Tubular instrument and related devices and methods

The tubular instrument with a multi-material construction and delivery device addresses catheter-related issues by ensuring extended catheter lifespan and reducing vein trauma through axial rigidity and a soft interface, enhancing patient comfort and reducing costs.

JP2025147021APending Publication Date: 2025-10-03BECTON DICKINSON & CO
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Patent Information

Application Number
JP2025129698
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2021-01-06
Filing Date
2025-08-01
Publication Date
2025-10-03

AI Technical Summary

Technical Problem

Catheters used for extended periods in patients face issues such as vein stenosis, kinking, blockage, and require additional needlesticks for blood collection, leading to patient discomfort and increased costs, while existing tubular instruments cause vein trauma due to high stiffness and sharp ends.

Method used

A tubular instrument with axial structural rigidity and a multi-material construction, featuring stripes for stiffness and a softer interface, allowing advancement without buckling and reducing vein trauma, combined with a delivery device for extending catheter lifespan.

Benefits of technology

Facilitates extended catheter dwell times with high flow rates and reduces vein trauma by providing gentle contact, eliminating the need for additional needlesticks and minimizing complications.

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Abstract

To provide a delivery device that can advance a tubular instrument into a catheter and / or beyond a distal tip of the catheter for fluid infusion or blood draw when the catheter is compromised or nearing an end of its life.SOLUTION: A delivery device configured to deliver a tubular instrument into a catheter includes: a tubular instrument, which includes an annular wall including a distal end and forming a lumen and also includes a distal opening within the distal end of the annular wall; and an adapter, which is coupled to a proximal end of the tubular instrument and includes a coupling mechanism for coupling the adapter with the catheter assembly.SELECTED DRAWING: Figure 7
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Description

[Technical Field]

[0001] TECHNICAL FIELD The present disclosure relates generally to vascular access devices. In particular, the present disclosure relates to tubular instruments and related devices and methods. [Background technology]

[0002] Catheters are commonly used to infuse fluids into a patient's vascular system. For example, catheters may be used to infuse saline, various medications, or total parenteral nutrition. Catheters may also be used to withdraw blood from a patient.

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

[0004] To verify proper placement of the introducer needle and / or catheter within the blood vessel, the clinician typically confirms the presence of a "flashback" of blood within the flashback chamber of the catheter assembly. Once needle placement is confirmed, the clinician can temporarily occlude flow within the vasculature and withdraw the introducer needle, leaving the catheter in place for later blood collection or transfusion.

[0005] Blood collection using a catheter can be difficult for several reasons, especially when the catheter's residence time within the vasculature exceeds one day. For example, if a catheter is left inserted in a patient for an extended period of time, the catheter or vein may become more susceptible to stenosis, breakage, kinking, blockage by debris (e.g., fibrin or platelet clots), and adhesion of the catheter tip to the vasculature. For this reason, catheters are often used to obtain blood samples at the time of catheter placement but less frequently during the catheter placement period. Thus, when a blood sample is needed, an additional needlestick is required to provide venous access for collection, which can be painful for the patient and results in higher material costs.

[0006] In some instances, tubular instruments may be used to access a patient's vascular system through a catheter to avoid additional needlesticks. The tubular instrument may be inserted into the vascular system through a catheter to extend the catheter's lifespan and allow blood to be withdrawn through the catheter without additional needlesticks. Generally, tubular instruments have high stiffness and thin walls. High stiffness allows the tubular instrument to be advanced without buckling, and thin walls facilitate increased flow rate through the tubular instrument. However, high stiffness combined with thin walls results in a sharp and hard distal end of the tubular instrument, which can induce trauma to the vein wall. In particular, if the tubular instrument is advanced distally beyond the distal tip of the catheter, the tubular instrument may damage the vein wall, increasing the risk of thrombosis and other complications. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] U.S. Patent Application No. 16 / 037,246 [Patent Document 2] U.S. Patent Application No. 16 / 388,650 [Patent Document 3] U.S. Patent Application No. 16 / 037,319 [Patent Document 4] U.S. Patent Application No. 16 / 502,541 [Patent Document 5] U.S. Patent Application No. 16 / 691,217 [Patent Document 6] U.S. Patent Application No. 16 / 742,013 [Patent Document 7] U.S. Patent Application No. 16 / 838,831 Summary of the Invention [Problem to be solved by the invention]

[0008] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in certain environments such as those described above. Rather, this background is provided only to illustrate one example technology area where some of the embodiments described herein may be practiced. [Means for solving the problem]

[0009] The present disclosure relates generally to vascular access devices. In particular, the present disclosure relates to tubular instruments and related devices and methods. In some embodiments, a delivery device for delivering a tubular instrument into a catheter can facilitate extended catheter dwell times. More specifically, the delivery device can be used to advance a tubular instrument into a catheter and / or beyond the distal tip of the catheter for fluid injection or blood withdrawal when the catheter is damaged or nearing the end of its life.

[0010] In some embodiments, the delivery device may include a tubular instrument, which may include axial structural rigidity to facilitate advancement of the tubular instrument without buckling. In some embodiments, the tubular instrument may also have an inner diameter to facilitate high flow rates for fluid injection and / or blood withdrawal. While providing axial structural rigidity and high flow rates, unlike prior art tubular instruments, the tubular instrument may also provide gentle, soft contact between the tubular instrument and the vein wall, which may reduce trauma to the vein wall. In some embodiments, the tubular instrument may also maintain flexure. In some embodiments, advantages of the tubular instrument may result from its multi-material construction.

[0011] In some embodiments, the tubular instrument may include an annular wall. In some embodiments, the annular wall may include a distal end and a proximal end. In some embodiments, the annular wall may form a lumen that may extend through the distal end of the annular wall and / or the proximal end of the annular wall. In some embodiments, the tubular instrument may include a distal opening, which may be disposed within the distal end of the annular wall.

[0012] In some embodiments, the tubular device may include one or more stripes disposed within the annular wall. In some embodiments, the stripes may extend proximally from the distal end of the annular wall. In some embodiments, the stripes may be aligned with the longitudinal axis of the tubular device. In some embodiments, the stripes may extend proximally from the distal opening. In some embodiments, the stripes may extend proximally from a location proximal to the distal opening.

[0013] In some embodiments, the outer periphery of each of the stripes may be surrounded by an annular wall. In some embodiments, the stripes may be co-extruded within the annular wall. In some embodiments, the stripes may be constructed of a first material and the annular wall may be constructed of a second material. In some embodiments, the first material may have a greater durometer than the second material. Thus, in some embodiments, the stripes may be harder than the annular wall.

[0014] In some embodiments, the first material may include a thermoplastic elastomer, a thermoplastic polyurethane, a polyurethane, a nylon, a polyimide, a silicone, or another suitable polymer. In some embodiments, the first material may include a metal. In some embodiments, each of the stripes may include a wire, which may be composed of a metal. In some embodiments, the wire may be configured to hold the tubular device in a bent position in response to the wire being bent. In some embodiments, the second material may include polypropylene, a polyurethane, a polyurethane, a nylon, a polyimide, a silicone, or another suitable polymer. In some embodiments, the second material may be similar to the first material but may have a lower density.

[0015] In some embodiments, the stripes may provide stiffness to the tubular device, which may facilitate advancement of the tubular device through the catheter assembly and beyond the distal tip of the catheter without buckling. In some embodiments, a second material may be disposed on the outer surface of the tubular device, which may provide a softer interface with the vein.

[0016] In some embodiments, the annular wall may include an inner surface and an outer surface. In some embodiments, the inner surface may be adjacent to the lumen of the tubular device. In some embodiments, the inner surface may be cylindrical, and / or the stripes may protrude to form ribs on the outer surface. In some embodiments, the outer surface may be cylindrical except for ribs on the outer surface formed by the stripes. In some embodiments, the outer surface may be cylindrical, and / or the stripes may protrude to form ribs on the inner surface. In some embodiments, the outer surface may be cylindrical except for ribs on the other surface formed by the stripes. In some embodiments, the inner surface may be cylindrical except for ribs on the inner surface formed by the stripes.

[0017] In some embodiments, the stripes may be closer to the inner surface than to the outer surface. In some embodiments, the stripes may be closer to the outer surface than to the inner surface. In some embodiments, the stripes may be spaced apart around the annular wall. In some embodiments, the stripes may be evenly spaced apart around the annular wall.

[0018] In some embodiments, the annular wall can include a first annular section and a second annular section distal to the first annular section. In some embodiments, the durometer of the first annular section can be greater than the durometer of the second annular section. In some embodiments, the second annular section can include a distal opening.

[0019] In some embodiments, the first annular section may be constructed of a first material. In some embodiments, the second annular section may be constructed of a second material. In some embodiments, the durometer of the first material may be greater than the durometer of the second material. In some embodiments, the thickness of the first annular section may be greater than the thickness of the second annular section. In some embodiments, the outer surface of the second annular section may include a plurality of grooves that may extend perpendicular to the longitudinal axis of the tubular device.

[0020] In some embodiments, the first annular section may include one or more stripes that may be co-extruded within the first annular section. In some embodiments, the stripes may be aligned with the longitudinal axis of the tubular device. In some embodiments, the stripes may be constructed of a first material. In some embodiments, the second annular section may be constructed of a second material. In some embodiments, the first material may have a greater durometer than the second material.

[0021] In some embodiments, the annular wall may include a third annular section between the first and second annular sections. In some embodiments, the third annular section may be adjacent to the first and / or second annular sections. In some embodiments, the first annular section may be adjacent to the second annular section.

[0022] In some embodiments, the distal end of the annular wall may include 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 second annular layer may surround the first annular layer. In some embodiments, the first annular layer may be constructed of a first material. In some embodiments, the second annular layer may be constructed of a second material. In some embodiments, the first material may have a greater durometer than the second material.

[0023] In some embodiments, the distal end of the annular wall may include a third annular layer that may be disposed within the first and second annular layers. In some embodiments, the first annular layer may surround the third annular layer. In some embodiments, the third annular layer may be constructed of the second material or the third material. In some embodiments, the first material may have a greater durometer than the third material.

[0024] In some embodiments, the thickness of the second annular layer may be greater than the thickness of the first annular layer at a first location along the length of the tubular device. In some embodiments, the thickness of the second annular layer may be the same as the thickness of the first annular layer at a second location along the length of the tubular device. In some embodiments, the second location may be proximal to the first location. In some embodiments, the thickness of the second annular layer may be less than the thickness of the first annular layer at a third location along the length of the tubular device. In some embodiments, the third location may be proximal to the second location.

[0025] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention as claimed. It is to be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. It is also to be understood that embodiments may be combined or other embodiments may be utilized, and that structural changes may be made without departing from the scope of the various embodiments of the invention, unless so claimed. Therefore, the following detailed description is not to be taken in a limiting sense. [Brief explanation of the drawings]

[0026] Exemplary embodiments will be described and explained with additional specificity and detail through the use of accompanying drawings. [Figure 1] FIG. 1 is a top perspective view of an exemplary tubular device, according to some embodiments. [Figure 2A] 2A is a cross-sectional view of the tubular device of FIG. 1 taken along line 2-2 of FIG. 1, according to some embodiments. [Figure 2B] 2B is another cross-sectional view of the tubular device of FIG. 1 taken along line 2-2 of FIG. 1, according to some embodiments. [Figure 2C] 2C is another cross-sectional view of the tubular device of FIG. 1 taken along line 2-2 of FIG. 1, according to some embodiments. [Figure 2D] 2D is another cross-sectional view of the tubular device of FIG. 1 taken along line 2-2 of FIG. 1, according to some embodiments. [Figure 2E] 2E is another cross-sectional view of the tubular device of FIG. 1 taken along line 2-2 of FIG. 1, according to some embodiments. [Figure 2F] 2F is another cross-sectional view of the tubular device of FIG. 1 taken along line 2-2 of FIG. 1, according to some embodiments. [Figure 3A] FIG. 3A is a top perspective view of an exemplary tubular device, according to some embodiments. [Figure 3B]3B is a cross-sectional view of the tubular device of FIG. 3A taken along line 3B-3B of FIG. 3A, according to some embodiments. [Figure 3C] 3C is a cross-sectional view of the tubular device of FIG. 3A taken along line 3C-3C in FIG. 3A, according to some embodiments. [Figure 3D] 3D is a cross-sectional view of the tubular device of FIG. 3A taken along line 3D-3D in FIG. 3A, according to some embodiments. [Figure 4A] FIG. 4A is a longitudinal cross-sectional view of a portion of another exemplary tubular device, according to some embodiments. [Figure 4B] FIG. 4B is a cross-sectional view of the tubular device of FIG. 4A, according to some embodiments. [Figure 5A] FIG. 5A is a top perspective view of another tubular device, according to some embodiments. [Figure 5B] FIG. 5B is a cross-sectional view of the tubular device of FIG. 5A taken along line 5B-5B of FIG. 5A, according to some embodiments. [Figure 6] FIG. 6 is a top perspective view of another exemplary tubular device, according to some embodiments. [Figure 7] FIG. 7 is a top perspective view of an exemplary delivery device, according to some embodiments. [Figure 8A] FIG. 8A is a top perspective view of another exemplary delivery device coupled to an exemplary catheter assembly, according to some embodiments. [Figure 8B] FIG. 8B is a cross-sectional view of the alternative delivery device of FIG. 8A, according to some embodiments. [Figure 8C] FIG. 8C is a cross-sectional view of the catheter assembly of FIG. 8A showing an exemplary tubular instrument in an advanced or distal position, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0027] Referring now to FIG. 1 , in some embodiments, a delivery device for delivering tubular device 10 within a catheter can facilitate extended catheter dwell times. More specifically, the delivery device can be used to advance tubular device 10 into and / or beyond the distal tip of a catheter for fluid injection or blood withdrawal when the catheter is damaged or nears the end of its useful life. In some embodiments, tubular device 10 can have axial structural rigidity to facilitate advancement of tubular device 10 without buckling. In some embodiments, tubular device 10 can also have an inner diameter to facilitate high flow rates for fluid injection and / or blood withdrawal. While providing axial structural rigidity and high flow rates, unlike prior art tubular devices, the tubular device 10 can also provide gentle, soft contact between the tubular device 10 and the vein wall, which can reduce trauma to the vein wall. In some embodiments, tubular device 10 can also maintain flexure.

[0028] In some embodiments, tubular instrument 10 may include an annular wall 12. In some embodiments, annular wall 12 may include a distal end 14 and a proximal end 16. In some embodiments, annular wall 12 may form a lumen 18 that may extend through distal end 14 of annular wall 12 and / or proximal end 16 of annular wall 12. In some embodiments, tubular instrument 10 may include a distal opening 20, which may be disposed within distal end 14 of annular wall 12.

[0029] In some embodiments, the distal opening 20 may be aligned with the longitudinal axis 22 of the tubular device 10. In other embodiments, the portion of the distal end 14 aligned with the longitudinal axis 22 may be closed, and the distal opening 20 may be disposed transverse to the longitudinal axis 22 through the annular wall 12. In some embodiments, the distal end 14 may include one or more diffusion holes (not shown) that may extend through the annular wall 12. In some embodiments, the diffusion holes may be disposed proximal to the distal opening 20. In some embodiments, the distal end 14 may be blunt, tapered, or another suitable shape.

[0030] 2A-2F, in some embodiments, the tubular device 10 may include one or more stripes 24 that may be disposed within the annular wall 12. In some embodiments, the stripes 24 may include long, narrow bands or strips. In some embodiments, each of the stripes 24 may have a uniform diameter or a variable diameter along the length of the stripe 24. In some embodiments, the stripes 24 may allow the annular wall 12 to be thinned for high flow rates through the tubular device 10 without increasing the sharpness of the distal end 14 and the risk of trauma to the vein.

[0031] In some embodiments, the stripes 24 may extend along all or part of the length of the annular wall 12 between the distal end 14 and the proximal end 16. In some embodiments, the stripes 24 may extend proximally from the distal end 14 of the annular wall 12. In some embodiments, the distal-most portion of each of the stripes 24 may be spaced apart from the distal-most surface of the distal end 14. In these embodiments, the stripes 24 may extend proximally from a location near the distal opening 20 but proximal to the distal opening within the distal end 14, which may increase the softness of the distal-most portion of the distal end 14 that may contact the patient's venous wall. In these embodiments, the annular wall 12 may encapsulate or completely surround the stripes 24. In some embodiments, the stripes 24 may extend proximally from the distal opening 20 and / or the distal-most surface of the distal end 14. In some embodiments, the stripes 24 may be aligned or generally aligned with the longitudinal axis 22 of the tubular device 10.

[0032] In some embodiments, the number of stripes 24 may vary. In some embodiments, between one and three stripes 24 may be disposed within the annular wall 12. In some embodiments, more than three stripes 24 may be disposed within the annular wall 12. As shown in FIG. 2A, in some embodiments, the tubular device 10 may include four stripes 24. In some embodiments, the stripes 24 may be spaced apart around the annular wall 12. In some embodiments, the stripes 24 may be evenly spaced apart around the annular wall 12, for example, as shown in FIG. 2A. In some embodiments, the periphery of each of the stripes 24 may be surrounded by the annular wall 12 along all or part of its length, for example, as shown in FIG. 2A.

[0033] In some embodiments, the stripes 24 may be co-extruded within the annular wall 12. In some embodiments, the stripes 24 may be constructed of a first material and the annular wall 12 may be constructed of a second material. In some embodiments, the first material may have a greater durometer than the second material. Thus, in some embodiments, the stripes 24 may be harder than the annular wall 12.

[0034] In some embodiments, the first material may be 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, each of the stripes 24 may include a wire, which may be constructed of a metal. In some embodiments, the wire may be configured to hold the tubular device 10 in a bent position in response to bending of the wire, which may position the tubular device 10 away from the vein wall or valve and toward the center of the vein.

[0035] In some embodiments, the second material may be 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 may have a lower density.

[0036] In some embodiments, the stripes 24 may provide stiffness to the tubular device 10, which may facilitate advancement of the tubular device 10 through a catheter assembly and beyond the distal tip of the catheter without buckling. In some embodiments, a second material may be disposed on all or a portion of the outer surface and circumference of the tubular device 10, which may provide a softer interface with the vasculature.

[0037] In some embodiments, the annular wall 12 may include an inner surface 30 and an outer surface 32. In some embodiments, the inner surface 30 may be proximate the lumen 18 of the tubular device 10. In some embodiments, the inner surface 30 may be cylindrical, and / or the stripes 24 may protrude to form ribs 34 on the outer surface 32. In some embodiments, the outer surface 32 may be cylindrical, except for the ribs 34 on the outer surface 32 formed by the stripes 24.

[0038] In some embodiments, the outer surface 32 may be cylindrical, for example, as shown in FIGS. 2B-2C, and / or the stripes 24 may protrude to form ribs 34 on the inner surface 30. In some embodiments, the inner surface 30 may be cylindrical, except for the ribs 34 on the inner surface 30 formed by the stripes 24. In some embodiments, the tubular device 10 may include only one stripe 24, for example, as shown in FIG. 2C. In some embodiments, the ribs 34 may reduce contact between the annular wall 12 and the vein wall. In some embodiments, the stripes 24 may extend through the annular wall 12, for example, as shown in FIG. 2D.

[0039] For example, as shown in FIG. 2E , in some embodiments, the distal end 14 of the annular wall 12 may include a first annular layer 36 and a second annular layer 38. In some embodiments, the first annular layer 36 may be disposed within the second annular layer 38. In some embodiments, the second annular layer 38 may surround the first annular layer 36. In some embodiments, the first annular layer 36 may be constructed of a first material. In some embodiments, the second annular layer 38 may be constructed of a second material. In some embodiments, the first material may have a greater durometer than the second material.

[0040] In some embodiments, the first annular layer 36 and the second annular layer 38 may be concentrically co-extruded. In some embodiments, the first annular layer 36 may have a uniform thickness or a variable thickness along the length of the first annular layer 36. In some embodiments, the second annular layer 38 may have a uniform thickness or a variable thickness along the length of the second annular layer 38.

[0041] In some embodiments, the first annular layer 36 and / or the second annular layer 38 may extend along all or part of the length of the annular wall 12 between the distal end 14 and the proximal end 16. In some embodiments, the first annular layer 36 and / or the second annular layer 38 may extend proximally from the distal end 14 of the annular wall 12. In some embodiments, the distal-most portion of each of the first annular layers 36 may be spaced apart from the distal-most surface of the distal end 14. In these embodiments, the first annular layer 36 may extend proximally from a position near the distal opening 20 but proximal to the distal opening within the distal end 14, which may increase the softness of the distal-most portion of the distal end 14 that may contact the patient's venous wall. In some embodiments, the first annular layer 36 and / or the second annular layer 38 may extend proximally from the distal opening 20 and / or the distal-most surface of the distal end 14.

[0042] For example, as shown in FIG. 2F , in some embodiments, the distal end 14 of the annular wall 12 may include a third annular layer 40 that may be disposed within the first annular layer 36 and the second annular layer 38. In some embodiments, the first annular layer 36 may surround and be adjacent to the third annular layer 40. In some embodiments, the third annular layer 40 may be constructed of the second material or the third material. In some embodiments, the first material may have a greater durometer than the third material. In some embodiments, the first annular layer 36, the second annular layer 38, and the third annular layer 40 may be concentrically coextruded.

[0043] 3A-3D, a tubular device 10 is shown, according to some embodiments. In some embodiments, the first annular layer 36 and / or the second annular layer 38 may have a variable thickness along the length of the tubular device 10. In some embodiments, the stiffness of the tubular device 10 may gradually increase in the proximal direction. Thus, the distal end 14 may be stiffer than the proximal end 16, facilitating gentle, soft contact between the distal end 14 and the vein wall while simultaneously preventing buckling.

[0044] For example, as shown in FIG. 3B, in some embodiments, the thickness of the second annular layer 38 may be greater than the thickness of the first annular layer 36 at a first location along the length of the tubular device 10. For example, as shown in FIG. 3C, the thickness of the second annular layer 38 may be the same as the thickness of the first annular layer 36 at a second location along the length of the tubular device 10. In some embodiments, the second location may be proximal to the first location. For example, as shown in FIG. 3D, the thickness of the second annular layer 38 may be less than the thickness of the first annular layer 36 at a third location along the length of the tubular device 10. In some embodiments, the third location may be proximal to the second location.

[0045] 4A-4B, in some embodiments, the distal-most portion of each of the stripes 24 may be spaced from the distal-most surface of the distal end 14. In some embodiments, the inner surface 30 may be cylindrical and / or the stripes 24 may protrude to form ribs 34 on the outer surface 32. In some embodiments, the outer surface 32 may be cylindrical, except for the ribs 34 on the outer surface 32 formed by the stripes 24. In some embodiments, the portion of the tubular device 10 that includes the stripes 24 may have a larger outer diameter than the portion of the tubular device 10 that does not include the stripes 24, e.g., the portion of the tubular device 10 that is proximate the distal-most surface of the distal end 14.

[0046] 5A-5B, in some embodiments, the outer surface of the distal end 14 of the tubular instrument 10 may include a plurality of grooves 42, which may improve the flexibility of the distal end 14. In some embodiments, the grooves 42 may include arcuate slots. In some embodiments, the grooves 42 may extend around a portion of the circumference of the distal end 14. In some embodiments, the tubular instrument 10 may be formed from a single or multiple material extrusion. In some embodiments, the tubular instrument 10 may be constructed of a single material, such as a first material, along the entire length of the tubular instrument 10 between the distal end 14 and the proximal end 16.

[0047] 6 , in some embodiments, the annular wall 12 may include a first annular section 44 and a second annular section 46 distal to the first annular section 44. In some embodiments, the first annular section 44 may be constructed of a first material. In some embodiments, the second annular section 46 may be constructed of a second material. In some embodiments, the durometer of the first material and the first annular section 44 may be greater than the durometer of the second material and the second annular section 46.

[0048] In some embodiments, the second annular section 46 may be disposed at the distal-most portion of the distal end 14, which may provide a gentle, soft contact between the tubular device 10 and the vein wall. In some embodiments, the second annular section 46 may include the distal opening 20. In some embodiments, the thickness of the first annular section 44 may be greater than the thickness of the second annular section 46, which may increase the stiffness or rigidity of the first annular section 44 compared to the second annular section 46.

[0049] In some embodiments, first annular section 44 may include one or more of stripes 24 (see, e.g., FIGS. 2A-2D ), which may be coextruded within first annular section 44. In some embodiments, stripes 24 may be aligned with the longitudinal axis of tubular device 10. In some embodiments, stripes 24 may be constructed of a first material. In some embodiments, second annular section 46 and / or annular wall 12 of first annular section 44 may be constructed of a second material.

[0050] In some embodiments, the first annular section 44 may be adjacent to the second annular section 46, or there may be an abrupt transition between the first annular section 44 and the second annular section 46, such as via bonding or another suitable method. In these embodiments, the first annular section 44 and the second annular section 46 may be joined together without the third annular section 48. In some embodiments, the first annular section 44 and the second annular section 46 may be continuous structures or formed via continuous extrusion.

[0051] In some embodiments, the annular wall 12 may include a third annular section 48 between the first annular section 44 and the second annular section 46. In some embodiments, the third annular section 48 may be proximate to the first annular section 44 and / or the second annular section 46. In some embodiments, one or more of the first annular section 44, the second annular section 46, and the third annular section 48 may extend inwardly from the outer surface of the tubular device 10 to the lumen 18.

[0052] In some embodiments, the third annular section 48 may transition from the first annular section 44 to the second annular section 46. In some embodiments, the third annular section 48 may include a durometer between the durometers of the first annular section 44 and the second annular section 46. In some embodiments, the third annular section 48 may include a joint that joins the first annular section 44 to the second annular section 46. In some embodiments, the joint may be formed via solvent, adhesive bonding, rocking, ultrasonic welding, chipping, or another suitable method.

[0053] In some embodiments, the tubular instrument 10 may be coupled to any suitable delivery device. In some embodiments, the catheter of the catheter assembly may include one or more features of one or more of the tubular instruments 10 described with respect to Figures 1-6. Figures 7-9 illustrate some non-limiting examples of delivery devices. In some embodiments, the delivery device may be further described in U.S. Patent Application Publication No. 2018 / 013999, filed July 17, 2018, entitled "Extension for Accommodating a Probe or Intravenous Catheter," U.S. Patent Application Publication No. 2019 / 013999, filed April 18, 2019, entitled "Instrument Delivery Device with Rotating Element," U.S. Patent Application Publication No. 2019 / 013999, filed July 17, 2018, entitled "Multiple Diameter Catheters and Associated Devices and Methods," U.S. Patent Application Publication No. 2019 / 013999, filed July 3, 2019, entitled "Delivery Device for Vascular Access Devices," U.S. Patent Application Publication No. 2019 / 0139999, filed November 21, 2019, entitled "Syringe-Based Delivery Device for Vascular Access Devices," U.S. Patent Application Publication No. 2020 / 0139999, filed January 14, 2020, entitled "Catheter Delivery Devices and Associated Systems and Methods," and U.S. Patent Application Publication No. 2020 / 0139999, filed April 2, 2020, entitled "Vascular Access Devices with Fluid-Permeable Structures and Associated Devices and Methods," which are incorporated by reference in their entireties.

[0054] 7, in some embodiments, a delivery device 50 may deliver a tubular instrument 10 into a catheter of a catheter assembly, such as, for example, catheter assembly 64 of FIGS. 8A and 8C. Catheter assembly 64, according to some embodiments, is shown in FIGS. 8A and 8C. In some embodiments, delivery device 50 may include an extension that may be adjacent to and / or coupled to a proximal end of a catheter adapter of the catheter assembly. In some embodiments, the extension may include an adapter 52 that may be coupled to the proximal end of tubular instrument 10. In some embodiments, adapter 52 may be compatible with a Becton Dickinson Vacutainer® single-use holder or a similar holder.

[0055] In some embodiments, adapter 52 may be configured to move from a proximal position to a distal position and / or from a distal position to a proximal position along slot 54 in housing 56. In some embodiments, in response to movement of adapter 52 along slot 54 from a proximal position to a distal position, tubular instrument 10 may be advanced beyond the distal end of housing 56. In some embodiments, in response to movement of adapter 52 along slot 54 from a distal position to a proximal position, tubular instrument 10 may be retracted into housing 56.

[0056] In some embodiments, the extension may include an advancement tab 58 that may be coupled to the proximal end of the tubular instrument 10 and / or the adapter 52. In some embodiments, a clinician may pinch or grasp the advancement tab 58 to move the tubular instrument 10 to a proximal and / or distal position. In some embodiments, when the adapter 52 is positioned in a distal position, the tubular instrument 10 may be advanced beyond the distal end of the housing 56. In some embodiments, the advancement tab 58 may be positioned in any number of positions.

[0057] In some embodiments, the distal end of the housing 56 may include a coupling mechanism 60 that may couple the delivery device 50 with a catheter assembly. In some embodiments, the coupling mechanism 60 may include a luer fitting.

[0058] 8A-8C, delivery device 62 may be coupled to a catheter assembly 64. In some embodiments, catheter assembly 64 may include a catheter adapter 66 and a catheter 68, which may extend distally from catheter adapter 66. In some embodiments, catheter 68 may be secured within catheter adapter 66. In some embodiments, catheter 68 may include a peripheral intravenous catheter (“PIVC”), a peripherally inserted central catheter (“PICC”), or a midline catheter.

[0059] In some embodiments, the delivery device 62 may be coupled directly to the proximal end of the catheter adapter 66. In these and other embodiments, the catheter assembly 64 may include a straight or non-integrated catheter assembly. In some embodiments, the delivery device 62 may be coupled to an extension set 70 of the catheter assembly 64, as shown in FIG. 8A. In these and other embodiments, the catheter assembly 64 may include an integrated catheter assembly. More specifically, in some embodiments, the catheter adapter 66 of the catheter assembly 64 may include an integrated extension tube, such as, for example, the BD NEXIVA™ Closed IV Catheter System, the BD NEXIVA™ DIFFUSICS™ Closed IV Catheter System, or the Becton Dickinson PEGASUS™ Safety Closed IV Catheter System.

[0060] In some embodiments, delivery device 62 may include a rotating element 72 and a housing 74. In some embodiments, in response to rotation of rotating element 72 relative to housing 74 in a first direction, distal end 14 of tubular instrument 10 may be advanced beyond distal end 76 of catheter 68. In some embodiments, in response to rotation of rotating element 72 relative to housing 74 in a first direction, distal end 14 of tubular instrument 10 may be disposed at a first position relative to catheter assembly 64. An example of the first position is shown in FIG. 8B.

[0061] In some embodiments, in response to further rotation of the rotating element 72 relative to the housing 74 in the first direction, the distal end 14 of the tubular instrument 10 may be disposed at a second position relative to the catheter assembly 64. In some embodiments, the second position may be distal to the first position. An example of the second position is shown in FIG. 8C. In some embodiments, the tubular instrument 10 may be continuously advanced in the distal direction as the rotating element 28 is continuously rotated.

[0062] In some embodiments, in response to rotation of the rotating element 72 relative to the housing 74 in a first direction, the distal end 14 of the tubular instrument 10 may be positioned a first amount beyond the distal end 76 of the catheter 68. In some embodiments, in response to rotation of the rotating element 72 relative to the housing 74 in the first direction, the distal end 14 of the tubular instrument 10 may be positioned a second amount beyond the distal end 76 of the catheter 68. In some embodiments, the second amount may be greater than the first amount.

[0063] In some embodiments, rotating element 72 may also rotate relative to housing 74 in a second direction opposite to the first direction. In some embodiments, in response to rotation of rotating element 72 relative to housing 74 in the second direction, distal end 14 of tubular instrument 10 may be moved proximally.

[0064] In some embodiments, the rotating element 72 may include a support surface or groove 78 that may extend around at least a portion of the circumference of the rotating element 72. In some embodiments, the groove 78 may include a width that is approximately equal to or slightly greater than the tubular instrument 10, which may facilitate support of the tubular instrument 10.

[0065] All examples and conditional language set forth herein are intended for educational purposes to help the reader understand the concepts provided by the inventor to further the invention and technology, and should be construed as not being limited to the specifically recited examples and conditions. Although embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and alterations can be made herein without departing from the spirit and scope of the present invention.

Claims

[Claim 1] 1. A delivery device for delivering a tubular instrument into a catheter, the delivery device comprising: an annular wall including a distal end and defining a lumen; a distal opening in the distal end of the annular wall; a stripe within the annular wall and extending proximally from the distal end of the annular wall, A delivery device comprising a tubular instrument, the stripes being co-extruded within an annular wall, the stripes being constructed of a first material and the annular wall being constructed of a second material, the first material having a greater durometer than the second material.

Citation Information

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