Reduced-vein-injury tubular devices and related apparatus and methods

Abstract

A delivery device to deliver a tubular instrument into a catheter extending distally from a catheter adapter. The delivery device can include a housing configured to couple to the catheter adapter. The delivery device can include a tubular instrument configured to be inserted through the catheter. The tubular instrument can include a distal end, a proximal end, and a lumen extending between the distal end and the proximal end. The distal end can include a distal tip that can be closed. The proximal end can be secured within the housing. The tubular instrument can be configured to be advanced distally relative to the housing. A portion of the distal end proximal to the distal tip can include a first material and can be more rigid than the distal end including a second material. The first material can be stiffer than the second material.

Description

Background Technology

[0001] Catheters are commonly used to deliver fluids into a patient's vascular system. For example, catheters can be used to infuse saline solutions, various medications, or total parenteral nutrition. Catheters can also be used to draw blood from a patient.

[0002] The catheter may include a peripheral venous (“IV”) catheter. In this case, the catheter may be mounted on a guide needle with a sharp distal tip. The catheter and guide needle may be assembled such that the distal tip of the guide needle extends beyond the distal tip of the catheter, and the bevel of the needle faces upward away from the patient’s skin. The catheter and guide needle are typically inserted into the patient’s vascular system through the skin at a shallow angle.

[0003] To verify proper placement of the guide needle and / or catheter in a blood vessel, clinicians typically confirm the presence of a "flashback" of blood in the flashback chamber of the catheter assembly. Once needle placement is confirmed, the clinician can temporarily block flow in the vascular system and remove the needle, leaving the catheter in place for future blood draws or fluid infusions.

[0004] Drawing blood using a catheter is difficult, which can be due to several reasons, especially when the catheter remains in the vascular system for more than a day. When a catheter is inserted into a patient for an extended period, the catheter or vein can become more prone to narrowing, collapsing, twisting, becoming clogged with debris (such as fibrin or platelet clots), and the catheter tip can adhere to the vascular system. Therefore, catheters are typically used to collect blood samples while in place, but are less frequently used to collect blood samples during the catheter's residence time. Consequently, when a blood sample is needed, an additional needle prick is usually required to provide venous access for blood collection, which can be painful for the patient and result in higher material costs.

[0005] In some cases, tubular instruments can be used to access a patient's vascular system via a catheter to avoid additional needle pricks. Tubular instruments can be inserted into the vascular system through a catheter to prolong the catheter's lifespan and allow blood to be drawn through the catheter without additional needle pricks. In some embodiments, tubular instruments extending through a catheter may come into contact with veins and cause damage.

[0006] The subject matter claimed herein is not limited to embodiments that address any shortcomings or operate only in environments such as those described above. Rather, this background is provided merely to illustrate an example technical field in which some of the implementations described herein can be practiced. Summary of the Invention

[0007] This disclosure generally relates to tubular instruments and related apparatus and methods. In some embodiments, a delivery device for delivering a tubular instrument into a catheter can help increase the catheter's residence time. More specifically, when a catheter is damaged or nearing the end of its lifespan, the delivery device can be used to advance the tubular instrument into and / or beyond the distal tip of the catheter for fluid infusion or blood aspiration. In some embodiments, the tubular instrument can be configured to reduce damage to the patient's vein upon contact with it, compared to prior art devices.

[0008] In some embodiments, by utilizing existing vascular access devices that remain within the vascular system, the delivery device can provide needle-free delivery of a tubular instrument to a patient's vascular system for blood collection, fluid delivery, patient or device monitoring, or other clinical needs. In some embodiments, the delivery device may include a tubular instrument that may include axial structural stiffness to facilitate forward movement of the tubular instrument without bending. In some embodiments, the tubular instrument may also have an inner diameter to facilitate high flow rates for fluid infusion and / or blood aspiration. Unlike tubular instruments in the prior art, while providing axial structural stiffness and high flow rates, the tubular instrument can also provide gentle, soft contact between the tubular instrument and the vein wall, which can reduce damage to the vein wall. In some embodiments, the advantages of the tubular instrument may arise from its multi-material structure.

[0009] In some embodiments, the delivery device may include a housing configured to be coupled to a catheter adapter. In some embodiments, the catheter may extend distally from the catheter adapter. In some embodiments, the delivery device may include a tubular instrument configured for insertion through the catheter. In some embodiments, the tubular instrument may include a distal end, a proximal end, and a lumen extending between the distal and proximal ends. In some embodiments, the proximal end of the tubular instrument may be secured within the housing. In some embodiments, the tubular instrument may be disposed within the housing. In some embodiments, the tubular instrument may be configured to advance distally relative to the housing.

[0010] In some embodiments, the distal end of the tubular device may include a distal tip that is closable. In some embodiments, the distal end may be closable to increase the tubular device's resistance to distal tip occlusion and thrombosis. Therefore, in some embodiments, the catheter assembly through which the tubular device extends may be flushed less frequently, for example, once a week, rather than, for example, once per clinician shift.

[0011] In some embodiments, the distal portion near the distal tip may include a first material. In some embodiments, the distal tip may include a second material. In some embodiments, the hardness of the first material may be greater than the hardness of the second material. In some embodiments, the distal tip may include a chamfered edge or a rounded edge. In some embodiments, the second material and / or the edge of the distal tip, such as a chamfered edge or a rounded edge, may reduce damage to the patient's vein when the distal end of the tubular instrument comes into contact with the patient's vein.

[0012] In some embodiments, the tubular instrument may include one or more holes within the distal end and proximal to the distal apex. In some embodiments, the holes may reduce the stiffness of the distal end of the tubular instrument. In some embodiments, the holes may include a first hole and a second hole proximal to the first hole. In some embodiments, the diameter of the first hole may be larger than the diameter of the second hole. In some embodiments, each of these holes may be rectangular. In these embodiments, the length of each of these holes may be parallel to the longitudinal axis of the tubular instrument, and the width of each of these holes may be perpendicular to the longitudinal axis of the tubular instrument.

[0013] In some embodiments, an elongated rigid member may be disposed within a tubular device. In some embodiments, the rigid member may include a specific first material. In some embodiments, the distal end of the tubular device may include a specific second material. In some embodiments, the hardness of the specific first material may be greater than the hardness of the specific second material. In some embodiments, the elongated rigid member may include a solid core disposed within the tubular device. In some embodiments, the elongated rigid member may include a wire surrounded by a spring. In some embodiments, the elongated rigid member may include a rounded distal end. In some embodiments, the elongated rigid member may include a tube coupled to a blood collection device. In some embodiments, after the tubular device has been moved forward within a vein, the elongated rigid member may retract proximally relative to the tubular device.

[0014] In some embodiments, the distal end of the tubular device may include a distal opening, and the most distal portion of the distal end of the tubular device may include a flap. In some embodiments, the flap may be configured to fold over the tip of an elongated rigid member extending through the distal opening. In some embodiments, the distal end of the tubular device may include an insert. In some embodiments, the insert may include a distal opening, and the most distal portion of the insert may include a flap.

[0015] In some embodiments, the distal end of the tubular device includes a first annular layer and a second annular layer. In some embodiments, the first annular layer may be disposed within the second annular layer. In some embodiments, the first annular layer may include a specific first material. In some embodiments, the second annular layer may include a specific second material. In some embodiments, the specific first material may have a greater hardness than the second material.

[0016] In some embodiments, at a first location along the length of the tubular instrument, the thickness of the second annular layer may be greater than the thickness of the first annular layer. In some embodiments, at a second location along the length of the tubular instrument, the thickness of the second annular layer may be the same as the thickness of the first annular layer. In some embodiments, the second location may be proximal to the first location. In some embodiments, at a third location along the length of the tubular instrument, the thickness of the second annular layer may be less than the thickness of the first annular layer. In some embodiments, the third location may be proximal to the second location.

[0017] In some embodiments, the distal end of the tubular device may include an annular wall and one or more strips co-extruded within the annular wall. In some embodiments, the strips may include a specific first material. In some embodiments, the annular wall may include a specific second material. In some embodiments, the specific first material may include a material with a greater hardness than the specific second material. In some embodiments, the strips may be aligned with the longitudinal axis of the tubular device. In some embodiments, the outer periphery of each of these strips may be surrounded by the annular wall. In some embodiments, each of these strips is uniformly spaced around the annular wall.

[0018] In some embodiments, the annular wall may include a first annular segment and a second annular segment distal to the first annular segment. In some embodiments, the hardness of the first annular segment may be greater than the hardness of the second annular segment. In some embodiments, the first annular segment may include a specific first material. In some embodiments, the second annular segment may include a specific second material. In some embodiments, the hardness of the first material may be greater than the hardness of the second material.

[0019] In some embodiments, the thickness of the first annular segment may be greater than the thickness of the second annular segment. In some embodiments, the annular wall may include a third annular segment between the first annular segment and the second annular segment. In some embodiments, the third annular segment may be close to the first annular segment and the second annular segment.

[0020] In some embodiments, the housing may include a proximal end, a distal end, and a slot. In some embodiments, the delivery device may include a guide feature disposed within the housing. In some embodiments, the guide feature may extend through the slot. In some embodiments, the guide feature may include a channel. In some embodiments, the channel may generally be generally U-shaped. In some embodiments, the instrument may be tubular, disposed within the housing, and extend through the channel. In some embodiments, in response to movement of the guide feature along the slot in a distal direction, the instrument may move through the channel, and a first end of the instrument may move forward in a distal direction. In some embodiments, a second end of the instrument may be stationary relative to the housing.

[0021] In some embodiments, the delivery device may include a housing configured to be coupled to a catheter adapter. In some embodiments, a tubular instrument may be configured to be inserted through a catheter. In some embodiments, the tubular instrument may include a distal end, a proximal end, and a lumen extending between the distal and proximal ends. In some embodiments, the distal end of the tubular instrument may include a distal tip. In some embodiments, the distal end may be closed.

[0022] In some embodiments, the tubular instrument may include one or more holes within the distal end and proximally at the distal apex. In some embodiments, the holes may include a first hole and a second hole proximally to the first hole. In some embodiments, the diameter of the first hole may be larger than the diameter of the second hole. In some embodiments, each of these holes may be rectangular. In some embodiments, the length of each of these holes may be parallel to the longitudinal axis of the tubular instrument. In some embodiments, the width of each of these holes may be perpendicular to the longitudinal axis of the tubular instrument.

[0023] It should be understood that the foregoing overview and the following detailed description are illustrative and exemplary, and not limiting as claimed. It should be understood that the various embodiments are not limited to the arrangements and means shown in the accompanying drawings. It should also be understood that, unless so required, these embodiments may be combined, or other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of this disclosure. Therefore, the following detailed description is not limiting. Attached Figure Description

[0024] The exemplary embodiments will be described and explained in additional specific detail using the accompanying drawings, in which:

[0025] Figure 1A This is a top perspective view of an example tubular device according to some embodiments;

[0026] Figure 1B According to some embodiments Figure 1A A side view of the distal end of an example tubular instrument;

[0027] Figure 1C According to some embodiments Figure 1A Longitudinal cross-sectional view of the distal end of the tubular instrument;

[0028] Figure 1D According to some embodiments Figure 1A A longitudinal cross-sectional view of the distal end of a tubular instrument, showing an example slender rigid member disposed within the tubular instrument;

[0029] Figure 1E It is according to some embodiments along Figure 1A 1E-1E line Figure 1A A cross-sectional view of the distal end of a tubular instrument;

[0030] Figure 1F According to some embodiments Figure 1A A partial sectional view of the distal end of a tubular instrument;

[0031] Figure 1G According to some embodiments Figure 1A Another example of a tubular instrument: a superior perspective view of the distal end;

[0032] Figure 1H According to some embodiments Figure 1A Another example of a tubular instrument, a superior perspective view of the distal end;

[0033] Figure 1I According to some embodiments Figure 1A Another example of a tubular instrument: a superior perspective view of the distal end;

[0034] Figure 2A This is a top perspective view of another example tubular device according to some embodiments;

[0035] Figure 2B According to some embodiments along Figure 2A 2B-2B line Figure 2A A cross-sectional view of a tubular instrument;

[0036] Figure 2C According to some embodiments along Figure 2A Line 2C-2C Figure 2A A cross-sectional view of a tubular instrument;

[0037] Figure 2D According to some embodiments along Figure 2A 2D-2D lines Figure 2A A cross-sectional view of a tubular instrument;

[0038] Figure 3A This is a longitudinal cross-sectional view of the example distal end of another example tubular device according to some embodiments;

[0039] Figure 3B According to some embodiments Figure 3A A transverse cross-sectional view of a tubular instrument;

[0040] Figure 4A This is a top perspective view of another example tubular device according to some embodiments;

[0041] Figure 4B It is according to some embodiments along Figure 4A The line 4B-4B cut Figure 4A A cross-sectional view of a tubular instrument;

[0042] Figure 5 This is a top perspective view of another example tubular device according to some embodiments;

[0043] Figure 6A This is a top perspective view of another example tubular device according to some embodiments;

[0044] Figure 6B According to some embodiments Figure 6A An example of a tubular instrument, showing the upper distal perspective view;

[0045] Figure 6C According to some embodiments Figure 6B Longitudinal cross-sectional view of the far end;

[0046] Figure 6D According to some embodiments Figure 6A Another example of a tubular instrument, a superior perspective view of the distal end;

[0047] Figure 6E According to some embodiments Figure 6A Another example of a tubular instrument: a superior perspective view of the distal end;

[0048] Figure 6F According to some embodiments Figure 6E Longitudinal cross-sectional view of the far end;

[0049] Figure 6G According to some embodiments Figure 6A Another example of a tubular instrument: a superior perspective view of the distal end;

[0050] Figure 7A This is a longitudinal cross-sectional view of another exemplary tubular device and another example elongated rigid member according to some embodiments, each in a first position;

[0051] Figure 7B According to some embodiments Figure 7A Longitudinal cross-sectional views of tubular instruments and slender rigid components, each in the second position;

[0052] Figure 7C It is a longitudinal cross-sectional view of a tubular device in a first position according to some embodiments and another exemplary elongated rigid member;

[0053] Figure 7D It is in the second position according to some embodiments. Figure 7C Longitudinal cross-sectional view of tubular instruments and slender rigid components;

[0054] Figure 7E This is a partial cross-sectional view of a tubular device in a first position according to some embodiments and another exemplary elongated rigid member;

[0055] Figure 7F It is in the second position according to some embodiments. Figure 7E Longitudinal cross-sectional view of tubular instruments and slender rigid components;

[0056] Figure 7G It is a longitudinal cross-sectional view of a tubular device in a first position according to some embodiments and an elongated rigid member according to another example;

[0057] Figure 7H It is in the second position according to some embodiments. Figure 7G Longitudinal cross-sectional view of tubular instruments and slender rigid components;

[0058] Figure 8A This is a top perspective view of another example delivery device coupled to an example catheter assembly according to some embodiments, showing another exemplary tubular instrument in a proximal position;

[0059] Figure 8B It is connected to the catheter assembly according to some embodiments. Figure 8A The upper perspective view of the delivery device shows the tubular instrument in a distal position;

[0060] Figure 8C According to some embodiments Figure 8A The upper perspective view of the delivery device shows the tubular instrument in a proximal position;

[0061] Figure 8D According to some embodiments Figure 8A The upper perspective view of the delivery device shows the tubular instrument in a distal position;

[0062] Figure 9A This is a top perspective view of another example delivery device according to some embodiments;

[0063] Figure 9B According to some embodiments Figure 9A A cross-sectional view of the delivery device;

[0064] Figure 9C This is a cross-sectional view of an example catheter system according to some embodiments, showing a tubular instrument in an advanced position;

[0065] Figure 10A This is a top perspective view of another exemplary delivery device according to some embodiments, showing an example tubular instrument and an example elongated rigid member, each in a fully retracted position;

[0066] Figure 10B According to some embodiments Figure 10A The longitudinal cross-sectional view of the delivery device shows the tubular instrument and the slender rigid member, each in the fully retracted position;

[0067] Figure 10C According to some embodiments Figure 10A The upper perspective view of the delivery device shows tubular instruments and slender rigid components, each in a fully forward-positioned position;

[0068] Figure 10D According to some embodiments Figure 10A The longitudinal cross-sectional view of the delivery device shows the tubular instrument and the slender rigid member, each in the fully forward-moved position;

[0069] Figure 10E According to some embodiments Figure 10A The upper perspective view of the delivery device shows the tubular instrument in the fully forward position and the slender rigid member in the partially retracted position.

[0070] Figure 10F According to some embodiments Figure 10A The longitudinal cross-sectional view of the delivery device shows the tubular instrument in the fully forward position and the slender rigid member in the partially retracted position.

[0071] Figure 11A This is a top view of another example delivery device according to some embodiments, showing another example tubular instrument and an example support tube in the fully retracted position;

[0072] Figure 11B According to some embodiments Figure 10A A top view of the delivery device, showing the tubular instrument in a partially forward-positioned position; while

[0073] Figure 11C According to some embodiments Figure 10A A top view of the delivery device, showing the instrument in its fully forward-moved position. Detailed Implementation

[0074] Now for reference Figure 1A-1CIn some embodiments, a delivery device for delivering the tubular instrument 10 into the catheter can help increase the catheter's residence time. More specifically, when the catheter is damaged or nearing the end of its lifespan, the delivery device can be used to advance the tubular instrument 10 into and / or beyond the distal tip of the catheter for fluid infusion or blood aspiration. In some embodiments, the tubular instrument 10 can be configured to reduce damage to the patient's vein upon contact with it, compared to prior art devices.

[0075] In some embodiments, by utilizing existing vascular access devices that remain within the vascular system, the delivery device can provide needle-free delivery of the tubular device 10 to a patient's vascular system for blood collection, fluid delivery, patient or device monitoring, or other clinical needs. In some embodiments, the tubular device 10 may have an inner diameter to facilitate high flow rates for fluid infusion and / or blood aspiration. Unlike tubular devices in the prior art, the tubular device 10 provides axial structural stiffness and high flow rates while also providing gentle, soft contact between the tubular device 10 and the vein wall, which can reduce damage to the vein wall. In some embodiments, the advantages of the tubular device 10 may arise from its multi-material structure.

[0076] In some embodiments, the tubular device 10 may include a distal end 12, a proximal end 14, and a lumen 16 extending between the distal end 12 and the proximal end 14. In some embodiments, the lumen 16 may extend through the proximal end 14. In some embodiments, the distal end 12 of the tubular device 10 may include a distal tip 18, which may be closed. In some embodiments, the distal tip 18 may be closed to increase the tubular device's resistance to obstruction and thrombosis at the distal tip 18. Therefore, in some embodiments, the catheter assembly through which the tubular device 10 extends may be flushed less frequently, for example, once a week, rather than, for example, once per clinician shift.

[0077] In some embodiments, the portion of distal end 12 near the distal tip 18 may include a first material. In some embodiments, the distal tip 18 may include a second material. In some embodiments, the hardness of the first material may be greater than the hardness of the second material, such that the rigidity of the portion of distal end 12 is greater than that of the distal tip 18. In some embodiments, the second material may provide a softer contact surface with the vein. In some embodiments, the distal tip 18 may be rounded and / or smooth. In some embodiments, the first material may provide rigidity to the tubular instrument 10, which may facilitate the advancement of the tubular instrument 10 through the catheter assembly and beyond the distal tip of the catheter without buckling. In some embodiments, the distal tip 18 may include the most distal surface of distal end 12. In some embodiments, the distal tip 18 may be aligned with the lumen 16 and close the distal end of the lumen 16.

[0078] In some embodiments, the first material may include a thermoplastic. In some embodiments, the first material may include an elastomer, polyurethane, nylon, polyimide, silicone, or another suitable polymer. In some embodiments, the first material may include a metal. In some embodiments, the second material may include a thermoplastic. In some embodiments, the second material may include polypropylene, polyurethane, nylon, polyimide, silicone, or another suitable polymer. In some embodiments, the second material may be similar to the first material but with a lower density. In some embodiments, the tubular device 10 may be integrally formed or integrally formed as a single unit.

[0079] In some embodiments, the tubular device 10 may include one or more holes 20 within the distal end 12 and / or proximal to the distal apex 18. In some embodiments, the holes 20 may reduce the stiffness of the distal end 12 of the tubular device 10. In some embodiments, the holes 20 may be arranged in various patterns. For example, the holes 20 may include rows of straight lines that may be offset from each other.

[0080] Now for reference Figure 1D In some embodiments, an elongated rigid member 22 may be disposed within the tubular device 10. In some embodiments, the rigidity of the elongated rigid member 22 may be greater than that of the distal end 12 and / or the distal tip 18. In some embodiments, the elongated rigid member 22 may comprise a first material or another suitable material. In some embodiments, the distal end 12 and / or the distal tip 18 may comprise a second material or another suitable material.

[0081] In some embodiments, the elongated rigid member 22 may include a solid core disposed within the tubular device, such as... Figure 1D As shown. In some embodiments, the elongated rigid member 22 may include a rounded distal end that may approach and contact the distal tip 18. In some embodiments, after the tubular instrument 10 has been moved forward within the vein, the elongated rigid member 22 may retract proximally relative to the tubular instrument 10.

[0082] Now for reference Figure 1E-1F In some embodiments, the distal end 12 of the tubular device 10 may include a first annular layer 24 and a second annular layer 26. In some embodiments, the first annular layer 24 may be disposed within the second annular layer 26. In some embodiments, the second annular layer 26 may surround the first annular layer 24. In some embodiments, the orifice 20 may be in fluid communication with the lumen 16. In some embodiments, the orifice 20 may extend through the first annular layer 24 and the second annular layer 26.

[0083] In some embodiments, the first annular layer 24 may include a first material or another suitable material. In some embodiments, the second annular layer 26 may include a second material or another suitable material. In some embodiments, the first annular layer 24 may have a greater hardness or stiffness than the second annular layer 26.

[0084] In some embodiments, the first annular layer 24 and the second annular layer 26 may be co-extruded concentrically. In some embodiments, the first annular layer 24 may have a uniform or variable thickness along its length. In some embodiments, the second annular layer 26 may have a uniform or variable thickness along its length.

[0085] In some embodiments, the first annular layer 24 and / or the second annular layer 26 may extend from the distal tip 18 along all or part of the length of the tubular instrument 10. In some embodiments, the distal tip 18 may include a closed portion of the first annular layer 24 and a closed portion of the second annular layer 26, which may contact each other. In some embodiments, the second annular layer 26 may increase the softness of the distal tip 18 that can contact the vein wall.

[0086] Now for reference Figure 1G The holes 20 can be arranged in various patterns within the distal end 12. In some embodiments, the holes 20 can be staggered along the distal-proximal direction.

[0087] Now for reference Figure 1H In some embodiments, the size of the aperture 20 may decrease along the proximal direction or along the direction away from the distal tip 18. In these and other embodiments, the aperture 20 may contribute to increased flexibility or suppleness of the tubular instrument 10 toward the distal tip 18. In some embodiments, the aperture 20 may include at least a first aperture 20a and a second aperture 20b proximal to the first aperture 20a. In some embodiments, the diameter of the first aperture 20a may be larger than the diameter of the second aperture. In some embodiments, the first aperture 20a and the second aperture 20b may be equidistant from the longitudinal axis 28 of the tubular instrument 10.

[0088] Now for reference Figure 1I In some embodiments, each of the holes 20 may be rectangular. In these embodiments, the length of each of the holes 20 may be parallel to the longitudinal axis 28 of the tubular instrument 10, and the width of each of the holes 20 may be perpendicular to the longitudinal axis 28 of the tubular instrument 10.

[0089] Now for reference Figure 2A-2D According to some embodiments, a portion of a tubular device 30 is shown. In some embodiments, the tubular device 30 may be similar to or equivalent to in one or more features and / or operations. Figure 1A-1IThe tubular device 10. In some embodiments, the tubular device 10 may include a first annular layer 24 and a second annular layer 26. In some embodiments, the stiffness of the tubular device 10 may increase in the proximal direction.

[0090] In some embodiments, at a first location along the length of the tubular device 10, the thickness of the second annular layer 26 may be greater than the thickness of the first annular layer 24, for example, as... Figure 2B As shown. In some embodiments, at a second location along the length of the tubular device 10, the thickness of the second annular layer 26 may be the same as the thickness of the first annular layer 24, for example, as Figure 2C As shown. In some embodiments, the second position may be proximal to the first position. In some embodiments, at a third position along the length of the tubular device 10, the thickness of the second annular layer 26 may be less than the thickness of the first annular layer 24, for example, as Figure 2D As shown. In some embodiments, the third position may be located near the second position.

[0091] Now for reference Figures 3A-3B According to some embodiments, a portion of a tubular device 32 is shown. In some embodiments, the tubular device 32 may be similar to or equivalent to in one or more features and / or operations. Figure 1A-1I 10 and / or tubular instruments Figure 2A-2D 30. Tubular instruments.

[0092] In some embodiments, the distal tip 18 of the tubular device 21 may be closed. In some embodiments, the distal end 12 of the tubular device 32 may include an annular wall 34 and one or more strips 36 co-extruded within the annular wall 34. In some embodiments, the strips 36 may include a first material or another suitable material. In some embodiments, the annular wall 34 may include a second material or another suitable material. In some embodiments, the strips 36 may have greater stiffness or rigidity than the annular wall 34, which may facilitate the advancement of the tubular device 32 through the catheter assembly and beyond the distal tip of the catheter without buckling.

[0093] In some embodiments, the strip 36 may be spaced apart from the distal tip 18, or may extend through the distal tip 18. In some embodiments, the strip 36 may be aligned with or parallel to the longitudinal axis 28 of the tubular device 32. In some embodiments, the outer periphery of each of the strips 36 may be surrounded by an annular wall 34. In some embodiments, the individual strips 36 may be evenly spaced around the annular wall 34.

[0094] In some embodiments, the annular wall 34 may include an inner surface and an outer surface. In some embodiments, the inner surface may be adjacent to the lumen 16 of the tubular device 32. In some embodiments, the inner surface may be cylindrical and / or the strip 36 may protrude to form ribs on the outer surface. In some embodiments, in addition to the ribs formed on the outer surface by the strip 36, the outer surface may be cylindrical. In some embodiments, the outer surface may be cylindrical and / or the strip 36 may protrude to form ribs on the inner surface. In some embodiments, in addition to the ribs formed on the outer surface by the strip 36, the outer surface may be cylindrical. In some embodiments, in addition to the ribs formed on the inner surface by the strip 36, the inner surface may be cylindrical.

[0095] Now for reference Figures 4A-4B According to some embodiments, a portion of a tubular device 38 is shown. In some embodiments, the tubular device 38 may be similar to or equivalent to one or more of the following in one or more features and / or operations: Figure 1A-1I 10. Tubular instruments Figure 2A-2D tubular instruments 30 and Figures 3A-3B The tubular device 32. In some embodiments, the outer surface of the distal end 12 of the tubular device 38 may include a plurality of grooves 40, which may enhance the flexibility of the distal end 12 near the distal tip 18. In some embodiments, the grooves 40 may include arcuate slots in fluid communication with the lumen 16. In some embodiments, the grooves 40 may extend around a portion of the outer circumference of the distal end 12.

[0096] Now for reference Figure 5 According to some embodiments, a tubular device 42 is shown. In some embodiments, the tubular device 42 may be similar to or equivalent to one or more of the following in one or more features and / or operations: Figure 1A-1I 10. Tubular instruments Figure 2A-2D 30 tubular instruments Figures 3A-3B tubular instruments 32 and Figures 4A-4B The tubular device 38. In some embodiments, the tubular device 42 may include a first annular segment 41 and a second annular segment 44 distal to the first annular segment 41. In some embodiments, the hardness of the first annular segment 41 may be greater than the hardness of the second annular segment 44. In some embodiments, the first annular segment 41 may include a first material or another suitable material. In some embodiments, the second annular segment 44 may include a second material or another suitable material. In some embodiments, the hardness of the first material may be greater than the hardness of the second material.

[0097] In some embodiments, the first annular segment 41 may be adjacent to the second annular segment 44, and there may be an abrupt change between the first annular segment 41 and the second annular segment 44, for example, by joining or another suitable method. In these embodiments, the first annular segment 41 and the second annular segment 44 may be joined together without a third annular segment 46. In some embodiments, the first annular segment 41 and the second annular segment 44 may be a continuous structure or formed via continuous extrusion.

[0098] In some embodiments, the tubular device 42 may include a third annular segment 46 between the first annular segment 41 and the second annular segment 44. In some embodiments, the third annular segment 46 may be adjacent to the first annular segment 41 and the second annular segment 44. In some embodiments, one or more of the first annular segment 41, the second annular segment 44, and the third annular segment 46 may extend inward from the outer surface of the tubular device 42 into the lumen 16.

[0099] In some embodiments, the third annular segment 46 may transition from the first annular segment 41 to the second annular segment 44. In some embodiments, the third annular segment 46 may have a hardness between that of the first annular segment 41 and the second annular segment 44. In some embodiments, the third annular segment 46 may include a joint that joins the first annular segment 41 to the second annular segment 44. In some embodiments, the joint may be formed via solvent bonding, adhesive bonding, forging, ultrasonic welding, tipping, or other suitable methods.

[0100] Now for reference Figure 6A According to some embodiments, a tubular device 48 is shown. In some embodiments, the tubular device 48 may be similar to or equivalent to one or more of the following in one or more features and / or operations: Figure 1A-1I 10. Tubular instruments Figure 2A-2D 30 tubular instruments Figures 3A-3B 32 tubular instruments Figures 4A-4B tubular instruments 38 and Figure 5 The tubular device 42. In some embodiments, the distal tip 18 of the tubular device 48 may include a distal opening 50.

[0101] Now for reference Figures 6B-6C In some embodiments, the distal tip 18 may include an annular chamfered edge 52. In some embodiments, the distal tip 18 may be made of a second material or another suitable material. In some embodiments, the portion of the distal end 12 near the distal tip 18 may be made of a first material or another suitable material. In some embodiments, the second material and / or the annular chamfered edge 52 may reduce damage to the patient's vein when the distal end 12 of the tubular instrument 48 comes into contact with a patient's vein.

[0102] Now for reference Figure 6D In some embodiments, the distal tip 18 may include a rounded edge 54. In some embodiments, the distal tip 18 may be made of a second material or another suitable material. In some embodiments, the portion of the distal end 12 near the distal tip 18 may be made of a first material or another suitable material. In some embodiments, the second material and / or the rounded edge 54 may reduce damage to the patient's vein when the distal end 12 of the tubular instrument 48 comes into contact with the patient's vein.

[0103] Now for reference Figure 6E-6F In some embodiments, the distal end 12 of the tubular device 48 may include a distal opening 50, and the most distal portion of the distal end 12 of the tubular device 48 may include a flap 56. In some embodiments, the flap 56 may be configured to fold over a particular elongated rigid member 22 (e.g., see...). Figure 1D At the tip of the particular elongated rigid member 22, the tip may extend through the distal opening 50. In some embodiments, the distal end 12 of the tubular device 48 may include an insert, such as... Figure 6E-6F As shown. In some embodiments, the insert may include a distal opening 50, and the distal portion of the insert may include a flap 56. In some embodiments, the insert may include a stepped surface and a portion proximal to the stepped surface, which may be inserted into the annular wall 34 of the tubular instrument 48.

[0104] Now for reference Figure 6G In some embodiments, the distal opening 50 may include a first arcuate shape 58a opposite to a second arcuate shape 58b. In some embodiments, the first arcuate shape 58a may engage the second arcuate shape 58b at the top and bottom of the distal end 12. In some embodiments, the first arcuate shape 58a and the second arcuate shape 58b may be tilted outward or laterally relative to each other to increase the size of the distal opening 50. In some embodiments, the distal opening 50 may be configured to increase the blood inlet area if the distal end 12 abuts against the vein wall 59.

[0105] Now for reference Figures 7A-7B According to some embodiments, a tubular device 60 is shown. In some embodiments, an elongated rigid member 22 may be disposed within the tubular device 60. In some embodiments, the elongated rigid member 22 may have greater rigidity than the tubular device 60 and have greater stiffness. In some embodiments, the tubular device 60 may be similar to or identical to one or more of the following in one or more aspects of its features and / or operation: Figure 1A-1I 10. Tubular instruments Figure 2A-2D 30 tubular instruments Figures 3A-3B 32 tubular instruments Figures 4A-4B 38. Tubular instruments Figure 5 tubular instruments 42 and Figure 6A-6G 48. Tubular instruments.

[0106] In some embodiments, the elongated rigid member 22 may include a wire 64 surrounded by a helical spring 66. In some embodiments, the elongated rigid member 22 may include a rounded distal end 68 which may be coupled to the wire 64. In some embodiments, the elongated rigid member 22 and the tubular instrument 60 may be moved together distally into the vein, such as... Figure 7A As shown. Figure 7B As shown, in some embodiments, in response to both the elongated rigid member 22 and the tubular device 60 being disposed within a vein, the elongated rigid member 22 may be moved further forward in the distal direction than the distal end 12 of the tubular device 60, or the tubular device 60 may be retracted proximally such that the elongated rigid member 22 extends distally beyond the distal end 12 of the tubular device 60.

[0107] Now for reference Figures 7C-7D The distal end 12 of the tubular device 60 may be closed. More specifically, in some embodiments, a portion of the distal end 12 aligned with the central axis of the tubular device 60 may be closed. In some embodiments, the tubular device 60 may include one or more holes 69 disposed on the side of the tubular device 60. In some embodiments, the holes 69 may extend through the wall of the tubular device 60 to provide fluid communication with the lumen 16. In some embodiments, the elongated rigid member 22 may, for example... Figure 7C The first position shown is, for example, Figure 7D The movement occurs between the second positions shown. In some embodiments, when the elongated rigid member 22 is in the first position, the elongated rigid member 22 can block the orifice 69 and prevent fluid from flowing into the tubular device 60. In some embodiments, when the elongated rigid member 22 is in the second position, the elongated rigid member 22 does not block the orifice 69.

[0108] In some embodiments, the elongated rigid member 22 may include a distal portion 71. In some embodiments, the second position may be distal to the first position, and / or the most distal portion of the distal portion 71 may contact the distal end 12 in the second position. In some embodiments, the distal portion 71 may have a larger outer diameter than the portion of the elongated rigid member 22 near the distal head 71 and proximal to the distal head 71. In some embodiments, the distal portion 71 may be located at the distal end of the elongated rigid member 22 and may be blunt to reduce the risk of the distal portion 71 damaging the tubular instrument 60.

[0109] In some embodiments, the distal portion 71 may extend across the entire width of the lumen 16. In some embodiments, the distal portion 71 may contact an opposing portion of the inner surface of the tubular instrument 60. In some embodiments, in response to movement of the elongated rigid member 22 between a first position and a second position, the distal portion 71 may remove a thrombus from the inner surface of the tubular instrument 60. In some embodiments, the elongated rigid member 22 may move from the first position to the second position for blood aspiration, facilitating blood flow through the orifice 69. In some embodiments, after blood aspiration is complete, the elongated rigid member 22 may be moved back from the second position to the first position, which may block the orifice 69.

[0110] Now for reference Figure 7E-7F In some embodiments, the distal portion 71 may include a channel 73 extending through the distal portion 71. For example, the channel 73 may extend from the base 75 of the distal portion 71 through one side of the distal portion 71. In some embodiments, the base 75 may be adjacent to the portion of the elongated rigid member 22 near the distal head 71 and proximal to the distal head 71. In some embodiments, the elongated rigid member 22 may, for example, Figure 7E The first position shown is, for example, Figure 7F Rotation between the second positions shown. In some embodiments, the elongated rigid member 22 may rotate about the central axis of the elongated rigid member 22 and / or the tubular device 60.

[0111] In some embodiments, in response to the elongated rigid member 22 being in a first position, the distal portion 71 may block the orifice 69 disposed on one side of the tubular instrument 60. In some embodiments, in response to the elongated rigid member 22 being in a second position, the proximal end of the channel 73 may be aligned with the orifice 69, thereby facilitating blood flow into the lumen 16 and the proximal end.

[0112] Now for reference Figure 7G-7H In some embodiments, the tubular device 60 may include one or more holes 69 disposed on a side of the tubular device 60. In some embodiments, the holes 69 may extend through the wall of the tubular device 60 to provide fluid communication with the lumen 16. In some embodiments, the elongated rigid member 22 may, for example... Figure 7G The movement occurs between a first position and a second position proximal to the first position. In some embodiments, when the elongated rigid member 22 is in the first position, the elongated rigid member 22 may block the hole 69. In some embodiments, when the elongated rigid member 22 is in the second position, the elongated rigid member 22 does not block the hole 69. In some embodiments, the elongated rigid member 22 may move proximal and be removed after being in the first position, for example, as shown. Figure 7H As shown, this can relieve the blockage of the orifice 69 and promote blood flow into the tubular instrument 60 and proximal flow for collection.

[0113] Now for reference Figures 8A-8D In some embodiments, the delivery device 70, which delivers the tubular instrument 72 into the catheter 74, can help prolong the residence time of the catheter 74. More specifically, when the catheter 74 is damaged or nearing the end of its lifespan, the delivery device 70 can be used to advance the tubular instrument 72 into the catheter 74 and / or beyond the distal tip 75 of the catheter 74 for fluid infusion or blood aspiration.

[0114] In some embodiments, the delivery device 70 may include a housing 76 configured to be coupled to the catheter adapter 80. In some embodiments, the delivery device 70 may include a tubular instrument 72. In some embodiments, the tubular instrument 60 may be similar to or equivalent to one or more of the following in one or more features and / or operations: Figure 1A-1I 10. Tubular instruments Figure 2A-2D 30 tubular instruments Figures 3A-3B 32 tubular instruments Figures 4A-4B 38. Tubular instruments Figure 5 42 tubular instruments Figure 6A-6G tubular instruments 48 and Figures 7A-7H The tubular device 60. In some embodiments, the proximal end 14 of the tubular device 72 may be secured within the housing 76. In some embodiments, the tubular device 72 may be disposed within the housing 76 and / or configured to be distally displaced relative to the housing 76.

[0115] In some embodiments, delivery device 70 may include any suitable delivery device. Non-limiting examples of delivery devices that can be used with tubular device 72 include U.S. Patent Application No. 16 / 037,246, filed July 17, 2018, entitled “EXTENSION HOUSING APROBE OR INTRAVENOUS CATHETER”; U.S. Patent Application No. 16 / 388,650, filed April 18, 2019, entitled “INSTRUMENT DELIVERY DEVICE HAVING A ROTARY ELEMENT”; U.S. Patent Application No. 16 / 037,319, filed July 17, 2018, entitled “MULTI-DIAMETER CATHETER AND RELATED DEVICES AND METHODS”; and U.S. Patent Application No. 16 / 037,319, filed July 3, 2019, entitled “DELIVERY DEVICE FOR A VASCULAR ACCESS”. Further descriptions of this invention can be found in U.S. Patent Application No. 16 / 502,541 entitled “SYRINGE-BASED DELIVERY DEVICE FOR A VASCULAR ACCESS INSTRUMENT”, filed November 21, 2019; U.S. Patent Application No. 62 / 794,437 entitled “CATHETER DELIVERY DEVICE AND RELATED SYSTEMS AND METHODS”, filed January 18, 2019; and U.S. Patent Application No. 62 / 830,286 entitled “VASCULAR ACCESS INSTRUMENT HAVING AFLUID PERMEABLE STRUCTURE AND RELATED DEVICES AND METHODS”, filed April 5, 2019, which are incorporated herein by reference in their entirety.

[0116] In some embodiments, in response to distal forward movement of the tubular device 72 relative to the housing 76, the delivery device 70 may be configured to introduce the tubular device 72 into a catheter assembly 78, which may include a catheter adapter 80 and a catheter 74. In some embodiments, when the tubular device 72 may be introduced into the catheter assembly 78, the tubular device 72 may enter a fluid path of the catheter assembly 78 and / or the tubular device 72 may extend through the catheter assembly 78 to access the patient's vascular system.

[0117] In some embodiments, catheter assembly 78 may include or correspond to any suitable catheter assembly, such as BDNEXIVA. TM Closed IV catheter system, BD CATHENA TM Catheter system, BD VENFLON TM Pro SafelyShielded IV Catheter System, BD NEOFLON TM IV casing system, BD INSYTE TM AUTOGUARD TM The BC ShieldedIV catheter system or another suitable catheter assembly. In some embodiments, catheter assembly 78 may be integrated with an integrated extension tube 82. In other embodiments, catheter assembly 78 may be non-integrated. In some embodiments, catheter 74 may include a peripheral venous catheter (PIVC), a peripherally inserted central catheter (PICC), or a midline catheter.

[0118] In some embodiments, the catheter 74 may be secured within and extend distally from the catheter adapter 80. In some embodiments, the catheter adapter 80 may include a distal end 84, a proximal end 86, and a lumen 88 extending through the distal end 84 and the proximal end 86. In some embodiments, a diaphragm may be disposed within the lumen of the catheter adapter 80. In some embodiments, the tubular instrument 72 may be delivered to the vascular system via the diaphragm or proximal to the diaphragm.

[0119] In some embodiments, the delivery device 70 may include an adapter 90 that may be coupled to the proximal end 86 of the conduit assembly 78 or another portion, such as a Y-type adapter. In some embodiments, the adapter 90 may include a sliding, threaded, or clamp male Luer adapter. In some embodiments, the adapter 90 may include a sliding, threaded, or clamp female Luer adapter. In some embodiments, the housing 76 may include a distal end 91 and a proximal end 93.

[0120] In some embodiments, the delivery device 70 may include a blood collection device 92. In some embodiments, the blood collection device 92 may include or correspond to a blood collection container. In some embodiments, the blood collection container may include a syringe, a vacuum blood collection tube 94, a small sample collection device, or any other container configured to collect blood from a patient by means of a pressure differential.

[0121] In some embodiments, the blood collection device may include a needle assembly that may include a needle 96 configured to receive a blood collection container. In some embodiments, the proximal tip of the needle 96 may be disposed within an elastomeric sheath. In some embodiments, in response to the blood collection container pushing the elastomeric sheath distally, the needle 96 may pierce the elastomeric sheath and insert into the blood collection container. In these and other embodiments, the blood collection container may include a vacuum blood collection tube 94.

[0122] In some embodiments, the blood collection device may include a retainer 98, which may be configured to receive a vacuum blood collection tube 94. In some embodiments, the blood collection device may include... A disposable retainer is available from Becton, Dickinson and Company, Franklin Lakes, New Jersey. In some embodiments, the blood collection device 92 may be coupled to and in fluid communication with the proximal end 14 of the tubular instrument 72. In some embodiments, the blood collection device 92 may be coupled to and in fluid communication with the proximal end 14 of the tubular instrument 72 via a fluid path extending through the needle 96 and the tubular instrument 72. In some embodiments, the blood collection device 92 may be coupled to the proximal end 14 of the tubular instrument 72 in any suitable manner (e.g., via integration, Luer connection, etc.).

[0123] In some embodiments, the delivery device 70 may include a forward movement element, such as a tab 100 or a gripper, which can be moved by a clinician to advance the tubular instrument 72 distally and / or retract the tubular instrument 72 proximally. In some embodiments, the forward movement element may be coupled to the tubular instrument 72. In some embodiments, the forward movement element may be rotatable. In some embodiments, the forward movement element may be movable along a slot 102 in the housing 76, such as... Figures 8A-8B As shown. In some embodiments, the tubular device 72 may extend and move through the proximal end 86 of the housing 76.

[0124] In some embodiments, in response to a significant residence time within the vascular system, the catheter 74 of the catheter assembly 78 may be prone to narrowing, collapse, kinking, or blockage by debris (e.g., fibrin or platelet clots), and the distal tip 75 of the catheter 74 may adhere to the vascular system. Therefore, drawing blood using the catheter 74 can be difficult. In some embodiments, the tubular device 72 may include or act as another catheter that provides access to the patient's vascular system without any additional needle insertion. Thus, in some embodiments, the tubular device 72 can be used for needleless blood collection and / or fluid infusion. In some embodiments, the tubular device 72 may include a pressure-sensitive valve that can reduce the sensitivity of the tubular device 10 to obstruction and thrombosis during blood collection and / or fluid infusion.

[0125] Now for reference Figures 9A-9C The delivery device 104 can be coupled to the catheter assembly 78. In some embodiments, the delivery device 104 can be directly coupled to the proximal end of the catheter adapter 80. In these and other embodiments, the catheter assembly 78 may include a straight or non-integrated catheter assembly. In some embodiments, the delivery device 104 can be coupled to an extension kit 106 of the catheter assembly 78, such as... Figure 9A As shown. In some embodiments, the delivery device 104 may be similar to or equivalent to in one or more features and / or operations. Figures 8A-8D Delivery device 70.

[0126] In some embodiments, the delivery device 104 may include a rotating element 108 and a housing 76. In some embodiments, in response to rotation of the rotating element 108 relative to the housing 76 in a first direction, the distal end 12 of the tubular instrument 72 may be moved forward beyond the distal tip 75 of the catheter 74. In some embodiments, in response to rotation of the rotating element 108 relative to the housing 76 in a first direction, the distal end 12 of the tubular instrument 72 may be positioned in a first position relative to the catheter assembly 78. Figure 9B An example of the first position is shown.

[0127] In some embodiments, in response to further rotation of the rotating element 108 relative to the housing 76 in a first direction, the distal end 12 of the tubular instrument 72 may be positioned in a second position relative to the catheter assembly 78. In some embodiments, the second position may be distal to the first position. Figure 9C An example of a second position is shown. In some embodiments, as the rotating element 108 rotates continuously, the tubular device 72 can move forward continuously in the distal direction.

[0128] In some embodiments, in response to rotation of the rotating element 108 relative to the housing 76 along a first direction, the distal end 12 of the tubular instrument 72 may be positioned at a first distance beyond the distal tip 75 of the catheter 74. In some embodiments, in response to further rotation of the rotating element 108 relative to the housing 76 along the first direction, the distal end 12 of the tubular instrument 72 may be positioned at a second distance beyond the distal tip 75 of the catheter 74. In some embodiments, the second distance may be greater than the first distance.

[0129] In some embodiments, the rotating element 108 may also rotate relative to the housing 76 in a second direction opposite to the first direction. In some embodiments, in response to the rotation of the rotating element 108 relative to the housing 76 in the second direction, the distal end 12 of the tubular device 72 may move proximally.

[0130] In some embodiments, the rotating element 108 may include a support surface or a groove 110 that may extend around at least a portion of the circumference of the rotating element 108. In some embodiments, the groove 110 may include a width approximately equal to or slightly larger than that of the tubular device 72, which may aid in the support of the tubular device 72.

[0131] Now for reference Figures 10A-10F In some embodiments, the delivery device 112 for delivering the catheter 74 into the catheter assembly 78 and / or a vein may include a housing 76, which may include a distal end 91, a proximal end 93, and a slot 102. In some embodiments, the delivery device 112 may include a tubular instrument 72. In some embodiments, the delivery device 112 may be similar to or equivalent to [other device / mechanism] in one or more features and / or operations. Figures 8A-8D Delivery device 70 and / or Figures 9A-9C Delivery device 104.

[0132] In some embodiments, the delivery device 112 may include a tubular instrument hub 114, which may be disposed within the housing 76. In some embodiments, the tubular instrument 72 may be secured to the tubular instrument hub 114. In some embodiments, the proximal end 14 of the tubular instrument 72 may be secured to the tubular instrument hub 114, for example, as... Figure 10B As shown. In some embodiments, a portion of the tubular instrument hub 114 may extend through the slot 102 and may move along the slot 102 to advance the tubular instrument 72 in a distal direction and / or retract the tubular instrument 72 in a proximal direction. In some embodiments, when the tubular instrument 72 is fully and / or partially advanced, the distal end 12 of the tubular instrument 72 may be positioned distal to the distal end 91 of the housing 76.

[0133] In some embodiments, the tubular device 72 may include a variable outer diameter and / or a variable inner diameter, as further described, for example, in U.S. Patent Application No. 16 / 037,319 entitled “MULTI-DIAMETER CATHETER AND RELATED DEVICES AND METHODS”, filed July 17, 2018, which is incorporated herein by reference in its entirety.

[0134] In some embodiments, a portion of the tubular instrument hub 114 extending through the slot 102 may be coupled to the blood collection device 92. In some embodiments, the portion of the tubular instrument hub 114 extending through the slot 102 may be directly coupled to the blood collection device. In some embodiments, the portion of the tubular instrument hub 114 extending through the slot 102 may be coupled to the blood collection device via an extension tube 116, which may include a connector located at the proximal end of the extension tube for connecting a blood sampling device to the extension tube 116. In some embodiments, the connector may be disposed on the portion of the tubular instrument hub 114 extending through the slot 102. In some embodiments, the fluid path of the delivery device 112 may include the tubular instrument 72, the tubular instrument hub 114, and the extension tube 116.

[0135] In some embodiments, the delivery device 112 may include an elongated rigid member 22, which may include a guidewire. In some cases, the elongated rigid member 22 may be used to facilitate the placement of the tubular instrument 72 into a patient's vein, which may result in less vein-related injury, and may support the tubular instrument 72 during advancement to prevent the tubular instrument 72 from passing through the catheter (e.g., Figures 8A-8B When the catheter 74 shown in 9C collapses or bends, the elongated rigid member 22 can retract when the tubular instrument 72 is successfully placed in the vein.

[0136] In some embodiments, an elongated rigid member 22 may be disposed within the tubular device 72. In some embodiments, the outer diameter of the elongated rigid member 22 may be smaller than the inner diameter of the tubular device 72, allowing fluid to flow into and / or through the tubular device 72. In some embodiments, fluid may flow between the outer surface of the elongated rigid member 22 and the inner surface of the tubular device 72. In some embodiments, a rigid member hub 118 may be disposed within the housing 76, proximal to the tubular device hub 114.

[0137] In some embodiments, the elongated rigid member 22 may be fixed to the rigid member hub 118. In some embodiments, the proximal end 120 of the elongated rigid member 22 may be fixed to the rigid member hub 118, for example, as... Figure 10BAs shown. In some embodiments, a portion of the rigid member hub 118 may extend through the slot 102 and may move along the slot 102 to move the guidewire forward in a distal direction and / or retract the guidewire in a proximal direction.

[0138] Figures 10A-10B The diagram illustrates the elongated rigid member 22 and the tubular device 72 in a fully retracted position before, according to some embodiments, the elongated rigid member 22 or the tubular device 72 is moved forward in a distal direction, or after the tubular device 72 and / or the elongated rigid member 22 has returned from the forward position. In some embodiments, when the rigid member hub 118 is fully retracted proximally to retract the elongated rigid member 22, the rigid member hub 118 may contact the proximal end of the slot 102 and / or the proximal end 86 of the housing 76, which may serve as a stop.

[0139] In some embodiments, the tubular instrument hub 114 and / or the rigid member hub 118 may each include a tab 100, which may be coupled to a portion of the tubular instrument hub 114 extending through the slot 102. In some embodiments, the tubular instrument hub 114 may include a diaphragm 122 that may prevent fluids such as blood from moving proximally to the tubular instrument hub 114. In some embodiments, an elongated rigid member 22 may extend through the diaphragm 122. In some embodiments, the delivery device 112 may include a blood control diaphragm 124, which may be disposed within the lumen of the delivery device 112.

[0140] In some embodiments, when the elongated rigid member 22 is fully and / or partially moved forward, the distal end 126 of the elongated rigid member 22 may be positioned distal to the distal end 91 of the housing 76. In some embodiments, when the tubular instrument 72 is fully moved forward in the distal direction and the guidewire is fully moved forward in the distal direction, the distal end 126 of the elongated rigid member 22 may be approximately aligned with the distal end 12 of the tubular instrument 72. In some embodiments, movement of the rigid member hub 118 in the distal direction may also cause movement of the tubular instrument hub 114 in the distal direction, thereby moving the elongated rigid member 22 and the tubular instrument 72 forward. In some embodiments, movement of the tubular instrument hub 114 in the proximal direction may also cause movement of the rigid member hub 118 in the proximal direction, thereby retracting the elongated rigid member 22 and the tubular instrument 72. In some embodiments, the tubular instrument hub 114 and the rigid member hub 118 may be configured to move independently of each other.

[0141] Now for reference Figure 11A-11CIn some embodiments, the delivery device 130 may include a support tube 132 extending from the guide feature 134. In some embodiments, the proximal end 135 of the support tube 132 may be secured to the guide feature 134. In some embodiments, the delivery device 130 may be similar to or identical to one or more of the following in one or more features and / or operations: Figures 8A-8D Delivery device 70 Figures 9A-9C Delivery device 104 and Figures 10A-10F Delivery device 112.

[0142] In some embodiments, in response to movement of the guide feature 134 along the slot 102 in the distal direction 136, the tubular instrument 72 can move through the support tube 132. In some embodiments, the support tube 132 may include an inner diameter larger than the outer diameter of the instrument, such that the tubular instrument 72 can move through the support tube 132. In some embodiments, the support tube 132 may provide support to the distal end 12 or free end of the tubular instrument 72. In some embodiments, in response to movement of the guide feature 134 along the slot 102 in the distal direction 136 a first distance, the distal end 140 of the support tube 132 may advance in the distal direction 136 by a distance equal to the first distance (“1:1 advance ratio”), while the distal end 12 of the tubular instrument 72 may advance by a distance greater than the first distance, for example, twice the first distance (“1:2 advance ratio”). In some embodiments, different forward displacement ratios of the guide feature 134 relative to the distal end 12 and the guide feature 134 relative to the support tube 132 may cause the support tube 132 not to move distally beyond the diameter reduction portion of the tubular instrument 72, and the diameter reduction portion of the tubular instrument 72 to move distally through the catheter assembly and into the vascular system.

[0143] In some embodiments, the delivery device 130 may facilitate the timely or delayed withdrawal of the tubular instrument 72 from the support tube 132. More specifically, in some embodiments, the distal end 12 of the tubular instrument 72 may be shortened such that when the guide feature 134 is fully retracted, it is positioned proximal to at least a portion of the support tube 132.

[0144] In some embodiments, given a 1:2 advance ratio between the guide feature 134 and the distal end 12 of the tubular instrument 72 (or another advance ratio where the second distance is greater than the first distance) and a 1:1 advance ratio between the guide feature 134 and the distal end 140 of the support tube 132, the distal end 12 of the tubular instrument 72 may be withdrawn from the distal end 140 of the support tube 132. In some embodiments, the distal end 12 of the tubular instrument 72 may be withdrawn from the distal end 140 of the support tube 132 to allow the tubular instrument 72 to enter portions of the catheter assembly that may be too narrow for the support tube 132 to access.

[0145] In some embodiments, the support tube 132 may be more rigid and have greater stiffness than the tubular device 72. In some embodiments, the support tube 132 may be more rigid and have greater stiffness than at least the distal tip 18 of the tubular device 72. In some embodiments, the support tube 132 may be made of a first material or another suitable material.

[0146] All examples and conditional language cited herein are for illustrative purposes, to aid the reader in understanding the concepts of this disclosure and the inventors' contributions to the advancement of the art, and are to be construed as not being limited to these specifically cited examples and conditions. Although embodiments of this disclosure have been specifically described, it should be understood that various changes, substitutions, and modifications can be made thereto without departing from the spirit and scope of this disclosure.

Claims

1. A delivery device for delivering a tubular instrument into a catheter extending distally from a catheter adapter, the delivery device comprising: A housing configured to be connected to the conduit adapter; The tubular device is configured to be inserted through the conduit, the tubular device including a distal end, a proximal end, and a lumen extending between the distal end and the proximal end, wherein the distal end includes a distal tip, wherein the distal tip is closed, wherein a portion of the distal end near the distal tip includes a first material, wherein the distal tip includes a second material, wherein the hardness of the first material is greater than the hardness of the second material, and wherein the tubular device is configured to be distally forward relative to the housing; The tubular instrument includes a plurality of holes located within the distal end and proximal to the distal apex, and The plurality of holes includes at least a first hole, a second hole proximal to the first hole, and a third hole proximal to the second hole. The size of the plurality of holes decreases in the direction away from the distal tip, such that the diameter of the first hole is larger than the diameter of the second hole, and the diameter of the second hole is larger than the diameter of the third hole, thereby increasing flexibility toward the distal tip of the tubular instrument. A rigid member, the rigid member comprising a solid core disposed within the tubular instrument.

2. The delivery device according to claim 1, wherein, The plurality of holes includes a fourth hole aligned with the second hole, a fifth hole aligned with the second hole, and a sixth hole aligned with the third hole, wherein the diameter of the first hole is equal to the diameter of the fourth hole, the diameter of the second hole is equal to the diameter of the fifth hole, and the diameter of the third hole is equal to the diameter of the sixth hole.

3. The delivery device according to claim 1, wherein, The outer surface of the solid core contacts the inner side of the distal tip.

4. A delivery device for delivering a tubular instrument into a catheter extending distally from a catheter adapter, the delivery device comprising: A housing configured to be connected to the conduit adapter; The tubular instrument is configured for insertion through the catheter, the tubular instrument including a distal end, a proximal end, and a lumen extending between the distal end and the proximal end, wherein the distal end of the tubular instrument includes a distal opening; and An elongated rigid member, comprising a solid core, is disposed within the tubular device, wherein the rigid member comprises a first material, wherein the distal end comprises a second material, wherein the hardness of the first material is greater than the hardness of the second material, and wherein the tubular device is configured to be distally advanced relative to the housing. The distal end includes a winglet, wherein the winglet is configured to fold over the top of the elongated rigid member extending through the distal opening.

5. The delivery device according to claim 4, wherein the farthest portion of the distal end includes the wing.

6. The delivery device according to claim 4, wherein, The distal end of the tubular device includes an insert, wherein the insert includes the distal opening, and the distal portion of the insert includes the flap.

7. The delivery device according to claim 4, wherein, The elongated rigid member is configured to retract from the tubular instrument.

8. The delivery device according to claim 4, wherein, The elongated rigid member comprises a wire surrounded by a spring and a rounded distal end.

9. A delivery device for delivering a tubular instrument into a catheter extending distally from a catheter adapter, the delivery device comprising: A housing configured to be connected to the conduit adapter; The tubular instrument is configured for insertion through the catheter, the tubular instrument including a distal end, a proximal end, and a lumen extending between the distal end and the proximal end, wherein the distal end includes a distal tip, wherein the distal tip is closed, and wherein the distal end further includes a first annular layer and a second annular layer, wherein the first annular layer is disposed within the second annular layer, wherein the first annular layer comprises a first material, and wherein the second annular layer comprises a second material, wherein the first material has a greater hardness than the second material. The tubular instrument includes a plurality of holes located within the distal end and proximal to the distal apex, and The plurality of holes includes at least a first hole, a second hole proximal to the first hole, and a third hole proximal to the second hole. The size of the plurality of holes decreases in the direction away from the distal tip, such that the diameter of the first hole is larger than the diameter of the second hole, and the diameter of the second hole is larger than the diameter of the third hole, thereby increasing flexibility toward the distal tip of the tubular instrument. A solid core is disposed within the tubular instrument.

10. The delivery device according to claim 9, wherein, At a first position along the length of the tubular device, the thickness of the second annular layer is greater than the thickness of the first annular layer, wherein at a second position along the length of the tubular device, the thickness of the second annular layer is the same as the thickness of the first annular layer, wherein the second position is near the first position.

11. The delivery device according to claim 10, wherein, At a third position along the length of the tubular instrument, the thickness of the second annular layer is less than the thickness of the first annular layer, wherein the third position is proximal to the second position.

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