Extension kit with patency device

Abstract

An extension kit may include a tube, which may include a distal end, a proximal end, and an outer surface. The extension kit 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 extension kit may include a patency device disposed within the tube. The extension kit may include a translation handle coupled to the outer surface of the tube. 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 device between a retracted position and an extended position. In response to the distal end of the patency device being in the extended position, the distal end of the patency device may extend beyond the distal end of the tube.

Description

Technical Field

[0001] This disclosure relates to medical devices. In some embodiments, this disclosure relates to an extension kit for connection to an IV device. Background Technology

[0002] Patency refers to the state or quality of a fluid pathway within a patient's body that is not obstructed. Specifically, an intravenous (IV) device can have a degree of patency when a fluid, such as blood or medication, can pass through the IV device. During the use of an IV device, the device is inserted into the patient's blood vessel, and in some embodiments, the needle is withdrawn from the catheter while it remains within the patient's vessel. In some cases, the IV device may remain in the patient's vessel for up to 30 days or longer. This is done to allow clinicians or other healthcare providers (HCPs) to have fluid access to the patient's blood flow during care. This continuous fluid access to the patient's blood flow allows clinicians or other HCPs to draw one or more blood samples as appropriate, or to administer one or more infusion fluids, such as saline solution, various medications, and total parenteral nutrition.

[0003] However, when an IV device is inside a patient's blood vessel, its patency can be compromised. Any blockage can persist and cause the IV device to fail, requiring the administration of another IV device. This can increase patient discomfort and lead to other medical problems, such as vascular inflammation and other complications.

[0004] The subject matter claimed herein is not limited to embodiments that address any shortcomings or operate only in environments such as those described above. Rather, this background is provided merely to illustrate an example technical field in which some of the implementations described herein can be practiced. Summary of the Invention

[0005] This disclosure generally relates to an extension kit for connection to an IV device, providing a fluid pathway to the IV device and also providing a patency device for periodically checking or improving the patency of the IV device when it is located within a patient's blood vessel. In some embodiments, the extension kit may include a tube that may include a distal end, a proximal end, a lumen extending between the distal and proximal ends, and an outer surface. In some embodiments, the tube may include or correspond to any suitable housing that includes a lumen extending therethrough.

[0006] In some embodiments, the extension kit may include a distal connector coupled to the distal end of the tube. In some embodiments, the extension kit may include a proximal connector coupled to the proximal end of the tube. In some embodiments, the extension kit may include a patency device disposed within the tube. In some embodiments, the patency device may include a guidewire or another suitable patency enhancement structure.

[0007] In some embodiments, the extension kit may include a translation handle coupled to the 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 device between a retracted position and an extended position. In some embodiments, in response to the distal end of the patency device being in the extended position, the distal end of the patency device may extend beyond the distal end of the tube.

[0008] In some embodiments, the extension kit may include a connector element disposed within the tube. In some embodiments, the patency device may extend distally from the connector element. In some embodiments, a translation handle may compress a portion of the tube between the connector element and the translation handle. In some embodiments, this portion of the tube may engage the connector element such that movement of the translation handle along the outer surface of the tube causes the connector element to translate within the tube and moves the distal end of the patency device between a retracted position and a forward position. In some embodiments, the translation handle may include a plurality of ball bearings or more wheels to provide localized compression of the tube to engage the connector element.

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

[0010] In some embodiments, the extension kit may include a seal adjacent to the distal end of the tube. In some embodiments, the seal may be disposed within the distal connector and / or the distal end of the tube. In some embodiments, another tube and patency device may extend through the seal. In some embodiments, the distal end of the space may be sealed by the seal to prevent fluid from entering the space.

[0011] In some embodiments, the extension kit may include one or more fluid paths disposed within the wall of the tube. In some embodiments, the lumen may be sealed relative to the fluid paths, which may correspond to fluid channels, and a patency device may extend through the lumen, which may correspond to a non-fluid channel. In some embodiments, the fluid paths may form protrusions into the lumen of the tube. In some embodiments, the outer surface of the connector element may include one or more grooves aligned with the protrusions. In some embodiments, the grooves may extend through the connector element. In some embodiments, the seal may include orifices aligned with the fluid paths and may seal and isolate the lumen relative to the fluid paths.

[0012] In some embodiments, a method of providing access to a patient's vascular system may include coupling an extension kit to a catheter assembly or another IV device. In some embodiments, coupling the extension kit to the catheter assembly may include coupling the distal end of a tube to the catheter assembly. In some embodiments, the method may include moving the 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 a patency device may extend beyond the distal end of the tube into the catheter assembly and / or the patient's vascular system. In these embodiments, the patency device may extend beyond the distal end of the catheter in the catheter assembly.

[0013] In some embodiments, the method may include coupling the blood collection device to the proximal connector after moving the translation handle along the tube from a proximal position to a distal position. In some embodiments, the method may include moving the translation handle from a distal position to a proximal position after collecting blood within the blood collection device. In some embodiments, in response to moving the translation handle from a distal position to a proximal position, the distal end of the patency device may retract into the tube.

[0014] It should be understood that the foregoing summary description and the following detailed description are illustrative and not intended to limit the claimed invention. It should be understood that the various embodiments are not limited to the arrangements and means shown in the accompanying drawings. It should also be understood that, unless so required, these embodiments may be combined, or other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the invention. Therefore, the following detailed description is not restrictive. Attached Figure Description

[0015] The exemplary embodiments will be described and explained in additional specific detail using the accompanying drawings, in which:

[0016] Figure 1A This is a top perspective view of an example extended kit according to some embodiments, showing an example patency device in a retracted position;

[0017] Figure 1B According to some embodiments Figure 1A The upper perspective view of the extended kit shows the patency device in a forward position;

[0018] Figure 1C According to some embodiments Figure 1A A cross-sectional view of a portion of the extended kit;

[0019] Figure 1D It is according to some embodiments along Figure 1B 1D-1D line Figure 1B A cross-sectional view of the extended kit;

[0020] Figure 2A This is a top perspective view of another example extended kit according to some embodiments, showing an example patency device in the retracted position;

[0021] Figure 2B It is along line 2B-2B according to some embodiments Figure 2A A cross-sectional view of the extended kit;

[0022] Figure 2C It is along line 2B-2B according to some embodiments Figure 2A Alternative cross-sectional views of the extended kit;

[0023] Figure 2D According to some embodiments Figure 2A The upper perspective view of the extended kit shows another example unclog device in a forward position, with the example distal connector removed for illustrative purposes; and

[0024] Figure 2E It is along line 2E-2E according to some embodiments Figure 2A A cross-sectional view of the extended kit. Detailed Implementation

[0025] As used herein, the terms “proximal” and “distal” can refer to the direction closer to and further away from the clinician who positions the catheter system to contact the patient, respectively. Thus, for example, the end of the catheter system that first touches the patient's body will be the distal end, while the opposite end of the catheter system will be the proximal end.

[0026] Now for reference Figure 1A-1C In some embodiments, the extension kit 10 may include a tube 12, which may include a distal end 14, a proximal end 16, a lumen 18 extending between the distal end 14 and the proximal end 16, and an outer surface 20. In some embodiments, the tube 12 may include or correspond to any suitable housing that includes a lumen extending therethrough.

[0027] In some embodiments, the extension kit 10 may include a distal connector 22 coupled to the distal end 14 of the tube 12. In some embodiments, the distal connector 22 may include a male Luer connector, a female Luer connector, a blunt sleeve, and opposing lever arms (e.g., such as...). Figure 1A-1B (as shown), or another suitable connector configured to connect to a catheter assembly or another IV device. In some embodiments, the extension kit 10 may include a proximal connector 24 connected to the proximal end 16 of the tube 12. In some embodiments, the proximal connector 24 may include a male Luer connector, a female Luer connector, a needleless access connector, a blunt sleeve, and opposing lever arms (e.g., as shown). Figure 1A-1B (as shown), or another suitable connector. In some embodiments, the proximal connector 24 may include a Luer element and / or may be coupled to a pinless access connector, for example via thread, coupling or other suitable method.

[0028] In some embodiments, the extension kit 10 may include a patency device 26 disposed within the tube 12. In some embodiments, the patency device 26 may include a guidewire or other suitable patency enhancement structure. In some embodiments, the guidewire may generally be configured as a wire, a spring, a combination of wires and springs, and / or the like. In some embodiments, the extension kit 10 may include a translation handle 28 coupled to the outer surface 20 of the tube 12.

[0029] In some embodiments, the translation handle 28 may include any suitable translation handle or grip, and the patency device 27 may include any suitable patency device. The translation handle 28 and / or the patency device 27 may be described in further detail, for example, in U.S. Patent Application No. 17 / 127,588, filed December 18, 2020, entitled “FLUSH PATENCY INSTRUMENT WITH BLOOD EXPOSURE PROTECTION ANDRELATED METHODS” and U.S. Patent Application No. 17 / 127,623, filed December 18, 2020, entitled “MULTI-LUMEN EXTENSION SYSTEM”, the entire contents of which are incorporated herein by reference.

[0030] In some embodiments, the translation handle 28 may be configured to move along the outer surface 20 of the tube 12 between a proximal position and a distal position to translate the distal end 30 of the patency device 26 between a retracted position and a forward position. In some embodiments, in response to the distal end 30 of the patency device 26 being in the forward position, the distal end 30 of the patency device 26 may extend beyond the distal end 14 of the tube 12 and the distal connector 22.

[0031] In some embodiments, the patency device 26 extends from the connector element 32 disposed within the tube 12. In some embodiments, the proximal end of the patency device 26 may be secured within the connector element 32. In some embodiments, the patency device 26 may extend distally from the connector element 32. In some embodiments, the patency device 26 may extend distally from the connector element 32 to facilitate translation of the patency device 26 within the tube 12 without direct contact.

[0032] In some embodiments, the translation handle 28 may compress a portion of the tube 12 between the connector element 32 and the translation handle 28. In some embodiments, this portion of the tube 12 may engage the connector element 32 such that movement of the translation handle 28 along the outer surface 20 of the tube 12 causes the connector element 32 to translate within the tube 12 and causes the distal end 30 of the patency device 26 to move between a retracted position and a forward position. In some embodiments, the translation handle 28 may include a plurality of features 34, which may include ball bearings, wheels, low-friction sliders, or other suitable features to provide partial compression of the tube for engagement of the connector element. In some embodiments, the features 34 may be coupled to the translation handle 28. In some embodiments, the features 34 may be directly coupled to the translation handle 28. In some embodiments, the features 34 and the translation handle 28 may be molded together or integrally formed as a single unit. In some embodiments, the features 34 and the translation handle 28 may be integrated or assembled together.

[0033] In some embodiments, feature 34 may include a clamping mechanism and may be positioned to clamp or press against the outer surface of tube 12. In some embodiments, one or more of these features 34 may be opposite to or located on opposite sides of tube 12. In some embodiments, the inner surface of tube 12 within translation handle 28 may be too small to allow connector element 32 to pass through. In some embodiments, feature 34 may include a wheel rotatably coupled to translation handle 28. In some embodiments, feature 34 may include a ball bearing that can rotate within a socket formed in translation handle 28. In some embodiments, feature 34 may include a slider that may be smooth and / or made of plastic and can slide along tube 12. In some embodiments, the slider may be stationary or static relative to translation handle.

[0034] In some embodiments, the translation handle 28 may extend partially (e.g., a C-shaped channel) or completely around the tube 12. In some embodiments, the translation handle 28 may include a collar. In some embodiments, the connector element 32 may be magnetically attracted to the translation handle 28 through the tube 12 to facilitate movement of the instrument 26 without direct contact.

[0035] In some embodiments, the extension kit 10 may include another tube 36. In some embodiments, the other tube 36 may include or correspond to any suitable housing including a lumen extending therethrough. In some embodiments, the other tube 36 may be disposed within the tube 12 and may extend through the connector element 32. In some embodiments, the space 38 between the other tube 36 and the tube 12 may be sealed to prevent fluid from entering the space 38. In some embodiments, the other tube 36 may form a fluid passage, while the space 38 may correspond to a non-fluid passage. 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 annular.

[0036] In some embodiments, the extension kit 10 may include a seal 40 adjacent to the distal end 14 of the tube 12. In some embodiments, the seal 40 may be elastomeric. In some embodiments, the seal 40 may be disposed within the distal connector 22 and / or within the distal end 14 of the tube 12. In some embodiments, the distal end of the space 38 may be sealed by the seal 40 to prevent fluid from entering the space 38.

[0037] In some embodiments, lumen 18, such as space 38, may include ventilation facilities to allow airflow into and out of lumen 18, which may facilitate movement of translation handle 28 and connector element 32. In some embodiments, the size of one or more vents providing ventilation may be reduced to allow air movement while still maintaining good sterile protection of patency device 26 and / or other parts of extension kit 10.

[0038] In some embodiments, the patency device 26 may be centered within the tube 12, which may facilitate smooth forward movement of the patency device 26. In these and other embodiments, another 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 another tube 36 may be centered within the tube 12.

[0039] In some embodiments, the outer surface of the connector 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 feature portion 34 may include a lubricant. In some embodiments, one or more of the following: the connector element 32, the tube 12, and the feature portion 34 may be made of a lubricating material (e.g., PEG polyurethane, silicone polyurethane, fluorinated polyurethane, silicone resin, or another suitable material) to reduce friction.

[0040] In some embodiments, tube 12 may be flexible. In some embodiments, the outer surface 20 of tube 12 may include one or more visual markers or tactile elements (pawls, grooves, ribs, etc.) to provide feedback to the user regarding the position of the patency device 26 relative to the IV device. In some embodiments, the inner surface of connector element 32 and / or the outer surface of another tube 36 may include a lubricant, which may facilitate movement of connector element 32 relative to another tube 36, which may be stationary. In some embodiments, the distal and / or proximal ends of the other tube 36 may be secured within extension kit 10. In some embodiments, the proximal end of the other tube 36 may be wedged or secured within proximal connector 24 such that blood cannot flow into space 8 between proximal connector 24 and the other tube 36.

[0041] Now for reference Figure 1D In some embodiments, another tube 36 and the patency device 26 may extend through the seal 40, which may contact the edges of the other tube 36 and the patency device 26 to prevent fluid flow between the seal 40 and the other tube 36, and between the seal 40 and the patency device 26. In some embodiments, in response to the translation handle 28 being in a proximal position, the distal end 30 of the patency device 26 may be proximal to the seal 40, the proximal position including a fully retracted position. In these and other embodiments, in response to movement of the translation handle 28 from the proximal position to the distal position, the patency device 26 extends through the seal 40.

[0042] Now for reference Figure 2A-2B An extension kit 42 according to some embodiments is shown. In some embodiments, the extension kit 42 may be similar to or identical to the extension kit 10 in one or more features and / or operations. In some embodiments, the extension kit 42 may include one or more fluid paths 44 disposed within the wall 46 of the tube 12. In some embodiments, a lumen 18 may be sealed relative to the fluid paths 44, which may correspond to fluid channels, and a patency device 26 may extend through the lumen 18, which may correspond to non-fluid channels. In some embodiments, the fluid paths 44 may be arranged within the wall 46 in various locations and configurations.

[0043] Now for reference Figure 2B-2CIn some embodiments, the fluid path 44 may form a protrusion 48 within the lumen 18 of the tube 12, and the thickness of the wall 46 may vary. In some embodiments, the fluid path 44 may protrude inward from the wall 46 toward, for example, the central axis of the tube 12, or protrude outward from the wall 46 away from the central axis of the tube 12. In some embodiments, the outer surface 50 of the connector element 32 may include one or more grooves 52 aligned with the protrusion 48. In some embodiments, the grooves 52 may extend through the connector element 32 and may facilitate movement and / or guidance of the connector 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.

[0044] In some embodiments, tube 12 can be extruded via a co-extrusion process comprising a first material and a second material that is harder than the first material. In some embodiments, the first material can form a portion of tube 12 clamped by feature 34, and the second material can form another portion of tube 12 adjacent to and / or forming fluid path 44. In some embodiments, the first material and said portion of tube 12 can be soft or flexible. In some embodiments, fluid path 44 can be formed via a multi-lumen extrusion process, or can be formed as a separate extruded tube contained within the inner diameter of tube 12 of a larger non-fluid path extension conduit. In some embodiments, the separate extruded tubes can be concentrically aligned or offset from the axis of tube 12. Alternatively, in some embodiments, fluid path 44 can extend from another component of extension kit 42, such as a specific connector or sleeve. In some embodiments, the volume of lumen 18 can be larger than the volume of each of the various fluid paths 44, which can accommodate connector element 32.

[0045] Now for reference Figure 2E In some embodiments, the seal 40 may include an orifice 54 aligned with the fluid path 44 and may seal and isolate the lumen 18 relative to the fluid path 44. In some embodiments, the seal 40 may contact the edge of the patency device 26 to prevent fluid from flowing between the seal 40 and the patency device 26.

[0046] In some embodiments, a method of providing access to a patient's vascular system may include extending the extension kit (e.g., regarding...) Figure 1A-1D Discussion of extended kit 10 or about Figures 2A-2E The extension kit 42 discussed is coupled to the catheter assembly or another IV device. In some embodiments, when the extension kit is coupled to the catheter assembly, the catheter assembly may reside within the patient's vascular system, and the patency device 26 may increase the patency of the catheter assembly throughout the residence time.

[0047] In some embodiments, attaching the extension kit to the catheter assembly may include attaching the distal end 14 of the tube 12 to the catheter assembly. In some embodiments, the method may include moving a translation handle 28 from a proximal position to a distal position along the tube 12. In some embodiments, in response to the translation handle 28 being moved to the distal position, the distal end 30 of the patency device 26 may extend beyond the distal end 14 of the tube 12 into the catheter assembly and / or the patient's vascular system. In these embodiments, the patency device 26 may extend beyond the distal end of the catheter in the catheter assembly. In some embodiments, the catheter may include a peripheral IV catheter, a peripherally inserted central catheter, or a midline catheter.

[0048] In some embodiments, the method may include coupling the blood collection device to the proximal connector 24 after moving the translation handle 28 along the tube 12 from a proximal position to a distal position. In some embodiments, the blood collection device may include any suitable blood collection device, such as the VACUTAINER available from Becton Dickinson and Company, Franklin Lake, New Jersey. ® or VACUTAINER ® LUER-LOK™, syringe, or point-of-care collection device. In some embodiments, the blood collection device may be integrated with the proximal connector 24 or integrally formed as a single unit.

[0049] In some embodiments, the method may include moving the translation handle 28 from a distal position to a proximal position after blood has been collected in the blood collection device. In some embodiments, in response to moving the translation handle 28 from the distal position to the proximal position, the distal end 30 of the patency device 26 may retract into the tube.

[0050] In some embodiments, the extension kit can reduce hemolysis of blood samples collected via a fluid path, which may include another tube 36 (e.g., referenced). Figure 1A-1D (Discussed) or fluid path 44. In some embodiments, the extension kit may provide an appropriate fluid flow rate. Blood cells are subjected to shear stress as they flow in the fluid path. The maximum shear stress is along the wall of the blood cell, or wall shear stress. Wall shear stress on blood cells is considered a major source of mechanical damage to blood cells. For a cylindrical fluid path, wall shear stress is typically expressed as:

[0051]

[0052] Where ΔP is the pressure drop along a path of length L and inner radius r, and k is the contraction exponent.

[0053] The time required to fill a certain volume of collection tube V at a flow rate Q can be easily estimated using the following formula:

[0054]

[0055] Where μ is the dynamic viscosity of the fluid. Hemolysis is generally related to wall shear stress and the duration of blood cell exposure to wall shear stress. Based on the literature, it is generally believed that the hemolysis index may approximate a function of the following factors:

[0056]

[0057] Where A, α, and β are coefficients.

[0058] In principle, the hemolysis index is related to the pressure gradient and the characteristic dimensions of the cross-section:

[0059]

[0060] In some embodiments, the length of the other tube 36 and / or fluid path 44 may be selected based on one or more of the following: the specification of a particular catheter, a particular catheter assembly configuration, or a clinical setting. In some embodiments, the patency device 110 may include a length L. In some embodiments, the other tube 36 and / or fluid path 44 may include an inner diameter D.

[0061] When the fluid path is tubular, the Poiseuille equation can be used to analyze the fluid flow rate in the fluid path (e.g., the fluid path of another pipe 36 and / or fluid path 44):

[0062]

[0063] in, It represents the pressure gradient change along the length of the fluid path, where D and L are the inner diameter and length of the fluid path, respectively, and μ is the viscosity of the fluid. = This refers to fluid resistance. Since μ is the viscosity of the fluid, and not part of the extension tube geometry, a geometry factor G is defined. f , making (fluid resistance) is G f G f = .

[0064] In some embodiments, the fluid pathway may have multiple segments with lengths (L1, L2, L3) and inner diameters (D1, D2, D3), then the geometric factors are:

[0065]

[0066] In some embodiments, the fluid path may have an inner diameter that varies with the length of the fluid path, then the geometric factor is:

[0067]

[0068] In some embodiments, the fluid pathway may have a non-circular cross-section or a complex inner diameter profile. Then, the fluid with a known viscosity (μ) can be measured at a given pressure. The flow rate (Q) is used to determine the geometry factor:

[0069]

[0070] G can be selected via a fluid path f The value is used to reduce the maximum shear stress of each conduit specification to be equal to or less than BD 21G VACUTAINER. ® UltraTouch ™ The maximum shear stress of the button blood collection kit (available from Becton, Dickinson & Company, Franklin Lake, New Jersey) was previously considered the gold standard for blood collection. In some embodiments, a fluid-based approach can be selected. f Values ​​are set to reduce the maximum shear stress for each catheter specification to be equal to or less than BD 25G VACUTAINER. ® UltraTouch ™ Maximum shear stress of the button blood collection kit (available from Becton, Dickinson & Company, Franklin Lake, New Jersey).

[0071] In some embodiments, the extended fluid pathway of the blood collection system may include one or more of a blood collection device, another tube 36 and / or fluid path 44, and a catheter assembly (which may include an extension tube). The extended fluid pathway of the blood collection system may include the entire blood collection pathway through which blood flows after exiting the vascular system during blood collection and enters or passes through the blood collection device. The system geometry factor G of the extended fluid pathway of the blood collection system. fs It can be determined in a manner similar to the fluid pathways described above (e.g., the fluid path of another pipe 36 and / or fluid path 44). In some embodiments, when the translation handle 28 is in the distal position, the system geometry factor G... fs It can be equal to or greater than 7.34E+06 (1 / in) 3 In some embodiments, G fs It may include another value. In some embodiments, the system geometry factor G fs It could be 7.34E+06 (1 / in) 3Add or subtract 10%, add or subtract 25%, add or subtract 50%, or add or subtract 75%. In some embodiments, G fs Another value may be included, which can be selected based on the catheter's specifications and / or length.

[0072] All examples and conditional language described herein are for educational purposes, to aid the reader in understanding the invention and the concepts contributed by the inventors to the field, and are to be construed as not being limited to these specifically enumerated examples and conditions. Although embodiments of this disclosure have been described in detail, it should be understood that various changes, substitutions, and modifications can be made thereto without departing from the spirit and scope of the disclosed embodiments.

Claims

1. An extension kit comprising: A tube, comprising a distal end, a proximal end, a lumen extending between the distal end and the proximal end, and an outer surface; A distal connector that connects to the distal end of the tube; A proximal connector, which is attached to the proximal end of the tube; A patency device installed inside the tube; A translation handle, coupled to the outer surface of the tube, wherein the translation handle is 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 extended position, wherein, in response to the distal end of the patency device being in the extended position, the distal end of the patency device extends beyond the distal end of the tube; and A connector element is disposed within the tube, wherein the patency facilitator extends distally from the connector element, wherein a translation handle compresses a portion of the tube between the connector element and the translation handle, wherein said portion of the tube engages the connector element such that movement of the translation handle along the outer surface of the tube causes the connector element to translate within the tube, and causes the distal end of the patency facilitator to move between the retracted position and the forward position; and The extension kit further includes another tube disposed within the tube and extending through the connector element, wherein the space between the other tube and the tube is sealed to prevent fluid from entering the space, and wherein the patency device extends through the space.

2. The extension kit of claim 1, wherein, The other tube forms a fluid channel, while the space corresponds to a non-fluid channel.

3. The extension set of claim 1, further comprising a seal adjacent the distal end of the tube, wherein, The other tube and the patency device extend through the seal, wherein the distal end of the space is sealed by the seal to prevent fluid from entering the space.

4. The extension kit of claim 1, wherein, The patency device includes a guidewire.

5. The extension kit of claim 1, wherein, The translation handle includes multiple ball bearings, multiple wheels, or multiple sliders to provide localized compression of the tube for engagement of the connector element.

6. The extension kit of claim 1, wherein, The lumen (18) includes a venting facility to allow airflow into and out of the lumen (18) to facilitate movement of the translation handle (28) and the connector element (32).

7. The extension kit of claim 1, wherein, The outer surface of the connector element (32) and / or the inner surface of the tube (12) include a lubricant to facilitate the translation of the patency device (26) within the tube (12).

8. The extension kit of claim 1, wherein, The outer surface (20) of the tube (12) includes one or more visual markers or tactile elements to provide the user with feedback on the position of the patency device (26) relative to the intravenous device.

9. The extension kit according to claim 1, wherein, The proximal end of the other tube (36) is wedged into or fixed within the proximal connector (24).

10. An extension kit comprising: A tube, comprising a distal end, a proximal end, a lumen extending between the distal end and the proximal end, and an outer surface; A distal connector that connects to the distal end of the tube; A proximal connector, which is attached to the proximal end of the tube; A patency device installed inside the tube; A translation handle is coupled to the outer surface of the tube, wherein the translation handle is 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 extended position, wherein, in response to the distal end of the patency device being in the extended position, the distal end of the patency device extends beyond the distal end of the tube. The fluid path (44) contained within the wall (46) of the tube; and A connector element (32) disposed within the tube, wherein the patency device extends distally from the connector element (32), wherein the translation handle compresses a portion of the tube between the connector element (32) and the translation handle, wherein the portion of the tube engages the connector element (32) such that movement of the translation handle along the outer surface of the tube causes the connector element to translate within the tube and causes the distal end of the patency device to move between the retracted position and the forward position; In this embodiment, the inner surface of the wall (46) of the pipe containing the fluid path (44) forms a protrusion (48) into the lumen (18) of the pipe, such that the thickness of the wall (46) varies along the circumference of the pipe; and The outer surface (50) of the connector element (32) includes a groove (52) aligned with the protrusion (48), wherein the groove (52) extends through the connector element (32) to facilitate movement and / or guidance of the connector element (32) within the tube (12).

11. The extension kit of claim 10, wherein, The thinner portion of the wall (46) is configured to reduce the force required to translate the patency device (26).

12. The extension kit of claim 10, wherein, The cavity is sealed and isolated relative to the fluid path.

13. The extension kit of claim 12, further comprising a seal disposed adjacent to the distal end of the tube, wherein, The seal includes an orifice aligned with the fluid path, wherein the patency device extends through the seal, and wherein the lumen is sealed and isolated relative to the fluid path by means of the seal.

14. The extension kit of claim 10, wherein, The patency device includes a guidewire.

15. The extension kit of claim 10, wherein, The translation handle includes multiple ball bearings or multiple wheels to provide localized compression of the tube, thereby engaging the connector element.

16. The extension kit of claim 10, wherein, The extension kit includes multiple fluid paths (44) disposed within the wall of the tube.

17. The extension kit of claim 16, wherein, The volume of the lumen (18) is larger than the volume of each of the plurality of fluid paths (44) to accommodate the connector element (32).

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