Vascular access devices and related equipment and methods

Abstract

Providing a device for advancing equipment. [Solution] The vascular access system 10 may include a catheter assembly 12, a catheter adapter 14, and a catheter 16 extending distally from the catheter adapter. The vascular access system may include an instrument advancement device 28 coupled to the catheter assembly. The instrument advancement device may include a vascular access instrument 32. The vascular access instrument may include a coil formed by a flat wire wound around an axis in multiple loops. The instrument advancement device may be configured to advance the vascular access instrument from a stowed position to an advanced position beyond the distal end of the catheter. The distal end 36 of the catheter may include a distal opening. The coil may extend through the distal opening of the catheter in response to the vascular access instrument being in the advanced position.

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 fluid into a patient's vascular system. For example, a catheter can be used to inject saline, various drugs, or total parenteral nutrition. A catheter may also be used to draw blood from a patient.

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

[0004] To verify proper placement of the introducer needle and / or catheter within the blood vessel, a clinician generally confirms that there is a "flashback" of blood within the flashback chamber of the catheter assembly. Once the needle placement is confirmed, the clinician can temporarily occlude the flow within the vascular system, remove the needle, and leave the catheter in place for subsequent blood sampling or 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 tip 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, vascular access instruments may be configured to be inserted via a vascular access device, such as a catheter assembly. In some embodiments, a vascular access instrument may include a coil formed by a flat wire wound in multiple loops around an axis. As referred to in this disclosure, the term “flat wire” may correspond to a wire including a first side and a second side opposite the first side, where the first side and / or second side are flat before the wire is wound in loops around an 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. In some embodiments, a core wire may be coupled to the inner surface of the coil. In some embodiments, each loop of the coil may be spaced apart from the next adjacent loop of the loop.

[0010] In some embodiments, the vascular access device may include a core wire extending through at least a portion of the coil. In some embodiments, the core wire may be cylindrical. In some embodiments, the core wire may be flat. In some embodiments, the core wire may be aligned with the axis. In some embodiments, the core wire may be offset from the axis.

[0011] In some embodiments, the vascular access device may include an elongated strip extending through a coil. In some embodiments, each of the loops may include a distal end and a proximal end. In some embodiments, the distal end of each loop and the proximal end of each loop are in contact with the elongated strip. In some embodiments, the elongated strip may be linear and / or aligned with an axis.

[0012] In some embodiments, the vascular access device may include a plurality of support beams extending between the coils. In some embodiments, a first set of support beams may be arranged along a first line parallel to the axis. In some embodiments, a second set of support beams may be arranged along a second line parallel to the axis. In some embodiments, the first line may be spaced apart from the second line. In some embodiments, the first line may be 180 degrees apart from the second line.

[0013] In some embodiments, a third set of support beams may be arranged along a third line parallel to the axis. In some embodiments, the first line, the second line, and the third line may be evenly spaced around the circumference of the coil. In some embodiments, the complete turn of the coil is located between one or more of the next adjacent support beams of the first set, the next adjacent support beams of the second set, and the next adjacent support beams of the third set.

[0014] In some embodiments, the coil may include several other loops. In some embodiments, the other loops may be adjacent to the loop. In some embodiments, each of the other loops of the coil may contact the next adjacent loop of the other loop around the circumference of the next adjacent loop of the other loop.

[0015] In some embodiments, the vascular access system may include a catheter assembly, 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 coil may extend through the distal opening of the catheter in response to the vascular access instrument being in the advanced position. In some embodiments, the distal end of the catheter may include one or more diffuser holes. In some embodiments, a gap in the core wire may be located at the distal opening of the catheter.

[0016] In some embodiments, another vascular access device configured to be inserted through a vascular access device may include a distal end that may include a tubular element. In some embodiments, the tubular element may include one or more holes. In some embodiments, another vascular access device may include a wire. In some embodiments, another vascular access device may include a connector positioned between the tubular element and the wire. In some embodiments, the connector may include one or more other holes. In some embodiments, the distal end of the tubular element may be closed.

[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 an enlarged cross-sectional view of another part of a vascular access system, showing a vascular access instrument in an advanced position according to several embodiments. [Figure 1E] Figure 1E is a cross-sectional view of a vascular access system showing an exemplary vascular access system in an advanced position within the vascular system, according to several embodiments. [Figure 1F]FIG. 1F is an enlarged cross-sectional view of a portion of an exemplary coil of a vascular access device, according to some embodiments. [Figure 1G] FIG. 1G is an enlarged cross-sectional view of a vascular access device disposed within a vascular access system, showing the vascular device in a forward position, according to some embodiments. [Figure 1H] FIG. 1H is an enlarged cross-sectional view of a vascular access device disposed within a vascular access system, showing the vascular device in a forward position, according to some embodiments. [Figure 2] FIG. 2 is a bar graph showing exemplary totals of maximum shear ratios and exemplary totals of blood collection rate ratios, according to some embodiments. [Figure 3A] FIG. 3A is a top perspective view of an exemplary distal end of a vascular access device, according to some embodiments. [Figure 3B] FIG. 3B is a cross-sectional view of the distal end of the vascular access device of FIG. 3A, according to some embodiments. [Figure 3C] FIG. 3C is a cross-sectional view of a portion of the vascular access device of FIG. 3A disposed within an exemplary catheter, according to some embodiments. [Figure 4A] FIG. 4A is a top perspective view of another exemplary distal end of a vascular access device, according to some embodiments. [Figure 4B] FIG. 4B is a cross-sectional view of a portion of the vascular access device of FIG. 4A, according to some embodiments. [Figure 5A] FIG. 5A is a top perspective view of a vascular access device showing an exemplary elongated strip, according to some embodiments. [Figure 5B] FIG. 5B is a top view of the vascular access device of FIG. 5A, according to some embodiments. [Figure 6A] FIG. 6A is a top perspective view of another exemplary distal end of a vascular access device disposed within a vascular access system, showing the vascular device in a forward position, according to some embodiments. [Figure 6B]Figure 6B is a cross-sectional view of the distal end of the vascular access device of Figure 6A, positioned within a vascular access system, showing the vascular device in an advanced position according to several embodiments. [Figure 6C] Figure 6C is a cross-sectional view of a portion of the vascular access device shown in Figure 6A, according to several embodiments. [Figure 6D] Figure 6D is a top perspective view of a portion of the vascular access device shown in Figure 6A, according to several embodiments. [Figure 6E] Figure 6E is a cross-sectional view of the vascular access device shown in Figure 6A, according to several embodiments. [Figure 7A] Figure 7A is a top perspective view of a vascular access device according to several embodiments. [Figure 7B] Figure 7B is a cross-sectional view of the distal end of the vascular access device of Figure 7A, positioned within a vascular access system, showing the vascular device in an advanced position according to several embodiments. [Figure 7C] Figure 7C is a magnified top perspective view of the distal end of the vascular access device of Figure 7A, positioned within a vascular access system, showing the vascular device in an advanced position according to several embodiments. [Figure 7D] Figure 7D is a magnified cross-sectional view of the distal end of the vascular access device of Figure 7A, positioned within a vascular access system, showing the vascular device in an advanced position according to several embodiments. [Figure 8] Figure 8 is a bar graph showing exemplary mean values ​​of maximum shear ratio and blood collection rate ratio for several embodiments. [Figure 9A] Figure 9A is a top perspective view of a vascular access device according to several embodiments. [Figure 9B] Figure 9B is a cross-sectional view of the vascular access device shown in Figure 9A, extending from a catheter, according to several embodiments. [Figure 9C] Figure 9C is an enlarged cross-sectional view of a portion of the vascular access device shown in Figure 9A, according to several embodiments. [Figure 9D]Figure 9D is an enlarged cross-sectional view of the vascular access device of Figure 9A, positioned within a vascular access system, showing the vascular device in an advanced position according to several embodiments. [Figure 10A] Figure 10A is a top perspective view of a vascular access device according to several embodiments. [Figure 10B] Figure 10B is a top perspective view of a vascular access device according to several embodiments. [Figure 10C] Figure 10C is a top perspective view of a vascular access device according to several embodiments. [Figure 10D] Figure 10D is a top perspective view of a vascular access device according to several embodiments. [Figure 10E] Figure 10E is a top perspective view of the vascular access device shown in Figure 10D, extending from a catheter in an advanced position, according to several embodiments. [Figure 10F] Figure 10F is an enlarged top perspective view of the vascular access device shown in Figure 10D, extending from a catheter in an advanced position, according to several embodiments. [Figure 11] Figure 11 is a cross-sectional view of another exemplary vascular access device positioned in an advanced position within a catheter, according to several embodiments. [Figure 12A] Figure 12A is a top perspective view of an exemplary instrument advancement device according to several embodiments. [Figure 12B] Figure 12B is a cross-sectional view of an instrument advancement device 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 can receive 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 tip 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 tip 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 along a slot 40 by the user to move the vascular access instrument 32 between the retracted position and the advanced position. 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 made 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 made of metal or another suitable material. In some embodiments, the coil 42 may be made of metal or another suitable material. In some embodiments, the distal end 36 of the catheter 16 may be symmetrical or asymmetrical.

[0026] Referring here to Figures 1C-1F, in some embodiments, the vascular access device 32 may include a coil 42 formed into multiple loops 46 by a flat wire wound around an axis 44. In some embodiments, the coil 42 may be positioned at the distal end of the vascular access device 32 and / or adjacent to the distal tip 34. In some embodiments, each of the loops 46 of the coil 42 may be spaced apart from the next adjacent loop 46, which may facilitate fluid permeability at the distal end of the vascular access device 32. In some embodiments, the coil 42 may provide multiple 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 42 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 42 and the vascular access device 32 may facilitate a reduction in blood collection time. In some embodiments, the coil 42 can reduce the shear stress and associated risks of hemolysis of blood in and / or through the catheter 16.

[0027] In some embodiments, the coil 42 can facilitate soft and gentle contact with the wall of the vascular system in response to the insertion of the vascular access instrument 32 into the vascular system. In some embodiments, the coil 42 can reduce shear stress on the fluid moving through the vascular access instrument 32.

[0028] In some embodiments, the vascular access device 32 may include a core wire 48 extending through at least a portion of the coil 42. In some embodiments, the core wire 48 may be cylindrical, as shown in Figures 1C–1F. In some embodiments, the core wire 48 may be aligned with the axis 44. In some embodiments, the core wire 48 may provide structural support to the vascular access device 32.

[0029] In some embodiments, the flat wire may include a first side 50 and a second side 52 parallel to the first side 50 before the flat wire is wound around the axis 44 into a loop 46 during manufacturing. In some embodiments, the first side 50 may form the outer surface of the coil. In some embodiments, the second side 52 may form the inner surface of the coil 42. In some embodiments, a core wire 48 may be coupled to the inner surface of the coil 42.

[0030] In some embodiments, a flat wire can increase the inner diameter 49 of the coil 42, thereby facilitating an increase in fluid flow through the vascular access device 32. In some embodiments, a flat wire may increase the inner diameter 49 of the coil 42, allowing the outer diameter 51 of the coil 42 to be the same length as the outer diameter of a standard vascular access device.

[0031] In some embodiments, the distal end 36 of the catheter 16 may include a distal opening 53. In some embodiments, the coil 42 may extend through the distal opening 53 of the catheter 16 in response to the vascular access device 32 being in an advanced position. In some embodiments, the outer diameter 51 of the coil 42 may be smaller than the diameter of the distal opening 53, which may create a gap through which fluid can flow. In some embodiments, the distal end 36 of the catheter 16 may include one or more diffuser holes 54 that can be aligned with a portion of the vascular access device 32, including the coil 42, to facilitate blood flow into the catheter assembly 12 and / or fluid injection into the vascular system.

[0032] In some embodiments, the dimensions of the coil 42 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 42, the number or size of fluid pathways along the length of the vascular access device 32, or other factors.

[0033] Referring here to Figure 1G, in some embodiments, the vascular access device 32 may not include a core wire 48 that can increase the flow through the coil 42 and / or catheter 16.

[0034] Referring here to Figure 1H, in some embodiments the core wire 48 may be flat, which may increase the flow through the coil 42 and / or catheter 16. In some embodiments the flat wire may include a first side 64 and a second side 66 opposite the first side 64. In some embodiments the first side 64 may be parallel to the second side 66.

[0035] Referring here to Figure 2, the bar graph shows the sum of the blood collection rate ratio to 21G UT ("BDVACUTANER® ULTRATOUCH®") and the sum of the maximum shear ratio to 21G UT ("BDVACUTANER® ULTRATOUCH®") in a particular vascular access system having a coil 42 containing a flat wire wound around an axis 44 to form a loop 46, another particular vascular access system having a coil 42 containing a cylindrical wire wound around an axis 44 to form a loop 46, and another particular vascular access system without a core wire 48, according to several embodiments.

[0036] Referring here to Figures 3A-3C, in some embodiments, the core wire 48 may be offset from the axis 44, which may facilitate blood flow to the catheter assembly 12 and / or fluid injection into the vascular system along the axis 44 and the central portion of the coil 42 and / or the central portion of the catheter 16. In some embodiments, the core wire 48 offset from the axis 44 may be bonded to the coil 42 at one or more points. In some embodiments, the core wire 48 may be bonded to the inner surface of the coil 42 at one or more points. For example, the core wire 48 may be bonded to the coil 42 or the inner surface of the coil 42. In some embodiments, the core wire 48 may be coated with a thin layer of polymer material, heated while in contact with the coil 42, and then cooled to bond to the coil 42 or the inner surface of the coil 42.

[0037] In some embodiments, the distal tip 34 may be rounded or blunt, which can prevent damage to the vascular system. In some embodiments, the distal tip 34 may be located at the distal end of the core wire 48, and / or the distal end of the core wire 48 may be formed monolithically as a single unit. Additionally or alternatively, in some embodiments, the distal tip 34 may be coupled to the distal end of the coil 42.

[0038] Referring here to Figures 4A-4C, in some embodiments, the core wire 48 may be offset from the axis 44 and / or the plane, which may facilitate blood flow to the catheter assembly 12 and / or fluid injection into the vascular system along the axis 44 and the central portion of the coil 42 and / or the central portion of the catheter 16. In some embodiments, the core wire 48 offset from the axis 44 may be coupled to the coil 42 at one or more points.

[0039] Referring here to Figures 5A-5B, in some embodiments the vascular access device 32 may include an elongated strip 55 extending through the coil 42. In some embodiments, each of the loops 46 may include a distal end 56 and a proximal end 58. In some embodiments, the distal end 56 of each loop 46 and the proximal end 58 of each loop 46 are in contact with the elongated strip 55. In some embodiments, the elongated strip 55 may be linear and / or aligned with the axis 44. In some embodiments, the elongated strip 55 may provide structural support to the vascular access device 32. In some embodiments, the elongated strip 55 may extend along all or part of the coil 42. In some embodiments, the elongated strip 55 may be located on the top, bottom, or side of the vascular access device 32.

[0040] In some embodiments, the distal tip 34 may be rounded or blunt. In some embodiments, the distal tip 34 may be located at the distal end of the elongated strip 55 and / or may be formed integrally with the distal end of the elongated strip 55 as a single unit. Additionally or alternatively, in some embodiments, the distal tip 34 may be coupled to the distal end of the coil 42.

[0041] Referring here to Figures 6A–6E, in some embodiments, the vascular access device 32 may include a plurality of support beams 60 extending between the coils 42. In some embodiments, a first set of support beams 60a may be arranged along a first line parallel to the axis 44. In some embodiments, a second set of support beams 60b may be arranged along a second line parallel to the axis 44. In some embodiments, the first line may be spaced apart from the second line. In some embodiments, as shown in Figures 6A–6E, the first line may be 180 degrees apart from the second line.

[0042] In some embodiments, a third set of support beams 60c may be arranged along a third line parallel to the axis 44. In some embodiments, the first, second, and third lines may be evenly spaced around the circumference of the coil 42. In some embodiments, the full turn of the coil 42 is located between the next adjacent support beams of the first set of support beams 60a. In some embodiments, the full turn of the coil 42 is located between the next adjacent support beams of the second set of support beams 60b. In some embodiments, the full turn of the coil 42 is located between the next adjacent support beams of the third set of support beams 60c.

[0043] In some embodiments, at least a portion of the vascular access device 32 may not include a core wire 48 that can facilitate blood flow through the vascular access device 32 to the catheter 16. In some embodiments, a support beam 60 may be welded to the coil 42.

[0044] Referring here to Figures 7A-7D, in some embodiments, the core wire 48 may include one or more gaps 68 along the length of the coil 42. In some embodiments, a particular gap 68 of the core wire 48 may be located in the distal opening 53 of the catheter 16. In some embodiments, one or more ends of the core wire 48 may be bent toward the coil 42 and / or coupled to the coil 42. In some embodiments, the gap 68 may correspond to locations where high shear stress on red blood cells and susceptibility to hemolysis are expected.

[0045] Referring here to Figure 8, the bar graph shows the mean blood collection rate ratio to 21G UT ("BDVACUTANER® ULTRATOUCH®") and the mean maximum shear ratio on blood cells to 21G UT ("BDVACUTANER® ULTRATOUCH®") in a particular vascular access system having a coil 42 containing a flat wire wound around an axis 44 to form a loop 46, another particular vascular access system having a coil 42 containing a cylindrical wire wound around an axis 44 to form a loop 46, and another particular vascular access system without a core wire 48, according to several embodiments.

[0046] Referring here to Figures 9A-9D, in some embodiments, the coil 42 may include a plurality of other loops 62. In some embodiments, the other loops 62 may be adjacent to loop 46. In some embodiments, each of the other loops 62 of coil 42 may contact the next adjacent loop of the other loop 62 around the circumference of the next adjacent loop of the other loop 62. In some embodiments, the pitch of coil 42 may vary from loop 46 having an open pitch to the other loops 62 having a closed pitch. In some embodiments, loop 46 and the other loops 62 may be formed monolithically as a single unit. In some embodiments, a gap 68 in the core wire 48 may be located within the other loops 62. In some embodiments, the core wire 48 may be adjacent to or adjacent to the proximal end of the other loops 62 and / or be re-started and / or coupled to a coil 42.

[0047] Referring here to Figures 10A to 10F, in some embodiments, the pitch of the coil 42 may vary along the length of the coil 42. In some embodiments, for example, as shown in Figure 10A, the pitch may be smaller at the ends of the coil 42. In some embodiments, the pitch may be smaller at the ends of the coil 42 and / or one or more other parts between the ends. In some embodiments, the other parts of the coil 42 may be evenly spaced, for example, as shown in Figure 10C. In some embodiments, for example, as shown in Figure 10B, the pitch of the coil 42 may be constant along the length of the coil. In some embodiments, the pitch may be larger, or the loops 46 of the coil 42 may be more spaced in areas of high shear stress.

[0048] In some embodiments, the distal end of the core wire 48 may be spaced apart from the distal tip 34 of the vascular access device 32, which may facilitate fluid flow through the distal tip of the vascular access device 32. In some embodiments, the distal tip 34 may be formed by a coil 42.

[0049] Referring here to Figure 11, in some embodiments, another vascular access instrument 70 configured to be inserted through a vascular access device such as a catheter assembly 12 may include a distal end 72 which may include a tubular element 74. In some embodiments, the tubular element 74 may include one or more holes 76. In some embodiments, the other vascular access instrument may include a wire 78. In some embodiments, the other vascular access instrument may include a connector 80 positioned between the tubular element 74 and the wire 78. In some embodiments, the connector 80 may include one or more other holes 82. In some embodiments, the distal end of the tubular element may be closed.

[0050] Referring here to Figures 12A-12B, 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 proximal end of the vascular access instrument 32 may be connected 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 a retracted position and an advanced position.

[0051] 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 device for advancing an instrument, A housing having a distal end configured to connect to a needleless connector, A blood collection device adapter coupled to the housing, wherein the housing defines a flow path from the distal end to the blood collection device adapter, A vascular access device configured to be movably positioned within a portion of the aforementioned flow path and to be inserted via a vascular access device, A coil formed by a flat wire wound around an axis, forming a first set of multiple loops, A first core wire extending through the coil, wherein the distal end of the first core wire is coupled to the coil, the proximal end of the vascular access device includes the proximal end of the first core wire, and the proximal end of the first core wire is fixed within the housing, A second core wire located distal to the first core wire, the proximal end of the second core wire being coupled to the coil, A vascular access device having, A device for advancing an instrument, equipped with the following features.

2. The instrument advancing device according to claim 1, wherein each of the first plurality of loops of the coil is spaced apart from the next adjacent loop of the first plurality of loops, defining a plurality of fluid paths between the adjacent loops, and the coil forms an internal fluid path extending along the axis toward the proximal end of the coil.

3. The device advancing device according to claim 1, wherein the first core wire and the second core wire are cylindrical.

4. The instrument advancing device according to claim 1, wherein the first core wire and the second core wire are flat.

5. The instrument advancing device according to claim 1, wherein the first core wire and the second core wire are aligned with the axis.

6. The instrument advancing device according to claim 1, wherein the first core wire and the second core wire are offset from the axis.

7. The instrument advancing device according to claim 6, wherein the flat wire includes a first side and a second side opposite to the first side, the first side forming the outer surface of the coil, the second side forming the inner surface of the coil, and the core wire is coupled to the inner surface of the coil.

8. The instrument advancing device according to claim 1, further comprising an elongated strip extending through the coil, wherein each of the first plurality of loops includes a distal end and a proximal end, the distal end and the proximal end in contact with the elongated strip.

9. The instrument advancing device according to claim 1, further comprising a plurality of support beams extending between the coils in the portion of the coil between the distal end of the first core wire and the proximal end of the second core wire, wherein a first set of the plurality of support beams is arranged along a first line parallel to the axis, a second set of the plurality of support beams is arranged along a second line parallel to the axis, and the first line is spaced apart from the second line.

10. The instrument advancing device according to claim 9, wherein the first line is 180 degrees away from the second line.

11. The instrument advancing device according to claim 9, wherein a third set of the plurality of support beams is arranged along a third line parallel to the axis, and the first line, the second line, and the third line are evenly spaced around the circumference of the coil.

12. The instrument advancing device according to claim 11, wherein the complete twist of the coil is positioned between the next adjacent support beam of the first set, the next adjacent support beam of the second set, and the next adjacent support beam of the third set.

13. The device advancing device according to claim 1, wherein the coil includes a second plurality of loops, the second plurality of loops are adjacent to the first plurality of loops, and each of the second plurality of loops of the coil contacts the next adjacent loop of the second plurality of loops along the circumference of the next adjacent loop of the second plurality of loops.

14. The device advancing device according to claim 13, wherein the coil includes a third plurality of loops adjacent to the second plurality of loops, and each of the third plurality of loops of the coil is spaced apart from the next adjacent loop of the third plurality of loops, defining a plurality of fluid paths between the adjacent loops.

15. A vascular access system, A catheter assembly comprising a catheter adapter and a catheter extending distally from the catheter adapter, The instrument advancement device described in any one of claims 1-14 is coupled to the catheter assembly, A vascular access device movably disposed within the flow channel, wherein the device advancement device is configured to advance the vascular access device from a stored position to an advanced position beyond the distal end of the catheter, Includes, A vascular access system wherein the distal end of the catheter includes a distal opening, the coil extends through the distal opening of the catheter in response to the vascular access device being in the forward position, and the plurality of loops extend from the distal tip of the vascular access device to the distal end of the catheter.

16. The vascular access system according to claim 15, wherein the distal end of the catheter is provided with a plurality of diffuser holes.

17. The blood collection device coupled to the blood collection device adapter is the vascular access system according to claim 15.

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