Vascular Access Devices

Abstract

The present invention relates to an instrument configured to be inserted through a vascular access device, the instrument including a tubular member having a first end, a second end opposite the first end, and a sidewall extending between the first and second ends, the tubular member defining a central passage, and the first end of the tubular member having a closed end disposed perpendicular to the sidewall.

Description

[Technical Field]

[0001] This application claims priority to U.S. Provisional Application Serial No. 63 / 399,893, entitled "Vascular Access Instrument," filed in the United States on August 22, 2022, the entire contents of which are incorporated herein by reference.

[0002] The present invention relates to vascular access devices. [Background technology]

[0003] Catheters are frequently used to deliver fluids into and out of the body. In various settings, such as hospitals and home healthcare, patients receive fluids, medications, and blood products by inserting a vascular access device into their vascular system. Catheters of various types and sizes are widely used in a variety of procedures, including treating infections, providing anesthesia or pain relief, providing nutrition, treating cancerous tumors, maintaining blood pressure and heart rhythm, and many other clinical applications. A typical vascular access device is a plastic catheter inserted into a patient's vein. Catheter lengths can vary from a few centimeters for peripheral access to tens of centimeters for central access. Catheters are commonly incorporated into catheter adapters to aid in the ease, availability, and practicality of the catheter. The catheter adapter is configured to receive one end of the catheter, such that the end of the catheter is supported by the catheter adapter and the body, and the tip of the catheter extends beyond the first end of the catheter adapter. The catheter adapter further includes a second end for accepting additional infusion components typically used with the catheter. For example, the second end of the catheter adapter can include a series of threads for attaching an intravenous line or for connecting a syringe to the catheter adapter, thereby providing access to the patient's vascular system via the attached catheter.

[0004] Catheters can be inserted percutaneously. When inserted percutaneously, catheter insertion is typically aided by an introducer needle. The introducer needle is typically housed within the catheter lumen and has a needle dimension approximately equal to the catheter's inner diameter. The needle is positioned within the catheter with the tip extending beyond the catheter's tip, thereby allowing the needle to penetrate the patient's vein and provide an opening for the catheter to be inserted.

[0005] To confirm proper placement of the introducer needle and / or catheter within the vessel, the clinician typically checks for "backflow" of blood within the flashback chamber of the catheter assembly. Once needle placement is confirmed, the clinician can temporarily block flow within the vessel and remove the introducer needle, leaving the catheter in place for future blood draws, fluid infusions, or probe access.

[0006] Using a catheter to withdraw or inject blood can be difficult for several reasons, especially when the catheter is left in the patient for more than a day. For example, when a catheter remains in the patient's body for an extended period of time, it becomes susceptible to stenosis, collapse, kinking, blockage by foreign material (e.g., fibrin, platelet clumps, or thrombus), and adhesion of the catheter tip to the blood vessel. Therefore, catheters are commonly used to collect blood samples at the time of catheterization, but are used much less frequently during the catheterization period. Therefore, when a blood sample is required, an additional needlestick is performed to access a vein for blood collection, which can be painful for the patient and can increase material costs. Summary of the Invention

[0007] In one aspect or embodiment, an instrument configured to be inserted through a vascular access device includes a tubular member having a first end, a second end disposed opposite the first end, and a sidewall extending between the first and second ends, the tubular member defining a central passage, and the first end of the tubular member including a closed end disposed perpendicular to the sidewall.

[0008] The first end of the tubular member may be integrally and continuously formed with a sidewall. The first end of the tubular member may include a rounded edge. The first end of the tubular member may include a plurality of ribs extending from the sidewall of the tubular member. The tubular member may define a plurality of sidewall openings in fluid communication with a central passage.

[0009] In another aspect or embodiment, an apparatus configured to be inserted through a vascular access device includes a helical coil formed from a wire and defining a central passage, a core wire extending through at least a portion of the central passage of the helical coil along a longitudinal axis of the helical coil, and a flow tube having a distal end, the core wire attached to the flow tube via an adhesive.

[0010] In another aspect or embodiment, an instrument configured to be inserted through a vascular access device includes a helical coil formed of wire and defining a central passage; a core wire extending along a longitudinal axis of the helical coil through at least a portion of the central passage of the helical coil; a flow tube having a distal end and a proximal end; and a hub having a first end and a second end positioned opposite the first end, the hub defining an opening extending between the first end and the second end, the flow tube attached to the first end of the hub and the core wire attached to the second end of the hub.

[0011] The core wire may extend from the distal end to the proximal end and pass through the flow tube. A diameter of the opening at the first end of the hub may be larger than a diameter of the opening at the second end of the hub. The flow tube may be attached to the first end of the hub via an adhesive, and the core wire may be attached to the second end of the hub via an adhesive.

[0012] In another aspect or embodiment, an instrument configured to be inserted through a vascular access device includes a helical coil formed from a wire and defining a central passageway, a core wire extending through at least a portion of the central passageway of the helical coil along a longitudinal axis of the helical coil, and a flow tube having a distal end and a proximal end, a portion of the core wire encapsulated within the material forming the flow tube.

[0013] The flow tube may be overmolded onto or co-extruded with the core wire. The distal end of the flow tube may be tapered and configured to form a seal with the inner diameter of the catheter.

[0014] In another aspect or embodiment, an instrument configured to be inserted through a vascular access device includes a helical coil formed from a wire defining a central passageway, and a flow tube having a distal end and a proximal end, a portion of the helical coil encapsulated within the material forming the flow tube.

[0015] The flow tube may be overmolded onto the helical coil or co-extruded with the helical coil.

[0016] In another aspect or embodiment, an instrument configured to be inserted through a vascular access device includes a helical coil formed from a wire and defining a central passageway, and a flow tube having a distal end and a proximal end, a portion of the helical coil housed within and attached to the flow tube.

[0017] The helical coil has a distal portion and a proximal portion, and the proximal portion of the helical coil is received in the flow tube. The diameter of the distal portion of the helical coil may be smaller than the diameter of the proximal portion of the helical coil. The distal end of the flow tube may be tapered. The flow tube may be a heat shrink film.

[0018] In another aspect or embodiment, a vascular access system includes a catheter adapter having a catheter configured to be inserted into a patient's blood vessel; and an instrument advancement device coupled to the catheter adapter, wherein the instrument advancement device includes a tubular member having a first end, a second end disposed opposite the first end, and a sidewall extending between the first end and the second end, the tubular member defining a central passage, the first end of the tubular member including a closed end disposed perpendicular to the sidewall, and the instrument advancement device configured to advance an instrument from a retracted position to an advanced position beyond the distal end of the catheter. [Brief explanation of the drawings]

[0019] The above and other features and advantages of the present disclosure, as well as the manner in which they are achieved, will become more apparent, and the disclosure itself will be more fully understood, by reference to the following description of embodiments of the present disclosure taken in conjunction with the accompanying drawings.

[0020] [Figure 1A] FIG. 1 is a perspective view of a vascular access system according to an aspect or embodiment of the present application, showing the device in a retracted position. [Figure 1B]FIG. 1B is a perspective view of the vascular access system of FIG. 1A showing the device in an advanced position. [Figure 1C] FIG. 1B is a partial perspective view of the vascular access system of FIG. 1A showing the device in an advanced position. [Figure 1D] FIG. 1B is a partial cross-sectional view of the vascular access system of FIG. 1A showing the device in an advanced position. [Figure 1E] 1B is a cross-sectional view of the vascular access system of FIG. 1A showing the advanced position of the device within the patient's vessel. [Figure 2] FIG. 1B is a perspective view of a device of the vascular access system of FIG. 1A according to one aspect or embodiment of the present application. [Figure 3] FIG. 3 is a cross-sectional view of the device of FIG. 2. [Figure 4] FIG. 3 is a cross-sectional view of the device of FIG. 2. [Figure 5] FIG. 1 is a perspective view of an apparatus according to another aspect or embodiment of the present application. [Figure 6] FIG. 1 is a perspective view of an apparatus according to another aspect or embodiment of the present application. [Figure 7] FIG. 2 is a schematic diagram of an apparatus according to another aspect or embodiment of the present application. [Figure 8] FIG. 8 is a cross-sectional view of the device of FIG. 7. [Figure 9] FIG. 1 is a partial perspective view of a device according to another aspect or embodiment of the present application, showing a middle portion of the device. [Figure 10] FIG. 10 is a partial perspective view of the device of FIG. 9, showing the end of the device. [Figure 11] FIG. 1 is a side view of a device according to another aspect or embodiment of the present application. [Figure 12] FIG. 12 is a perspective view of the device of FIG. [Figure 13] 1 is a longitudinal cross-sectional view of a device according to another aspect or embodiment of the present application. [Figure 14] FIG. 14 is a cross-sectional view of the device of FIG. 13. [Figure 15] 1 is a cross-sectional view of a device according to another aspect or embodiment of the present application. [Figure 16] FIG. 16 is a front view of the device of FIG. 15. [Figure 17]FIG. 1 is a side view of a device according to another aspect or embodiment of the present application. [Figure 18] FIG. 1 is a side view of a device according to another aspect or embodiment of the present application. [Figure 19] FIG. 1 is a side view of a device according to another aspect or embodiment of the present application. [Figure 20] FIG. 2 is a schematic diagram of an apparatus according to another aspect or embodiment of the present application. [Figure 21] FIG. 1 is a schematic diagram of an apparatus according to another aspect or embodiment of the present disclosure. [Figure 22] 1 is a partial cross-sectional view of an apparatus according to another aspect or embodiment of the present application. [Figure 23] FIG. 1 is a side view of a device according to another aspect or embodiment of the present application. [Figure 24] 1 is a partial cross-sectional view of an apparatus according to another aspect or embodiment of the present application. [Figure 25] FIG. 1 is a partial perspective view of an apparatus according to another aspect or embodiment of the present application. [Figure 26] FIG. 22 is a cross-sectional view of the device of FIG. 21. [Figure 27] FIG. 1 is a partial perspective view of an apparatus according to another aspect or embodiment of the present application.

[0021] Corresponding reference symbols in the various drawings indicate corresponding parts throughout the various drawings. The examples set forth in this disclosure illustrate one embodiment of the present disclosure, and these examples are not intended to limit the scope of the present disclosure in any way. DETAILED DESCRIPTION OF THE INVENTION

[0022] Spatial or directional terms such as "left," "right," "inside," "outside," "above," "below," etc. should not be construed as limitations on the present invention as the present invention may have various alternative orientations.

[0023] In the following description, terms such as "upper," "lower," "right," "left," "vertical," "horizontal," "upper," "lower," "lateral," "longitudinal," and derivatives thereof, refer to the orientation of the invention as shown in the accompanying drawings. However, unless expressly specified to the contrary, it should be understood that the invention is susceptible to various alternative modifications. It should also be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the invention.

[0024] Unless otherwise specified, all ranges or ratios disclosed in this disclosure should be understood to encompass the starting and ending values, and all subranges or subratios therein. For example, a range or ratio stated as "1 to 10" should be interpreted to include all subranges or subratios between, inclusive of, the minimum value of 1 and the maximum value of 10. That is, all subranges or subratios having a minimum value of 1 or greater and a maximum value of 10 or less are included.

[0025] The terms "first," "second," etc. do not denote a particular order or chronology, but rather are used to distinguish between different states, properties, or elements.

[0026] In this disclosure, "at least one" is synonymous with "one or more." For example, "at least one of A, B, and C" means any one of A, B, or C, or any combination of two or more of A, B, and C. That is, "at least one of A, B, and C" includes one or more As only, one or more Bs only, one or more Cs only, one or more As and one or more Bs, one or more As and one or more Cs, one or more Bs and one or more Cs, or one or more As, Bs, and Cs.

[0027] 1A-4 , in one aspect or embodiment, a vascular access system 10 includes a catheter assembly 12, which may include a catheter adapter 14 and a catheter 16. The catheter 16 may be a peripheral intravenous catheter, a peripherally inserted central catheter, or a midline catheter. In some aspects or embodiments, the catheter adapter 14 includes a distal end 18, a proximal end 20, and a lumen extending through the distal end 18 and the proximal end 20. In some aspects or embodiments, the catheter 16 extends distally from the distal end 18 of the catheter adapter 14. The catheter adapter 14 may be integrated with an extension tube 22 extending from a side port 24 of the catheter adapter 14. In some aspects or embodiments, an adapter 26, such as a Y adapter or a T adapter, may be coupled to the proximal end of the extension tube 22. An instrument advancement device 28 may be coupled to the catheter assembly 12 in various ways. In one aspect or embodiment, the instrument advancement device 28 is coupled to a port of the adapter 26. In one aspect or embodiment, instrument advancement device 28 is coupled to a needleless connector 29 disposed between the port of adapter 26 and instrument advancement device 28. Instrument advancement device 28 can be coupled to the proximal end 20 of catheter adapter 14. In some aspects or embodiments, another extension tube and / or blood draw set adapter can be coupled to another port of adapter 26. The blood draw set adapter can accommodate a blood draw device, such as, for example, a syringe or blood draw tube.

[0028] Instrument advancement device 28 may include a housing 30 that is connectable to catheter assembly 12. Instrument advancement device 28 includes an instrument 32. In some aspects or embodiments, instrument advancement device 28 may include any suitable delivery device. Examples of instrument advancement devices that can be used with instrument 32 are described in U.S. patent application Ser. No. 16 / 037,246, filed July 17, 2018, entitled "EXTENSION HOUSING A PROBE OR INTRAVENOUS CATHETER," U.S. patent application Ser. No. 16 / 388,650, filed April 18, 2019, entitled "INSTRUMENT DELIVERY DEVICE HAVING A ROTARY ELEMENT," U.S. patent application Ser. No. 16 / 037,319, filed July 17, 2018, entitled "MULTI-DIAMETER CATHETER AND RELATED DEVICES AND METHODS," and U.S. patent application Ser. No. 16 / 502,541, filed July 3, 2019, entitled "DELIVERY DEVICE FOR A VASCULAR ACCESS" No. 16 / 691,217, filed November 21, 2019, entitled "SYRINGE-BASED DELIVERY DEVICE FOR A VASCULAR ACCESS INSTRUMENT," U.S. Patent Application No. 62 / 794,437, filed January 18, 2019, entitled "CATHETER DELIVERY DEVICE AND RELATED SYSTEMS AND METHODS," and U.S. Patent Application No. 62 / 830,286, filed April 5, 2019, entitled "VASCULAR ACCESS INSTRUMENT HAVING A FLUID PERMEABLE STRUCTURE, AND RELATED DEVICES AND METHODS," each of which is incorporated by reference in its entirety.

[0029] In some aspects or embodiments, the instrument advancement device 28 may be configured to introduce the instrument 32 into the catheter assembly 12. Once the instrument 32 is introduced into the catheter assembly 12, the instrument 32 may access a fluid path of the catheter assembly 12 or the instrument 32 may pass through the catheter assembly 12 to access a patient's blood vessel (see FIG. 1E). The instrument advancement device 28 may be configured to advance the instrument 32, for example, from the retracted position shown in FIG. 1A to the advanced position shown in FIG. 1B. In some aspects or embodiments, the distal tip 34 of the instrument 32 may be positioned distal to the distal end 36 of the catheter 16, corresponding to the instrument 32 being in the advanced position. Also, in some aspects or embodiments, the distal tip 34 of the instrument 32 may be positioned within the housing 30, corresponding to the instrument 32 being in the retracted position. Additionally, the proximal end of the instrument 32 may be coupled to an advancement tab 38, which allows a user to grasp and move the advancement tab 38 along a slot 40 to move the instrument 32 between the retracted and advanced positions. The advancement tab 38 extends through the slot 40 , and the portion of the advancement tab 38 connected to the proximal end of the instrument 32 may be disposed within the housing 30 .

[0030] In some aspects or embodiments, the catheter 16 is made of fluorinated ethylene propylene, TEFLON TM , silicone, thermoplastic elastomer, thermoplastic polyurethane, fluorinated polymer, hydrophilic material, hydrophobic material, anti-fouling material, or other suitable material. Also, in some aspects or embodiments, catheter 16 may have an anti-thrombogenic coating. Also, in some aspects or embodiments, all or a portion of device 32 may be constructed from metal or other suitable material. In some aspects or embodiments, distal end 36 of catheter 16 may be symmetrical or asymmetrical.

[0031] 1C-1E, in some embodiments, the device 32 may include a helical coil 42 formed by a wire wound around an axis 44 into multiple loops 46. The wire may have a variety of cross-sectional shapes, such as flat, circular, oval, or semicircular. In some aspects or embodiments, the helical coil 42 may be constructed from metal or other suitable materials. In some aspects or embodiments, the helical coil 42 may be positioned near the distal end and / or distal tip 34 of the device 32. In some aspects or embodiments, each loop 46 of the helical coil 42 may be spaced apart from adjacent loops 46, which may promote fluid permeability at the distal end of the device 32. The helical coil 42 may provide multiple fluid pathways along the length of the device 32, which may promote the flow of blood into the catheter assembly 12 from portions of the vasculature more distal from the catheter 16. In some aspects or embodiments, the fluid pathways along the length of the helical coil 42 and the device 32 may increase the flow rate of fluid through the device 32 and the catheter 16. In some aspects or embodiments, the helical coil 42 and fluid path along the length of the device 32 can facilitate shorter blood draw times. In some aspects or embodiments, the helical coil 42 can reduce shear stress and the associated risk of hemolysis on blood entering and / or passing through the catheter 16. In some aspects or embodiments, the helical coil 42 can promote soft and gentle contact with the vessel wall as the device 32 is inserted into the vessel. In one aspect or embodiment, the device 32 includes a core wire 48 extending through at least a portion of the helical coil 42.

[0032] In some aspects or embodiments, during manufacture, before the wire is wound around the axis 44 into the loop 46, the wire may include a first side 50 and a second side 52 opposite and parallel to the first side 50. The first side 50 forms the outer surface of the helical coil 42, and the second side 52 forms the inner surface of the helical coil 42. A core wire 48 may be coupled to the inner surface of the helical coil 42. In some aspects or embodiments, the wire can increase the inner diameter of the helical coil 42 to increase fluid flow through the device 32. The wire can increase the inner diameter of the helical coil 42 while still allowing the outer diameter of the helical coil 42 to be the same as the outer diameter of a standard vascular access device.

[0033] 1D , the distal end 36 of the catheter 16 includes a distal opening 53. In some aspects or embodiments, the coil 42 may extend through the distal opening 53 of the catheter 16, corresponding to the device 32 being in the advanced position. The outer diameter of the helical coil 42 may be smaller than the diameter of the distal opening 53, thereby creating a gap through which fluid can flow. The distal end 36 of the catheter 16 may include one or more diffusion holes 54, which may be aligned with the portion of the device 32 that includes the coil 42 and may facilitate the inflow of blood into the catheter assembly 12 and / or the infusion of fluids into the blood vessel.

[0034] In some aspects or embodiments, the dimensions of the helical coil 42 may vary based on the gauge size of the catheter 16, the stiffness of the device 32, the spacing between each loop 46 of the helical coil 42, the number or size of the fluid paths along the length of the device 32, and other factors.

[0035] In some aspects or embodiments, the distal tip 34 may be rounded or formed with an obtuse angle to prevent damage to the blood vessel. The distal tip 34 may be disposed at the distal end of the core wire 48 or may be integrally formed with the distal end of the core wire 48 and configured as a single unit. Additionally or alternatively, in some embodiments, the distal tip 34 may be coupled to the distal end of the helical coil 42.

[0036] In some aspects or embodiments, the distal tip 34 may be rounded or formed with an obtuse angle. The distal tip 34 may be disposed at the distal end of the elongated strip 55 or may be integrally formed with the distal end of the elongated strip 55 and configured as a single unit. Additionally or alternatively, in some aspects or embodiments, the distal tip 34 may be coupled to the distal end of the helical coil 42.

[0037] 2-4, in one aspect or embodiment, the core wire 48 extends along the longitudinal axis 60 of the helical coil 42 through at least a portion of the central passage 62 of the helical coil 42. Here, at least a portion of the core wire 48 includes a planar surface 64 extending in a direction along the longitudinal axis 60 and a semi-cylindrical surface 66 extending in a direction along the longitudinal axis 60. As shown in FIG. 4, the core wire 48 has a first cross-sectional shape, which includes a straight portion 68 and a semi-circular portion 70. As shown in FIG. 3, the core wire 48 has a second cross-sectional shape. The second cross-sectional shape is circular. The first cross-sectional shape is less than 33% of the cross-sectional area of ​​the central passage 62. As shown in FIG. 2, the core wire 48 tapers in size from the second cross-sectional shape to the first cross-sectional shape. In some aspects or embodiments, the radius of the semi-cylindrical surface 66 is equal to or less than the radius of the interior of the helical coil 42, and the planar surface 64 extends along a chord of the central passage 62. In some aspects or embodiments, the length of the straight portion 68 is less than the diameter of the central passage 62. In some aspects or embodiments, the first cross-sectional shape is D-shaped. The planar surface 64 of the core wire 48 may be formed by grinding one side of a round wire or by shaving a round wire. The planar surface 64 of the core wire 48 increases the flexibility of at least a portion of the device 32 and is configured to keep a sufficient portion of the central passage 62 open to maximize fluid flow therethrough.

[0038] 5 and 6 , in another aspect or embodiment, the core wire 48 includes a first wire 80 having a first diameter and a second wire 82 having a second diameter, where the first diameter of the first wire 80 is larger than the second diameter of the second wire 82. At least a portion of the second wire 82 extends within the central passage 62, and the first wire 80 is coupled to the second wire 82 to form the core wire 48. As shown in FIG. 6 , in one aspect or embodiment, the first wire 80 and the second wire 82 overlap in a direction extending along the longitudinal axis 60. As shown in FIG. 5 , in one aspect or embodiment, one end of the first wire 80 is coupled to one end of the second wire 82. The first wire 80 can be coupled to the second wire 82 via at least one of welding, brazing, soldering, an adhesive, and the like. In some aspects or embodiments, the core wire 48 includes a connection 84, such as an adhesive connection, configured to hold the second wire 82 to the side of the helical coil 42. For clarity, the connecting portion 84 is shown as having a larger diameter than the first wire 80 and the second wire 82, but the connecting portion 84 may be the same diameter as or smaller than the first wire 80.

[0039] 7 and 8 , in another aspect or embodiment, at least a portion of the length of core wire 48 has a C-shaped cross-section. The radius of an outer surface 90 of core wire 48 may be equal to or less than the inner radius of helical coil 42. Core wire 48 may include a first portion 92 of C-shaped cross-section that includes the length of core wire 48 and a second portion 94 of circular cross-section. The C-shaped cross-section provides stiffness and support during device insertion while maintaining sufficient cross-sectional area within central passageway 62 to maximize fluid flow.

[0040] 9-12, a device 100 according to another aspect or embodiment of the present application is shown. The device 100 functions generally similarly to the device 32 described above. Instead of providing a helical coil 42, the device 100 includes a tubular member 102 having a first end 104 and a second end 106 disposed opposite the first end 104, the tubular member 102 defining a central passageway 108 and a plurality of sidewall openings 110 in fluid communication with the central passageway 108. The plurality of sidewall openings 110 are disposed from the first end 104 to the second end 106 of the tubular member 102. The fluid pathway of the device 100 shown in FIGS. 9-12 may be contained within the tubular member 102, rather than having the fluid exit the catheter lumen, as shown in FIG. 1E. Sidewall openings 110 may be located only distal to the catheter tip or may be located both distal and proximal to the catheter tip to reduce the possibility of fluid mixing and / or contamination from within the catheter, thus providing a pathway to a blood collection device, such as instrument advancement device 28, that extends through instrument advancement device 28 rather than through adapter 26.

[0041] As shown in Figure 9, in one aspect or embodiment, a core wire 112 is attached to the first end 104 of the tubular member 102. As shown in Figure 11, in one aspect or embodiment, rather than providing a core wire 112, the device 100 includes a proximal member 114 extending from and integrally formed with the tubular member 102, the proximal member 114 having a continuous, uninterrupted sidewall 116.

[0042] In one aspect or embodiment, the tubular member 102 is formed from a shape memory alloy. The multiple sidewall openings 110 may be formed in the tubular member 102 by laser cutting or other methods. The tubular member 102 is configured to retain its outer and inner diameters without a core wire disposed within the tubular member 102, thereby increasing the cross-sectional area of ​​the fluid path through the central passage 108 and improving fluid flow through the central passage 108. In one aspect or embodiment, the tubular member 102 is formed from a polymeric material. Increasing the size or number of the sidewall openings 110 allows for tailoring of the position and size of the multiple sidewall openings 110, improving manufacturability, or increasing flexibility of a portion of the tubular member 102, such as the distal tip 118. In one aspect or embodiment, the shape or access direction of the sidewall openings 110 is configured to increase flexibility of a portion of the tubular member 102. For example, the sidewall openings 110 may be formed from one side or in an intermittent spiral pattern. In one aspect or embodiment, the sidewall openings 110 are configured to have smaller diameter holes near the distal tip 118 of the device 100 or each hole has a smaller diameter at the proximal end of each sidewall opening 110 to improve thrombus migration prevention. In one aspect or embodiment, the device 100 is formed of metal and configured to transmit electrical signals to enable communication with a sensor (not shown). The tubular member 102 can be configured to inhibit mixing and contamination within the catheter assembly 12 and fittings.

[0043] 13-16 , in another aspect or embodiment, the first end 104 of the tubular member 102 of the device 100 includes a closed end 120 disposed perpendicular to the sidewall 116. As shown in FIGS. 13 and 14 , in one aspect or embodiment, the first end 104 of the tubular member 102 is integrally and continuously formed with the sidewall 116. The first end 104 of the tubular member 102 has a rounded edge 122, although other suitable edge shapes can be employed. The closed end 120 shown in FIGS. 13 and 14 can be formed by a deep-drawn punch and die process, although other suitable methods can be used. As shown in FIGS. 15 and 16 , in one aspect or embodiment, the first end of the tubular member 102 includes multiple leaflets 124 extending from the sidewall 116, forming the closed end 120. A device 100 having a closed end 120 functions in a similar manner as described above. The closed end 120 is configured to prevent thrombus or other intravenous material from becoming trapped as it enters the vein through the catheter. The closed end 120 is further configured to reduce trauma to the vein, increase flow rate by maximizing the inner diameter of the tubular member 120, and avoid tip occlusion. The rounded edge 122 is configured to provide an atraumatic tip.

[0044] 17 , in another aspect or embodiment, device 130 includes a helical coil 42 formed from a wire, a core wire 48 extending along the longitudinal axis of helical coil 42 through at least a portion of central passage 108 of helical coil 42, and a flow tube 132 having a distal end 134. Core wire 48 is attached to flow tube 132 by adhesive 136. As shown in FIG. 17 , core wire 48 is attached to the outside of flow tube 132, thereby configuring flow tube 132 to maintain its overall diameter. Device 130 functions generally similarly to devices 32, 100 described above.

[0045] 18 , in another aspect or embodiment, device 150 includes helical coil 42, core wire 48 extending along the longitudinal axis of helical coil 42 and through at least a portion of central passage 108, flow tube 152 having distal and proximal ends 154 and 156, and hub 158 having a first end 160 and a second end 162 opposite first end 160. Hub 158 defines an opening 164 extending between first end 160 and second end 162. Flow tube 152 is attached to first end 160 of hub 158, and core wire 48 is attached to second end 162 of hub 158. In some aspects or embodiments, as shown in FIG. 18 , core wire 48 extends from distal end 154 to proximal end 156 of flow tube 152. The diameter of the opening 164 at the first end 160 of the hub 158 is larger than the diameter of the same opening 164 at the second end 162, although other suitable arrangements may be employed. The flow tube 152 is attached to the first end 160 of the hub 158 via adhesive 166. The core wire 48 is attached to the second end 162 of the hub 158 via adhesive 168. The flow tube 152 is configured to support the core wire 48 during use, thereby allowing for the use of a smaller diameter core wire 48. The hub 158 may include a side port 170 in fluid communication with the opening 164.

[0046] 19, in another aspect or embodiment, a portion of core wire 48 of device 130 is included in the material that forms flow tube 132. Flow tube 132 may be formed over core wire 48 by a method such as a molding or overmolding process, whereby core wire 48 is attached to flow tube 132.

[0047] 20, in another aspect or embodiment, a portion of the core wire 48 of the device 130 is included in the material that forms the flow tube 132 by an extrusion process. The core wire 48 and the flow tube 132 may be co-extruded, and the helical coil 42 is then attached to the core wire 48.

[0048] 21, in another aspect or embodiment, a portion of the helical coil 42 of the device 130 is encapsulated in the material that forms the flow tube 132. As shown in FIG. 21, the core wire 48 can be omitted, and the flow tube 132 supports the helical coil 42. The flow tube 132 may be overmolded or co-extruded with the helical coil.

[0049] 22 , in another aspect or embodiment, a portion of the helical coil 42 of the device 130 is housed within and adhered to the flow tube 132. The helical coil 42 has a distal portion 180 and a proximal portion 182. The proximal portion 182 of the helical coil 42 is housed within the flow tube 132, and the distal portion 180 of the helical coil 42 has a smaller diameter than the proximal portion 182. The distal end 134 of the flow tube 132 may be tapered. In one aspect or embodiment, the proximal portion 182 of the helical coil 42 is attached to the flow tube 132 using heat shrink, tipping, or other thermal properties of the plastic material of the flow tube 132.

[0050] Referring to FIG. 23, in another aspect or embodiment similar to the embodiment shown in FIG. 22, the diameter of the helical coil 42 is constant and the helical coil 42 is attached to the flow tube 132 by a post-process heat shrinking or tipping process.

[0051] 24, in another aspect or embodiment, a portion of the helical coil 42 of the device 130 is housed within a flow tube 132. The flow tube 132 is a heat shrink film, thin film, or moldable plastic tube that adheres the flow tube 132 to the helical coil 42. The flow tube 132 may be used to attach an external plastic tube to the device 130 by melting, heating, molding, overmolding, shrinking, or other suitable joining methods.

[0052] 25-27 , in another aspect or embodiment, a portion of the core wire 48 of the device 130 is included in the material forming the flow tube 132 by co-extruding the core wire 48 and the flow tube 132 or by dip-coating the core wire 48 with the polymer material that forms the flow tube 132. The material of the flow tube 132 may be polyimide, polyurethane, or other suitable polymer material. After the helical coil 42 is attached to the core wire 48, the flow tube 132 may be dip-coated onto the core wire 48. The distal end 134 of the flow tube 132 may be tapered and configured to form a seal with the inner diameter of the catheter 16, as shown more clearly in FIG. 27 . Thus, the distal end 134 of the flow tube 132 may be configured to form a blocking function to seal the fluid path of the catheter 16.

[0053] While the present disclosure has been described in detail for purposes of illustrating the invention based on embodiments presently considered to be the most practical and preferred, these detailed descriptions are for the purpose only, and the present invention is not limited to the disclosed embodiments, but is intended to encompass modifications and similar configurations within the spirit and scope of the claims. For example, it should be understood that the present invention contemplates that one or more features of any embodiment can be combined with one or more features of any other embodiment, to the extent possible.

Claims

1. 1. An instrument configured to be inserted through a vascular access device, comprising:

1. An instrument comprising: a tubular member having a first end, a second end disposed opposite the first end, and a sidewall extending between the first end and the second end, the tubular member defining a central passage, the first end of the tubular member including a closed end disposed perpendicular to the sidewall.

2. The device of claim 1 , wherein the first end of the tubular member is integral and continuous with the sidewall of the tubular member.

3. The device of claim 1 , wherein the first end of the tubular member has a rounded edge.

4. The device of claim 1 , wherein the first end of the tubular member has a plurality of leaflets extending from the sidewall of the tubular member.

5. The device of claim 1 , wherein the tubular member defines a plurality of sidewall openings in fluid communication with the central passage.

6. 1. An instrument configured to be inserted through a vascular access device, comprising: a helical coil formed from wire and defining a central passage; a core wire extending through at least a portion of the central passage of the helical coil along a longitudinal axis of the helical coil; a flow tube having a distal end, the core wire being attached to the flow tube via an adhesive; Equipment comprising:

7. 1. An instrument configured to be inserted through a vascular access device, comprising: a helical coil formed from wire and defining a central passage; a core wire extending through at least a portion of the central passage of the helical coil along a longitudinal axis of the helical coil; a flow tube having a distal end and a proximal end; a hub having a first end and a second end opposite the first end, the hub defining an opening extending between the first end and the second end, the flow tube attached to the first end of the hub and the core wire attached to the second end of the hub; Equipment comprising:

8. The device of claim 7 , wherein the core wire extends through the flow tube from the distal end to the proximal end.

9. 9. The device of claim 8, wherein a diameter of the opening in the hub at the first end of the hub is greater than a diameter of the opening in the hub at the second end of the hub.

10. 10. The device of claim 9, wherein the flow tube is attached to the first end of the hub via an adhesive and the core wire is attached to the second end of the hub via an adhesive.

11. 1. An instrument configured to be inserted through a vascular access device, comprising: a helical coil formed from wire and defining a central passage; a core wire extending through at least a portion of the central passage of the helical coil along a longitudinal axis of the helical coil; a flow tube having a distal end and a proximal end, a portion of the core wire being included in a material forming the flow tube; Equipment comprising:

12. The device of claim 11 , wherein the flow tube is overmolded onto the core wire.

13. The device of claim 11 , wherein the flow tube is co-extruded with the core wire.

14. The device of claim 11 , wherein the distal end of the flow tube is tapered and configured to form a seal with the inner diameter of a catheter.

15. 1. An instrument configured to be inserted through a vascular access device, comprising: a helical coil formed from wire and defining a central passage; a flow tube having a distal end and a proximal end, a portion of the helical coil being contained within a material forming the flow tube; Equipment comprising:

16. The device of claim 15 , wherein the flow tube is overmolded onto the helical coil.

17. 16. The device of claim 15, wherein the flow tube is co-extruded with the helical coil.

18. 1. An instrument configured to be inserted through a vascular access device, comprising: a helical coil formed from wire and defining a central passage; a flow tube having a distal end and a proximal end, a portion of the helical coil being contained within and joined to the flow tube.

19. 20. The device of claim 18, wherein the helical coil has a distal portion and a proximal portion, the proximal portion of the helical coil is contained within the flow tube, and the diameter of the distal portion of the helical coil is smaller than the diameter of the proximal portion of the helical coil.

20. 20. The device of claim 19, wherein the distal end of the flow tube is tapered.

21. 20. The device of claim 19, wherein the flow tube comprises a heat shrink film.

22. 1. A vascular access system comprising: a catheter adapter including a catheter configured to be inserted into a blood vessel of a patient; an instrument advancement device coupled to the catheter adapter, the instrument advancement device including: a tubular member having a first end, a second end disposed opposite the first end, and a sidewall extending between the first end and the second end, the tubular member defining a central passage; and Equipped with the first end of the tubular member includes a closed end disposed perpendicular to the sidewall; the instrument advancement device is configured to advance an instrument beyond the distal end of the catheter from a retracted position to an advanced position. Vascular access systems.

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