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.

In pediatric patients, including neonates, where veins may be smaller and more difficult to access, in an attempt to position the PIVC in a vein, catheter placement may be more difficult. Thus, in some instances, more vulnerable patients, including children, may receive more needle sticks, which may result in pain and other complications. Traditional vascular access devices have not adequately addressed these issues. Therefore, a catheter system that mitigates difficulties that arise in pediatric care is needed.

<CIT> discloses a catheter hub attachment assembly.

<CIT> discloses an adhesive backed IV catheter with auto release liner.

<CIT> discloses a catheter tubing, a catheter, and a catheter assembly.

<CIT> discloses an intravenous catheter system.

<CIT> discloses an arrangement in a catheter unit with attachment wings, for infusion cannulas.

The subject matter of the invention is defined by independent claim <NUM>.

The present disclosure relates to catheter systems and related devices and methods (not claimed) configured to facilitate catheter insertion. The catheter system may reduce complications that may be associated with insertion of a catheter tube into a vein of a patient. The catheter system may be particularly useful for pediatric patients, including neonates, to improve catheter placement in smaller veins. It may also reduce the risk that these more vulnerable patients experience unnecessary needle sticks.

The catheter system includes a catheter adapter having a distal end, a proximal end, and a lumen extending therebetween. An outer surface of the lumen includes an upper surface and a lower surface. The lower surface includes an adhesive. The adhesive may be an integrated tape strip that includes a removable backing layer. The system includes a catheter cannula extending distally from the catheter adapter. A needle hub is also included in the system that may be removably coupled to a proximal end of the catheter adapter and an introducer needle extending through the catheter tube. A proximal end of the introducer needle is secured within the needle hub.

The catheter system includes a pediatric catheter system. In such pediatric catheter systems, the catheter tube may be <NUM> gauge or <NUM> gauge. A length of the catheter tube may be approximately <NUM> and the catheter cannula may include a peripheral intravenous catheter.

The catheter adapter includes one or more wings, which extend outwardly from the catheter adapter. The wings are configured to fold upwardly. The one or more wings may include a first surface and a second surface where an adhesive may be coupled to the second surface.

The catheter system includes a housing, which may be removably coupled to the catheter adapter. The housing fits over the catheter adapter and secure the wings in an upward position. The housing may also include a finger grip, which may extend outwardly from a distal end of the housing. The housing may be removed from over the catheter adapter to extend the plurality of wings.

The catheter adapter further comprises a push tab that extends upwardly from the upper surface of the catheter adapter. The catheter adapter includes a first push tab and a second push tab that extend upwardly from between the plurality of wings.

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 invention, as claimed. It should be understood that the various embodiments 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 in this or any other application claiming priority to this application, but is merely representative of exemplary embodiments of the present disclosure.

Referring now to <FIG>, an embodiment of a catheter system <NUM> is illustrated. The catheter system <NUM> may be similar to the BD Neoflon™ IV Cannula System or another suitable catheter system. For pediatric use, especially neonatal patients with capillary brittleness and where a non-traumatic and delicate needle may be preferred, a smaller gauge cannula and catheter may be preferred for patient comfort during a catheter insertion and/or indwell period.

The catheter system <NUM> includes a catheter adapter <NUM> and a catheter cannula <NUM>. The catheter cannula <NUM> extends distally from the catheter adapter <NUM>. In some embodiments, the catheter cannula <NUM> may include a small gauge catheter sized for a pediatric patient, which may include, for example, a neonatal patient. For example, the catheter cannula <NUM> may have a gauge size of <NUM> or smaller. In these and other embodiments, the catheter cannula <NUM> may include an external diameter approximately equal to <NUM> and/or a length approximately equal to <NUM>. In some embodiments, a water flow rate through the catheter tube <NUM> may be approximately <NUM>/min. As another example, the catheter cannula <NUM> may have a gauge size of <NUM>. In these and other embodiments, the catheter cannula <NUM> may include an external diameter approximately equal to <NUM> and/or a length approximately equal to <NUM>. In some embodiments, a water flow rate through the catheter tube <NUM> may be approximately <NUM>/min. The appropriate needle gauge and length may be determined by a number of factors, including the target body tissue, injection formulation and/or viscosity, and patient proportions.

In some embodiments, the catheter cannula <NUM> may be constructed of thermoplastic polyurethane ("TPU") or another suitable material. The catheter cannula <NUM> may be constructed solely or partially of TPU. The TPU or other suitable material may facilitate a smooth insertion of the catheter cannula <NUM> into the vein of the patient or may provide less resistance as a user inserts the catheter cannula <NUM> into the vein than a standard catheter tube. A standard catheter tube may be constructed of polytetrafluoroethylene ("PTFE") or a similar material, which may be difficult to insert into the vein of the patient, providing resistance which may lead to collapse of the standard catheter tube. The catheter cannula <NUM> constructed of TPU or other suitable material may ease insertion into the vein of the patient and help avoid collapse of the catheter cannula <NUM> during insertion. Further, the catheter cannula <NUM> constructed of TPU may reduce a risk of phlebitis and extend an indwelling period of the catheter cannula <NUM>.

The catheter adapter <NUM> includes a distal end, a proximal end, and a lumen extending therebetween. In some embodiments, an outer surface of the lumen includes an upper surface and a lower surface. The upper surface of the lumen may include a push tab <NUM> to withdraw the needle after insertion. In some embodiments, the upper surface of the lumen may include a second push tab <NUM>. In some embodiments, the push tab <NUM> and/or push tab <NUM> may enable a clinician to improve the control of the catheter adapter <NUM> during use.

The catheter adapter <NUM> includes a plurality of wings <NUM>, which may extend outwardly from the catheter adapter <NUM> to retain the catheter in place. The wings <NUM> may extend a lower portion of the catheter adapter <NUM>. The catheter adapter <NUM> may be constructed of a relatively flexible plastic. In some embodiments, the wings <NUM> may include a scoring <NUM> to facilitate the wings <NUM> folding to an upward and/or downward position.

Referring now to <FIG>, a catheter system <NUM> is illustrated. The catheter system <NUM> includes: the catheter adapter <NUM>, the catheter cannula <NUM>, a housing <NUM>, a needle hub <NUM>, a needle <NUM>, and optionally a flow control plug <NUM>, and an end cap <NUM>. The housing <NUM> may be removably coupled to the catheter adapter <NUM>. The housing <NUM> may be useful for the user, such as a clinician, to grip during insertion of the catheter cannula <NUM> into the vein of the patient. Also, the housing <NUM> may provide a larger surface area to grip as compared to the catheter adapter <NUM> itself. In some embodiments, the housing <NUM> further includes a finger grip <NUM> configured to aid in insertion and/or withdrawal of the catheter system <NUM> from a patient. The housing finger grip <NUM> may extend outwardly from a distal end of the housing <NUM>. The housing <NUM> may be generally square to fit over the wings and hold them in an upward position. When the catheter system <NUM> is in an insertion position prior to inserting the catheter system <NUM> into the patient, the wings <NUM> may be disposed in the upward position within the housing <NUM>, as will be explained in further detail.

A proximal end of the needle <NUM> is secured within the needle hub <NUM>. The proximal end of the needle <NUM> may be press-fit within the needle hub <NUM>. The needle <NUM> may include an introducer needle having a sharp distal tip to facilitate insertion of the catheter cannula <NUM> into a vein of the patient. The needle hub <NUM> includes a thumb grip <NUM>, which may be configured to aid in removal of the needle hub <NUM> and needle <NUM> from the catheter system <NUM>, after the catheter cannula <NUM> is inserted into the vein of the patient. The needle <NUM> may be constructed of stainless steel or another suitable material.

In some embodiments, the flow control plug <NUM> may be configured to vent air, such as, for example, with a semi-permeable membrane, porous membrane, and/or micro grooves disposed within the flow control plug <NUM>, but may contain blood. An end cap <NUM> may be coupled to the proximal end of the flow control plug <NUM>. The end cap <NUM> may prevent venting of the flow control plug <NUM> when the end cap <NUM> is secured to the flow control plug <NUM>. The end cap <NUM> and/or proximal end of the flow control plug <NUM> may include a luer adapter, such as a slip or thread male or female luer adapter, or another suitable connector, which may facilitate coupling of the end cap <NUM> and the flow control plug <NUM>. In some embodiments, an extension tube may be coupled to the luer adapter.

A lumen may extend from a distal end of the catheter adapter <NUM> to a proximal end of the catheter adapter. A proximal end of the catheter adapter <NUM> may include a luer adapter, such as a slip or thread male or female luer adapter, or another suitable connector. A distal end of the needle hub <NUM> may include a connector configured to couple with the connector of the proximal end of the catheter adapter <NUM>. For example, the distal end of the needle hub <NUM> may include a luer adapter, such as a slip or thread male or female luer adapter, or another suitable connector.

Referring now to <FIG>, the catheter system <NUM> of <FIG> is illustrated in a position corresponding to after insertion of the catheter cannula <NUM> into the vein of the patient but prior to removal of the needle <NUM>. In this position, the wings <NUM> may be disposed in a downward position for securement to skin of the patient via an adhesive <NUM>. In some embodiments, the wings <NUM> include a first surface and a second surface. The second surface of the wings <NUM> may be configured to contact the skin of the patient when the wings are disposed in the downward position. The adhesive <NUM> may be applied to the second surface so that the wings <NUM> may be secured to the skin. The adhesive <NUM> may be an integrated tape strip. In some embodiments, the adhesive <NUM> may include a backing layer that is removable prior to securement of the wings to the skin of the patient. The catheter adapter <NUM> may include an upper surface and a lower surface. In some embodiments, the lower surface of the catheter adapter includes an adhesive <NUM> that secures the catheter adapter <NUM> to the skin of the patient. The adhesive <NUM>, <NUM> may avoid catheter dislodgement in case there is an unexpected movement by the patient.

Referring now to <FIG>, the upper surface of the catheter adapter <NUM> includes a push tab <NUM>. The push tab <NUM> may extend upwardly from the upper surface of the catheter adapter <NUM>. The push tab <NUM> may be distal to the housing <NUM> to be more accessible to the user. The push tab <NUM> is a first push tab and the catheter adapter <NUM> includes a second push tab <NUM> that extends upwardly from between the plurality of wings. The second push tab <NUM> may not extend as far as the first push tab <NUM> so that the second push tab <NUM> fits underneath the housing <NUM>. The first push tab <NUM> and/or the second push tab <NUM> may enable the clinician to control the catheter adapter <NUM> during removal and/or insertion.

Before insertion of the needle <NUM> and the catheter cannula <NUM> into the patient, the housing <NUM> may be removed. Upon removal, the first push tab <NUM> and/or the second push tab <NUM> may enable a clinician to withdraw the needle <NUM> after insertion into the vein of the patient. The first push tab <NUM> and/or the second push tab <NUM> may provide a surface or grip that a clinician uses to separate the needle hub <NUM> from the catheter adapter <NUM>. Further, the first push tab <NUM> and/or the second push tab <NUM> may enable the user to separate the needle hub <NUM> from the catheter adapter <NUM> with one hand.

Referring now to <FIG>, in some embodiments, the housing <NUM> may include a distal wall <NUM>, which may include a first arched gate <NUM>, and proximal wall <NUM> (illustrated, for example, in <FIG>), which may include a second arched gate <NUM>. The first arched gate <NUM> and the second arched gate <NUM> may each include a width that is slightly larger than a diameter of the catheter adapter <NUM>, such that the housing <NUM> may be pushed with a sliding fit over the catheter adapter <NUM>. The gates <NUM>, <NUM> may embrace the catheter adapter <NUM> ahead of and/or behind the wings <NUM>. Also, a height <NUM> of the housing <NUM> may be at least a same dimension as a length of wings <NUM>.

Referring now to <FIG>, in some embodiments, the wings <NUM> may be folded upwardly, and then the housing <NUM>, having an opening in at least a bottom portion, may be pushed with the sliding fit over the catheter adapter <NUM>, securing the wings <NUM> within the housing <NUM>. After or prior to the normal manipulations, i.e. vein puncture, positive insertion of the catheter tube <NUM> into the vein, and separation of the needle hub <NUM> from the catheter adapter <NUM>, have been carried out by means of the housing finger grip <NUM> and/or the thumb grip <NUM>, the housing <NUM> may be removed from the catheter adapter <NUM>, and the wings <NUM> may be unfolded and then fixed to skin of the patient.

Referring now to <FIG>, a wedge <NUM> is illustrated, according to some embodiments. The wedge <NUM> may secure the catheter cannula <NUM> within the catheter adapter <NUM>. The wedge <NUM> may be constructed of metal, plastic, or another suitable material.

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. It is to be understood that any of the embodiments of the present disclosure, or any portion(s) of any of the embodiments of the present disclosure, may be combined together in any number of different ways.

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. Thus, the claims following this Description Of Embodiments are hereby expressly incorporated into this Description Of Embodiments, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of the independent claims with their dependent claims.

Recitation in the claims of the term "first" with respect to a feature or element does not necessarily imply the existence of a second or additional such feature or element. Elements recited in means-plus-function format are intended to be construed in accordance with <NUM> U. §<NUM> Para. It will be apparent to those having skill in the art that changes may be made to the details of the above-described embodiments without departing from the underlying principles set forth herein.

Standard medical directions, planes of reference, and descriptive terminology are employed in this specification. For example, anterior means toward the front of the body. Posterior means toward the back of the body. Superior means toward the head. Inferior means toward the feet. Medial means toward the midline of the body. Lateral means away from the midline of the body. Axial means toward a central axis of the body. Abaxial means away from a central axis of the body. Ipsilateral means on the same side of the body. Contralateral means on the opposite side of the body. A sagittal plane divides a body into right and left portions. A midsagittal plane divides the body into bilaterally symmetric right and left halves. A coronal plane divides a body into anterior and posterior portions. A transverse plane divides a body into superior and inferior portions. These descriptive terms may be applied to an animate or inanimate body.

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.

While specific embodiments and applications of the present disclosure have been illustrated and described, it is to be understood that the scope of the appended claims is not limited to the precise configuration and components disclosed herein. Various modifications, changes, and variations which will be apparent to those skilled in the art may be made in the arrangement, operation, and details of the apparatus and systems disclosed herein.

Claim 1:
A pediatric catheter system, comprising:
a catheter adapter (<NUM>) having a distal end, a proximal end, and a lumen extending therebetween, wherein an outer surface of the lumen comprises an upper surface and a lower surface;
a plurality of wings extends outwardly from the catheter adapter, wherein the plurality of wings is configured to fold upwardly;
a housing (<NUM>), wherein the housing is disposed over the catheter adapter and secures the plurality of wings in an upward position, wherein the housing comprises a finger grip (<NUM>);
a catheter cannula (<NUM>) extending distally from the catheter adapter;
a needle hub (<NUM>) removably coupled to the proximal end of the catheter adapter and comprising a thumb grip (<NUM>); and
an introducer needle (<NUM>) extending through the catheter cannula, wherein a proximal end of the introducer needle is secured within the needle hub,
CHARACTERIZED IN THAT
the catheter adapter comprises a first push tab (<NUM>) distal to the plurality of wings, and a second push tab (<NUM>) extending upwardly from between the plurality of wings, wherein the first push tab is distal to the housing, and the second push tab is disposed within the housing and fits underneath the housing,
wherein a height of the thumb grip (<NUM>) is greater than a height of the first push tab (<NUM>), a height of the second push tab (<NUM>), and a height of the finger grip (<NUM>), and
wherein when the plurality of wings is in the upward position, a height of the plurality of wings is greater than the height of the second push tab.