Expansion set with opening device

Abstract

An expansion set is provided that includes an opening device for interfacing with an intravenous device or the like. [Solution] The expansion set may include a tube, which may have a distal end, a proximal end, and an outer surface. The expansion set may include a distal connector coupled to the distal end of the tube and / or a proximal connector coupled to the proximal end of the tube. The expansion set may include a patency instrument disposed within the tube. The expansion set may include a translation handle coupled to the outer surface of the tube. The translation handle may be configured to move between a proximal position and a distal position along the outer surface of the tube to translate the distal end of the patency instrument between a retracted position and an advanced position. In response to the distal end of the patency instrument being in the advanced position, the distal end of the patency instrument may extend beyond the distal end of the tube.

Description

[Technical Field]

[0001] The present invention relates to an expansion set with an opening tool for interfacing with an intravenous device or the like. [Background technology]

[0002] Patency is the state or property of a fluid channel within a patient's body being free of blockage. In particular, an intravenous (IV) device may have a certain level of patency if fluids, such as blood or medications, can pass through the IV device. During use of an IV device, the IV device is inserted into a patient's blood vessel, and in some embodiments, the needle is withdrawn from the catheter while the catheter remains within the patient's blood vessel. In some cases, the IV device remains within the patient's blood vessel for 30 days or more. This allows a clinician or other healthcare provider (HCP) to fluidly access the patient's bloodstream during care. This continuous fluid access to the patient's bloodstream allows the clinician or other HCP to withdraw one or more blood samples or administer one or more infusions, such as saline, various medications, and total parenteral nutrition, as needed.

[0003] The patency of the IV device, however, can be compromised while the IV device is in the patient's blood vessel. Blockage can persist, causing the IV device to fail and necessitating the administration of another IV device into the patient's body. This can increase the trauma felt by the patient and can lead to other medical problems, such as vascular inflammation, among other medical problems.

[0004] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is provided only to illustrate one example technology area where some implementations described herein may be practiced. Summary of the Invention [Means for solving the problem]

[0005] The present disclosure generally relates to an expansion set used to interface with an IV device, providing a fluid pathway to the IV device while also providing a patency instrument used to periodically check or improve the patency of the IV device while the IV device is in a patient's blood vessel. In some embodiments, the expansion set can include a tube, which can include a distal end, a proximal end, a lumen extending between the distal and proximal ends, and an exterior surface. In some embodiments, the tube can include or correspond to any suitable housing including a lumen extending therethrough.

[0006] In some embodiments, the expansion set can include a distal connector coupled to the distal end of the tube. In some embodiments, the expansion set can include a proximal connector coupled to the proximal end of the tube. In some embodiments, the expansion set can include a patency device disposed within the tube. In some embodiments, the patency device can include a guidewire or another suitable patency enhancing structure.

[0007] In some embodiments, the expansion set may include a translation handle coupled to an outer surface of the tube. In some embodiments, the translation handle may be configured to move along the outer surface of the tube between a proximal position and a distal position to translate the distal end of the patency instrument between a retracted position and an advanced position. In some embodiments, in response to the distal end of the patency instrument being in the advanced position, the distal end of the patency instrument may extend beyond the distal end of the tube.

[0008] In some embodiments, the expansion set may include a coupling element disposed within the tube. In some embodiments, the patency instrument may extend distally from the coupling element. In some embodiments, the translation handle may compress a portion of the tube between the coupling element and the translation handle. In some embodiments, the portion of the tube engages the coupling element such that movement of the translation handle along the outer surface of the tube translates the coupling element within the tube and moves the distal end of the patency instrument between the retracted and advanced positions. In some embodiments, the translation handle may include multiple ball bearings or multiple wheels to provide localized compression of the tube to engage the coupling element.

[0009] In some embodiments, the expansion set may include another tube. In some embodiments, the another tube may include or correspond to any suitable housing including a lumen extending therethrough. In some embodiments, the another tube may be disposed within the tube and extend through the coupling element. In some embodiments, the space between the another tube and the tube is sealed to prevent fluid from entering the space. In some embodiments, the another tube may form a fluidic channel, and the space may correspond to a non-fluidic channel. In some embodiments, the patency device may extend through the space.

[0010] In some embodiments, the expansion set can include a seal adjacent the distal end of the tube. In some embodiments, the seal can be disposed within the distal connector and / or within the distal end of the tube. In some embodiments, other tubing and patency instruments can extend through the seal. In some embodiments, the distal end of the space can be sealed by the seal, preventing fluid from entering the space.

[0011] In some embodiments, the expansion set may include one or more fluid pathways disposed within the wall of the tube. In some embodiments, the lumen may be sealed from the fluid pathway, which may correspond to a fluid channel, and the patency device may extend through the lumen, which may correspond to a non-fluid channel. In some embodiments, the fluid pathway may form a protrusion into the lumen of the tube. In some embodiments, the outer surface of the coupling element may include one or more grooves aligned with the protrusions. In some embodiments, the grooves may extend through the coupling element. In some embodiments, the seal may include a hole aligned with the fluid pathway to seal the lumen from the fluid pathway.

[0012] In some embodiments, a method of providing access to a patient's vasculature can include coupling an expansion set to a catheter assembly or another IV device. In some embodiments, coupling the expansion set to the catheter assembly can include coupling a distal end of a tube to the catheter assembly. In some embodiments, the method can include moving a translation handle along the tube from a proximal position to a distal position. In some embodiments, in response to the translation handle moving to the distal position, the distal end of the patency instrument can extend beyond the distal end of the tube and into the catheter assembly and / or the patient's vasculature. In these embodiments, the patency instrument can extend beyond the distal end of the catheter of the catheter assembly.

[0013] In some embodiments, the method may include moving the translating handle along the tubing from a proximal position to a distal position before coupling the blood collection device to the proximal connector. In some embodiments, the method may include moving the translating handle from the distal position to the proximal position after drawing blood into the blood collection device. In some embodiments, in response to moving the translating handle from the distal position to the proximal position, the distal end of the patency instrument may be retracted into the tubing.

[0014] It is to be understood that both the foregoing general description and the following detailed description are examples and explanations only and are not intended to limit 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 the embodiments may be combined or alternative embodiments may be utilized, and that structural changes may be made without departing from the scope of the various embodiments of the present invention, unless otherwise claimed. Therefore, the following detailed description is not to be taken in a limiting sense. [Brief explanation of the drawings]

[0015] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Figure 1A] 1 is a top perspective view of an exemplary expansion set showing an exemplary patency device in a retracted position, according to some embodiments. [Figure 1B] 1B is a top perspective view of the expansion set of FIG. 1A showing the patency device in an advanced position, according to some embodiments. [Figure 1C] 1B is a cross-sectional view of a portion of the expansion set of FIG. 1A according to some embodiments. [Figure 1D] 1D is a cross-sectional view of the expansion set of FIG. 1B taken along line 1D-1D of FIG. 1B, according to some embodiments. [Figure 2A] FIG. 10 is a top perspective view of another exemplary expansion set showing an exemplary patency device in a retracted position, according to some embodiments. [Figure 2B] 2B is a cross-sectional view of the expansion set of FIG. 2A taken along line 2B-2B, according to some embodiments. [Figure 2C] 2B is another cross-sectional view of the expansion set of FIG. 2A taken along line 2B-2B, according to some embodiments. [Figure 2D] 2B is a top perspective view of the expansion set of FIG. 2A showing another exemplary patency device in an advanced position and an exemplary distal connector removed for illustrative purposes, according to some embodiments. [Figure 2E] FIG. 2E is a cross-sectional view of the expansion set of FIG. 2A taken along line 2E-2E, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0016] As used herein, the terms "proximal" and "distal" can refer to directions toward and away from, respectively, a clinician who brings the catheter system into contact with a patient. Thus, for example, the end of the catheter system that first contacts the patient's body would be the distal end, and the opposite end of the catheter system would be the proximal end of the catheter system.

[0017] 1A-1C, in some embodiments, expansion set 10 may include tube 12, which may include a distal end 14, a proximal end 16, a lumen 18 extending between distal end 14 and proximal end 16, and an exterior surface 20. In some embodiments, tube 12 may include or correspond to any suitable housing including a lumen extending therethrough.

[0018] In some embodiments, the expansion set 10 may include a distal connector 22 coupled to the distal end 14 of the tubing 12. In some embodiments, the distal connector 22 may include a male luer connector, a female luer connector, a blunt cannula and opposing lever arms (e.g., as shown in FIGS. 1A-1B), or another suitable connector configured to couple to a catheter assembly or another IV device. In some embodiments, the expansion set 10 may include a proximal connector 24 coupled to the proximal end 16 of the tubing 12. In some embodiments, the proximal connector 24 may include a male luer connector, a female luer connector, a needleless access connector, a blunt cannula and opposing lever arms (e.g., as shown in FIGS. 1A-1B), or another suitable connector. In some embodiments, the proximal connector 24 may include a luer and / or may be coupled to a needleless access connector, such as via threading, bonding, or another suitable method.

[0019] In some embodiments, the expansion set 10 may include a patency device 26 disposed within the tube 12. In some embodiments, the patency device 26 may include a guidewire or another suitable patency enhancing structure. In some embodiments, the guidewire may be generally configured as a wire, a spring, a combination of a wire and a spring, and / or the like. In some embodiments, the expansion set 10 may include a translation handle 28 coupled to the outer surface 20 of the tube 12.

[0020] In some embodiments, the translation handle 28 may include any suitable translation handle or grip to facilitate the patency of the instrument. 26 The translation handle 28 and / or patency instrument may include any suitable patency instrument. 26 This is described in further detail, for example, in U.S. patent application Ser. No. 17 / 127,588, filed December 18, 2020, entitled "FLUSH PATENCY INSTRUMENT WITH BLOOD EXPOSURE PROTECTION AND RELATED METHODS," and U.S. patent application Ser. No. 17 / 127,623, filed December 18, 2020, entitled "MULTI-LUMEN EXTENSION SYSTEM," both of which are incorporated by reference in their entireties.

[0021] In some embodiments, the translation handle 28 can be configured to be moved between a proximal and a distal position along the outer surface 20 of the tube 12 to translate the distal end 30 of the patency instrument 26 between a retracted position and an advanced position. In some embodiments, in response to the distal end 30 of the patency instrument 26 being in the advanced position, the distal end 30 of the patency instrument 26 can extend beyond the distal end 14 of the tube 12 and the distal connector 22.

[0022] In some embodiments, the patency device 26 extends from a coupling element 32 disposed within the tube 12. In some embodiments, the proximal end of the patency device 26 may be secured within the coupling element 32. In some embodiments, the patency device 26 may extend distally from the coupling element 32. In some embodiments, the patency device 26 may extend distally from the coupling element 32 to facilitate translation of the patency device 26 within the tube 12 without the need for direct contact.

[0023] In some embodiments, the translation handle 28 may compress a portion of the tube 12 between the coupling element 32 and the translation handle 28. In some embodiments, a portion of the tube 12 engages the coupling element 32, such that movement of the translation handle 28 along the outer surface 20 of the tube 12 translates the coupling element 32 within the tube 12, and the distal end 30 of the patency device 26 is moved between a retracted position and an advanced position. In some embodiments, the translation handle 28 may include multiple main portions 34, which may include ball bearings, wheels, low-friction sliders, or other suitable features to provide localized compression of the tube to engage the coupling element. In some embodiments, the main portions 34 may be coupled to the translation handle 28. In some embodiments, the main portions 34 may be directly coupled to the translation handle 28. In some embodiments, the main portions 34 and the translation handle 28 may be molded together or monolithically formed as a single unit. In some embodiments, the main portions 34 and the translation handle 28 may be integrated or mated together.

[0024] In some embodiments, the main portion 34 may include a clamping mechanism and may be positioned to pinch or press against the outer surface of the tube 12. In some embodiments, one or more of the main portions 34 may be opposite or on either side of the tube 12 as one or more other of the main portions 34. In some embodiments, the inner surface of the tube 12 within the translation handle 28 may be too small for the coupling element 32 to pass therethrough. In some embodiments, the main portion 34 may include a wheel, which may be rotatably coupled to the translation handle 28. In some embodiments, the main portion 34 may include a ball bearing, which may be rotatable within a socket formed in the translation handle 28. In some embodiments, the main portion 34 may include a slider, which may be smooth and / or constructed of plastic and may slide along the tube 12. In some embodiments, the slider may be fixed or stationary relative to the translation handle.

[0025] In some embodiments, the translation handle 28 may extend partially (e.g., a C-channel) or completely around the tube 12. In some embodiments, the translation handle 28 may include a collar. In some embodiments, the coupling element 32 may be magnetically attracted to the translation handle 28 through the tube 12 to facilitate movement of the patency instrument 26 without direct contact.

[0026] In some embodiments, the expansion set 10 may include another tube 36. In some embodiments, the another tube 36 may include or correspond to any suitable housing including a lumen extending therethrough. In some embodiments, the another tube 36 may be disposed within the tube 12 or may extend through the coupling element 32. In some embodiments, the space 38 between the another tube 36 and the tube 12 may be sealed to prevent fluid from entering the space 38. In some embodiments, the another tube 36 may form a fluidic channel, and the space 38 may correspond to a non-fluidic channel. In some embodiments, the patency device 26 may extend through the space 38. In some embodiments, the space 38 may be part of the lumen 18 and / or the annulus.

[0027] In some embodiments, expansion set 10 may include a seal 40 adjacent distal end 14 of tube 12. In some embodiments, seal 40 may be elastomeric. In some embodiments, seal 40 may be disposed within distal connector 22 and / or within distal end 14 of tube 12. In some embodiments, the distal end of space 38 may be sealed by seal 40 to prevent fluid from entering space 38.

[0028] In some embodiments, the lumen 18, such as the space 38, may include a vent to allow air flow into and out of the lumen 18, thereby facilitating movement of the translation handle 28 and coupling element 32. In some embodiments, one or more vents for providing a vent may be reduced in size to allow air movement while still maintaining good sterility protection of the patency instrument 26 and / or other portions of the expansion set 10.

[0029] In some embodiments, the patency device 26 may be centered within the tube 12, which facilitates smooth advancement of the patency device 26. In these and other embodiments, the separate tube 36 may be off-center within the tube 12. In some embodiments, the patency device 26 may be off-center within the tube 12 and / or the separate tube 36 may be centered within the tube 12.

[0030] In some embodiments, the outer surface of the coupling element 32 and / or the inner surface of the tube 12 may include a lubricant to facilitate translation of the patency device 26 within the tube 12. In some embodiments, the outer surface of the tube 12 and / or the main portion 34 may include a lubricant. In some embodiments, one or more of the coupling element 32, the tube 12, and the main portion 34 may be composed of a lubricious material, such as PEG polyurethane, siliconized polyurethane, fluorinated polyurethane, silicone, or another suitable material for reducing friction.

[0031] In some embodiments, the tubing 12 may be flexible. In some embodiments, the outer surface 20 of the tubing 12 may include one or more visual markings or tactile elements (such as detents, grooves, ribs, etc.) to provide user feedback regarding the position of the patency instrument 26 relative to the IV device. In some embodiments, the inner surface of the coupling element 32 and / or the outer surface of the other tube 36 may include a lubricant, which may facilitate movement of the coupling element 32 relative to the other tube 36, which may be stationary. In some embodiments, the distal end and / or proximal end of the other tube 36 may be secured within the expansion set 10. In some embodiments, the proximal end of the other tube 36 may be wedged or secured within the proximal connector 24, such that blood does not enter the space between the proximal connector 24 and the other tube 36. 38 cannot flow into

[0032] 1D , in some embodiments, the further tube 36 and the patency instrument 26 may extend through the seal 40, and the seal 40 may contact the edges of the further tube 36 and the patency instrument 26, preventing fluid from flowing between the seal 40 and the further tube 36 and between the seal 40 and the patency instrument 26. In some embodiments, the distal end 30 of the patency instrument 26 may be proximal to the seal 40 in response to the translation handle 28 being in a proximal position, which may include a fully retracted position. In these and other embodiments, the patency instrument 26 extends through the seal 40 in response to movement of the translation handle 28 from the proximal position to the distal position.

[0033] 2A-2B, an expansion set 42 is shown according to some embodiments. In some embodiments, the expansion set 42 may be similar to or identical to the expansion set 10 in one or more features and / or operation. In some embodiments, the expansion set 42 may include one or more fluid pathways 44 disposed within a wall 46 of the tube 12. In some embodiments, the lumen 18 may be sealed from the fluid pathways 44, which may correspond to fluid channels, and the patency device 26 may extend through the lumen 18, which may correspond to non-fluid channels. In some embodiments, the fluid pathways 44 may be disposed in various positions and configurations within the wall 46.

[0034] 2B-2C , in some embodiments, the fluid pathway 44 may form a protrusion 48 into the lumen 18 of the tube 12, and the thickness of the wall 46 may vary. In some embodiments, the fluid pathway 44 may protrude, for example, inward from the wall 46 toward the central axis of the tube 12 or outward from the wall 46 away from the central axis of the tube 12. In some embodiments, the outer surface 50 of the coupling element 32 may include one or more grooves 52 that align with the protrusions 48. In some embodiments, the grooves 52 may extend through the coupling element 32 and may facilitate movement and / or guidance of the coupling element 32 within the tube 12. In some embodiments, a thinner portion of the wall 46 may reduce the force required to translate the patency device 26.

[0035] In some embodiments, the tube 12 may be extruded by a co-extrusion process including a first material and a second material that is harder than the first material. In some embodiments, the first material may form a portion of the tube 12 sandwiched by the main section 34, and the second material may form another portion of the tube 12 adjacent to and / or forming the fluid pathway 44. In some embodiments, the first material and the portion of the tube 12 may be soft or flexible. In some embodiments, the fluid pathway 44 may be created by a multi-lumen extrusion process or may be created as a separate extruded tube that is enclosed within the inner diameter of the tube 12 of a larger non-fluid pathway extension tubing. In some embodiments, the separate extruded tube may be concentrically aligned or offset from the axis of the tube 12. Alternatively, in some embodiments, the fluid pathway 44 may extend from another component of the extension set 42, such as a particular connector or cannula. In some embodiments, the volume of lumen 18 may be larger than the volume of each of fluid paths 44 and may accommodate coupling element 32 .

[0036] 2E, in some embodiments, the seal 40 may include holes 54 aligned with the fluid pathway 44 and may seal the lumen 18 from the fluid pathway 44. In some embodiments, the seal 40 may contact the edge of the patency device 26, preventing fluid from flowing between the seal 40 and the patency device 26.

[0037] In some embodiments, a method of providing access to a patient's vasculature can include coupling an expansion set (such as expansion set 10 described with respect to FIGS. 1A-1D or expansion set 42 described with respect to FIGS. 2A-2E) to a catheter assembly or another IV device. In some embodiments, the catheter assembly can be placed within the patient's vasculature when the expansion set is coupled to the catheter assembly, and the patency device 26 can increase the patency of the catheter assembly throughout its placement time.

[0038] In some embodiments, coupling the expansion set to the catheter assembly can include coupling the distal end 14 of the tube 12 to the catheter assembly. In some embodiments, the method can include moving the translation handle 28 along the tube 12 from a proximal position to a distal position. In some embodiments, in response to the translation handle 28 moving to the distal position, the distal end 30 of the patency device 26 can extend beyond the distal end 14 of the tube 12 and into the catheter assembly and / or the patient's blood vessel. In these embodiments, the patency device 26 can extend beyond the distal end of the catheter of the catheter assembly. In some embodiments, the catheter can include a peripheral IV catheter, a peripherally inserted central catheter, or a midline catheter.

[0039] In some embodiments, the method may include moving the translating handle 28 along the tube 12 from a proximal position to a distal position before coupling the blood collection device to the proximal connector 24. In some embodiments, the blood collection device may include any suitable blood collection device, such as, for example, a VACUTAINER® or VACUTAINER® LUER-LOK™ available from Becton Dickinson and Company of Franklin Lakes, New Jersey. In some embodiments, the blood collection device may be integrated with the proximal connector 24 or monolithically formed as a single unit.

[0040] In some embodiments, the method may include, after drawing blood into the blood collection device, moving the translating handle 28 from a distal position to a proximal position. In some embodiments, in response to moving the translating handle 28 from the distal position to the proximal position, the distal end 30 of the patency instrument 26 may be retracted into the tube.

[0041] In some embodiments, the expansion set may reduce hemolysis of a blood sample drawn through a fluid pathway, which may include another tube 36 (e.g., as discussed with respect to FIGS. 1A-1D) or fluid pathway 44. In some embodiments, the expansion set may provide an adequate fluid flow rate. Blood cells experience shear stress as they flow through a fluid pathway. The greatest shear stress is along the wall of the blood cell, i.e., wall shear stress. Wall shear stress on blood cells is considered the primary source of mechanical damage to blood cells. For a cylindrical fluid pathway, wall shear stress is typically expressed as:

number

[0042] The time required to fill a blood collection tube of a particular volume, V, at a flow rate, Q, can be easily evaluated by the following formula:

number

number

[0043] In principle, the hemolysis index is related to the pressure gradient and the cross-sectional characteristic dimensions.

number

[0044] In some embodiments, the length of the separate tube 36 and / or fluid path 44 may be selected based on one or more of the following: the gauge of the particular catheter, the particular catheter assembly configuration, or the clinical setting. 26may include a length L. In some embodiments, the further tube 36 and / or the fluid pathway 44 may include an inner diameter D.

[0045] Fluid flow within a fluid path (such as the fluid flow of another tube 36 and / or fluid path 44) can be analyzed using Poiseuille's equation if the fluid path is tubular.

number

[0046] In some embodiments, the fluid path may have multiple sections with lengths (L1, L2, L3) and inner diameters (D1, D2, D3), with geometric coefficients as follows:

number

number

number

[0047] G of the fluid path f The values ​​are selected to reduce the maximum shear stress for each catheter gauge and can be made equal to or less than the maximum shear stress of the BD21G VACUTAINER® UltraTouch™ push-button blood collection set (available from Becton, Dickinson and Company, Franklin Lakes, NJ), previously considered the gold standard for blood collection. In some embodiments, the G f The values ​​were selected to reduce the maximum shear stress for each catheter gauge, allowing it to be equal to or less than the maximum shear stress of the BD25G VACUTAINER® UltraTouch™ Push-Button Blood Collection Set (available from Becton, Dickinson and Company, Franklin Lakes, New Jersey).

[0048] In some embodiments, the fluid path of the blood collection system may include one or more of the blood collection device, the separate tubing 36 and / or fluid path 44, and the catheter assembly (which may include an extension tubing), and may comprise the entire blood collection path through which blood flows into or through the blood collection device during blood collection after exiting the vascular system. A system geometric coefficient G for the extension fluid path of the blood collection system fs may be determined in a similar manner to the fluid paths previously described (such as for the separate tubes 36 and / or fluid paths 44). In some embodiments, the system geometric coefficient G fs is 7.34E+06(1 / in) when the translation handle 28 is in the distal position. 3 ) or more. In some embodiments, G fs may include other values. In some embodiments, the system geometric coefficient G fs is 7.34E+06(1 / in 3 ) may be plus or minus 10 percent, plus or minus 25 percent, plus or minus 50 percent, or plus or minus 75 percent. In some embodiments, G fsmay include other values, which may be selected based on the gauge and / or length of the catheter.

[0049] All examples and conditional language set forth herein are intended for educational purposes to aid the reader in understanding the concepts brought forth by the inventors to further the invention and the art, and should be construed as not being limited to such specifically set forth examples and conditions. Although embodiments of the present disclosure have been described in detail, it should be understood that various changes, substitutions, and alterations can be made without departing from the spirit and scope of the disclosed embodiments. [Explanation of symbols]

[0050] 10 Expansion Sets 12 tubes 14 distal end 16 Proximal end 18 lumen 20 Exterior 22 Distal Connector 24 Proximal Connector 26 Patency devices 28 Translation Handle 32 Bonding Elements 34 Main part

Claims

1. a tube including a distal end, a proximal end, a lumen extending between the distal end and the proximal end, and an exterior surface; a distal connector coupled to the distal end of the tube; a proximal connector coupled to the proximal end of the tube; a patency device disposed within the tube and including a distal end and a proximal end; a translation handle coupled to the outer surface of the tube, the translation handle configured to move along the outer surface of the tube between a proximal position and a distal position to translate the distal end of the patency device between a retracted position and an advanced position, wherein in response to the distal end of the patency device being in the advanced position, the distal end of the patency device extends beyond the distal end of the tube; a coupling element disposed within the tube, the proximal end of the patency instrument secured to the coupling element, the patency instrument extending distally from the coupling element, the translation handle compressing a portion of the tube between the coupling element and the translation handle, the portion of the tube engaging the coupling element, such that movement of the translation handle along the outer surface of the tube translates the coupling element within the tube, and the distal end of the patency instrument is moved between the retracted position and the advanced position; and another tube disposed within the tube and serving as a fluid channel extending from the proximal connector through the coupling element and through a seal adjacent the distal end of the tube, wherein a space between the other tube and the other tube is sealed to prevent fluid from entering the space, and the patency device includes the other tube extending through the space. Expansion set.

2. An expansion set as described in claim 1, wherein the other tube and the patency device extend through the seal, and the distal end of the space is sealed by the seal to prevent fluid from entering the space.

3. The expansion set of claim 1 , wherein the patency device comprises a guidewire.

4. The expansion set of claim 1 , wherein the translating handle includes multiple ball bearings, multiple wheels, or multiple sliders to locally compress the tube and engage the coupling element.

5. a tube including a distal end, a proximal end, a lumen extending between the distal end and the proximal end, and an exterior surface; a distal connector coupled to the distal end of the tube; a proximal connector coupled to the proximal end of the tube; a patency device disposed within the tube and including a distal end and a proximal end; a translation handle coupled to the outer surface of the tube, the translation handle configured to move along the outer surface of the tube between a proximal position and a distal position to translate the distal end of the patency device between a retracted position and an advanced position, wherein in response to the distal end of the patency device being in the advanced position, the distal end of the patency device extends beyond the distal end of the tube; a fluid pathway disposed within a wall of the tube; a coupling element disposed within the tube, the patency instrument extending distally from the coupling element, the translation handle compressing a portion of the tube between the coupling element and the translation handle, the portion of the tube engaging the coupling element such that movement of the translation handle along the outer surface of the tube translates the coupling element within the tube and the distal end of the patency instrument is moved between the retracted position and the advanced position; the fluid pathway forms a protrusion within the lumen of the tube, the outer surface of the coupling element includes a groove aligned with the protrusion, the groove extending through the coupling element; Expansion set.

6. The expansion set of claim 5 , wherein the lumen is sealed from the fluid pathway and the patency device extends through the lumen.

7. 7. The expansion set of claim 6, further comprising a seal disposed adjacent the distal end of the tube, the seal including a hole aligned with the fluid pathway, the patency instrument extending through the seal, and the lumen sealed from the fluid pathway by the seal.

8. The expansion set of claim 5 , wherein the patency device comprises a guidewire.

9. The expansion set of claim 5 , wherein the translating handle includes multiple ball bearings or multiple wheels to locally compress the tube and engage the coupling element.

10. The expansion set of claim 5 , wherein the expansion set includes a plurality of fluid paths disposed within the wall of the tube.

Images