Patent Description:
Intravascular (IV) catheters may be used to infuse fluids into the vascular system of a patient, such as saline solution, various medicaments, total parenteral nutrition, etc. IV catheters may also be used to withdraw blood from the patient or to monitor various parameters of the patient's vascular system.

Peripheral IV catheters may be relatively short (typically on the order of about two inches or less in length). The most common type of IV catheter is an over-the-needle peripheral IV catheter. As its name implies, an over-the-needle IV catheter is mounted over an introducer needle having a sharp distal tip. At least the distal portion of the catheter tightly engages the outer surface of the needle to prevent "peel-back" of the catheter and thus facilitates insertion of the catheter into the blood vessel. The distal tip of the introducer needle may extend beyond the distal tip of the catheter with the bevel of the needle facing up away from the patient's skin.

The catheter and introducer needle assembly may be inserted at a shallow angle through the patient's skin into a blood vessel. There are many techniques for inserting such a catheter and introducer needle assembly into a patient. In one insertion technique, the introducer needle and catheter are inserted completely into the blood vessel together. In another technique, the introducer needle is partially withdrawn into the catheter after the initial insertion into the blood vessel. The catheter is then threaded over the needle and inserted completely into the blood vessel.

In order to verify proper placement of the catheter in the blood vessel, the clinician may confirm that there is flashback of blood in a flashback chamber. The flashback chamber is typically formed as part of a needle component or needle hub. Alternatively, the introducer needle could include a notch or opening formed along a distal portion thereof so that the blood flashback can be observed in the annular space between the introducer needle and the catheter when the catheter is transparent or at least translucent. The clinician may then withdraw the introducer needle, leaving the catheter in place, and/or attach an appropriate device to the catheter. Such a device can include a fluid delivery device, a PRN, a deadender cap, a blood pressure monitoring probe, etc..

One common method of administering fluids into a patient's blood flow is through an intravenous delivery system. Intravenous delivery systems may include a liquid source such as a liquid bag, a drip chamber used to determine the flow rate of fluid from the liquid bag, tubing for providing a connection between the liquid bag and the patient, and an intravenous access unit, such as a catheter, that is positioned intravenously in the patient. The catheter may include a catheter adapter with one or more connectors or ports that are configured to allow "piggybacking" of intravenous delivery systems which may be used to administer medicine, among other functions.

Although typical IV catheter and introducer needle assemblies generally perform their functions satisfactorily, they do have certain drawbacks. For example, the procedure for properly placing a catheter into a patient's blood vessel can result in a significant amount of blood leakage from the catheter between the initial venipuncture and the time that an appropriate device is connected to the catheter. This blood leakage is problematic because of potential contamination to a clinician from an infected patient. This is especially worrisome because of diseases such as Acquired Immune Deficiency Syndrome ("AIDS") which can be transmitted by the exchange of body fluids from an infected person to another person.

In order to minimize blood leakage, a self-sealing septum may be placed in the proximal end of the catheter adapter. The septum allows the introducer needle to extend through the septum and the catheter to allow the catheter to be placed into a patient's blood vessel. In addition, the septum allows the clinician to withdraw the introducer needle from the catheter and the septum, which then closes after the introducer needle has been completely withdrawn from the catheter hub. This arrangement may minimize blood leakage from the catheter adapter. The use of a septum may significantly increase the force that the clinician needs to exert on the introducer needle in order to withdraw the introducer needle from the catheter. Additionally, if the introducer needle is located in the septum for extended periods of time, the septum may take a compression set about the introducer needle preventing the septum from completely sealing once the introducer needle is withdrawn from the septum.

Once the catheter has been placed in a patients' vein, and the introducer needle has been removed, the clinician will typically secure the catheter adapter body to the patient's skin to prevent accidental removal of the catheter from the patient's vein. However, catheter different materials may be more expensive and difficult to manufacture because of their complexity. Accordingly, there is a need for soft body catheter adapters that better conform to the patient's body, improve patient comfort, and can be more securely affixed to the patient. Moreover, soft body catheter adapters may achieve a reduced cost of manufacture because they may be substantially molded from a single compliant material in an integral fashion, thus reducing the number and/or amount of different materials that may be needed during the manufacturing process.

<CIT> discloses a percutaneous access device for aseptically introducing catheters into the body.

<CIT> discloses a one-piece low drag septum for preventing escape of fluid from an introducer needle during removal of the needle from a catheter and introducer assembly.

The invention is defined by independent claim <NUM> and subsequent dependent claims <NUM> - <NUM>.

In some embodiments, a compliant catheter adapter may include a catheter adapter body formed of a compliant material. For example, some embodiments of the present invention comprise a compliant material having a durometer hardness of from approximately <NUM> Shore A to approximately <NUM> Shore D. In some embodiments, a compliant material comprises a durometer hardness of from approximately <NUM> Shore A to approximately <NUM> Shore D. The catheter adapter body may have a proximal end, a distal end, and a generally elongate shape formed about a longitudinal axis extending between the proximal end and the distal end of the catheter adapter body. The catheter adapter body may also have an inner chamber with a generally elongate shape formed about the longitudinal axis. The catheter adapter body may further include a compression resistant septum that is formed in the compliant material of the catheter adapter body and disposed toward the proximal end of the catheter adapter body. The compression resistant septum may also have a lumen that is configured to receive an elongate object. The compression resistant septum may be further coupled to a compression cap that imparts a compression force on the compression resistant septum such that the lumen narrows and seals when the elongate object is removed from the lumen. In some instances, the compression force comprises radial and axial compression forces.

In other embodiments, a compliant catheter adapter may include a catheter adapter body formed of a compliant material. The catheter adapter body may have a proximal end, a distal end, and a generally elongate shape formed about a longitudinal axis extending between the proximal end and the distal end of the catheter adapter body. The catheter adapter body may also have an inner chamber with a generally elongate shape formed about the longitudinal axis. The catheter adapter body may further include a first compression resistant septum abutted against a second compression resistant septum. The first compression resistant septum may have a first lumen, and the second compression resistant septum may have a second lumen, both of which are configured to receive an elongate object. The first and second compression resistant septa may be further coupled to a compression cap that imparts a
compression force on the first and second compression resistant septa such that the first and second lumens narrow and seal when the elongate object is removed from the first and second lumens. In some instances, the compression force comprises radial and axial compression forces.

In yet other embodiments, a catheter system may include a needle component having a needle hub, a needle coupled to the needle hub, and a grip coupled to the needle hub. The catheter system may also include a compliant catheter adapter having a catheter adapter body formed of a compliant material. The catheter adapter body may have a proximal end, a distal end, and a generally elongate shape formed about a longitudinal axis extending between the proximal end and the distal end of the catheter adapter body. The catheter adapter body may also have an inner chamber with a generally elongate shape formed about the longitudinal axis. The catheter adapter body may further include a compression resistant septum that is formed in the compliant material of the catheter adapter body and disposed toward the proximal end of the catheter adapter body. The compression resistant septum may also have a lumen that is configured to receive an elongate object. The compression resistant septum may be further coupled to a compression cap that imparts a compression force on the compression resistant septum such that the lumen narrows and seals when the elongate object is removed from the lumen. In some instances, the compression force comprises radial and axial compression forces.

These and other features and advantages of the present disclosure may be incorporated into certain embodiments and will become more fully apparent from the following description and appended claims, or may be learned by the practice of the present disclosure as set forth hereinafter. The present disclosure does not require that all the advantageous features and all the advantages described herein be incorporated into every embodiment.

Exemplary embodiments of the present disclosure will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. Understanding that these drawings depict only exemplary embodiments and are therefore not to be considered limiting of the disclosure's scope, the exemplary embodiments of the present disclosure will be described with additional specificity and detail through use of the accompanying drawings in which:.

The presently preferred embodiments of the present disclosure may be understood by reference to the drawings, wherein like parts may be 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, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description is not intended to limit the scope of the present disclosure as claimed, but is merely representative of presently preferred embodiments.

Moreover, the Figures may show simplified or partial views, and the dimensions of elements in the Figures may be exaggerated or otherwise not in proportion for clarity. In addition, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to a terminal includes reference to one or more terminals. In addition, where reference is made to a list of elements (e.g., elements a, b, c), such reference is intended to include any one of the listed elements by itself, any combination of less than all of the listed elements, and/or a combination of all of the listed elements.

The term "substantially" means that the recited characteristic, parameter, or value need not be achieved exactly, but that deviations or variations, including for example, tolerances, measurement error, measurement accuracy limitations and other factors known to those of skill in the art, may occur in amounts that do not preclude the effect the characteristic was intended to provide.

As used herein, the term "proximal", "top", "up" or "upwardly" refers to a location on the device that is closest to the clinician using the device and farthest from the patient in connection with whom the device is used when the device is used in its normal operation. Conversely, the term "distal", "bottom", "down" or "downwardly" refers to a location on the device that is farthest from the clinician using the device and closest to the patient in connection with whom the device is used when the device is used in its normal operation.

As used herein, the term "in" or "inwardly" refers to a location with respect to the device that, during normal use, is toward the inside of the device. Conversely, as used herein, the term "out" or "outwardly" refers to a location with respect to the device that, during normal use, is toward the outside of the device.

The phrases "connected to," "coupled to," 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.

<FIG> illustrate various isometric views of an IV catheter set <NUM>, according to one embodiment of the present disclosure. The IV catheter set <NUM> may generally include a compliant catheter adapter <NUM>, a needle component <NUM>, an extension tube <NUM>, a slide clamp <NUM>, and an infusion set <NUM>. <FIG> shows the IV catheter set <NUM> with the needle component <NUM> removed from the compliant catheter adapter <NUM>. <FIG> shows the IV catheter set <NUM> with the needle component <NUM> partially inserted into the compliant catheter adapter <NUM> and <FIG> shows the IV catheter set <NUM> with the needle component <NUM> fully inserted into the compliant catheter adapter <NUM>.

The compliant catheter adapter <NUM> may include a catheter adapter body <NUM> formed of a compliant material. A compliant material generally comprises a soft, flexible polymer material that may be comfortable against the skin of a patient. For example, some embodiments of the present invention comprise a compliant material having a durometer hardness of from approximately <NUM> Shore A to approximately <NUM> Shore D. In some embodiments, a compliant material comprises a durometer hardness of from approximately <NUM> Shore A to approximately <NUM> Shore D. The catheter adapter body <NUM> may be integrally formed from a compression set resistant elastomeric material including, but not limited to: a thermoplastic elastomer material, a liquid silicone rubber material, a polyisoprene material, and the like. In at least some embodiments, the catheter adapter body <NUM> may be substantially formed from a single compression set resistant elastomeric material. The compliant catheter adapter <NUM> may also include a compression cap <NUM>, one or more stabilization members <NUM>, and a catheter lumen <NUM>, as will be discussed in more detail below.

The compliant catheter adapter <NUM> may include a feature that allows the compliant catheter adapter <NUM> to be coupled to an extension tube <NUM>. The extension tube <NUM> may pass through a slide clamp <NUM> and couple to an infusion set <NUM>. The infusion set <NUM> may include one or more connectors or injection ports that allow intravenous fluid communication with the patient, as generally known in the art.

The needle component <NUM> may include a needle hub <NUM>, a grip <NUM> coupled to the needle hub <NUM>, and an elongate object coupled to the needle hub <NUM> (such as a needle <NUM>). The needle component <NUM> may be used to facilitate insertion of the catheter lumen <NUM> into a vein of a patient (not shown). The embodiment shown in <FIG> illustrates a grip <NUM> having a paddle-like shape or style. However, in other embodiments the grip <NUM> may include any number of suitable shapes and styles including but not limited to: paddle grips, straight grips, ported grips, etc. For example, <FIG>, <FIG>, and <FIG> illustrate various examples of grips having different shapes and styles. Likewise, the needle hub <NUM> may also include any number of suitable shapes and styles.

<FIG> and <FIG> illustrate various views of a catheter system <NUM> and a compliant catheter adapter <NUM>, according to another embodiment of the present disclosure. <FIG> illustrate a compression cap <NUM> that may be used with the compliant catheter adapter <NUM>. <FIG> shows a needle component <NUM> removed from the compliant catheter adapter <NUM> and <FIG> show the needle component <NUM> fully inserted into the compliant catheter adapter <NUM>. <FIG> also shows the compliant catheter adapter <NUM> without the needle component <NUM>. The needle component <NUM> may include a needle hub <NUM>, a grip <NUM> coupled to the needle hub <NUM>, and an elongate object, such as a needle <NUM>, coupled to the needle hub <NUM>. The needle component <NUM> embodiment shown in <FIG> and <FIG> illustrates a grip <NUM> having a paddle shape.

Continuing with <FIG> collectively, the inventive compliant catheter adapter <NUM> includes a catheter adapter body <NUM> formed of a compliant material. The catheter adapter body <NUM> is integrally formed from a compression set resistant elastomeric material such as a thermoplastic elastomer, a liquid silicone rubber, and a polyisoprene. The catheter adapter body <NUM> is formed from a single compression set resistant elastomeric material. The inventive catheter adapter body <NUM> is integrally manufactured from a compliant material to form an inner chamber <NUM>, a port <NUM>, a compression resistant septum <NUM> with a lumen <NUM> extending there through, a catheter wedge <NUM>, and one or more stabilization members <NUM>. The catheter adapter body <NUM> may also be coupled to any number of non-integral components including, but not limited to: a compression cap <NUM>, a catheter lumen <NUM>, and an extension tube <NUM>.

The catheter adapter body <NUM> may have a proximal end <NUM> and a distal end <NUM>. The catheter adapter body <NUM> may have a generally elongate shape formed about a longitudinal axis of the catheter adapter body <NUM> (not shown) extending between the proximal end <NUM> and the distal end <NUM> of the catheter adapter body <NUM>. The inner chamber <NUM> may be disposed within the catheter adapter body <NUM> and also have a generally elongate shape formed about the longitudinal axis of the catheter adapter body <NUM>. The inner chamber <NUM> may be in fluid communication with the catheter lumen <NUM>. The inner chamber <NUM> may also include a catheter wedge <NUM>, which may be integrally formed with the inner chamber <NUM>, or may be separately formed from the inner chamber <NUM> and then coupled to the inner chamber <NUM>. The catheter wedge <NUM> may be disposed toward the distal end <NUM> of the catheter adapter body <NUM> and configured to guide an elongate object into the catheter lumen <NUM> as the elongate object is inserted through the catheter adapter body <NUM>. For example, the catheter wedge <NUM> may facilitate and/or guide insertion of the needle <NUM> into the catheter lumen <NUM>.

The port <NUM> may be in fluid communication with the inner chamber <NUM> and configured to receive an extension tube <NUM>. The port <NUM> shown in <FIG> and <FIG> has a portion that is generally forms a Y-shape in relation to the inner chamber <NUM> and another portion that generally runs parallel to the inner chamber <NUM>. However, it is understood that the port <NUM> can be any suitable shape and size including, but not limited to: a Y-shaped port, a T-shaped port, a V-shaped port, a parallel-shaped port, etc..

The one or more stabilization members <NUM> may be coupled to the catheter adapter body <NUM> and configured to stabilize the catheter adapter body <NUM> with respect to a patient (not shown). In at least one embodiment, the one or more stabilization members <NUM> may be integrally formed with the catheter adapter body <NUM> such that they are formed from the same compliant material as the catheter adapter body <NUM>. This may allow the catheter adapter body <NUM> to better conform to the patient's body, improve patient comfort, and improve fixation of the catheter adapter body <NUM> to the patient after the catheter lumen <NUM> has been inserted.

The compression resistant septum <NUM> may be integrally formed in the compliant material of the catheter adapter body <NUM> and disposed toward the proximal end <NUM> of the catheter adapter body <NUM>. The compression resistant septum <NUM> may include a lumen <NUM> that is formed through the compression resistant septum <NUM> and configured to receive an elongate object therein, such as the needle <NUM>. In at least one embodiment, the compression resistant septum <NUM> may be integrally formed of the same compression set resistant elastomeric material as the catheter adapter body <NUM>.

The compression cap <NUM> may be coupled to the compression resistant septum <NUM> and the compression cap <NUM> may be configured to impart a compression force to the compression resistant septum <NUM>, such that the lumen <NUM> of the compression resistant septum <NUM> narrows and seals when the elongate object is removed from the lumen <NUM>. In some embodiments, the compression force comprises radial and axial compression forces. In at least one embodiment, the compression cap <NUM> may have a generally cylindrical shape. However, it will be understood that the compression cap <NUM> may include any number of suitable shapes that are configured to impart radial and axial compression forces. The compression cap <NUM> may have a proximal end <NUM> and a distal end <NUM>. The proximal end <NUM> may have a first aperture <NUM> formed therein and configured to receive the elongate object there through. The distal end <NUM> may have a second aperture <NUM> configured to receive at least a portion of the catheter adapter body <NUM> and/or at least a portion of the compression resistant septum <NUM>. The compression cap <NUM> may also include a compression surface <NUM> that extends intermediate the proximal end <NUM> and the distal end <NUM> of the compression cap <NUM>. The compression surface <NUM> may enclose a hollow portion <NUM> formed in the compression cap <NUM>. The hollow portion <NUM> may be configured to receive at least a portion of the compression resistant septum <NUM> therein, and the compression surface <NUM> may be configured to impart the radial and axial compression forces to the compression resistant septum <NUM>, such that the lumen <NUM> of the compression resistant septum <NUM> narrows and seals when the elongate object is removed from the lumen <NUM>. In at least one embodiment, the compression cap <NUM> is a separate piece that may be coupled to the compression resistant septum <NUM>. However, in other embodiments the compression cap <NUM> may be integrally formed with the compression resistant septum <NUM>. In yet other embodiments, the compression cap <NUM> may be coupled to the compression resistant septum <NUM> through an over-molding manufacturing process.

<FIG> shows a cross-sectional side view of a compliant catheter adapter <NUM>, according to another embodiment of the present disclosure. The compliant catheter adapter <NUM> may include similar features to the compliant catheter adapter <NUM> of <FIG> and 3C, such as: a catheter adapter body <NUM> having a proximal end <NUM> and a distal end <NUM>, a catheter lumen <NUM>, a compression cap <NUM>, one or more one or more stabilization members <NUM>, an extension tube <NUM>, an inner chamber <NUM>, a port <NUM>, and a catheter wedge <NUM>. However, the compliant catheter adapter <NUM> may also include additional features, such as: a first compression resistant septum <NUM>, a second compression resistant septum <NUM>, a septum chamber <NUM> intermediate the first compression resistant septum <NUM> and the second compression resistant septum <NUM>, a first lumen <NUM>, and a second lumen <NUM>.

The first compression resistant septum <NUM> may be positioned to abut at least a portion of the proximal end <NUM> of the catheter adapter body <NUM> and/or the second compression resistant septum <NUM>. The first lumen <NUM> may be configured to receive an elongate object. The second compression resistant septum <NUM> may include a second lumen <NUM> formed there through which may also be configured to receive the elongate object. In at least some embodiments, the second compression resistant septum <NUM> may be disposed within the inner chamber <NUM> of the catheter adapter body <NUM>. The second compression resistant septum <NUM> may be positioned to abut the first compression resistant septum <NUM> and the septum chamber <NUM> may be formed between the first compression resistant septum <NUM> and the second compression resistant septum <NUM>. The compression cap <NUM> may be configured to couple the first compression resistant septum <NUM> to the catheter adapter body <NUM> and/or the second compression resistant septum <NUM>. The compression cap <NUM> may also be configured to impart radial and axial compression forces to the first compression resistant septum <NUM> and/or the second compression resistant septum <NUM> such that the first lumen <NUM> and the second lumen <NUM> narrow and seal when the elongate object is removed from the first lumen <NUM> and the second lumen <NUM>. This configuration may provide additional sealing capabilities and thus, additional safety.

<FIG> illustrate various views of a catheter system <NUM>, according to another embodiment of the present disclosure. <FIG> show the catheter system <NUM> with a needle component <NUM> in various positions relative to a compliant catheter adapter <NUM> and <FIG> shows a cross-sectional view of the catheter system <NUM> of <FIG>. The catheter system <NUM> may include similar features to other catheter system described herein, such as: a catheter adapter body <NUM> having a proximal end <NUM> and a distal end <NUM>, a catheter lumen <NUM>, a compression cap <NUM>, one or more stabilization members <NUM>, an extension tube <NUM>, an inner chamber <NUM>, a port <NUM>, a catheter wedge <NUM>, a needle hub <NUM>, a grip <NUM>, and a needle <NUM>. Furthermore, as can be seen in <FIG>, the catheter system <NUM> may also include a first compression resistant septum <NUM>, a second compression resistant septum <NUM>, a septum chamber <NUM> intermediate the first compression resistant septum <NUM> and the second compression resistant septum <NUM>, a first lumen <NUM>, and a second lumen <NUM>. In some instances, second compression resistant septum <NUM> may be termed the primary or high pressure septum, and first compression resistant septum <NUM> may be termed the low pressure or secondary septum.

The first compression resistant septum <NUM> may be positioned to abut at least a portion of the proximal end <NUM> of the catheter adapter body <NUM> and/or the second compression resistant septum <NUM>. The first lumen <NUM> may be configured to receive an elongate object. The second compression resistant septum <NUM> may include a second lumen <NUM> formed there through which may also be configured to receive the elongate object. In at least some embodiments, the second compression resistant septum <NUM> may be disposed within the inner chamber <NUM> of the catheter adapter body <NUM>. The second compression resistant septum <NUM> may be positioned to abut the first compression resistant septum <NUM> and the septum chamber <NUM> may be formed between the first compression resistant septum <NUM> and the second compression resistant septum <NUM>. The compression cap <NUM> may be configured to couple the first compression resistant septum <NUM> to the catheter adapter body <NUM> and/or the second compression resistant septum <NUM>. The compression cap <NUM> may also be configured to impart radial and axial compression forces to the first compression resistant septum <NUM> and/or the second compression resistant septum <NUM> such that the first lumen <NUM> and/or the second lumen <NUM> narrow and seal when the elongate object is removed from the first lumen <NUM> and/or the second lumen <NUM>. In at least one embodiment, the compression cap <NUM>, the first compression resistant septum <NUM>, and/or the second compression resistant septum <NUM> may be positioned within the proximal end <NUM> of the catheter adapter body <NUM>, as can be seen in <FIG>.

<FIG> illustrate various views of a catheter system <NUM>, according to another embodiment of the present disclosure. The catheter system <NUM> may include similar features to other catheter system described herein, such as: a catheter adapter body <NUM> having a proximal end <NUM> and a distal end <NUM>, a catheter lumen <NUM>, a compression cap <NUM>, one or more one or more stabilization members <NUM>, an extension tube <NUM>, an inner chamber <NUM>, a port <NUM>, a catheter wedge <NUM>, a needle hub <NUM>, a grip <NUM>, and a needle <NUM>. Furthermore, as can be seen in <FIG>, the catheter system <NUM> may also include a first compression resistant septum <NUM> with a first lumen formed there through, a second compression resistant septum <NUM> with a second lumen formed there through, and a septum chamber <NUM> intermediate the first compression resistant septum <NUM> and the second compression resistant septum <NUM>.

The first compression resistant septum <NUM> may be positioned to abut at least a portion of the proximal end <NUM> of the catheter adapter body <NUM> and/or the second compression resistant septum <NUM>. The first and second lumens may be configured to receive an elongate object. In at least some embodiments, the second compression resistant septum <NUM> may be disposed within the inner chamber <NUM> of the catheter adapter body <NUM>. The second compression resistant septum <NUM> may be positioned to abut the first compression resistant septum <NUM> and the septum chamber <NUM> may be formed between the first compression resistant septum <NUM> and the second compression resistant septum <NUM>. The compression cap <NUM> may be configured to couple the first compression resistant septum <NUM> to the catheter adapter body <NUM> and/or the second compression resistant septum <NUM>. The compression cap <NUM> may also be configured to impart radial and axial compression forces to the first compression resistant septum <NUM> and/or the second compression resistant septum <NUM> such that the first lumen and the second lumen narrow and seal when the elongate object is removed from the first lumen and the second lumen.

<FIG> illustrate two views of a catheter system <NUM>, according to another embodiment of the present disclosure. The catheter system <NUM> may include similar features to other catheter system described herein, such as: a compliant catheter adapter <NUM> including a catheter adapter body <NUM> having a proximal end <NUM> and a distal end <NUM>, a catheter lumen <NUM>, a compression cap, one or more one or more stabilization members <NUM>, an extension tube <NUM>, an inner chamber <NUM>, a port <NUM>, and a catheter wedge <NUM>. The catheter system <NUM> may also have a needle component including a needle hub, a grip, and a needle <NUM>. Furthermore, the catheter system <NUM> may also include a first compression resistant septum with a first lumen formed there through, a second compression resistant septum <NUM> with a second lumen formed there through, and a septum chamber <NUM> intermediate the first compression resistant septum and the second compression resistant septum <NUM>.

The first compression resistant septum may be positioned to abut at least a portion of the proximal end <NUM> of the catheter adapter body <NUM> and/or the second compression resistant septum <NUM>. The first and second lumens may be configured to receive an elongate object. In at least some embodiments, the second compression resistant septum <NUM> may be disposed within the inner chamber <NUM> of the catheter adapter body <NUM>. The second compression resistant septum <NUM> may be positioned to abut the first compression resistant septum and the septum chamber <NUM> may be formed between the first compression resistant septum and the second compression resistant septum <NUM>. The compression cap may be configured to couple the first compression resistant septum to the catheter adapter body <NUM> and/or the second compression resistant septum <NUM>. The compression cap may also be configured to impart radial and axial compression forces to the first compression resistant septum and/or the second compression resistant septum <NUM> such that the first lumen and the second lumen narrow and seal when the elongate object is removed from the first lumen and the second lumen.

<FIG> illustrate another catheter system <NUM>, according to some embodiments. In some embodiments, the catheter system <NUM> may include similar features to other catheter systems described in the present disclosure, such as: a compliant catheter adapter that includes a catheter adapter body <NUM> having a proximal end <NUM> and a distal end <NUM>, a catheter lumen <NUM>, a compression cap <NUM>, one or more stabilization members <NUM>, an extension tube <NUM>, an inner chamber <NUM>, a port <NUM>, a catheter wedge <NUM>, a needle hub <NUM>, a grip <NUM>, a needle <NUM>, a first compression resistant septum <NUM>, a second compression resistant septum <NUM>, and a septum chamber <NUM> intermediate the first compression resistant septum <NUM> and the second compression resistant septum <NUM>.

Furthermore, as can be seen in <FIG>, in some embodiments, the catheter system <NUM> may include one or more protrusions or bumps <NUM> that may increase friction and aid in gripping of the stabilization members <NUM> and/or the grip <NUM>, as illustrated, for example, in <FIG>. In some embodiments, the bumps <NUM> may facilitate breathing of skin of the patient that contacts the stabilization members <NUM> and/or the grip <NUM>. The bumps <NUM> may be arranged in any number of patterns. For example, multiple of the bumps <NUM> may be evenly spaced apart and/or may be arranged in rows. In some embodiments, the bumps <NUM> on a surface of the stabilization members <NUM> and/or on a surface of the grip <NUM> may be arranged in a single row or arc. The bumps <NUM> may include any number of shapes. For example, the bumps <NUM> may be circular, oval, square, etc..

Furthermore, in some embodiments, the catheter system <NUM> may include a support element <NUM> that may support a finger or thumb of the clinician and/or facilitate gripping of the catheter system <NUM> by the finger or the thumb, as illustrated, for example, in <FIG>. In some embodiments, the support element <NUM> may extend upwardly from the grip <NUM> to a height equal to or greater than a height of the stabilization members <NUM>. Thus, in some embodiments, a diameter of the support element <NUM> may be equal to or greater than a diameter of the stabilization members <NUM>. In some embodiments, the support element <NUM> may be coupled with the needle hub <NUM> and/or the grip <NUM>. In some embodiments, the support element <NUM> may be integrally formed with the needle hub <NUM> and/or the grip <NUM>. In some embodiments, the catheter system <NUM> may include multiple support elements <NUM>, which may be disposed on opposing sides of the catheter system <NUM>.

In some embodiments, a color contrast between the support element <NUM> and one or more of the stabilization members <NUM> may be provided. For example, the support element may include a translucent or a white color, while the stabilization members <NUM> may include a different color than the support element such as, for example, green, pink, blue, yellow, purple, etc. In some embodiments, a color of the stabilization members <NUM> may correspond to a gauge size of a catheter of the catheter system <NUM>. The color contrast may facilitate identification by the clinician of parts of the catheter system <NUM> that separate from one another during insertion of the catheter system <NUM> into the vein of the patient, including, for example, hooding of the catheter.

In some embodiments, the support element <NUM> may extend along at least a portion of an edge of a particular stabilization member <NUM>. As illustrated in <FIG>, in some embodiments, the support element <NUM> may extend to a side of the particular stabilization member <NUM> and/or a side of the grip <NUM>. As illustrated in <FIG>, in some embodiments, the support element <NUM> may extend along a proximal end of the particular stabilization member <NUM> and/or a proximal end of the grip <NUM>. In some embodiments, a curvature of an inner edge of the support element <NUM> may correspond to a curvature of the grip <NUM>.

In some embodiments, when the catheter system <NUM> is gripped as illustrated in <FIG>, the bumps <NUM> may contact the finger and/or the thumb of the clinician. In some embodiments, if the thumb, in contact with an upper surface of a particular stabilization member <NUM>, is advanced distally while a forefinger, in contact with a lower surface of the grip <NUM>, is retracted proximally, the catheter may be hooded and/or advanced for insertion of the catheter in a vein of the patient. When the catheter is hooded, a tip of the needle <NUM> may be fully encapsulated by the catheter.

In some embodiments, the needle hub <NUM> may include a flash chamber that may be coupled to a proximal end of the needle hub <NUM>. In some embodiments, the flash chamber may provide secondary confirmation that the catheter is properly positioned within the vein. In some embodiments, because a proximal end of the needle <NUM> opens into the flash chamber and because the flash chamber may be vented to an external environment, blood pressure of the patient may cause blood to flow into the flash chamber.

Various embodiments of the present invention may further comprise a safety mechanism configured to secure the sharpened, distal tip of the introducer needle following removal and separation of the needle component from the catheter adapter. 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 needle. The crimp or bump formed in the needle 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 component 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 body or stabilization member(s), wherein the safety mechanism does not overlap the catheter adapter body or stabilization member(s). In some instances, a portion of the safety mechanism is positioned within the catheter adapter body, with the balance of the safety mechanism being positioned external to the catheter adapter body, such as within the needle hub. In some embodiments, a portion of the catheter adapter body or stabilization member(s) is extended proximally to provide a housing in which at least a portion of the safety mechanism is housed. In some instances, the entire safety mechanism is housed within the housing of the catheter adapter body or stabilization member(s) prior to catheterization.

In some embodiments, the assembled position of the safety mechanism positions the proximal end of the catheter adapter body between the distal end of the safety mechanism and a distal end of a grip of the needle component. In some instances, the assembled position of the safety mechanism positions the proximal end of the catheter adapter body between the distal end of the safety mechanism and a proximal end of a grip of the needle component. In some instances, a portion of the safety mechanism overlaps a portion of a grip of the needle component. In some embodiments, at least some portion of at least one of the catheter adapter body and the grip overlaps at least some portion of the safety mechanism. In some embodiments, no portion of the catheter adapter body or 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 IV catheter system. In some embodiments, a distal end of the safety mechanism is selectively coupled to a proximal end of the catheter adapter body. In one embodiment, the safety mechanism interlocks internally to the proximal end of the catheter adapter body. In one embodiment, the safety mechanism interlocks externally to the proximal end of the catheter adapter body. In some embodiments, a distal end of the safety mechanism is selectively coupled to a proximal end of the stabilization member(s). 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 body, a blood control valve, an extension tube, and the stabilization member(s). In some instances, the mechanical connection is defeated upon securement of the needle tip within the safety mechanism.

In some embodiments, a particular catheter device, such as, for example, the catheter device of any of the <FIG>, 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: <CIT>; <CIT>; <CIT>. In some embodiments, the safety mechanism may include a clip disposed within the catheter adapter, a non-limiting example of which is provided in <CIT>.

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 <CIT>. 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 <CIT>. 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 theBD™ 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.

Claim 1:
A compliant catheter adapter (<NUM>) comprising:
a catheter adapter body (<NUM>) formed of a compression set resistant elastomeric material, the catheter adapter body integrally manufactured to form:
a port (<NUM>);
a catheter wedge (<NUM>);
one or more stabilization platforms (<NUM>);
a proximal end (<NUM>) and a distal end, the catheter adapter body (<NUM>) having a generally elongate shape formed about a longitudinal axis extending between the proximal end (<NUM>) and the distal end of the catheter adapter body (<NUM>);
an inner chamber (<NUM>) disposed within the catheter adapter body (<NUM>), the inner chamber (<NUM>) having a generally elongate shape formed about the longitudinal axis extending between the proximal end (<NUM>) and the distal end of the catheter adapter body (<NUM>);
a compression resistant septum (<NUM>) disposed toward the proximal end (<NUM>) of the catheter adapter body (<NUM>); and
a lumen (<NUM>) formed through the compression resistant septum (<NUM>), the lumen (<NUM>) configured to receive an elongate object therein; and
a compression cap (<NUM>) coupled to the compression resistant septum (<NUM>), the compression cap (<NUM>) configured to impart a compression force to the compression resistant septum (<NUM>) such that the lumen (<NUM>) narrows and seals when the elongate object is removed from the lumen (<NUM>).