Tubular implement and related devices and methods
By designing a delivery device for catheters, tubular instruments are delivered into the catheters, providing axial stiffness and soft contact, solving the problems of difficult blood draws and venous damage when catheters are in place for a long time, and achieving efficient fluid infusion and blood extraction.
Patent Information
- Application Number
- CN202110079109.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2020-01-21
- Filing Date
- 2021-01-21
- Publication Date
- 2026-01-02
- Estimated Expiration
- 2041-01-21
AI Technical Summary
When existing catheters remain in the vascular system for extended periods, blood draws become difficult and are prone to blockage. Additional needle pricks cause patient pain and high costs, while high-rigidity, thin-walled tubular devices may damage the venous walls.
Design a delivery device for delivering tubular instruments into a catheter, providing axial structural stiffness and high flow rate while providing soft contact with the vein wall, employing a multi-material structure and strip design to reduce damage.
Extending the catheter's dwell time reduces damage to the vein wall, improves the efficiency of fluid infusion and blood extraction, and avoids the pain and cost of additional needle pricks.
Smart Images

Figure CN113209445B_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The present disclosure relates generally to medical devices, such as vascular access devices. In particular, the present disclosure relates to tubular instruments and related devices and methods. In some embodiments, the present disclosure relates to delivery devices for delivering tubular instruments into a catheter. BACKGROUND
[0002] Catheters are commonly used to infuse fluids into a patient's vasculature. For example, catheters can be used to infuse a saline solution, various medicaments, or total parenteral nutrition. Catheters can also be used to withdraw blood from a patient.
[0003] Catheters can include an over-the-needle peripheral intravenous ("IV") catheter. In this case, the catheter can be mounted on an introducer needle having a sharp distal tip. The catheter and introducer needle can be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter with the bevel of the needle facing upward away from the skin of the patient. The catheter and introducer needle are typically inserted into the patient's vasculature at a shallow angle.
[0004] To verify proper placement of the introducer needle and / or catheter in the blood vessel, the clinician typically confirms the presence of a "flashback" of blood in the flashback chamber of the catheter assembly. Once the placement of the needle is confirmed, the clinician can temporarily occlude flow in the vasculature and remove the needle, leaving the catheter in place for future blood withdrawal or fluid infusion.
[0005] Blood withdrawal using a catheter can be difficult for several reasons, particularly when the catheter is left in place in the vasculature for more than one day. When a catheter is left in place in a patient for an extended period of time, the catheter or vein can be more susceptible to narrowing, collapse, kinking, occlusion by debris (e.g., fibrin or platelet clots), and sticking of the catheter tip to the vasculature. Thus, catheters are typically used to take blood samples at the time of catheter placement, but are less frequently used to take blood samples during the period of catheter dwell. Therefore, when a blood sample is needed, an additional needle stick is typically required to provide venous access for blood collection, which can be painful for the patient and results in higher material costs.
[0006] In some cases, to avoid additional needle sticks, a tubular implement can be used to access a patient's vasculature via a catheter. The tubular implement can be passed through the catheter and inserted into the vasculature to extend the life of the catheter and allow blood to be withdrawn through the catheter without additional needle sticks. Typically, the tubular implement has high stiffness and a thin wall. The high stiffness allows the tubular implement to be advanced without buckling, and the thin wall helps to increase the flow rate through the tubular implement. However, the combination of high stiffness and thin wall results in a sharp, rigid distal edge of the tubular implement that can cause damage to the vein wall. In particular, when the tubular implement is advanced distally beyond the distal tip of the catheter, the tubular implement can damage the vein wall and increase the risk of thrombosis and other complications.
[0007] The subject matter claimed herein is not limited to implementations that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is included as merely representative of one example technology area where some implementations described herein can be practiced. SUMMARY
[0008] The present disclosure relates generally to vascular access devices. In particular, the present disclosure relates to tubular implements and related devices and methods. In some embodiments, a delivery device to deliver a tubular implement into a catheter can help to increase the dwell time of the catheter. In more detail, the delivery device can be used to advance a tubular implement into a catheter and / or beyond the distal tip of the catheter for fluid infusion or blood withdrawal when the catheter is damaged or near the end of its life.
[0009] In some embodiments, the delivery device can include a tubular implement that can include axial structural stiffness to facilitate advancement of the tubular implement without buckling. In some embodiments, the tubular implement can also have an inner diameter to facilitate a high flow rate of fluid infusion and / or blood withdrawal. Unlike tubular implements in the prior art, the tubular implement can provide a gentle, soft contact between the tubular implement and the vein wall while providing axial structural stiffness and a high flow rate. In some embodiments, the tubular implement can also withstand flexural bending. In some embodiments, the advantages of the tubular implement can result from a multi-material structure.
[0010] In some embodiments, the tubular implement can include an annular wall. In some embodiments, the annular wall can include a distal end and a proximal end. In some embodiments, the annular wall can form a lumen that can extend through the distal end of the annular wall and / or the proximal end of the annular wall. In some embodiments, the tubular implement can include a distal opening that can be disposed within the distal end of the annular wall.
[0011] In some embodiments, the tubular instrument can include one or more strips that can be disposed within the annular wall. In some embodiments, the strips can extend proximally from a distal end of the annular wall. In some embodiments, the strips can be parallel to a longitudinal axis of the tubular instrument. In some embodiments, the strips can extend proximally from a distal opening. In some embodiments, the strips can extend proximally from a location proximal of the distal opening.
[0012] In some embodiments, an outer perimeter of each of the strips can be surrounded by the annular wall. In some embodiments, the strips can be co-extruded within the annular wall. In some embodiments, the strips can be composed of a first material and the annular wall can be composed of a second material. In some embodiments, the first material can have a greater durometer than the second material. Thus, in some embodiments, the strips can be more rigid than the annular wall.
[0013] In some embodiments, the first material can 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 can include a metal. In some embodiments, each of the strips can include a wire that can be composed of a metal. In some embodiments, the wire can be configured to hold the tubular instrument in a curved position in response to the wire being bent. In some embodiments, the second material can include a polypropylene, a polyurethane, a polyurethane, a nylon, a polyimide, a silicone, or another suitable polymer. In some embodiments, the second material can be similar to the first material but less dense.
[0014] In some embodiments, the strips can provide rigidity to the tubular instrument that can help the tubular instrument to be advanced through a catheter assembly and beyond a distal tip of the catheter without buckling. In some embodiments, the second material can be disposed on an outer surface of the tubular instrument that can provide a softer surface to contact a vein.
[0015] In some embodiments, the annular wall can include an inner surface and an outer surface. In some embodiments, the inner surface can be proximal to a lumen of the tubular instrument. In some embodiments, the inner surface can be cylindrical and / or the strips can protrude to form ribs on the outer surface. In some embodiments, the outer surface can be cylindrical except for the ribs formed by the strips on the outer surface. In some embodiments, the outer surface can be cylindrical and / or the strips can protrude to form ribs on the inner surface. In some embodiments, the inner surface can be cylindrical except for the ribs formed by the strips on the inner surface. In some embodiments, the inner surface can be cylindrical and / or the strips can protrude to form ribs on the outer surface. In some embodiments, the outer surface can be cylindrical except for the ribs formed by the strips on the outer surface.
[0016] In some embodiments, the strips can be closer to the inner surface than to the outer surface. In some embodiments, the strips can be closer to the outer surface than to the inner surface. In some embodiments, the strips can be spaced apart around the annular wall. In some embodiments, the strips can be evenly spaced around the annular wall.
[0017] 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 first annular section can have a greater hardness than the second annular section. In some embodiments, the second annular section can include a distal opening.
[0018] In some embodiments, the first annular section can be composed of a first material. In some embodiments, the second annular section can be composed of a second material. In some embodiments, the first material can have a greater hardness than the second material. In some embodiments, the first annular section can have a greater thickness than the second annular section. In some embodiments, the outer surface of the second annular section can include a plurality of grooves that can extend perpendicular to the longitudinal axis of the tubular implement.
[0019] In some embodiments, the first annular section can include one or more strips that can be co-extruded within the first annular section. In some embodiments, the strips can be parallel to the longitudinal axis of the tubular implement. In some embodiments, the strips can be composed of a first material. In some embodiments, the second annular section can be composed of a second material. In some embodiments, the first material can have a greater hardness than the second material.
[0020] In some embodiments, the annular wall can include a third annular section between the first annular section and the second annular section. In some embodiments, the third annular section can be proximal to the first annular section and / or the second annular section. In some embodiments, the first annular section can be proximal to the second annular section.
[0021] In some embodiments, the distal end of the annular wall can include a first annular layer and a second annular layer. In some embodiments, the first annular layer can be disposed within the second annular layer. In some embodiments, the second annular layer can surround the first annular layer. In some embodiments, the first annular layer can be composed of a first material. In some embodiments, the second annular layer can be composed of a second material. In some embodiments, the first material can have a greater hardness than the second material.
[0022] In some embodiments, the distal end of the annular wall can include a third annular layer, which can be disposed within the first annular layer and the second annular layer. In some embodiments, the first annular layer can enclose the third annular layer. In some embodiments, the third annular layer can be composed of a second material or a third material. In some embodiments, the first material can have a greater hardness than the third material.
[0023] In some embodiments, at a first location along the length of the tubular implement, the thickness of the second annular layer can be greater than the thickness of the first annular layer. In some embodiments, at a second location along the length of the tubular implement, the thickness of the second annular layer can be the same as the thickness of the first annular layer. In some embodiments, the second location can be proximal to the first location. In some embodiments, at a third location along the length of the tubular implement, the thickness of the second annular layer can be less than the thickness of the first annular layer. In some embodiments, the third location can be proximal to the second location.
[0024] 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 application claimed. It should be understood that various embodiments are not limited to the arrangements and instrumentalities shown in the attached drawings. It should also be understood that the embodiments can be combined or that other embodiments can be utilized, and that structural changes can be made without departing from the scope of the various embodiments of the present application. Accordingly, the following detailed description is not limiting. BRIEF DESCRIPTION OF DRAWINGS
[0025] Example embodiments will be described and explained with additional specificity and detail by the use of the accompanying drawings in which:
[0026] Figure 1 is a top perspective view of an example tubular implement in accordance with some embodiments;
[0027] Figure 2A is a cross-sectional view of the tubular implement of Figure 1 taken along line 2-2 of Figure 1
[0028] Figure 2B is another cross-sectional view of the tubular implement of Figure 1 taken along line 2-2 of Figure 1
[0029] Figure 2C is another cross-sectional view of the tubular implement of Figure 1 taken along line 2-2 of Figure 1
[0030] Figure 2D is a longitudinal cross-sectional view of a portion of another example tubular implement according to some embodiments, taken along line 3D-3D of FIG. 3B; Figure 1 is another transverse cross-sectional view of the tubular implement of FIG. 2, taken along line 2-2 of FIG. 2; Figure 1 is another transverse cross-sectional view of the tubular implement of FIG. 2, taken along line 2-2 of FIG. 2;
[0031] Figure 2E is a longitudinal cross-sectional view of a portion of another example tubular implement according to some embodiments, taken along line 3D-3D of FIG. 3B; Figure 1 is another transverse cross-sectional view of the tubular implement of FIG. 2, taken along line 2-2 of FIG. 2; Figure 1 is another transverse cross-sectional view of the tubular implement of FIG. 2, taken along line 2-2 of FIG. 2;
[0032] Figure 2F is a longitudinal cross-sectional view of a portion of another example tubular implement according to some embodiments, taken along line 3D-3D of FIG. 3B; Figure 1 is another transverse cross-sectional view of the tubular implement of FIG. 2, taken along line 2-2 of FIG. 2; Figure 1 is another transverse cross-sectional view of the tubular implement of FIG. 2, taken along line 2-2 of FIG. 2;
[0033] Figure 3A is a longitudinal cross-sectional view of a portion of another example tubular implement according to some embodiments, taken along line 3D-3D of FIG. 3B;
[0034] Figure 3B is a longitudinal cross-sectional view of a portion of another example tubular implement according to some embodiments, taken along line 3D-3D of FIG. 3B; Figure 3A is a longitudinal cross-sectional view of a portion of another example tubular implement according to some embodiments, taken along line 3D-3D of FIG. 3B; Figure 3A is a longitudinal cross-sectional view of a portion of another example tubular implement according to some embodiments, taken along line 3D-3D of FIG. 3B;
[0035] Figure 3C is a longitudinal cross-sectional view of a portion of another example tubular implement according to some embodiments, taken along line 3D-3D of FIG. 3B; Figure 3A is a longitudinal cross-sectional view of a portion of another example tubular implement according to some embodiments, taken along line 3D-3D of FIG. 3B; Figure 3A is a longitudinal cross-sectional view of a portion of another example tubular implement according to some embodiments, taken along line 3D-3D of FIG. 3B;
[0036] Figure 3D is a longitudinal cross-sectional view of a portion of another example tubular implement according to some embodiments, taken along line 3D-3D of FIG. 3B; Figure 3A is a longitudinal cross-sectional view of a portion of another example tubular implement according to some embodiments, taken along line 3D-3D of FIG. 3B; Figure 3A is a longitudinal cross-sectional view of a portion of another example tubular implement according to some embodiments, taken along line 3D-3D of FIG. 3B;
[0037] Figure 4A is a longitudinal cross-sectional view of a portion of another example tubular implement according to some embodiments, taken along line 3D-3D of FIG. 3B;
[0038] Figure 4B is a longitudinal cross-sectional view of a portion of another example tubular implement according to some embodiments, taken along line 3D-3D of FIG. 3B; Figure 4A is a longitudinal cross-sectional view of a portion of another example tubular implement according to some embodiments, taken along line 3D-3D of FIG. 3B;
[0039] Figure 5A is a longitudinal cross-sectional view of a portion of another example tubular implement according to some embodiments, taken along line 3D-3D of FIG. 3B;
[0040] Figure 5B is a longitudinal cross-sectional view of a portion of another example tubular implement according to some embodiments, taken along line 3D-3D of FIG. 3B; Figure 5A is a longitudinal cross-sectional view of a portion of another example tubular implement according to some embodiments, taken along line 3D-3D of FIG. 3B; Figure 5A is a longitudinal cross-sectional view of a portion of another example tubular implement according to some embodiments, taken along line 3D-3D of FIG. 3B;
[0041] Figure 6 is a longitudinal cross-sectional view of a portion of another example tubular implement according to some embodiments, taken along line 3D-3D of FIG. 3B;
[0042] Figure 7 is a top perspective view of another example delivery device coupled to an example catheter assembly in accordance with some embodiments;
[0043] Figure 8A is a top perspective view of another example delivery device coupled to an example catheter assembly in accordance with some embodiments;
[0044] Figure 8B is a top perspective view of another example delivery device coupled to an example catheter assembly in accordance with some embodiments; Figure 8A is a cross-sectional view of the delivery device of
[0045] Figure 8C is a cross-sectional view of the delivery device of Figure 8A is a cross-sectional view of the catheter assembly of DETAILED DESCRIPTION
[0046] Reference is now made to Figure 1 In some embodiments, a delivery device to deliver the tubular implement 10 into a catheter can facilitate increased dwell time of the catheter. In more detail, the delivery device can be used to advance the tubular implement 10 into and / or beyond a distal tip of the catheter for fluid infusion or blood withdrawal when the catheter is damaged or near the end of its useful life. In some embodiments, the tubular implement 10 can include axial structural rigidity to facilitate advancement of the tubular implement 10 without buckling. In some embodiments, the tubular implement 10 can also have an internal diameter to facilitate high flow rates of fluid infusion and / or blood withdrawal. Unlike prior art tubular implements, the tubular implement 10 can provide a gentle, soft contact between the tubular implement 10 and the vein wall while providing axial structural rigidity and high flow rates, which can reduce damage to the vein wall. In some embodiments, the tubular implement 10 can also withstand flexural bending.
[0047] In some embodiments, the tubular implement 10 can include an annular wall 12. In some embodiments, the annular wall 12 can include a distal end 14 and a proximal end 16. In some embodiments, the annular wall 12 can form a lumen 18, which can extend through the distal end 14 of the annular wall 12 and / or the proximal end 16 of the annular wall 12. In some embodiments, the tubular implement 10 can include a distal opening 20, which can be disposed within the distal end 14 of the annular wall 12.
[0048] In some embodiments, distal opening 20 can be aligned with longitudinal axis 22 of tubular implement 10. In other embodiments, a portion of distal end 14 aligned with longitudinal axis 22 can be closed, and distal opening 20 can be disposed laterally of longitudinal axis 22 through annular wall 12. In some embodiments, distal end 14 can include one or more diffusion holes (not shown) that can extend through annular wall 12. In some embodiments, the diffusion holes can be disposed proximally of distal opening 20. In some embodiments, distal end 14 can be blunt, tapered, or otherwise suitably shaped.
[0049] Referring now to Figures 2A-2F In some embodiments, tubular implement 10 can include one or more strips 24 that can be disposed within annular wall 12. In some embodiments, strips 24 can include long, narrow bands or strips. In some embodiments, each of strips 24 can have a uniform or variable diameter along the length of strip 24. In some embodiments, strips 24 can allow annular wall 12 to be thinner for high flow rates through tubular implement 10 without increasing the sharpness of distal end 14 and the risk of causing damage to a vein.
[0050] In some embodiments, strips 24 can extend along all or a portion of the length of annular wall 12 between distal end 14 and proximal end 16. In some embodiments, strips 24 can extend proximally from distal end 14 of annular wall 12. In some embodiments, a distal-most portion of each of strips 24 can be spaced apart from a distal-most surface of distal end 14. In these embodiments, strips 24 can extend proximally from a location proximally of distal opening 20 but within distal end 14 of distal opening 20, which can increase the softness of the distal-most portion of distal end 14 that can contact the vein wall of a patient. In these embodiments, annular wall 12 can encapsulate or completely enclose strips 24. In some embodiments, strips 24 can extend proximally from distal opening 20 and / or a distal-most surface of distal end 14. In some embodiments, strips 24 can be parallel or substantially parallel to longitudinal axis 22 of tubular implement 10.
[0051] In some embodiments, the number of strips 24 can vary. In some embodiments, one to three strips 24 can be disposed within annular wall 12. In some embodiments, more than three strips 24 can be disposed within annular wall 12. As shown in Figure 2A some embodiments, tubular implement 10 can include four strips 24. In some embodiments, each of strips 24 can be spaced apart around annular wall 12. In some embodiments, each of strips 24 can be uniformly spaced apart around annular wall 12, for example, as shown inFigure 2A In some embodiments, the outer circumference of each of the individual bars 24 can be surrounded along all or a portion of its length by the annular wall 12, for example, as shown in Figure 2A
[0052] In some embodiments, the bars 24 can be co-extruded within the annular wall 12. In some embodiments, the bars 24 can be composed of a first material and the annular wall 12 can be composed of a second material. In some embodiments, the first material can have a greater hardness than the second material. Thus, in some embodiments, the bars 24 can be more rigid than the annular wall 12.
[0053] In some embodiments, the first material can be thermoplastic. In some embodiments, the first material can include an elastomer, polyurethane, polyurethane, nylon, polyimide, silicone, or another suitable polymer. In some embodiments, the first material can include a metal. In some embodiments, each of the individual bars 24 can include a wire that can be composed of a metal. In some embodiments, the wire can be configured to hold the tubular device 10 in a curved position in response to the wire being bent, which can position the tubular device 10 away from the vein wall or valve and into the center of the vein.
[0054] In some embodiments, the second material can be thermoplastic. In some embodiments, the second material can include polypropylene, polyurethane, polyurethane, nylon, polyimide, silicone, or another suitable polymer. In some embodiments, the second material can be similar to the first material but less dense.
[0055] In some embodiments, the bars 24 can provide rigidity to the tubular device 10, which can aid the tubular device 10 in passing through a catheter assembly and beyond the distal tip of the catheter without buckling. In some embodiments, the second material can be disposed on all or a portion of the outer surface and outer circumference of the tubular device 10, which can provide a softer contact surface with the vasculature.
[0056] In some embodiments, the annular wall 12 can include an inner surface 30 and an outer surface 32. In some embodiments, the inner surface 30 can be proximate to the lumen 18 of the tubular device 10. In some embodiments, the inner surface 30 can be cylindrical and / or the bars 24 can protrude to form ribs 34 on the outer surface 32. In some embodiments, the outer surface 32 can be cylindrical except for the ribs 34 formed by the bars 24 on the outer surface 32.
[0057] In some embodiments, the outer surface 32 can be cylindrical and / or the bars 24 can protrude to form ribs 34 on the inner surface 30, for example, as shown in Figures 2B-2C as shown. In some embodiments, the inner surface 30 can be cylindrical, except for the ribs 34 on the inner surface 30 formed by the bar member 24. In some embodiments, the tubular device 10 can include no more than one bar member 24, for example, as shown in Figure 2C In some embodiments, the ribs 34 can reduce contact between the toroidal wall 12 and the vein wall. In some embodiments, the bar member 24 can extend through the toroidal wall 12, for example, as shown in Figure 2D
[0058] In some embodiments, the distal end 14 of the toroidal wall 12 can include a first toroidal layer 36 and a second toroidal layer 38, for example, as shown in Figure 2E In some embodiments, the first toroidal layer 36 can be disposed within the second toroidal layer 38. In some embodiments, the second toroidal layer 38 can enclose the first toroidal layer 36. In some embodiments, the first toroidal layer 36 can be composed of a first material. In some embodiments, the second toroidal layer 38 can be composed of a second material. In some embodiments, the first material can have a greater durometer than the second material.
[0059] In some embodiments, the first toroidal layer 36 and the second toroidal layer 38 can be co-extruded concentrically. In some embodiments, the first toroidal layer 36 can have a uniform or variable thickness along the length of the first toroidal layer 36. In some embodiments, the second toroidal layer 38 can have a uniform or variable thickness along the length of the second toroidal layer 38.
[0060] In some embodiments, the first toroidal layer 36 and / or the second toroidal layer 38 can extend along all or a portion of the length of the toroidal wall 12 between the distal end 14 and the proximal end 16. In some embodiments, the first toroidal layer 36 and / or the second toroidal layer 38 can extend proximally from the distal end 14 of the toroidal wall 12. In some embodiments, the distal most portion of each of the first toroidal layer 36 can be spaced apart from the distal most surface of the distal end 14. In these embodiments, the first toroidal layer 36 can extend proximally from a location near the distal opening 20 but proximally of the distal opening within the distal end 14, which can increase the softness of the distal most portion of the distal end 14, which can contact the vein wall of a patient. In some embodiments, the first toroidal layer 36 and / or the second toroidal layer 38 can extend proximally from the distal most surface of the distal opening 20 and / or the distal end 14.
[0061] As shown, for example, in Figure 2F In some embodiments, the distal end 14 of the annular wall 12 can include a third annular layer 40, which can be disposed within the first annular layer 36 and the second annular layer 38. In some embodiments, the first annular layer 36 can surround and be proximal to the third annular layer 40. In some embodiments, the third annular layer 40 can be composed of a second material or a third material. In some embodiments, the first material can 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 can be co-extruded concentrically.
[0062] Referring now to Figures 3A-3D , a tubular implement 10 is shown, in accordance with some embodiments. In some embodiments, the first annular layer 36 and / or the second annular layer 38 can have a variable thickness along the length of the tubular implement 10. In some embodiments, the stiffness of the tubular implement 10 can gradually increase in the proximal direction. Thus, the rigidity of the distal end 14 can be greater than the proximal end 16, which can facilitate a gentle, soft contact between the distal end 14 and the vein wall, while also preventing buckling.
[0063] As shown, for example, in Figure 3B , at a first location along the length of the tubular implement 10, the thickness of the second annular layer 38 can be greater than the thickness of the first annular layer 36. As shown, for example, in Figure 3C , at a second location along the length of the tubular implement 10, the thickness of the second annular layer 38 can be the same as the thickness of the first annular layer 36. In some embodiments, the second location can be proximal to the first location. As shown, for example, in Figure 3D , at a third location along the length of the tubular implement 10, the thickness of the second annular layer 38 can be less than the thickness of the first annular layer 36. In some embodiments, the third location can be proximal to the second location.
[0064] Referring now to Figures 4A-4B , in some embodiments, the distal most portion of each of the struts 24 can be spaced apart from the distal most surface of the distal end 14. In these and other embodiments, the inner surface 30 can be cylindrical and / or the struts 24 can protrude to form ribs 34 on the outer surface 32. In some embodiments, the outer surface 32 can be cylindrical except for the ribs 34 formed by the struts 24. In some embodiments, the portion of the tubular implement 10 that includes the struts 24 can have a greater outer diameter than the portion of the tubular implement 10 that does not include the struts 24, such as the portion of the tubular implement 10 proximal to the distal most surface of the distal end 14.
[0065] Referring now to Figures 5A-5BIn some embodiments, the outer surface of the distal end 14 of the tubular device 10 can include a plurality of grooves 42, which can improve the flexibility of the distal end 14. In some embodiments, the grooves 42 can include arcuate slots. In some embodiments, the grooves 42 can extend around a portion of the outer circumference of the distal end 14. In some embodiments, the tubular device 10 can be formed by single material or multi-material extrusion. In some embodiments, the tubular device 10 can be composed of a single material (e.g., the first material) along the entire length of the tubular device 10 between the distal end 14 and the proximal end 16.
[0066] Referring now to Figure 6 In some embodiments, the annular wall 12 can 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 can be composed of the first material. In some embodiments, the second annular section 46 can be composed of the second material. In some embodiments, the first material and the first annular section 34 can have a greater hardness than the second material and the second annular section 46.
[0067] In some embodiments, the second annular section 46 can be disposed at the distal-most portion of the distal end 14, which can provide a gentle, soft contact between the tubular device 10 and the vein wall. In some embodiments, the second annular section 46 can include the distal opening 20. In some embodiments, the first annular section 44 can have a greater thickness than the second annular section 46, which can provide increased rigidity or hardness of the first annular section 44 compared to the second annular section 46.
[0068] In some embodiments, the first annular section 44 can include one or more of the struts 24 (e.g., see Figures 2A-2D ) that can be co-extruded within the first annular section 44. In some embodiments, the struts 24 can be parallel to the longitudinal axis of the tubular device 10. In some embodiments, the struts 24 can be composed of the first material. In some embodiments, the annular wall 12 of the second annular section 46 and / or the first annular section 44 can be composed of the second material.
[0069] In some embodiments, the first annular section 44 can be proximate to the second annular section 46, and there can be an abrupt change between the first annular section 44 and the second annular section 46, e.g., via bonding or other suitable methods. In these embodiments, the first annular section 44 and the second annular section 46 can be joined together without a third annular section 48. In some embodiments, the first annular section 44 and the second annular section 46 can be a continuous structure or formed by continuous extrusion.
[0070] In some embodiments, the annular wall 12 may include a third annular segment 48 between the first annular segment 44 and the second annular segment 46. In some embodiments, the third annular segment 48 may be adjacent to the first annular segment 44 and the second annular segment 46. In some embodiments, one or more of the first annular segment 44, the second annular segment 46, and the third annular segment 48 may extend inward from the outer surface of the tubular device 10 into the lumen 18.
[0071] In some embodiments, the third annular segment 48 may transition from the first annular segment 44 to the second annular segment 46. In some embodiments, the third annular segment 48 may have a hardness between that of the first annular segment 44 and the second annular segment 46. In some embodiments, the third annular segment 48 may include a joint connecting the first annular segment 44 to the second annular segment 46. In some embodiments, the joint may be formed via solvent bonding, adhesive bonding, forging, ultrasonic welding, tipping, or other suitable methods.
[0072] In some embodiments, the tubular device 10 can be coupled to any suitable delivery device. In some embodiments, the conduit of the conduit assembly may include conduits related to... Figures 1-6 The tubular apparatus 10 described has one or more features of one or more tubular apparatuses. Figure 7FIGS. 8a-8c illustrate several non-limiting examples of delivery devices. In some embodiments, the delivery devices can be further described in U.S. Patent Application No. 16 / 037,246, filed July 17, 2018, entitled EXTENSION HOUSING A PROBE 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, U.S. Patent Application No. 16 / 502,541, filed July 3, 2019, entitled DELIVERY DEVICE FOR A VASCULAR ACCESS INSTRUMENT, U.S. Patent Application No. 16 / 691,217, filed November 21, 2019, entitled SYRINGE-BASED DELIVERY DEVICE FOR A VASCULAR ACCESS INSTRUMENT, U.S. Patent Application No. 16 / 742,013, filed January 14, 2020, entitled CATHETER DELIVERY DEVICE AND RELATED SYSTEMS AND METHODS, and U.S. Patent Application No. 16 / 838,831, filed April 2, 2020, entitled VASCULAR ACCESS INSTRUMENT HAVING A FLUID PERMEABLE STRUCTURE AND RELATED DEVICES AND METHODS, all of which are incorporated by reference herein in their entireties.
[0073] Referring now to Figure 7 In some embodiments, the delivery device 50 can deliver the tubular instrument 10 into a catheter of a catheter assembly, such as Figure 8A and 8Ccatheter assembly 64. According to some embodiments, the catheter assembly 64 is shown in Figure 8A and 8C In some embodiments, the delivery device 50 can include an extension that can be proximal to and / or coupled to a catheter adapter of a catheter assembly. In some embodiments, the extension can include an adapter 52 that can be coupled to a proximal end of the tubular implement 10. In some embodiments, the adapter 52 can correspond to a Becton Dickinson a single-use holder or similar holder.
[0074] In some embodiments, the adapter 52 can be configured to move along the slot 54 in the housing 56 from a proximal position to a distal position and / or from the distal position to the proximal position. In some embodiments, in response to the adapter 52 moving along the slot 54 from the proximal position to the distal position, the tubular implement 10 can be advanced beyond a distal end of the housing 56. In some embodiments, in response to the adapter 52 moving along the slot 54 from the distal position to the proximal position, the tubular implement 10 can be withdrawn into the housing 56.
[0075] In some embodiments, the extension can include an advancement tab 58 that can be coupled to a proximal end of the tubular implement 10 and / or the adapter 52. In some embodiments, a clinician can pinch or grasp the advancement tab 58 to move the tubular implement 10 to a proximal position and / or a distal position. In some embodiments, when the adapter 52 is disposed in the distal position, the tubular implement 10 can be advanced beyond a distal end of the housing 56. In some embodiments, the advancement tab 58 can be disposed in any number of positions.
[0076] In some embodiments, a distal end of the housing 56 can include a coupling mechanism 60 that can couple the delivery device 50 with a catheter assembly. In some embodiments, the coupling mechanism 60 can include a luer fitting.
[0077] Referring now to Figures 8A-8C , the delivery device 62 can be coupled to a catheter assembly 64. In some embodiments, the catheter assembly 64 can include a catheter adapter 66 and a catheter 68 that can extend distally from the catheter adapter 66. In some embodiments, the catheter 68 can be fixed within the catheter adapter 66. In some embodiments, the catheter 68 can include a peripheral intravenous catheter (“PIVC”), a peripheral inserted central catheter (“PICC”), or a midline catheter.
[0078] In some embodiments, the delivery device 62 can be directly coupled to the proximal end of the catheter adapter 66. In these and other embodiments, the catheter assembly 64 can comprise a straight or non-integrated catheter assembly. In some embodiments, the delivery device 62 can 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 can comprise an integrated catheter assembly. In more detail, in some embodiments, the catheter adapter 66 of the catheter assembly 64 can comprise an integrated extension tube, such as the BD NEXIVA Figure 8A closed IV catheter system, the BD NEXIVA TM closed IV catheter system, the BD NEXIVA TM DIFFUSICS TM closed IV catheter system, or the BD PEGASUS TM safety closed IV catheter system.
[0079] In some embodiments, the delivery device 62 can comprise a rotation element 72 and a housing 74. In some embodiments, in response to rotation of the rotation element 72 relative to the housing 74 in a first direction, the distal end 14 of the tubular implement 10 can be advanced beyond the distal end 76 of the catheter 68. In some embodiments, in response to rotation of the rotation element 72 relative to the housing 74 in the first direction, the distal end 14 of the tubular implement 10 can be disposed in a first position relative to the catheter assembly 64. An example first position is shown in FIG. 8B.
[0080] In some embodiments, in response to further rotation of the rotation element 72 relative to the housing 74 in the first direction, the distal end 14 of the tubular implement 10 can be disposed in a second position relative to the catheter assembly 64. In some embodiments, the second position can be distal to the first position. An example second position is shown in FIG. 8C. In some embodiments, the tubular implement 10 can be continuously advanced in the distal direction as the rotation element 28 is continuously rotated.
[0081] In some embodiments, in response to rotation of the rotation element 72 relative to the housing 74 in the first direction, the distal end 14 of the tubular implement 10 can be disposed a first amount beyond the distal end 76 of the catheter 68. In some embodiments, in response to further rotation of the rotation element 72 relative to the housing 74 in the first direction, the distal end 14 of the tubular implement 10 can be disposed a second amount beyond the distal end 76 of the catheter 68. In some embodiments, the second amount can be greater than the first amount.
[0082] In some embodiments, the rotation element 72 can also be rotated relative to the housing 74 in a second direction opposite the first direction. In some embodiments, in response to rotation of the rotation element 72 relative to the housing 74 in the second direction, the distal end 14 of the tubular implement 10 can be moved proximally.
[0083] In some embodiments, the rotating element 72 can include a bearing surface or groove 78 that can extend around at least a portion of the circumference of the rotating element 72. In some embodiments, the groove 78 can include a width that is approximately equal to or slightly greater than the tubular implement 10, which can facilitate bearing of the tubular implement 10.
[0084] All examples and conditional language recited herein are intended for pedagogical purposes to aid the reader in understanding the present application and the concepts contributed by the inventor to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions.
Claims
1. A delivery device to deliver a tubular instrument into a catheter, the delivery device comprising: the tubular instrument formed only of an annular wall and a plurality of strips, wherein: the annular wall comprises a distal end and forms a lumen and a distal opening within the distal end of the annular wall; wherein the plurality of strips are disposed within the annular wall so as to be completely embedded in the annular wall and extend proximally from the distal end of the annular wall, wherein the plurality of strips are co-extruded within the annular wall, wherein the plurality of strips are comprised of a first material, wherein the annular wall is comprised of a second material, wherein the first material has a higher durometer than the second material; wherein each of the plurality of strips extends proximally within the annular wall from a location proximal of the distal opening to a proximal end of the annular wall, such that a distal-most portion of the annular wall does not include the plurality of strips, and such that the distal-most portion of the annular wall has an increased softness as compared to the remaining proximal portion of the annular wall having the plurality of strips therein, and wherein a portion of the distal end aligned with a longitudinal axis of the tubular instrument is closed, and the distal opening is formed through the annular wall and disposed lateral to the longitudinal axis.
2. The delivery device of claim 1, wherein, each of the plurality of strips is parallel to a longitudinal axis of the tubular instrument.
3. The delivery device of claim 1, wherein, an outer circumference of each of the plurality of strips is surrounded by the annular wall.
4. The delivery device of claim 3, wherein, the annular wall comprises an inner surface and an outer surface, wherein each of the plurality of strips protrudes to form a rib on the outer surface.
5. The delivery device of claim 3, wherein, the annular wall comprises an inner surface and an outer surface, wherein each of the plurality of strips protrudes to form a rib on the inner surface.
6. The delivery device of claim 1, wherein, the plurality of strips are evenly spaced around the annular wall.
7. The delivery device of claim 1, wherein, each of the plurality of strips comprises a wire configured to hold the tubular instrument in a curved position.
Citation Information
Patent Citations
Syringe-based delivery device for a vascular access instrument
US11337628B2
Instrument delivery device having a rotary element
US12226595B2
Extension housing a probe or intravenous catheter
US20190021640A1
Multi-diameter catheter and related devices and methods
US20190321590A1
Delivery device for a vascular access instrument
US20200016374A1