Coiled vascular access devices and related systems

Abstract

A vascular access device configured to be inserted through a vascular access device, such as a catheter assembly. The vascular access device includes a wire (42) monolithically formed as a single unit. The wire (42) includes a coil portion (44) including multiple loops (46) wound around a central coil axis (48). The wire (42) includes a core portion (50) extending through the coil portion (44) and aligned with the central axis (48). The wire (42) includes a bent portion (52) connecting a distal end of the coil portion (44) to a distal end of the core portion (50). The bent portion (52) may be blunt and atraumatic.

Description

TECHNICAL FIELD

[0001] The present invention relates to a vascular access device and a vascular access system.

BACKGROUND ART

[0002] Catheters are commonly used to inject fluids into the patient's vasculature. For example, catheters may be used to inject saline, various medications, or total parenteral nutrition. Catheters may also be used to draw blood from a patient.

[0003] The catheter may include an over-the-needle peripheral intravenous ("IV") catheter. In this case, the catheter may be mounted over an introducer needle having a sharp distal tip. The catheter and the introducer needle may be assembled such that the distal end of the introducer needle extends beyond the distal end of the catheter, with the bevel of the needle oriented away from the patient's skin. The catheter and the introducer needle are typically inserted into the patient's vasculature at a shallow angle through the skin.

[0004] To verify proper placement of the introducer needle and / or the catheter within the blood vessel, clinicians generally confirm that there is a "flashback" of blood within the flashback chamber of the catheter assembly. Once needle placement is confirmed, the clinician may temporarily occlude flow within the vasculature, remove the needle, and leave the catheter in place for subsequent blood collection or fluid infusion.

[0005] Blood sampling using a catheter can be difficult for several reasons, particularly when the catheter remains in the vascular system for more than a day. When a catheter is left in a patient for an extended period, the catheter and vein may become more susceptible to narrowing, rupture, twisting, blockage by debris (e.g., fibrin or platelet clots), and adhesion of the catheter tip to the vascular system. Therefore, catheters are often used to obtain blood samples when they are in place, but less frequently during the catheter's indwelling period. Consequently, when a blood sample is needed, it often requires an additional needle stick to access a vein for sampling, which can be painful for the patient and result in higher material costs.

[0006] In some cases, to avoid additional needle sticks, vascular access devices may be used to access the patient's vascular system through a catheter. These devices are inserted into the vascular system through the catheter, potentially extending the catheter's lifespan and allowing blood to be drawn through the catheter without additional needle sticks.

[0007] The subject matter claimed herein is not limited to embodiments that resolve any shortcomings or embodiments that operate only in the environments described above. Rather, this background art is provided merely to illustrate an example of the technical area in which some of the embodiments described herein can be carried out. [Overview of the project]

[0008] This disclosure relates in general to vascular access devices. More specifically, this disclosure relates to vascular access devices that can be delivered to a patient's vascular system via a catheter assembly and an instrument advancement device. In some embodiments, the vascular access device may facilitate an increase in the catheter residence time of the catheter assembly within the patient's vascular system. In some embodiments, when the catheter is compromised to overcome obstacles such as thrombi, valves, and / or fibrin sheaths within or around the catheter that can prevent blood collection, an instrument advancement device may be used to advance the vascular access device into and / or beyond the distal end of the catheter. In some embodiments, the instrument advancement device may provide needle-free delivery of the vascular access device to the patient's vascular system for blood collection, fluid delivery, patient or device monitoring, or other clinical needs by utilizing an existing catheter present in the vascular system.

[0009] In some embodiments, the vascular access instrument may be configured to be inserted via a vascular access device, such as a catheter assembly. In some embodiments, the vascular access instrument may include a wire that can be formed monolithically as a single unit. In some embodiments, the wire may include a coiled portion which may include multiple loops wound around a central axis. In some embodiments, the wire may include a core portion that extends through the coiled portion and is aligned with the central axis. In some embodiments, the wire may include a bent portion that connects the distal end of the coiled portion to the distal end of the core portion.

[0010] In some embodiments, the bent portion may form the distal end of the wire. In some embodiments, the bent portion may be located distal to the coil portion. In some embodiments, the distal end of the wire may be blunt. In some embodiments, the bent portion may include a U-shape. In some embodiments, the bent portion may include a loop.

[0011] In some embodiments, the coil portion may be formed by a flat portion of wire wound in a loop around a central axis. As referred to in this disclosure, the term “flat portion of flat wire” may correspond to a portion of wire including a first side and a second side opposite the first side, the first side and / or second side being planar before the wire is wound in a loop around a central axis during manufacturing. In some embodiments, the first side may form the outer surface of the coil. In some embodiments, the second side may form the inner surface of the coil portion. In some embodiments, the core portion may be in contact with the inner surface of the coil portion.

[0012] In some embodiments, each loop of the coil portion may be spaced apart from the next adjacent loop. In some embodiments, each loop of the coil portion may contact the next adjacent loop around the circumference of the next adjacent loop. In some embodiments, the coil portion and / or core portion may be cylindrical. In some embodiments, the core portion may be flat. In some embodiments, the core portion may be offset from the central axis. In some embodiments, the proximal end of the coil portion may be joined to the core portion. In some embodiments, the coil portion may be tapered. In some embodiments, the proximal end of the core portion may taper outward in the proximal direction.

[0013] In some embodiments, the wire may include a straight portion connected to the proximal end of the coil portion. In some embodiments, the straight portion may be parallel to the proximal end of the core portion. In some embodiments, the inner portion of the straight portion and the inner portion of the proximal end of the core portion may be joined together. In some embodiments, the inner portion of the straight portion and the inner portion of the proximal end of the core portion may not be joined together.

[0014] In some embodiments, the vascular access device may include a straight portion of the core and other wires coupled to the proximal end. In some embodiments, the other wires may be made of nitinol or stainless steel. In some embodiments, the distal end of the other wires may be positioned proximal to the coil portion.

[0015] In some embodiments, the vascular access device may include a tube surrounding the straight portion and / or proximal end of the core. In some embodiments, the tube may be made of nitinol or stainless steel. In some embodiments, the distal end of the tube may be positioned proximal to the coil portion. In some embodiments, the tube may be connected to the straight portion and / or proximal end of the core.

[0016] In some embodiments, the vascular access system may include a catheter assembly that may include a catheter adapter and a catheter extending distally from the catheter adapter. In some embodiments, an instrument advancement device may be coupled to the catheter assembly. In some embodiments, the instrument advancement device may include a vascular access instrument. In some embodiments, the instrument advancement device may be configured to advance the vascular access instrument from a retracted position to an advanced position beyond the distal end of the catheter. In some embodiments, the distal end of the catheter may include a distal opening. In some embodiments, a coiled portion may extend through the distal opening of the catheter in response to the vascular access instrument being in the advanced position.

[0017] It should be understood that both the above-mentioned general description and the following detailed description are illustrative and for illustrative purposes only, and do not limit the claimed disclosure. It should be understood that various embodiments are not limited to the arrangements and vascular access devices shown in the drawings. Also, the drawings are not necessarily to scale. It should also be understood that embodiments can be combined. For example, one or more features of a particular vascular access device may be combined with one or more features of another particular vascular access device. It should also be understood that other embodiments may be used, and structural modifications may be made without departing from the scope of the various embodiments of the invention, unless so claimed. Accordingly, the following detailed description should not be construed as restrictive. [Brief explanation of the drawing]

[0018] Exemplary embodiments are described and explained in more specific and detail with reference to the accompanying drawings. [Figure 1A] Figure 1A is a top perspective view of an exemplary vascular access system, showing exemplary vascular access instruments in exemplary storage positions according to several embodiments. [Figure 1B] Figure 1B is a top perspective view of a vascular access system showing an exemplary vascular access instrument in an advanced position according to several embodiments. [Figure 1C] Figure 1C is an enlarged top perspective view of a portion of a vascular access system, showing a vascular access device in an advanced position according to several embodiments. [Figure 1D] Figure 1D is a top perspective view of an exemplary distal portion of a vascular instrument according to several embodiments. [Figure 2A] Figure 2A is a top perspective view of another vascular access system, showing an exemplary vascular access instrument in an advanced position according to several embodiments. [Figure 2B] Figure 2B is a top perspective view of the distal portion of a vascular access device, showing an exemplary U-shape according to several embodiments. [Figure 2C] FIG. 2C is a top perspective view of the distal portion of a vascular access device, showing a bent section including a U-shape and an exemplary loop, in accordance with some embodiments. [Figure 3A] FIG. 3A is a top perspective view of the distal portion of a vascular access device, showing an exemplary distal end, in accordance with some embodiments. [Figure 3B] FIG. 3B is a side view of the distal portion of a vascular access device, showing the distal end of FIG. 3A, in accordance with some embodiments. [Figure 3C] FIG. 3C is another top perspective view of the distal portion of a vascular access device, showing an exemplary closed coil section, in accordance with some embodiments. [Figure 3D] FIG. 3D is a top perspective view of an exemplary proximal portion of a vascular access device, showing an exemplary straight section, in accordance with some embodiments. [Figure 3E] FIG. 3E is a top perspective view of the proximal portion of a vascular access device, showing a straight section and an exemplary core section connected together, in accordance with some embodiments. [Figure 3F] FIG. 3F is a top perspective view of the proximal portion of a vascular access device, showing a coil section terminating at a core section, in accordance with some embodiments. [Figure 3G] FIG. 3G is a top perspective view of the proximal portion of a vascular access device, showing an exemplary twist, in accordance with some embodiments. [Figure 3H] FIG. 3H is a top perspective view of the proximal portion of a vascular access device, showing a straight section and an exemplary bend, in accordance with some embodiments. [Figure 3I] FIG. 3I is a top perspective view of a coil section, showing an exemplary taper, in accordance with some embodiments. [Figure 3J] FIG. 3J is a side view of a coil section showing a taper, in accordance with some embodiments. [Figure 4A] FIG. 4A is a top perspective view of the distal portion of a vascular access device, showing the absence of a core section, in accordance with some embodiments. [Figure 4B] Figure 4B is a top perspective view of the proximal portion of a vascular device, showing the absence of a core portion in several embodiments. [Figure 5] Figure 5 is a top perspective view of an exemplary tapered core portion according to several embodiments. [Figure 6] Figure 6 is a top perspective view of the distal portion of a vascular access device, showing an exemplary cap according to several embodiments. [Figure 7A] Figure 7A is a top perspective view of the proximal portion of a vascular access device, showing other exemplary wires according to several embodiments. [Figure 7B] Figure 7B is a top perspective view of the proximal portion of a vascular access device, showing an exemplary tube according to several embodiments. [Figure 7C] Figure 7C is a top perspective view of the proximal portion of a vascular access device, showing tubes connected to a straight section and a core section, according to several embodiments. [Modes for carrying out the invention]

[0019] Referring here to Figures 1A and 1B, several embodiments of the vascular access system 10 are shown. In some embodiments, the vascular access system 10 may include a catheter assembly 12, which may include a catheter adapter 14 and a catheter 16. In some embodiments, the catheter 16 may include a peripheral venous catheter, a peripherally inserted central catheter, or a midline catheter. In some embodiments, the catheter adapter 14 may include a distal end 18, a proximal end 20, and a lumen extending through the distal end 18 and the proximal end 20. In some embodiments, the catheter 16 may extend distally from the distal end 18 of the catheter adapter 14.

[0020] In some embodiments, the catheter adapter 14 may be integrated with an extension tube 22 that may extend from the side port 24 of the catheter adapter 14. In some embodiments, an adapter 26, such as a Y-adapter or T-adapter, may be coupled to the proximal end of the extension tube 22.

[0021] In some embodiments, the instrument advancement device 28 can be coupled to the catheter assembly 12 in various ways. For example, the instrument advancement device 28 can be coupled to a port on the adapter 26. In another embodiment, the instrument advancement device 28 can be coupled to a needleless connector 29 positioned between the port on the adapter 26 and the instrument advancement device 28. In yet another embodiment, the instrument advancement device 28 can be coupled to the proximal end 20 of the catheter adapter 14. In some embodiments, another extension tube and / or blood collection device adapter can be coupled to another port on the adapter 26. In some embodiments, the blood collection device adapter may accept a blood collection device, such as a syringe or blood collection tube.

[0022] In some embodiments, the instrument advancement device 28 may include a housing 30 configured to connect to the catheter assembly 12. In some embodiments, the instrument advancement device 28 may include a vascular access instrument 32. In some embodiments, the instrument advancement device 28 may include any suitable delivery device. Some examples of instrument advancement devices that may be used with the vascular access instrument 32 are: U.S. Patent Application No. 16 / 037,246, filed July 17, 2018, titled “Extension for housing a probe or intravenous catheter”; U.S. Patent Application No. 16 / 38650, filed April 18, 2019, titled “Instrument delivery device with a rotating element”; U.S. Patent Application No. 16 / 037,319, filed July 17, 2018, titled “MULTI-diameter catheter and related devices and methods”; and U.S. Patent Application No. 3, filed July 3, 2019, titled “Delivery device for vascular access instrument”. Further descriptions may be found in U.S. Patent Application No. 16 / 691,217, filed November 21, 2019, entitled "Syringe-Based Delivery Device for Vascular Access Instruments," U.S. Patent Application No. 16 / 742,013, filed January 14, 2019, entitled "Catheter Delivery Device and Related Systems and Methods," and U.S. Patent Application No. 16 / 838,831, filed April 2, 2020, entitled "Vascular Access Instrument Having a Fluid Permeable Structure, and Related Devices and Methods," each of which is incorporated by reference in its entirety.

[0023] In some embodiments, the instrument advancement device 28 may be configured to introduce the vascular access instrument 32 into the catheter assembly 12. In some embodiments, in response to the introduction of the vascular access instrument 32 into the catheter assembly 12, the vascular access instrument 32 may access the fluid pathway of the catheter assembly 12 and / or extend through the catheter assembly 12 to access the patient's vascular system.

[0024] In some embodiments, the instrument advancement device 28 may be configured to advance the vascular access instrument 32 between, for example, a retracted position shown in Figure 1A and, for example, an advanced position shown in Figure 1B. In some embodiments, the distal end 34 of the vascular access instrument 32 may be positioned distal to the distal end 36 of the catheter 16 in response to the vascular access instrument 32 being in the advanced position. In some embodiments, the distal end 34 of the vascular access instrument 32 may be positioned within the housing 30 in response to the vascular access instrument 32 being in the retracted position. In some embodiments, the proximal end of the vascular access instrument 32 may be coupled to an advancement tab 38, which may be grasped and moved by the user along a slot 40 to move the vascular access instrument 32 between the retracted position and the advanced position. In some embodiments, the advancement tab 38 may extend through the slot 40, and a portion of the advancement tab 38 coupled to the proximal end of the vascular access instrument 32 may be within the housing 30.

[0025] In some embodiments, the catheter 16 may be composed of fluorinated ethylene propylene, TEFLON®, silicone, thermoplastic elastomer, thermoplastic polyurethane, fluorinated polymer, hydrophilic material, hydrophobic material, anti-contamination material, or another suitable material. In some embodiments, the catheter 16 may include an antithrombotic coating. In some embodiments, all or part of the vascular access instrument 32 may be composed of metal or another suitable material.

[0026] Referring here to Figures 1C-1D, in some embodiments the vascular access device 32 may include a wire 42 that can be formed monolithically as a single unit. In some embodiments the vascular access device 32 may include one or fewer wires 42 that can be continuous. A prior art vascular access device may consist of four or more components that can be joined together. In some embodiments, a wire 42 formed monolithically as a single unit may facilitate an increase in fluid flow rate from the vascular access device 32 to the catheter 16 and a reduction in shear stress on the fluid moving through the vascular access device 32.

[0027] In some embodiments, the wire 42 may include a coil portion 44 which may include a plurality of loops 46 wound around a central axis 48. In some embodiments, the wire 42 may include a core portion 50 which may extend through the coil portion 44. In some embodiments, the core portion 50 may be straight and may be aligned with the central axis 48. In some embodiments, the wire 42 may include a bent portion 52 which connects the distal end of the coil portion 44 to the distal end of the core portion 50.

[0028] In some embodiments, the bent portion 52 may form the distal end 34 of the wire 42. In some embodiments, the bent portion 52 may be located distal to the coiled portion 44. In some embodiments, the distal end 34, which may include the most distal surface of the wire 42, may be blunt. In some embodiments, the distal end 34 may facilitate soft and gentle contact with the vascular wall in response to the insertion of the vascular access instrument 32 into the vascular system. In some embodiments, the distal end 34 and / or the coiled portion 44 may reduce shear stress on the fluid moving through the vascular access instrument 32.

[0029] In some embodiments, the coil portion 44 may be formed by a flat portion of wire 42 wound in a loop 46 around a central axis 48. As referred to in this disclosure, the term “flat portion of flat wire” may correspond to a portion of wire 42 including a first side 54 and a second side 56 opposite the first side 54, wherein the first side 54 and / or the second side 56 are planar before the wire 42 is wound in the loop 46 around the central axis 48 during manufacturing. In some embodiments, the first side 54 may form the outer surface of the coil portion 44. In some embodiments, the second side 56 may form the inner surface of the coil portion 44.

[0030] In some embodiments, the flat portion may increase the inner diameter of the coil portion 44, thereby facilitating an increase in fluid flow through the vascular access device 32. In some embodiments, the flat portion may increase the inner diameter of the coil portion 44, allowing the outer diameter of the coil portion 44 to be approximately equal to the outer diameter of a standard vascular access device. In some embodiments, the dimensions of the coil portion 44 may vary based on the gauge size of the catheter 16, the stiffness of the vascular access device 32, the spacing between each of the loops 46 of the coil portion 44, the number or size of fluid paths along the length of the vascular access device 32, or other factors. In some embodiments, the pitch of the coil portion 44 may vary along the length of the coil portion 44.

[0031] In some embodiments, the core portion 50 may be in contact with the inner surface of the coil portion or may be spaced apart from the coil portion. In some embodiments, the core portion 50 may be coupled to the inner surface of the coil portion 44. However, in some embodiments, since the wire 42 is formed monolithically as a single unit, the core portion 50 does not have to be coupled to the inner surface of the coil portion 44, but may still be fixed and provide structural support to the vascular access device 32.

[0032] In some embodiments, each loop 46 of the coil portion 44 may be spaced apart from the next adjacent loop of the loop 46, which may facilitate fluid permeability of the vascular access device 32. In these embodiments, the coil portion 44 may be referred to as open. In some embodiments, the coil portion 44 may provide multiple and / or continuous fluid pathways along the length of the vascular access device 32, which may facilitate the entry of blood into the catheter assembly 12 from a portion of the vascular system further away from the catheter 16. In some embodiments, the fluid pathways along the length of the coil portion 44 and the vascular access device 32 may facilitate an increase in the flow rates of fluid through the vascular access device 32 and the catheter 16. In some embodiments, the fluid pathways along the length of the coil portion 44 and the vascular access device 32 may facilitate a reduction in blood collection time. In some embodiments, the coil portion 44 may reduce the shear stress and associated risks of hemolysis of blood in and / or through the catheter 16.

[0033] In some embodiments, the coil portion 44 and / or the core portion 50 may be cylindrical. In some embodiments, the core portion 50 may be flat, which may increase the flow through the coil portion 44 and / or the catheter 16. In some embodiments, the core portion 50 may be offset from the central axis 48, which may facilitate blood flow to the catheter assembly 12 and / or fluid injection into the vascular system along the central axis 48 and the central portion of the coil portion 44 and / or the central portion of the catheter 16.

[0034] Referring here to Figure 2A, the instrument advancement device 28 may include a housing 30, and the housing 30 may include an extension tube. In some embodiments, the instrument advancement device 28 may be configured to connect to the catheter assembly 12 via a distal connector 60 which may include a Luer adapter and / or one or more lever arms. In some embodiments, the instrument advancement device 28 may include a vascular access instrument 32. In some embodiments, the proximal end of the vascular access instrument 32 may be connected to the housing or an advance tab 38, which may be grasped and moved along the housing 30 to move the vascular access instrument 32 between a retracted position and an advanced position. In some embodiments, the housing 30 may facilitate the movement of the vascular access instrument 32 without direct contact by the user, such as by clamping the proximal end of the vascular access instrument 32, by translation of one or more ball bearings along the housing 30, or via another suitable mechanism.

[0035] Referring here to Figure 2B, in some embodiments, the bent portion 52 may include a U-shape 62 which may be blunt and intact. In some embodiments, the U-shape 62 may generally be aligned with the central axis 48. Referring here to Figure 2C, additionally or alternatively, in some embodiments, the bent portion 52 may include one or more loops 64 which may be blunt and intact. In some embodiments, the wire 42 may include a straight portion 66 connected to the proximal end of the coil portion 44. In some embodiments, the straight portion 66 may be parallel to the core portion 50. In some embodiments, the straight portion 66 and the core portion 50 may be coupled to a particular advance tab of a particular instrument advance device.

[0036] Referring here to Figures 3A-3B, in some embodiments, the U-shape 62 may be generally perpendicular to the central axis 48, which may help reduce the risk of damage to the vascular system. Referring here to Figure 3C, in some embodiments, each of the loops 46 of the coil portion 44 may be in contact with the next adjacent loop of the loop 46 around the circumference of the next adjacent loop. Thus, in some embodiments, the coil portion 44 may be called closed type because little or no fluid passes between adjacent coils.

[0037] Referring here to Figure 3D, in some embodiments, the straight portion 66 may be parallel to the proximal end 68 of the core portion 50. In some embodiments, the inner portion of the straight portion 66 and the inner portion of the proximal end 68 of the core portion 50 may not be joined together. In some embodiments, the proximal end 68 of the core portion 50 may be located proximal to the coil portion 44.

[0038] Referring now to Figure 3E, in some embodiments, the inner portion of the straight section 66 and the inner portion of the proximal end 68 of the core section 50 can be joined together for axial rigidity. For example, the inner portion of the straight section 66 and the inner portion of the proximal end 68 of the core section 50 can be joined together via adhesive, welding, coating, or any other suitable joining method.

[0039] Referring now to Figure 3F, in some embodiments, the proximal end of the coil portion 44 may be joined to the core portion 50. Referring here to Figure 3G, in some embodiments, the vascular access device 32 may include a twist 70 adjacent to the coil portion 44 and / or core portion 50. In some embodiments, one end of the twist 70 may extend from the coil portion 44, and the other end of the twist 70 may extend from the core portion 50.

[0040] Referring here to Figure 3H, in some embodiments, there may be a bend 72 at the proximal end of the straight portion 66, and / or the vascular access instrument 32 may include one or more additional bends, which may form a loop around the proximal end 68 of the core portion 50 for additional strength and rigidity. In some embodiments, the bend 72 and / or additional bends may be about 180 degrees. In some embodiments, the bend 72 may provide three parallel wire sections to increase rigidity. In some embodiments, each of the additional bends may provide an additional parallel wire section for additional rigidity.

[0041] Referring here to Figures 3I-3J, in some embodiments, the coil portion 44 may be tapered. For example, as shown in Figures 3I-3J, the coil portion 44 may be tapered outward in the proximal direction.

[0042] Referring here to Figures 4A-4B, in some embodiments, the vascular access instrument 32 does not include a core portion 50 and may increase flow through the coil portion 44 and / or catheter 16. In these embodiments, the distal end 34 may be oriented in a different direction from the loop 46 of the coil portion 44 and may include one or more other loops 74 that can ensure an intact tip. In some embodiments, there may be a ball or cap positioned at the distal end 18.

[0043] Referring now to Figure 5, in some embodiments, the proximal end 68 of the core portion 50 may taper outward in the proximal direction, which may provide increased rigidity to the vascular access instrument 32.

[0044] Referring here to Figure 6, in some embodiments, the U-shaped wire 76 may extend around the coil portion 44 and be positioned distal to the coil portion 44. In some embodiments, the cap 77 may be positioned around the distal end of the U-shaped wire 76 and the distal end of the coil portion 44, which may help reduce the risk of injury to the vascular system. In some embodiments, the cap 77 may be bonded to the U-shaped wire 76 via adhesive, welding, coating, or any other suitable joining method. In some embodiments, the ends of the U-shaped wire 76 and / or the coil portion 44 may be coupled to a specific advancing tab of a particular instrument advancing device.

[0045] Referring here to Figure 7A, in some embodiments, the vascular access instrument 32 may include another wire 78 coupled to the straight portion 66 and proximal end 68 of the core portion 50. In some embodiments, the other wire 78 may provide additional support to one or more of the proximal end 44, straight portion 66, and proximal end 68 of the core portion 50. In some embodiments, the other wire 78 may include nitinol, stainless steel, or another suitable material. In some embodiments, one or more of the coil portion 44, straight portion 66, bent portion 52 (see, for example, Figures 1D and 2B-3C), and core portion 50 may be made of nitinol, stainless steel, carbon steel, steel, chromium, or another suitable material. In some embodiments, one or more of the coil portion 44, straight portion 66, bent portion 52, and core portion 50 may include a coating such as Teflon® or parylene. In some embodiments, the distal end 80 of the other wire 78 may be positioned proximal to the coil portion 44.

[0046] Referring here to Figures 7B-7C, in some embodiments, the vascular access instrument 32 may include a tube 82 surrounding the straight portion 66 and / or proximal end 68 of the core portion 50. In some embodiments, the tube 82 may provide additional support to the wire 42. In some embodiments, the tube 82 may include nitinol, stainless steel, polymer tubing, polyimide, coating, heat shrink tubing, or another suitable material. In some embodiments, the distal end 84 of the tube 82 may be positioned proximal to the coil portion 44. As shown in Figure 7C, in some embodiments, the tube 82 may be joined to the straight portion 66 and / or proximal end 68 of the core portion 50 by means of adhesive, welding, coating, or any other suitable joining method.

[0047] All examples and conditional statements set forth herein are intended for educational purposes to help in understanding the concepts provided by the inventors to advance the invention and the art, and should be construed as not being limited to the examples and conditions specifically listed herein. While embodiments of the invention are described in detail, it should be understood that various changes, substitutions, and modifications can be made herein without departing from the spirit and scope of the invention.

Claims

1. A vascular access device configured to be inserted via a vascular access device, wherein the vascular access device is A wire formed monolithically as a single unit, A coil section having multiple loops wound around a central axis, A core portion extending through the coil portion and aligned with the central axis, A bent portion that connects the distal end of the coil portion to the distal end of the core portion, the bent portion forming the distal end of the wire, The wire includes, A vascular access device in which the wire of the coil portion is routed so that the plurality of loops are adjacent to each other in the direction of extension of the vascular access device, forming a space on the inner surface side of the coil portion that extends in the same direction as the vascular access device.

2. The vascular access device according to claim 1, wherein the bent portion is positioned distal to the coil portion.

3. The vascular access device according to claim 2, wherein the bent portion includes a U-shape.

4. The vascular access device according to claim 3, wherein the bent portion includes a loop.

5. The vascular access device according to claim 1, wherein the coil portion is formed by the flat portion of the wire wound in the plurality of loops around the central axis.

6. The vascular access device according to claim 1, wherein each of the plurality of loops in the coil portion is spaced apart from the next adjacent loop of the plurality of loops.

7. The vascular access device according to claim 1, wherein each of the plurality of loops of the coil portion contacts the next adjacent loop of the plurality of loops around the circumference of the next adjacent loop.

8. The vascular access device according to claim 1, wherein the coil portion and the core portion are cylindrical.

9. The vascular access device according to claim 2, wherein the core portion is offset from the central axis.

10. The vascular access device according to claim 1, wherein the flat portion of the wire includes a first side and a second side opposite to the first side, the first side forming the outer surface of the coil portion, the second side forming the inner surface of the coil portion, and the core portion contacts the inner surface of the coil portion.

11. The vascular access device according to claim 1, wherein the distal end of the wire is blunt.

12. The vascular access device according to claim 1, wherein the wire further comprises a straight portion connected to the proximal end of the coil portion, the straight portion being parallel to the proximal end of the core portion.

13. The vascular access device according to claim 12, wherein the inner portion of the straight portion and the inner portion of the proximal end of the core portion are connected together.

14. The vascular access device according to claim 12, wherein the inner portion of the straight portion of the core portion and the inner portion of the proximal end are not connected together.

15. The vascular access device according to claim 12, further comprising another wire coupled to the straight portion and the proximal end of the core portion, wherein the other wire comprises nitinol or stainless steel, and the distal end of the other wire is positioned proximal to the coil portion.

16. The vascular access device according to claim 12, further comprising a tube surrounding the straight portion and the proximal end of the core portion, wherein the tube is made of nitinol or stainless steel, and the distal end of the tube is positioned proximal to the coil portion.

17. The vascular access device according to claim 16, wherein the tube is connected to the straight portion and the proximal end of the core portion.

18. The vascular access device according to claim 1, wherein the proximal end of the coil portion is connected to the core portion.

19. The vascular access device according to claim 1, wherein the proximal end of the core portion tapers outward in the proximal direction.

20. A catheter assembly comprising a catheter adapter and a catheter extending distally from the catheter adapter, An instrument advancement device coupled to the catheter assembly, wherein the instrument advancement device includes a vascular access instrument, and the instrument advancement device is configured to advance the vascular access instrument from a stored position to an advanced position beyond the distal end of the catheter, A vascular access system comprising the vascular access device being the vascular access device described in any one of claims 1 to 19.

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