and/or contact the paddle grip <NUM>. In some embodiments, the paddle grip <NUM> may extend distally beyond the wing <NUM> of the catheter adapter <NUM>.

The wing <NUM> of the catheter adapter <NUM> may include and upper surface and a lower surface. The upper surface of the wing may include a grip feature <NUM>. In some embodiments, the grip feature <NUM> may enable the user to control the catheter adapter <NUM> as they administer the catheter system <NUM> to the patient. The grip feature <NUM> may include ridges and or nubs. In some embodiments, the lower surface of the wing <NUM> of the catheter adapter <NUM> may include a recess <NUM>.

Referring now to <FIG>, the recess <NUM> may be configured to couple to the raised feature <NUM> on the paddle grip <NUM> when a tip of the introducer needle is withdrawn within the catheter tube. In some embodiments, the coupling of the raised feature <NUM> and the recess <NUM> provides a tactile indication to the user that the tip of the introducer needle <NUM> has been withdrawn into the catheter tube <NUM>. The tactile indication may provide an indication to the user that the catheter tube <NUM> may be safely repositioned and/or further inserted into the vein of the patient without causing damage to the vein by the tip of the introducer needle <NUM>. After the catheter tube <NUM> is placed in the desired indwell location, the raised feature <NUM> on the paddle grip <NUM> and the recess <NUM> may be decoupled and the introducer needle <NUM> may be completely withdrawn from the catheter adapter <NUM>.

Referring now to <FIG>, the needle hub <NUM> may include the flash chamber <NUM> where, in response to the insertion of the catheter tube <NUM> into the vein of a patent, blood flows into the flash chamber <NUM>. In some embodiments, the flash chamber <NUM> may be transparent to provide an indication to the user that the catheter tube <NUM> is positioned within the vein. The flash chamber <NUM> may confirm the proper placement of the catheter tube <NUM> within the vein. In some embodiments, the flash chamber may include an air vent <NUM> to remove air as it is displaced within the flash chamber <NUM> and/or catheter system <NUM> as blood flows into the catheter tube <NUM> and into the flash chamber <NUM>. The air vent may include a membrane that filters air and may be impermeable to fluids.

The flash chamber may have a sufficient capacity to provide a blood sample. In some embodiments, the blood and/or fluid within the flash chamber <NUM> may be used as a sample. The flash chamber <NUM> may have a capacity between about <NUM> to about <NUM>. The blood within the flash chamber <NUM> may be sampled because the catheter system <NUM> has not been primed with priming fluid, which may diminish the sample. In using the blood within the flash chamber for a sample, a clinician would not need to stick the patient again after placing the catheter tube <NUM> within the vein. Further, the sample may be obtained without using other blood collection accessories. In some embodiments, the sample may be discharged through the introducer needle <NUM>. For example, a sample tube <NUM> may be coupled to the flash chamber <NUM> to sample the blood and the introducer needle <NUM> may be placed into the sample tube <NUM> and a vacuum within the sample tube may draw the blood and/or fluid from the flash chamber into the sample tube. This method of sampling may be especially valuable for the care of pediatrics and/or neonates where placing a catheter and/or drawing blood may be more difficult.

Reference throughout this specification to "an embodiment" or "the embodiment" means that a particular feature, structure or characteristic described in connection with that embodiment is included in at least one embodiment.

Similarly, it should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, Figure, or description thereof for the purpose of streamlining the disclosure. This disclosure format, however, is not to be interpreted as reflecting an intention that any claim requires more features than those expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment.

The phrases "connected to," "coupled to," "engaged with," and "in communication with" refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be functionally coupled to each other even though they are not in direct contact with each other. The term "abutting" refers to items that are in direct physical contact with each other, although the items may not necessarily be attached together. The phrase "fluid communication" refers to two features that are connected such that a fluid within one feature is able to pass into the other feature.

As defined herein, "substantially equal to" means "equal to," or within about a + or - <NUM>% relative variance from one another.

While the various aspects of the embodiments are presented in the Figures, the Figures are not necessarily drawn to scale unless specifically indicated.

Claim 1:
A catheter system (<NUM>), comprising:
a catheter adapter (<NUM>) having a distal end, a proximal end, and a lumen extending therebetween;
a catheter tube (<NUM>) extending distally from the catheter adapter;
an extension tube (<NUM>) coupled to the proximal end of the catheter adapter, wherein the extension tube is extendable;
a locking mechanism (<NUM>) comprising a lever coupled to a proximal end of the extension tube and removably coupled to a flange disposed on the proximal end of the catheter adapter, the lever having a proximal end configured to be depressed, and a distal end comprising a lip configured to selectively engage the flange, the extension tube being positioned between the lever and the flange, wherein in response to a depression of the proximal end of the lever, the lip disengages the lever from the flange;
a needle hub (<NUM>) removably coupled to the proximal end of the catheter adapter; and
an introducer needle (<NUM>) extending through the catheter tube, wherein a proximal end of the introducer needle is secured within the needle hub.