Extension kits and related systems and methods

Abstract

An extension kit may include a tube having an outer surface. An instrument, such as a tubing or probe, may be disposed within the tube and may include a proximal end and a distal end. A translation handle may be coupled to the outer surface of the tube and may move along the outer surface between a proximal position and a distal position to translate the distal end of the instrument between a retracted position and an advanced position. In the advanced position, the distal end of the instrument may extend beyond the distal end of the tube and extend into the catheter assembly and / or the patient's vascular system.

Description

Technical Field

[0001] This application relates to the medical field, and in particular to extension kits and related systems and methods. Background Technology

[0002] Catheters are commonly used for various infusion therapies. For example, catheters can be used to deliver fluids such as saline solution, various medications, and total parenteral nutrition to patients. Catheters can also be used to draw blood from patients to obtain blood samples.

[0003] A common type of catheter is the peripheral intravenous (“IV”) catheter. As the name suggests, a IV catheter is fitted onto a guide needle with a sharp distal tip. The catheter and guide needle can be assembled such that the distal tip of the guide needle extends beyond the distal tip of the catheter, with the bevel of the guide needle facing upwards away from the patient's skin. The catheter and guide needle are typically inserted into the patient's vascular system through the skin at a shallow angle.

[0004] To verify proper placement of the guide needle and / or catheter in the blood vessel, clinicians typically confirm the presence of a "flashback" of blood in the flashback chamber of the catheter assembly. Once needle placement is confirmed, the clinician can temporarily block flow in the vascular system and remove the needle, leaving the catheter in place for future blood draws, fluid infusions, or probe access.

[0005] Blood collection or infusion using catheters can be difficult for a variety of reasons, especially when the catheter remains in place in the patient for more than a day. For example, when a catheter is inserted for an extended period, it is more likely to narrow, collapse, become kinked, become clogged with debris (e.g., fibrin clots or platelet clots), and have its tip adhere to the vascular system. Therefore, catheters are typically used to obtain blood samples during catheter placement, but rarely for obtaining blood samples during the duration of catheter indwelling. Consequently, when blood samples are needed, the use of additional needles to provide venous access for blood collection can be painful for the patient and result in higher material costs.

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

[0007] This disclosure generally relates to an extension kit comprising a tube, such as a probe or conduit, that can accommodate an instrument. The instrument can be inserted into a patient's vascular system during the indwelling time of a vascular access device, such as a catheter assembly, for drug and fluid delivery and / or blood acquisition. In some embodiments, the instrument can enter the fluid channel of the catheter assembly. In other embodiments, the instrument can extend through the catheter assembly to enter the patient's vasculature.

[0008] In some embodiments, the extension kit may include a tube, which may include a proximal end, a distal end, and an outer surface. In some embodiments, an instrument, such as a probe or conduit, may be disposed within the tube and may include a proximal end and a distal end. In some embodiments, the tube may protect the instrument from contaminants and / or isolate any blood or other fluids that may remain on the instrument after entering the fluid passage of the catheter assembly. In some embodiments, the tube may protect the instrument from the surrounding external environment.

[0009] In some embodiments, a translation handle may be coupled to the outer surface of the tube. In some embodiments, the translation handle may move along the outer surface between a proximal position and a distal position. Thus, in some embodiments, the translation handle may translate the distal end of the instrument between a retracted position and an advanced position. In some embodiments, in the advanced position, the distal end of the instrument may extend beyond the distal end of the tube.

[0010] In some embodiments, the fluid pathway assembly may include the device, a proximal end, and a distal end. In some embodiments, an extension tube may be coupled to the proximal end of the device. In some embodiments, the proximal end of the fluid pathway assembly may include a proximal connector configured to connect to a blood collection device. In some embodiments, the fluid pathway assembly may extend through the tube.

[0011] In some embodiments, the distal end of the tube may include a distal connector. In some embodiments, the distal end of the tube and / or the distal connector may include a fluid seal to seal the tube and create a closed fluid path.

[0012] In some embodiments, the instrument may extend distally from the connector element to facilitate translation of the instrument within the tube without direct contact. In some embodiments, the extension tube may be coupled to the instrument via the connector element. In some embodiments, the tube may be axially compressible such that the translation handle compresses a portion of the tube between the connector element and the translation handle. In some embodiments, the compressed portion of the tube may engage with the connector element such that movement of the translation handle along the outer surface of the tube translates the distal end of the instrument between the retracted position and the distal position.

[0013] In some embodiments, the connector element and / or the tube may contain a lubricant to facilitate movement of the instrument within the tube. In these and other embodiments, the translation handle may include rollers and / or bearings to provide localized compression of the tube to engage the connector element through the tube.

[0014] In some embodiments, the device may be disposed within the tube and may include a proximal end and a distal end. In some embodiments, in response to movement of the translation handle to the distal end of the tube, the distal end of the device may extend beyond the distal end of the tube.

[0015] In some embodiments, a method of providing access to a patient's vascular system may include coupling the extension kit to a catheter assembly. In some embodiments, the extension kit may include the tubing, an instrument disposed within the tubing, and a translation handle coupled to an outer surface of the tubing. In some embodiments, coupling the extension kit to the catheter assembly may include coupling a distal end of the tubing to the catheter assembly. In some embodiments, the method may further include moving the translation handle along the tubing from a proximal position to a distal position. In some embodiments, in the distal position, the distal end of the instrument may extend beyond the distal end of the tubing into the catheter assembly.

[0016] In some embodiments, coupling the distal end of the tube to the catheter assembly may include coupling a distal connector of the tube to the catheter assembly. In some embodiments, the catheter assembly may include a catheter extending from its distal end. In some embodiments, in response to movement of the translation handle to the distal position, the instrument may extend through the distal end of the catheter.

[0017] In some embodiments, the extension kit may include the blood collection device. In some embodiments, after blood has been collected in the blood collection device, the method may include moving the translation handle from the distal position to the proximal position. In some embodiments, moving the translation handle to the proximal position may retract the distal end of the device into the tube.

[0018] It should be understood that the foregoing general description and the following detailed description are illustrative and explanatory, and do not limit the invention as claimed. It should be understood that the various embodiments are not limited to the arrangements and means shown in the accompanying drawings. It should also be understood that embodiments may be combined, other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the invention, unless so claimed. Therefore, the following detailed description should not be construed as restrictive. Attached Figure Description

[0019] Exemplary embodiments will be described and explained in further detail with reference to the accompanying drawings, wherein:

[0020] Figure 1 This is a top perspective view of an exemplary extension kit according to certain embodiments, showing an exemplary device in a forward position;

[0021] Figure 2 A top perspective view of an extension kit coupled to an exemplary catheter assembly according to certain embodiments;

[0022] Figure 3 This is a partial cross-sectional view of an extension kit according to certain embodiments, showing the device in a retracted position;

[0023] Figure 4 This is a partial cross-sectional view of an extension kit according to certain embodiments, showing the device in the forward position;

[0024] Figure 5A A cross-sectional view of an exemplary translation device according to certain embodiments;

[0025] Figure 5B A cross-sectional view of another exemplary translation device of the extension kit according to certain embodiments;

[0026] Figure 6 This is a partial exploded view of an exemplary translation device of an extended kit according to certain embodiments;

[0027] Figure 7 This is a top perspective view of an extension kit according to certain embodiments, showing the device in a retracted position;

[0028] Figure 8 This is a top perspective view of an extension kit according to certain embodiments, showing the device in a forward position;

[0029] Figure 9A A top perspective view of an exemplary translation handle and an exemplary connector element according to certain embodiments; and

[0030] Figure 9B for Figure 9A A cross-sectional view of the translation handle and connector elements according to certain embodiments. Detailed Implementation

[0031] When used in this document, the terms “proximal” and “distal” may refer, respectively, to the direction closer to and further away from the clinician who places the catheter system in contact with the patient. Thus, for example, the end of the catheter system that first contacts the patient’s body would be the distal end, while the opposite end of the catheter system would be the proximal end.

[0032] According to certain embodiments, the extension kit can provide access to the patient's vascular system. As discussed in more detail below, in some embodiments, the extension kit can provide access to a fluid channel to the catheter assembly. In some embodiments, the extension kit can provide access to the patient's vascular system throughout the indwelling time of the catheter assembly for drug and fluid delivery and / or blood aspiration.

[0033] As previously mentioned, catheters with significant indwelling time within a patient's vascular system can be prone to narrowing, collapse, kinking, blockage by debris (e.g., fibrin clots or platelet clots), and adhesion of the catheter tip to the patient's vascular system. Therefore, blood aspiration using catheters can be difficult. Advantageously, in some embodiments, the extension kit may include an instrument, such as another catheter or probe, disposed within the tube. In some embodiments, the instrument can provide access to the patient's vascular system without any additional needle insertion. Therefore, in some embodiments, the extension kit 100 can be used for needle-free blood collection and / or fluid infusion.

[0034] Now for reference Figure 1In some embodiments, the extension kit 100 may include a tube 102, which may include a proximal end 104, a distal end 106, and an outer surface 108. In some embodiments, the tube 102 may be flexible, rigid, or semi-rigid. In some embodiments, the device 110 may be disposed within the tube 102 and may include a proximal end 112 and a distal end 114. In some embodiments, the distal end 114 may be non-invasive or blunt. In some embodiments, the extension kit 100 may provide a non-fluid path through the tube 102 to protect the device 110 from contaminants and the surrounding external environment. The non-fluid path may be configured such that blood drawn from the patient does not come into contact with the non-fluid path. In some embodiments, the extension kit 100 may also isolate blood or other fluids that may remain on the device 110 after use. Further, in some embodiments, the extension kit 100 may provide support, alignment, and aseptic delivery of the device 110 through the catheter assembly and into the patient's vascular system.

[0035] In some embodiments, the translation handle 116 may be coupled to the outer surface 108 of the tube 102 to facilitate movement of the instrument 110 without direct contact with it. In some embodiments, the translation handle 116 may move along the length of the outer surface 108 of the tube 102 between proximal and distal positions. In some embodiments, the tube 102 may comprise an axially compressible, biocompatible, elastomeric or polymeric material. In this way, in some embodiments, the translation handle 116 may produce localized compression of the tube 102.

[0036] As discussed in more detail below, in some embodiments, the compressed portion of tube 102 may engage with a connector element 117 coupled to the proximal end 112 of instrument 110, such that a translation handle 116 may translate the distal end 114 of instrument 110 in the direction of movement of the translation handle 116. In some embodiments, the translation handle 116 may translate the distal end 114 of instrument 110 between a retracted position and an advanced position. Figure 1 As shown, in the forward position 124, the distal end 114 of the device 110 can extend beyond the distal end 106 of the tube 102 and extend into, for example, a catheter assembly or the patient's vascular system.

[0037] Now for reference Figure 2 In some embodiments, the extension kit 100 may be coupled to the catheter assembly 200, which may include a distal end 204. In some embodiments, the instrument 110 may extend through the distal end 204 of the catheter assembly 200 in response to a translation handle 116 moving to a distal position.

[0038] In some embodiments, device 110 may include a probe having one or more openings and / or sensors to provide intravenous patient and device monitoring. In some embodiments, the probe openings and / or sensors may be positioned toward the distal end 114. In some embodiments, the openings may serve as fluid inlets and / or outlets. In some embodiments, the sensors may measure one or more parameters and / or detect one or more elements related to, for example, diagnostic information, blood chemistry, pH, temperature, pressure, flow rate, drug recognition, microbiology, placement of implantable stents, intravenous catheter tip stability characteristics, or other device or physiological measures. In some embodiments, extension kit 100 may facilitate placement of the sensor-containing portion of the probe within the fluid pathway of the catheter assembly and / or the patient's vascular system.

[0039] In some embodiments, device 110 may include a conduit and may function as both a probe and a catheter, thereby incorporating elements of both. In some embodiments, device 110 may include a conduit to provide fluid infusion and / or aspiration. In some embodiments, the conduit may include a standard catheter tip or an asymmetric catheter tip. In some embodiments, a diffuser orifice may be provided in the tip of the conduit. In some embodiments, the conduit may comprise polyurethane, fluorinated ethylene propylene copolymer (FEP), polytetrafluoroethylene, silicone, thermoplastic elastomer (TPE), thermoplastic polyurethane (TPU), fluoropolymer, polyimide, or any other suitable material or combination thereof. In some embodiments, the conduit material may be hydrophilic, hydrophobic, and / or may include any other desired properties or characteristics, such as antifouling materials. Some embodiments of the conduit may include a coating, such as an antithrombotic coating, or other coatings to impart other desired properties to the conduit.

[0040] In some embodiments, extension tube 206 may be coupled to the proximal end of translation handle 116 and / or the proximal end 112 of device 110. In some embodiments, extension tube 206 may be flexible. In some embodiments, extension tube 206 may comprise thermoplastic elastomer (TPE), thermoplastic polyurethane (TPU), polyvinyl chloride (PVC), or other suitable medical tubing material. In some embodiments, extension tube 206 may be substantially transparent and / or may include markings to inform clinicians of the position of device 110 relative to the catheter or catheter feature. In some embodiments, extension tube 206 may comprise a textured surface to reduce contact friction. Some embodiments of extension tube 206 may vent air via, for example, an open air passage, a breathable filter membrane, a porous venting material, microchannels, or the like.

[0041] In some embodiments, the proximal connector 208 may be coupled to or integrated with the proximal end of the extension tube 206 for connection to, for example, a blood collection device 210 (see, for example, see...). Figure 3 The blood collection device may include an infusion device or a monitoring device. In some embodiments, the blood collection device may comprise any suitable blood collection device, such as one available from Becton Dickinson and Company, Franklin Lake, New Jersey. or LUER-LOK TM The proximal connector 208 may include, for example, a male or female Luer connector, a blunt sleeve, or another suitable connector.

[0042] In some embodiments, the distal end 106 of the tube 102 may be coupled to or integrated with a distal connector 212, which may include a fluid seal 214 to seal the tube 102 and form a closed fluid path. In some embodiments, the distal connector 212 may include, for example, a male or female Luer connector, a blunt sleeve, or another suitable connector.

[0043] In some embodiments, the extension tube 206 may extend through a proximal connector 209 integrated with or coupled to the proximal end 104 of the tube 102. In some embodiments, a tight fit or diaphragm may be present between the extension tube 206 and the proximal connector 209, which may form a seal but still allow movement of the extension tube 206 relative to the proximal connector 209. In some embodiments, the translation handle 116 may be moved from a proximal position to a distal position such that the distal end 114 of the instrument 110 is advanced distally beyond the tube 102 and / or the proximal connector 208 is moved closer to the proximal connector 209. In some embodiments, after blood has been collected in the blood collection device 210, the translation handle 116 may be moved from a distal position to a proximal position such that the distal end 114 of the instrument 110 is retracted into the tube 102 and / or the proximal connector 208 is moved away from the proximal connector 209. In some embodiments, the translation handle 116 may comprise any suitable translation handle, such as that described in more detail in U.S. Patent Application No. 17 / 127,588, filed December 18, 2020, entitled “Flush Instrument with Blood Exposure Protection and Relatedemethos” and U.S. Patent Application No. 17 / 127,623, filed December 18, 2020, entitled “Multi-lumen Extension System”, which are incorporated herein by reference in their entirety.

[0044] In some embodiments, the extension kit 100 can reduce hemolysis of blood samples collected via the fluid path. In some embodiments, the extension kit 100 can provide an appropriate fluid flow rate. Blood cells are subjected to shear stress as they flow in the fluid channel. The maximum shear stress is along the blood cell wall, or wall shear stress. Wall shear stress on blood cells is considered a major source of mechanical damage to blood cells. For cylindrical fluid paths, wall shear stress is typically expressed as:

[0045]

[0046] Where ΔP is the pressure drop along a path with length L and inner radius r. k is the contraction exponent.

[0047] To fill a given volume V of the collection tube at a flow rate Q, the required time can be easily estimated as follows:

[0048]

[0049] Where μ is the dynamic viscosity of the fluid. Hemolysis is generally related to wall shear stress and the time that blood cells are exposed to wall shear stress. According to the literature, the hemolysis index is widely considered to be a function that can be applied as follows:

[0050] HI(%)=A*t α *T β

[0051] Where A, α, and β are coefficients.

[0052] In principle, the hemolysis index is related to the pressure gradient and the characteristic dimensions of the cross-section:

[0053]

[0054] In some embodiments, the length of the extension kit 100 may be selected based on one or more of the following: a specific catheter specification, a specific catheter assembly construction, or clinical setup. In some embodiments, the extension kit 100 may include a length L. In some embodiments, the extension kit 100 may include an inner diameter D.

[0055] The Poiseuille equation can be used to analyze fluid flow in the fluid path through the tubular extension kit 100:

[0056]

[0057] Where ΔP is the change in pressure gradient across the length of the fluid path, D and L are the inner diameter and length of the fluid channel, respectively, and μ is the viscosity of the fluid. For fluid resistance. Since μ is the viscosity of the fluid rather than part of the extension tube geometry, a geometry factor G is defined. f So that R f (fluid resistance) is in

[0058] In some embodiments, the fluid channel through the extension kit 100 may have multiple segments with lengths (L1, L2, L3) and inner diameters (D1, D2, D3), thus the geometric factors are:

[0059]

[0060] In some embodiments, the fluid channel through the extension kit 100 may have an inner diameter that varies along the length of the extension kit 100, and therefore the geometric factor is:

[0061]

[0062] In some embodiments, the fluid channel through the extension kit 100 may have a non-circular cross-section or may have a complex inner diameter profile. Therefore, the geometric factors can be determined by measuring the flow rate (Q) at a given pressure (ΔP) using a fluid of known viscosity (μ).

[0063]

[0064] G can be selected through the fluid channels of the extension kit 100 f The value is designed to reduce the maximum shear stress to be equal to or less than that of Beckton Dickinson's specification 21 (BD 21G) for each catheter size. UltraTouch TM The maximum shear stress of the button blood collection device (available from Becton, Dickinson & Company, Franklin Lake, New Jersey), which was previously considered the gold standard for blood aspiration. In some embodiments, the G of the fluid channel can be selected. f The value is designed to reduce the maximum shear stress for each catheter specification to be equal to or less than that of Beckton Dickinson's specification 21 (BD 21G). UltraTouch TM Maximum shear stress of the push-button blood collection device (available from Becton, Dickinson & Company, Franklin Lake, New Jersey).

[0065] In some embodiments, the fluid passage of the blood collection system (which may include one or more of a blood collection device, extension kit 100, and catheter assembly 200 (which may include an extension tube extending from side port 224)) may encompass the entire blood collection passage through which blood flows after exiting the vascular system and into or through the blood collection device during blood collection. This can be described as G through the fluid passage of extension kit 100 as previously described. f The system geometry factor G of the fluid channels in a blood collection system is determined in a similar manner. fs In some embodiments, when the device 110 is in the forward position, the system geometric factor G... fs It can be equal to or greater than 7.34E+06(1 / in) 3 In some embodiments, G fs It may contain another value. In some embodiments, the system geometry factor G fs It can be 7.34E+06(1 / in) 3 Add or subtract 10%, 25%, 50%, or 75%. In some embodiments, G fsAnother value may be included, which may be selected based on the specifications and / or length of catheter 223.

[0066] In some embodiments, the distal connector 212 can connect the extension kit 100 to the catheter assembly 200. In some embodiments, the catheter assembly 200 may include a catheter adapter 220, which may include a distal end 221, a proximal end 222, and a lumen extending therethrough. In some embodiments, the catheter adapter 220 may include a side port 224 from which another extension tube can extend. In some embodiments, the other extension tube may be connected to an adapter, such as a Y-adaptor or a T-adaptor. In some embodiments, the distal end 106 of the tube 102 may be connected to the proximal end 222 of the catheter adapter 220, the side port 224, the adapter, or another portion of the catheter assembly 200. In some embodiments, the distal end 204 of the catheter assembly 200 may include a catheter 223, which may be secured within the catheter adapter 220 and extend distally from the distal end 221 of the catheter adapter 220. In some embodiments, catheter 223 may comprise a peripheral intravenous (IV) catheter, a midline catheter, or a peripherally inserted central catheter.

[0067] In some embodiments, catheter 223 may comprise a standard catheter tip or an asymmetrical catheter tip. In some embodiments, catheter 223 may comprise one or more diffuser orifices disposed in the tip of catheter 223. In some embodiments, catheter 223 may comprise polyurethane, fluorinated ethylene propylene copolymer (FEP), polytetrafluoroethylene, silicone, thermoplastic elastomer (TPE), thermoplastic polyurethane (TPU), fluorinated polymer, polyimide, or any other suitable material or combination thereof. In some embodiments, the material of catheter 223 may be hydrophilic, hydrophobic, and / or may include any other desired properties or characteristics, such as antifouling materials. Some embodiments of catheter 223 may include a coating such as an antithrombotic coating or other coatings to impart other desired properties to catheter 223.

[0068] Now for reference Figure 3-4 In some embodiments, the fluid seal 214 may allow the instrument 110 to advance and / or retract while maintaining a closed fluid path. In some embodiments, the fluid seal 214 may comprise silicone rubber, an elastomer, or another suitable material. In some embodiments, the fluid seal 214 may include an orifice, slit, or the like to accommodate the instrument 110 passing through it.

[0069] In some embodiments, the compressed portion 302 of the tube 102 may engage with the connector element 117 such that movement of the translation handle 116 along the outer surface 108 of the tube 102 causes the distal end 114 of the instrument 110 to... Figure 3 The retraction position shown is the same as Figure 4 Translation between the forward positions shown. In some embodiments, the connector element 117 may be coupled to the instrument 110 and / or the extension tube 206 by, for example, an interference fit, an adhesive, or both. In some embodiments, the extension tube 206 and the instrument 110 may be integrally formed as a single unit and may extend through the connector element 117.

[0070] Now for reference Figure 5A and 5B In some embodiments, the connector element 117 may engage or otherwise engage one or more features of the translation handle 116 via the tube 102 to allow translation of the instrument 110 without any direct contact between the translation handle 116 and the connector element 117 coupled to the instrument 110. For example, in some embodiments, such as Figure 5A As shown, the connector element 117 may comprise a disc-shaped or elliptical shape 506 having a flat or recessed central portion 504. The flat or recessed central portion 504 may be aligned with the opposing feature 500 of the translation handle 116 to facilitate smooth translation. In some embodiments, the feature 500 may comprise a roller, ball bearing, low-friction sliding surface, etc. In some embodiments, the feature 500 may be circular, angled, spherical, or cylindrical.

[0071] In some embodiments, the distance between the opposing features 500 may be less than the outer diameter of the tube 102, so that the tube 102 is sandwiched between the feature 500 and the connector element 117. In some embodiments, such as Figure 5B As shown, the connector element 117 may include a disc-shaped or elliptical shape with a tapered end 508. The tapered end 508 may be adapted to the feature portion 500 of the translation handle 116 to facilitate smooth translation.

[0072] In some embodiments, feature 500 may be coupled to translation handle 116 to provide localized compression of tube 102. In some embodiments, feature 500 may engage with connector element 117 via tube 102 to facilitate smooth translation of instrument 110 within tube 102. In some embodiments, feature 500 may be coupled to the inner edge of translation handle 116. In some embodiments, the surface of connector element 117 that engages with feature 500 may be generally recessed to facilitate smooth bidirectional movement along outer surface 108 of tube 102.

[0073] According to various embodiments, the connector element 117 may include a tapered end 508 to enhance its ability to accommodate rounded corners during its movement between the proximal end 104 and the distal end 106 of the tube 102. In these and other embodiments, the connector element 117 may include fins to facilitate downward travel along the tube 102. In some embodiments, the connector element 117 may include perforations, ribs, or channels to facilitate fluid flow, such as air and / or liquids. In some embodiments, air may flow around the connector element 117, for example, through perforations, ribs, or channels, so as to reduce or eliminate vacuum in response to distal or proximal movement of the connector element 117. In other embodiments, the connector element 117 may include orifices to accommodate fluid flow, such as fluid infused into a patient's vascular system or blood aspirated from a patient's vascular system. In some embodiments, the connector element 117 may include one or more colors or patterns to increase its visibility.

[0074] In some embodiments, longitudinal ribs may be molded onto the outer surface of the connector element 117 to keep the connector element 117 oriented parallel to the tube 102, thereby facilitating unobstructed bidirectional movement of the connector element 117 through the tube 102. In some embodiments, the longitudinal ribs may contact opposing features on the inner surface of the tube 102 to prevent the connector element 117 from rotating within the tube 102.

[0075] In some embodiments, the inner surface of the connector element 117 and / or tube 102 may contain a lubricant 304 to facilitate translation of the instrument 110 within the tube 102. In some embodiments, the lubricant 304 may be disposed around the connector element 117 and / or within the non-fluid path lumen 510 of the tube 102. In other embodiments, the lubricant 304 may be applied to the exterior of the non-fluid path lumen 510 around the feature 500 of the translation handle 116. In some embodiments, the connector element 117 may contain a lubricating material to facilitate movement within the non-fluid path lumen 510. In these and other embodiments, the extension kit 100 may include a vent to maintain atmospheric pressure and allow air movement within the non-fluid path lumen 510 during bidirectional translation of the instrument 110. In some embodiments, the non-fluid path lumen 510 may include a vent to allow airflow into and out of the non-fluid path lumen 510, which may facilitate movement of the translation handle 116 and the connector element 117. In some embodiments, the size of one or more vent holes used to provide venting can be reduced to allow air movement while still maintaining good sterile protection for the instrument 110 and / or other parts of the extension kit 100.

[0076] Now for reference Figure 6-8In some embodiments, the extension kit 100 and catheter assembly 200 may include a fluid pathway assembly 600 that facilitates blood collection. In some embodiments, the fluid pathway assembly 600 may include an instrument 110, which may contain tubing, such as a microtubule. In some embodiments, the tubing may contain a polymer material, polyimide, or another suitable material. In some embodiments, the proximal connector 208 may be coupled to a needleless connector or a female Luer connector. In some embodiments, blood can flow through the instrument 110 and through the extension tube 206 into the blood collection device.

[0077] In some embodiments, the non-fluid path extension component 602 can be accessed via a catheter placed within the vascular system (e.g., see...). Figure 2 The catheter 223 is used to provide support, alignment, and sterile delivery of the device 110. In some embodiments, a majority of the non-fluid path extension assembly 602, or the portion of the non-fluid path extension assembly 602 proximal to the fluid seal 214, may not contact blood drawn from the patient via the extension kit 100. In some embodiments, the portion of the non-fluid path extension assembly distal to the fluid seal 214 may have some contact with blood or saline solution that may be in the fluid path of the catheter. In some embodiments, the non-fluid path extension assembly 602 may include one or more of the following: tube 102, translation handle 116, distal connector 212 at distal end 106, and proximal connector 209 disposed at proximal end. In some embodiments, the distal end 106 of tube 102 and / or distal connector 212 may include fluid seal 214 to seal the distal end of the non-fluid path extension assembly 602. In some embodiments, fluid seal 214 may form a seal around the device 110 through which it may extend. Advantageously, the extension kit 100 according to certain embodiments can be easily scaled in length based on, for example, the size or length of the catheter 123 or the catheter assembly 200.

[0078] Now for reference Figure 9A and 9B In some embodiments, the translation handle 116 may include a collar 900 surrounding the tube 102. For illustrative purposes, the tube 102 is in Figure 9BThe area is shown as transparent. In some embodiments, the collar 900 may extend completely or partially around the tube 102. In some embodiments, the collar 900 may be movable bidirectionally along the tube 102. In some embodiments, the collar 900 and the connector element 117 may be magnetically attracted to each other through the tube 102 to facilitate movement of the instrument 110 without direct contact. These and other embodiments of the collar 900 may include features 500 to improve ease of movement along the outer surface 108 of the tube 102. In some embodiments, the outer surface of the collar 900 may include one or more gripping features, such as ribs, textured surfaces, push tabs, or other protrusions, to provide ease of operation.

[0079] In some embodiments, feature 500 may include one, two, or three ball bearings radially symmetrically distributed around the longitudinal axis of tube 102. In some embodiments, feature 500 may be coupled to the inner surface of collar 900 to adjust the contact between collar 900 and the outer surface 108 of tube 102. In other embodiments, any number of feature 500 may be present and any number of feature 500 may be arranged in a variety of symmetrical and asymmetrical arrangements.

[0080] All examples and conditional language cited herein are intended for pedagogical purposes to aid the reader's understanding of the invention and the concepts contributed by the inventors to the art, and should be interpreted as not being limited to such specifically enumerated examples and conditions. Although embodiments of the invention 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 invention.

Claims

1. An extension kit for providing access to a patient's vascular system, the extension kit comprising: A tube, the tube comprising a proximal end, a distal end, and an outer surface; An instrument disposed within the tube, the instrument comprising a proximal end and a distal end; as well as 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 instrument between a retracted position and an advanced position, wherein in response to the distal end of the instrument being in the advanced position, the distal end of the instrument extends beyond the distal end of the tube. as well as The device includes a connector element positioned in the tube, wherein the translation handle radially inwardly compresses a portion of the tube between the connector element and the translation handle, and then the radially inwardly compressed portion of the tube engages with the connector element such that, without direct contact between the translation handle and the device, movement of the translation handle along the outer surface of the tube causes the distal end of the device to translate between the retracted position and the forward position.

2. The extension kit according to claim 1, characterized in that, The device includes tubing.

3. The extension kit of claim 1, further comprising a fluid path assembly including the instrument, a proximal end and a distal end, wherein an extension tube is coupled to the proximal end of the instrument, and wherein the proximal end of the fluid path assembly includes a proximal connector configured to connect to a blood collection device.

4. The extension kit according to claim 1, characterized in that, The distal end of the tube includes a distal connector.

5. The extension kit according to claim 4, characterized in that, The distal end of the tube or the distal connector includes a fluid seal to seal the tube.

6. The extension kit according to claim 1, characterized in that, At least one of the connector element and the tube includes a lubricant to facilitate translation of the instrument within the tube.

7. The extension kit according to claim 1, characterized in that, The translation handle includes at least one of a roller and a bearing to provide localized compression of the tube to engage the connector element through the tube.

8. An extension kit for providing access to a patient's vascular system, the extension kit comprising: A fluid pathway assembly, the fluid pathway assembly including an instrument, an extension tube, and a proximal connector configured to be coupled to a blood collection device; A tube, the tube including a proximal end, a distal end, and an outer surface, wherein a translation handle is coupled to the outer surface and configured to move between the proximal end and the distal end; and The device is disposed within the tube and includes a proximal end and a distal end, wherein the proximal end of the device engages with the translation handle and is configured to move between a proximal position and a distal position, wherein in response to movement of the translation handle to the distal end of the tube, the distal end of the device extends beyond the distal end of the tube. The proximal end of the instrument includes a connector element positioned in the tube, wherein the translation handle radially inwardly compresses a portion of the tube between the connector element and the translation handle, and then the radially inwardly compressed portion of the tube engages with the connector element, such that, without direct contact between the translation handle and the instrument, movement of the translation handle along the outer surface of the tube causes the distal end of the instrument to translate between a retracted position and an advanced position.

9. The extension kit according to claim 8, characterized in that, The device includes tubing.

10. The extension kit according to claim 8, characterized in that, The fluid path assembly extends through the tube, wherein the instrument is configured to move relative to the tube between a retracted position and an advanced position.

11. The extension kit according to claim 8, characterized in that, The distal end of the tube includes a distal connector.

12. The extension kit according to claim 11, characterized in that, The distal end of the tube or the distal connector includes a fluid seal to seal the tube.

13. The extension kit according to claim 8, characterized in that, At least one of the connector element and the tube includes a lubricant to facilitate translation of the instrument within the tube.

14. The extension kit according to claim 8, characterized in that, The translation handle includes at least one of a roller and a bearing to provide localized compression of the tube to engage the connector element through the tube.

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