Patent Description:
Often the male luer fitting and/or the female luer fitting are bulky and/or may have protruding, sharp edges that may irritate or damage skin of the patient, particularly when the patient is an elderly or neonate patient. In some instances, the sharp edges may result in pain or even infection. The bulkiness of the male luer fitting and/or the female luer fitting may also raise the catheter from the patient, which may increase a chance of accidental dislodgement of the catheter from the vasculature of the patient. Accordingly, there is a need for catheter systems and methods that stabilize the catheter within the vasculature of the patient and reduce a risk of skin damage.

<CIT> shows relevant background art for the present invention. In <CIT>, a medical device for delivery of a fluid to a patient from a line terminating in a tubing needle is described. The medical device of <CIT> includes a cannula assembly for coupling the fluid into a cannula that is inserted into the patient. The cannula assembly of <CIT> has a first locking element disposed in a fixed position with respect to the cannula. In <CIT>, coupling the line to the cannula assembly is an infusion flap. The infusion flap in <CIT> includes a second locking element for engaging the first locking element of the cannula assembly and a lift tab for disconnecting the infusion flap from the cannula assembly. In <CIT>, coupling of the first and second locking elements requires initial mating of the infusion flap and cannula assembly followed by locking through rotation of the infusion flap with respect to the cannula assembly.

The present disclosure may relate generally to devices, systems, and associated methods (such methods not being claimed) to stabilize a catheter inserted into vasculature of a patient and/or prevent irritation of skin of the patient by a catheter adapter coupled to the catheter or by a luer fitting. In some embodiments, a low-profile extension may be coupled to the catheter adapter, which may allow the catheter adapter to sit closer to the skin. If the catheter adapter is disposed close to the skin, an insertion depth of the catheter extending from the catheter adapter may increase, reducing a risk of dislodgement of the catheter and providing stability to the catheter. The extension may also allow remote manipulation of a luer connection, which may prevent disruption of an insertion site of the catheter.

According to the invention, the catheter adapter includes a proximal end, a distal end, and a lumen extending therebetween. The proximal end of the catheter adapter includes first and second slots and a proximal lumen opening. Furthermore, the distal end of the catheter adapter includes the catheter, which is configured to be inserted into the vasculature of the patient.

The extension includes a distal end, a proximal end, and a lumen extending therebetween. The distal end of the extension includes two cantilever arms and an insertion feature spaced apart from the cantilever arms. The insertion feature is configured to insert into the lumen of the catheter adapter to provide a fluid connection between the catheter adapter and the extension. Each of the cantilever arms is configured to engage in a snap-fit with the catheter adapter.

In further detail, the cantilever arms are configured to insert into the slots to engage in a snap-fit with the catheter adapter. Distal ends of each of the cantilever arms include a hook. Each of the cantilever arms deflects as the hook of the corresponding cantilever arm is inserted into a corresponding slot of the catheter adapter. As the hook reaches a groove proximate the slot, the cantilever arm returns to an original shape of the cantilever arm prior to insertion into the slot.

In some embodiments, the insertion feature may be spaced apart from the cantilever arms by separator elements that may extend outwardly with respect to a longitudinal axis of the extension. According to the invention, the cantilever arms include a first cantilever arm and a second cantilever arm. In some embodiments, the first cantilever arm may oppose the second cantilever arm.

In some embodiments, the proximal end of the extension may be configured to be coupled to a male luer fitting or another connector. For example, the proximal end of the extension may include a female luer fitting.

In some embodiments, the extension may include an elongated tubular element, which may be disposed between the distal end and the proximal end. In some embodiments, the extension may include a grip portion, which may be disposed between the distal and proximal ends of the extension. In some embodiments, the grip portion may include one or more wings and/or one or more protrusions. In some embodiments, the grip portion may be disposed proximal to the tubular element.

In some embodiments, the catheter adapter may include a stabilization platform. In some embodiments, the slots may be disposed within the stabilization platform. In some embodiments, a width of each of the separator elements may be approximately equal to a width of the stabilization platform, which may prevent formation of any protruding edges when the extension is secured to the catheter adapter. Protruding edges could contact the skin of the patient and cause irritation.

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

It will be readily understood that the components of the present invention, as generally described and illustrated in the Figures in the present disclosure, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of the embodiments, represented in <FIG>, is not intended to limit the scope of the invention, as claimed, but is merely representative of some embodiments of the invention.

<FIG> illustrates a catheter assembly <NUM> in accordance with one or more embodiments. According to the invention, the catheter assembly <NUM> includes a catheter adapter <NUM> configured to be selectively coupled to a needle shield <NUM>. A catheter <NUM> extends distally from the catheter adapter <NUM>, and a proximal end of the catheter <NUM> is secured within the catheter adapter <NUM>. In some embodiments, the needle shield <NUM> may include a needle hub (not illustrated), which may secure a proximal end of an introducer needle <NUM>. In some embodiments, when the needle <NUM> is ready to be inserted into vasculature of the patient, the needle <NUM> may extend through the catheter <NUM> and beyond a tip of the catheter <NUM>, as illustrated in <FIG>.

In some embodiments, once the needle <NUM> has been used to insert the catheter <NUM> into the vasculature of a patient, the needle hub may be retracted into the needle shield <NUM> such that the needle <NUM> is fully contained within the needle shield <NUM>. When the needle <NUM> is retracted into the needle shield <NUM>, a blood control septum disposed within a lumen of the catheter adapter will close to prevent blood leakage. In some embodiments, the needle shield <NUM> may be uncoupled from the catheter adapter <NUM> in response to the catheter <NUM> being inserted into the vasculature of the patient and/or the needle <NUM> being retracted into the needle shield <NUM>. Generally, a male luer fitting may then be coupled to the catheter adapter <NUM>, and fluid may be infused into the vasculature of the patient via the catheter <NUM>. According to the invention, an extension is configured to be coupled with the proximal end of the catheter adapter. The male luer fitting may be coupled to a proximal end of the extension, as will be described in further detail. In these embodiments, the fluid may be infused into the vasculature of the patient via a fluid pathway that includes the extension.

The catheter assembly <NUM> may include any suitable type of catheter assembly. In some embodiments, the catheter assembly <NUM> may include an intravenous (IV) catheter assembly. As an example, the catheter assembly <NUM> may include one or more features of the BD INSYTE™ AUTOGUARD™ Shield IV Catheter, and the needle shield <NUM> may be spring loaded. As another example, the catheter assembly <NUM> may include one or more features of the BD NEXIVA™ DIFFUSICS™ Closed IV Catheter System. Suitable materials for the catheter adapter <NUM> and/or the extension <NUM> may include, but are not limited to, thermoplastic polymeric resins such as polycarbonate, polystyrene, polypropylene, polyethylene terephthalate glycol (PETG), and the like.

Referring now to <FIG>, in some embodiments, the extension <NUM> may include an elongated body. In some embodiments, a distal end of the extension <NUM> may include a connector element <NUM>. According to the invention, the extension includes an insertion feature <NUM> and two cantilever arms <NUM> spaced apart from the insertion feature <NUM>. In some embodiments, the cantilever arms <NUM> may be disposed generally parallel to the insertion feature <NUM>. In some embodiments, the cantilever arms <NUM> may extend in a distal direction. In some embodiments, the cantilever arms <NUM> may be spaced apart from the insertion feature <NUM> by outwardly-extending separator elements <NUM>. In some embodiments, the insertion feature <NUM> may be aligned with a longitudinal axis of the extension <NUM>.

In some embodiments, the first cantilever arm <NUM> and the second cantilever arm <NUM> may be aligned on opposite sides of the extension <NUM>, as illustrated in <FIG>. In some embodiments, the connector element <NUM> may include an annular cantilever arm <NUM>, which may surround the insertion feature <NUM>.

In some embodiments, the proximal end of the extension <NUM> may be configured to connect to another device. In some embodiments, the proximal end of the extension may include a female luer fitting <NUM>. In some embodiments, the proximal end of the extension <NUM> may include one or more threads for connection to the male luer fitting or another connector.

In some embodiments, the extension <NUM> may include a grip portion <NUM>, which may facilitate insertion of the extension <NUM> into the catheter adapter <NUM> by a user. In some embodiments, the grip portion <NUM> may include one or more wings <NUM> and/or protrusions <NUM>.

Referring now to <FIG>, according to the invention, the cantilever arms <NUM> engage in a snap-fit with the catheter adapter <NUM>. In further detail, each of the cantilever arms <NUM> includes a distal end that includes a hook <NUM>. Each of the cantilever arms <NUM> deflects as the hook <NUM> of the corresponding cantilever arm <NUM> is inserted into a corresponding slot <NUM> of the catheter adapter <NUM>. As the hook <NUM> reaches a groove <NUM> proximate the slot <NUM>, the cantilever arm <NUM> returns to an original shape of the cantilever arm <NUM> prior to insertion into the slot <NUM>. The insertion feature <NUM> is sized and configured to insert into the lumen <NUM> of the catheter adapter <NUM> and open the blood control septum <NUM> when the cantilever arms <NUM> engage in the snap-fit with the catheter adapter <NUM>. Thus, in some embodiments, the insertion feature <NUM> may include an actuator.

In some embodiments, once the connector element <NUM> is secured in the catheter adapter <NUM> via the snap-fit, a connection between the extension <NUM> and the catheter adapter <NUM> may be permanent, decreasing a risk of the user to blood exposure. In further detail, it may be difficult for the user to remove the extension <NUM> from the catheter adapter <NUM> without a tool once the connector element <NUM> is secured in the catheter adapter <NUM> in the snap-fit. In some embodiments, the grooves <NUM> may include an adhesive <NUM>, which may increase a strength of the connection between the extension <NUM> and the catheter adapter <NUM>.

In some embodiments, the catheter adapter <NUM> may include a stabilization platform <NUM>. In some embodiments, the stabilization platform <NUM> may include one or more wings, which may extend outwardly from a body of the catheter adapter <NUM>. In some embodiments, the slots <NUM> may be disposed within the stabilization platform <NUM>. In some embodiments, a first slot <NUM> corresponding to a first cantilever arm <NUM> may be disposed on a first side of the stabilization platform <NUM>, and a second slot <NUM> corresponding to a second cantilever arm <NUM> may be disposed on a second side of the stabilization platform <NUM>. In some embodiments, the slots <NUM> may be generally parallel to a longitudinal axis <NUM> of the catheter adapter <NUM> and the extension <NUM>. In some embodiments, the slots <NUM> may be spaced apart from the lumen <NUM> of the catheter adapter <NUM>.

In some embodiments, the extension <NUM> may include a lumen <NUM> extending therethrough. In further detail, the lumen <NUM> of the extension <NUM> may extend through the insertion feature <NUM> of the distal end of the extension <NUM> to a proximal end of the extension <NUM>. The extension <NUM> may be integrally formed or include separate components. In some embodiments, the connector element <NUM> may be coupled with a tubular element <NUM> of the extension <NUM>. In other embodiments, the tubular element <NUM> and the connector element <NUM> may be integrally formed. In some embodiments, the tubular element <NUM> may have a uniform inner diameter, which may be greater than an inner diameter of the insertion feature <NUM>.

Referring now to <FIG>, in some embodiments, a shape of the stabilization platform <NUM> may be generally planar or flat, which may allow the stabilization platform <NUM> to have a low-profile. In some embodiments, a distal end of the stabilization platform <NUM> may include a gradual taper. In some embodiments, the stabilization platform <NUM> may include a push tab <NUM> disposed on an upper surface of the stabilization platform <NUM>. In some embodiments, the push tab <NUM> may be integrally molded from a same material as the stabilization platform <NUM>. In some embodiments, the upper surface of the stabilization platform <NUM> may be smooth except for the push tab <NUM>. In some embodiments, a bottom surface of the stabilization platform <NUM>, or a surface of the stabilization platform <NUM> closest to skin of the patient, may be smooth. In some embodiments, the catheter adapter <NUM> and/or the extension <NUM> may be free of protruding edges that may irritate the skin of the patient.

In some embodiments, the separator elements <NUM> may complete a geometric shape of the catheter adapter <NUM> when the connector element <NUM> is secured to the catheter adapter <NUM>. In these and other embodiments, a width of the separator elements <NUM> may be approximately equal to a width of the catheter adapter <NUM> such that the separator elements <NUM> do not protrude above or below the catheter adapter <NUM> and irritate the skin of the patient, as illustrated in <FIG>.

In some embodiments, the stabilization platform <NUM> may support one or more digits of the user as the user inserts the catheter <NUM> at the insertion site, hoods the needle <NUM>, or moves the catheter assembly <NUM> from an insertion configuration to a fluid delivery configuration. In some embodiments, the user may pinch or grip the stabilization platform <NUM>, which may extend outwardly from the longitudinal axis <NUM>.

The securement platform <NUM> may optionally be "soft," i.e., formed of a relatively compliant material that conforms easily to the skin of the patient. In some embodiments, the securement platform <NUM> may be formed of a soft plastic, an elastomer such as silicone rubber, and/or the like.

As illustrated in <FIG>, a conventional catheter adapter <NUM> may be directly connected to the male luer fitting <NUM>, which may increase a gap or distance between the catheter adapter <NUM> and the skin <NUM> of the patient due to threading between the catheter adapter <NUM> and the male luer fitting <NUM>. The male luer fitting <NUM> directly connected to the conventional catheter adapter <NUM> may also increase an angle of the catheter adapter <NUM> with respect to the skin <NUM>.

As illustrated in <FIG>, in some embodiments, the extension <NUM> may be secured to the catheter adapter <NUM> without any turning or twisting, which may allow the catheter adapter <NUM> and the extension <NUM> to maintain a low-profile. Thus, the catheter adapter <NUM> may sit closer to the skin <NUM> than the conventional catheter adapter <NUM>, maximizing a catheter insertion depth and stability of the catheter <NUM>. Also, a side of the catheter adapter <NUM> may be allowed to contact the skin <NUM>, further increasing the stability of the catheter <NUM>. In these and other embodiments, an outer diameter of the catheter adapter <NUM> may be decreased or tapered at a tip or nose of the catheter adapter <NUM> compared to the conventional catheter adapter <NUM>, which may allow the catheter adapter <NUM> to maintain a low-profile.

In some embodiments, the male luer fitting <NUM> may include one or more protruding sharp edges, which may more easily contact the skin <NUM> in absence of the extension <NUM>, as illustrated in <FIG>. Advantageously, in some embodiments, the extension <NUM> may allow for remote manipulation of the male luer fitting <NUM> and luer connection, which may reduce a risk of disturbing an insertion site of the catheter <NUM>.

Referring now to <FIG>, in some embodiments, these not forming part of the claimed invention, the catheter adapter <NUM> may not include the blood control septum <NUM>, such as, for example, in neonatal applications. In some embodiments, a conical seal may be relied upon to provide blood control. In further detail, in some embodiments, a male conical surface of the insertion feature <NUM> may wedge into or be engaged in an interference fit with a female conical surface of the catheter adapter <NUM>. In these and other embodiments, an outer diameter of the insertion feature <NUM> and an inner diameter of the catheter adapter <NUM> may be approximately the same.

Referring now to <FIG>, in some embodiments, the proximal end of the catheter adapter <NUM> may include a connector, such as, for example, a female luer-type fitting <NUM>. In some embodiments, the proximal end of the extension <NUM> may include another female luer-type fitting. In some embodiments, the female luer-type fitting <NUM> and the other female luer-type fitting may be a same or similar size. In some embodiments, the other female luer-type fitting may include the female luer fitting <NUM>. In some embodiments, the female luer-type fitting <NUM> of the catheter adapter <NUM> may have a reduced size compared to the female luer fitting <NUM> of the proximal end of the extension <NUM>. In further detail, in some embodiments, a proximal end and/or threads <NUM> of the female luer-type fitting <NUM> may have a reduced diameter compared to a proximal end and/or threads <NUM> of the female luer fitting <NUM>. Thus, in some embodiments, a corresponding male luer-type fitting <NUM> of the distal end of the extension <NUM> may be reduced in size compared to the male luer fitting <NUM>, allowing the catheter adapter <NUM> and the extension <NUM> to maintain a low-profile. The low-profile of the catheter adapter <NUM> and/or the extension <NUM> may allow the catheter adapter <NUM> to sit close to the skin <NUM>, which may increase an catheter insertion depth and stability of the catheter <NUM>. In these and other embodiments, a side of the catheter adapter <NUM> may contact the skin <NUM>, increasing the stability of the catheter <NUM>.

In some embodiments, the male luer fitting <NUM> and/or the female luer fitting <NUM> may correspond to International Organization for Standardization ("ISO") <NUM>-<NUM>. In some embodiments, a cross-sectional diameter at a distal end of a tip of the male luer fitting <NUM> may be between about <NUM> inches (<NUM>) and about <NUM> inches (<NUM>). In some embodiments, an inner cross-sectional diameter at an open proximal end of the female luer fitting <NUM> may be between about <NUM> inches (<NUM>) and about. <NUM> inches (<NUM>).

In some embodiments, the male luer-type fitting <NUM> and/or the female luer-type fitting <NUM> may be smaller than ISO <NUM>-<NUM>. In some embodiments, a cross-sectional diameter at a distal end of a tip of the male luer-type fitting <NUM> may be less than about <NUM> inches (<NUM>) for rigid material and less than about <NUM> inches (<NUM>) for semi-rigid material. In some embodiments, an inner cross-sectional diameter at an open proximal end of the female luer-type fitting <NUM> may be less than about <NUM> inches (<NUM>).

In some embodiments, the male luer-type fitting <NUM>, the female luer-type fitting <NUM>, and/or the tubular element <NUM> may be sized to reduce a priming volume for sensitive applications such as infusion for neonates. In these and other embodiments, the male luer-type fitting <NUM> and the female luer-type fitting <NUM> may be sized smaller than International Organization for Standardization ("ISO") <NUM>-<NUM>, and a size of the tubular element <NUM> may correspond to the male luer-type fitting <NUM>. For example, a portion of the lumen <NUM> of the extension <NUM> that extends through the male luer-type fitting <NUM> and the tubular element <NUM> may have a generally uniform diameter.

Claim 1:
A catheter system (<NUM>), comprising:
a catheter adapter (<NUM>), comprising a proximal end, a distal end, and a lumen (<NUM>) extending therebetween, wherein the proximal end comprises a first slot (<NUM>), a second slot (<NUM>), and a proximal lumen opening, the lumen comprises a septum (<NUM>), the distal end comprises a catheter (<NUM>) configured to be inserted into vasculature of a patient, and the catheter adapter is configured to be selectively coupled with a distal end of a needle shield (<NUM>); and
an extension (<NUM>), comprising a distal end, a proximal end, and a lumen (<NUM>) extending therebetween, the distal end comprising:
a first cantilever arm (<NUM>) having a distal end comprising a hook (<NUM>);
a second cantilever arm (<NUM>) having a distal end comprising a hook (<NUM>); and
an insertion feature (<NUM>) positioned between and spaced apart from the first and second cantilever arms,
wherein the insertion feature is configured to insert into the proximal lumen opening of the catheter adapter to open the septum and provide a fluid connection between the catheter adapter and the extension, and
wherein the first cantilever arm and the second cantilever arm are configured to insert within the first and second slots, respectively, whereby the distal ends of each of the first and second cantilever arms deflect outwardly as the hook of the corresponding cantilever arm is inserted into the corresponding slot, and, upon further insertion, the hook of the distal end of each of the first and second cantilever arms reaches and engages a groove (<NUM>) in a snap-fit connection, whereby the first and second cantilever arms return to an original shape.