JP7586900B2 - CATHETER ASSEMBLY FOR ACCESSING THE VASCULAR SYSTEM OF A PATIENT - Patent application - Google Patents

Description

The present invention relates to medical devices, and in particular to integrated catheter assemblies.

The current method of placing an acute central venous catheter ("ACVC") involves a multi-step procedure in which an introducer needle, including a syringe attached to a needle hub, is used to access the vasculature under ultrasound guidance. The syringe is removed from the introducer needle hub to observe blood flow and ensure that the needle is properly placed in the vein and not the artery. A guidewire is introduced from the introducer needle, the introducer needle is removed over the guidewire, an incision is made with a scalpel, one or more dilators are introduced over the guidewire, and finally a CVC catheter is introduced over the guidewire. The guidewire and/or introducer needle can then be removed. The various steps of exchanging different devices, such as removing the needle from the introducer needle hub, often result in accidental movement, which results in the loss of the vein, and the aborted attempt. Accessing an artery rather than a vein can lead to serious medical complications. Additionally, the clinician must hold the guidewire throughout the procedure to avoid losing it in the vessel, which makes it vulnerable to contamination by exposing it to non-sterile surfaces. Furthermore, exchanging multiple devices increases the risk of infection.

Disclosed herein is an integrated catheter assembly, which in an exemplary embodiment includes a sharp-angled central venous catheter with a peripherally inserted venous catheter portion at its distal end, allowing for rapid insertion of the catheter portion into a patient.

Briefly, embodiments disclosed herein relate to a catheter assembly and associated methods. The catheter assembly (also referred to as a rapid insertion central catheter or "RICC") includes an elongated catheter body including a central venous catheter ("CVC") portion, and a peripheral intravenous catheter ("PIV"). The PIV portion includes a needle disposed at the distal end of the elongated body and within the lumen of the PIV portion. The PIV portion facilitates insertion of the catheter assembly to streamline the insertion procedure, reduce the risk of infection, and reduce the risk of aborted attempts. Additionally, the catheter assembly includes a guidewire with a permanently attached hub to prevent loss of the guidewire into the vasculature.

Disclosed herein is a catheter assembly for accessing a patient's vascular system, the catheter assembly including an elongate catheter body extending from a proximal end to a distal end and defining a first lumen, the catheter body comprising a central venous catheter ("CVC") portion including a needle access opening disposed through a sidewall of the central venous catheter ("CVC") portion, a transition portion, and a peripheral intravenous ("PIV") portion defining a peripheral intravenous ("PIV") lumen portion of the first lumen; a catheter hub coupled to a proximal end of the catheter body; a peripheral intravenous ("PIV") hub defining a peripheral intravenous ("PIV") hub lumen; and a needle lumen. a needle defining a first lumen and a needle hub coupled to a proximal end thereof, the needle extending through a PIV hub lumen, a needle access opening and a PIV lumen portion beyond the distal end of the elongate body; and a guidewire disposed in a proximal portion of the first lumen.

In some embodiments, the guidewire includes a guidewire hub permanently attached to its proximal end and configured to prevent the proximal end of the guidewire from advancing distally into the first lumen. The catheter assembly further includes a syringe coupled to the needle hub and in communication with the needle lumen, the syringe creating a vacuum to draw blood flow from the needle lumen and confirm vascular access. The PIV hub includes a clip for coupling the PIV hub to the catheter body. The PIV hub is configured to align the tip of the needle with the distal end of the catheter body such that the bevel of the needle is distal to the distal end of the catheter body. The PIV hub includes an anti-rotation feature that orients the bevel of the needle in a predetermined position. The anti-rotation feature includes a slot disposed in the PIV hub and a rib disposed in the needle hub, the rib and the slot being oriented such that the PIV hub and the needle hub are fully engaged only when the bevel is in an upward position. The catheter hub includes an extension leg extending proximally from its proximal end, the extension leg defining an extension leg lumen in communication with the first lumen, and including a connector at its proximal end.

In some embodiments, the needle access opening includes a slit valve that closes the needle access opening when the needle is removed from the needle access opening. The catheter body further includes a second lumen extending from the catheter hub to an exit opening disposed through a sidewall of the CVC section proximate its distal end. The catheter hub includes a second extension leg, the second extension leg defining a second extension leg lumen in communication with the second lumen of the catheter body. The PIV section defines a first diameter and the CVC section defines a second diameter, the first diameter being smaller than the second diameter. The transition section includes a tapered outer surface extending from the first diameter to the second diameter. The PIV section includes a tip, the tip forming a tapered outer profile and defining an inner lumen diameter, the inner lumen diameter being smaller than an outer diameter of the needle shaft.

Disclosed herein is a method for inserting a catheter into a patient's vascular system comprising providing a catheter assembly including an elongate catheter body extending from a proximal end to a distal end and defining a first lumen, the catheter body including a central venous catheter ("CVC") portion including a needle access opening disposed through a sidewall thereof, a transition portion, and a peripheral intravenous ("PIV") portion defining a peripheral intravenous ("PIV") lumen portion of the first lumen. the catheter assembly including: an elongated catheter body having a distal end, a catheter hub coupled to a proximal end of the catheter body; a peripheral intravenous ("PIV") hub coupled to the proximal end of the catheter body and defining a peripheral intravenous ("PIV") hub lumen; a needle including a needle hub defining a needle lumen and coupled to the PIV hub, the needle being disposed through the PIV hub lumen, the needle access opening and a PIV lumen portion and extending beyond the distal end of the catheter body; and a guidewire disposed within the first lumen. The method further includes inserting a needle into the patient to access the vascular system such that the distal end of the catheter body is disposed within the patient's vascular system, observing blood flow with the needle hub to confirm access to the vascular system, detaching the needle hub from the PIV hub, withdrawing the needle proximally from the PIV hub, advancing the PIV portion distally within the vascular system, removing the PIV hub from the catheter body, advancing a guidewire into the first lumen such that the distal end of the guidewire is distal to the distal end of the catheter body, and advancing the catheter body over the guidewire such that the CVC portion is disposed within the vascular system.

In some embodiments, the PIV portion includes a tip, the tip defining a tapered outer profile and defining a lumen diameter, the lumen diameter being smaller than the outer diameter of the needle shaft to secure the tip of the PIV portion to the needle shaft. The PIV portion defines a first diameter, the CVC portion defines a second diameter, the first diameter being smaller than the second diameter, and the transition portion includes a tapered outer surface extending from the first diameter to the second diameter. The PIV hub includes a clip for coupling the PIV hub to the catheter body and further includes an anti-rotation feature that engages the needle hub to orient the bevel of the needle in a predetermined position. The anti-rotation feature includes a slot disposed on the PIV hub and a rib disposed on the needle hub, the rib engaging the slot to orient the bevel in an upward position. The needle access opening includes a valve that closes the needle access opening when the needle is removed from the needle access opening. The catheter body further includes a second lumen extending from the catheter hub to an exit opening disposed through the sidewall of the CVC section, the catheter hub including a second extension leg defining a second extension leg lumen in communication with the second lumen. The distal end of the guidewire is positioned near the needle access opening before the needle accesses the patient's vasculature. The method further includes a syringe coupled to the needle hub and in communication with the needle lumen, the syringe creating a vacuum to draw blood flow from the needle lumen to confirm vascular access.

A more particular description of the present disclosure will be provided by reference to specific embodiments thereof that are illustrated in the accompanying drawings. These drawings depict only typical embodiments of the invention and therefore should not be considered as limiting its scope. Exemplary embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings.

FIG. 1 shows a perspective view of a catheter assembly including a needle, a syringe and a guidewire according to an embodiment disclosed herein. 2 shows a perspective view of the catheter shown in FIG. 1 according to an embodiment disclosed herein. 3 shows an enlarged view of a distal portion of the catheter of FIG. 2 according to an embodiment disclosed herein. 2 shows an enlarged view of a distal portion of the catheter assembly of FIG. 1 according to an embodiment disclosed herein. 2 illustrates various details of the distal end of the catheter assembly of FIG. 1 according to an embodiment disclosed herein. 2 illustrates various details of the distal end of the catheter assembly of FIG. 1 according to an embodiment disclosed herein. 2 illustrates various details of the distal end of the catheter assembly of FIG. 1 according to an embodiment disclosed herein.

Reference is now made to the Figures, in which like structure is provided with like reference designations. The drawings are diagrammatic and schematic representations of exemplary embodiments of the present invention and are not intended to be limiting and are not necessarily drawn to scale.

With respect to the terms used herein, these terms are intended to describe certain specific embodiments, and these terms are not intended to limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps, and do not provide serial or numerical limitations. For example, the "first," "second," and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment that includes such features or steps is not necessarily limited to three features or steps. Designations such as "left," "right," "up," "down," "front," "rear," etc. are for convenience and do not imply, for example, a specific fixed position, direction, orientation, etc. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

For clarity, the term "proximal" refers to a direction relatively closer to a clinician who will use the devices described herein, and the term "distal" refers to a direction relatively farther from the clinician. For example, with respect to the "proximal," "proximal portion," or "proximal end portion" of a catheter disclosed herein, includes the portion of the catheter that is intended to be near the clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter that is intended to be near the clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter includes the end of the catheter that is intended to be near the clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter. However, the proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context suggests otherwise, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

For example, with respect to the "distal," "distal portion," or "distal end portion" of a catheter disclosed herein, includes the portion of the catheter intended to be near or within the patient when the catheter is used with the patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter intended to be near or within the patient when the catheter is used with the patient. For example, the "distal end" of a catheter includes the end of the catheter intended to be near or within the patient when the catheter is used with the patient. The distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter. However, the distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless the context suggests otherwise, the distal portion, distal end portion, or distal length of a catheter is not the terminal portion or terminal length of the catheter. Also, the terms "including," "having," and "having" as used herein, including the claims, shall have the same meaning as the word "including."

The terms "needle" and "cannula" are used interchangeably herein and can refer to a member having a sharp or beveled end for insertion into an injection site of a subject. In one embodiment, the needle can be a thin, hollow, tubular member. "Axial" means along or parallel to the longitudinal axis of the needle, and "radial" directions are those perpendicular to the axial direction. The forward direction is the direction toward the distal end of the device. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

The embodiments disclosed herein relate to a catheter assembly 100 that includes features that provide a streamlined insertion procedure and reduce the risk of medical complications. With reference to Figures 1 and 2, a catheter assembly 100 is disclosed for accessing a patient's vascular system for introducing fluids, medications, and the like. As shown in Figure 1, the catheter assembly 100 generally includes an elongated catheter body 110 extending from a proximal end 102 to a distal end 104, a catheter hub 120 disposed at the proximal end 102, one or more extension legs, e.g., extension legs 122, 124, 126, a guidewire 180, a needle 162, a syringe 160, and a PIV hub 148. The elongated catheter body 110 defines one or more lumens extending from the proximal end 102 to the distal end 104 for administration or aspiration of fluids or introduction of elongated medical devices. For example, the exemplary embodiment shown in Figure 1 includes a three lumen embodiment, although catheters having more or fewer lumens are contemplated. Similar catheter assembly configuration embodiments, including various lumen, needle, and guidewire configurations, and associated methods, are disclosed in U.S. Pat. No. 1,037,675, which is incorporated herein by reference in its entirety.

The catheter hub 120 is disposed at the proximal end 102 of the elongated catheter body 110 and provides one or more openings that each communicate with one or more lumens of the elongated body 110. The catheter hub 120 further includes various stabilizing features 128 for securing the hub to various catheter stabilizing devices and for securing the catheter 110 to a patient. The stabilizing features 128 can include various wings, tabs, holes, abutments, collars, etc., or combinations thereof.

In one embodiment, the catheter hub 120 includes one or more extension legs, e.g., extension legs 122, 124, 126. Each extension leg defines an extension leg lumen in communication with the lumen of the catheter body 110. Each extension leg also includes a connector, e.g., connectors 132, 134, 136, disposed at its proximal end to communicate the extension leg lumen with various fluid lines, syringes, or similar devices for introducing fluids, medications, and the like, via the catheter 110 to the patient. The connectors 132, 134, 136 can include luer locks, spin nuts, and the like.

In one embodiment, the lumen of the catheter body 110 can be configured to accept an elongated medical device, such as a guidewire, stylet, trocar, or the like, or a combination thereof. As shown in FIG. 1, the guidewire 180 is disposed within the lumen of the catheter body 110 through the connector 134, the extension leg 124, and the catheter hub 120. The guidewire 180 includes a guidewire hub 182 permanently attached to the proximal end of the guidewire 180. In one embodiment, the guidewire hub 182 includes a locking feature to engage the connector 134 and secure the guidewire within the catheter 100. As shown, the guidewire hub 182 has a generally cylindrical shape, but can include other shapes, such as a cube, sphere, etc., designed to prevent the proximal end of the guidewire from entering the lumen of the catheter 110. Optionally, one or more of the extension legs 122, 124, 126 have a clamp 138 for selectively preventing the flow of fluid therethrough and/or the movement of a guidewire 180 disposed therein. The guidewire 180 may be solid, hollow, or wire-like and may be formed of stainless steel, nitinol, alloys, plastics, polymers, or similar suitable materials.

The elongated catheter body 110 extends from the proximal end 102 to the distal end 104 along a longitudinal axis. The elongated body 110 includes a central venous catheter ("CVC") section 112, a transition section 114, and a peripheral intravenous ("PIV") section 116. The elongated body 110 may be made of a flexible, biocompatible plastic, polymer, silicone rubber, or similar suitable material, or combinations thereof. It is noted that, as shown in FIG. 2, the elongated body 110 is deflected from the longitudinal axis for illustrative purposes. The catheter 110, or portions thereof, may further include various reinforcements to maintain the shape of the catheter 100 and/or the patency of the lumen(s).

The CVC section 112 extends from the distal end of the catheter hub 120 to the proximal end of the transition section 114. The transition section 114 extends from the distal end of the CVC section 112 to the proximal end of the PIV section 116. The PIV section 116 extends from the distal end of the transition section 114 to the tapered peripheral intravenous catheter tip 142. In one embodiment, the PIV section 116 extends between 1 cm and 20 cm, and in a preferred embodiment, 7 cm. However, the PIV section 116 can vary in length beyond these measurements and is within the scope of the present invention. Additionally, the relative lengths of the CVC section 112, transition section 114, and PIV section 116 can also vary and is within the scope of the present invention.

In one embodiment, the CVC portion 112 and the PIV portion 116 define different structural and mechanical properties. The CVC portion 112 defines a relatively large diameter and includes one or more lumens, as described in more detail herein. The material forming the CVC portion 112 has a relatively soft durometer of about 93A Shore, which allows the CVC portion 112 to pass through a patient's tortuous vasculature.

The PIV portion 116 defines a relatively smaller diameter than the CVC portion 112 and typically defines only a single lumen. However, embodiments are contemplated in which the PIV portion 116 defines one or more lumens. The material forming the PIV portion 116 is relatively harder than the CVC portion 112, with a durometer of about 72 D Shore. The PIV portion 116 also defines greater columnar strength and greater hoop strength than the CVC portion 112, and in one embodiment includes reinforcements disposed within the walls of the PIV portion 116 to improve columnar and hoop strength. This allows the PIV portion 116 to withstand greater compressive forces along the longitudinal axis as it is forced distally and also sustained while being inserted through the patient's skin surface and subcutaneous tissue. The PIV portion 116, in turn, can maintain the overall shape of the PIV portion 116 and the patency of any lumens formed therein.

The transition section 114 transitions the different structural and mechanical properties between the CVC section 112 and the PIV section 116. The transition section 116 includes a taper to provide a smooth outer profile between the relatively small diameter of the PIV section 116 and the relatively large diameter of the CVC section 112. Advantageously, as described in more detail herein, the transition section 114 provides a self-expanding function when the catheter body 110 is advanced into the patient.

In one embodiment, the PIV section 116, the transition section 114, the CVC section 112, or a combination thereof includes a lubricious coating. As described herein, the CVC section 112, the transition section 114, and the PIV section 116 of the catheter body 110 are provided as a single structure. In one embodiment, the CVC section 112, the transition section 114, and the PIV section 116, or a combination thereof, may be provided as separate structures and connected using various temporary or permanent bonds. For example, one or more sections 112, 114, 116 of the catheter body 110 may be provided as separate structures and bonded, welded, fused, or glued together. Methods of forming catheters such as the catheters described herein having one or more sections are disclosed in U.S. Provisional Application No. 62/898,408, filed September 10, 2019, which is incorporated herein in its entirety.

3 shows an enlarged view of the PIV section 116, the transition section 114, and the distal end of the CVC section 112. The distal end of the CVC section 112 includes a needle access opening 144 and one or more exit openings, e.g., a first exit opening 146 disposed through a sidewall of the CVC section 112. As described herein, the elongate body 110 includes one or more lumens. A first lumen 152 extends from the first connector 132 to the first exit opening 146 disposed through a sidewall of the CVC section 112. A second lumen 154 extends from the second connector 134 to an opening at the distal end 104 of the elongate body 110. A third lumen (not shown) extends from the third connector 136 to a second exit opening (not shown) disposed through a sidewall of the CVC portion 112 opposite the first exit opening 146. In one embodiment, the first and third lumens 152, 156 also extend through the PIV portion 116 to the distal end 104.

In one embodiment, the guidewire 180 is positioned within the second lumen 154 such that the distal end of the guidewire 180 is positioned proximate the distal end of the CVC portion 112, e.g., adjacent the needle access opening 144. Advantageously, the guidewire is provided preloaded within the catheter body 110, allowing for rapid deployment of the guidewire since it is already proximate the distal end 104 of the catheter 110. In one embodiment, the outer diameter of the guidewire 180 is approximately the same as the inner diameter of the second lumen 154, such that fluid flowing proximally through the lumen 154 is substantially blocked by the guidewire 180 positioned therein. In one embodiment, the guidewire 180 extends through the CVC portion 112, the transition portion 114, and into the PIV lumen portion 150 of the second lumen 154. In one embodiment, when the guidewire hub 182 engages the connector 134, the guidewire 180 extends to the distal end 104 of the catheter 110. In one embodiment, the guidewire 180 extends distally beyond the distal end 104 of the catheter 110. In one embodiment, the guidewire 180 extends 15 cm beyond the distal end 104 of the catheter 110. In one embodiment, the guidewire 180 extends sufficiently beyond the distal end 104 of the catheter 110 to reach the lower third of the superior vena cava ("SVC"). In one embodiment, the clamp 138 can selectively secure the guidewire 180 in place.

As shown in FIGS. 1 and 4, the catheter assembly 100 includes a syringe 160 and a needle 162. The proximal end of the needle hub 166 includes a connector that allows various medical lines, syringes, and the like, such as the syringe 160, to communicate with the lumen of the needle 162. The connector between the hub 166 and the syringe 160 may be a luer lock, spin nut, or similar suitable connector. In one embodiment, the needle 162 and needle hub 166 include a valve device that prevents flow through the needle when the syringe 160 is not connected. In one embodiment, the needle 162 and needle hub 166 include a blood flashback indicator device to indicate that the needle tip 164 has accessed the patient's vasculature. In one embodiment, the syringe 160 or a similar device can induce a vacuum to draw in blood flow to confirm that the needle tip 164 has properly accessed the vasculature. In one embodiment, the syringe 160 can be selectively removed from the needle 162 to observe blood flow to confirm that the needle tip 164 has properly accessed the vasculature. For example, if the blood flow is substantially steady and dark red, the clinician has confirmed venous access and can proceed with the procedure. However, if the blood flow is pulsatile and bright red, the clinician has confirmed arterial access.

The needle 162 extends through the needle access opening 144 into the PIV lumen portion 150 of the second lumen 154 such that the needle tip 164 extends distally beyond the distal end 104 of the catheter body 110. In one embodiment, the needle access opening 144 includes a slit, a U-shaped slit, a circular or oval opening, or a similar structure. In one embodiment, the needle access opening 144 includes a needle-penetrable material, such as silicone, that allows the needle 162 to penetrate the needle access opening 114 but prevents fluid from leaking when the needle 162 is removed. In one embodiment, the needle access opening 144 includes a valve that allows access to the needle 162 and closes the needle access opening 144 when the needle 162 is removed.

4, in one embodiment, the PIV hub 148 is coupled to the elongated body 110 to define a PIV hub lumen substantially parallel to the longitudinal axis and aligned with the needle access opening 144 and the PIV lumen portion 150. The PIV hub 148 facilitates alignment of the needle 162 with the needle access opening 144 and the PIV lumen portion 150. In one embodiment, the PIV hub 148 includes an anti-rotation feature that aligns the beveled end 174 of the needle 162 in a predetermined position, e.g., an upper position, a lower position, etc. In one embodiment, the proximal end of the PIV hub 148 includes various detents, abutments, guides, etc., or combinations thereof that engage with similar structures on the needle hub 166 to align the beveled end 174 of the needle 162 in the upper position. In one embodiment, the needle hub 166 includes a rib that engages with a slot located on the PIV hub 148. The slots and ribs are oriented so that the PIV hub 148 and needle hub 166 fully engage only when the bevel of the needle 162 is properly oriented upward to facilitate skin puncture.

In one embodiment, the PIV hub 148 further includes a tab 170. The tab 170 can be used by a clinician to stabilize the PIV hub 148 when separating the needle hub 166 from the PIV hub 148. In one embodiment, the PIV hub 148 includes a clip 172 that secures the PIV hub 148 to an adjacent portion of the elongate body 110, i.e., the distal end of the CVC portion 112. The clip 172 stabilizes the PIV hub 148 and the needle 162 coupled to the PIV hub 148 to prevent the needle 162 from being inadvertently withdrawn from the needle access opening 144. The clip 172 also allows the PIV hub 148 to be selectively removed from the device 100. Additionally, the PIV hub 148 is coupled to the CVC section 112 in a position such that the lie distance between the needle tip 164 and the distal end 104 of the catheter body 110 is properly aligned, as described in more detail below. In one embodiment, the catheter body 110 includes various markings, detents, protrusions, or combinations thereof to properly position the PIV hub 148 on the catheter body 110 relative to the distal end 104.

Figures 5A-5C show enlarged cross-sectional views of the distal end of the PIV portion 116. Figure 5A shows the distal end of the PIV portion 116 without the needle 162 disposed therein. The tip 142 of the PIV portion 116 defines a tapered outer profile, gradually decreasing from a relatively large diameter at the PIV portion 116 to a relatively small diameter at the distal end 104. The lumen diameter of the tip portion 142 is also tapered, gradually decreasing from the relatively large diameter of the PIV lumen portion 150 to the relatively small diameter of the lumen at the distal end 104.

5B shows an enlarged cross-sectional view of the distal end of the PIV section 116 with the needle 162 positioned therein. The outer diameter of the needle 162 is sized to fit snugly within the PIV lumen section 150. The inner diameter of the lumen of the distal end 104 is sized to be relatively smaller than the outer diameter of the needle 162. Thus, when the needle 162 is positioned through the distal end 104 such that the entire bevel 174 of the needle 162 extends distally beyond the distal end 104 of the catheter 110, the distal end 104 extends to snugly engage around the outer diameter of the shaft of the needle 162. As described herein, the PIV hub 148 is positioned to ensure the correct distance between the needle tip 164 and the distal end 104, for example, as shown in FIG. 5B.

In contrast, as shown in FIG. 5C, if the distance between the needle tip 164 and the distal end 104 is misaligned, a portion of the bevel 174 of the needle 162 remains proximal to the distal end 104. Thus, when the catheter assembly 100 is advanced into the patient, tissue and fluids may be forced between the inner wall of the lumen 150 and the needle 162, preventing smooth advancement of the catheter assembly 100.

In an exemplary method of use, the catheter assembly 100 is provided in a preassembled form as described herein. However, the components of the catheter assembly 100 may also be provided in an unassembled form as a kit or may be provided separately and assembled by the clinician prior to use. The clinician uses the needle tip 164 to access the patient's vasculature. Proximal blood flow through the needle lumen 168 can be observed at the needle hub 166 to confirm correct vascular access. For example, a dark red and relatively steady blood flow indicates venous access and the procedure can continue. However, a bright red and pulsatile blood flow indicates arterial access and the procedure can be discontinued. It is important to note that arterial access using conventional CVC placement techniques can result in serious medical complications. However, arterial access using the relatively small diameter needle 162 and PIV portion 116 can be resolved by simply applying pressure. In one embodiment, the syringe 160 or similar device coupled to the needle hub 166 can induce a vacuum to draw blood flow proximally from the needle lumen 168. This can be used to confirm proper vascular access when blood pressure alone is insufficient to drive blood flow proximal to the needle hub 166. In one embodiment, the syringe 160 can also contain any blood flowing from the needle hub 166. In one embodiment, the needle hub 166 can further include a valve to prevent blood flow when the syringe 160 is removed.

Once vascular access is confirmed, the clinician can remove the catheter 110 from the needle 162/syringe 160 assembly by stabilizing the PIV hub 148 with their fingers and removing the needle hub 166 proximally. The PIV push-off tab 170 can provide a surface on which the clinician can stabilize the PIV hub 148. Once removed, the PIV portion 116 can be advanced distally away from the needle 162 and into the patient's vasculature. The clinician can grasp the PIV hub 148 and advance the PIV portion 116, and then withdraw the needle 162/syringe 160 assembly proximally and discard it. In one embodiment, once the needle 162 is removed from the catheter body 110, a valve or similar structure closes the needle access opening 144 to stop blood flow through the needle access opening 144. The PIV hub 148 can then be removed from the catheter body 110 and discarded.

The tapered tip 142 of the PIV portion 116 is securely attached and fixed around the shaft of the needle 162. This provides a smooth outer profile as the needle 162/PIV tip 142 assembly penetrates the skin surface and accesses the vasculature. With the needle 162 removed and the PIV tip 142 positioned within the vasculature, the guidewire 180 can be advanced through the lumen 150 of the PIV portion 116 and into the vasculature. The PIV portion 116 provides sufficient columnar and hoop strength to be pushed distally over the guidewire 180 into the vasculature without kinking, maintaining patency of the PIV lumen 150. The PIV portion 116 is also relatively small in diameter and optionally includes a lubricious coating to facilitate distal advancement into the vasculature.

With the needle 162 removed, the guidewire 180 positioned within the lumen 154 can then be advanced through the PIV lumen portion 150 past the distal end 104 and into the patient's vasculature. The guidewire can be advanced to a target location, such as the lower third of the superior vena cava. A guidewire hub 182 permanently attached to the guidewire 180 prevents the guidewire 182 from advancing too far into the vasculature, even if the clinician accidentally releases the guidewire, and also prevents the guidewire 180 from being accidentally lost within the vasculature.

The guidewire 180 is provided preloaded within the lumen 154 prior to the start of the procedure. The distal end of the guidewire 180 positioned near the needle access opening 144 allows for rapid deployment of the guidewire 180 once the needle 162 is removed. The distal end of the guidewire 180 only needs to travel the distance of substantially the PIV portion 116 to access the vasculature. In contrast, conventional methods of placing a CVC catheter require the guidewire to be fed to the proximal end of the CVC catheter and advanced along the entire length of the CVC catheter to advance into the vasculature, which is time consuming and increases the risk of infection.

With the guidewire in place, the catheter 110 can then be advanced over the guidewire 180. As the transition section 114 passes over the guidewire 180 and through the insertion site, the tapered outer profile automatically expands the insertion site from the diameter of the PIV section 116 to the relatively larger diameter of the CVC section 112. In one embodiment, the transition section 114, the CVC section 112, or a combination thereof, can include a lubricious coating disposed thereon to facilitate access.

The catheter body 110 is then advanced over the guidewire 180 until the exit opening, e.g., exit opening 146, is located at the desired location. The guidewire 180 can then be removed once the catheter hub 120 is secured near the insertion site. Additionally, various medical lines can be connected to the connectors 132, 134, 136 to introduce fluids, medications, etc. into the vasculature via the exit opening (e.g., exit opening 146). In one embodiment, the guidewire lumen 154 can be used to introduce fluids through the needle access opening 144, an opening in the distal end 104, or a combination thereof.

Advantageously, the catheter assembly 100 provides the ease of placement typically associated with a PIV catheter with the functionality of a CVC catheter. Traditional methods of placing a CVC catheter are complex procedures that involve surgical incisions to access the vascular system, increasing the risk of significant medical complications and infection. In contrast, placement of the catheter assembly 100 requires a relatively small puncture site and fewer devices to be introduced and removed, which can expedite the procedure and reduce the risk of complications and infection.

Although some specific embodiments are disclosed herein, and the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and/or modifications may be apparent to those skilled in the art, and the broader aspects also encompass these adaptations and/or modifications. Thus, one may depart from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims (14)

1. A catheter assembly for accessing the vascular system of a patient, comprising:
An elongate catheter body extending from a proximal end to a distal end and defining a first lumen, the catheter body comprising:
a central venous catheter ("CVC") portion including a needle access opening disposed through a sidewall thereof; and
The transition part and
a peripheral intravenous ("PIV") portion defining a peripheral intravenous ("PIV") lumen portion of a first lumen;
a catheter hub coupled to a proximal end of the catheter body;
a peripheral intravenous ("PIV") hub defining a peripheral intravenous ("PIV") hub lumen;
a needle defining a needle lumen and a needle hub coupled to a proximal end thereof, the needle hub engaging the proximal end of the PIV hub such that the needle extends through the PIV hub lumen, the needle access opening and a portion of the PIV lumen beyond the distal end of the elongate catheter body;
a guidewire disposed in a proximal portion of the first lumen. The catheter assembly of claim 1, wherein the guidewire includes a guidewire hub permanently attached to its proximal end and configured to prevent the proximal end of the guidewire from advancing distally into the first lumen. The catheter assembly of claim 1 or 2, further comprising a syringe coupled to the needle hub and in communication with the needle lumen, the syringe creating a vacuum to draw blood flow from the needle lumen to confirm vascular access. The catheter assembly of any one of claims 1 to 3, wherein the PIV hub includes a clip for connecting the PIV hub to the catheter body. The catheter assembly of any one of claims 1 to 4, wherein the PIV hub is configured to align the tip of the needle with the distal end of the catheter body such that the beveled end of the needle is distal to the distal end of the catheter body. The catheter assembly of any one of claims 1 to 5, wherein the PIV hub includes an anti-rotation feature that orients the needle bevel in a predetermined position. The catheter assembly of claim 6, wherein the anti-rotation feature includes a slot disposed on the PIV hub and a rib disposed on the needle hub, the rib and the slot being oriented such that the PIV hub and the needle hub are fully engaged only when the beveled end is in the upward position. The catheter assembly of any one of claims 1 to 7, wherein the catheter hub includes an extension leg extending proximally from its proximal end, the extension leg defining an extension leg lumen in communication with the first lumen, and including a connector at its proximal end. The catheter assembly of any one of claims 1 to 8, wherein the needle access opening is provided with a slit valve that closes the needle access opening when the needle is removed from the needle access opening. The catheter assembly of any one of claims 1 to 9, wherein the catheter body further has a second lumen extending from the catheter hub to an exit opening disposed through a sidewall of the CVC portion proximate its distal end. The catheter assembly of claim 10, wherein the catheter hub includes a second extension leg, the second extension leg defining a second extension leg lumen in communication with the second lumen of the catheter body. A catheter assembly according to any one of claims 1 to 11, wherein the PIV portion defines a first diameter and the CVC portion defines a second diameter, the first diameter being smaller than the second diameter. The catheter assembly of claim 12, wherein the transition portion includes a tapered outer surface extending from the first diameter to the second diameter. The catheter assembly of any one of claims 1 to 13, wherein the PIV portion has a distal end, the distal end forming a tapered outer profile and defining a lumen diameter, the lumen diameter being smaller than the outer diameter of the needle shaft.

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