CATHETER ADAPTER WITH DISTAL INTERNAL DIAMETER CURVATURE THAT PROVIDES RESISTANCE TO BENDING
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
Smart Images
Figure MX434760B0 
Figure MX434760B1
Abstract
Description
Some aspects of the present description relate to an adapter with a catheter adapter tip opening having an internal curve to hold the tubular catheter as it passes from the catheter adapter into a patient's vein to prevent catheter bending and occlusion, and also vascular access devices that include catheter adapters. BACKGROUND Infusion therapy, which uses catheters to administer fluids to and drain from the body, has been standard practice in medical procedures for years. Patients in various settings, including hospitals, home care, and other care facilities, receive fluids, pharmaceuticals, and blood products through a vascular access device inserted into their vascular system. Catheters of various types and sizes have been widely used by clinicians in a variety of procedures, including, but not limited to, treating infection, delivering anesthesia or pain relief, providing nutritional support, treating cancer, 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 procedures and treatments. The curvature of the catheter reduces the fluid volume delivery rate and, in many cases, causes an interruption of the flow and rupture of the catheter wall with a concurrent loss of fluid. Intravenous therapy is facilitated by vascular access devices located outside a patient's vascular system (extravascular devices). 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 Access Luer Device from Becton, Dickinson and Company; syringes; split septum devices; catheters; and intravenous (IV) fluid chambers. A vascular device may remain in place for a short period (days), a moderate period (weeks), or a prolonged period (months to years). A vascular access device can be used for continuous infusion therapy or for intermittent therapy. ινΐΛ / a / zuzz / ui 4i yj A common vascular access device is a plastic catheter inserted into a patient's vein. The catheter's length can range from a few centimeters for peripheral access to many centimeters for central access. Typically, the catheter is incorporated into a catheter adapter to facilitate its use, accessibility, and utility. Generally, a catheter adapter is a rigid, tubular plastic member designed to accommodate one end of the catheter, such that one end is held by the adapter and the catheter's body and tip extend beyond a first end of the adapter. Typically, a catheter adapter 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, thereby providing access to the patient's vasculature through the attached catheter. The catheter can be inserted transcutaneously. When inserted transcutaneously, catheter insertion is typically assisted by an introduction needle. The introduction needle is usually positioned within the catheter lumen so that its gauge approximates the catheter's internal diameter. The needle is then positioned inside the catheter so that its tip extends beyond the catheter's 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 generally approached at an angle of approximately 30°, with the needle initially piercing the patient's epidermis and then advancing into the vein. Once the needle and catheter tip are in the vein, they are repositioned, generally parallel to the vein, to allow for insertion into the vein lumen. After the catheter is properly positioned, the needle is withdrawn from the catheter lumen, and a catheter adapter is secured to the patient to prevent premature catheter removal. Typically, the catheter adapter is secured to the patient by attaching it to the patient's skin with tape, a clamping device, and / or a securing bandage. When securing the catheter adapter to the patient's skin, the root portion of the catheter that immediately emerges from the adapter should be curved to accommodate the catheter's transition from the generally parallel, clamped orientation to the catheter's insertion angle, approximately 30°. The general practice allows the catheter to be inserted into a patient in such a way that an extended section of the catheter remains between the patient and the catheter adapter to allow for transient splay of the catheter. This exposed, splayed length of catheter tilts the catheter toward the patient's skin, and therefore the catheter root region experiences leverage forces since the catheter acts as a lever and the first end of the catheter adapter acts as a fulcrum, exerting an upward force on the catheter root region. This upward force from the first end of the catheter adapter is undesirably due to the likelihood of occlusion of the catheter root region against the more rigid catheter adapter. Commonly, occlusion occurs as the patient or the catheter moves, which increases the insertion angle relative to the fixed position of the catheter adapter.For example, if catheter repositioning and / or patient movement causes the catheter to be inserted further into the patient, the archable length of the catheter between the patient and the catheter adapter decreases, increasing the insertion angle and the upward force on the catheter adapter 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 bend. Catheter occlusion is undesirable because it slows or stops flow through the catheter, creating unwanted backpressures that can cause the infusion system to malfunction and / or be damaged. Furthermore, occlusions reduce the effectiveness of the infusion system, which could negatively impact patient treatment or diagnostic procedures. Additionally, the exposed, arced section of catheter could become contaminated, posing a health risk to the patient. For example, an exposed section of the catheter could become contaminated and then be reinserted into the patient as the patient and / or the catheter is readjusted due to normal use by the patient and / or clinician. To reduce the likelihood of contamination and subsequent patient exposure, clinicians aim to 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, which increases the likelihood of occlusion within the catheter root region. Contamination of the catheter and / or the 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, bend-resistant catheter adapters that can support catheters are desirable because they can reduce the possibility of occlusions and maintain a minimum fluid volume delivery rate. While various attempts have been made to provide vascular access devices with a bend-resistant catheter, there remains a need for a vascular access device that reduces the catheter's susceptibility to bending when flexed or bent during fluid delivery. It would also be desirable to provide a bend-resistant catheter adapter that increases ease of penetration into a patient's vein while maintaining patency and flow rate 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 and remains flat against the skin after steep insertion. COMPENDIUM A first embodiment relates to a vascular access device comprising a catheter including a flexed portion, a catheter adapter with a distal and a proximal end with a total length extending from the distal to the proximal end, an internal cavity, a top portion, a bottom portion, and a distal tip with a catheter adapter tip opening having a circumference through which the catheter extends. The catheter adapter tip opening has an internal curvature defining a tapered region at the bottom. The tapered region supports the flexed portion of the catheter to provide an insertion angle for the catheter without restricting flow through it. The tapered region provides a conical relief to the catheter. The total length is substantially equivalent at the top and bottom, and the tapered region is less than the total length. In one embodiment, the internal curvature of the lower portion of the catheter adapter tip opening defines a bevel. In another embodiment, the internal curvature of the lower portion of the catheter adapter tip opening is 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 gradually decreases as it extends away from the distal tip. In one or more embodiments, the upper portion of the catheter adapter tip opening does not include an internal curve extending from the distal tip. The vascular access device can be a central venous catheter, a peripherally inserted central catheter, a peripheral intravenous cannula, an arterial catheter, or a midline catheter. Part of the catheter is housed within the internal cavity of the catheter adapter. The catheter is securely attached to the catheter adapter. iviA / a / zuzz / ui 4i yj In one modality, the insertion angle is within a range of approximately 10 to 60°. In a specific modality, the insertion angle is approximately 15-45°. In one design, the upper radius is asymmetrical with respect to the lower radius. In another design, the upper part of the catheter adapter is oriented tangentially to the catheter. In one modality, the internal curvature on the lower part of the adapter extends along part of the circumference of the catheter adapter tip opening and defines an arc that forms an angle in the range of 90° to 360°. In a specific modality, the angle is in the range of 180° to 360°. The vascular access device further comprises an introduction needle into the internal cavity; the needle has a distal end and a proximal end, and the needle hub is connected to the proximal end of the introduction 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 luer access, a blood control septum, an air vent, and a slot in the introduction needle. In one embodiment, the vascular access device further comprises a fin element extending radially outward from the catheter adapter. The fin element comprises a first fin member extending from one side of the catheter adapter. In yet another embodiment, the fin element further comprises a second fin member extending opposite one side of the catheter adapter. In one embodiment, at least a portion of the catheter adapter is made of a first material, and at least a portion of the distal tip is made of a second material that is more flexible than the first material. In yet another embodiment, at least a larger portion of the catheter adapter is made of a first material, and at least a portion of the distal tip is made of a second material that is more flexible than the first material. In one or more embodiments, the distal tip includes a flexible, bend-resistant extension that extends from the opening of the catheter adapter tip to provide support to the catheter. In one modality, the needle also includes a bevel at the distal tip, and the bevel of the needle is oriented asymmetrically with respect to the conical relief. In one or more modalities, the upper part is absent in an opening of the catheter adapter tip with an internal curvature that defines a conical region. Another aspect of the description relates to a device for preventing restricted flow within a catheter. In one embodiment, the device comprises a catheter adapter with a distal and a proximal end, the total length of which extends from the distal to the proximal end, an internal cavity, an upper portion, a lower portion, and a distal tip having an opening through which a catheter, including a flexed portion, extends. The total length is substantially equivalent in the upper and lower portions. The lower portion of the adapter has a curved surface to hold the flexed portion of the catheter at a desired insertion angle in a patient and to prevent catheter kinking.In one or more modalities, the upper part of the adapter in contact with the catheter has a substantially straight surface and a constant thickness to maintain catheter rigidity during catheter insertion into a patient. In one or more configurations, the upper portion of the catheter adapter tip opening transversely defines a semicircular arc forming an angle within the range of 0° to 270°, and the lower portion of the catheter adapter tip opening transversely defines a partial ellipse. In one or more configurations, the lower portion of the catheter adapter tip opening forms an angle within the range of 0° to 270°. BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 illustrates a perspective view of a catheter adapter according to a first modality; Figure 2 is a partial cross-sectional view of one modality of a vascular access device, where a catheter of the device is inserted into a patient; Figure 3 is a cross-sectional view of a catheter adapter that includes a beveled opening; Figure 4 is a partial cross-sectional view of one modality of a vascular access device, where a catheter of the device is inserted into a patient and a tip of the catheter adapter is profiled at the bottom; Figure 5 is a partial cross-sectional view of a catheter adapter that includes a beveled opening; Figure 6A illustrates a cross-sectional profile of a catheter adapter tip according to one modality; Figure 6B illustrates a cross-sectional profile of a catheter adapter tip according to one modality; Figure 6C illustrates a cross-sectional profile of a catheter adapter tip according to a modality; and Figure 7 is a perspective view of one or more modalities of a vascular access device that includes a catheter adapter according to a modality. DETAILED DESCRIPTION Before describing various illustrative examples, it should be understood that this description is not limited to the construction details or process stages indicated below. The devices described herein allow for other configurations and can be implemented or carried out in various ways. In the present description, a convention is followed in which 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 the professional. The description outlines several types of catheter adapters, which can be used in conjunction 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 in the various views thereof, Figures 1-6 illustrate a catheter adapter 20 and Figure 7 illustrates a non-exhaustive example of a vascular access device 10 using a catheter adapter according to one or more modalities of the present description. As shown in Figures 1-5, the catheter adapter 20, which can be assembled with a cone assembly as further described below with reference to Figure 7, includes a catheter 12 with a proximal end 14, a distal end 16, and a flexed portion 21; a catheter adapter 20 with a distal end 22 and a proximal end 24; an internal cavity 26; a top portion 28; a bottom portion 30; and an adapter tip 32 with a catheter adapter tip opening 34 having a circumference through which the catheter 12 extends. As shown in Figures 2 and 3, the catheter adapter 20 is connected to the proximal end 14 of the catheter 12. The catheter adapter 20 extends from the adapter tip 32 to the proximal end 24, defining a catheter adapter length "L". An introduction needle 36 extends through the catheter 12.A needle cone 40 is connected to the proximal end 38 of the introduction needle 36. ινΐΛ / a / zuzz / ui 4i yj As shown in Figures 2-5, the total length L of the catheter adapter is substantially equivalent to the top and bottom portions, and the catheter adapter tip opening 34 has an internal curvature that defines a tapered region on surface 35 at the bottom of the catheter adapter but not at the top. This tapered region on surface 35 supports the flexed portion of the catheter to provide an insertion angle without restricting flow through the catheter. The tapered region is less than the total length. The internal curvature on surface 35 at the bottom of the catheter adapter tip opening 34 defines a bevel. As more clearly shown in Figure 3, the lower portion of the opening in the tip of catheter adapter 34 defines a radius "R" at the distal tip that gradually decreases with distance from the distal tip in a proximal direction. In other words, because the lower portion of the tip of catheter adapter 34 has a surface 35, the radius R will be greater at the most distal part of the tip than the radius measured at sites located some distance from the tip in a proximal direction. Therefore, the radius R decreases continuously as the radius of the opening is measured at sites farther from the tip of adapter 32 in a proximal direction. In one or more configurations, the upper portion of the opening in the tip of catheter adapter 34 does not include an internal curvature extending from the distal tip. The radius of the upper portion may be asymmetrical with respect to the radius of the lower portion.In one or more modalities, the upper part of the catheter adapter is oriented tangentially with respect to the catheter. As shown in Figures 3-5, in one or more configurations, the internal curvature on surface 35 of the lower portion of the catheter adapter tip opening 34 defines a bevel. In yet another configuration, the internal curvature on surface 35 of the lower portion of the catheter adapter tip opening 34 is rounded or trumpet-shaped. In one or more configurations, the internal curvature on surface 35 on the lower portion of the adapter extends over a portion of the circumference of the catheter adapter tip opening 34 and defines an arc that forms an angle in the range of 90° to 270°. In one specific configuration, the angle is in the range of 180° to 270°. In one or more embodiments, the catheter adapter 18 may form part of an apparatus for preventing restricted flow within a catheter 12, which includes a catheter adapter 18, as described above, with a distal end 22, a proximal end 24, a total length L extending from the distal end to the proximal end, an internal cavity 26, an upper portion 28, a lower portion 30, and a distal tip 32 with a catheter adapter tip opening 34 through which a catheter extends, including a flexed portion 21, wherein the total length is substantially equivalent at the upper and lower portions, the lower portion of the adapter having a curved surface to hold the flexed portion of the catheter at a desired insertion angle in a patient and to prevent curvature of the catheter.The upper portion of the adapter in contact with the catheter 12 has a substantially straight surface and a constant thickness to maintain catheter rigidity during catheter insertion into a patient. In one or more embodiments, the upper portion of the catheter adapter tip opening 34 transversely defines 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 opening 34 transversely defines a partial ellipse. In general, a 12-gauge catheter is a flexible, tubular structure with a uniform thickness and length. It also includes a lumen. The diameter of this lumen can vary and is selected to accommodate the desired flow rate and / or pressure from the intravenous fluid source. Catheters can range in size from 14 to 26 gauge. As shown in Figures 2 and 4, catheter 12 also includes a flexed portion 21. The flexed portion 21 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 51. The length is defined by the distance between the flexed portion 21 of catheter 12 and the catheter tip 31. The proximity of the flexed portion 21 to the first end of the catheter adapter 18 causes the flexed portion to tend toward occlusion. This is because the first end of the catheter adapter exerts an upward force on the flexed portion 21 when the catheter 12 moves independently of and with respect 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 the catheter remains uninserted.This allows the flexed portion of the catheter to curve slightly as it transitions from the catheter adapter to the insertion site, thereby preventing occlusion due to over-insertion of the catheter. In one or more configurations, the 12-gauge catheter can be made of a biomaterial designed to reduce infiltration and mechanical phlebitis. In one or more configurations, the 12-gauge catheter can be made of polyurethane. In one specific configuration, the biomaterial can be a polyurethane that softens up to 70% in the vein or artery to allow for greater patient comfort while providing resistance to bending and improving catheter dwell time. Catheter 12 further includes a catheter tip 31. The catheter tip 31 includes a catheter opening 46 selected to provide clearance for the introduction needle 36. The introduction 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 introduction needle 36 and the inner surface of the catheter opening 46. In this way, the catheter tip 31 can provide a sufficiently sized access route to a patient's vein 64. The introduction needle 36 may further include a bevel on its distal tip. The needle bevel may be oriented asymmetrically with respect to the conical relief or internal curvature on the underside of the catheter adapter tip opening 34. In one or more embodiments, the lower portion of the adapter tip 32 includes a distal opening that has the circumference through which the catheter extends, and wherein a catheter exiting the distal opening is flexibly supported by the internal curvature on the surface 35 of the lower portion of the catheter adapter tip opening 34. Figures 3-5 show the support area of the integrally molded, curved transition element of the catheter tip. The catheter adapter tip opening 34 includes a surface 35 with an internal curvature that defines a tapered region on the lower portion but not the upper portion, wherein the tapered region supports the flexed portion of the catheter to provide an insertion angle for the catheter without restricting flow through the catheter; the tapered region is less than the overall length.After catheter insertion, the tapered region provides transitional support at an insertion angle for the catheter without restricting flow through it. The opening of the catheter adapter tip 34 can include either a steep or gradual insertion angle. Figure 4 shows the support area of the integrally molded, bend-resistant transition element of the catheter tip. The internal curvature that defines a tapered region at the bottom eliminates the abrupt, unsustained change in direction experienced by current catheters as they exit the catheter adapter 20, thereby minimizing localized stress on the catheter 12 and thus minimizing the possibility of catheter collapse and bending, and occlusion of fluid flow. In one or more embodiments, the total length L of the catheter adapter is substantially equivalent at the top and bottom, and the opening of the catheter adapter tip 34 has an internal curvature that defines a conical region, and wherein the internal curvature of the bottom of the opening of the catheter adapter tip 34 defines a bevel. In one or more embodiments, the catheter adapter 18 is generally tubular. A portion of the catheter is housed within the internal cavity of the catheter adapter. The catheter 12 is inserted into a catheter adapter 18 using industry-standard methods. The catheter adapter 20 further includes a body 48 that extends between the proximal end 24 and the distal end 22. In one or more embodiments, the catheter is securely attached to the catheter adapter in a hermetic manner. In this way, fluid from the intravenous fluid source can flow through the lumen 44 and into the catheter 12 without interruption. The distal end 22 of the catheter adapter is generally tapered and includes a catheter adapter tip opening 34 through which the catheter 12 extends. Generally, the proximal end 24 includes an access port 54 for accessing the lumen 44 of the catheter.Access port 54 can be a dual access port that provides multiple options for fluid and drug administration. Additional elements of the catheter adapter may include a side access port 56 that extends from and is in fluid communication with the catheter adapter. An extension tube 60 may be attached to the side access port 56 to allow controlled re-entry. The side access port 56 may be connected to a section of the extension tube 60 to establish fluid communication between an intravenous fluid source and the internal cavity 26 of the catheter adapter or the lumen 44 of the catheter. In one or more configurations, the 60 extension tube extends from the lateral access port or proximal end of the catheter adapter to establish smooth communication with the adapter's internal cavity. The extension tube may extend in line with or laterally to the catheter adapter body. The extension tube may be incorporated to reduce contamination and mechanical phlebitis by eliminating manipulation at the insertion site. The extension tube may be compatible with high-pressure injection. The extension tube provides continuous confirmation of vessel access during catheter advancement into the patient's vein. The catheter adapter 18 can also be configured to accommodate the introduction needle 36 for inserting the catheter 12 into a patient. In one or more configurations, the introduction needle 36 includes a groove 58 to provide immediate confirmation of the vessel's entry at the insertion site, thus improving first-attempt placement. As shown in Figures 1 and 7, one or more embodiments of catheter adapter 20 may include a fin element 62. The fin element 62 is attached to catheter adapter 20 and extends radially outward from catheter adapter 20. In one or more embodiments, the fin element 62 includes a first fin member 68 extending from one side of the catheter adapter 18. In yet another embodiment, the fin element includes a first fin member 68 extending in a first direction from one side of the catheter adapter 18 and a second fin member 70 extending in a direction opposite to the first direction. In one or more embodiments, the first fin member and the second fin member 70 are integrally molded. However, the first fin member and the second fin member 70 need not be integrally molded, and each of these components may be molded separately from the same or different materials. Furthermore, while the first fin member 68 and the second fin member 70 are shown as a contiguous piece to form the fin element 62, the first fin member 68 and the second fin member 70 may be separate parts.Furthermore, according to one or more modalities, the fin element may comprise a single fin member, either the first fin member 68 or the second fin member 70. The first fin member 68 and the second fin member 70 provide increased catheter stability and thus increase dwell time. 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 the tip of adapter 32 is made of a second material that is more flexible than the first material. In one specific embodiment, at least the majority of catheter adapter 18 is made of a first material, and at least a portion of the tip of adapter 32 is made of a second material that is more flexible than the first material. As used herein, "majority" refers to more than 50% of the volume of the catheter adapter, excluding the fin element.To determine the quantity of the first material, the total volume of the first material is determined, the total 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. In one or more embodiments, the catheter adapter, excluding the fin element and the catheter, may be made of a rigid polymeric material selected from one or more of the following: polyester, copolyester, polycarbonate, polyethylene, polystyrene, or polypropylene. In one or more embodiments, the first fin member 68 and the second fin member 70 may be made of a soft, flexible polymeric material selected from one or more of the following: thermoplastic elastomer (TPE), thermoplastic polyurethane (TPU), thermoplastic vulcanized elastomer (TPV), olefin block copolymers (OBC), polyisoprene, or silicone. In one or more forms, 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. The durometer hardness can be determined using the ASTM D2240 test method. With reference to Figure 2 below, the catheter adapter 18 is illustrated in a generally horizontal orientation. In use, the catheter adapter 18 is attached 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 53. The insertion angle 53 is defined by the angle of exit of the catheter at the catheter adapter tip opening 34 when the catheter tubing is tilted downward against the lower curved surface of the catheter adapter's ID. The insertion angle 53 may include any angle necessary to introduce the catheter into the patient's vascular system. For example, an insertion angle 53 may be selected within the range of 10° to 60°, with a preferred insertion angle range of 15° to 45°. Following the insertion of catheter 12, the flexed portion 21 of the catheter curves into a general arc shape to adapt the transition of catheter 12 from the catheter adapter 20 to the catheter insertion site 51. This element also allows for a steeper insertion angle, which can be useful for subcutaneous injection, as it supports the catheter and remains flat against the skin after a steep insertion. Following catheter insertion at the insertion site, the catheter experiences increased leverage forces. 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, this upward force is dissipated by the internal curvature of the catheter adapter tip opening 34. This curvature defines a tapered region at the bottom of the catheter, preventing kinking and occlusion, thereby maintaining patency and flow rate throughout the device's lifespan.This is particularly useful when drawing blood from a permanent vascular access device, including peripheral intravenous catheters (PIVCs), peripherally inserted central catheters (PICCs), or central venous catheters (CVCs). In one or more designs, the opening of the catheter adapter tip is beveled, increasing 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 sharply before contacting the adapter tip opening, resulting in occlusion. In one design, the catheter adapter tip opening is beveled at an angle less than 90° to the typically horizontal plane. This beveled opening allows for a greater length of catheter to be inserted before occlusion occurs due to delayed contact between the tip opening and the catheter.Therefore, as the flexed portion of the catheter is inserted further into the patient, the flexed portion is allowed to bend to a greater degree before making contact and oscillating at the tip opening, resulting in catheter occlusion at the flexed portion. ινΐΛ / a / zuzz / ui 4i yj The degree of curvature on surface 35 is selected to support the flexed portion of the catheter while maintaining an insertion angle within the desired range. In this configuration, the flexed portion 21 of the catheter curves over and along the contour of the rounded, curved, or beveled lower portion of the catheter adapter tip opening 34. The flexed portion is supported by the lower portion of the catheter adapter tip opening 34, maintaining the necessary degree of catheter curvature to prevent occlusion and ensure the ideal insertion angle. The rounded, curved, or beveled opening minimizes the fulcrum function of the distal end 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 from the distal end. This minimizes the likelihood of occlusion.The flexed portion can form a slight arc, thereby preventing catheter occlusion due to over-insertion. The length of the uninserted catheter, and therefore the maximum insertion point, is selected so that a sufficient length of the catheter remains uninserted. The internal curvature of the catheter adapter tip opening at the bottom provides structural support for the catheter's direction and angular change as it exits the adapter into the patient's body, eliminating the abrupt change in direction experienced by current catheters upon exiting the adapter. Therefore, the internal curvature of the catheter adapter tip opening at the bottom minimizes localized stress and the possibility of collapse and bending.After catheter insertion, the tapered region provides transitional support at an insertion angle for the catheter without restricting flow through it. This allows the flexed portion of the catheter to curve slightly as it transitions from the catheter adapter to the insertion site, thereby preventing catheter occlusion. The shape and profile of the internal curvature of the catheter adapter tip opening 34 can be optimized for each individual catheter size, for a given insertion depth d, to reduce localized stress and provide structural support for the angular change in catheter direction. In the configuration illustrated above in Figure 5, the curvature extends from opposite cross-sectional quadrants of the catheter adapter's internal diameter and transitions downward in the patient direction. The upper portion 28 of the catheter adapter tip opening is uncurved and provides upward curvature support during catheter insertion.Following insertion and removal of the insertion needle, the internal curvature of the tip opening of the 34 catheter adapter at the bottom allows the adapter and catheter, having been inserted at an angle, to lie flat against the patient's skin without unnecessary localized tension or abrupt directional change. As shown in Figure 5, the internal curvature of the tip opening of the 34 catheter adapter at the bottom reduces the impact of an abrupt angle change when the catheter (shown in hidden lines) is clamped to the patient after a steep insertion angle, thus reducing the risk of catheter kinking at the catheter adapter's exit point. The catheter adapter, according to one or more modalities, may provide various transverse transitions at the catheter adapter tip opening 34. The transverse transition may vary to provide the desired curved support for the catheter, depending on the possible direction of curvature of the catheter. This transverse transition element, according to one or more modalities, reduces the risk of catheter tubing kinking and flow restriction through the device to the patient during an infusion procedure, as well as from the patient through the blood collection device and while patency is being assessed.The examples shown in Figures 6A, 6B, and 6C show curvature only at the bottom of the inner diameter. However, many other alternatives exist, including a full circular inner diameter expansion without curvature (e.g., trumpet-shaped), or any number of variable axial or rotational transitions. Figures 6A, 6B, and 6C illustrate three non-exhaustive examples of catheter tip cross-sections, showing the catheter adapter tip at the catheter outlet opening. Figure 6A shows a first modified adapter tip opening 34a with a beveled surface 35a at the bottom. Figure 6B shows a second modified adapter tip opening 34b with a curved surface 35b at the bottom. Figure 6C shows a third modified adapter tip opening 34c with a rounded surface 35c at the bottom. In one or more modalities, the catheter adapter includes a flexible, bend-resistant extension that extends from the tip opening of the catheter adapter to provide support to the catheter. The catheter adapter 20 described with respect to Figures 1-6 can be used as part of a vascular access device described with respect to Figure 7. 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 the extension tube 60 to establish fluid communication between an intravenous 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 tube 60 extends in line with or laterally to the body of the catheter adapter. In one or more configurations, the extension tube 60 is incorporated to reduce contamination and mechanical phlebitis by eliminating manipulation at the insertion site. In one or more configurations, the extension tube 60 is compatible with high-pressure injection.In one or more modalities, the extension tube 60 provides continuous confirmation of the vessel access during advancement of the catheter into the patient's vein 64. In one or more embodiments, the needle hub assembly 50 is assembled with the catheter adapter by inserting the needle into the lumen 44 of the catheter 12. The needle hub assembly is shown as including finger grips 84 located on the sides of the needle hub assembly 50 to facilitate various insertion techniques. In one or more embodiments, there may be protrusions on the finger grips to indicate where the user can grasp the device to withdraw the needle. In one or more embodiments, a thumb pusher 85, with a slightly convex surface, is provided at the proximal end of the needle hub assembly 50. A flange 86, with a slightly convex surface, is provided at the proximal end of the hub assembly to provide a finger pusher. The first fin members 68, second fin members 70, thumb pusher 85 and flange 86 can be used by the user during insertion, allowing the user to select 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 retain 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 agreed-upon user technique. The needle tip is completely covered by the needle guard in a fixed position. In one or more embodiments, a bushing, crimp, or other structure may be included near the tip for engagement 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 also be included on the extension tubing to prevent blood flow when replacing the access port. The proximal end of the introduction needle can be compressed to provide a tight seal. The introduction needle can be secured or mechanically interlocked 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 blood control split septum 74 associated with the first luer access 72, and an air vent 76 associated with the second luer access 73. The split septum 74 allows for the reduction of catheter-related bloodstream infection (CRBSI) while providing unrestricted flow and a straight fluid pathway and functions as a blood control septum. In one or more embodiments, the split 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 split septum 74 may be located at the 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 specification to "an embodiment," "certain embodiments," "one or more embodiments," or "the embodiment" mean that a particular element, structure, material, or feature described in connection with the embodiment is included in at least one embodiment of the invention. Therefore, when phrases such as "in one or more embodiments," "in certain embodiments," "in an embodiment," or "in the embodiment" appear in various places in this specification, they do not necessarily refer to the same embodiment of the invention. Furthermore, the particular elements, structures, materials, or features may be combined in any suitable manner in one or more embodiments. Although the invention herein is described with reference to particular embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It will be evident to those skilled in the art that various modifications and variations of the method and apparatus of the present invention may be made without departing from the scope and spirit of the invention. Accordingly, 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 including a flexed portion;and a catheter adapter with a distal end, a proximal end, a total length extending from the distal end to the proximal end, an internal cavity, a top, a bottom, and a distal tip having a catheter adapter tip opening with a circumference through which the catheter extends, wherein the total length is substantially equivalent at the top and bottom, and the catheter adapter tip opening having an internal curvature defining a tapered region at the bottom, where the tapered region supports the flexed portion of the catheter to provide an insertion angle for the catheter without limiting flow through the catheter, the tapered region being less than the total length, the top of the catheter adapter tip opening not including an internal curvature extending from the distal tip.
2. The vascular access device of claim 1, wherein the internal curvature of the lower portion of the catheter adapter tip opening defines a bevel.
3. The vascular access device of claim 1, wherein the internal curvature of the lower part of the catheter adapter tip opening is rounded or trumpet-shaped.
4. The vascular access device of claim 1, wherein the lower portion of the catheter adapter tip opening defines a radius at the distal tip that gradually decreases as it moves away from the distal tip.
5. The vascular access device of claim 1, wherein the upper portion of the catheter adapter tip opening does not include an internal curvature extending from the distal tip.
6. The vascular access device of claim 1, wherein a radius of the upper part is asymmetrical with respect to the radius of the lower part.
7. The vascular access device of claim 1, wherein the internal curvature on the lower portion of the catheter adapter extends through a portion of a circumference of the catheter adapter tip opening and defines an arc forming an angle in a range of 90° to 270°.
8. The vascular access device of claim 1, further comprising an introduction needle into the internal cavity, the introduction needle having a distal end and a proximal end and a needle cone connected to the proximal end of the introduction needle.
9. The vascular access device of claim 8, further comprising an extension tube extending from the catheter adapter and in fluid communication with the internal cavity of the catheter adapter.
10. The vascular access device of claim 1, further comprising a wing element extending radially outward from the catheter adapter.
11. The vascular access device of claim 1, wherein at least a portion of the catheter adapter is made of a first material and at least a portion of the distal tip is made of a second material that is more flexible than the first material.
12. The vascular access device of claim 1, wherein the distal tip includes a bend-resistant flexible extension extending from the tip opening of the catheter adapter to provide support to the catheter.
13. The vascular access device of claim 11, wherein the conical region provides a conical relief to the catheter.