Catheter assembly with advancement feature for shield needle

Abstract

The present disclosure relates to a catheter assembly having an advancement feature for a shield needle. Catheter assembly vascular access devices using such assemblies are disclosed. The catheter assembly includes a catheter, an introducer needle, a needle hub, and a catheter distal tip support element. The assembly includes an advancement assembly disposed between the needle hub and the distal tip of the introducer needle, the advancement assembly configured to advance the catheter distal tip support element a distance sufficient to advance the distal end of the elongate tubular portion to cover the distal tip of the needle in the shielded position.

Description

TECHNICAL FIELD

[0001] The present invention relates to a catheter assembly including a relatively soft catheter positioned over an introducer needle, and a catheter distal tip support that is relatively rigid and movable relative to the catheter positioned over the introducer needle. BACKGROUND

[0002] Intravenous (IV) catheters are commonly used for various infusion therapies. For example, IV catheters are used to infuse a saline solution, various medications, or total parenteral nutrition into a patient. IV catheters can also be used to withdraw blood from a patient.

[0003] A common type of IV catheter is an over-the-needle peripheral IV catheter. As the name implies, an over-the-needle peripheral IV catheter includes a catheter tube that fits tightly over an introducer needle having a sharp distal tip. The introducer needle and IV catheter are inserted into a patient's vasculature at a shallow angle with the bevel of the introducer needle facing away from the patient's skin. During insertion, the sharp distal tip of the introducer needle is distal of the distal end of the IV catheter. Thus, after the vasculature is pierced with the introducer needle, the IV catheter can be inserted into the vasculature.

[0004] Generally, the introducer needle is constructed of metal, while the catheter tube is constructed of a relatively softer material, such as a thermoplastic or elastomeric material. The relatively softer catheter tube material is more comfortable for the patient, causes less irritation, and improves dwell as compared to a stiffer material. However, if the catheter tube is too soft, it can lack the column strength to resist the forces necessary to penetrate the patient's skin and tissue.

[0005] In some instances, the catheter tube has a tendency to kink, peel back, or move proximally away from the distal tip of the introducer needle when the introducer needle and IV catheter are inserted into a patient. This can occur due to the patient's skin or tissue pushing against the distal tip of the IV catheter during the insertion process. When the catheter tube peels back or moves proximally away from the distal tip of the introducer needle, the catheter tube can adopt an enlarged cross-section, which can require greater insertion forces, increased distension at the insertion site, and / or increased pain for the patient.

[0006] There is a need to provide a catheter assembly that improves insertion success, reduces placement-related complications, and provides a softer, longer-dwelling catheter tube than those provided by traditional short-line and mid-line peripheral IV catheters. SUMMARY

[0007] One aspect of the present disclosure relates to a catheter assembly configured for insertion into a vasculature of a patient. In one embodiment, the catheter assembly includes a catheter including a catheter lumen and extending from a distal end of a catheter hub having a proximal end. The catheter includes a catheter stepped surface disposed within the catheter lumen and having a distal surface with a first inner diameter, a proximal surface with a second inner diameter that is larger than the first inner diameter, and a shoulder disposed between the distal surface and the proximal surface. The catheter further includes an elongated tubular portion proximal to the catheter stepped surface and having the second inner diameter of the proximal surface, and a distal end.

[0008] The catheter assembly further includes an introducer needle disposed within the catheter lumen, the introducer needle including a sidewall defining a proximal end, a distal tip, and a lumen extending therethrough from the proximal end to the distal tip, the proximal end being attached to a needle hub. The catheter assembly further includes a catheter distal tip support element movably disposed within the catheter lumen and over the introducer needle, the catheter distal tip support element including a proximal end and a support material having a Shore hardness that is higher than a Shore hardness of a second material of the elongated tubular portion of the catheter, the catheter distal tip support element being movable relative to the catheter and the introducer needle and having a distal surface configured to contact the shoulder of the catheter and to prevent kinking or buckling of the second material of the elongated tubular portion as the catheter is advanced in a distal direction and with the catheter into the vasculature of the patient.

[0009] The catheter assembly further includes an advancement assembly disposed between the needle hub and the distal tip of the introducer needle, the advancement assembly being configured to advance the catheter distal tip support element a distance sufficient to advance the distal end of the elongated tubular portion to cover the distal tip of the needle in a sheathed position. BRIEF DESCRIPTION OF DRAWINGS

[0010] Figure 1A is a top view of a catheter assembly according to one or more embodiments; Figure 1B is a cross-sectional view of a catheter assembly according to one or more embodiments Figure 1A is a cross-sectional view of a catheter on needle of the catheter assembly of Figure 1C is a top view of a catheter on needle of the catheter assembly of Figure 1B is a top view of a catheter on needle of the catheter assembly of Figure 1D is a top view of a catheter on needle of the catheter assembly of Figure 1A is a top view of a catheter on needle of the catheter assembly of Figure 2 is a cross-sectional view of a portion of a catheter assembly including an introducer needle, a catheter over the introducer needle, and a reinforced distal catheter tip according to one or more embodiments; Figure 3AThis is a cross-sectional view of a catheter assembly according to a first embodiment of the present disclosure, wherein the catheter is in a pre-insertion position; Figure 3B yes Figure 3A The diagram shows a cross-sectional view of the catheter adapter assembly in a partially advanced position with the catheter positioned above the distal tip of the guide needle. Figure 4 This is a top cross-section of a second embodiment of the catheter assembly, showing the on-needle catheter in a pre-insertion position; Figure 5 yes Figure 4 An isometric view of the catheter assembly shown, with the catheter on the needle in the pre-insertion position; Figure 6 yes Figure 5 The diagram shows a cross-sectional view of the portion of the catheter assembly taken along line 6-6; and Figure 7 This is a side view of the advancing feature. Detailed Implementation

[0011] Before describing several exemplary embodiments of this disclosure, it should be understood that this disclosure is not limited to the details of the construction or process steps set forth in the following description. This disclosure can have other embodiments and can be practiced or implemented in various ways.

[0012] Embodiments of this disclosure provide a catheter assembly capable of use with a variety of vascular access devices (VADs) and applicable to a variety of methods and systems. One or more embodiments provide catheter assemblies that offer one or more of improved insertion success, reduced placement-related complications, and provide a more flexible, longer indwelling catheter conduit than those provided by conventionally placed short-line and midline peripheral IV catheters. Embodiments of the catheter assemblies and systems of this disclosure provide VADs with much more flexible and longer indwelling catheter material placed via an on-needle catheter placement device. This is achieved by providing a movable distal catheter tip support and a "hooding" feature, as well as a softer, more compliant, and kink-resistant catheter material. One or more embodiments also provide catheter assemblies configured to place longer catheters for deeper venous placement, which often involves steeper insertion angles and more stringent angle changes that can be susceptible to kinking or bending. According to one or more embodiments, catheter assemblies and systems that are less complex than existing catheter assemblies are provided.

[0013] Embodiments of this disclosure generally relate to a catheter assembly configured for insertion into a patient's vascular system, as well as related apparatus and methods. Reference is now made to... Figure 1A In one or more embodiments, the catheter assembly 10 includes an on-needle catheter 12 and a guide needle 14.Figure 1A An example is shown of a guide needle 14 in the insertion position for insertion into a patient. The guide needle 14 includes a distal tip, a proximal end, and a notch (or groove) 52. In one or more embodiments, when the guide needle 14 is in the insertion position, the sharp distal tip 16 of the guide needle 14 is positioned outside the distal tip 18 of the needle catheter 12.

[0014] In one or more embodiments, the catheter assembly 10 includes a catheter adapter 20. As shown, the proximal end of the on-needle catheter 12 is secured within the catheter adapter 20, and the on-needle catheter 12 extends distally from the catheter adapter 20. The proximal end of the guide needle 14 is secured within the needle hub 22 of the catheter assembly 10.

[0015] The catheter assembly 10 shown includes any type of catheter assembly with an on-needle catheter and a guide needle. Although Figure 1A The catheter assembly 10 in the example is shown as having an integrated extension tube, but it should be understood that the catheter assembly 10 may be straight or non-integrated. Non-limiting examples of integrated IV catheter systems include, for example, the BD NEXIVA™ Closed IV Catheter System, the BDNEXIVA™ DIFFUSICS™ Closed IV Catheter System, or the Becton Dickinson PEGASUS™ Secure Closed IV Catheter System. A non-limiting example of a straight catheter or non-integrated catheter assembly is the BD INSYTE™ AUTOGUARD™ Protective IV Catheter. In one or more embodiments, the catheter assembly 10 includes any kind of needle safety mechanism that can protect the distal tip 16 of the guide needle 14.

[0016] In one or more embodiments, the catheter assembly 10 includes any suitable type of blood control diaphragm disposed within the lumen of the catheter adapter 20. Figure 1A An exemplary blood control diaphragm 24 according to one or more embodiments is illustrated. In one or more embodiments, after the on-needle catheter 12 is properly positioned within the vascular system, the guide needle 14 is withdrawn proximally through the diaphragm 24. In one or more embodiments, the diaphragm 24 is elastomeric. In one or more embodiments, the diaphragm 24 can divide the lumen of the catheter adapter 20 into a proximal chamber and a distal chamber.

[0017] Now for reference Figure 1BIn one or more embodiments, the on-needle conduit 12 includes a distal tip 18 made of a first material having a first Shore hardness value. In one or more embodiments, the first material is rigid or semi-rigid. In one or more embodiments, the on-needle conduit 12 includes a first stepped surface 26, which in some embodiments refers to an annular conduit stepped surface 26. In other embodiments, the stepped surface 26 may include one or more discrete protrusions projecting from the inner surface of the lumen 40 of the on-needle conduit 12, providing the stepped surface 26 and forming a shoulder. In one or more embodiments, the first stepped surface 26 includes a rigid or semi-rigid distal surface 28 having a first inner diameter 30, a proximal surface 32 having a second inner diameter 34 greater than the first inner diameter 30, and a rigid or non-rigid first transition surface defining a shoulder 36 disposed between the distal surface 28 and the proximal surface 32. According to one or more embodiments, the first inner diameter 30 is uniform. In some embodiments, the second inner diameter 34 is uniform.

[0018] In one or more embodiments, the distal tip is entirely made of a first material, which may also be referred to as the distal tip material. In one or more embodiments, at least the distal surface 28 and the first transition surface defining the shoulder 36 of the first stepped surface 26 are part of the distal tip 18 of the on-needle guide 12 and are therefore made of the first material. In one or more embodiments, the distal surface 28, the first transition surface defining the shoulder 36, and the proximal surface 32 of the first stepped surface 26 are part of the distal tip 18 and are therefore made of the first material. In some embodiments, the distal type includes a window or opening (not shown).

[0019] In one or more embodiments, the catheter 12 includes an elongated tubular portion 38 adjacent to and coupled to the distal tip 18 of the catheter 12. In one or more embodiments, the tubular portion 38 is made of a second material. In one or more embodiments, the Shore hardness value of the first material is equal to or greater than that of the second material (the harder material). In one or more embodiments, the Shore hardness of the first and second materials is equal, and in some embodiments, the first and second materials comprise, are composed of, or are substantially composed of the same material. In one or more embodiments, the distal tip 18 and the tubular portion 38 include a catheter lumen 40 extending therethrough. In one or more embodiments, a first stepped surface 26 is disposed within the catheter lumen 40.

[0020] Now for reference Figure 1CIn one or more embodiments, at least a portion of the outer surface of the distal tip 18 is tapered, which can facilitate the insertion of the on-needle conduit 12 into the patient's skin and tissue behind the distal tip 16 of the guide needle 14 as the distal tip 16 cuts the path. (See also...) Figure 1D The catheter assembly 10 includes a guide needle 14 having a length extending from a distal tip 16.

[0021] In one or more embodiments, the first material and / or the second material comprises a composite material. In one or more embodiments, the first material comprises one or more of the following: silicone resin, polyurethane, metal, plastic, and another suitable material. In one or more embodiments, the second material may be one or more of the following: silicone resin, polyurethane, metal, plastic, and another suitable material. In one or more embodiments, the first material comprises a first polyurethane, and the second material comprises a second polyurethane. In one or more embodiments, the first material comprises a first silicone resin, and the second material comprises a second silicone resin. In one or more embodiments, the first material comprises a metal and / or the second material comprises a plastic. In one or more embodiments, the second material comprises a flexible material. In one or more embodiments, the second material comprises a soft polymer material, such as silicone rubber, nylon, polyurethane, fluoroethylene polymer (FEP), polytetrafluoroethylene polymer (PTFE), polyethylene terephthalate (PET), latex, and thermoplastic elastomers.

[0022] In one or more embodiments, the second material comprises a material that is softer than the first material, which is more comfortable for the patient and results in fewer indwelling problems. In one or more embodiments, the softer second material may allow the over-needle catheter 12 to be inserted into the vascular system for a longer period before complications occur.

[0023] Reference Figure 2 The catheter assembly includes a distal tip support element 60 movably disposed within the lumen 40 of the on-needle catheter 12 and above the guide needle 14. The distal tip support element 60 includes a support material whose Shore hardness is equal to or greater than that of a second material constituting the elongated tubular portion 38 of the on-needle catheter 12. In an embodiment, the first material has a greater Shore hardness than the second material, and therefore the first material is harder than the second material.

[0024] The distal tip support element 60 is movable in both distal and proximal directions relative to the on-needle catheter 12 and the guide needle 14. In some embodiments, the distal tip support element 60 has an outer diameter 62 and a distal support surface 64 configured to contact the shoulder 36 of the on-needle catheter 12, and to advance the on-needle catheter 12 distally as it is advanced into the patient's vascular system, and to prevent kinking or bending of the second material of the on-needle catheter 12. In one or more embodiments, when the guide needle 14 is in the insertion position, the distal support surface 64 can contact the shoulder 36 of the on-needle catheter 12, such that proximal movement of the distal tip 16 relative to the guide needle 14 is inhibited, and the compressive force required for the distal tip 16 to penetrate the skin is transmitted to the distal tip 18 of the on-needle catheter 12. In one or more embodiments, when the guide needle 14 is in the insertion position, the contact between the distal support surface 64 and the shoulder 36 may allow the second material to be potentially more flexible than a standard catheter body. In one or more embodiments, when the catheter adapter 20 is secured to the patient's skin, the second material may allow the tubular portion 38 to bend, while the first material may facilitate successful insertion of the needle-on-catheter 12 into the vascular system.

[0025] In one or more implementations, for example, Figure 1B In one embodiment, a first transition surface defines a shoulder 36, which is arranged at approximately 90 degrees relative to the longitudinal axis of the catheter assembly 10. In one or more embodiments, the first transition surface defining the shoulder 36 is arranged at an angle other than 90 degrees relative to the longitudinal axis of the catheter assembly 10. In one or more embodiments, the first transition surface defining the shoulder 36 is smooth and / or planar. In one or more embodiments, the first transition surface defining the shoulder 36 is not smooth, rough, or irregular. In one or more embodiments, the first transition surface defining the shoulder 36 is curved.

[0026] Figure 2 This is a cross-sectional view of a catheter assembly 10 according to one or more embodiments, the catheter assembly 10 including a guide needle 14 and an on-needle catheter 12 having a distal tip 18.

[0027] The catheter assembly 10 is configured for insertion into a patient's vascular system. The catheter assembly 10 includes an on-needle catheter 12, which includes a stepped catheter surface 26 having a distal surface 28 with a first inner diameter 30, a proximal surface 32 with a second inner diameter 34 larger than the first inner diameter 30, and a shoulder 36 disposed between the distal surface 28 and the proximal surface 32.

[0028] The catheter assembly 10 further includes an elongated tubular portion 38 adjacent to the catheter stepped surface 26 and having a second inner diameter 34 with a proximal surface 32, wherein the shoulder 36, the proximal surface 32, and the distal surface 28 are made of a first material with a Shore hardness equal to or greater than that of a second material of the elongated tubular portion 38. The on-needle catheter 12 has a catheter lumen 40 extending therethrough, and the catheter stepped surface 26 is disposed within the catheter lumen 40.

[0029] The catheter assembly 10 further includes a guide needle 14 disposed within the catheter lumen 40, the guide needle 14 including a sidewall 15 defining a proximal end 17, a distal tip 16 and a needle lumen 54 extending through the sidewall 15 from the proximal end 17 to the distal tip 16.

[0030] The catheter assembly 10 further includes a distal tip support element 60 movably disposed within the catheter lumen 40 and above the guide needle 14. The distal tip support element 60 includes a support material having a Shore hardness equal to or greater than that of a second material of the elongated tubular portion 38 of the catheter. The distal tip support element 60 is movable relative to the on-needle catheter 12 and the guide needle 14 and has a distal support surface 64 configured to contact the shoulder 36 of the on-needle catheter 12 and to advance the on-needle catheter 12 in a distal direction and to prevent kinking or bending of the second material of the catheter as it is advanced into the patient's vascular system.

[0031] One method frequently used during catheter placement is known as the "coaching" method. During insertion, after initial blood return confirms that the needle has pierced the target vein, clinicians often pause further needle advancement and advance the catheter partially until it covers the needle tip and bevel. This helps prevent unnecessary venous injury from the bevel during the remainder of the insertion process. With the catheter coached, the angle is typically reduced or lowered, and the catheter can be fully advanced into the vein. While coaching is currently used as an insertion method, it is entirely dependent on the user's skill and technique and often fails to work. According to one or more embodiments, a catheter assembly is provided that establishes a mechanically defined position to enable proper and stable coaching while providing support for the tip to allow successful catheter advancement with much softer materials.

[0032] Therefore, it will be understood that the distal tip support element 60 of the catheter includes a sleeve, as shown, which slides over the guide needle 14 and is clamped between the sidewall 15 of the needle and the tubular portion 38 of the catheter 12 on the needle. In some embodiments, the sleeve comprises a sleeve material having a Shore hardness equal to or greater than the Shore hardness of a second material of the tubular portion 38 of the catheter (a harder material). In some embodiments, the Shore hardness of the sleeve is equal to or greater than the Shore hardness of the distal tip 18 of the catheter 12 on the needle. The sleeve material may include plastic or metal.

[0033] Now for reference Figure 3A and Figure 3B This illustrates an embodiment of a catheter assembly 11 configured for insertion into a patient's vascular system. The catheter assembly 11 includes, as shown... Figure 1B to Figure 1D and Figure 2 The guide needle 14 and catheter 12 are shown and described. Therefore, the catheter assembly 11 includes the catheter 12, which includes a catheter lumen 40 and extends from the distal end 50d of the catheter hub 50 having a proximal end 50p.

[0034] The catheter 12 of the catheter assembly 11 includes a stepped catheter surface 26 disposed within the catheter lumen 40 and having a distal surface 28 having a first inner diameter 30, a proximal surface 32 having a second inner diameter 34 larger than the first inner diameter 30, and a shoulder 36 disposed between the distal surface 28 and the proximal surface 32.

[0035] The catheter 12 of the catheter assembly 11 further includes an elongated tubular portion 38 adjacent to the stepped surface 26 of the catheter and having a second inner diameter 34 of a proximal surface 32 and a distal tip 18.

[0036] Figure 3A and Figure 3B The catheter assembly 11 shown further includes a guide needle 14 disposed within the catheter lumen 40. The guide needle includes a sidewall 15 defining a proximal end 17, a distal tip 16, and a lumen 54 extending from the proximal end 17 through to the distal tip 16. The proximal end 17 is attached to the needle hub 80.

[0037] Still referencing Figure 3A and Figure 3B The catheter assembly 11 includes a distal tip support element 60, which is movably disposed within the catheter lumen 40 and above the guide needle 14. The distal tip support element 60 includes a proximal end 60p (e.g., Figure 7(As shown) and a support material having a Shore hardness higher than that of the second material of the elongated tubular portion 38 of the catheter 12. The distal tip support element 60 of the catheter is movable relative to the catheter 12 and the guide needle 14 and has a distal surface 64 configured to contact the shoulder 36 of the catheter 12 and to advance the catheter 12 in a distal direction and to prevent kinking or bending of the second material of the elongated tubular portion 38 as the catheter 12 is advanced into the patient's vascular system.

[0038] Figure 3A Figure 3b further shows the catheter assembly 11, which includes an advance assembly 65 disposed between the needle hub 80 and the distal tip 16 of the guide needle 14. In the illustrated embodiment, the advance assembly is shown between the proximal end 50p and the distal end 50d of the catheter hub 50. The advance assembly 65 is configured to advance the distal tip support element 60 of the catheter a distance sufficient to advance the distal tip 18 of the catheter 12 to cover the distal tip 16 of the guide needle 14 in the shielded position.

[0039] Reference Figure 3A and Figure 3B The propulsion assembly 65 includes a propulsion feature 70 coupled to the distal tip support element 60 of the catheter. In some embodiments, the propulsion feature 70 is coupled adjacent to the proximal end 60p of the distal tip support element 60. In some embodiments, the propulsion feature 70 extends transversely to the distal tip support element 60. In some embodiments, the propulsion feature 70 is in the form of a rod or beam attached to the distal tip support element 60.

[0040] Still referencing Figure 3A and Figure 3BThe propulsion assembly 65 further includes a lever element 68 that engages with the propulsion feature 70. In a specific embodiment, the lever element includes a groove 66, and the propulsion feature 70 engages with the groove 66. In one or more embodiments of the catheter assembly 11, the lever element 68 and the propulsion feature 70 engage with the catheter hub 50. According to one or more embodiments, engagement with the catheter hub means that the lever element 68 and the propulsion feature 70 are attached, secured to, or assembled to a portion of the catheter hub. For example, the propulsion assembly 65, including one or more of the lever element 68 and the propulsion feature 70, is contained within a recess or hollow region of the catheter hub 50. In some embodiments, one or more of the lever element 68 and the propulsion feature 70 are attached to the catheter hub 50 by a bracket or any other suitable method of attaching the feature to the catheter hub 50. In one or more embodiments, the component engages with or is attached to the catheter hub 50 such that the propulsion assembly can advance the distal tip 18 of the catheter 12 a predetermined distance to cover the distal tip 18 of the guide needle 14 over the distal tip 16 of the guide needle 14. In some embodiments, the lever element 68 and the propulsion feature 70 engage with the proximal end 50p of the guide hub 50.

[0041] Therefore, continue to refer to Figure 3A and Figure 3B The advancement assembly 65 applies a user-applied displacement force to the distal tip support element 60 of the catheter 12, which forces the distal tip 18 of the catheter 12 to advance the catheter assembly 11 and the catheter 12 into a "shielded" position. As discussed herein, a "shielded" catheter refers to the practice of advancing the catheter 12 to cover the distal tip 16 of the guide needle after the guide needle 14 has punctured a patient's vein or artery. This allows the remainder of catheter placement and advancement to be performed more safely with a lower risk of injury to the vein or artery.

[0042] During initial insertion, the distal tip support element 60 provides support for the distal tip 18 of the catheter to maintain its position relative to the distal tip 16 of the guide needle 14, thus preventing the softer catheter material from compressing or bending during penetration of the patient's skin. Following venipuncture and during the remainder of the insertion process (angle reduction, advancement, threading, and needle removal), the advancement assembly 65 provides synchronized displacement forces on both the catheter hub 50 and the distal tip 18 of the catheter 12 to "shield" the guide needle 14.

[0043] Figure 3A The lever and propulsion assembly 65 are shown in their initial position, with the propulsion feature 70 located in the lower part of the slot 66. For example, by rotating the lever element 68 in the direction of arrow A1, the lever element 68 is moved in the distal direction, causing the propulsion feature 70 to... Figure 3BThe movement in the distal direction indicated by the middle arrows A2 and A3 results in the distal tip 16 of the guide needle 14 of the catheter 12 shield.

[0044] In some embodiments, the lever element 68 is pivotable about the advance feature 70. In other embodiments, a thrust is applied to the lever element 68 to advance the advance feature. In some embodiments, pivoting the lever element 68 advances the distal tip support element 60 of the catheter a distance sufficient to advance the distal tip 18 of the catheter 12 to cover the distal tip 16 of the guide needle 14 in the shielded position. In some embodiments, the lever element 68 is pivotable in the distal direction. In other embodiments, the lever element 68 is pivotable in the proximal direction. In some embodiments, the lever element is displaced by rotation to advance the advance feature 70.

[0045] Now for reference Figure 4 to Figure 6 The image shows a second embodiment of the catheter assembly 10, which includes a different type of catheter hub 50 having a propulsion assembly 65, the propulsion assembly 65 including a lever element 68 adjacent to the proximal end 50p of the catheter hub 50. The catheter assembly 10 includes a catheter flap 51 adjacent to the distal end 50d of the catheter hub 50. Figure 4 and Figure 5 The operation of the catheter assembly 10 shown is similar to Figure 3A and Figure 3B The operation of the catheter assembly 11 shown.

[0046] The catheter assemblies described in this disclosure are applicable to a wide range of medical devices. They can be used with peripheral venous catheters (PIVCs), long PIVCs, mini midline catheters, midline catheters, arterial devices, and port access vascular access devices. Embodiments of the catheter assemblies can be used with various needle safety features, including V-clamps, simple clips, spring retractors, SAFT-T-INTIMA type safety devices, etc. Advantageously, one or more embodiments of this disclosure provide a catheter assembly configured to place longer indwelling soft catheters using conventional PIVC insertion methods while ensuring appropriate shielding technology. One or more embodiments of the catheter assemblies described herein are configured for use with robust needle safety mechanisms and provide higher flow rates than existing soft catheter alternatives.

[0047] One or more embodiments provide a catheter assembly with a sheath-supported sleeve that advances only, meaning the advancement assembly is configured to advance the catheter a distance sufficient to sheath the catheter above the distal tip of the guide needle. In some embodiments, the catheter can be further advanced manually by the user of the device. Advantageously, a sheath displacement force is applied via user input to advance the catheter via pivoting, distal rotation, proximal rotation, squeezing, a button, a sliding mechanism, or a button with a spring element, or other suitable advancement means. Thus, in some embodiments, the catheter assembly includes means for actuating the advancement assembly to move the distal tip of the catheter to the sheath position, the means being selected from a distal rotation actuation feature, a proximal rotation actuation feature and squeezing mechanism, an actuation button, a sliding mechanism, and a button with a spring element.

[0048] In some embodiments, the distal rotation actuation feature is operated, thereby operating the propulsion assembly by rotating the component in the distal direction. In some embodiments, the proximal rotation actuation feature is operated, thereby operating the propulsion assembly by rotating the component in the proximal direction. In some embodiments, a squeezing mechanism is operated, thereby allowing the propulsion assembly to be operated by a device user applying squeezing force to advance the conduit. In some embodiments, an activation button is operated, thereby operating the propulsion assembly to actuate the propulsion mechanism and move the conduit by pressing the button. In some embodiments, a sliding mechanism is operated, thereby operating the propulsion assembly by sliding a component that propels the conduit. In some embodiments, a button with a spring element is operated, thereby operating the propulsion assembly by pressing a button coupled to a spring element that biases the conduit in the distal direction.

[0049] In some embodiments, the catheter assembly may further include a guidewire to improve placement success. In some embodiments, the advance assembly applies a direct force to an advance feature coupled to the distal tip support element of the catheter. Optionally, the advance assembly applies a force to a tip guard that contacts the advance feature coupled to the distal tip support element of the catheter.

[0050] In some embodiments, the distal tip of the catheter includes a fenestrated and / or reinforced catheter tip, providing a more rigid material at the distal tip. In one or more embodiments, the catheter material includes an antimicrobial additive. In one or more embodiments, a distal tip support element is configured to cover the tip of the inserter needle to provide needle safety and prevent accidental needlesticking. In other embodiments, the catheter assembly includes a needle safety mechanism.

[0051] Although the disclosure herein has been described with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the disclosure. Those skilled in the art will appreciate that various modifications and variations can be made to the methods and apparatus of this disclosure without departing from the spirit and scope of the disclosure. Therefore, this disclosure is intended to include modifications and variations within the scope of the appended claims and their equivalents.

Claims

1. A catheter assembly configured for insertion into a patient's vascular system, the catheter assembly comprising: A catheter, the catheter including a lumen and extending distally from a catheter hub, the catheter hub having a proximal end, the catheter comprising: A stepped surface of the catheter, the stepped surface of the catheter being disposed within the catheter lumen and having a distal surface with a first inner diameter, a proximal surface with a second inner diameter larger than the first inner diameter, and a shoulder disposed between the distal surface and the proximal surface; and An elongated tubular portion with the second inner diameter near the stepped surface of the conduit and having the proximal surface, and a distal tip; and A guide needle disposed within the catheter lumen, the guide needle including a proximal end, a distal tip, and a sidewall defining a lumen extending from the proximal end through to the distal tip, the proximal end being attached to a needle hub; and A distal tip support element for a catheter, movably disposed within the catheter lumen and above the guide needle, the distal tip support element comprising a proximal end and a support material having a Shore hardness higher than that of a second material of the elongated tubular portion of the catheter, the distal tip support element being movable relative to the catheter and the guide needle and having a distal surface configured to contact the shoulder of the catheter and to advance the catheter in a distal direction and to prevent kinking or bending of the second material of the elongated tubular portion as the catheter is advanced into the patient's vascular system; and An advance assembly disposed between the needle hub and the distal tip of the guide needle, the advance assembly being configured to advance the distal tip support element of the catheter a distance sufficient to advance the distal tip of the catheter to cover the distal tip of the guide needle in a shielded position.

2. The catheter assembly of claim 1, wherein the advancement assembly includes an advancement feature coupled to the distal tip support element of the catheter.

3. The catheter assembly of claim 2, wherein the advancement feature is coupled adjacent to the proximal end of the distal tip support element of the catheter.

4. The catheter assembly of claim 2, wherein the advancement feature extends laterally to the distal support element of the catheter.

5. The conduit assembly of claim 4, wherein the propulsion assembly further comprises a lever element engaging with the propulsion feature.

6. The catheter assembly of claim 5, wherein the lever element includes a groove.

7. The conduit assembly of claim 6, wherein the advance feature engages with the groove.

8. The catheter assembly of claim 3, wherein the lever element and the advance feature engage with the catheter hub.

9. The catheter assembly of claim 8, wherein the lever element and the advance feature engage with the proximal end of the catheter hub.

10. The conduit assembly of claim 7, wherein the lever element is pivotable about the propulsion feature.

11. The catheter assembly of claim 5, wherein pivoting the lever element advances the distal tip support element of the catheter a distance sufficient to advance the distal end of the catheter to cover the distal tip of the guide needle in a shielded position.

12. The catheter assembly of claim 11, wherein the lever element is pivotable in the distal direction.

13. The catheter assembly of claim 11, wherein the lever element is pivotable in the proximal direction.

14. The catheter assembly of claim 4, wherein the distal tip support element of the catheter comprises a sleeve.

15. The catheter assembly of claim 14, wherein the shoulder, the proximal surface, and the distal surface are made of a first material having a Shore hardness equal to or greater than that of the second material of the elongated tubular portion.

16. The catheter assembly of claim 15, wherein the sleeve comprises a sleeve material having a Shore hardness greater than that of the second material.

17. The catheter assembly of claim 16, wherein the sleeve material comprises plastic.

18. The catheter assembly of claim 16, wherein the sleeve material comprises metal.

19. The catheter assembly of claim 4, wherein the propulsion assembly includes means for actuating the propulsion assembly.

20. The catheter assembly of claim 4, wherein the advancement assembly includes means for actuating the advancement assembly to move the distal tip of the catheter to a shield position, the means being selected from an activation button, a sliding activation element, an activation lever, and a rotary activation mechanism.

Images