Integrated acute central venous catheter and peripherally inserted intravenous catheter

Abstract

The present application relates to an integrated acute central venous catheter and a peripherally inserted intravenous catheter. The catheter assembly includes a peripheral intravenous ("PIV") portion that provides rapid vascular access. The catheter assembly includes an elongated catheter body that defines a first lumen and includes a CVC portion, a transition portion, and a PIV portion. The PIV portion defines a relatively small diameter, a tapered tip, and a lumen configured to receive a needle. The needle extends through a needle entry hole that is arranged through the side wall of the catheter body and through the PIV lumen to a point beyond the distal end of the catheter body. The clinician uses the needle and PIV portion to enter the vascular system. The needle is then removed, and a guide wire is advanced into the vascular system through the lumen of the catheter body and the PIV portion. The CVC portion is then advanced into the vascular system over the guide wire, causing the insertion site to self-expand as the transition portion enters the vascular system.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 905,363, filed September 24, 2019, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present invention relates to the field of medical devices, and more particularly to an integrated acute central venous catheter and a peripherally inserted venous catheter. Background Art

[0004] Current methods for placing an acute central venous catheter ("ACVC") involve a multi-step process: under ultrasound guidance, the vasculature is entered using an introducer needle (which includes a syringe attached to a needle hub); the syringe is removed from the introducer needle hub to observe blood flow and ensure that the needle is properly placed in a vein rather than an artery; a guidewire is introduced through the introducer needle; the introducer needle is removed over the guidewire; an incision is made using a surgical scalpel; and one or more dilators are introduced over the guidewire; and finally, a CVC catheter is introduced over the guidewire. The guidewire and / or introducer can then be removed. Often, the various steps of changing between different devices (such as removing the needle from the introducer needle hub) result in unintended movement, thereby missing a vein and aborting the attempt. Entering an artery rather than a vein can lead to serious medical complications. Further, the clinician needs to maintain control of the guidewire throughout the procedure to prevent it from being lost in the vasculature, and the guidewire is susceptible to contamination from exposure to unsterile surfaces. Moreover, changing multiple devices increases the risk of infection. Summary of the Invention

[0005] Disclosed herein are integrated catheter assemblies that, in exemplary embodiments, may include an acute central venous catheter having a peripherally inserted intravenous catheter portion at a distal end to provide for rapid insertion of the device into a patient.

[0006] Briefly, embodiments disclosed herein relate to catheter assemblies and associated methods. A catheter assembly (also referred to as a rapid insertion central catheter or "RICC") comprises an elongated catheter body comprising a central venous catheter ("CVC") portion and a peripheral intravenous catheter ("PIV"). The PIV portion is disposed at the distal end of the elongated body and comprises a needle disposed within the lumen of the PIV portion. The PIV portion facilitates insertion of the catheter assembly, streamlines the insertion process, reduces the risk of infection, and reduces the risk of aborting an attempt. Further, the catheter assembly comprises a guidewire having a permanently attached sleeve to prevent the guidewire from being lost into the vascular system.

[0007] The present invention discloses a catheter assembly for accessing a patient's vascular system, comprising an elongated catheter body and a catheter hub, a peripheral intravenous ("PIV") hub, a needle and a needle hub connected to the proximal end of the needle, and a guidewire, the elongated catheter body extending from the proximal end to the distal end and defining a first inner cavity, the catheter body comprising a central venous catheter ("CVC") portion (which includes a needle entry hole arranged through its side wall), a transition portion and a peripheral intravenous ("PIV") portion (which defines a PIV inner cavity portion of the first inner cavity), the catheter hub being connected to the proximal end of the catheter body, the PIV hub defining a PIV hub inner cavity, the needle defining a needle inner cavity, the needle extending through the PIV hub inner cavity, the needle entry hole and the PIV inner cavity portion to a point distal to the distal end of the elongated body, and the guidewire being arranged in the proximal portion of the first inner cavity.

[0008] In some embodiments, the guidewire includes a guidewire hub that is permanently attached to the proximal end of the guidewire and is configured to prevent the proximal end of the guidewire from being advanced distally into the first lumen. The catheter assembly further includes a syringe coupled to the needle hub and in fluid communication with the needle lumen, the syringe generating a vacuum to draw blood flow through the needle lumen and confirm vascular entry. The PIV hub includes a clip to couple 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 on the needle hub, the rib and slot being oriented such that the PIV hub and the needle hub are fully engaged only when the bevel is oriented in an upward position. The catheter hub includes an extension leg extending proximally from a proximal end thereof, the extension leg defining an extension leg lumen in fluid communication with the first lumen, the extension leg including a connector at a proximal end thereof.

[0009] In some embodiments, the needle access port includes a slit valve that closes the needle access port when the needle is removed from the needle access port. The catheter body further includes a second lumen extending from the catheter hub to an exit port disposed near its distal end through a sidewall of the CVC portion. The catheter hub includes a second extension leg defining a second extension leg lumen in fluid communication with the second lumen of the catheter body. The PIV portion defines a first diameter, while the CVC portion defines a second diameter, the first diameter being smaller than the second diameter. The transition portion includes a tapered outer surface extending from the first diameter to the second diameter. The PIV portion includes a tip defining a tapered outer profile and defining an inner lumen diameter that is smaller than the outer diameter of the shaft of the needle.

[0010] Also disclosed is a method for inserting a catheter into a patient's vascular system, comprising: providing a catheter assembly comprising an elongated catheter body, a catheter hub, a peripheral intravenous ("PIV") hub, a needle and a guidewire, the elongated 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, the central venous catheter portion comprising a needle entry hole, a transition portion and a peripheral intravenous ("PIV") portion arranged through its side wall, the PIV portion defining a PIV lumen portion of the first lumen, the catheter hub arranged at the proximal end of the catheter body, the peripheral intravenous hub connected to the catheter body and defining a PIV hub lumen, the needle defining a needle lumen and comprising a needle hub connected with the PIV hub, the needle arranged through the PIV hub lumen, the needle entry hole, the PIV lumen portion and extending beyond the distal end of the elongated body, and the guidewire arranged in the first lumen. Inserting a needle into a patient to access the patient's vasculature such that the distal end of the catheter body is disposed within the vasculature; observing blood flow at the needle hub to confirm vascular access; removing the needle hub from the PIV hub; withdrawing the needle proximally from the PIV hub; advancing the PIV portion distally into the vasculature; removing the PIV hub from the catheter body; advancing a guidewire through 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 vasculature.

[0011] In some embodiments, the PIV portion includes a tip defining a tapered outer profile and defining an inner lumen diameter that is smaller than the outer diameter of the shaft of the needle to secure the tip of the PIV portion to the shaft. The PIV portion defines a first diameter and 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 to couple the PIV hub to the catheter body and includes an anti-rotation feature that engages with the needle hub to orient 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 on the needle hub that engages with the slot to orient the bevel in an upward position. The needle access port includes a valve that closes the needle access port when the needle is removed from the needle access port. The catheter body further includes a second lumen extending from the catheter hub to an exit port disposed through a sidewall of the CVC portion, the catheter hub including a second extension leg defining a second extension leg lumen in fluid communication with the second lumen. Prior to entering the patient's vasculature with the needle, a distal end of the guidewire is positioned adjacent the needle entry port. The method further includes a syringe coupled to the needle hub and in fluid communication with the needle lumen, the syringe generating a vacuum to draw blood flow through the needle lumen and confirm vascular entry. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] A more detailed description of the present disclosure will be presented with reference to specific embodiments of the present disclosure illustrated in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and, therefore, should not be considered as limiting the scope of the invention. Example embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which:

[0013] Figure 1 shows a perspective view of a catheter assembly including a needle, a syringe, and a guidewire according to embodiments disclosed herein;

[0014] Figure 2 Demonstrates the use of the embodiments disclosed herein Figure 1 A perspective view of the catheter shown in FIG;

[0015] Figure 3 Demonstrates the embodiment disclosed herein Figure 2 a close-up view of the distal portion of the catheter;

[0016] Figure 4 Demonstrates the embodiment disclosed herein Figure 1 a close-up view of the distal portion of the catheter assembly; and

[0017] Figures 5A to 5C Demonstrates the embodiment disclosed herein Figure 1 Various details of the distal end of the catheter assembly. DETAILED DESCRIPTION

[0018] Reference will now be made to the drawings, wherein like structures will have like reference numerals. It should be understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the invention and are neither restrictive nor necessarily drawn to scale.

[0019] About the term used in this article, it should also be understood that these terms are for the purpose of describing some specific embodiments, and these terms do not limit the scope of the concept provided herein. Ordinal number (for example, first, second, third etc.) is usually used to distinguish or identify the different features or different steps in a set of features or a set of steps, and sequence or numerical limitation is not provided. For example, "first", "second" and "third" features or steps do not necessarily need to appear in order, and the specific embodiment including such features or steps does not necessarily need to be limited to these three features or steps. Labels such as "left", "right", "up", "down", "front", "back" etc. are used for convenience, rather than being intended to imply such as any specific fixed position, orientation or direction. On the contrary, such labels are used to reflect such as relative position, orientation or direction. Unless otherwise clearly indicated in context, singular form "one", "a kind of" and "the" include plural references.

[0020] For the sake of clarity, it will be understood that the word "proximal" refers to the direction relatively close to the clinician using the device described herein, while the word "distal" refers to the direction relatively further away from the clinician. For example, when a catheter is used on a patient, the "proximal," "proximal portion," or "proximal end portion" of a catheter disclosed herein includes a portion of the catheter that is intended to be close to the clinician. Similarly, for example, when a catheter is used on a patient, the "proximal length" of the catheter includes the length of the catheter that is intended to be close to the clinician. For example, when a catheter is used on a patient, the "proximal end" of the catheter includes an end of the catheter that is intended to be close to the clinician. The proximal portion, proximal portion, or proximal length of the catheter can include the proximal end of the catheter; however, the proximal portion, proximal portion, or proximal length of the catheter do not need to include the proximal end of the catheter. That is, unless the context indicates otherwise, the proximal portion, proximal portion, or proximal length of the catheter is not the terminal portion or terminal length of the catheter.

[0021] For example, about the "distal side", "distal portion" or "distal end portion" of the catheter disclosed herein, include the catheter portion that should be close to the patient or in the patient when the catheter is used on the patient. Similarly, for example, the "distal length" of the catheter includes the length of the catheter that should be close to the patient or in the patient when the catheter is used on the patient. For example, the "distal end" of the catheter includes an end of the catheter that should be close to the patient or in the patient when the catheter is used on the patient. The distal portion, distal portion or distal length of the catheter can include the distal end of the catheter; however, the distal portion, distal portion or distal length of the catheter does not need to include the distal end of the catheter. That is, unless the context indicates otherwise, the distal portion, distal portion or distal length of the catheter are not the terminal portion or terminal length of the catheter. In addition, the words "comprise", "have" and "with" as used herein (including claims) should have the same meaning as the word "comprising".

[0022] The terms "needle" and "cannula" are used interchangeably herein to refer to a member having a sharp or beveled end for insertion into an injection site on a subject. In one embodiment, the needle can be a thin, hollow, tubular member. "Axial" refers to the direction along or parallel to the longitudinal axis of the needle, and the "radial" direction is the direction 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.

[0023] The embodiments disclosed herein relate to a catheter assembly 100 that includes features that provide for a streamlined insertion procedure and a reduced risk of medical complications. Figures 1 to 2 , discloses a catheter assembly 100 for entering a patient's vascular system to introduce fluids, medications, etc. Figure 1As shown in FIG, 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 administering or aspirating fluids or introducing elongated medical devices. For example, Figure 1 The exemplary embodiment shown in includes a three-lumen embodiment, but catheters with more or fewer lumens can be envisioned. Embodiments of similar catheter assembly configurations, including various lumens, needles, and guidewire configurations and associated methods, can be found in US 10,376,675, the entire contents of which are incorporated herein by reference.

[0024] The catheter hub 120 is disposed at the proximal end 102 of the elongated catheter body 110 and provides one or more openings that 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, in turn, securing the catheter 110 to the patient. The stabilizing features 128 may include various wings, tabs, holes, abutments, loops, or the like, or combinations thereof.

[0025] In an embodiment, the catheter hub 120 includes one or more extension legs, such as extension legs 122, 124, 126. Each extension leg defines an extension leg lumen that is in fluid communication with the lumen of the catheter body 110. Each extension leg also includes a connector (e.g., connector 132, 134, 136) disposed at the proximal end of the extension leg to provide fluid communication between the extension leg lumen and various fluid lines, syringes, or similar devices used to introduce fluids, medications, etc. to a patient via the catheter 110. The connectors 132, 134, 136 can include a Luer lock, a swivel nut, etc.

[0026] In an embodiment, the lumen of the catheter body 110 can be configured to receive an elongated medical device, such as a guidewire, a stylet, a trocar, or the like, or a combination thereof. Figure 1, a guidewire 180 is disposed through the connector 134, the extension legs 124, and the catheter hub 120, and into the lumen of the catheter body 110. The guidewire 180 includes a guidewire hub 182 permanently attached to the proximal end of the guidewire 180. In an 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 includes a substantially cylindrical shape, but it will be understood that the guidewire hub 182 may include other shapes designed to prevent the proximal end of the guidewire from entering the lumen of the catheter 110, such as a cube, a sphere, etc. Optionally, one or more of the extension legs 122, 124, 126 include a clamp 138 for selectively inhibiting fluid flow therethrough, or selectively inhibiting movement of the guidewire 180 disposed therein, or a combination thereof. The guidewire 180 may be solid, hollow, or wire-like and formed from stainless steel, nitinol, alloys, plastics, polymers, or similar suitable materials.

[0027] The elongated catheter body 110 extends along a longitudinal axis from a proximal end 102 to a distal end 104. The elongated body 110 includes a central venous catheter ("CVC") portion 112, a transition portion 114, and a peripheral intravenous ("PIV") portion 116. The elongated body 110 can be formed from a flexible and biocompatible plastic, polymer, silicone rubber, or similar suitable material, or a combination thereof. Note that, as Figure 2 As shown in FIG, the elongated body 110 is offset from the longitudinal axis, however, this is 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).

[0028] 14. The CVC portion 112 extends from the distal end of the catheter hub 120 to the proximal end of the transition portion 114. The transition portion 114 extends from the distal end of the CVC portion 112 to the proximal end of the PIV portion 116. The PIV portion 116 extends from the distal end of the transition portion 114 to a tapered peripheral intravenous catheter tip 142. In an embodiment, the PIV portion 116 extends between 1 cm and 20 cm, with an embodiment extending 7 cm being preferred. However, it will be understood that the PIV portion 116 can vary in length beyond these measurements and fall within the scope of the present invention. It will also be understood that the relative lengths of the CVC portion 112, the transition portion 114, and the PIV portion 116 can also vary and still remain within the scope of the present invention.

[0029] In an 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 includes a relatively soft hardness of approximately 93A Shore A. This allows the CVC portion 112 to navigate the tortuous vasculature of the patient.

[0030] The PIV portion 116 defines a relatively smaller diameter than the CVC portion 112 and typically defines only a single lumen. However, it will be understood that embodiments of the PIV portion 116 defining one or more lumens are also contemplated. The material forming the PIV portion 116 is relatively harder than the material forming the CVC portion 112, having a Shore hardness of approximately 72D. The PIV portion 116 also defines a greater columnar strength and greater hoop strength than the CVC portion 112, and in an embodiment, includes reinforcements arranged within the walls of the PIV portion 116 to improve the columnar strength and hoop strength. This allows the PIV portion 116 to withstand greater compressive forces along the longitudinal axis, such as those suffered while being urged distally and inserted through the patient's skin surface and subcutaneous tissue. The PIV portion 116 can then maintain the overall shape of the PIV portion 116 and the patency of any lumen defined therein.

[0031] The transition portion 114 provides a transition between the different structures and mechanical properties of the CVC portion 112 and the PIV portion 116. The transition portion 116 includes a tapered portion to provide a smooth outer profile between the relatively small diameter of the PIV portion 116 and the relatively large diameter of the CVC portion 112. Advantageously, the transition portion 114 provides a self-expanding feature as the catheter body 110 is advanced into the patient, as described in more detail herein.

[0032] In an embodiment, the PIV portion 116, the transition portion 114, the CVC portion 112, or a combination thereof includes a lubricating coating. As described herein, the CVC portion 112, the transition portion 114, and the PIV portion 116 of the catheter body 110 are provided as a single structure. It will be understood that in an embodiment, the CVC portion 112, the transition portion 114, and the PIV portion 116, or a combination thereof, may also be provided as separate structures and connected using various temporary couplings or permanent couplings. For example, one or more portions 112, 114, 116 of the catheter body 110 may be provided as separate structures and bonded, welded, fused, or adhered together. Methods for forming a catheter, such as a catheter having one or more portions as described herein, are disclosed in U.S. Provisional Application No. 62 / 898,408, filed September 10, 2019, the entire contents of which are incorporated herein.

[0033] Figure 3 A close up view of the distal end of the PIV portion 116, the transition portion 114, and the CVC portion 112 is shown. The distal end of the CVC portion 112 includes a needle entry port 144 and one or more exit ports, such as a first exit port 146, disposed through a sidewall of the CVC portion. As described herein, the elongated body 110 includes one or more lumens. A first lumen 152 extends from the first connector 132 to the first exit port 146 disposed through a sidewall of the CVC portion 112. A second lumen 154 extends from the second connector 134 to an opening at the distal end 104 of the elongated body 110. A third lumen (not shown) extends from the third connector 136 to a second exit port (not shown), disposed through the sidewall of the CVC portion 112 opposite the first exit port 146. In an embodiment, the first lumen 152 and the third lumen 156 also extend through the PIV portion 116 to the distal end 104.

[0034] In an embodiment, the guidewire 180 is disposed within the second lumen 154 such that the distal end of the guidewire 180 is disposed proximate to the distal end of the CVC portion 112, e.g., adjacent the needle port 144. Advantageously, this allows for rapid deployment of the guidewire since it is preloaded within the catheter body 110 and already proximate to the distal end 104 of the catheter 110. In an embodiment, the outer diameter of the guidewire 180 is substantially the same as the inner diameter of the second lumen 154 such that any fluid flowing proximally through the lumen 154 is substantially blocked by the guidewire 180 disposed therein. In an 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 an embodiment, when the guidewire hub 182 engages the connector 134, the guidewire 180 extends to the distal end 104 of the catheter 110. In an embodiment, the guidewire 180 extends distally beyond the distal end 104 of the catheter 110. In an embodiment, the guidewire 180 extends 15 cm beyond the distal end 104 of the catheter 110. In an embodiment, the guidewire 180 extends sufficiently beyond the distal end 104 of the catheter 110 to reach the lower portion of the superior vena cava ("SVC"). 1 / 3. In an embodiment, the clamp 138 can selectively secure the guidewire 180 in place.

[0035] like Figure 1 and 4 In the embodiment shown in, catheter assembly 100 comprises syringe 160 and needle 162.The proximal end of needle hub 166 comprises connector, to allow various medical circuits, syringes etc. (for example, syringe 160) to be communicated with the lumen fluid of needle 162.The connector between needle hub 166 and syringe 160 can be Luer lock, swivel nut or similar suitable connector.In an embodiment, needle 162 and needle hub 166 comprise valve device, to prevent the flow by needle when syringe 160 is not connected thereto.In an embodiment, needle 162 and needle hub 166 comprise blood flashback (flashback) indicator device, to indicate when needle tip 164 has entered patient's vascular system.In an embodiment, syringe 160 or similar device can cause vacuum to aspirate blood flow, to confirm that needle tip 164 has correctly entered vascular system.In an embodiment, syringe 160 can be selectively unloaded from needle 162 to observe blood flow, to confirm that needle tip 164 has correctly entered vascular system. For example, if the blood flow is essentially steady and dark red, the clinician can confirm venous access and proceed with the procedure. However, if the blood flow is pulsating and bright red, the clinician can confirm arterial access.

[0036] The needle 162 extends through the needle entry hole 144 and 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 an embodiment, the needle entry hole 144 comprises a slit, a U-shaped slit, a circular or oval hole, or a similar structure. In an embodiment, the needle entry hole 114 comprises a needle-penetrable material such as silicone, etc., which allows the needle 162 to penetrate the hole 114, but prevents any fluid from escaping once the needle 162 is removed. In an embodiment, the needle entry hole 114 includes a valve that allows entry of the needle 162 and closes the hole 144 when the needle 162 is removed.

[0037] like Figure 4 As shown in , in an embodiment, the PIV bushing 148 is coupled to the elongated body 110 and defines a PIV bushing lumen (substantially parallel to the longitudinal axis) that is aligned with the needle entry aperture 144 and the PIV lumen portion 150. The PIV bushing 148 facilitates alignment of the needle 162 with the needle entry aperture 144 and the PIV lumen portion 150. In an embodiment, the PIV bushing 148 includes an anti-rotation feature that aligns the bevel 174 of the needle 162 in a predetermined position, such as an upward position, a downward position, etc. In an embodiment, the proximal end of the PIV bushing 148 includes various stops, stands, guides, etc., or combinations thereof, that engage with similar structures on the needle bushing 166 to align the bevel 174 of the needle 162 in an upward position. In an embodiment, the needle bushing 166 includes ribs that engage slots disposed in the PIV bushing 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 (oriented upward to facilitate skin penetration).

[0038] In an embodiment, the PIV hub 148 further includes a tab 170. The clinician can use the tab 170 to stabilize the PIV hub when separating the needle hub 166 from the PIV hub 148. In an embodiment, the PIV hub 148 includes a clip 172 that secures the PIV hub 148 to an adjacent portion of the elongated 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 thereto and prevents the needle 162 from being accidentally withdrawn from the needle access port 144. The clip 172 also allows the PIV hub 148 to be selectively removed from the device 100. Further, the PIV hub 148 is coupled to the CVC portion 112 at 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 an embodiment, the catheter body 110 includes various markings, stops, protrusions, or combinations thereof to ensure that the PIV hub 148 is properly positioned on the catheter body 110 relative to the distal end 104 .

[0039] Figures 5A to 5C A close-up cross-sectional view of the distal end of the PIV portion 116 is shown. Figure 5A The distal end of the PIV portion 116 is shown without the needle 162 disposed therein. The tip 142 of the PIV portion 116 defines a tapered outer profile that gradually decreases from a relatively large diameter of the PIV portion 116 to a relatively small diameter of the distal end 104. The lumen diameter of the tip portion 142 is also tapered, gradually decreasing from a relatively large diameter of the PIV lumen portion 150 to a relatively small diameter of the lumen of the distal end 104.

[0040] Figure 5B A close up cross-sectional view of the distal end of the PIV portion 116 is shown having a needle 162 disposed therein. The outer diameter of the needle 162 is sized to fit tightly within the PIV lumen portion 150. The inner diameter of the lumen at 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 stretches to fit tightly around the outer diameter of the shaft of the needle 162. As described herein, the PIV bushing 148 is positioned to ensure the correct placement distance between the needle tip 164 and the distal end 104, e.g., Figure 5B As shown in .

[0041] On the contrary, Figure 5C , when the seating distance between needle tip 164 and distal end 104 is misaligned, a portion of bevel 174 of needle 162 remains proximal to distal end 104. Thus, if catheter assembly 100 is advanced into a patient, tissue and fluid may be compressed between the inner wall of lumen 150 and needle 162, thereby disrupting smooth advancement of catheter assembly 100.

[0042] In an exemplary method of use, as described herein, the catheter assembly 100 is provided in a preassembled form. However, it will be understood that the components of the catheter assembly 100 may also be provided as a kit in an unassembled form or provided separately and may be assembled by a clinician before use. The clinician uses the needle tip 164 to access the patient's vascular system. Proximal blood flow through the needle lumen 168 can be observed at the needle hub 166 to ensure correct vascular access. For example, a dark red, relatively stable flow indicates venous access, and the procedure can continue. However, a bright red, pulsating flow indicates arterial access, and the procedure may be aborted. It is important to note that arterial access using a traditional CVC placement procedure can lead to serious medical complications. However, arterial access using a relatively small diameter needle 162 and PIV portion 116 can be solved by simply applying pressure. In an embodiment, a syringe 160 or similar device connected to the needle hub 166 can induce a vacuum to draw blood proximally through the needle lumen 168. This can be used to confirm correct vascular access, where blood pressure alone is insufficient to propel blood proximally to the needle hub 166. In an embodiment, the syringe 160 may also contain any blood that flows from the needle hub 166. In an embodiment, the needle hub 166 may further include a valve that prevents blood flow when the syringe 160 is removed.

[0043] Once vascular access is confirmed, the clinician can remove the catheter 110 from the needle 162 / syringe 160 assembly by using a finger to stabilize the PIV hub 148 and remove the needle hub 166 in a proximal direction. The PIV breakaway tab 170 can provide a surface that the clinician can use to 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 to advance the PIV portion 116 and withdraw the needle 162 / syringe 160 assembly proximally and discard it. In an embodiment, once the needle 162 has been removed from the catheter body 110, a valve or similar structure closes the needle hole 144 to prevent blood flow therethrough. The PIV hub 148 can then be removed from the catheter body 110 and discarded.

[0044] Note that the tapered tip 142 of the PIV portion 116 fits tightly around the axis of the needle 162 and is secured to the needle 162. This provides a smooth outer profile as the needle 162 / PIV tip 142 assembly penetrates the skin surface and enters 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 column and hoop strength to be pushed distally over the guidewire 180 into the vasculature without kinking and to maintain the patency of the PIV lumen 150. The PIV portion 116 also includes a relatively small diameter and optionally includes a lubricious coating to facilitate distal advancement into the vasculature.

[0045] With the needle 162 removed, a guidewire 180 disposed within the lumen 154 may then be advanced through the PIV lumen portion 150 and beyond the distal end 104 into the patient's vasculature. The guidewire may be advanced to a target location, such as the lower portion of the superior vena cava. 1 / 3. It will be appreciated that the guidewire hub 182 being permanently attached to the guidewire 180 prevents the guidewire 182 from being advanced too far into the vasculature and prevents the guidewire 180 from being accidentally lost into the vasculature even if the clinician accidentally releases the guidewire.

[0046] Note that before the procedure begins, the guidewire 180 is preloaded within the lumen 154. Once the needle 162 has been removed, the distal end of the guidewire 180, positioned adjacent the needle entry hole 144, allows for rapid deployment of the guidewire 180. The distal end of the guidewire 180 only needs to travel the distance of substantially the PIV portion 116 to enter the vascular system. In contrast, conventional methods of placing a CVC catheter would require feeding the guidewire into the proximal end of the CVC catheter and advancing it along the entire length of the CVC catheter to enter the vascular system, which takes additional time and provides an increased risk of infection.

[0047] With the guidewire in place, the catheter 110 can then be advanced over the guidewire 180. As the transition portion 114 passes over the guidewire 180 and through the insertion site, the tapered outer profile provides for automatic expansion of the insertion site from the diameter of the PIV portion 116 to the relatively larger diameter of the CVC portion 112. In embodiments, the transition portion 114, the CVC portion 112, or a combination thereof can include a lubricious coating disposed thereon to facilitate entry.

[0048] The catheter body 110 is then advanced over the guidewire 180 until the exit hole (e.g., exit hole 146) is positioned at the desired location. The catheter hub 120 is then secured near the insertion site and the guidewire 180 can be removed. Various medical circuits can then be connected to the connectors 132, 134, 136 to introduce fluids, medicaments, etc. into the vascular system through the exit hole (e.g., exit hole 146). In an embodiment, the guidewire lumen 154 can be used to introduce fluids via the needle port 144, an opening at the distal end 104, or a combination thereof.

[0049] Advantageously, the catheter assembly 100 utilizes the functionality of a CVC catheter to provide the convenience of placement typically associated with a PIV catheter. Traditional methods of placing a CVC catheter involve a complex procedure that involves accessing the vascular system through a surgical incision and increases the risk of significant medical complications and infection. In contrast, placement of the catheter assembly 100 requires a relatively small puncture site and requires the introduction and removal of fewer devices. This can expedite the procedure and reduce the risk of medical complications and infection.

[0050] Although some specific embodiments have been disclosed herein, and although specific embodiments have been disclosed in detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications will be apparent to those of ordinary skill in the art and are encompassed in the broader aspects. Accordingly, departures from the specific embodiments disclosed herein may be made without departing from the scope of the concepts provided herein.

Claims

1. A catheter assembly for accessing a patient's vascular system, comprising: an elongated catheter body extending from a proximal end to a distal end and defining a first lumen, the catheter body comprising: a central venous catheter portion comprising a needle access port disposed through a side wall of the central venous catheter portion; transitional sections; and a peripheral intravenous portion defining a peripheral intravenous lumen portion of said first lumen; and a catheter hub coupled to the proximal end of the catheter body; a peripheral intravenous liner defining a peripheral intravenous liner lumen; a needle defining a needle lumen and a needle hub coupled to a proximal end of the needle, the needle extending through the PII hub lumen, the needle access port, and the PII lumen portion to a point distal to the distal end of the catheter body; and A guidewire is disposed through the catheter hub and in the proximal portion of the first lumen, with a distal end of the guidewire disposed adjacent the needle access port.

2. The catheter assembly of claim 1, wherein the guidewire comprises a guidewire hub permanently attached to the proximal end of the guidewire and configured to prevent the proximal end of the guidewire from being advanced distally into the first lumen.

3. The catheter assembly according to claim 1 or 2, further comprising a syringe coupled to the needle hub and in fluid communication with the needle lumen, the syringe generating a vacuum to draw blood flow through the needle lumen and confirm vascular entry. 4 . The catheter assembly of claim 1 , wherein the PIV sleeve comprises a clip to couple the PIV sleeve to the catheter body.

5. The catheter assembly of claim 1, wherein the peripheral intravenous liner is configured to align the tip of the needle with the distal end of the catheter body so that the bevel of the needle is distal to the distal end of the catheter body.

6. The catheter assembly of claim 1, wherein the peripheral intravenous hub includes an anti-rotation feature that orients the bevel of the needle in a predetermined position.

7. The catheter assembly of claim 6 , wherein the anti-rotation feature comprises a slot disposed in the peripheral intravenous sleeve and a rib disposed on the needle sleeve, the rib and the slot being oriented such that the peripheral intravenous sleeve and the needle sleeve are fully engaged only when the bevel is oriented in an upward position.

8. The catheter assembly of claim 1 , wherein the catheter hub includes an extension leg extending proximally from a proximal end thereof, the extension leg defining an extension leg lumen in fluid communication with the first lumen, the extension leg including a connector at its proximal end.

9. The catheter assembly of claim 1, wherein the needle access port includes an isolation valve that closes the needle access port when the needle is removed from the needle access port.

10. catheter assembly according to claim 1, wherein said catheter body further comprises a second lumen, said second lumen extending from said catheter hub to an exit aperture, said exit aperture being arranged near its distal end by the sidewall of said central venous catheter portion.

11. The catheter assembly of claim 10, wherein the catheter hub includes a second extension leg defining a second extension leg lumen in fluid communication with the second lumen of the catheter body.

12. conduit tube component according to claim 1, wherein said peripheral vein part limits first diameter, and said central venous catheter part limits second diameter, and said first diameter is less than said second diameter.

13. The catheter assembly of claim 12, wherein the transition portion comprises a tapered outer surface extending from the first diameter to the second diameter.

14. The catheter assembly of claim 1, wherein the peripheral intravenous portion comprises a tip defining a tapered outer profile and defining a lumen inner diameter that is smaller than the outer diameter of the shaft of the needle.

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