Stretching set and related systems and methods

Abstract

To provide an extension set that allows instruments such as tubing to access a patient's vascular system without additional needle punctures. The extension set may include a tube having an outer surface. An instrument, such as a tube 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 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 into the catheter assembly and / or the patient's vasculature.

Description

[Technical Field]

[0001] The present invention relates to an extension set in a catheter or the like. [Background technology]

[0002] Catheters are commonly used for a variety of infusion therapies. For example, catheters may be used to infuse fluids, such as normal saline, various medications, and total parenteral nutrition, into a patient. Catheters may also be used to withdraw blood from a patient to obtain a blood sample.

[0003] A common type of catheter is the over-the-needle peripheral intravenous ("IV") catheter. As the name suggests, an over-the-needle catheter may be mounted over an introducer needle having a sharp distal end. The catheter and introducer needle may be assembled such that the distal end of the introducer needle extends beyond the distal end of the catheter, with the bevel of the needle facing up and away from the patient's skin. The catheter and introducer needle are generally inserted at a shallow angle through the patient's skin and into the vasculature.

[0004] To confirm proper placement of the introducer needle and / or catheter within the blood vessel, the clinician typically checks for blood "backflow" within the flashback chamber of the catheter assembly. Once needle placement is confirmed, the clinician may temporarily block flow through the vasculature and remove the needle, leaving the catheter in place for future blood draws, infusions, or probe access.

[0005] Blood collection or infusion using a catheter can be difficult for several reasons, especially when the catheter remains in place in the patient for more than a day. For example, when a catheter remains inserted in a patient for an extended period of time, the catheter may become susceptible to stenosis, collapse, kinking, blockage by debris (e.g., fibrin or platelet clots), and adhesion of the catheter tip to the vasculature. For this reason, catheters are often used to collect blood samples at the time of catheter placement but much less frequently to collect blood samples during the catheterization period. Therefore, when a blood sample is needed, an additional needle puncture is used to access the vein for collection, which can be painful for the patient and result in higher material costs.

[0006] 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]

[0007] The present disclosure generally relates to an extension set including a tube that may house an instrument, such as, for example, a probe or a tube. The instrument may access a patient's vascular system during placement of a vascular access device, such as a catheter assembly, for medication and fluid delivery and / or blood sampling. In some embodiments, the instrument may access a fluid path of the catheter assembly. In other embodiments, the instrument may extend through the catheter assembly to access the patient's vascular system.

[0008] In some embodiments, the extension set may include a tube, which may include a proximal end, a distal end, and an exterior surface. In some embodiments, an instrument, such as a probe or tube, may be disposed within the tube and may include a proximal end and a distal end. In some embodiments, the tube may shield the instrument from contaminants and / or isolate blood or other fluids that may remain in the instrument after accessing the fluid path 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. In some embodiments, the translation handle may thus 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 an instrument, a proximal end, and a distal end. In some embodiments, an extension tube may be coupled to the proximal end of the instrument. In some embodiments, the proximal end of the fluid pathway assembly may include a proximal connector, the proximal connector configured to connect to a blood collection device. In some embodiments, the fluid pathway assembly may extend through a tube.

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

[0012] In some embodiments, the instrument may extend distally from the coupling element to facilitate translating the instrument within the tube without the need for direct contact. In some embodiments, the extension tube may be coupled to the instrument via the coupling element. In some embodiments, the tube may be axially compressible such that the translation handle compresses a portion of the tube between the coupling element and the translation handle. In some embodiments, the compressed portion of the tube may engage the coupling 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 coupling element and / or the tube may include a lubricant to facilitate translation of the instrument within the tube. In these and other embodiments, the translation handle may include rollers and / or bearings to locally compress the tube and engage the coupling element through the tube.

[0014] In some embodiments, the instrument can be disposed within the tube and can include a proximal end and a distal end, hi some embodiments, in response to the translation handle being moved toward the distal end of the tube, the distal end of the instrument can extend beyond the distal end of the tube.

[0015] In some embodiments, a method of providing access to a patient's vasculature can include coupling an extension set to a catheter assembly. In some embodiments, the extension set can include a tube, an instrument disposed within the tube, and a translation handle coupled to an exterior surface of the tube. In some embodiments, coupling the extension set to the catheter assembly can include coupling a distal end of the tube to the catheter assembly. In some embodiments, the method can further include moving the translation handle along the tube from a proximal position to a distal position. In some embodiments, at the distal position, the distal end of the instrument can extend into the catheter assembly beyond the distal end of the tube.

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

[0017] In some embodiments, the extension set can include a blood collection device. In some embodiments, the method can include moving the translating handle from a distal position to a proximal position after blood is collected in the blood collection device. In some embodiments, moving the translating handle to the proximal position can include retracting the distal end of the instrument into the tube.

[0018] 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. Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief explanation of the drawings]

[0019] [Figure 1] FIG. 1 is a top perspective view of an exemplary extension set showing an exemplary instrument in an advanced position, according to some embodiments. [Figure 2] FIG. 1 is a top perspective view of an extension set coupled to an exemplary catheter assembly, according to some embodiments. [Figure 3]FIG. 10 is a partial cutaway view of the extension set showing the instrument in a retracted position, according to some embodiments. [Figure 4] FIG. 10 is a partial cutaway view of the extension set showing the instrument in an advanced position, according to some embodiments. [Figure 5A] 1A and 1B are cross-sectional views of an exemplary translation device, according to some embodiments. [Figure 5B] FIG. 10 is a cross-sectional view of another exemplary translation device of a stretching set, according to some embodiments. [Figure 6] FIG. 10 is a partial exploded view of an exemplary translation device of a stretching set, according to some embodiments. [Figure 7] FIG. 10 is a top perspective view of the extension set showing the instrument in a retracted position, according to some embodiments. [Figure 8] FIG. 12 is a top perspective view of the extension set showing the instrument in an advanced position, according to some embodiments. [Figure 9A] FIG. 10 illustrates a top perspective view of an exemplary translation handle and an exemplary coupling element, according to some embodiments. [Figure 9B] 9B is a cross-sectional view of the translation handle and coupling element of FIG. 9A, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0020] 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.

[0021] The extension set, according to some embodiments, may provide access to a patient's vasculature. As discussed in more detail below, in some embodiments, the extension set may provide access to the fluid pathway of the catheter assembly. In some embodiments, the extension set may provide access to the patient's vasculature throughout the indwelling time of the catheter assembly for drug and fluid delivery and / or blood sampling.

[0022] As previously mentioned, catheters that have a significant dwell time within a patient's vasculature can be susceptible to stenosis, collapse, kinking, blockage by debris (e.g., fibrin or platelet clots), and adhesion of the catheter tip to the patient's blood vessel. Thus, drawing blood using a catheter can be difficult. Advantageously, in some embodiments, the extension set can 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 vasculature without an additional needle puncture. Thus, in some embodiments, the extension set 100 can be used for needleless blood collection and / or infusion.

[0023] Referring now to FIG. 1 , in some embodiments, the stretched set 100 may include a tube 102, which may include a proximal end 104, a distal end 106, and an exterior surface 108. In some embodiments, the tube 102 may be flexible, rigid, or semi-rigid. In some embodiments, the instrument 110 may be disposed within the tube 102 and may include a proximal end 112 and a distal end 114. The distal end 114 may, in some embodiments, be atraumatic or blunt. In some embodiments, the stretched set 100 may provide a non-fluid pathway through the tube 102 to shield the instrument 110 from contaminants and the surrounding external environment. The non-fluid pathway may be configured to prevent blood drawn from a patient from contacting the non-fluid pathway. In some embodiments, the stretched set 100 may also isolate blood or other fluids that may remain on the instrument 110 after use. Additionally, in some embodiments, extension set 100 may provide support, alignment, and sterile delivery of device 110 into the patient's vasculature via a catheter assembly.

[0024] 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 requiring direct contact with the instrument 110. In some embodiments, the translation handle 116 may move between a proximal and a distal position along the length of the outer surface 108 of the tube 102. In some embodiments, the tube 102 may comprise an axially compressible, biocompatible, elastomeric or polymeric material. In this manner, in some embodiments, the translation handle 116 may create a localized compression of the tube 102.

[0025] As described in more detail below, in some embodiments, the compressed portion of the tube 102 can engage a coupling element 117 coupled to the proximal end 112 of the instrument 110, such that the translation handle 116 can translate the distal end 114 of the instrument 110 in the direction of movement of the translation handle 116. In some embodiments, the translation handle 116 can translate the distal end 114 of the instrument 110 between a retracted position and an advanced position. In the advanced position 124, as shown in FIG. 1 , the distal end 114 of the instrument 110 can extend beyond the distal end 106 of the tube 102, for example, into a catheter assembly or a patient's vasculature.

[0026] 2, in some embodiments, extension set 100 may be coupled to catheter assembly 200, which may include a distal end 204. In some embodiments, instrument 110 may extend through distal end 204 of catheter assembly 200 in response to translation handle 116 being moved to a distal position.

[0027] In some embodiments, the instrument 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 located toward the distal end 114. In some embodiments, the openings may function as fluid inlets and / or outlets. In some embodiments, the sensors may measure one or more parameters and / or detect one or more factors related to, for example, diagnostic information, blood chemistry, pH, temperature, pressure, flow rate, drug identification, microorganisms, placement of an implantable stent, stabilization function of an intravenous catheter tip, or other device or physiological measures. In some embodiments, the extension set 100 may facilitate placement of a portion of the probe, including the sensor, within the fluid pathway of the catheter assembly and / or the patient's vasculature.

[0028] In some embodiments, the device 110 can include a tube and can function as both a probe and a catheter, including both elements. In some embodiments, the device 110 can include a tube for providing fluid infusion and / or withdrawal. In some embodiments, the tube can include a standard catheter tip or an asymmetric catheter tip. In some embodiments, a diffuser hole can be located at the tip of the tube. In some embodiments, the tube can include polyurethane, FEP, Teflon, silicone, TPE, TPU, fluorinated polymer, polyimide, or any other suitable material or combination thereof. In some embodiments, the tube material can be hydrophilic, hydrophobic, and / or include any other desired properties or characteristics, such as an antifouling material. Some embodiments of the tube can include a coating, such as an anti-thrombogenic coating or other coating, to impart other desired properties to the tube.

[0029] In some embodiments, the extension tube 206 may be coupled to the proximal end of the translation handle 116 and / or the proximal end 112 of the instrument 110. In some embodiments, the extension tube 206 may be flexible. In some embodiments, the extension tube 206 may comprise TPE, TPU, PVC, or other suitable medical tubing. In some embodiments, the extension tube 206 may be substantially transparent and / or include markers to inform the clinician of the position of the instrument 110 relative to the catheter or catheter features. In some embodiments, the extension tube 206 may include a textured surface to reduce contact friction. Some embodiments of the extension tube 206 may be vented, for example, by an open air passage, a breathable filter membrane, a porous vent material, microchannels, etc.

[0030] In some embodiments, proximal connector 208 may be coupled to or integral with the proximal end of extension tube 206 and may be connected to, for example, a blood collection device 210 (see, e.g., FIG. 3), an infusion device, or a monitoring device. 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. Proximal connector 208 may include, for example, a male or female luer, a blunt cannula, or another suitable connector.

[0031] In some embodiments, the distal end 106 of the tube 102 may be coupled to or integral 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, a blunt cannula, or another suitable connector.

[0032] In some embodiments, the extension tube 206 may extend through a proximal connector 209 that is integral with or coupled to the proximal end 104 of the tube 102. In some embodiments, there may be a tight fit or septum 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 is collected into 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 include any suitable translation handle, as described in further detail, for example, in U.S. patent application Ser. No. 17 / 127,588, filed December 18, 2020, entitled "FLUSH 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.

[0033] In some embodiments, the stretching set 100 can reduce hemolysis of a blood sample drawn through a fluid path. In some embodiments, the stretching set 100 can provide an appropriate fluid flow rate. Blood cells experience shear stress as they flow through a fluid path. 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 cause of mechanical damage to blood cells. For a cylindrical fluid path, wall shear stress is typically expressed as:

number

[0034] 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

[0035] In principle, the hemolysis index is related to the pressure gradient and the cross-sectional characteristic dimensions.

number

[0036] In some embodiments, the length of the stretched set 100 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. In some embodiments, the stretched set 100 may comprise a length L. In some embodiments, the stretched set 100 may comprise an inner diameter D.

[0037] Fluid flow within the fluid path through the tubular stretching set 100 can be analyzed using Poiseuille's equation.

number

[0038] In some embodiments, the fluid path through the stretching set 100 may have multiple sections with lengths (L1, L2, L3) and inner diameters (D1, D2, D3), with geometric coefficients as follows:

number

number

number

[0039] G of the fluid path through the stretch set 100 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 fThe 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).

[0040] In some embodiments, the fluid path of the blood collection system may include one or more of the blood collection device, the extension set 100, and the catheter assembly 200 (which may include an extension tube extending from the side port 224), and the fluid path may include the entire blood collection path through which blood flows within or through the blood collection device during blood collection after exiting the vascular system. A system geometric coefficient G for the fluid path of the blood collection system fs is the G of the fluid path through the stretch set 100. f In some embodiments, the system geometric coefficient G fs is 7.34E+06(1 / in) when the instrument 110 is in the forward 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 fs may include other values, which may be selected based on the gauge and / or length of the catheter 223.

[0041] In some embodiments, the distal connector 212 may couple the extension set 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 may extend. In some embodiments, the other extension tube may be coupled to an adapter, such as a Y adapter or a T adapter. In some embodiments, the distal end 106 of the tube 102 may be coupled to the proximal end 222 of the catheter adapter 220, the side port 224, an 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 include a peripheral IV catheter, a midline catheter, or a peripherally inserted central catheter.

[0042] In some embodiments, the catheter 223 may include a standard catheter tip or an asymmetric catheter tip. In some embodiments, the catheter 223 may include one or more diffuser holes, which may be located at the tip of the catheter 223. In some embodiments, the catheter 223 may include polyurethane, FEP, Teflon, silicone, TPE, TPU, fluorinated polymer, polyimide, or any other suitable material or combination thereof. In some embodiments, the material of the catheter 223 may be hydrophilic, hydrophobic, and / or include any other desired properties or characteristics, such as an anti-fouling material. Some embodiments of the catheter 223 may include a coating, such as an anti-thrombogenic coating or other coating, to impart other desired properties to the catheter 223.

[0043] 3-4, in some embodiments, the fluid seal 214 may maintain a closed fluid pathway while allowing advancement and / or retraction of the instrument 110 therethrough. In some embodiments, the fluid seal 214 may comprise silicone rubber, an elastomer, or other suitable material. In some embodiments, the fluid seal 214 may include an aperture, slit, or the like to accommodate the instrument 110 therethrough.

[0044] In some embodiments, the compressed portion 302 of the tube 102 can engage the coupling element 117, such that movement of the translation handle 116 along the outer surface 108 of the tube 102 translates the distal end 114 of the instrument 110 between a retracted position shown in FIG. 3 and an advanced position shown in FIG. 4. In some embodiments, the coupling element 117 can be coupled to the instrument 110 and / or the extension tube 206, for example, by an interference fit, adhesive, or both. In some embodiments, the extension tube 206 and the instrument 110 can be monolithically formed as a single unit and can extend through the coupling element 117.

[0045] 5A and 5B, in some embodiments, coupling element 117 may engage or otherwise mate with one or more features of translation handle 116 via tube 102 to enable translation of instrument 110 without direct contact between translation handle 116 and coupling element 117 coupled to instrument 110. For example, in some embodiments, as shown in FIG. 5A, coupling element 117 may include a disk-like or elliptical shape 506 having a flat or concave central portion 504. Flat or concave central portion 504 may align with an opposing main portion 500 of translation handle 116 to facilitate smooth translation. In some embodiments, main portion 500 may include rollers, ball bearings, low-friction sliding surfaces, etc. In some embodiments, main portion 500 may be round, angled, spherical, or cylindrical.

[0046] In some embodiments, the distance between the opposing main portions 500 may be less than the outer diameter of the tube 102, such that the tube 102 is sandwiched between the main portions 500 and the coupling element 117. In some embodiments, as shown in FIG. 5B, the coupling element 117 may include a disk-like or oval shape with a tapered end 508. The tapered end 508 may receive the main portion 500 of the translation handle 116 to facilitate smooth translation.

[0047] In some embodiments, main portion 500 may be coupled to translation handle 116 to provide localized compression of tube 102. In some embodiments, main portion 500 may engage coupling element 117 through tube 102 to facilitate smooth translation of instrument 110 within tube 102. In some embodiments, main portion 500 may be coupled to an inner edge of translation handle 116. In some embodiments, the surface of coupling element 117 that interfaces with main portion 500 may be substantially concave, facilitating smooth bidirectional movement along outer surface 108 of tube 102.

[0048] According to various embodiments, the coupling element 117 may include a tapered end 508 to improve its ability to round corners during movement between the proximal end 104 and the distal end 106 of the tube 102. In these and other embodiments, the coupling element 117 may include fins to facilitate movement down the tube 102. In some embodiments, the coupling element 117 may include fenestrations, ribs, or channels to facilitate the flow of fluids, such as air and / or liquid. In some embodiments, air can flow around the coupling element 117 through fenestrations, ribs, channels, or the like, and a vacuum is reduced or removed in response to moving the coupling element 117 distally or proximally. In another embodiment, the coupling element 117 may include a bore to accommodate the flow of fluid, such as fluid to be infused into or blood to be aspirated from the patient's vascular system. In some embodiments, the coupling element 117 may include one or more colors or patterns to enhance its visibility.

[0049] In some embodiments, longitudinal ribs may be molded on the outer surface of coupling element 117 to keep coupling element 117 oriented parallel to tube 102, thereby facilitating unhindered bidirectional movement of coupling element 117 through tube 102. In some embodiments, the longitudinal ribs may contact opposing features on the inner surface of tube 102 to prevent coupling element 117 from rotating within tube 102.

[0050] In some embodiments, the coupling element 117 and / or the inner surface of the tube 102 may include 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 coupling element 117 and / or inside the non-fluid pathway lumen 510 of the tube 102. In another embodiment, the lubricant 304 may be applied to the exterior of the non-fluid pathway lumen 510 around the main portion 500 of the translation handle 116. In some embodiments, the coupling element 117 may include a lubricant material to facilitate movement within the non-fluid pathway lumen 510. In these and other embodiments, the extension set 100 may include a vent to maintain atmospheric pressure and allow movement of air within the non-fluid pathway lumen 510 during bidirectional movement of the instrument 110. In some embodiments, the non-fluid pathway lumen 510 may include a vent to allow air flow into and out of the non-fluid pathway lumen 510, which may facilitate movement of the translation handle 116 and the coupling element 117. In some embodiments, one or more vent holes for providing ventilation may be reduced in size to allow air movement while still maintaining good sterility protection of the instrument 110 and / or other parts of the extension set 100.

[0051] 6-8 , in some embodiments, extension set 100 and catheter assembly 200 may include a fluid pathway assembly 600 that facilitates blood collection. In some embodiments, fluid pathway assembly 600 may include instrument 110, which may include tubing, such as a microtube. In some embodiments, the tubing may include a polymer material, polyimide, or other suitable material. In some embodiments, proximal connector 208 may be coupled to a needleless connector or a female Luer connector. In some embodiments, blood may flow through instrument 110 and extension tube 206 into a blood collection device.

[0052] In some embodiments, the non-fluidic path extension assembly 602 may provide support, alignment, and sterile delivery of the instrument 110 via a catheter (see, e.g., catheter 223 in FIG. 2 ) placed within the vascular system. In some embodiments, the majority of the non-fluidic path extension assembly 602, or the portion of the non-fluidic path extension assembly 602 proximal to the fluid seal 214, may not come into contact with blood being withdrawn from the patient through the extension set 100. In some embodiments, the portion of the non-fluidic path extension assembly distal to the fluid seal 214 may have some contact with blood or saline that may be in the catheter's fluid path. In some embodiments, the non-fluidic path extension assembly 602 may include one or more of the tube 102, the translation handle 116, the distal connector 212 at the distal end 106, and the proximal connector 209 disposed at the proximal end. In some embodiments, the distal end 106 of the tube 102 and / or the distal connector 212 may include a fluid seal 214 to seal off the distal end of the non-fluid pathway extension assembly 602. In some embodiments, the fluid seal 214 may form a seal around the instrument 110 through which the instrument 110 may extend. Advantageously, the extension set 100 according to some embodiments may be easily adjusted in length based on, for example, the size or length of the catheter 123 or catheter assembly 200.

[0053] 9A and 9B, in some embodiments, the translation handle 116 may include a collar 900 around the tube 102. The tubing 102 is shown in see-through form in FIG. 9B for illustrative purposes. In some embodiments, the collar 900 may extend completely or partially around the tube 102. In some embodiments, the collar 900 may move bidirectionally along the tube 102. In some embodiments, the collar 900 and the coupling element 117 may be magnetically attracted to one another via the tube 102, facilitating movement of the instrument 110 without direct contact. These and other embodiments of the collar 900 may include a main portion 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 grips, such as ribs, a textured surface, push tabs, or other protrusions, to facilitate handling.

[0054] In some embodiments, the main portion 500 may include one, two, or three ball bearings distributed radially symmetrically about the longitudinal axis of the tube 102. In some embodiments, the main portion 500 may be coupled to the inner surface of the collar 900 to mediate contact between the collar 900 and the outer surface 108 of the tube 102. In other embodiments, there may be any number of main portions 500, and they may be arranged in a variety of symmetric and asymmetric configurations.

[0055] All examples and conditional language set forth herein are intended for educational purposes to aid the reader in understanding the concepts contributed 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.

Claims

1. 1. An extension set for providing access to a patient's vascular system, comprising: a tube including a proximal end, a distal end, and an exterior surface; an instrument disposed within the tube and including a proximal end and a distal 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 instrument between a retracted position and an advanced position such that the distal end of the instrument extends beyond the distal end of the tube in response to the distal end of the instrument being in the advanced position; Equipped with the instrument includes a coupling element, the translation handle compresses a portion of the tube between the coupling element and the translation handle, and 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 distal end of the instrument between the retracted position and the advanced position. Extension set.

2. The tensioning set of claim 1 , wherein the device comprises a tube.

3. 10. The extension set 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 the proximal end of the fluid path assembly includes a proximal connector configured to connect to a blood collection device.

4. The extension set of claim 1 , wherein the distal end of the tube includes a distal connector.

5. The extension set of claim 4 , wherein the distal end of the tube or the distal connector includes a fluid seal that seals the tube.

6. The extension set of claim 1 , wherein at least one of the coupling element and the tube includes a lubricant to facilitate translation of the instrument within the tube.

7. The stretching set of claim 1 , wherein the translation handle includes at least one of a roller and a bearing to locally compress the tube and engage the coupling element through the tube.

8. 1. An extension set for providing access to a patient's vascular system, comprising: a fluid pathway assembly including an instrument, an extension tube, and a proximal connector configured to couple to a blood collection set; a 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; the instrument disposed within the tube and including a proximal end and a distal end, the proximal end of the instrument configured to engage the translation handle and move between a proximal position and a distal position, and in response to movement of the translation handle toward the distal end of the tube, the distal end of the instrument extends beyond the distal end of the tube; Equipped with the proximal end of the instrument includes a coupling element, the translation handle compresses 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 distal end of the instrument between the retracted position and the advanced position; Extension set.

9. The extension set of claim 8 , wherein the device comprises a tube.

10. The extension set of claim 8 , wherein the fluid pathway assembly is configured to extend through the tube such that the instrument moves between a retracted position and an advanced position relative to the tube.

11. The extension set of claim 8 , wherein the distal end of the tube includes a distal connector.

12. The extension set of claim 11 , wherein the distal end of the tube or the distal connector includes a fluid seal that seals the tube.

13. The extension set of claim 8 , wherein at least one of the coupling element and the tube includes a lubricant to facilitate translation of the instrument within the tube.

14. The stretching set of claim 8 , wherein the translation handle includes at least one of a roller and a bearing to locally compress the tube and engage the coupling element through the tube.

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