Catheter adapter with distal inner diameter curvature providing kink resistance

Catheter adapters and vascular access device including catheter adapters are discloses. The catheter adapter tip opening has an internal curvature defining a tapered region in the lower portion, but not the upper portion, to support a flexured portion of the catheter to prevent kinking and occlusion.

TECHNICAL FIELD

Aspects of the present disclosure relate to an adapter having a catheter adapter tip opening with an internal curvature to support the tubular catheter as it transitions from the catheter adapter to a patient's vein to prevent catheter kinking and occlusion, and also vascular access devices including catheter adapters.

BACKGROUND

Infusion therapy using catheters to administer fluids into and drain fluids out of the body has been a standard practice in medical procedures for years. Patients in a variety of settings including in hospitals, in home care, and other patients receive fluids, pharmaceuticals, and blood products via a vascular access device inserted into a patient's vascular system. Catheters of various types and sizes have been used extensively by physicians in a variety of procedures including, but not limited to, treating an infection, providing anesthesia or analgesia, providing nutritional support, treating cancerous growths, maintaining blood pressure and heart rhythm, and many other clinically significant uses. However, catheter occlusion is a frequent complication experienced when using catheters in medical procedures and treatment. Catheter kinking results in a reduction of fluid volume delivery rate and, in many cases, causes a fluid stoppage and a rupture of the catheter wall with an accompanying loss of fluid.

Intravenous therapy is facilitated by vascular access devices located outside the vascular system of a patient (extravascular devices). Extravascular devices that may access a patient's peripheral or central vasculature, either directly or indirectly include closed access devices, such as the BD Q-SYTE™ closed luer access device of Becton, Dickinson and Company; syringes; split-septum devices; catheters; and intravenous (IV) fluid chambers. A vascular 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 vascular access device is a plastic catheter that is inserted into a patient's vein. The catheter length may vary from a few centimeters for peripheral access to many centimeters for central access. The catheter is commonly incorporated into a catheter adapter to aid in the ease of use, accessibility and utility of the catheter. A catheter adapter is generally a rigid, plastic, tubular member adapted to house one end of the catheter such that one end of the catheter is supported by the catheter adapter and the body and tip of the catheter extends beyond a first end of the catheter adapter. A catheter adapter generally further includes a second end adapted to receive additional infusion components for use with the catheter. For example, the second end of a catheter adapter may include a set of threads for attaching an intravenous line or for coupling a syringe to the catheter adapter thereby providing access to the patient's vasculature via the attached catheter.

The catheter may be inserted transcutaneously. When inserted transcutaneously, the insertion of the catheter is commonly aided by an introducer needle. The introducer needle is commonly housed inside the lumen of the catheter such that the gauge of the needle approximates the inner diameter of the catheter. The needle is positioned within the catheter such that the needle tip extends beyond the tip of the catheter whereby the needle is used to penetrate the patient's vein and provide an opening for insertion of the catheter.

During insertion into a patient, the needle and catheter generally approach the patient's vein at an angle of about 30° wherein the needle initially punctures the patient's epidermis and then continues into the vein. Once the needle and catheter tip enter the patient's vein, the needle and catheter are then repositioned so that the needle and catheter are brought into a position generally parallel with the patient's vein so that the needle and catheter may be inserted into the lumen of the patient's vein. When the catheter has been properly positioned within the patient's vein, the needle is removed from the lumen of the catheter and the catheter adapter is secured to the patient to prevent premature removal of the catheter.

Typically the catheter adapter is secured to the patient by fastening the catheter adapter to the patient's skin via tape, a securement device and/or a securement dressing. When securing the catheter adapter to the patient's skin, the root region of the catheter immediately exiting the catheter adapter must arch to accommodate the catheter's transition from the generally parallel, secured orientation of the catheter adapter, to the insertion angle of the catheter; an angle of approximately 30°.

General practice provides that the catheter be inserted into a patient such that an extended section of catheter is left between the patient and the catheter adapter to allow for transitional arching of the catheter. This exposed, archable length of catheter biases the catheter towards the patient's skin and thus the root region of the catheter experiences leverage forces because the catheter acts as a lever and the first end of the catheter adapter acts as a fulcrum exerting an upward force on the root region of the catheter. This upward force of the first end of the catheter adapter is undesirable due to the likelihood of occlusion of the root region of the catheter against the more rigid catheter adapter. Occlusion typically occurs as the patient and or the catheter is moved, increasing the angle of insertion in relation to the fixed position of the catheter adapter. For example, if the repositioning of the catheter and/or patient causes the catheter to be inserted further into the patient, the archable length of catheter between the patient and the catheter adapter decreases, which increases the angle of insertion and the upward force of the immobilized catheter adapter on the root region of the catheter. As the angle of insertion increases, the upward force of the catheter adapter also increases until the structural rigidity of the catheter wall is overcome, causing the catheter to kink.

Occlusion of the catheter is undesirable because occlusions slow or stop the flow through the catheter, creating undesirable backpressures that may cause the infusion system to malfunction and/or be damaged. Furthermore, occlusions reduce the efficiency of the infusion system, which could negatively affect treatment of the patient or the diagnostic procedure. Moreover, the exposed arched catheter section may become contaminated and pose a health risk to the patient. For example, an exposed section of catheter may become contaminated and then inserted into the patient as the patient and/or catheter is readjusted due to normal use by the patient and/or clinician. To reduce the likelihood of contamination and subsequent exposure to the patient, clinicians seek to minimize the length of exposed catheter by initially over-inserting the catheter into the patient. By reducing the length of exposed catheter, the upward force of the first end of the catheter adapter is increased, increasing the likelihood of occlusion within the root region of the catheter.

Contamination of the catheter and/or patient is undesirable for obvious reasons, the most obvious being that contamination may lead to secondary infection and/or complications unanticipated by the treating physician. Furthermore, a contaminated catheter may introduce a virus and/or bacteria to the patient that may conflict with the patient's primary therapy such that the patient is unable to receive further needed treatment.

Therefore, kink-resistant catheter adapters which can support catheters are desirable because they can reduce the possibility of occlusions and maintain a minimum fluid volume delivery rate. Although various attempts have been made to provide vascular access devices with a kink resistant catheter, there is still a need to provide a vascular access device that reduces the susceptibility of the catheter to kinking when flexed or bent during fluid delivery. It would also be desirable to provide a kink resistant catheter adapter that increases ease of penetration into a patient's vein, while providing the benefit of maintaining patency and flow rates throughout the life of the device. There is also a need for a vascular access device that allows for a steeper insertion angle which can be useful for subcutaneous injection as it supports the catheter as it is secured flat against the skin after a steep insertion.

SUMMARY

A first embodiment pertains to a vascular access device comprising a catheter including a flexured portion, a catheter adapter having a distal end and a proximal end with an overall length extending from the distal end to the proximal end, an internal cavity, an upper portion, a lower portion, a distal tip having a catheter adapter tip opening having a circumference and through which the catheter extends, the catheter adapter tip opening having an internal curvature defining a tapered region in the lower portion. The tapered region supports the flexured portion of the catheter to provide an angle of insertion for the catheter without restricting a flow through the catheter. The tapered region provides conical relief to the catheter. The overall length is substantially equivalent at the upper portion and the lower portion, and the tapered region is less than the overall length.

In one embodiment, the internal curvature of the lower portion of the catheter adapter tip opening defines a chamfer. In yet another embodiment, the internal curvature of the lower portion of the catheter adapter tip opening is either rounded or trumpet shaped.

In one or more embodiments, the lower portion of the catheter adapter tip opening defines a radius at the distal tip that incrementally decreases moving away from the distal tip. In one or more embodiments, the upper portion of the catheter adapter tip opening does not include an internal curvature extending from the distal tip.

The vascular access device may be a central venous catheter, a peripherally inserted central catheter, a peripheral intravenous cannula, an arterial catheter, or a mid-line catheter.

A portion of the catheter is housed within the internal cavity of the catheter adapter. The catheter is fixedly attached to the catheter adapter.

In one embodiment, the angle of insertion is within a range of about 1° to about 60°. In a specific embodiment, the angle of insertion is about 15-45°.

In one embodiment, a radius of the upper portion is asymmetrical in relation to the radius of the lower portion. In another embodiment, the upper portion of the catheter adapter is oriented tangentially to the catheter.

In one embodiment, the internal curvature in the lower portion of the adapter extends across a portion of a circumference of catheter adapter tip opening and defines an arc forming an angle in a range of 90° to 360°. In a specific embodiment, the angle is in the range of 180° to 360°.

The vascular access device further comprises an introducer needle in the internal cavity, the needle having a distal end a proximal end and a needle hub connected to the proximal end of the introducer needle.

The vascular access device further comprises an extension tube extending from the catheter adapter and in fluid communication with the internal cavity of the catheter adapter, at least one at of a luer access, a blood control septum, an air vent and a notch in the introducer needle.

In one embodiment, the vascular access device further comprises a wing element extending radially outward from the catheter adapter. The wing element comprises a first wing member extending from one side of the catheter adapter. In yet another embodiment, the wing element further comprises a second wing member extending opposite the one side of the catheter adapter.

In one embodiment, at least a portion of the catheter adapter is made from a first material and at least a portion of the distal tip is made from a second material that is more flexible than the first material. In yet another embodiment, at least a majority of the catheter adapter is made from a first material and at least a portion of the distal tip is made from a second material that is more flexible than the first material. In one or more embodiments, the distal tip includes a flexible, kink resistant extension extending from the catheter adapter tip opening to provide support for the catheter.

In one embodiment, the needle further includes a bevel on the distal tip and the bevel of the needle is oriented in an asymmetrical orientation in relation to the conical relief.

In one or more embodiments, the upper portion is absent a catheter adapter tip opening having an internal curvature defining a tapered region.

Another aspect of the disclosure pertains to an apparatus for preventing a restricted flow within a catheter. In one embodiment, the apparatus comprises a catheter adapter having a distal end and a proximal end with an overall length extending from the distal end to the proximal end, an internal cavity, an upper portion, a lower portion and a distal tip having a catheter adapter tip opening through which a catheter including a flexured portion extends. The overall length is substantially equivalent at the upper portion and the lower portion. The lower portion of the adapter has a curved surface to support the flexured portion of the catheter at a desired angle of insertion into a patient and to prevent kinking of the catheter. In one or more embodiments, the upper portion of the adapter in contact with the catheter has a substantially straight surface and constant thickness to maintain rigidity of the catheter during insertion of the catheter into a patient.

In one or more embodiments, the upper portion of the catheter adapter tip opening defines in cross section a semicircular arc forming an angle in a range of 0° to 270° and the lower portion of the catheter adapter tip opening defines in cross section a partial ellipse. In one or more embodiments, the lower portion of the catheter adapter tip opening forms an angle in a range of 0° to 270.

DETAILED DESCRIPTION

Before describing several exemplary embodiments of the disclosure, it is to be understood that the description provided is not limited to the details of construction or process steps set forth in the following description. The devices described herein are capable of other embodiments and of being practiced or being carried out in various ways.

In this disclosure, a convention is followed wherein the distal end of the device is the end closest to a patient and the proximal end of the device is the end away from the patient and closest to a practitioner.

The disclosure describes various embodiments of a catheter adapter, which may be used in combination with other components such as a needle hub assembly including a needle to provide various vascular access devices. Vascular access devices according to one or more embodiments include but are not limited to central venous catheters, peripheral inserted central catheters, peripheral intravenous cannulas, arterial catheters, and mid-line catheters.

Referring to the drawings in which like reference characters refer to like parts throughout the several views thereof,FIGS. 1-6illustrates a catheter adapter20andFIG. 7illustrates a non-limiting example of a vascular access device10utilizing a catheter adapter in accordance with one or more embodiments of the present disclosure.

As shown inFIGS. 1-5, catheter adapter20, which can be assembled with a hub assembly as described further below with respect toFIG. 7, includes a catheter12having a proximal end14, a distal end16and flexured portion21, a catheter adapter20having a distal end22and a proximal end24, an internal cavity26, an upper portion28, a lower portion30and an adapter tip32having a catheter adapter tip opening34having a circumference through which the catheter12extends. As shown inFIGS. 2 and 3, the catheter adapter20is connected to the proximal end14of the catheter12. The catheter adapter20extends from the adapter tip32to the proximal end24defining a catheter adapter length “L”. An introducer needle36extends through the catheter12. A needle hub40is connected to the proximal end38of the introducer needle36.

As shown inFIGS. 2-5, the overall length L of the catheter adapter is substantially equivalent at the upper portion and the lower portion, and the catheter adapter tip opening34has an internal curvature defining a tapered region at surface35in the lower portion of the catheter adapter but not the upper portion of the catheter adapter, wherein the tapered region at surface35supports the flexured portion of the catheter to provide an angle of insertion for the catheter without restricting a flow through the catheter, the tapered region being less than the overall length. The internal curvature at surface35of the lower portion of the catheter adapter tip opening34defines a chamfer.

As best seen inFIG. 3, the lower portion of the catheter adapter tip opening34defines a radius “R” at the distal tip that incrementally decreases moving away from the distal tip in a proximal direction. In other words, since the lower portion of the catheter adapter tip34has surface35, the radius R will be larger at the distal most portion of the tip than the radius measured at locations located a distance away from the tip in a proximal direction. Thus, the radius R continually decreases as the radius of the opening is measured at locations that are further away from the adapter tip32in a proximal direction. In one or more embodiments, the upper portion of the catheter adapter tip opening34does not include an internal curvature extending from the distal tip. The radius of the upper portion may be asymmetrical in relation to the radius of the lower portion. In one or more embodiments, the upper portion of the catheter adapter is oriented tangentially to the catheter.

As shown inFIGS. 3-5, in one or more embodiments, the internal curvature at surface35of the lower portion of the catheter adapter tip opening34defines a chamfer. In yet another embodiment, the internal curvature at surface35of the lower portion of the catheter adapter tip opening34is rounded or trumpet shaped. In one or more embodiments, the internal curvature at surface35in the lower portion of the adapter extends across a portion of the circumference of catheter adapter tip opening34and defines an arc forming an angle in the range of 90° to 270°. In a specific embodiment, the angle is in the range of 180° to 270°.

In one or more embodiments, the catheter adapter18can be a part of an apparatus for preventing a restricted flow within a catheter12including a catheter adapter18as described above having a distal end22, a proximal end24, an overall length L extending from the distal end to the proximal end, an internal cavity26, an upper portion28, a lower portion30and a distal tip32having a catheter adapter tip opening34through which a catheter including a flexured portion21extends, wherein the overall length is substantially equivalent at the upper portion and the lower portion, the lower portion of the adapter has a curved surface to support the flexured portion of the catheter at a desired angle of insertion into a patient and to prevent kinking of the catheter, the upper portion of the adapter in contact with the catheter12having a substantially straight surface and constant thickness to maintain rigidity of the catheter during insertion of the catheter into a patient. In one or more embodiments, the upper portion of the catheter adapter tip opening34defines in cross section a semicircular arc forming an angle in the range of 90° to 180°. In one or more embodiments, the lower portion of the catheter adapter tip opening34defines in cross section a partial ellipse.

Catheter12is generally tubular and flexible comprising a shaft of uniform thickness having a length. Catheter12further includes a lumen44. The diameter of the lumen44may vary and is selected to accommodate a desired flow rate and/or pressure from the intravenous fluid source. Catheter12may be from 14-26 gauge.

As shown inFIGS. 2 and 4, catheter12further includes a flexured portion21. Flexured portion21is defined as the uninserted section of the catheter between the first end of the catheter adapter tip opening and the catheter insertion site51of the patient52. The length is defined by the distance between flexured portion21of catheter12and catheter tip31. The proximity of flexured portion21to the first end of the catheter adapter18makes the flexured portion prone to occlusion. This is because the first end of the catheter adapter exerts an upward force on flexured portion21when the catheter12is moved independent of and relative to the generally horizontal plane of the catheter adapter. The length of uninserted catheter, and therefore the point of maximum insertion, is selected such that a sufficient length of catheter remains uninserted. This allows the flexured portion of the catheter to gently bend in making the transition from the catheter adapter to the insertion site thereby preventing an occlusion due to over-insertion of the catheter.

In one or more embodiments, catheter12may be made from a biomaterial designed to reduce mechanical phlebitis and infiltration. In one or more embodiments, catheter12may be made from polyurethane. In a specific embodiment, the biomaterial may be a polyurethane that softens up to 70% in the vascular vein or artery to allow for increased patient comfort while providing kink resistance and improving catheter dwell time.

Catheter12further includes a catheter tip31. Catheter tip31includes a catheter opening46selected to provide clearance for introducer needle36. Introducer needle36extends coaxially through a catheter of the catheter adapter. The diameter of the catheter opening46is selected to provide minimal tolerance between the outer surface of introducer needle36and the inner surface of catheter opening46. As such, catheter tip31may provide a sufficiently sized access route into a patient's vein64. The introducer needle36may further include a bevel on the distal tip. The bevel of the needle may be oriented in an asymmetrical orientation in relation to the conical relief or the internal curvature at surface35of the lower portion of the catheter adapter tip opening34.

In one or more embodiments, the lower portion of adapter tip32includes the tip having the distal opening having the circumference through which the catheter extends, and wherein a catheter exiting the distal opening is flexibly supported by the internal curvature at surface35of the lower portion of the catheter adapter tip opening34.FIGS. 3-5show the area of support of the integrally molded tip catheter transition kink resistant feature. The catheter adapter tip opening34includes a surface35having an internal curvature defining a tapered region in the lower portion but not the upper portion, wherein the tapered region supports the flexured portion of the catheter to provide an angle of insertion for the catheter without restricting a flow through the catheter, the tapered region being less than the overall length. After insertion of the catheter, the tapered region provides transitional support at an angle of insertion for the catheter without restricting flow through the catheter. The catheter adapter tip opening34may include a steep or gradual insertion angle.FIG. 4shows the area of support of the integrally molded tip catheter transition kink resistant feature. The internal curvature defining a tapered region in the lower portion eliminates the non-supported, abrupt change in direction current catheters experience upon exiting the catheter adapter20, thereby minimizing the localized stress on the catheter12and therefore minimizing the chance of collapsing and kinking the catheter and occluding the fluid flow.

In one more embodiments, the overall length L of the catheter adapter is substantially equivalent at the upper portion and the lower portion, and the catheter adapter tip opening34has an internal curvature defining a tapered region, and wherein the internal curvature of the lower portion of the catheter adapter tip opening34defines a chamfer.

In one or more embodiments, catheter adapter18is generally tubular. A portion of the catheter is housed within the internal cavity of the catheter adapter. The catheter12is incorporated into a catheter adapter18using industry standard methods. Catheter adapter20further includes a body48extending between the proximal end24and the distal end22. In one or more embodiments, the catheter is fixedly attached to the catheter adapter in a fluid-tight manner. As such, a fluid from the intravenous fluid source may flow through the lumen44and into the catheter12without interruption. The distal end22of the catheter adapter is generally tapered and includes catheter adapter tip opening34through which the catheter12extends. The proximal end24generally includes an access port54for accessing lumen44of the catheter. Access port54may be a dual access port that provides multiple options for administration of fluid and medications.

Additional features of the catheter adapter may include a lateral access port56extending from and being in fluid communication with the catheter adapter. An extension tube60may be attached to the lateral access port56to permit controlled flashback. The lateral access port56may be connected to a section of extension tube60for establishing fluid communication between an intravenous fluid source and the internal cavity26of the catheter adapter or lumen44of the catheter.

In one or more embodiments, extension tube60extends from the lateral access port or proximal end of the catheter adapter to establish a fluid communication with the internal cavity of the adapter. The extension tubing could extend in line with or laterally with the body of the catheter adapter. The extension tubing may be built-in to reduce contamination and mechanical phlebitis by eliminating manipulation at the insertion site. The extension tubing may be-compatible with high pressure injection. The extension tubing provides continuous confirmation of vessel access during advancement of the catheter into the patient vein.

Catheter adapter18may also be configured to house introducer needle36for inserting the catheter12into a patient. In one or more embodiments, introducer needle36includes a notch58to provide immediate confirmation of vessel entry at the point of insertion to improve first-stick success.

As shown inFIGS. 1 and 7, one or more embodiments of the catheter adapter20may include wing element62. Wing element62is attached to the catheter adapter20and extends radially outward from the catheter adapter20.

In one or more embodiments, wing element62includes a first wing member68extending from one side of the catheter adapter18. In yet another embodiment, the wing element includes a first wing member68extending in a first direction from the one side of the catheter adapter18and a second wing member70extending in a direction opposite to the first direction. In one or more embodiments, the first wing member and second wing member70are integrally molded. However, the first wing member and second wing member70need not be integrally molded, and each of these components can be separately molded from the same or different materials. In addition, while first wing member68and second wing member70are shown as being a contiguous piece to form the wing element62, first wing member68and second wing member70can be separate pieces. In addition, according to one or more embodiments, the wing element can comprise a single wing member, either first wing member68or second wing member70. First wing member68and second wing member70provide increased catheter stability and therefore increase dwell time.

In one or more embodiments, at least a portion of the catheter adapter18is made from a first material and at least a portion of the adapter tip32is made from a second material that is more flexible than the first material. In a specific embodiment at least a majority of the catheter adapter18is made from a first material and at least a portion of the adapter tip32is made from a second material that is more flexible than the first material. As used herein, “majority” means greater than 50% of the volume of catheter adapter, excluding the wing element. To determine the amount of the first material, the overall volume of the first material is determined, the overall volume of the second material excluding the wing element is determined, and the total volume of the catheter adapter is determined by adding the volume of the first material and the volume of the second material excluding the wing element. The percent of the first material is determined by dividing the volume of the first material divided by the total volume of the catheter adapter.

In one or more embodiments, the catheter adapter, excluding the wing element and catheter, may be made from a rigid polymeric material selected from one or more of a polyester, co-polyester, polycarbonate, polyethylene, polystyrene or polypropylene. In one or more embodiments, first wing member68and second wing member70may be made from a soft, flexible polymeric material selected from one or more of a thermoplastic elastomer (TPE), thermoplastic polyurethane (TPU), thermoplastic vulcanizate elastomer (TPV), olefin block copolymers (OBC), polyisoprene, or silicone. In one or more embodiments, the second material has a durometer value in the range of 30 Shore A to 90 Shore D, with a preferred range of ˜50 to 90 Shore A. Durometer hardness may be determined under test method ASTM D2240.

Referring now toFIG. 2, catheter adapter18is illustrated in a generally horizontal orientation. In use, the catheter adapter18is secured to a patient and the catheter tip31is inserted into the patient's vascular system. The catheter12is positioned and inserted within the patient's vascular system at a determined insertion angle53. Insertion angle53is defined by the exit angle of the catheter at the catheter adapter tip opening34of the adapter when the catheter tubing is biased downward against the bottom curved surface of the ID of the catheter adapter. The insertion angle53may include any angle necessary to introduce the catheter into the patient's vascular system. For example, an insertion angle53may be selected within the range of 1° to 60°, with a preferable range of angle of insertion from 15° to 45°.

Following insertion of the catheter12, the flexured portion21of the catheter is bent in a general arch shape to accommodate the transition of the catheter12from the catheter adapter20to the catheter insertion site51. This feature also allows for a steeper insertion angle which can be useful for subcutaneous injection as it supports the catheter as it is secured flat against the skin after a steep insertion.

Upon insertion of the catheter into the insertion site, the catheter experiences higher leverage forces. Thus, the catheter acts as a lever and the rigid first end of the catheter adapter acts as a fulcrum exerting an upward force on the catheter. As the catheter is inserted further into the insertion site, the upward force of the catheter is dissipated by the internal curvature of the catheter adapter tip opening34which defines a tapered region in the lower portion with the catheter to prevent kinking and occlusion of the catheter, therefore, maintaining patency and flow rates throughout the life of the device. This is particularly useful in cases of drawing blood from an indwelling vascular access device including peripheral intravenous catheters (PIVC), peripherally inserted central catheter (PICC) or central venous catheter (CVC).

In one or more embodiments, the catheter adapter tip opening is chamfered such that the tolerance between the distal end of the catheter adapter and the flexured portion of the catheter is increased. Thus, the flexured portion of the catheter may bend more sharply before the catheter contacts the catheter adapter tip opening resulting in an occlusion. In one embodiment, the catheter adapter tip opening is chamfered at an angle which is less than 90° relative to the generally horizontal plane. The chamfered opening permits a greater length of catheter to be inserted before an occlusion occurs due to the delayed contact of the tip opening and the catheter. Therefore, as the flexured portion of the catheter is further inserted into the patient, the flexured portion is allowed to bend to a greater degree before contacting and pivoting on the tip opening resulting in an occlusion of the catheter at the flexured portion.

The degree of curvature at surface35is selected to support the flexured portion of the catheter in maintaining an insertion angle within the desired range. In this embodiment, the flexured portion21of the catheter is bent over and along the contour of the rounded, curved or chamfered lower portion of the catheter adapter tip opening34. The flexured portion is supported by the lower portion of the catheter adapter tip opening34in maintaining the necessary degree of curvature for the catheter so as to avoid an occlusion and maintain the optimal degree of insertion. The rounded, curved or chamfered opening minimizes the fulcrum function of the distal end of the catheter adapter on the flexured portion of the catheter such that the catheter may be maximally inserted into the patient with minimal upward force of the distal end of the catheter. This minimizes the likelihood of occlusion. The flexured portion may form a gentle arch thus preventing an occlusion of the catheter12due to over-insertion of the catheter12. The length of uninserted catheter, and therefore the point of maximum insertion is selected such that a sufficient length of catheter12remains uninserted. The internal curvature of the catheter adapter tip opening34in the lower portion provides structural support for the catheter's direction and angular change from the adapter into the patient's body, thereby eliminating the abrupt change in direction that current catheters experience upon exiting the catheter adapter. Therefore, the internal curvature of the catheter adapter tip opening34in the lower portion minimizes the localized stress and chance of collapsing and kinking. After insertion of the catheter, the tapered region provides transitional support at an angle of insertion for the catheter without restricting flow through the catheter. This allows the flexured portion of the catheter12to gently bend in making the transition from the catheter adapter to the insertion site thereby preventing an occlusion of the catheter.

The shape and profile of the internal curvature of the catheter adapter tip opening34can be optimized for each individual size catheter, for a given insertion depth d, to reduce localized stress and provide structural support for the catheter's angular directional change. In the embodiment illustrated above inFIG. 5, the curvature extends from the opposite cross sectional quadrants of the catheter adapter inner diameter and transitions downward in the direction of the patient. The upper portion28of the catheter adapter tip opening is without curvature and provides upward bending support during the catheter insertions process. Upon insertion and removal of the insertion needle, the internal curvature of the catheter adapter tip opening34of the lower portion allows the adapter and catheter, having been inserted at some angle, to be laid flat against the patient's skin without undue localized stress and abrupt directional change. As shown inFIG. 5, the internal curvature of the catheter adapter tip opening34in the lower portion decreases the impact of an abrupt angle change when the catheter (shown in phantom) is secured to the patient after a steep insertion angle, reducing the risk of the catheter kinking at the exit of the catheter adapter nose.

The catheter adapter according to one or more embodiments can provide a variety of cross sectional transitions at the catheter adapter tip opening34. The cross-sectional transition can be varied to provide an intended curved support for the catheter depending on the potential direction of bending of the catheter. This cross-sectional transition feature according to one or more embodiments reduces the risk of the catheter tube kinking and restricting flow through the device to the patient during an infusion procedure, as well as from the patient through the device for drawing blood and while checking patency. The examples shown inFIGS. 6A, 6B and 6Ccurvature is only on the bottom portion of the inner diameter, however, many other alternatives exist, including a full round inner diameter expansion if the curvature (e.g, trumpet shaped), or any number of rotationally or axially variable transitions.FIGS. 6A, 6B and 6Cillustrate three non-limiting examples of cross-sectional profiles of catheter tips, wherein the view is of the catheter adapter tip at the catheter exit opening.FIG. 6Ashows an adapter first modified tip opening34ahaving a chamfered surface35aat the lower portion.FIG. 6Bshows a second modified adapter tip opening34bhaving a curved surface35bat the lower portion.FIG. 6Cshows a third modified adapter tip opening34chaving a rounded surface35cat the lower portion.

In one or more embodiments, the catheter adapter includes a flexible, kink resistant extension extending from the catheter adapter tip opening to provide support for the catheter.

The catheter adapter20described with respect toFIGS. 1-6can be used as part of a vascular access device described with respect toFIG. 7.

As shown inFIG. 7, the catheter adapter18may be part of a vascular access device10, with additional components in fluid communication with the catheter adapter18. As shown inFIG. 7, the lateral access port56may be connected to a section of extension tube60for establishing fluid communication between an intravenous fluid source and the internal cavity26of the catheter adapter or lumen44of the catheter. In one or more embodiments, the extension tube60extends in line with or laterally with the body of the catheter adapter. In one or more embodiments, the extension tube60is built-in to reduce contamination and mechanical phlebitis by eliminating manipulation at the insertion site. In one or more embodiments, the extension tube60is compatible with high pressure injection. In one or more embodiments, the extension tube60provides continuous confirmation of vessel access during advancement of the catheter into the patient's vein64.

In one or more embodiments, needle hub assembly50is assembled with the catheter adapter by inserting the needle into the lumen44of the catheter12. The needle hub assembly is shown as including finger grips84positioned at the sides of the needle hub assembly50to facilitate various insertion techniques. In one or more embodiments, bumps may be present on the finger grip to indicate where to the user may grip the device for needle removal. In one or more embodiments, a thumb pad85, having a gently convex surface, is provided at the proximal end of the needle hub assembly50. A flange86, having a gently convex surface, is provided at the proximal end of the hub assembly to provide a finger pad.

First wing members68, second wing member70, thumb pad85and flange86may be utilized by the user during insertion, permitting the user to elect which insertion technique to employ.

In one or more embodiments, the needle hub assembly50includes a needle shield80. The needle shield may be a design adapted to secure the tip of the needle within the shield after use. In one or more embodiments, the needle shield may be activated passively to ensure compliance with compromising user technique. The needle tip is completely covered by the needle shield in a fixed position. In one or more embodiments, a ferrule, crimp or other structure may be included near the tip for engagement with a needle shield in certain applications.

A push tab81may be provided to facilitate catheter advancement during insertion. The push tab also allows for one-handed or two-handed advancement. In one or more embodiments, the push tab is removed with the needle shield. A clamp82may also be included on the extension tubing to prevent blood flow when replacing the access port.

The proximal end of the introducer needle may be crimped to provide a fluid-tight seal around the proximal end of the introducer needle. The introducer needle may be glued or mechanical interlocks may be formed to secure the introducer needle to the hub.

In one or more embodiments, the vascular access device10further includes a first luer access72and a second luer access73in fluid communication with the extension tube60, a blood control split septum74associated with the first luer access72, and an air vent76associated with the second luer access73. Split septum74allows for a reduction in catheter-related bloodstream infection (CRBSI) while providing unrestricted flow and a straight fluid path and functions as a blood control septum. In one or more embodiments, the split septum74may be located in an internal cavity of the catheter adapter or on the distal end of the catheter adapter. In yet another embodiment, the split septum74may be located on a distal end of the extension tube60. The air vent76allows air to escape from the system during insertion, providing continuous confirmation of vascular access while preventing leakage of blood from the system during insertion. In one or more embodiments, the air vent76may be at the distal end of extension tube60.