Preformed catheter devices, systems, and manufacturing methods

Abstract

A catheter (12) may include an elongate tube (16) having a body portion (20), a distal tip portion (22) extending in a distal direction from a distal end of the body portion, a distal opening at a distal end of the distal tip portion, an outer surface (47), and an inner surface defining a lumen terminating at the distal opening and extending through the body portion and the distal tip portion. The elongate tube may include a preformed curve proximate the distal end of the body portion and configured to direct the distal opening away from or parallel to a distal inner surface of a vessel. The elongate tube may include one or more voids extending proximally from a distal opening at a distal end of the distal tip portion. The catheter (12) may be part of or configured to be used in an over-the-needle catheter system (10).

Description

Atty. Docket No. 1404.10101 1 1CATHETER DEVICES, SYSTEMS, AND METHODSCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 841,666 filed on July 10, 2025; U.S. Provisional Patent Application Serial No. 63 / 743,386 filed on January 9, 2025; U.S. Provisional Patent Application Serial No. 63 / 705,172 filed on October 9, 2024, the disclosures of which are incorporated herein by reference.TECHNICAL FIELD

[0002] The present disclosure pertains to catheter devices, systems, and methods. More specifically, the present disclosure relates to catheter devices and systems for injecting fluids into vessel lumens, and methods of using and making the catheter devices and systems.BACKGROUND

[0003] A wide variety of intracorporeal and extracorporeal medical devices and systems have been developed for medical use, for example, in accessing vessel lumens. Some of these devices and systems include guidewires, catheters, catheter systems, needles, pump devices, and the like. These devices and systems are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices, systems, and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices and systems as well as alternative methods for manufacturing and using medical devices and systems.BRIEF SUMMARY

[0004] This disclosure provides design, material, manufacturing method, and use alternatives for medical devices, including catheters and catheter systems. A first example may include a catheter comprising an elongate tube having a body portion, a distal tip portion extending in a distal direction from a distal end of the body portion, aAty. Docket No. 1404.10101 1 1 distal opening at a distal end of the distal tip portion, an outer surface, and an inner surface defining a lumen terminating at the distal opening and extending through the body portion and the distal tip portion, and wherein the elongate tube comprises a preformed curve proximate the distal end of the body portion, the preformed curve is configured to direct the distal opening away from or parallel to a distal inner surface of a vessel when in a deployed configuration within a lumen of the vessel.

[0005] Alternatively or additionally to any of the examples above, at least a portion of the preformed curve may extend along one of the body portion or the distal tip portion.

[0006] Alternatively or additionally to any of the examples above, the preformed curve may extend along the body portion and the distal tip portion.

[0007] Alternatively or additionally to any of the examples above, the elongate tube may be formed from a resilient material proximate the distal end of the body portion such that the elongate tube adjusts to a delivery configuration when a needle is advanced through the distal tip portion and adjusts to the deployed configuration when a needle tip of the needle is withdrawn to a location proximal of the distal end of the body portion.

[0008] Alternatively or additionally to any of the examples above, the elongate tube may be configured to further curve proximate the distal end of the body portion in response to the distal tip portion engaging the distal inner surface of the vessel.

[0009] Alternatively or additionally to any of the examples above, the distal tip portion may have a taper such that an outer diameter of the distal tip tapers toward the distal end of the distal tip portion.

[0010] Alternatively or additionally to any of the examples above, the distal tip portion may include a bottom portion and a top portion opposing the bottom portion and the taper may have a first portion along the bottom portion that extends distally from a first longitudinal location and a second portion along the top portion that extends distally from a second longitudinal location distal of the first longitudinal location.

[0011] Alternatively or additionally to any of the examples above, the distal opening may be perpendicular to a central axis of the lumen.Aty. Docket No. 1404.10101 1 1

[0012] Alternatively or additionally to any of the examples above, the distal tip portion may comprise a first bevel and a second bevel located distal of a proximal end of the taper.

[0013] Alternatively or additionally to any of the examples above, the distal tip portion may be more flexible than the body portion.

[0014] Alternatively or additionally to any of the examples above, the distal tip portion may be formed from silicone.

[0015] Alternatively or additionally to any of the examples above, the distal tip portion may be configured to expand in response to fluid passing through the lumen and out of the distal tip portion such that an inner diameter of the lumen and an outer diameter at the distal end of the distal tip portion are greater than the inner diameter of the lumen and an outer diameter at a proximal end of the distal tip portion.

[0016] Alternatively or additionally to any of the examples above, the body portion may include a plurality of openings extending between the lumen and the outer surface of the elongate tube.

[0017] Alternatively or additionally to any of the examples above, the elongate tube may comprise a portion along the preformed curve formed from a first material configured to expand at a first expansion rate based on a value of an environmental parameter and a second portion along the preformed curve formed from a second material configured to expand at a second expansion rate based on the value of the environmental parameter.

[0018] Alternatively or additionally to any of the examples above, the value of the environmental parameter may be a temperature set point.

[0019] Alternatively or additionally to any of the examples above, the elongate tube may comprise a portion along the preformed curve formed from a first material configured to expand when exposed to a liquid and a second portion along the preformed curve formed from a second material that is not configured to expand when exposed to the liquid.

[0020] In a further example, a method of forming a catheter may include forming a body portion and a distal tip in an elongate tube, the distal tip extending from a distal end of the body portion, heating material of the elongate tube from a first temperature toAty. Docket No. 1404.10101 1 1 a second temperature, and forming a curve in the elongate tube proximate the distal end of the body portion, wherein the curve may be formed in the material that is heated while a temperature of the material is above the first temperature.

[0021] Alternatively or additionally to any of the examples above, forming the curve in the elongate tube proximate the distal end of the body portion may comprise rolling the elongate tube about an axis perpendicular to a longitudinal axis of the elongate tube while the material of the elongate tube is above the first temperature.

[0022] Alternatively or additionally to any of the examples above, forming the curve in the elongate tube proximate the distal end of the body portion may comprise rolling the elongate tube about an axis perpendicular to a longitudinal axis of the elongate tube prior to heating the material of the elongate tube from the first temperature to the second temperature.

[0023] Alternatively or additionally to any of the examples above, forming the curve in the elongate tube proximate the distal end of the body portion may comprise inserting a support into the material of the elongate tube, the support having a preformed curve.

[0024] In a further example, a method of using a catheter may include inserting a needle and a distal tip of the catheter into a vessel lumen of a subject, forming a curve in a portion of the catheter within the vessel lumen by withdrawing the needle from the vessel lumen, and injecting infusate through a catheter lumen in the distal tip of the catheter and into the vessel lumen.

[0025] Alternatively or additionally to any of the examples above, the method may further include engaging the distal tip with an inner wall of the vessel lumen to further curve the catheter along the curve.

[0026] Alternatively or additionally to any of the examples above, injecting the infusate through the catheter lumen in the distal tip may cause an outer diameter at a distal end of the distal tip to be greater than an outer diameter at a proximal end of the distal tip.

[0027] In a further example, a catheter may include an elongate tube having a body, a distal tip extending in a distal direction from a distal end of the body, a distal opening at a distal end of the distal tip, an outer surface, and an inner surface defining aAty. Docket No. 1404.10101 1 1 lumen terminating at the distal opening and extending through the body and the distal tip, wherein the distal tip may comprise at least two opposing voids, the voids extending proximally from the distal opening to the distal end of the body.

[0028] Alternatively or additionally to any of the examples above, each void may comprise at least one bevel region.

[0029] Alternatively or additionally to any of the examples above, the at least two opposing voids may be formed at spaced intervals around the circumference of the elongate tube.

[0030] Alternatively or additionally to any of the examples above, the distal tip may have a taper such that an outer diameter of the distal tip tapers toward the distal end of the distal tip.

[0031] Alternatively or additionally to any of the examples above, at least one void may be located on a bottom region of the distal tip and at least one void is located on a top region of the distal tip.

[0032] In a further example, a method of using a catheter may include inserting a needle and a distal tip of the catheter including at least two voids into a vessel lumen of a subject, positioning at least one void to in engagement with an inner wall of the vessel lumen, positioning at least one cutout to face away from the inner wall of the vessel lumen, and injecting infusate through a catheter lumen in the distal tip of the catheter and into the vessel lumen.

[0033] Alternatively or additionally to any of the examples above, injecting the infusate through the catheter lumen in the distal tip may cause an outer diameter at a distal end of the distal tip to be greater than an outer diameter at a proximal end of the distal tip.

[0034] The above summary of some configurations is not intended to describe each disclosed configuration or every implementation of the present disclosure. The Figures, and Detailed Description, which follow, more particularly illustrate some of these configurations.BRIEF DESCRIPTION OF THE DRAWINGSAty. Docket No. 1404.10101 1 1

[0035] The disclosure may be more completely understood in consideration of the following detailed description in connection with the accompanying drawings, in which:

[0036] FIG. 1 is a schematic perspective view of an illustrative configuration of an over-the-needle catheter system;

[0037] FIG. 2 is a schematic side view of an illustrative configuration of the over- the-needle catheter system;

[0038] FIG. 3 is a schematic exploded view of the configuration of the over-the- needle catheter system depicted in FIG. 2;

[0039] FIG. 4 is a schematic view of a distal end of an illustrative configuration of an over-the-needle catheter system, with a catheter shown in cross-section and a needle shown from a side view within a lumen of the intravenous catheter;

[0040] FIG. 5 is a schematic view of a distal end of an illustrative configuration of an over-the-needle catheter system, with a catheter shown in cross-section and a needle shown from a side view within a lumen of the intravenous catheter;

[0041] FIG. 6 is a schematic perspective view of a distal end of an illustrative configuration of an over-the-needle catheter system;

[0042] FIG. 7A is a schematic perspective view of a distal end of an illustrative configuration of a catheter;

[0043] FIG. 7B is a schematic side view of the distal end of the illustrative catheter depicted in FIG. 7A;

[0044] FIG. 7C is a schematic top view of the distal end of the illustrative catheter depicted in FIG. 7A;

[0045] FIG. 7D is a schematic end view of the distal end of the illustrative catheter depicted in FIG. 7A;

[0046] FIG. 8A is a schematic perspective view of a distal end of an illustrative configuration of a catheter;

[0047] FIG. 8B is a schematic side view of the distal end of the illustrative catheter depicted in FIG. 8A;

[0048] FIG. 8C is a schematic top view of the distal end of the illustrative catheter depicted in FIG. 8A;Aty. Docket No. 1404.10101 1 1

[0049] FIG. 8D is a schematic end view of the distal end of the illustrative catheter depicted in FIG. 8A;

[0050] FIG. 9 is a schematic view of a distal end of an illustrative configuration of a catheter;

[0051] FIG. 10 is a schematic view of a distal end of an illustrative configuration of a catheter;

[0052] FIG. 11 is a schematic view of a distal end of an illustrative configuration of a catheter;

[0053] FIG. 12 is a schematic view of a distal end of an illustrative configuration of a catheter;

[0054] FIG. 13 depicts a schematic box diagram of an illustrative technique for forming a catheter;

[0055] FIG. 14 depicts a schematic box diagram of an illustrative technique of using a catheter;

[0056] FIG. 15 depicts a schematic box diagram of an illustrative technique of using a catheter;

[0057] FIGS. 16A-16D depict schematic views of steps in an illustrative technique of using an illustrative configuration of an over-the-needle catheter system;

[0058] FIGS. 17A-17D depict schematic views of steps in an illustrative technique of using an illustrative configuration of an over-the-needle catheter system;

[0059] FIGS. 18A-18D depict schematic views of steps in an illustrative technique of using an illustrative configuration of an over-the-needle catheter system;

[0060] FIGS. 19A-19D depict schematic views of steps in an illustrative technique of using an illustrative configuration of an over-the-needle catheter system;

[0061] FIGS. 20A-20D depict schematic views of steps in an illustrative technique of using an illustrative configuration of an over-the-needle catheter system;

[0062] FIGS. 21A-21D depict schematic views of steps in an illustrative technique of using an illustrative configuration of an over-the-needle catheter system; and

[0063] FIGS. 22A-22C depict schematic views of steps in an illustrative technique of using an illustrative configuration of an over-the-needle catheter system.Aty. Docket No. 1404.10101 1 1

[0064] While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. The intention is not to limit the disclosure to the particular configurations described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.DETAILED DESCRIPTION

[0065] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.

[0066] All numeric values are herein assumed to be modified by the term “about,” whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the term “about” may include numbers that are rounded to the nearest significant figure.

[0067] The recitation of numerical ranges by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0068] As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and / or” unless the content clearly dictates otherwise.

[0069] It is noted that references in the specification to “a configuration”, “some configurations”, “other configurations”, etc., indicate that the configuration described may include one or more particular features, structures, and / or characteristics. However, such recitations do not necessarily mean that all configurations include the particular features, structures, and / or characteristics. Additionally, when particular features, structures, and / or characteristics are described in connection with one configuration, such features, structures, and / or characteristics may also be used in connection with other configurations whether or not explicitly described unless clearly stated to the contrary.

[0070] The following detailed description should be read with reference to the drawings in which similar structures in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative configurations and are notAty. Docket No. 1404.10101 1 1 intended to limit the scope of the disclosure. Additionally, it should be noted that in any given figure, some features may not be shown, or may be shown schematically, for clarity and / or simplicity. Additional details regarding some components and / or method steps may be illustrated in other figures in greater detail. The devices and / or methods disclosed herein may provide a number of desirable features and benefits as described in more detail below.

[0071] Intravenous (IV) catheter insertion is an invasive procedure used when administering infusate such as medication, contrast media, and / or other fluids or combinations thereof. In some examples, an over-the-needle catheter system may be utilized for IV catheter insertion. IV catheter insertion may involve a needle insertion into a vessel lumen (e g., a lumen of a peripheral vein and / or a lumen of other suitable vessels) followed by introduction of the IV catheter over the needle. When fluid is to be administered through a lumen of the IV catheter after the catheter has been inserted into the vessel lumen, the needle may be withdrawn leaving the distal end of the IV catheter and one or more openings thereat in the vessel lumen. Once the needle is withdrawn, fluid (e.g., medicine, contrast solution and / or other suitable fluids) may be inserted through the lumen of the IV catheter, out of the one or more openings in the distal end of the IV catheter, and into the vessel lumen.

[0072] Although the concepts disclosed herein may be discussed with respect to IV catheters, the concepts may be applied to other suitable types of catheter. For example, the concepts disclosed herein may be applied to IV catheters, midline catheters, implantable port catheters, central venous catheters, peripherally inserted central catheters (PICC), and / or other suitable types of catheters.

[0073] Complications may occur due to caregiver error when utilizing an over- the-needle catheter system for delivering fluid (e.g., contrast media and / or other suitable fluids) to a vessel lumen. For example, when inserting the needle and / or the catheter into the vessel lumen, the needle and / or the vessel lumen may puncture a wall portion of the vessel lumen (e.g. puncture a distal inner surface of the vessel) opposing a wall portion of the vessel lumen at an entry location into the vessel lumen (e.g., a proximal inner surface of the vessel). Additionally or alternatively, once the catheter is positioned in the vessel lumen, a jet of fluid exiting the one or more openings at the distal end of the catheter mayAty. Docket No. 1404.10101 1 1 be directed at the vessel wall (e.g., the distal inner surface, which may or may not include a puncture lesion) and perforate the vessel wall (e.g., through a puncture in the wall of the vessel lumen), irritate the vessel wall, cause extravasation through the vessel wall, and / or cause one or more other complications with the vessel wall.

[0074] Illustrative configurations of the catheter discussed herein address complications with existing catheters by directing fluid exiting the one or more openings at the distal end of the catheter away from the wall portion of the vessel lumen opposing the entry point into the vessel lumen, by reducing a flow rate of fluid through the one or more openings at the distal end of the catheter, and / or by incorporating one or more other features discussed herein. The catheters discussed herein may be utilized in an over-the- needle catheter system, but other suitable configurations are contemplated.

[0075] FIG. 1 schematically depicts an illustrative configuration of an over-the- needle catheter system 10. The over-the-needle catheter system 10 may include a catheter assembly 12 (e.g., an intravenous (IV) catheter and / or other suitable catheter), a needle assembly 14, and / or other suitable components. As depicted in FIG. 1, the needle assembly 14 may be positioned within and / or coupled with the catheter assembly 12 and the needle assembly 14 may extend in a proximal direction and a distal direction from the catheter assembly 12 when fully inserted into the catheter assembly 12.

[0076] The catheter assembly 12 may have any suitable configuration. In some examples, the catheter assembly 12 may include an elongate tube 16 (e.g., a sheath or other suitable elongate tube) extending in a distal direction from a catheter hub 18. Although the elongate tube 16 may have other suitable configurations, the elongate tube 16 may include a body 20 (e.g., body portion or region) with a proximal end coupled with the catheter hub 18 and a distal tip 22 (e.g., a distal tip portion or region) having a proximal end extending in a distal direction from a distal end of the body 20 and terminating at a distal end of the distal tip 22. Although the proximal end of the distal tip 22 and the distal end of the body 20 are depicted in FIG. 1 as beginning and ending, respectively, at a taper defined by an outer surface 47 of the elongate tube 16, other suitable configurations for the positioning of the proximal end of the distal tip 22 and the distal end of the body 20 are contemplated. In some examples, the distal tip 22 may be more flexible than the body 20 of the elongate tube 16 (e.g., the distal tip 22 may beAty. Docket No. 1404.10101 1 1 made of a softer material, may have a thinner thickness, etc. than the body 20), but other suitable configurations are contemplated.

[0077] The elongate tube 16 may be formed from one or more materials and those materials may have any suitable configuration. Example suitable materials from which the elongate tube 16 may be formed include, but are not limited to, flexible materials, resilient materials, polymers, metals, polyurethane, polytetrafluoroethylene (PTFE, such as TEFLON®), silicon, hydrogels, hydratable materials, temperature sensitive materials, acrylamide, polyethylene Glycol Diacrylate (PEGDA), polyvinyl alcohol, polyethylene glycol (PEG), poly(2-hydroxyethyl methacrylate), polyacrylamide, polyurethane, citric acid, hyaluronic acid, chitosan, alginic acid, and / or other suitable material. In some examples, one or more portions of the elongate tube 16 may be formed from a flexible and / or resilient material. In some examples, the elongate tube 16 may be formed from a resilient material at least at a location proximate the distal end of the body 20 (e.g., at the distal tip 22, at the distal end of the body 20, etc.). The body 20 and the distal tip 22 may be formed from a same material and / or different materials. In one example, the distal tip 22 may be formed from silicone.

[0078] The catheter hub 18 may have any suitable configuration. For example, the catheter hub 18 may have one or more ports in fluid communication with one or more lumens of the elongate tube 16. In some examples, the catheter hub 18 may include one or more proximal ports 24 and / or one or more side ports 26 in fluid communication with a single lumen of the elongate tube 16. In one example and as depicted in FIG. 1, the catheter hub 18 may include a single proximal port 24 and a single side port 26, but other suitable configurations are contemplated. The proximal port 24 may be configured to receive and / or engage the needle assembly 14 and / or other suitable medical devices and the side port 26 may be configured to receive a medical device (e.g., a syringe, etc.) configured to facilitate delivering fluid (e.g., contrast media, medicine, saline, etc.) to a lumen of elongate tube 16 that is in communication with the distal tip 22.

[0079] The needle assembly 14 may have any suitable configuration. In some examples, the needle assembly 14 may include a needle 28 extending in a distal direction from a needle hub 30. Although the needle 28 of the needle assembly 14 may have other suitable configurations, the needle 28 may include a body portion 32 with a proximal endAty. Docket No. 1404.10101 1 1 coupled with the needle hub 30 and a sharpened tip 34 (e.g., a distal tip) having a proximal end extending in a distal direction from a distal end of the body portion 32 and terminating at a distal end of the sharpened tip 34. Although the proximal end of the sharpened tip 34 and the distal end of the body portion 32 of the needle 28 are depicted in FIG. 1 as beginning and ending, respectively, at a bevel of the needle 28, other suitable configurations for the positioning of the proximal end of the sharpened tip 34 and the distal end of the body portion 32 of the needle 28 are contemplated.

[0080] The needle 28 may be formed from any suitable materials. For example, the needle 28 may be formed from a polymer, a metal, a ceramic, and / or other suitable materials. In some examples, one or more portions of the needle 28 may be formed from a rigid material.

[0081] The needle hub 30 may have any suitable configuration. For example, the needle hub 30 may have one or more ports in fluid communication with one or more lumens of the needle 28. In some examples, the needle hub 30 may include one or more proximal ports 36 and / or one or more side ports in fluid communication with a single lumen of the needle 28. In one example and as depicted in FIG. 1, the needle hub 30 may include a single proximal port 36, but other suitable configurations are contemplated.The proximal port 36 of the needle hub 30 may be configured to couple with and / or be in fluid communication with a flashback chamber, an intravenous infusion line, and / or other suitable components.

[0082] FIG. 2 schematically depicts a side view of the over-the-needle catheter system 10 having a preformed curve at or proximate the distal tip 22 and / or a distal end of the body 20 of the elongate tube 16, with the needle assembly 14 fully inserted into and coupled with the catheter assembly 12 such that the preformed curve in the elongate tube 16 has been straightened. When the needle hub 30 is coupled with the catheter hub 18, at least part of or an entirety of the sharpened tip 34 of the needle 28 may extend in the distal direction beyond the distal end of the distal tip 22 of the elongate tube 16 such that the elongate tube is in a stressed state and the preformed curve is straightened to cause the elongate tube 16 and the needle 28 to be co-axial. In some examples, a portion of the body portion 32 of the needle 28 proximate the sharpened tip 34 may extend beyond the distal end of the distal tip 22 of the elongate tube 16, as depicted for exampleAty. Docket No. 1404.10101 1 1 in FIG. 2, but other suitable configurations are contemplated in which only the sharpened tip 34 extends beyond the distal end of the distal tip 22. In some examples, the sharpened tip 34 may extend beyond the distal end of the distal tip 22 a suitable distance such that the sharpened tip 34 may puncture a vessel lumen of a subject (e.g., a patient) and be positioned within the vessel lumen while the distal tip 22 of the elongate tube 16 is within the vessel lumen prior to removal of the needle 28 from the vessel lumen.

[0083] The needle 28 may be partially or fully withdrawn in a proximal direction relative to the distal tip 22 of the elongate tube 16 after detaching or uncoupling the needle hub 30 from the catheter hub 18 and moving the needle hub 30 in the proximal direction and / or the catheter hub 18 in the distal direction. FIG. 3 schematically depicts an exploded view of the over-the-needle catheter system 10 depicted in FIG. 2, with the needle assembly 14 fully withdrawn in a proximal direction relative to the catheter assembly 12 and the elongate tube 16 in a relaxed state. When in the relaxed state, elongate tube 16 may have a shape of the preformed curve formed at or proximate the distal tip 22 and / or the distal end of the body 20 (e.g., as depicted in FIG. 3, the preformed curve may be in the distal tip 22).

[0084] The catheter hub 18 and the needle hub 30 may couple with one another in any suitable manner. In some examples, the catheter hub 18 and the needle hub 30 may include mating portions configured to fixate the needle 28 within and / or relative to the elongate tube 16. For example, the catheter hub 18 and the needle hub 30 may include a luer fitting (e.g., as depicted in FIG. 3), a threaded fitting, a friction-fit fitting, and / or other suitable mating portions. As depicted in FIG. 3, the catheter hub 18 may include a female luer fitting 38 and the needle hub 30 may include a male luer fitting 40, but other suitable configurations of mating components are contemplated for coupling the catheter assembly 12 with the needle assembly 14.

[0085] The distal tip 22 and / or the distal end of the elongate tube 16 may be configured in any suitable manner. In some examples, the distal tip 22 and / or the distal end of the elongate tube 16 may be configured to facilitate insertion into of the elongate tube 16 into a vessel of a subject and / or transferring fluid through one or more distal openings of the elongate tube into the vessel, while mitigating damage and / or trauma to the vessel. For example, the distal tip 22 and / or the distal end of the elongate tube 16Aty. Docket No. 1404.10101 1 1 may include one or more features including, but not limited to, a taper in the distal direction, a tapered region that is configured to be longer than a bevel of a needle, an uneven tapered region where a portion (e.g., a bottom region) of the taper configured to be proximate a wall of the vessel opposing a needle entry location is longer than a portion (e.g., a top region) of the taper at an opposing wall of the elongate tube 16, one or more bevels in the distal tip 22, the distal tip 22 formed from a low elastic modulus material defining an opening, one or more curved region, the distal tip 22 formed from materials having different softness or hardness levels, an expandable distal tip 22, a distal tip having different thicknesses at different region (e.g., a bottom region of the distal tip 22) may be thinner than a top region), and / or other suitable features configured to mitigate damage to the vessel of the subject during use of the catheter assembly 12.

[0086] The top region and / or sections of the elongate tube 16 may oppose the bottom region and / or sections of the elongate tube 16. In some examples, the top portion of the elongate tube 16 may be a half of the elongate tube 16 proximate to and / or at least partially facing a portion of the vessel wall at which entry into the vessel lumen was made and a bottom region of the elongate tube 16 may be a half of the elongate tube 16 proximate to and / or at least partially facing a portion of the vessel opposing the vessel wall at which entry into the vessel lumen was made. Alternatively or additionally, the top region and / or the bottom region of the elongate tube 16 may be less than half of a circumference of the elongate tube 16 such that one or more side region may extend between the top region and / or the bottom region of the elongate tube 16.

[0087] FIG. 4 schematically depicts a distal end of an illustrative configuration of the elongate tube 16, shown in cross-section, with a distal end of the needle 28, shown in a side view, positioned within the elongate tube 16. As depicted in FIG. 4, the distal end of the elongate tube 16 may be formed from a single material and define a distal opening 42 leading to a lumen 44 (e.g., the lumen 44 may distally terminate at the distal opening 42) defined by an inner surface 45 of the elongate tube 16 and extending along and / or through an entirety of or at least a region of the elongate tube 16 (e.g., extending along and / or through the body 20 and the distal tip 22). In one example, the distal opening 42 may be perpendicular to a central axis of the lumen 44, but other suitable configurations are contemplated. The elongate tube 16 may include the inner surface 45 defining theAty. Docket No. 1404.10101 1 1 lumen 44 and the outer surface 47, where a wall thickness of the elongate tube may extend between the inner surface 45 and the outer surface 47. The elongate tube 16 may include a taper defined by the outer surface 47 at the distal tip 22, where the taper may extend from a distal end of the body 20 to or toward the distal end of the distal tip 22 (e.g., to the distal opening 42), but the taper, when included, may take on any other suitable configuration. Further, the material of the distal end of the elongate tube 16 may have a same or similar wall thickness circumferentially around the distal end of the elongate tube 16 at all longitudinal locations, as depicted in FIG. 4, or at least a circumferential portion (e.g., the bottom region) of the elongate tube 16 may have a thinner wall thickness than another circumferential portion (e.g., a top region) of the elongate tube 16 (see e.g., FIGS. 18A-18D). Other suitable configurations of the distal end of the elongate tube 16 are contemplated.

[0088] The distal end of the needle 28 may have any suitable configuration. In some examples, the distal end of the needle 28, as depicted in FIG. 4, may include a single bevel at the sharpened tip 34 defining an opening 46 that leads to a needle lumen 48 extending along an entirety of or at least a portion of the needle 28. Other suitable configurations of the needle 28 are contemplated.

[0089] As depicted in FIG. 4, the bevel portion of the needle 28 (e.g., of the sharpened tip 34) may have a length LI and the taper region of the elongate tube 16 (e.g., of the distal tip 22) may have a length L2. The length LI of the bevel portion of the needle 28 may be less than, equal to, or greater than the length L2 of the tapered region of the elongate tube 16. In one example, as depicted in FIG. 4, the length LI of the bevel portion of the needle 28 may be less than the length L2 of the tapered region of the elongate tube 16, which may facilitate inserting the elongate tube 16 into the vessel of the subject and orienting the distal opening 42 away from a vessel wall.

[0090] FIG. 5 schematically depicts a distal end of an illustrative configuration of the elongate tube 16, shown in cross-section, with a distal end of the needle 28, shown in a side view, positioned within the elongate tube 16. As depicted in FIG. 5, a distal end of the elongate tube 16 (e.g., the distal tip 22) defining the distal opening 42 and including the taper may be formed from a plurality of materials. In one example, a first region of the tapered region along the bottom region of the elongate tube 16 may be formed from aAty. Docket No. 1404.10101 1 1 first material 50 and a second region of the tapered region along the top region of the elongate tube 16 may be formed from a second material 52, which may or may not form other region of the distal end of the elongate tube 16. In some examples, the body 20 of the elongate tube 16 may be at least a partially formed from the first material 50 and / or the second material 52 (e.g., as depicted in FIG. 5). Although other suitable configurations are contemplated, the first material 50 may have a lower durometer than the second material 52. Utilizing a softer or lower durometer material as the first material on the bottom region of the elongate tube 16 may facilitate mitigating damage to the vessel wall when the bottom region of the elongate tube 16 contacts the vessel wall.

[0091] The first material 50 and the second material 52 may be formed from any suitable materials. Example suitable materials from which the first material 50 and / or the second material 52 may be formed include, but are not limited to, polymers, polyurethane, silicone, polyisoprene, and / or other suitable materials. In some examples, the first material 50 and the second material 52 may be the same material or different material and have different durometers. In one example, the first material 50 may be a polyurethane and the second material 52 may be a silicone or polyisoprene.

[0092] The taper at the distal end of the elongate tube 16 may be asymmetrical. In one example, the first region of the taper at the bottom region of the distal tip 22 may have the second length L2 and the second region of the taper at the top region of the distal tip 22 opposing the bottom region may have a third length L3, which is less than the second length L2. For example, the first region of the taper may extend in a distal direction from a first longitudinal location and the second region of the taper may extend in the distal direction a second location distal of the first longitudinal direction. The third length L3 may be less than, equal to, or greater than the second length LI of the bevel portion of the needle 28. Other suitable relative lengths of the first length LI, the second length L2, and the third length L3 are contemplated. Utilizing a longer a softer or lower durometer material as the first material on the bottom region of the elongate tube 16 may facilitate mitigating damage to the vessel wall of the bottom region of the elongate tube 16 contacts the vessel wall.

[0093] FIG. 6 schematically depicts a perspective view of a distal end of an illustrative configuration the elongate tube 16 with the needle 28 extending distally fromAty. Docket No. 1404.10101 1 1 the distal opening 42 of the elongate tube 16. As depicted in FTG. 6, the distal tip 22 of the elongate tube 16 may have a bevel configuration designed to direct fluid away from the wall of the vessel opposing an entry point into the vessel and reduce a flow of fluid at the distal opening 42 of the elongate tube 16.

[0094] The distal tip 22 of the elongate tube 16 may be beveled such that flow of a fluid therethrough may be dispersed as it exits the distal opening 42 in a direction away from a wall of the vessel proximate the bottom region of the elongate tube 16. Such a beveled configuration of the distal tip 22, in some examples, may include a first beveled region 54 and a second beveled region 56. In some examples, the first beveled region 54 and / or the second beveled region 56 may be located in the taper of the distal tip 22 (e.g., may be located distal of a proximal end of the taper), but other suitable configurations are contemplated. The first beveled region 54 and the second beveled region 56 may have any suitable configuration relative to one another that facilitates directing fluid away from the vessel wall and / or dispersing the fluid distal of the distal opening 42. In one example, as depicted in FIG. 6, the first beveled region 54 may extend proximal from the distal end of the distal tip 22 and around a bottom region of the distal tip 22, where the first beveled region 54 may be configured to engage the vessel wall and direct the distal end or distal opening 42 at the distal end of the distal tip 22 away from the vessel wall. The second beveled region 56 of the distal tip 22 may extend proximally from the distal end of the distal tip 22. In some examples, the second beveled region 56 may be angled at an angle that extends through the lumen 44 proximal of the distal end of the distal tip 22 and that enlarges or extends the distal opening 42 in a proximal direction from the distal end of the distal tip 22 to form a void 57 in the distal tip 22. The second beveled region 56 and the void 57 in the distal tip 22 may define a region of the distal opening 42 that is non-perpendicular with a central axis of the elongate tube 16. The enlarged distal opening 42 may direct fluid exiting the distal opening 42 away form a vessel wall proximate the bottom region of the elongate tube 16 and reduce a speed of the fluid exiting the distal opening 42 due to having a larger opening than when the distal opening 42 is perpendicular to a longitudinal axis of the elongate tube 16.

[0095] The first beveled region 54 and / or the second beveled region 56 may have any suitable angles. In some examples, the first beveled region 54 may have an angleAty. Docket No. 1404.10101 1 1 extending through the elongate tube 16 relative to a longitudinal axis of the elongate tube 16 that is greater than an angle of the region beveled region 56 extending through the elongate tube 16 relative to the longitudinal axis of the elongate tube 16. In some examples, the angle of the first beveled region 54 may be within a range of about 15 degrees to about 35 degrees relative to a longitudinal axis of the elongate tube 16 and the angle of the second beveled region 56 may be within a range of about 1 degree to about 15 degrees. Other suitable angles may be utilized for the first beveled region 54 and the second beveled region 56.

[0096] FIGS. 7A-7D schematically depict views of a distal end of an illustrative configuration of the elongate tube 16. As depicted in FIGS. 7A-7D, the distal tip 22 of the elongate tube 16 may have a beveled configuration designed to direct fluid away from a vessel wall of a vessel in which it is inserted and facilitate engaging the vessel wall upon insertion of the elongate tube 16 into the vessel.

[0097] FIG. 7A schematically depicts a perspective view of the distal end of an illustrative configuration of the elongate tube 16. As depicted in FIG. 7A, the beveled configuration of the distal tip 22 may include the first beveled region 54 on two sides (e.g., two opposing sides) of the distal tip 22, the second beveled region 56 on two sides (e.g., two opposing sides) of the distal tip 22, a first void 57a, and a second void 57b on a side of the distal tip 22 opposing the first void 57a. The first void 57a may be configured the same as or different than the second void 57b. The first void 57a and the second void 57b may be similar to or different than the void 57 discussed with respect to FIG. 6.

[0098] The first void 57a and the second void 57b may be circumferentially spaced from one another in any suitable manner. In some examples, the first void 57a and the second void 57b may be circumferentially spaced from one another by the first beveled region 54. In some examples, the first void 57a may extend along a top region 87 of the elongate tube 16 and the second void 57b may extend along a bottom region 82 of the elongate tube 16. In some examples, the first void 57a may oppose the second void 57b, as depicted for example in FIG. 7A. In one example with the first void 57a at the top region 87 of the elongate tube 16 and second void 57b opposing the first void 57a at the bottom region 82 of the elongate tube 16, the first void 57a may facilitate directing fluid away from the vessel wall and dispersing fluid through the distal opening 42 and theAty. Docket No. 1404.10101 1 1 second void 57b with the second beveled region 56 of or at the second void 57b is configured to engage the vessel wall in an atraumatic manner. The angle of the second bevel 56 of or at the second void 57b may be configured to deflect the distal tip 22 distally in the vessel as the second bevel 56 engages, and advances within, the vessel wall. The second void 57b may contribute to a flexibility of the distal tip 22 to mitigate trauma on the vessel wall as the elongate tube 16 engages the vessel wall. When the first void 57a and the second void 57b are diametrically opposed and similarly configured, the elongate tube 16 may be inserted into a vessel such that the elongate tube 16 at either of the first void 57a or at the second void 57b may engage the vessel wall of the vessel. The bottom region 82 discussed herein may be the side of the elongate tube 16 configured to engage the vessel wall and the top region 87 of the elongate tube 16 may be the side of the elongate tube 16 opposing the bottom side 82.

[0099] The distal tip 22 may include more than two voids 57a and 57b. Although the voids 57b and 57a are discussed as being at the bottom region 82 and the top region 87, respectively, of the elongate tube 16, the voids 57a and 57b may be located at one or more other suitable locations. In examples with more than two voids 57a and 57b at the distal tip 22 of the elongate tube 16, the voids 57a, 57b, and additional voids may be spaced circumferentially at suitable intervals such that the multiple voids may achieve additional functionality beyond that achieved by the two-void configuration. The intervals may be the same as each other or differ from each other.

[0100] The first beveled region 54, the second beveled region 56, and the voids 57a and 57b may be formed in any suitable manner. For example, the first beveled region 54, the second beveled region 56, and / or the voids 57a, 57b may be formed using molding techniques, laser cutting techniques, and / or other suitable forming techniques.

[0101] Although the opening 42 is defined by edges of the distal tip 22 formed by two surfaces intersecting or otherwise coming together to form thin edges, other suitable configurations are contemplated. For example, the opening 42 may be defined by rounded edges, pointed edges, and / or blunt edges of the distal tip 22 and / or may be defined by edges having other suitable configurations.

[0102] The first void 57a, the second void 57b, and / or other suitable voids may have any suitable dimensions. In some examples, the wider or longer the voids, the moreAty. Docket No. 1404.10101 1 1 the distal tip 22 at the opening 42 may flex outward from an inner diameter of the elongate tube 16.

[0103] FIG. 7B schematically depicts a side view of the distal end of the illustrative elongate tube 16 depicted in FIG. 7A. The distal tip 22 of the elongate tube 16 may be tapered, as depicted for example in FIG. 7B. In some examples, the distal tip 22 may be tapered such that the outer diameter of the distal tip 22 gradually decreases from the outer diameter of the body 20 to the outer diameter of the distal tip 22 at the distal opening 42. The broken or dashed lines in FIG. 7B represent the inner surface 45 of the elongate tube 16 defining the lumen 44 and an inner diameter of the elongate tube 16.

[0104] The bevels and / or tapers of the distal tip 22 may have any suitable angle relative to a longitudinal axis of the elongate tube 16. For example, the distal tip 22 may have an outer diameter that tapers from the distal end of the body 20 to the distal opening 42 a total of about 1 degree to about 35 degrees relative to the longitudinal axis of the elongate tube 16. In some examples, the angle of the taper of the distal tip 22 at a location proximal of the second beveled region 56 of the bottom region 82 and / or the top region 87 and / or at a location proximal of the first beveled regions 54 may be within a range of about 1 degree to about 3 degrees relative to the longitudinal axis of the elongate tube 16. The angles, lengths, and / or other suitable dimensions of first beveled regions 54 and / or the second beveled regions 56 may be determined, at least in part, based on a material used to form the distal tip 22, a thickness of the material used to form the distal tip, a durometer of the material used to form the distal tip 22, an angle of a bevel of a needle used with the catheter assembly 12, and / or based on one or more other suitable parameters. In some examples, the angle of the first beveled region 54 may be in a range of about 27 degrees to about 35 degrees. Other suitable angles may be utilized for the tapered region at one or more circumferential locations along distal tip.

[0105] FIG. 7C schematically depicts a top view of the distal end of the elongate tube 16 depicted in FIG. 7A. A width of the voids 57a, 57b may be the same as or different than the width of the distal opening 42. When both voids 57a, 57b are included in the distal tip 22, a width and / or a length of the first void 57a may be the same as, similar to, or different than the width and / or length of the second void 57b. The width ofAty. Docket No. 1404.10101 1 1 the voids 57a, 57b may affect the shape of the distal end of the distal tip 22. In FIG. 7C, the distal tip 22 is shown with a sharp or pointed distal end. However, decreasing a width of the voids 57a, 57b may result in the distal end of distal tip 22 becoming blunter and less pointed.

[0106] Adjustment of the width of the voids 57a, 57b may affect the flexibility of the distal tip 22. When any of the voids 57a, 57b are less wide at the distal end of the distal tip 22, the distal tip may be less flexible. When any of the voids 57a, 57b are wider at the distal end of the distal tip 22, the distal tip 22 may become more flexible and can be more easily placed into position within a vessel. Similarly, when any of the voids 57a, 57b extend proximal from the distal end of the distal tip 22 a shorter distance, the distal tip 22 may become less flexible and when any of the voids 57a, 57b extend proximal from the distal end of the distal tip 22 a longer distance, the distal tip 22 may be more flexible.

[0107] FIG. 7D schematically depicts an end view of the distal end of the elongate tube 16 depicted in FIG. 7A. As depicted in FIG. 7D, an outer diameter of the distal tip 22 at the distal end of the distal tip 22 may be equivalent to the outer diameter of the distal opening 42. FIG. 7D depicts the first beveled regions 54 as being equally spaced from one another and the second beveled regions 56 as being equally spaced from one another. In some examples, the first void 57a at the top region 87 of the elongate tube 16 and the second void 57b at the bottom region 82 of the elongate tube 16 may be diametrically opposed from one another, as depicted for example in FIG. 7D. Other suitable circumferential spacing configurations of the first bevels 54, the second bevels 56, the first void 57a, the second void 57b, and / or other suitable features of the elongate tube 16 are contemplated.

[0108] FIGS. 8A-8D schematically depict views of a distal end of an illustrative configuration of the elongate tube 16. As depicted in FIGS. 8A-8D, the distal tip 22 of the elongate tube 16 may have a beveled configuration designed to direct fluid away from a vessel wall of a vessel in which it is inserted and facilitate engaging the vessel wall upon insertion of the elongate tube 16 into the vessel.

[0109] FIG. 8A schematically depicts a perspective view of the distal end of an illustrative configuration of the elongate tube 16. The beveled configuration of the distal tip 22 may include the first beveled region 54 on two sides (e g., two opposing sides) ofAty. Docket No. 1404.10101 1 1 the distal tip 22, the second beveled region 56 on two sides (e.g., two opposing sides) of the distal tip, a first void 57a, and a second void 57b on a side of the distal tip 22 opposing the first void 57a. The first void 57a may be configured the same as or different than the second void 57b. In one example configuration and as depicted in FIG. 8A, the distal opening 42 defined by the first void 57a, the second void 57b, and distal ends of the first bevel 54, the second bevel 56, and the inner surface 45 may define two opposing points at the distal end of the distal tip 22. Other suitable configurations are contemplated in which the features of the distal tip 22 define a single point, two points, more than two points, and / or other geometric features at the distal end of the distal tip 22.

[0110] The first void 57a and the second void 57b may be entirely or at least partially circumferentially spaced from one another in any suitable manner. In some examples, the first void 57a and the second void 57b may be circumferentially spaced from one another by the first beveled region 54 and then meet at the distal end of the distal tip, as depicted for example in FIG. 8A. In some examples, the first void 57a may extend along a top region 87 of the elongate tube 16 and the second void 57b may extend along a bottom region 82 of the elongate tube 16. In some examples, the first void 57a may oppose the second void 57b, as depicted for example in FIG. 8A. In one example and similar to as discussed with respect to FIGS. 7A-7D, with the first void 57a at the top region 87 of the elongate tube 16 and second void 57b opposing the first void 57a at the bottom region 82 of the elongate tube 16, the first void 57a may facilitate directing fluid away from the vessel wall and dispersing fluid through the distal opening 42 and the second void 57b with the second beveled region 56 of or at the second void 57b may be configured to engage the vessel wall in an atraumatic manner. In some examples, a distal end of the distal tip 22 with the first void 57a and the second void 57b meeting, as depicted in FIG.8A, may result in a flexible distal end of the distal tip 22 that facilitates engaging the vessel wall in an atraumatic manner.

[0111] FIG. 8B schematically depicts a side view of the distal end of the illustrative elongate tube 16 depicted in FIG. 8A. The distal tip 22 of the elongate tube 16 may be tapered, as depicted for example in FIG. 8B. In some examples, the distal tip 22 may be tapered such that the outer diameter of the distal tip 22 gradually decreases from the outer diameter of the body 20 to the outer diameter of the distal tip 22 at theAty. Docket No. 1404.10101 1 1 distal opening 42. As discussed with respect to FIG. 8A, distal ends of the first bevels 54 and the second bevels 56 may define a point at the distal opening 42 located at the distal end of the distal tip 22.

[0112] FIG. 8C schematically depicts a top view of the distal end of the elongate tube 16 depicted in FIG. 8A. A width of the voids 57a, 57b may be the same as or different than the width of the distal opening 42. When both voids 57a, 57b are included in the distal tip 22, a width and / or a length of the first void 57a may be the same as, similar to, or different than the width and / or length of the second void 57b. The width of the voids 57a, 57b may affect the shape of the distal end of the distal tip 22. In FIG. 8C, the distal tip 22 is shown with a sharp or pointed distal end where the voids 57a, 57b.

[0113] FIG. 8D schematically depicts an end view of the distal end of the elongate tube 16 depicted in FIG. 8 A. As depicted in FIG. 8D, an outer diameter of the distal tip 22 at the distal end of the distal tip 22 may be equivalent to the outer diameter of the distal opening 42. FIG. 8D depicts the first beveled regions 54 as being equally spaced from one another and the second beveled regions 56 as being equally spaced from one another, where distal ends of the first beveled regions 54 and the second beveled regions meet to form a distal end of the distal opening 42. In some examples, the first void 57a at the top region 87 of the elongate tube 16 and the second void 57b at the bottom region 82 of the elongate tube 16 may be diametrically opposed from one another, as depicted for example in FIG. 8D. Other suitable circumferential spacing configurations of the first bevels 54, the second bevels 56, the first void 57a, the second void 57b, and / or other suitable features of the elongate tube 16 are contemplated.

[0114] The distal end of the elongate tube 16 may include a preformed curve configured to direct the distal opening 42 away from and / or parallel to an inner surface of a vessel (e.g., the distal inner surface of the vessel) proximate the bottom region 82 of the elongate tube 16 when the elongate tube 16 is in a deployed configuration within the vessel lumen. The preformed curve may be formed at any suitable axial or longitudinal location along the elongate tube 16 configured to be positioned within the vessel lumen so as to direct the distal opening 42 away from the distal inner surface of the vessel lumen. For example, the preformed curve may be formed at or proximate the distal endAty. Docket No. 1404.10101 1 1 of the body 20 of the elongate tube 16, but other suitable locations of the preformed curve are contemplated.

[0115] The distal end of the elongate tube 16 may be formed from a flexible and / or resilient material such that when the needle 28 is extending through the lumen 44 at the distal end of the elongate tube 16, the distal end of elongate tube 16 is in a straight or axial configuration (e.g., when the elongate tube 16 is in a stressed or a delivery configuration) and when the needle 28 is removed from the lumen 44 at the distal end of the elongate tube 16, the preformed curve automatically forms at the distal end of the elongate tube 16 (e.g., when the elongate tube 16 is in a relaxed state or a deployed configuration). In some examples, the distal end of the elongate tube 16 may be formed from a shape memory material (e.g., a shape memory polymer, metal, etc.) configured to be flexible enough to straighten when the needle 28 extends therethrough and then adjust to the preformed curve configuration when the needle 28 is removed from the elongate tube, may include a shape memory bias component (e.g., a support component, a spring, and / or other suitable component), and / or may be configured to adjust between the straightened configuration and the preformed curve configuration.

[0116] FIGS. 9-12 schematically depict perspective views of illustrative configurations of the distal end of the elongate tube 16 with the distal tip 22 extending distally from a distal end of the body 20 and the preformed curve 58 located proximate the distal end of the body 20. The performed curve 58 may have any suitable radius of curvature and / or other curve dimension. In some examples, the radius of curvature of the preformed curve 58 may depend on the anatomy in which the distal opening 42 of the elongate tube 16 is located. In some examples, the radius of curvature of the preformed curve 58 may be configured such that fluid exiting the distal opening 42 is parallel to a vessel wall or central axis of the vessel in which the elongate tube 16 is located.

[0117] FIG. 9 schematically depicts the distal end of the elongate tube 16 with the preformed curve 58 formed in the distal tip 22 proximate the distal end of the body 20 of the elongate tube 16. The preformed curve 58 depicted in FIG. 9 may be formed by shape memory material of the elongate tube 16 so as to automatically assume the preformed curve 58 when in the deployed configuration. The preformed curve 58, however, may be formed in one or more other suitable manners. When the elongate tubeAty. Docket No. 1404.10101 1 116 is transitioned from the delivery configuration to the deployed configuration within the vessel lumen, the distal opening 42 may automatically be directed away from the wall or inner surface of the vessel lumen (e.g., the distal inner surface of the vessel) and if the distal tip 22 engages the wall of the vessel lumen, the curvature of the distal tip 22 may further direct the distal opening 42 away from the wall or inner surface of the vessel lumen.

[0118] FIG. 10 schematically depicts the distal end of the elongate tube 16 with a preformed curve 58 formed in the body 20 proximate the distal end of the body 20 of the elongate tube 16 (e.g., at the distal end of the body 20). The preformed curve 58 depicted in FIG. 10 has been formed entirely or at least in part by a support or biasing member 60 (shown in broken lines) embedded in the material (e.g., a flexible material) of the elongate tube 16 so as to automatically assume the preformed curve 58 when in the deployed configuration. When the elongate tube 16 is transitioned from the delivery configuration to the deployed configuration within the vessel lumen, the distal opening 42 may automatically be directed away from the wall or inner surface of the vessel lumen (e.g., the distal inner surface of the vessel) and if the distal end of the body 20 engages the wall of the vessel lumen, the curvature of the body 20 may further direct the distal opening 42 away from the wall or inner surface of the vessel lumen.

[0119] The support or biasing member 60, when included, may have any suitable configuration to cause the elongate tube 16 to take the form of the preformed curve 58 when in a relaxed state. For example, the support or biasing member 60 may be formed as a longitudinally extending strip, a tubular spring, a cut or slotted tube, and / or other suitable configurations of support or biasing members configured to form the preformed curve 58 in the elongate tube 16 when in the relaxed state and allow for the elongate tube 16 to straighten when the needle 28 extends through the elongate tube 16 in a delivery configuration and / or when the elongate tube is exterior of a vessel. In one example, the support or biasing member 60 may be formed as a longitudinally extending strip embedded in material of the elongate tube 16, as depicted in FIG. 10, but other suitable configurations are contemplated.

[0120] The support or biasing member 60 may be formed from any suitable shape memory material. For example, the biasing member 60 may be formed from materialsAty. Docket No. 1404.10101 1 1 including, but not limited to, temperature activated materials, hydratable materials, shape memory polymers, shape memory metals, thermoplastic polymers, thermoset polymers, nickel -titanium alloys, and / or other suitable shape memory materials.

[0121] In addition to or as an alternative to including the biasing member 60, the elongate tube 16 along the preformed curve 58 and / or at other suitable locations may be formed entirely or at least partially from one or more shape memory materials and / or other suitable materials configured to form the preformed curve 58 when activated. In some examples, the materials of the elongate tube 16 may be configured to form the preformed curve 58 when activated in response to exposure to a particular temperature (e.g., at or around a body temperature of -98.6 degrees Fahrenheit (-37 degrees Celsius), etc.), a liquid, etc.

[0122] FIG. 11 schematically depicts the distal end of the elongate tube 16, with a first portion 16a (e.g., a top half or other suitable portion) of the elongate tube 16 at or along the preformed curve 58 formed of a first material (e.g., the first material 50 or other suitable material) and a second portion 16b (e.g., a bottom half or other suitable portion) of the elongate tube 16 at the preformed curve 58 formed of a second material (e.g., the second material 52 or other suitable material). Although the first portion 16a and the second portion 16b are depicted in FIG. 11 as being axial halves of the elongate tube 16, the first portion 16a and the second portion 16b may form other circumferential portions of the elongate tube 16 and elongate tube 16 may portions in addition to the first portion 16a and the second portion 16b. Although the first portion 16a and the second portion 16b of the elongated tube 16 are depicted as extending along the body 20 in FIG. 11, the first portion 16a and the second portion 16b may extend only along the distal tip 22 or along the body 20 and the distal tip 22.

[0123] The first material and the second material may have similar or different mechanical properties. In some examples, the first material and the second material may be configured to expand at different expansion rates, if at all, in response to being exposed to various environmental conditions or values of environmental parameters. For example, the first material may be activated and configured to longitudinally contract and the second material may remain inactivated and configured to flex in response to an environmental condition or a value of an environmental parameter, the second materialAty. Docket No. 1404.10101 1 1 may be activated and configured to longitudinally expand and the first material may remain inactivated and configured to flex in response to the environmental condition or the value of the environmental parameter, or the first material may be activated and configured to longitudinally contract and the second material may be activated and configured to longitudinally expand in response to the environmental condition or the value of the environmental parameter. In some examples, the first material at the first portion 16a of the elongate tube 16 may be a flexible material that is not configured to expand when exposed to blood (e.g., does not expand when exposed to the liquid of the blood, the temperature of blood, etc.) and the second material at the second portion 16b of the elongate tube 16 may be configured to expand longitudinally in response to a temperature change between room temperature (e.g., -72 degrees F (-22.2 degrees C)) and a temperature set point (e.g., a body temperature within a vessel or a temperature of blood within the vessel (e.g., -98.6 degrees Fahrenheit (-37 degrees Celsius)). In some examples, the first material at the first portion 16a of the elongate tube 16 may be a flexible material that is not configured to expand when exposed to blood or other suitable liquid and the second material at the second portion 16b of the elongate tube 16 may be formed from a hydratable material configured to expand longitudinally in response to being exposed to blood or other suitable liquid. Other suitable configurations of the one or more portions of the elongate tube 16 having additional or alternative materials to facilitate forming the preformed curve are contemplated.

[0124] The extent (e.g., length) of the elongate tube 16 formed with the first portion 16a and the second portion 16b may be formed in any suitable manner. In some examples, the first material and the second material may be co-extruded to form the first portion 16a and the second portion 16b of elongate tube 16. Other suitable manufacturing techniques may be used to form the elongate tube 16 with the first portion 16a and the second portion 16b.

[0125] The first material and the second material may be configured from any suitable materials. Example suitable materials that may be configured to flex and remain inactive when exposed to a vessel (e.g., body temperature and / or blood at the vessel) may include, but are not limited to, elastomers, urethane, and / or other suitable materials. Example suitable materials that may be configured to activate when exposed to a vesselAty. Docket No. 1404.10101 1 1(e.g., body temperature and / or blood at the vessel) may include, but are not limited to, hydratable materials, temperature sensitive materials, hydrogels, acrylamide, polyethylene Glycol Diacrylate (PEGDA), polyvinyl alcohol, polyethylene glycol (PEG), poly(2-hydroxyethyl methacrylate), polyacrylamide, polyurethane, citric acid, hyaluronic acid, chitosan, alginic acid, and / or other suitable materials.

[0126] FIG. 12 schematically depicts the distal end of the elongate tube 16 with the preformed curve 58 formed in the body 20 and the distal tip 22 proximate the distal end of the body 20 of the elongate tube 16. The preformed curve 58 depicted in FIG. 12 may be formed by shape memory material of the elongate tube 16 so as to automatically assume the preformed curve 58 when in the deployed configuration. The preformed curve 58, however, may be formed in one or more other suitable manners. When the elongate tube 16 is transitioned from the delivery configuration to the deployed configuration within the vessel lumen, the distal opening 42 may automatically be directed away from the wall or inner surface of the vessel lumen (e.g., the distal inner surface of the vessel) and if a proximal end of the distal tip 22 engages the wall of the vessel lumen, the curvature of the preformed curve 58 may further direct the distal opening 42 away from the wall or inner surface of the vessel lumen.

[0127] FIG. 13 schematically depicts a method 100 for forming a catheter (e.g., an IV catheter and / or other suitable type of catheter). In some examples, the catheter formed using the method 100 may be the catheter assembly 12 discussed herein and / or may be used in the over-the-needle catheter system 10, but other suitable configurations of the catheter are contemplated. Generally, the formed catheter may have an elongate tube extending in a distal direction from a catheter hub.

[0128] The method 100 may include forming 102 a body and a distal tip in an elongate tube. In some examples, the distal tip may be formed so as to extend from a distal end of the body, where the body may extend in the distal direction from the catheter hub. The elongate tube may be coupled with the catheter hub before, during, or after forming the distal tip and the body in the elongate tube.

[0129] The body and the distal tip in the elongate tube may be formed in any suitable manner. In some examples, the elongate tube may be extruded and a distal end of the elongate tube may be inserted into a mold and heated (e.g., reflowed) to form theAty. Docket No. 1404.10101 1 1 distal tip and / or the distal end of the body according to a configuration of the mold. In some examples, only a portion of the elongate tube configured to form the distal tip is inserted into the mold, such that the body may have a distal end at or proximate a proximal end of the distal tip and may be entirely or at least partially defined by the extruded elongate tube without reflowing that portion of the elongate tube. In another example, the distal tip may be formed (e.g., via a molding process and / or other suitable process) separate from the body and a proximal end of the distal tip may be coupled with a distal end of the body (e.g., via a threaded coupling, one or more welds, a connector sheath, etc.) Other suitable configurations for forming the distal tip and the body are contemplated.

[0130] When a mold is utilized to form the distal tip and / or the distal end of the body of the elongate tube, the mold may have any suitable configuration. For example, the mold may be configured to form a taper in the distal tip and / or the distal end of the body, form one or more bevels in the distal tip and / or the distal end of the body, form one or more openings in the distal tip and / or the distal end of the body, form one or more curves in the distal tip and / or the distal end of the body, and / or form one or more other suitable features in the distal tip and / or the distal end of the body.

[0131] As discussed herein, the distal tip and the body may be formed from one or more materials. In one example, the distal tip and the body may be formed from a same material. In another example, the distal tip may be formed from a first material and the body may be formed from a second material. When the distal tip is formed from a material different than a material of the body, the distal tip may be formed from a softer material and / or a material with a higher elastic modulus than a softness and / or elastic modulus of a material of the body, but other suitable configurations are contemplated.

[0132] The method 100 may include heating 104 the material of the elongate tube from a first temperature to a second temperature. In some examples, the heating 104 of the material of the elongate tube to the second temperature may facilitate forming a curve in the elongate tube. The heating 104 of the material may be part of or separate from the forming of the distal tip and the distal end of the body. In one example, the heating 104 of the material from the first temperature to the second temperature may occur after forming the distal tip and the body in the elongate tube, such that the first temperatureAty. Docket No. 1404.10101 1 1 may be a standard room temperature (e g., approximate twenty degrees Celsius to twenty- two degrees Celsius) and / or other suitable first temperature to a second temperature configured to allow a curve to be heat set into the material (e.g., a heat set temperature for the type of material forming the distal tip and / or the body). In some examples, the elongate tube may be heated at the distal tip and / or the distal end of the body to facilitate heat setting a curve into the elongate tube at or proximate the distal tip and / or the distal end of the body of the elongate tube.

[0133] The method 100 may include forming 106 a curve in the elongate tube proximate the distal end of the body, wherein the curve is formed in the material that is heated while the temperature of the material is above the first temperature (e.g., the temperature of the material is at a heat set temperature or is within a range of temperatures at which a shape may be heat set into the material of the elongate tube). The curve may be formed in the heated material in any suitable manner. For example, the elongate tube at the distal tip and / or proximate the distal end of the body may be wrapped or rolled about an axis perpendicular to a longitudinal axis of the elongate tube, the elongate tube at the distal tip and / or proximate the distal end of the body may be molded to form the curve, a support member may be inserted into the elongate material to at least partially form the curve, and / or the curve in the distal tip and / or proximate the distal end of the body may be formed in one or more other suitable manners. In some examples, the elongate tube may be wrapped around a mandrel and / or wrapped about itself (e.g., such that the elongate tube is wrapped or rolled about an axis perpendicular to a longitudinal axis of the elongate tube) to form a curve having desired dimensions. When wrapping or rolling the elongate tube to form the curve in the elongate tube, the elongate tube may be heated prior to wrapping or rolling the elongate tube such that the elongate tube at the location at which the curve is formed is heated above the first temperature when the elongate tube is wrapped or rolled. Alternatively, the elongate tube may be heated after wrapping or rolling the elongate tube such that the temperature at the location of the elongate tube at which the curve is formed is at the first temperature when the elongate tube is wrapped or rolled and the location at which the curve is formed is subsequently heated such that the curve may be heat set into the elongate tube. TheAty. Docket No. 1404.10101 1 1 elongate tube may remain in the wrapped or rolled configuration until the temperature of the material drops below a het set threshold temperature.

[0134] To facilitate forming the preformed curve in the distal tip and / or the body of the elongate tube proximate the distal end of the body, one or more support members may be inserted into the material of the elongate tube. The support member may be flexible and biased to a preformed curve when inserted into the material of the elongate shaft or a preformed curve to which the support member may be biased may be set in the support member after inserting the support member into the material of the elongate tube by heating and wrapping or rolling the elongate tube, molding the elongate tube, etc., as discussed herein or otherwise.

[0135] The support member may have any suitable configuration including, but not limited to, a longitudinally extending strip of material, a tubular spring, a cut or slotted tube, and / or other suitable configurations of a support or biasing member configured to form the preformed curve in the elongate tube when in the relaxed state and allow for the elongate tube to straighten when a needle extends through the elongate tube and the elongate tube is in a stressed state. The support member may be formed from any suitable flexible, resilient, and / or shape-memory material discussed herein or otherwise.

[0136] FIG. 14 schematically depicts a box diagram of an illustrative method 200 of using a catheter (e.g., an IV catheter and / or other suitable types of catheters). In some examples, the catheter may be in use as part of an over-the-needle catheter system, as described herein or otherwise.

[0137] The method 200 may include inserting 202 a needle and a distal tip of the catheter into a vessel lumen of a subject (e.g., a patient). When the needle and the catheter are part of an over-the-needle catheter system, the needle may be inserted through the catheter such that a distal end of the needle is extending beyond a distal end of a distal tip of the catheter. The portion of the needle exposed beyond the distal end of the distal tip of the catheter (e.g., at least a sharpened tip, etc.) may be inserted into the vessel lumen of the subject through an entry location in a wall of the vessel lumen. The needle may be advanced into the vessel lumen until the distal end of the distal tip of the catheter is in the vessel lumen. With the needle inserted through a lumen of the catheter,Aty. Docket No. 1404.10101 1 1 the catheter may be in a stressed state with a straight configuration such that the needle and the catheter are concentric about a central axis (e.g., co-axial).

[0138] The method 200 may include forming 204 a curve in a region of the catheter that is located within the vessel lumen. For example, once the distal end of the distal tip of the catheter is located within the vessel lumen, the needle may be withdrawn in a proximal direction relative to the distal tip of the catheter. In some examples, the needle may be entirely removed from the catheter or removed to at a location proximal of a preformed curved formed in the catheter. As the needle is withdrawn from the catheter, the catheter may transition from the stressed state to a relaxed state in which the catheter forms the preformed curve at and / or proximate the distal tip and / or the distal end of the body of the catheter. In some examples, the preformed curve may orient a distal opening at the distal tip of the catheter away from or parallel to a wall surface of the vessel lumen at an opposite side of the vessel lumen from the puncture location. Alternatively, the preformed curve of the catheter may orient the distal opening such that an axis through the distal opening may be at a smaller angle with the wall surface of the vessel lumen at an opposite side of the vessel lumen from the entry location than when the catheter is in the stressed state with a straightened configuration.

[0139] Once the preformed curve has been formed (e.g., entirely or at least partially) in the catheter, contrast media and / or other suitable fluid may be injected 206 through a lumen extending through the catheter (e.g., where the lumen may extend through the distal tip of the catheter) and into the vessel lumen. When the preformed curve is at least partially formed in the catheter, damage to the vessel wall (e.g., a portion of the vessel wall opposing the entry location and / or other suitable portions of the vessel wall) may be mitigated by reducing the angle at which the fluid contacts the wall relative to when an catheter may not include the preformed curve and fluid is injected into a vessel. In some examples, when the catheter may be in the relaxed state and forming the preformed curve within the vessel lumen, injecting fluid into the vessel lumen may cause the catheter to further bend or curve at or proximate the preformed curve, but other suitable configurations are contemplated in which catheter does not further bend or curve in response to fluid being injected therethrough.Aty. Docket No. 1404.10101 1 1

[0140] FIG. 15 schematically depicts a box diagram of an illustrative method 300 of using a catheter (e.g., an IV catheter and / or other suitable types of catheters). In some examples, the catheter may be in use as part of an over-the-needle catheter system, as described herein or otherwise.

[0141] The method 300 may include inserting 302 a needle and a distal tip of the catheter into a vessel lumen of a subject (e.g., a patient). When the needle and the catheter are part of an over-the-needle catheter system, the needle may be inserted through the catheter such that a distal end of the needle is extending beyond a distal end of a distal tip of the catheter. The portion of the needle exposed beyond the distal end of the distal tip of the catheter (e.g., at least a sharpened tip, etc.) may be inserted into the vessel lumen of the subject through an entry location in a wall of the vessel lumen. The needle may be advanced into the vessel lumen until the distal end of the distal tip of the catheter is in the vessel lumen.

[0142] Upon insertion of the catheter within the vessel, a first void and a second void of the catheter may be positioned relative to a wall of the vessel lumen opposite of the entry location. Such positioning may be aided by an alignment mark or longitudinal line visible to a caregiver on or within catheter assembly 12 and / or on a surface or within a wall of elongate tube 16 and / or hub 18 to indicate the position of at least one void. A first void may be positioned 304 such that the first void is engaged with or otherwise contacts the vessel wall opposing the entry location (the distal inner surface of or defining the vessel lumen). In some examples, once the first void contacts the vessel wall opposing the entry location, a distal end of the catheter may deflect away from vessel wall due to an angle of the first void or a bevel of the first void. A second void may be positioned 306 such that the second void faces away from the vessel wall opposing the entry location (e.g., the second void may face a proximal inner surface of the wall). The second void may facilitate dispersing the fluid through the catheter and out of a distal opening at least partially defined by the second void into the vessel lumen.

[0143] Once the first and second voids have been positioned, contrast media and / or other suitable fluid may be injected 308 through a lumen extending through the catheter (e.g., where the lumen may extend through the distal tip of the catheter) and into the vessel lumen. With the catheter positioned as discussed in steps 304 and 306, damageAty. Docket No. 1404.10101 1 1 to the vessel wall (e.g., a portion of the vessel wall opposing the entry location and / or other suitable portions of the vessel wall) may be mitigated by softening any contact between the distal tip and the vessel wall and reducing the angle at which the fluid exiting the distal opening contacts the vessel wall relative to when the catheter may not include the voids and fluid is injected into a vessel. Additionally, this positioning may reduce a speed at which the injected fluid enters the vessel lumen during disbursement of the fluid relative to when the catheter may not include the voids and fluid is injected into a vessel.

[0144] FIGS. 16a-22C schematically depict diagrams of illustrative methods of using the over-the-needle catheter system 10, where the distal end of the elongate tube 16 may have different configurations. FIGS. 16A-16D schematically depict an illustrative configuration of the elongate tube 16 with two bevels and a taper in the distal tip 22 and the preformed curve 58, where the illustrative configuration of the elongate tube 16 may be similar to the elongate tube 16 depicted in FIG. 6. FIGS 17A-17F schematically depict an illustrative configuration of the elongate tube 16 with the first void 57a and the second void 57b in the distal tip 22, where the illustrative configuration of the elongate tube 16 may be similar to the elongate tube 16 depicted in FIGS. 7A-7D. FIGS 18A-18D schematically depict an illustrative configuration of the elongate tube 16 with the first void 57a and the second void 57b in the distal tip 22, where the illustrative configuration of the elongate tube 16 may be similar to the elongate tube 16 depicted in FIGS. 8A-8D. FIGS. 19A-19D schematically depict an illustrative configuration of the elongate tube 16 with the distal tip 22 having a different material than the body 20 and the preformed curve 58. FIGS. 20A-20D schematically depict an illustrative configuration of the elongate tube 16 with openings 74 at a distal end of the body 20 and the preformed curve 58. FIGS. 21A-21D schematically depict an illustrative configuration of the elongate tube 16 with two bevels and a taper in the distal tip 22, a bottom side of the elongate tube 16 having a thinner wall than a wall at a top side of the elongate tube 16, and the preformed curve 58. FIGS. 22A-22C schematically depict an illustrative configuration of the elongate tube 16 having the preformed curve 58 and the first portion 16a formed from a first material and the second portion 16b formed from a second material, where the illustrative configuration of the elongate tube 16 may be similar to the elongate tube 16 depicted in FIG. 11.Aty. Docket No. 1404.10101 1 1

[0145] FIG. 16A schematically depicts a distal end of the over-the-needle catheter system 10 inserted into a vessel lumen 62 of a vessel 64 of a subject through an entry location 66 (e.g., a puncture location) in a first side 68 (e.g., a proximal inner surface) of a wall of the vessel lumen 62 opposing a second side 70 (e.g., a distal inner surface) of the wall. As depicted in FIG. 16A, the distal tip 22 may include a taper in a distal direction from the distal end of the body 20, the first beveled region 54, and the second beveled region 56. As the needle 28 is extending through the elongate tube 16, the elongate tube 16 may be in a stressed state.

[0146] FIG. 16B schematically depicts the distal end of elongate tube 16 positioned within the vessel lumen 62 with the needle 28 removed from the lumen 44 at least at the distal end of the elongate tube 16. With the needle 28 removed from the distal end of the elongate tube 16, the elongate tube 16 automatically adjusts to the relaxed state and forms the preformed curve 58 entirely or at least partially within the vessel lumen 62.

[0147] FIG. 16C schematically depicts the elongate tube 16 further inserted into the vessel lumen 62 and fluid 72 (e.g., contrast media and / or other suitable fluid) injecting into the vessel lumen 62. For example, the elongate tube 16 may be inserted into the vessel lumen 62 such that the first bevel 54 engages the second side 70 of the wall of the vessel lumen 62 and the fluid 72 may be injected through the lumen 44 of the elongate tube 16 and out of the distal opening 42. When the first beveled region 54 is engaged with the surface of the second side 70 of the vessel lumen 62, an angle at which fluid 72 passing through the lumen 44 of the elongate tube 16 may contact the wall of the vessel lumen may be reduced relative to when the first beveled region 54 is omitted. Further, engaging the distal tip 22 with the second side 70 of the vessel lumen 62 may result in putting the elongate tube 16 into a further stressed state and further curving or bending of the elongate tube 16 along the preformed curve 58. In some examples, the second beveled region 56 of the distal tip 22 may extend through the lumen 44 so as increase an area of the distal opening 42, which may reduce a speed at which the injected fluid 72 enters the vessel lumen 62. Further, the second beveled region 56 may be formed on a side of the distal tip 22 facing away from the second side 70 of the vessel lumen 62 to direct the fluid 72 into the vessel lumen 62 in a direction away from the second side 70.Aty. Docket No. 1404.10101 1 1

[0148] FIG. 16D schematically depicts the elongate tube 16 after the fluid 72 has been injected into the vessel lumen 62 with the distal end of the elongate tube 16 at least partially withdrawn from the vessel lumen 62. As the catheter is moved away from the second side 70 of the wall of the vessel lumen 62, the curve or bend at the preformed curve 58 may be reduced to a shape of the preformed curve 58 when the elongate tube 16 is in the relaxed state. After a desired amount of fluid has been injected into or otherwise delivered to the vessel lumen 62, the elongate tube 16 may be fully withdrawn from the vessel 64.

[0149] FIG. 17A schematically depicts a distal end of the over-the-needle catheter system 10 inserted into a vessel lumen 62 of a vessel 64 of a subject through an entry location 66 (e.g., a puncture location) in a first side 68 (e.g., a proximal inner surface) of a wall of the vessel lumen 62 opposing a second side 70 (e.g., a distal inner surface) of the wall. As depicted in FIG. 17A, the distal tip 22 may include a taper in a distal direction from the distal end of the body 20, the first bevel 54, the second bevel 56, the first void 57a, and the second void 57b. The needle 28 is extending through the elongate tube 16 to facilitate gaining access to the vessel lumen 62 at the entry location 66.

[0150] FIG. 17B schematically depicts the distal end of elongate tube 16 positioned within the vessel lumen 62 with the needle 28 removed from the lumen 44 at least at the distal end of the elongate tube 16. In some examples, as the needle 28 is removed from the lumen 44 of the elongate tube 16, the distal end of the distal tip 22 may be spaced from the second side 70 of the wall of the vessel lumen 62. Alternatively, prior to or while removing the needle 28 from the lumen 44 of the elongate tube 16, the elongate tube 16 may be advanced in the distal direction over the needle 28 such that the distal end of the elongate tube 16 may engage the second side 70 of the wall of the vessel lumen 62.

[0151] FIG. 17C schematically depicts the distal end of elongate tube 16 further inserted into the vessel lumen 62 and fluid 72 (e.g., contrast media and / or other suitable fluid) injecting into the vessel lumen. For example, the elongate tube 16 may be inserted into the vessel lumen 62 such that the second void 57b at the bottom region 82 of the elongate tube 16 engages or faces the second side 70 of the wall of the vessel lumen 62 and the fluid 72 may be injected through the lumen 44 of the elongate tube 16 and out ofAty. Docket No. 1404.10101 1 1 the distal opening 42 including at or through the first void 57a at the top region 87 of the elongate tube 16. When the second void 57b is engaged with the surface of the second side 70 of the wall of the vessel lumen 62, an angle at which and a force resulting from fluid 72 passing out of the distal opening 42 and contacting the second side 70 of the wall of the vessel lumen 62 may be reduced relative to when the second void 57b is omitted.

[0152] The first void 57a may be formed on a side of the distal tip 22 facing away from the second side 70 of the vessel lumen 62 (e.g., facing the first side 68) to direct the fluid 72 into the vessel lumen 62 in a direction away from the second side 70, which may further reduce the force at which the fluid 72 passing through the distal opening 42 engages the second side 70 of the vessel lumen 62. In some examples, the first void 57a and the second void 57b of the distal tip 22 may extend proximally through the lumen 44 so as to increase an area of the distal opening 42, which may reduce a speed at which the injected fluid 72 enters the vessel lumen 62 during disbursement of the fluid 72. In some example configurations, injecting the infusate through the lumen 44 and out of the distal opening 42 in the distal tip 22 may cause the distal end of the distal tip 22 to flex radially outward such that an inner diameter of the distal end of distal tip 22 may be greater than an inner diameter at a proximal end of the distal tip, which may result in a further reduction of speed of the fluid exiting through the distal opening 42.

[0153] FIG. 17D schematically depicts the elongate tube 16 after the fluid 72 has been injected into the vessel lumen 62 with the distal end of the elongate tube 16 at least partially withdrawn from the vessel lumen 62. After a desired amount of fluid has been injected into or otherwise delivered to the vessel lumen 62, the elongate tube 16 may be fully withdrawn from the vessel 64.

[0154] Although not depicted in FIGS. 16A-16D, the elongate tube 16 may have a preformed curve therein. When included, the elongate tube 16 may be in a straight, stressed state when the needle 28 is extending through the distal tip 22 and a curved, relaxed state when the needle 28 is removed from a portion of the elongate tube 16 including or defining the pre-formed curve.

[0155] FIG. 18A schematically depicts a distal end of the over-the-needle catheter system 10 inserted into a vessel lumen 62 of a vessel 64 of a subject through an entry location 66 (e g., a puncture location) in a first side 68 (e.g., a proximal inner surface) ofAty. Docket No. 1404.10101 1 1 a wall of the vessel lumen 62 opposing a second side 70 (e.g., a distal inner surface) of the wall. As depicted in FIG. 18A, the distal tip 22 may include a taper in a distal direction from the distal end of the body 20, the first bevel 54, the second bevel 56, the first void 57a, and the second void 57b, where the distal ends of the first bevels 54, the second bevels 56, the first void 57a, and the second void 57b come together to form a point at the distal end of the distal tip 22. The needle 28 is extending through the elongate tube 16 to facilitate gaining access to the vessel lumen 62 at the entry location 66.

[0156] FIG. 18B schematically depicts the distal end of elongate tube 16 positioned within the vessel lumen 62 with the needle 28 removed from the lumen 44 at least at the distal end of the elongate tube 16. In some examples, as the needle 28 is removed from the lumen 44 of the elongate tube 16, the distal end of the distal tip 22 may be spaced from the second side 70 of the wall of the vessel lumen 62. Alternatively, prior to or while removing the needle 28 from the lumen 44 of the elongate tube 16, the elongate tube 16 may be advanced in the distal direction over the needle 28 such that the distal end of the elongate tube 16 may engage the second side 70 of the wall of the vessel lumen 62.

[0157] FIG. 18C schematically depicts the distal end of elongate tube 16 further inserted into the vessel lumen 62 and fluid 72 (e.g., contrast media and / or other suitable fluid) injecting into the vessel lumen. For example, the elongate tube 16 may be inserted into the vessel lumen 62 such that the second void 57b at the bottom region 82 of the elongate tube 16 engages or faces the second side 70 of the wall of the vessel lumen 62 and the fluid 72 may be injected through the lumen 44 of the elongate tube 16 and out of the distal opening 42 including at or through the first void 57a at the top region 87 of the elongate tube 16. When the second void 57b is engaged with the surface of the second side 70 of the wall of the vessel lumen 62 and the distal opening 42 defining two opposing points at a distal end of the distal tip 22, an angle at which and a force resulting from fluid 72 passing out of the distal opening 42 and contacting the second side 70 of the wall of the vessel lumen 62 may be reduced relative to when the second void 57b is omitted or the distal opening 42 does not form opposing points at the distal end of the distal tip 22.Aty. Docket No. 1404.10101 1 1

[0158] The first void 57a may be formed on a side of the distal tip 22 facing away from the second side 70 of the vessel lumen 62 (e.g., facing the first side 68) to direct the fluid 72 into the vessel lumen 62 in a direction away from the second side 70, which may further reduce the force at which the fluid 72 passing through the distal opening 42 engages the second side 70 of the vessel lumen 62. In some examples, the first void 57a and the second void 57b of the distal tip 22 may extend proximally through the lumen 44 so as to increase an area of the distal opening 42, which may reduce a speed at which the injected fluid 72 enters the vessel lumen 62 during disbursement of the fluid 72. In some example configurations, injecting the infusate through the lumen 44 and out of the distal opening 42 in the distal tip 22 may cause the distal end of the distal tip 22 to flex radially outward such that an inner diameter of the distal end of distal tip 22 may be greater than an inner diameter at a proximal end of the distal tip, which may result in a further reduction of speed of the fluid exiting through the distal opening 42.

[0159] FIG. 18D schematically depicts the elongate tube 16 after the fluid 72 has been injected into the vessel lumen 62 with the distal end of the elongate tube 16 at least partially withdrawn from the vessel lumen 62. After a desired amount of fluid has been injected into or otherwise delivered to the vessel lumen 62, the elongate tube 16 may be fully withdrawn from the vessel 64.

[0160] Although not depicted in FIGS. 18A-18D, the elongate tube 16 may have a preformed curve therein. When included, the elongate tube 16 may be in a straight, stressed state when the needle 28 is extending through the distal tip 22 and a curved, relaxed state when the needle 28 is removed from a portion of the elongate tube 16 including or defining the pre-formed curve.

[0161] FIG. 19A schematically depicts a distal end of the over-the-needle catheter system 10 inserted into the vessel lumen 62 of the vessel 64 of a subject through the entry location 66 in the first side 68 of a wall of the vessel lumen 62 opposing the second side 70 of the wall. As depicted in FIG. 19A, the distal tip 22 may be formed from a material with a lower elastic modulus than an elastic modulus of material forming the body 20 and may include a taper in a distal direction from the distal end of the body 20 (e.g., toward a distal end of the distal tip 22). As the needle 28 is extending through the elongate tube 16, the elongate tube 16 may be in a stressed state.Aty. Docket No. 1404.10101 1 1

[0162] FIG. 19B schematically depicts the distal end of elongate tube 16 positioned within the vessel lumen 62 with the needle 28 removed from the lumen 44 at least at the distal end of the elongate tube 16. With the needle 28 removed from the distal end of the elongate tube 16, the elongate tube 16 adjusts to the relaxed state and forms the preformed curve 58 entirely or at least partially within the vessel lumen 62.

[0163] FIG. 19C schematically depicts the elongate tube 16 proximate the distal end of the body 20 in the relaxed, curved state, with fluid 72 (e.g., contrast media and / or other suitable fluid) injecting from the lumen 44 through the distal tip 22 and out of the distal opening 42 into the vessel lumen 62. In some examples, due to the force of the fluid 72 acting on the low elastic modulus material of the distal tip 22, the distal tip 22 may expand radially outward into a stressed state (e.g., an inner and / or outer diameter at a distal end of the distal tip 22 may be greater than an inner and / or outer diameter at a proximal end of the distal tip 22 and / or a distal end of the body 20 of the elongate tube 16). When the distal tip 22 expands radially outward, the distal opening 42 may expand such that the fluid 72 enters the lumen at a lower rate or lower force than when the distal opening 42 has not expanded, which mitigates damage to the wall of the vessel 64 defining the vessel lumen 62.

[0164] FIG. 19D schematically depicts the elongate tube 16 after the fluid 72 has been injected into the vessel lumen 62. After the fluid has been injected into the vessel lumen 62, the material of the distal tip 22 may return to its relaxed state and the elongate tube 16 may be ready for withdrawal from the vessel lumen 62. After a desired amount of fluid has been injected into or otherwise delivered to the vessel lumen 62, the elongate tube may be fully withdrawn from the vessel 64.

[0165] FIG. 20A schematically depicts a distal end of the over-the-needle catheter system 10 inserted into the vessel lumen 62 of the vessel 64 of a subject through the entry location 66 in the first side 68 of a wall of the vessel lumen 62 opposing the second side 70 of the wall. As depicted in FIG. 20A, the distal end of the body 20 may include one or more lateral openings 74 between the lumen 44 and the outer surface 47 of the elongate tube 16 for injecting fluid into the vessel lumen and the distal tip 22 may include a taper in a distal direction from the distal end of the body 20. As the needle 28 is extending through the elongate tube 16, the elongate tube 16 may be in a stressed state. WhenAty. Docket No. 1404.10101 1 1 included, the one or more openings 74 may have any suitable configuration including, but not limited to, any suitable size, axial location, circumferential location, number, and / or other suitable parameter.

[0166] FIG. 20B schematically depicts the distal end of elongate tube 16 positioned within the vessel lumen 62 with the needle 28 removed from the lumen 44 at least at the distal end of the elongate tube 16. With the needle 28 removed from the distal end of the elongate tube 16, the elongate tube 16 adjusts to the relaxed state and forms the preformed curve 58 entirely or at least partially within the vessel lumen 62. As depicted in FIG. 20B, the openings 74 may be formed at or and / or proximate the preformed curve 58 in the elongate tube 16. Further, in some examples, one or more of the openings 74 may be formed in the distal tip 22 of the elongate tube 16.

[0167] FIG. 20C schematically depicts the elongate tube 16 in the relaxed state with fluid 72 (e.g., contrast media and / or other suitable fluid) injecting into the vessel lumen 62. For example, the fluid 72 injected into the vessel lumen 62 may exit the lumen 44 of the elongate tube 16 via the distal opening 42 and / or the lateral openings 74 (e.g., at a location proximal of the distal opening 42. Due to the plurality of openings 42, 74, a velocity of the fluid 72 exiting the lumen 44 of the elongate tube 16 may be reduced relative to when the fluid 72 exits the lumen 44 only at the distal opening 42 of the elongate tube 16, which may reduce trauma to the vessel 64 as the fluid 72 enters the vessel lumen 62.

[0168] FIG. 20D schematically depicts the elongate tube 16 after the fluid 72 has been injected into the vessel lumen 62. After the fluid has been injected into the vessel lumen 62, the material of the distal tip 22 may return to its relaxed state and the elongate tube 16 may be ready for withdrawal from the vessel lumen 62. After a desired amount of fluid has been injected into or otherwise delivered to the vessel lumen 62, the elongate tube 16 may be fully withdrawn from the vessel 64.

[0169] FIG. 21A schematically depicts a distal end of the over-the-needle catheter system 10 inserted into the vessel lumen 62 of the vessel 64 of the subject through the entry location 66 in the first side 68 of the wall of the vessel lumen 62 opposing the second side 70 of the wall. As depicted in FIG. 21A, the distal tip 22 may include a taper in a distal direction from the distal end of the body 20, the first beveled region 54, and theAty. Docket No. 1404.10101 1 1 second beveled region 56, while a wall of a side of the elongate tube 16 (e.g., a top side) facing the first side 68 of the wall of the vessel lumen 62 has a first thickness T1 that is greater than a second thickness T2 of a wall of a side of the elongate tube 16 (e.g., a bottom side) facing the second side 70 of the wall of the vessel lumen 62. The side of the elongate tube 16 facing the second side 70 of the wall of the vessel lumen 62 having the second thickness T2 may be more flexible than the side of the elongate tube facing the first side 68 of the wall having the first thickness T1 due to having a thinner wall of material. The wall of the elongate tube may be defined by the inner surface 45 (e.g., as represented by broken lines in FIGS. 20A-20D) and the outer surface 47. Although the lumen 44 is depicted in FIGS. 20A-20D as tapering in a distal direction, other suitable configurations are contemplated in which the lumen 44 does not taper or tapers in one or more other suitable manners. As the needle 28 is extending through the elongate tube 16, the elongate tube 16 may be in a stressed state.

[0170] FIG. 2 IB schematically depicts the distal end of elongate tube 16 positioned within the vessel lumen 62 with the needle 28 removed from the lumen 44 at least at the distal end of the elongate tube 16. With the needle 28 removed from the distal end of the elongate tube 16, the elongate tube 16 adjusts to the relaxed state and forms the preformed curve 58 entirely or at least partially within the vessel lumen 62.

[0171] FIG. 21C schematically depicts the elongate tube 16 further inserted into the vessel lumen 62 and fluid 72 (e.g., infusate, such as contrast media, saline, blood products, blood, plasma, and / or other suitable fluid or combinations thereof) injecting into the vessel lumen 62. For example, the elongate tube 16 may be inserted into the vessel lumen 62 such that the first bevel 54 engages the second side 70 of the wall of the vessel lumen 62 and the fluid 72 may be injected through the lumen 44 of the elongate tube 16 and out of the distal opening 42. When the first beveled region 54 is engaged with the surface of the second side 70 of the vessel lumen 62, an angle at which fluid 72 passing through the lumen 44 of the elongate tube 16 may contact the wall of the vessel lumen 62 may be reduced relative to when the first beveled region 54 is omitted. Further, engaging the distal tip 22 with the second side 70 of the vessel lumen 62 while the fluid 72 is injected through the distal opening 42 may result in putting the elongate tube 16 into a further stressed state and curving or bending the elongate tube 16 along the preformedAty. Docket No. 1404.10101 1 1 curve 58, which may be facilitated by the wall facing the second side 70 of the wall of the vessel lumen 62 having the second thickness T2.

[0172] Similar to as discussed with respect to FIG. 21C, the second beveled region 56 of the distal tip 22 may extend through the lumen 44 so as increase an area of the distal opening 42, which may reduce a speed at which the injected fluid enters the vessel lumen 62. Further, the second beveled region 56 may be formed on a side of the distal tip 22 facing away from the second side 70 of the vessel lumen 62 to direct the fluid 72 into the vessel lumen 62 in a direction away from the second side 70.

[0173] FIG. 21D schematically depicts the elongate tube 16 after the fluid 72 has been injected into the vessel lumen 62 with the distal end of the elongate tube 16 at least partially withdrawn from the vessel lumen 62. As the catheter is moved away from the second side 70 of the wall of the vessel lumen 62, the curve or bend at the preformed curve 58 may be reduced to a shape of the preformed curve 58 when the elongate tube 16 is in the relaxed state. After a desired amount of fluid has been injected into or otherwise delivered to the vessel lumen 62, the elongate tube 16may be fully withdrawn from the vessel 64.

[0174] FIG. 22A schematically depicts a distal end of the elongate tube 16 of the over-the-needle catheter system 10. As depicted in FIG. 22A, the first portion 16a of the elongate tube 16 may be formed from one or more first materials and the second portion 16b of the elongate tube 16 may be formed from one or more second materials, such that the second portion 16b may be configured to longitudinally expand, while the first portion 16a may be configured to longitudinally expand to a lesser extent than the first material, longitudinally contract, or flex or bend without longitudinally expanding or contracting when exposed to an environment in the vessel 64, such as a vein. As the elongate tube is exterior of the vessel 64 in FIG. 22A, a preformed curve has not been formed in the elongate tube 16 due to the one or more first materials and the one or more second materials having a same configuration at room temperature.

[0175] FIG. 22B schematically depicts the distal end of the over-the-needle catheter system 10 inserted into the vessel lumen 62 of the vessel 64 of a subject through the entry location 66 in the first side 68 of a wall of the vessel lumen 62 opposing the second side 70 of the wall. As the needle 28 is extending through the elongate tube 16,Aty. Docket No. 1404.10101 1 1 the elongate tube 16 may remain in a straight configuration or other configuration defined by the needle 29 despite being exposed to an environment within the vessel 64 that may cause the first material of first portion 16a to flex or contract and / or may cause the second material of the second portion 16b to flex or expand when the needle is removed.

[0176] FIG. 22C schematically depicts the distal end of elongate tube 16 positioned within the vessel lumen 62 with the needle 28 removed from the lumen 44 at least at the distal end of the elongate tube 16. With the needle 28 removed from the distal end of the elongate tube 16, the first material of the first portion 16a may flex or longitudinally contract and / or the material of the second portion 16b may flex or longitudinally expand and form the preformed curve 58 entirely or at least partially within the vessel lumen 62. After using the elongate tube 16 for an intended purpose (e.g., delivering fluid to the vessel 64), the elongate tube 16 may be fully withdrawn from the vessel 64 and the elongate tube 16 may return to the straight configuration depicted in FIG. 22A in due time (e.g., as the first material and / or the second material change temperatures, dry, etc.)

[0177] Various configurations of the elongate tube and the over-the-needle catheter system 10 have been described herein. Features from the various configurations of the elongate tube 16 and / or the over-the-needle catheter system 10 may be suitably combined with one another unless expressly indicated otherwise.

[0178] It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the disclosure. This may include, to the extent that it is appropriate, the use of any of the features of one example configuration being used in other configurations. The scope of the disclosure is, of course, defined in the language in which the appended claims are expressed.

Claims

Aty. Docket No. 1404.10101 1 1CLAIMSWhat is claimed is:

1. A catheter, comprising: an elongate tube having a body portion, a distal tip portion extending in a distal direction from a distal end of the body portion, a distal opening at a distal end of the distal tip portion, an outer surface, and an inner surface defining a lumen terminating at the distal opening and extending through the body portion and the distal tip portion, and wherein the elongate tube comprises a preformed curve proximate the distal end of the body portion, the preformed curve is configured to direct the distal opening away from or parallel to a distal inner surface of a vessel when in a deployed configuration within a lumen of the vessel.

2. The catheter of claim 1, wherein at least a portion of the preformed curve extends along one of the body portion or the distal tip portion.

3. The catheter of claim 1 or claim 2, wherein the preformed curve extends along the body portion and the distal tip portion.

4. The catheter of any one of claims 1-3, wherein the elongate tube is formed from a resilient material proximate the distal end of the body portion such that the elongate tube adjusts to a delivery configuration when a needle is advanced through the distal tip portion and adjusts to the deployed configuration when a needle tip of the needle is withdrawn to a location proximal of the distal end of the body portion.

5. The catheter of any one of claims 1-4, wherein the elongate tube is configured to further curve proximate the distal end of the body portion in response to the distal tip portion engaging the distal inner surface of the vessel.Aty. Docket No. 1404.10101 1 16. The catheter of any one of claims 1-5, wherein the distal tip portion has a taper such that an outer diameter of the distal tip tapers toward the distal end of the distal tip portion.

7. The catheter of claim 6, wherein the distal tip portion includes a bottom portion and a top portion opposing the bottom portion and the taper has a first portion along the bottom portion that extends distally from a first longitudinal location and a second portion along the top portion that extends distally from a second longitudinal location distal of the first longitudinal location.

8. The catheter of claim 6 or claim 7, wherein the distal tip portion comprises a first bevel and a second bevel located distal of a proximal end of the taper.

9. The catheter of any one of claims 1-8, wherein the distal tip portion is more flexible than the body portion.

10. The catheter of any one of claims 1-9, wherein the distal tip portion is configured to expand in response to fluid passing through the lumen and out of the distal tip portion such that an inner diameter of the lumen and an outer diameter at the distal end of the distal tip portion are greater than the inner diameter of the lumen and an outer diameter at a proximal end of the distal tip portion.

11. The catheter of any one of claims 1-10, wherein the body portion includes a plurality of openings extending between the lumen and the outer surface of the elongate tube.

12. The catheter of any one of claims 1-11, wherein the elongate tube comprises a portion along the preformed curve formed from a first material configured to expand at a first expansion rate based on a value of an environmental parameter and a second portion along the preformed curve formed from a second material configured to expand at a second expansion rate based on the value of the environmental parameter.Aty. Docket No. 1404.10101 1 113. The catheter of any one of claims 1-12, wherein the elongate tube comprises a portion along the preformed curve formed from a first material configured to expand when exposed to a liquid and a second portion along the preformed curve formed from a second material that is not configured to expand when exposed to the liquid.

14. A method of forming a catheter, the method comprising: forming a body portion and a distal tip in an elongate tube, the distal tip extending from a distal end of the body portion; heating material of the elongate tube from a first temperature to a second temperature; and forming a curve in the elongate tube proximate the distal end of the body portion, wherein the curve is formed in the material that is heated while a temperature of the material is above the first temperature.

15. The method of claim 14, wherein forming the curve in the elongate tube proximate the distal end of the body portion comprises rolling the elongate tube about an axis perpendicular to a longitudinal axis of the elongate tube while the material of the elongate tube is above the first temperature.

16. The method of claim 14 or claim 15, wherein forming the curve in the elongate tube proximate the distal end of the body portion comprises rolling the elongate tube about an axis perpendicular to a longitudinal axis of the elongate tube prior to heating the material of the elongate tube from the first temperature to the second temperature.

17. The method of any one of claims 14-16, wherein forming the curve in the elongate tube proximate the distal end of the body portion comprises inserting a support into the material of the elongate tube, the support having a preformed curve.

18. A method of using a catheter, the method comprising: inserting a needle and a distal tip of the catheter into a vessel lumen of a subject;Aty. Docket No. 1404.10101 1 1 forming a curve in a portion of the catheter within the vessel lumen by withdrawing the needle from the vessel lumen; and injecting infusate through a catheter lumen in the distal tip of the catheter and into the vessel lumen.

19. The method of claim 18, the method further comprising: engaging the distal tip with an inner wall of the vessel lumen to further curve the catheter along the curve.

20. The method of claim 18 or claim 19, wherein injecting the infusate through the catheter lumen in the distal tip causes an outer diameter at a distal end of the distal tip to be greater than an outer diameter at a proximal end of the distal tip.

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