Catheter adapter that provides resistance to catheter tangles

MX434686BActive Publication Date: 2026-06-12BECTON DICKINSON & CO

Patent Information

Authority / Receiving Office: MX · MX
Patent Type: Patents
Current Assignee / Owner: BECTON DICKINSON & CO
Filing Date: 2018-04-25
Publication Date: 2026-06-12

AI Technical Summary

Technical Problem

Catheter occlusion and entanglement are common complications during medical procedures, leading to reduced fluid delivery rates and potential contamination, especially when catheters are subjected to lever forces and angle changes relative to the catheter adapter.

Method used

A vascular access device with a catheter adapter featuring a flexible tip and wing members made of a softer material than the main adapter body, designed to support the catheter transition and minimize occlusion by allowing for a steeper insertion angle and reducing lever forces.

Benefits of technology

The device maintains fluid flow rates and prevents catheter entanglement by dissipating upward forces through flexible materials, ensuring consistent infusion and reducing contamination risks.

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Abstract

A vascular access device is described comprising a catheter (12), a catheter adapter (18) having a distal end (20) and a proximal end (22), an overall length (24) extending from the distal end to the proximal end, an internal cavity (26), a top portion (28), a bottom portion (30), and a tip region (94) having a distal opening (34) with a circumference through which the catheter extends, an introducer needle (36) extending through the catheter, and a needle hub (40) connected to the proximal end of the introducer needle. The catheter adapter is connected to the proximal end of the catheter, and at least a majority of the catheter adapter is made of a first material, while at least a portion of the tip is made of a second material that is more flexible than the first material.

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Description

Catheter adapter that provides resistance to catheter tangles TECHNICAL FIELD Aspects of the present description relate to a vascular access device that has a catheter and a catheter adapter that includes a tangle-resistant flexible element to support the catheter as it transitions from the catheter adapter to a patient vein and to prevent entanglement and occlusion of the catheter. BACKGROUND Infusion therapy, which uses catheters to administer fluids into and drain fluids from the body, has been standard practice in medical procedures for years. Patients in a variety of settings, including hospitals, home healthcare, and other care facilities, receive fluids, pharmaceuticals, and blood products through a vascular access device inserted into a patient's vascular system. Catheters of various types and sizes have been used extensively by clinicians in a variety of procedures, including, but not limited to, treating infection, providing anesthesia or analgesia, providing nutritional support, treating cancerous growths, maintaining blood pressure and heart rate, and many other clinically significant uses. However, catheter occlusion is a common complication experienced when using catheters in medical treatments and procedures.Entanglement of catheters results in a reduction in the rate of fluid delivery and, in many cases, causes a cessation of fluid flow and a rupture of the catheter wall, which is accompanied by fluid loss. Intravenous therapy is facilitated by vascular access devices located outside a patient's vascular system (extravascular devices). Examples of extravascular devices that can 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 from Becton, Dickinson and Company; syringes; septum-rupturing devices; catheters; and intravenous (IV) fluid chambers. A vascular device may be in place for short (days), moderate (weeks), or long (months to years) periods. A vascular access device may be used for continuous infusion therapy or for intermittent therapy. A common vascular access device is a plastic catheter inserted into a patient's vein. The catheter's length can vary from less than one centimeter for peripheral access to several centimeters for central access. The catheter is commonly incorporated into a catheter adapter to aid in ease of use, accessibility, and utility. A catheter adapter is typically a rigid, tubular plastic member designed to accommodate one end of the catheter, such that one end is supported by the adapter, and the catheter body and tip extend beyond the adapter's first end. A catheter adapter usually also 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 attaching a syringe to the catheter adapter to provide access to the patient's vasculature via the attached catheter. The catheter can be inserted transcutaneously. When inserted transcutaneously, catheter insertion is commonly assisted by an introducer needle. The introducer needle is typically housed within the catheter lumen so that the needle gauge is close to the catheter's internal diameter. The needle is positioned within the catheter so that its tip extends beyond the catheter tip, allowing it to penetrate the patient's vein and create an opening for catheter insertion. During insertion into a patient, the needle and catheter are typically approached at an angle of approximately 30°. The needle initially pierces the patient's epidermis and then continues into the vein. Once the needle and catheter tip are in the vein, they are repositioned so that they are generally parallel to the vein, allowing them to be inserted into the vein lumen. When the catheter is properly positioned within the vein, the needle is removed, and the catheter adapter is secured to the patient to prevent premature removal. Typically, the catheter adapter is secured to the patient's skin with tape and / or other appropriate fastening devices and / or a fixation dressing.When the catheter adapter is secured to the patient's skin, the root region of the catheter that immediately emerges from the catheter adapter should be arched to accommodate the transition of the catheter from the generally parallel, fixed orientation of the catheter adapter, to the catheter insertion angle; an angle of approximately 30°. Standard practice dictates that the catheter be inserted into a patient so that an extended section of the catheter is left between the patient and the catheter adapter to allow for transitional arching of the catheter. This exposed, archable length of the catheter tilts the catheter toward the patient's skin, and therefore the catheter root region experiences leverage forces, as the catheter acts as a lever and the first end of the catheter adapter acts as a pivot, exerting an upward force on the catheter root region. This upward force from the first end of the catheter adapter is undesirable due to the likelihood of occlusion of the catheter root region against the more rigid adapter. Occlusion typically occurs as the patient and / or the catheter moves, increasing the insertion angle relative to the fixed position of the catheter adapter.For example, if repositioning the catheter and / or patient causes the catheter to be inserted further into the patient, the archable length of the catheter between the patient and the catheter adapter decreases. This increases the insertion angle and the upward force on the catheter adapter, which is immobilized at the catheter root. As the insertion angle increases, the upward force on the catheter adapter also increases until the structural rigidity of the catheter wall is exceeded, causing the catheter to become tangled. Catheter occlusion is undesirable because occlusions slow or stop flow through the catheter, creating undesirable backpressures that can cause the infusion system to malfunction and / or be damaged. Furthermore, occlusions reduce the efficiency of the infusion system, which could negatively impact patient treatment or diagnostic procedures. Additionally, the exposed section of the bfrnn Ln / zznz / E / YiAi arched catheter can become contaminated and pose a health risk to the patient. For example, an exposed section of the catheter can become contaminated and then be inserted into the patient during patient and / or catheter readjustment due to normal use by the patient and / or clinician. To reduce the likelihood of contamination and subsequent patient exposure, clinicians often minimize the exposed catheter length by initially overinserting the catheter into the patient.By reducing the length of the exposed catheter, the upward force on the first end of the catheter adapter increases, increasing the likelihood of occlusion within the catheter root region. Contamination of the catheter and / or patient is undesirable for obvious reasons, the most obvious being that contamination can lead to secondary infection and / or complications not anticipated by the treating physician. Furthermore, a contaminated catheter can introduce a virus and / or bacteria into the patient, which may interfere with the patient's primary therapy, preventing them from receiving necessary additional treatment. Therefore, tangle-resistant flexible catheter adapters are desirable because they can reduce the possibility of occlusions and maintain a minimum fluid volume delivery rate. Although several attempts have been made to provide vascular access devices with a tangle-resistant catheter, there is still a need for a vascular access device that reduces the catheter's susceptibility to tangling when flexed or bent during fluid delivery. It would also be desirable to provide a tangle-resistant catheter adapter that increases ease of penetration into a patient's vein while maintaining flow rate and patency throughout the device's lifespan.There is also a need for a vascular access device that allows a steeper insertion angle, which can be useful for subcutaneous injection as it supports the catheter while it is fixed flat against the skin after a steep insertion. COMPENDIUM A first embodiment refers to a vascular access device comprising a catheter having a proximal end and a distal end, 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, a top portion, a bottom portion, a tip region having a distal opening with a circumference through which the catheter extends, an introducer needle extending through the catheter, and a needle hub connected to the proximal end of the introducer needle. In one embodiment, the catheter adapter is connected to the proximal end of the catheter, and at least a portion of the catheter adapter is made of a first material, and at least a portion of the tip is made of a second material that is more flexible than the first material.In another embodiment, at least the majority of a portion of the catheter adapter is made of a first material, and at least a portion of the tip is made of a second material that is more flexible than the first material. The portion of the tip made of the second material includes the tip having the distal opening with the circumference through which the catheter extends, where the catheter exiting the distal opening is flexibly supported by the tip. In one embodiment, the tip may include a tangle-resistant, flexible extension extending from the distal opening to provide support for the catheter. In one embodiment, the vascular access device may further comprise a wing element attached to the catheter adapter and extending radially outward from the catheter adapter. In one embodiment, the wing element is made of the second material. In one embodiment, the vascular access device may further comprise at least one connecting channel formed between the wing element and the tip portion made of the second material. The connecting channel may be formed on a surface outside or inside the catheter adapter. In one or more embodiments, the wing element and the tip portion are both made of the second material. In one or more embodiments, a wing element is molded directly into the catheter adapter. In one or more embodiments, the first and second materials have different durometer values. In one embodiment, the first material is a rigid polymer selected from one or more polyesters, copolyesters, polycarbonates, polyethylene, polystyrene, or polypropylene, and the second material is a flexible polymer. In one embodiment, the flexible polymer selected from one or more thermoplastic elastomers, thermoplastic polyurethanes, vulcanized thermoplastic elastomers, olefin block copolymers, 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 approximately 50 to 90 Shore A. The durometer hardness can be determined under ASTM D2240. In one or more configurations, the overall length of the catheter adapter is substantially the same at the top and bottom, and the distal opening has an internal curvature that defines a tapered region. In one configuration, the internal curvature of the lower portion of the distal opening defines a bevel. The vascular access device may be a central venous catheter, a peripherally inserted central catheter, a peripheral intravenous cannula, an arterial catheter, or a midline catheter. In one or more of these types, the catheter is made of polyurethane. In one embodiment, the wing element comprises a first wing member extending from one side of the catheter adapter. In yet another embodiment, the wing element comprises a second wing member extending from the opposite side of the catheter adapter and the first wing. The second wing and the tip portion fabricated from the second material are entirely molded. In one embodiment, the vascular access device further comprises an extension tube extending from the catheter adapter and in fluid communication with the adapter's internal cavity. In one or more embodiments, the vascular access device may also comprise a Luer lock, a blood control septum, an air vent, and a notch in the introducer needle. In one modality, the distal opening has an internal curvature that defines a tapered region where the tapered region supports the catheter in the distal opening. Another aspect of the description refers to a vascular access device comprising a catheter having a proximal and a distal end, a catheter adapter having a distal and a proximal end with an overall length extending from the distal to the proximal end, an internal cavity, a top, a bottom, and a tip having a distal opening through which the catheter extends, an introducer needle having a distal and a proximal end, a needle hub connected to the proximal end of the introducer needle, and a flexible, tangle-resistant extension extending from the distal opening of the tip to support the catheter adjacent to the distal opening. The catheter adapter can be connected to the proximal end of the catheter. In one embodiment, the catheter adapter is made of a first material and the tangle-resistant flexible extension is made of a second material that is softer than the first material. The extension can be total together with the tip, or alternatively, the extension and the tip can be molded separately. In one or more embodiments, the vascular access device further comprises a wing element attached to the catheter adapter and extending radially outward from the catheter adapter. In one embodiment, the catheter adapter is made of a first material, and the wing element and the tangle-resistant flexible extension are made of a second material. In one embodiment, the first material is more rigid than the second material. The first material may be a rigid polymer material selected from one or more of polyester, copolyester, polycarbonate, polyethylene, polystyrene, or polypropylene. The second material is a flexible polymer material selected from one or more of a thermoplastic elastomer (TPE), thermoplastic polyurethane (TPU), thermoplastic vulcanized elastomer (TPV), olefin block copolymers (OBC), polyisoprene, or silicone. In one embodiment, the wing element comprises a first wing member extending from one side of the catheter adapter. In yet another embodiment, the vascular access device further comprises a second wing member extending from the opposite side of the catheter adapter. In one modality, the distal opening has an internal curvature that defines a tapered region where the tapered region supports the catheter in the distal opening. BRIEF DESCRIPTION OF THE FIGURES Figure 1 illustrates a perspective view of a catheter adapter according to a first modality; Figure 2 is a cross-sectional view of the catheter adapter shown in Figure 1 taken along lines 2-2; Figure 3 is a view of a distal end of the catheter adapter shown in Figure 1; Figure 4 is a bottom plan view of the catheter adapter shown in Figure 1; Figure 5 is a cross-sectional view of a catheter adapter that includes a beveled opening; Figure 6 is a cross-sectional view of the catheter adapter shown in Figure 1, demonstrating the improved tangling resistance provided by the device; Figure 7 illustrates a perspective view of one or more modalities of a vascular access device that includes a catheter adapter; bfrnn Ln / zznz / E / YiAi Figure 8 is a top perspective view of a catheter adapter according to a second modality; Figure 9 is a view of a distal end of the catheter adapter in Figure 8; and Figure 10 is a bottom plan view of the catheter adapter in Figure 8. DETAILED DESCRIPTION Before proceeding to describe the various example modalities of the description, it is necessary to understand that the description provided is not limited to the construction details or process steps outlined below. The devices described herein are capable of other modalities and can be implemented or carried out in various ways. In the present description, a convention is followed where the distal end of the device is the end closest to a patient and the proximal end of the device is the end furthest from the patient and closest to a physician. The description outlines several types of catheter adapters, which can be used in combination with other components, such as a needle hub assembly that includes a needle, to provide various vascular access devices. Vascular access devices, according to one or more of these adapter types, include, but are not limited to, central venous catheters, peripherally inserted central catheters, peripheral intravenous cannulas, arterial catheters, and midline catheters. With reference to the drawings in which similar reference characters refer to similar parts across the various views thereof, FIGURES 1-7 illustrate a catheter adapter 18 and a vascular access device 10 according to one modality of the present description. As shown in Figures 1-6, the catheter adapter 18, which can be assembled with a cone assembly as further described below with reference to Figure 7, includes a catheter 12 having a proximal end 14 and a distal end 16, a catheter adapter 18 having a distal end 20 and a proximal end 22, an overall length 24 extending from the distal end 20 to the proximal end 22, an internal cavity 26, a top portion 28, a bottom portion 30, and an adapter tip 32 having a catheter adapter tip opening 34 with a circumference through which the catheter 12 extends. As shown in Figures 1-4, the catheter adapter 18 is connected to the proximal end 14 of the catheter 12. An introducer needle 36 extends through the catheter 12. A needle cone 40 is connected to the proximal end 38 of the introducer needle. 36.In one or more embodiments, at least a portion of catheter adapter 18 is made of a first material, and at least a portion of adapter tip 32 is made of a second material that is more flexible than the first material. In one specific embodiment, at least a majority of catheter adapter 18 is made of a first material, and at least a portion of adapter tip 32 is made of a second material that is more flexible than the first material. As used herein, "majority" means more than 50% of the volume of the catheter adapter. Catheter adapter 18 extends from adapter tip 32 to the proximal end 22. In one or more embodiments, the first and second materials have different durometer values.The first material is a rigid polymeric material selected from one or more of a polyester, copolyester, polycarbonate, polyethylene, polystyrene, or polypropylene, and the second material is a flexible polymeric material. In one or more embodiments, the flexible polymeric material is selected from one or more of a thermoplastic elastomer (TPE), thermoplastic polyurethane (TPU), thermoplastic vulcanized elastomer (TPV), olefin block copolymer (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 approximately 50 to 90 Shore A. The durometer hardness can be determined under ASTM D2240. As shown in Figures 1-6, the portion of the catheter adapter made from the second material is an extension 88, which projects distally from the tip of the catheter adapter 32. Therefore, in the embodiment shown, the portion of the catheter adapter 18 made from the second material includes the extension 88, which has a distal end 90 and a proximal end 92. In other embodiments, the catheter adapter 18 does not include the extension 88, and the portion of the catheter adapter made from the second material includes the distal tip region 94, which, according to one or more embodiments, includes only the distal tip region 94 that extends distally from the needle cup 40 to the tip of the catheter adapter 32. It is understood that only a portion of the distal tip region 94 can be made from the second material.Therefore, according to one or more modalities, a majority of the 18 catheter adapter made from the first material means that 70-75%, 75-80%, 80-85%, 85-99%, 90-99%, 90-98%, 90-97%, 90-96%, 90-95%, or 90-94% of the volume of the 18 catheter adapter, excluding the wing element, is made from the first material, and the remainder of the catheter adapter's volume is made from the second material. 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 percentage of the first material is determined by dividing the volume of the first material by the total volume of the catheter adapter. The 12-gauge catheter is generally tubular and flexible, comprising a shaft of uniform thickness and length. The 12-gauge catheter also includes a lumen. The diameter of the lumen can vary and is selected to accommodate a desired flow rate and / or pressure from the intravenous (IV) fluid source. Catheter 12 also includes a flexed portion 42, shown as a dashed line in Figure 6, as catheter 12 bends at the tip of catheter adapter 32. The flexed portion 42 is defined as the uninserted section of the catheter between the first end of the catheter adapter tip opening and the patient's catheter insertion site. Its length is defined by the distance between the flexed portion 42 of catheter 12 and the catheter tip 31. The proximity of the flexed portion 42 to the first end of catheter adapter 18 makes the flexed portion susceptible to occlusion. This is because the first end of the catheter adapter exerts an upward force on the flexed portion 42 when catheter 12 moves independently and relative to the generally horizontal plane of the catheter adapter.The length of the uninserted catheter, and therefore the maximum insertion point, is selected so that a sufficient length of catheter remains uninserted. This allows the flexed portion of the catheter to bend smoothly as it transitions from the catheter adapter to the insertion site, thus preventing occlusion due to overinsertion of the catheter. In one or more variations, the 12-gauge catheter may be made of a biomaterial designed to reduce mechanical phlebitis and infiltration. In one or more variations, the 12-gauge catheter may be made of polyurethane. In one specific variation, the biomaterial may be a polyurethane that softens up to 70% in the artery or vein to allow for increased patient comfort while providing resistance to tangling and improving catheter dwell time. The 12-gauge catheter may be available in sizes from 14 to 26 gauge. Catheter 12 also includes a catheter tip 31. The catheter tip 31 includes a catheter opening 46 that is selected to provide space for the introducer needle 36. The introducer needle 36 extends coaxially through a catheter adapter. The diameter of the catheter opening 46 is selected to provide minimal clearance between the outer surface of the introducer needle 36 and the inner surface of the catheter opening 46. As such, the catheter tip 31 can provide a sufficiently sized access route in a patient's vein. In one or more embodiments, a portion of the adapter 32 tip, machined from the second material, includes the tip having the distal opening with the circumference through which the catheter extends, and where a catheter exiting the distal opening is flexibly supported by the adapter 32 tip. Figure 4 shows the support area of the tangle-resistant, integrally molded-tip catheter transition feature. The portion of the adapter 32 tip made from the second material eliminates the abrupt, unsupported change in direction experienced by current catheters when exiting the catheter adapter 18, thereby minimizing localized stress on the catheter 12 and thus minimizing the possibility of catheter collapse and tangling and occlusion of fluid flow. In one or more embodiments, the first and second materials have different durometer values. The first material may be a rigid polymer selected from one or more of the following: polyester, copolyester, polycarbonate, polyethylene, polystyrene, or polypropylene, and the second material is a flexible polymer. 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 approximately 50 to 90 Shore A. The durometer hardness can be determined using ASTM D2240. In one or more of the forms, the flexible polymeric material is selected from one or more of a thermoplastic elastomer (TPE), thermoplastic polyurethane (TPU), thermoplastic vulcanized elastomer (TPV), olefin block copolymers (OBC), polyisoprene, or silicone. In one or more configurations, the catheter adapter 18 is generally tubular, and most of the catheter adapter is made of a rigid material, examples of which are provided above. The catheter 12 is incorporated into a catheter adapter 18 using industry-standard methods. The catheter adapter 18 further includes a body 48 that extends between the proximal end 22 and the distal end 20. The distal end 20 of the catheter adapter is generally tapered and includes a catheter adapter tip opening 34 through which the catheter 12 extends. The proximal end 22 generally includes an access port 54 for accessing the catheter lumen 44. The access port 54 may be a dual access port, providing multiple options for fluid and medication administration. The catheter adapter 18 can also be configured to accommodate the introducer needle 36 for inserting the catheter 12 into a patient. In one or more configurations, the introducer needle 36 includes a notch 58 to provide immediate confirmation of vessel entry at the insertion site to improve first-puncture success. An additional, optional feature of the catheter adapter 18 may include a side access port 56 that extends from and is in fluid communication with the catheter adapter 18. As shown in Figures 1-4 and 6-7, one or more embodiments of catheter adapter 18 may include wing element 62. Wing element 62 is attached to catheter adapter 18 and extends radially outward from catheter adapter 18. In one or more embodiments, wing element 62 is made from the second material. In one or more embodiments, the wing element 62 includes a first wing member 68 extending from one side of the catheter adapter 18. In yet another embodiment, the wing element includes a first wing member 68 extending in a first direction from one side of the catheter adapter 18 and a second wing member 70 extending in a direction opposite to the first direction, and the first wing member 68, the second wing member 70, and the portion of the extension fabricated from the second material are molded as one. However, the first wing member and the second wing member 70 need not be molded as one, and each of these components may be molded separately from the same or different materials.Furthermore, while the first wing member 68 and the second wing member 70 are shown as being a single, contiguous piece forming wing element 62, they may be separate pieces. Additionally, depending on one or more of the designs, the wing element may consist of a single wing member, either the first wing member 68 or the second wing member 70. Wing element 62 provides increased catheter stability and thus increases dwell time. In one or more of the designs, the first wing member 68 and the second wing member 70 may be made of the second material to create a soft, flexible wing for patient comfort. In yet another embodiment, at least one connection channel is formed on an inner surface of the catheter adapter to provide an internal connection channel 66. As shown in Figure 2, the internal connection channel 66 is formed between the adapter tip 32 and the wing element 62. The internal connection channel 66 minimizes any potential impact on the external geometry of the catheter adapter's nosepiece. The internal connection channel 66 can be manufactured using a two-dose process to integrally mold the flexible tip and the catheter's transition point with the wing element 62. A first dose is the first material comprising a majority of the catheter adapter 18, and a second dose is the second material comprising a portion of the adapter tip 32. During use, the catheter adapter 18 is secured to a patient, and the catheter tip 31 is inserted into the patient's vascular system. The catheter 12 is positioned and inserted into the patient's vascular system at a predetermined insertion angle. The insertion angle can include any angle (α, β, γ ... After catheter insertion, the flexed portion of the catheter bends into a general arc shape to accommodate the transition from the catheter adapter to the catheter insertion site. This feature also allows for a steeper insertion angle, which can be useful for subcutaneous injection as it supports the catheter while it lies flat against the skin after a steep insertion.After the catheter is inserted into the insertion site, it experiences higher leverage forces. The catheter acts as a lever, and the rigid end of the catheter adapter acts as a pivot, exerting an upward force on the catheter. As the catheter is further inserted, this upward force is dissipated by the flexible tip of the catheter adapter, which is made of a second material. This tip also bends with the catheter to prevent tangling and occlusion.Therefore, according to one or more of the modalities described herein, where the vascular access device has a majority of the catheter adapter 18 made of a first material and at least a portion of the adapter tip 32 is made of a second material that is more flexible than the first material, flow rates and patency are maintained throughout the device's lifespan. This is particularly useful in cases of blood collection from a peripherally inserted central catheter, a peripherally inserted central catheter, or a central venous catheter vascular access device. In one or more of the following configurations, as shown in Figure 5, the opening of the catheter adapter tip 34 is round, curved, or beveled on surface 35 so that the opening includes an arc of no more than 90°. The degree of curvature is selected to support the flexed portion of the catheter and maintain an insertion angle within the desired range. In the present configuration, the flexed portion of the catheter is bent over and along the contour of the opening of the round or curved catheter adapter tip 34. The flexed portion is supported by the round opening, which maintains the necessary degree of curvature for the catheter to prevent occlusion and maintain the optimal degree of insertion. The round opening minimizes the influence of the distal end shaft of the catheter adapter on the flexed portion of the catheter, allowing the catheter to be inserted maximally into the patient with minimal upward force on the distal end of the catheter.This minimizes the likelihood of occlusion. In one or more configurations, the distal opening has an internal curvature that defines a tapered region on surface 35 where the tapered region supports the catheter in the distal opening. Following catheter insertion, the tapered region provides transitional support at an insertion angle for the catheter without restricting flow through the catheter. As shown in Figure 5, the overall length of the catheter adapter is substantially equivalent at the top and bottom, and the distal opening has an internal curvature that defines a tapered region, and where the internal curvature of the bottom of the distal opening defines a bevel. bfrnn Ln / zznz / E / YiAi In one or more embodiments, the tip opening of catheter adapter 34 is beveled to increase the clearance between the distal end of the adapter and the flexed portion of the catheter. This allows the flexed portion of the catheter to bend more quickly before it contacts the tip opening of the adapter, preventing occlusion. In one embodiment, the tip opening of the adapter is beveled at an angle less than 90° relative to the generally horizontal plane. This beveled opening allows a greater length of catheter to be inserted before occlusion occurs due to the delayed contact between the tip opening and the catheter.Therefore, as the flexed portion of the catheter is further inserted into the patient, the flexed portion is allowed to bend to a greater degree before making contact and rotating in the tip opening, resulting in catheter occlusion at the flexed portion. In one or more embodiments, the catheter adapter 18 is made of a first material, and the tangle-resistant flexible extension 88 is made of a second material that is softer than the first. In another embodiment, the tangle-resistant extension 88 may be made of the same material as the catheter adapter 18; however, the tangle-resistant extension 88 may be made of a thinner section of material to allow the tangle-resistant extension 88 to be more flexible than the catheter adapter 18. In one or more embodiments, the tangle-resistant extension 88 may be integrated with the tip of adapter 32, or the extension 88 and the tip of adapter 32 may be molded separately. Figures 8-10 show an embodiment in which the catheter adapter 118 is substantially the same as the catheter adapter 118 described with respect to Figures 1-4 and 6, except for the connecting channel as further described below. The catheter adapter 118 has a distal end 120 and a proximal end 122, an overall length 124 extending from the distal end 120 to the proximal end 122, a top portion 128, a bottom portion 130, and an adapter tip 132 having a distal opening 134 with a circumference through which the catheter extends (not shown). A majority of the catheter adapter, as described above, is made of a first material, and at least a portion of the adapter tip 132 is made of a second material that is more flexible than the first material.As used herein, "majority" means more than 50% of the volume of the catheter adapter and includes the intervals provided above. A portion of the adapter tip 132 includes at least one external connection channel 164 formed on an external surface of the catheter adapter and extending continuously between the adapter tip 132 and the wing element 162. In one or more embodiments, the wing element 162 and the adapter tip portion are both made of a second material. In one or more embodiments, the wing element 162 is molded directly into the catheter adapter. The optional wing element 162 is attached to the catheter adapter 18 and extends radially outward from the catheter adapter 118. In one or more modalities, the wing element 162 is made from the second material. In one or more embodiments, the wing element 162 includes a first wing member 168 extending from one side of the catheter adapter 118. In yet another embodiment, the wing element includes a first wing member 168 extending in a first direction from one side of the catheter adapter 118 and a second wing member 170 extending in a direction opposite to the first direction, and the first wing member 168, the second wing member 170, and the portion of the extension fabricated from the second material are integrally molded. However, the first wing member and the second wing member 170 need not be integrally molded, and each of these components can be molded separately from the same or different materials.Furthermore, while the first wing member 168 and the second wing member 170 are shown as being a single, contiguous piece forming wing element 162, they may be separate pieces. Additionally, in one or more embodiments, the wing element may comprise a single wing member, either the first wing member 168 or the second wing member 170. Wing element 162 provides increased catheter stability and thus increases dwell time. In one or more embodiments, the first wing member 168 and the second wing member 170 may be made of the second material to create a soft, flexible wing for patient comfort. In one or more embodiments, the first and second materials have different durometer values. The first material may be a rigid polymer selected from one or more of a polyester, copolyester, polycarbonate, polyethylene, polystyrene, or polypropylene, and the second material is a flexible polymer. In one or more embodiments, the flexible polymer selected from one or more of a thermoplastic elastomer (TPE), thermoplastic polyurethane (TPU), thermoplastic vulcanized elastomer (TPV), olefin block copolymer (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 approximately 50 to 90 Shore A. The durometer hardness may be determined under test method ASTM D2240. At least one external connection channel 164 is formed on an external surface of the catheter adapter between the wing element 162 and the adapter tip portion 132 made from the second material. The catheter adapter 118 can be formed using a two-dose injection molding process in which a first material comprising a majority of the catheter adapter 118 is injected into the mold and a second material comprising at least a portion of the adapter tip 132 is injected into the mold. The catheter adapter 118 described with reference to Figures 8-10 can be used as part of a vascular access device described with reference to Figure 7. Therefore, as described below, the catheter adapter 18 described with reference to Figure 7 can be replaced with the catheter adapter 118 described with reference to Figures 8-10. As shown in Figure 7, the catheter adapter 18 can be part of a vascular access device 10, with additional components in fluid communication with the catheter adapter 18. As shown in Figure 7, the side access port 56 can be connected to a section of extension tubing 60 to establish fluid communication between an IV fluid source and the internal cavity 26 of the catheter adapter or the lumen 44 of the catheter. In one or more configurations, the extension tubing 60 extends in line with or laterally to the catheter adapter body. In one or more configurations, the extension tubing 60 is recessed to reduce contamination and mechanical phlebitis by eliminating manipulation at the insertion site. In one or more configurations, the extension tubing 60 is compatible with high-pressure injection.In one or more modalities, the 60 extension tube provides continuous confirmation of vessel access during catheter advancement into the patient's vein. In one or more embodiments, the needle cone assembly 50 is assembled with the catheter adapter by inserting the needle into the lumen 44 of catheter 12. The needle cone assembly is shown as including the finger rest 84 located on the sides of the needle cone assembly 50 to facilitate various insertion techniques. In one or more embodiments, there may be protrusions present on the finger rest to indicate where the user can grip the device to remove the needle. In one or more embodiments, a thumb pad 85, having a barely convex surface, is provided at the proximal end of the needle cone assembly 50. A flange 86, with a barely convex surface, is provided at the proximal end of the cone assembly to provide a finger pad. The first wing members 68, the second wing member 70, the thumb pad 85, and the flange 86 can be used by the user during insertion, allowing the user to choose which insertion technique to employ. In one or more embodiments, the needle cone assembly 50 includes a needle guard 80. The needle guard may be of a design adapted to secure the needle tip within the guard after use. In one or more embodiments, the needle guard may be passively activated to ensure compliance with the user's technique. The needle tip is completely covered by the needle guard in a fixed position. In one or more embodiments, a ferrule, clamp, or other structure may be included near the tip for coupling with a needle guard in certain applications. A push tab 81 may be provided to facilitate catheter advancement during insertion. The push tab also allows for one-handed or two-handed advancement. In one or more modalities, the push tab is removed with the needle shield. A clamp 82 may be included on the extension tubing to prevent blood flow when the access port is replaced. The proximal end of the introducer needle can be corrugated to provide a fluid-tight seal around the proximal end. The introducer needle can be glued or mechanical locking devices can be formed to secure the introducer needle to the cone. In one or more embodiments, the vascular access device 10 further includes a first Luer access 72 and a second Luer access 73 in fluid communication with the extension tube 60, a separate blood control septum 74 associated with the first Luer access 72, and an air vent 76 associated with the second Luer access 73. The separate septum 74 allows for a reduction in catheter-related bloodstream infection (CRBSI) while providing unrestricted flow and direct fluid passage and functioning as a blood control septum. In one or more embodiments, the separate septum 74 may be located in an internal cavity of the catheter adapter or at the distal end of the catheter adapter. In yet another embodiment, the separate septum 74 may be located at a distal end of the extension tube 60.Air vent 76 allows air to escape from the system during insertion, providing continuous confirmation of vascular access while preventing blood leakage from the system during insertion. In one or more modalities, air vent 76 may be located at the distal end of extension tube 60. References throughout this descriptive report to a modality, certain modalities, one or more modalities, or a modality mean that a particular feature, structure, material, or characteristic described in connection with that modality is included in at least one modality of the description. Therefore, the use of phrases such as "in one or more modalities," "in certain modalities," or "in a modality" in various instances of the descriptive report does not necessarily refer to the same modality of the description. Furthermore, particular features, structures, materials, or characteristics may be combined in any appropriate way within one or more modalities. Although the description herein provides a description with reference to particular embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the present description. It will be evident to those skilled in the art that various modifications and variations to the method and apparatus of the present invention may be made without departing from the spirit and scope of the invention. Therefore, the present invention is intended to include modifications and variations that fall within the scope of the appended claims and their equivalents.

Claims

1. A vascular access device comprising: a catheter with a proximal end and a distal end; a catheter adapter having a distal end, a proximal end, an overall length extending from the distal end to the proximal end, an internal cavity, a top portion, a bottom portion, and a tip region having a distal opening having a circumference through which the catheter extends, the catheter adapter being connected to the proximal end of the catheter; an introducer needle having a distal end and a proximal end; a needle hub connected to the proximal end of the introducer needle; and a tangle-resistant flexible extension extending from the distal opening of the tip to support the catheter adjacent to the distal opening, the distal opening having an internal curvature defining a tapered region where the tapered region supports the catheter in the distal opening, a wing element;an internal connection channel formed on an internal surface of the catheter adapter, the internal connection channel is formed between the wing element and the tip of the catheter adapter, the internal connection channel configured to minimize the impact on the tip.; 2. The vascular access device according to claim 1, wherein the catheter adapter is made of a first material and the tangle-resistant flexible extension is made of a second material that is softer than the first material.

3. The vascular access device according to claim 2, wherein the extension is integral with the tip.

4. The vascular access device according to claim 2, wherein the extension and the tip are molded separately.

5. The vascular access device according to claim 1, the wing element attached to the catheter adapter and extending radially outward from the catheter adapter, wherein the catheter adapter is made of a first material and the wing element and the tangle-resistant flexible extension are made of a second material, wherein the first material is more rigid than the second material.

6. The vascular access device according to claim 2, wherein the first material is a rigid polymeric material selected from one or more of polyester, copolyester, polycarbonate, polyethylene, polystyrene or polypropylene, and the second material is a flexible polymeric material.

7. The vascular access device according to claim 6, wherein the flexible polymeric material is selected from one or more of a thermoplastic elastomer (TPE), thermoplastic polyurethane (TPU), thermoplastic vulcanized elastomer (TPV), olefin block copolymers (OBC), polyisoprene, or silicone.

8. The vascular access device according to claim 1, wherein the vascular access device is selected from the group consisting of a central venous catheter, a peripherally inserted central catheter, a peripheral intravenous cannula, an arterial catheter, and a midline catheter.

9. The vascular access device according to claim 5, wherein the wing element comprises a first wing member extending from one side of the catheter adapter.

10. The vascular access device according to claim 9, further comprising a second wing member extending opposite one side of the catheter adapter.

11. The vascular access device according to claim 1, wherein the catheter is made of polyurethane.