Extension Set and Related Systems and Methods

Abstract

The extension set can include a tube having an outer surface. An instrument, such as a tube or probe, can be disposed within the tube and can include a proximal end and a distal end. A translation handle is coupled to the outer surface of the tube and can 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 can extend beyond the distal end of the tube and into the catheter assembly and / or vasculature of the patient.

Description

Technical Field

[0001] Catheters are generally used for various infusion therapies. For example, a catheter can be used to inject fluids such as saline, various drugs, and total parenteral nutrition into a patient. A catheter can also be used to withdraw blood from a patient to obtain a blood sample.

Background Art

[0002] A common catheter is an over-the-needle type peripheral intravenous ("IV") catheter. As the name implies, an over-the-needle catheter is a catheter that can be mounted on a introducer needle having a sharp distal end. The catheter and the introducer needle can be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the catheter and the bevel of the needle faces away from the patient's skin. The catheter and the introducer needle are typically inserted into the patient's vasculature at a shallow angle from the skin.

[0003] To verify proper placement of the introducer needle and / or catheter within the blood vessel, a clinician generally confirms that there is a "flashback" of blood within the flashback chamber of the catheter assembly. Once the needle placement is confirmed, the clinician can temporarily occlude the flow within the vasculature, remove the needle, and leave the catheter in place for subsequent blood sampling or infusion.

[0004] Blood sampling or transfusion using a catheter can be difficult for several reasons, especially when the dwell time of the catheter within the patient exceeds one day. For example, when a catheter is left inserted in a patient for an extended period, the catheter is more likely to be affected by stenosis, breakage, kinking, occlusion by debris (e.g., fibrin or platelet clots), and attachment of the catheter tip to the vasculature. For this reason, catheters are often used to obtain blood samples during catheter placement, but are much less frequently used to obtain blood samples during the catheter dwell period. Thus, when a blood sample is needed, an additional needle stick to provide venous access for blood sampling is used, which can be painful for the patient and result in higher material costs.

[0005] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in the environments described above. Rather, this background art is provided only to illustrate an example of a technical area in which some of the embodiments described herein may be practiced. SUMMARY OF THE INVENTION

[0006] The present disclosure generally relates to an extension set that includes a tube that can accommodate an instrument, such as a probe or a tube. In some embodiments, the tube can include or correspond to any suitable housing that includes a lumen extending through the housing. The instrument can access the patient's vasculature for drug delivery and fluid delivery and / or blood sampling during the dwell time of a vascular access device, such as a catheter assembly. In some embodiments, the instrument can access the fluid path of the catheter assembly. In other embodiments, the instrument can extend through the catheter assembly to access the patient's vasculature.

[0007] In some embodiments, the extension set may include a tube that can include a proximal end, a distal end, and an outer surface. In some embodiments, an instrument such as a probe or tube can be disposed within the tube and can include a proximal end and a distal end. In some embodiments, the tube can shield the instrument from contaminants and / or separate blood or other fluids that may remain on the instrument after accessing the fluid pathway of the catheter assembly. In some embodiments, the tube can protect the instrument from the surrounding external environment.

[0008] In some embodiments, the translation handle can be coupled to the outer surface of the tube. In some embodiments, the translation handle can move along the outer surface between a proximal position and a distal position. In some embodiments, thus, the translation handle can translate the distal end of the instrument between a retracted position and a forward position. In some embodiments, in the forward position, the distal end of the instrument can extend beyond the distal end of the tube.

[0009] In some embodiments, the fluid pathway assembly can include an instrument, a proximal end, and a distal end. In some embodiments, the extension tube can be coupled to the proximal end of the instrument. In some embodiments, the proximal end of the fluid pathway assembly can include a proximal connector configured to connect to a blood collection device. In some embodiments, the fluid pathway assembly can extend through the tube.

[0010] 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 for sealing the tube and creating a closed fluid pathway.

[0011] In some embodiments, the instrument may extend distally from the coupler element to facilitate translation of 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 coupler element. In some embodiments, the tube may be axially compressible such that the translation handle compresses a portion of the tube between the coupler element and the translation handle. In some embodiments, the compressed portion of the tube may engage the coupler element such that movement of the translation handle along the outer surface of the tube translates the distal end of the instrument between a retracted position and a distal position.

[0012] In some embodiments, the coupler 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 one or more features to provide local compression of the tube to engage the coupler element through the tube. In some embodiments, the features may include ball bearings, wheels, low friction sliders, or other suitable features to facilitate local compression of the tube and slide along the tube. In some embodiments, the features may be coated with a lubricant or may be constructed of a lubricious material.

[0013] In some embodiments, the instrument may be disposed within the tube and may include a proximal end and a distal end. In some embodiments, in response to the translation handle moving to the distal end of the tube, the distal end of the instrument may extend beyond the distal end of the tube.

[0014] In some embodiments, a method of providing access to a patient's vasculature may include coupling an extension set to a catheter assembly. In some embodiments, the extension set may include a tube, an instrument disposed within the tube, and a translation handle coupled to the outer surface of the tube. In some embodiments, coupling the extension set to the catheter assembly may include coupling the distal end of the tube to the catheter assembly. In some embodiments, the method may 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 may extend into the catheter assembly beyond the distal end of the tube.

[0015] In some embodiments, coupling the distal end of the tube to the catheter assembly may include coupling the distal connector of the tube to the catheter assembly. In some embodiments, the catheter assembly may include a catheter extending from the distal end. In some embodiments, in response to the translation handle moving to the distal position, the instrument may extend through the distal end of the catheter and / or into the vasculature.

[0016] In some embodiments, the extension set may include a blood sampling device. In some embodiments, after blood is collected within the blood sampling 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 instrument into the tube.

[0017] It should be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the claimed invention. It should be understood that the various embodiments are not limited to the configurations and means shown in the drawings. Also, it should be understood that embodiments may be combined, or other embodiments may be used, and structural changes may be made without departing from the scope of the various embodiments of the present invention, unless so claimed. Accordingly, the following detailed description should not be construed in a limiting sense.

Brief Description of the Drawings

[0018] Exemplary embodiments will be described and explained in more specific and detailed manner by using the accompanying drawings.

[0019]

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[0020] As used in this disclosure, the terms "proximal" and "distal" can refer to directions approaching and receding, respectively, from a clinician who positions a catheter system to contact a patient. Thus, for example, the end of the catheter system that first touches the patient's body is the distal end, while the opposite end of the catheter system is the proximal end of the catheter system.

[0021] Extension sets according to some embodiments can provide access to a patient's vasculature. As discussed in more detail below, in some embodiments, an extension set can provide access to the fluid path of a catheter assembly. In some embodiments, an extension set can provide access to a patient's vasculature throughout the dwell time of a catheter assembly for delivery of a sensor for injection, blood sampling, or measurement.

[0022] As described above, catheters having a significant dwell time within a patient's vasculature can be susceptible to stenosis, collapse, kinking, occlusion by debris (e.g., fibrin, platelet aggregates, or thrombus), and attachment of the catheter tip to the patient's vasculature. Thus, blood sampling 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 any additional needle stick. Thus, in some embodiments, the extension set 100 can be used for needleless blood collection and / or fluid infusion.

[0023] Referring now to FIG. 1, in some embodiments, the extension set 100 can include a tube 102 that can include a proximal end 104, a distal end 106, and an outer surface 108. In some embodiments, the tube 102 can be flexible, rigid, or semi-rigid. In some embodiments, the instrument 110 can be disposed within the tube 102 and can include a proximal end 112 and a distal end 114. The distal end 114 can be non-traumatic or blunt in some embodiments. In some embodiments, the extension set 100 can provide a non-fluid path through the tube 102 to shield the instrument 110 from contaminants and the surrounding external environment. The non-fluid path can be configured such that blood withdrawn from the patient does not contact the non-fluid path. In some embodiments, the extension set 100 can also isolate blood or other fluids that can remain on the instrument 110 after use. Further, in some embodiments, the extension set 100 can provide support, alignment, and aseptic delivery of the instrument 110 to the patient's vasculature through a catheter assembly.

[0024] In some embodiments, the translation handle 116 can be coupled to the outer surface 108 of the tube 102 to facilitate moving the instrument 110 without the need for direct contact with the instrument 110. In some embodiments, the translation handle 116 can move along the length of the outer surface 108 of the tube 102 between a proximal position and a distal position. In some embodiments, the tube 102 can include axially compressible, biocompatible, and elastomeric or polymeric materials. In this way, in some embodiments, the translation handle 116 can generate local compression of the tube 102.

[0025] As discussed in more detail below, in some embodiments, the compressed portion of the tube 102 can engage a coupler element 117 coupled to the proximal end 112 of the instrument 110, and 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, thus, the translation handle 116 can translate the distal end 114 of the instrument 110 between a retracted position and a forward position. In the forward 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 and / or a patient's vasculature.

[0026] Referring now to FIG. 2, in some embodiments, the extension set 100 can be coupled to a catheter assembly 200 that can include a distal end 204. In some embodiments, the instrument 110 can extend through the distal end 204 of the catheter assembly 200 in response to the translation handle 116 moving to the distal position. In some embodiments, the extension set 100 can be permanently coupled, integrated, or formed as a single unit with the catheter assembly 200.

[0027] In some embodiments, the instrument 110 may include a probe having one or more apertures and / or sensors for providing intravascular and device monitoring of a patient. In some embodiments, the apertures and / or sensors of the probe may be disposed toward the distal end 114. In some embodiments, the apertures may function as fluid inlets and / or outlets. In some embodiments, the sensors may measure one or more parameters and / or one or more elements related to, for example, diagnostic information, blood chemistry, pH, temperature, pressure, flow rate, drug identification, microorganisms, placement of an implantable stent, intravascular catheter tip stabilization function, or other devices or physiological measures. In some embodiments, the extension set 100 may facilitate placement of a portion of a probe that includes a sensor within the fluid path of the catheter assembly and / or within the vasculature of the patient.

[0028] In some embodiments, the instrument 110 may include a tube and may function as both a probe and a catheter including both elements. In some embodiments, the instrument 110 may include a tube for providing fluid injection and / or withdrawal. In some embodiments, the tube may include a standard catheter tip or an asymmetric catheter tip. In some embodiments, diffuser holes may be disposed at the tip of the tube. In some embodiments, the tube may include polyurethane, FEP, Teflon, silicon, TPE, TPU, fluorinated polymer, polyimide, or any other suitable material or combinations thereof. In some embodiments, the tube material may be hydrophilic, hydrophobic, and / or may include any other desired properties or characteristics such as an anti-fouling material. Some embodiments of the tube may include a coating such as an anti-thrombogenic and / or antibacterial coating or other coating to impart other desired properties to the tube.

[0029] In some embodiments, the extension tube 206 can 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 can be flexible. In some embodiments, the extension tube 206 can include TPE, TPU, PVC, or other suitable medical tubing materials. In some embodiments, the extension tube 206 can be substantially clear and / or can include markers for informing the user of the position of the instrument 110 relative to the catheter or catheter features. In some embodiments, the extension tube 206 can include a textured surface to reduce contact friction. Some embodiments of the extension tube 206 can be ventilated, for example, by an open air path, a breathable filter membrane, a porous breathable material, microchannels, etc.

[0030] In some embodiments, the proximal connector 208 can be coupled or integrated with the proximal end of the extension tube 206 and connected, for example, to a blood sampling device 210 (see, e.g., FIG. 3), an infusion device, or a monitoring device. In some embodiments, the blood sampling device can include any suitable blood sampling device, such as, for example, a VACUTAINER® or VACUTAINER® LUER-LOK™ access device (LLAD) available from Becton Dickinson and Company of Franklin Lakes, New Jersey. The proximal connector 208 can include, for example, a male or female luer, a blunt cannula, or another suitable connector. In some embodiments, the blood sampling device 210 can be selectively coupled to the proximal connector 208. In some embodiments, the blood sampling device 210 can be pre-connected to the proximal connector 208 during manufacturing or assembly. In some embodiments, the blood sampling device 210 can be permanently coupled, integrated, or formed as a single unit with the proximal connector 208.

[0031] In some embodiments, the distal end 106 of the tube 102 can be coupled or integrated with the distal connector 212, which can include a fluid seal 214 to seal the tube 102 and create a closed fluid path. In some embodiments, the distal connector 212 can include, for example, a male or female luer, a blunt cannula, or another suitable connector. In some embodiments, the distal connector 212 can include a lever arm and / or clip to assist with fixation.

[0032] In some embodiments, the extension tube 206 can extend through a proximal connector 209 that is integrated or coupled with 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 can create a seal but still allow movement of the extension tube 206 relative to the proximal connector 209. In some embodiments, the translation handle 116 can be moved from a proximal position to a distal position, the distal end 114 of the instrument 110 can be advanced distally beyond the tube 102, and / or the proximal connector 208 can be moved closer to the proximal connector 209. In some embodiments, after blood has been collected within the blood collection device 210, the translation handle 116 can be moved from a distal position to a proximal position, the distal end 114 of the instrument 110 can be retracted into the tube 102, and / or the proximal connector 208 can be moved away from the proximal connector 209. In some embodiments, the translation handle 116 can include any suitable translation handle that can be described in further detail, for example, in U.S. Patent Application No. 17 / 127,588, filed December 17, 2020, entitled "Flash Instrument with Blood Exposure Protection and Related Methods" and U.S. Patent Application No. 17 / 127,623, filed December 17, 2020, entitled "Multi-Lumen Extension System".

[0033] In some embodiments, the extension set 100 can reduce hemolysis of a blood sample collected via a fluid path. In some embodiments, the extension set 100 can provide an appropriate fluid flow rate. Blood cells experience shear stress as they flow through the fluid path. The maximum shear stress is along the wall or wall shear stress of the blood cells. The wall shear stress of blood cells is considered to be the main cause of mechanical damage to blood cells. In the case of a cylindrical fluid path, the wall shear stress is typically expressed as follows:

[0034]

Number

[0035] where ΔP is the pressure drop along a path of length L and internal radius r. k is the contraction index.

[0036] The time required to fill a collection tube V of a specific volume with a flow rate Q can be easily evaluated by the following equation:

[0037]

Number

[0038] where μ is the kinematic viscosity of the fluid. Hemolysis is typically related to both the wall shear stress and the time the blood cells are exposed to the wall shear stress. From the literature, it has been widely considered that the hemolysis index can be approached as a function of the following:

[0039]

Number

[0040] where A, α, and β are coefficients.

[0041] In principle, the hemolysis index is related to the pressure gradient and cross-sectional characteristic dimensions:

[0042]

Number

[0043] In some embodiments, the length of the instrument 110 can be selected based on one or more of a particular catheter gauge, a particular catheter assembly configuration, or a clinical setting. In some embodiments, the instrument 110 can include a length L. In some embodiments, the instrument 110 can include an inner diameter D.

[0044] Fluid flow within the instrument 110 can be analyzed using Poiseuille's law when the instrument 110 is tubular:

[0045]

Number

[0046] ΔP is the change in the pressure gradient across the length of the fluid path of the instrument 110, D and L are the inner diameter and length of the fluid path of the instrument 110, respectively, μ is the viscosity of the fluid, and Rf = 128μL / πD 4 is the fluid resistance. Since μ is not part of the geometry of the extension tube, the geometric factor Gf is defined such that Rf (fluid resistance) is Rf = 128μ·Gf / π, where Gf = L / D 4 and the geometric factor Gf is defined.

[0047] In some embodiments, the instrument 110 can have a plurality of sections having lengths (L1, L2, L3) and inner diameters (D1, D2, D3), and the geometric factors are as follows:

[0048]

Number

[0049] In some embodiments, the instrument 110 can have an inner diameter that varies along the length of the instrument 110, and then the geometric factors are as follows:

[0050]

Number

[0051] In some embodiments, the instrument 110 may have a cross-section that is not a circular or complex inner diameter profile. The geometric factors can be determined by measuring the flow rate (Q) at a given pressure (ΔP) with a known viscosity (μ) fluid:

[0052] [Number]

[0053] The Gf value of the instrument 110 can be selected to reduce the maximum shear stress of each catheter gauge to be the same as or less than the maximum shear stress of the BD21G VACUTAINER® UltraTouch™ push-button blood collection set (available from Becton, Dickinson & Company of Franklin Lakes, New Jersey), which was previously regarded as the gold standard for blood collection. In some embodiments, the Gf value of the fluid path of the instrument 110 can be selected to reduce the maximum shear stress of each catheter gauge to be the same as or less than the maximum shear stress of the BD25G VACUTAINER® UltraTouch™ push-button blood collection set (available from Becton, Dickinson & Company of Franklin Lakes, New Jersey).

[0054] In some embodiments, the fluid path of a blood collection system that may include one or more of the blood collection device 210, the tube 102, the instrument 110, and the catheter assembly 200 may include the entire blood collection path through which blood flows during blood collection after leaving the patient's vasculature. The system geometric factor Gfs of the fluid path of the blood collection system can be determined in a similar manner as described above. In some embodiments, the system geometric factor Gfs is 7.34E+06 (1 / in 3)The above may be the case. In some embodiments, Gfs may include another value. In some embodiments, the system geometry factor Gfs is 7.34E+06 (1 / in when the instrument 110 is in the forward position 3 )The above may be the case. In some embodiments, the system geometry factor Gfs is 7.34E+06 (1 / in 3 )Plus or minus 10 percent, plus or minus 25 percent, plus or minus 50 percent, or plus or minus 75 percent. In some embodiments, Gfs may include another value that may be selected based on the catheter gauge and / or length.

[0055] 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 that 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 through which another extension tube may extend. In some embodiments, the other extension tube may be coupled to an adapter such as, for example, 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, 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, the catheter 223 may be fixed within the catheter adapter 220, and may extend distally from the distal end 221 of the catheter adapter 220. In some embodiments, the catheter 223 may include a peripheral IV catheter, a midline catheter, or a peripherally inserted central catheter.

[0056] In some embodiments, catheter 223 may include a standard catheter tip or an asymmetric catheter tip. In some embodiments, catheter 223 may include one or more diffusion holes that may be disposed at the tip of catheter 223. In some embodiments, catheter 223 may include polyurethane, FEP, Teflon, silicon, TPE, TPU, fluorinated polymer, polyimide, or any other suitable material or combinations thereof. In some embodiments, the material of catheter 223 may be hydrophilic, hydrophobic, and / or may include any other desired property or characteristic such as an anti-fouling material. Some embodiments of catheter 223 may include a coating such as an anti-thrombogenic and / or anti-microbial coating or other coating to impart other desired properties to catheter 223.

[0057] In some embodiments, extension set 100 may provide needleless delivery of instrument 110 to a patient's vasculature for blood sampling, fluid delivery, patient or device monitoring, or other clinical needs by utilizing an existing vascular access device (VAD) such as catheter 223. In some embodiments, extension set 100 and instrument 110 may reduce trauma to the vein, overcome a VAD or thrombus and fibrin sheath within or around the vein that may prevent infusion or blood sampling. In some embodiments, instrument 110 may displace any obstacle within the VAD or vein to open a path for vascular access. In some embodiments, a suction device such as an LLAD or syringe may be attached to the proximal end of extension set 100 to complete blood sampling. After completing blood sampling or infusion, the user may retract instrument 110 by rotating translation handle 116 in the proximal direction. Thereby, the user can disconnect extension set 100 from the VAD without exposing extension set 100 to blood.

[0058] Referring now to FIGS. 3-4, in some embodiments, the fluid seal 214 may allow for the advancement and / or retraction of the instrument 110 while maintaining a closed fluid path. In some embodiments, the fluid seal 214 may include silicone rubber, an elastomer, or another suitable material. In some embodiments, the fluid seal 214 may include an opening, slit, or the like for receiving the instrument 110 therethrough.

[0059] In some embodiments, the compression portion 302 of the tube 102 may engage the coupler element 117, and 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 the retracted position shown in FIG. 3 and the advanced position shown in FIG. 4. In some embodiments, the coupler element 117 may be coupled to the instrument 110 and / or the extension tube 206, for example, by 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 coupler element 117.

[0060] Referring now to FIGS. 5A and 5B, in some embodiments, the coupler element 117 may engage or otherwise interact with one or more features of the translation handle 116 through the tube 102 to allow for translation of the instrument 110 without any direct contact between the translation handle 116 and the coupler element 117 that is coupled to the instrument 110. For example, in some embodiments, as shown in FIG. 5A, the coupler element 117 may include a disk or ellipsoidal shape 506 having a flat or recessed central portion 504. The flat or recessed central portion 504 may align with the opposing feature 500 of the translation handle 116 to facilitate smooth translation. In some embodiments, the feature 500 may include a roller, a ball bearing, a low friction sliding surface, or the like. In some embodiments, the feature 500 may be rounded, angled, spherical, or cylindrical.

[0061] In some embodiments, the distance between opposing features 500 can be less than the outer diameter of the tube 102 such that the tube 102 is sandwiched between the feature 500 and the coupler element 117. In some embodiments, as shown in FIG. 5B, the coupler element 117 can include a disk or ellipsoidal shape having a tapered end 508. The tapered end 508 can accommodate the feature 500 of the translation handle 116 to facilitate smooth translation.

[0062] In some embodiments, the feature 500 can be coupled to the translation handle 116 to provide local compression of the tube 102. In some embodiments, the feature 500 can engage the coupler element 117 via the tube 102 to facilitate smooth translation of the instrument 110 within the tube 102. In some embodiments, the feature 500 can be coupled to the inner edge of the translation handle 116. In some embodiments, the surface of the coupler element 117 that interfaces with the feature 500 can be substantially concave to facilitate smooth two-way movement along the outer surface 108 of the tube 102.

[0063] According to various embodiments, the coupler element 117 can 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 coupler element 117 can include fins to facilitate movement down the tube 102. In some embodiments, the coupler element 117 can include windows, ribs, or channels to promote the flow of fluids such as air and / or liquid. In some embodiments, air can flow around the coupler element 117, such as through the windows, ribs, or channels, so that the vacuum is reduced or eliminated in response to moving the coupler element 117 distally or proximally. In other embodiments, the coupler element 117 can include a bore for containing fluid flow, such as fluid injected into the patient's vasculature or blood aspirated from the patient's vasculature. In some embodiments, the coupler element 117 can include one or more colors or patterns to increase its visibility.

[0064] In some embodiments, the longitudinal ribs are formed on the outer surface of the coupler element 117 and can keep the coupler element 117 oriented parallel to the tube 102, thereby facilitating unobstructed bidirectional movement of the coupler element 117 through the tube 102. In some embodiments, the longitudinal ribs can contact features on the opposite side of the inner surface of the tube 102 to prevent the coupler element 117 from rotating within the tube 102.

[0065] In some embodiments, the inner surface of the coupler element 117 and / or the tube 102 can include a lubricant 304 to facilitate translation of the instrument 110 within the tube 102. In some embodiments, the lubricant 304 can be disposed around the coupler element 117 and / or inside the non-fluid path lumen 510 of the tube 102. In other embodiments, the lubricant 304 can be applied outside the non-fluid path lumen 510 around the feature 500 of the translation handle 116. In some embodiments, the coupler element 117 can include a lubricating material to facilitate movement within the non-fluid path lumen 510. In these and other embodiments, the extension set 100 can include a vent to maintain atmospheric pressure and allow movement of air within the non-fluid path lumen 510 during bidirectional translation of the instrument 110. In some embodiments, the non-fluid path lumen 510 can include a vent to allow inflow and outflow of air into the non-fluid path lumen 510, which can facilitate movement of the translation handle 116 and the coupler element 117. In some embodiments, one or more vents providing ventilation can be sized to allow air movement while still maintaining good aseptic protection of the instrument 110 and / or other parts of the extension set 100.

[0066] Referring now to FIGS. 6 - 8, in some embodiments, the extension set 100 and the catheter assembly 200 may include a fluid path assembly 600 that facilitates blood collection. In some embodiments, the fluid path assembly 600 may include an instrument 110 that includes a tube, such as a microtube. In some embodiments, the tube may include a polymeric 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 may flow through the instrument 110 and through the extension tube 206 to the blood collection device.

[0067] In some embodiments, the non - fluid path extension assembly 602 may provide support, alignment, and sterile delivery of the instrument 110 through a catheter that remains within the vasculature (see, e.g., catheter 223 of FIG. 2). In some embodiments, most of the non - fluid path extension assembly 602 or a portion of the non - fluid path extension assembly 602 proximal to the fluid seal 214 may not contact blood withdrawn from the patient through the extension set 100. In some embodiments, a portion of the non - fluid path extension assembly distal to the fluid seal 214 may have some contact with blood or saline that may be within the fluid path of the catheter. In some embodiments, the non - fluid path extension assembly 602 may include one or more of the tube 102, the translation handle 116, the distal connector 212 of the distal end 106, and the proximal connector 209 disposed at the proximal end. In some embodiments, the distal end 106 and / or the distal connector 212 of the tube 102 may include a fluid seal 214 to seal the distal end of the non - fluid path extension assembly 602. In some embodiments, the fluid seal 214 may form a seal around the instrument 110, which may extend through the instrument 110. Advantageously, the extension set 100 according to some embodiments may be easily extensible in length, for example, based on the size or length of the catheter 123 or the catheter assembly 200.

[0068] Referring now to FIGS. 9A and 9B, in some embodiments, the translational handle 116 may include a collar 900 around the tube 102. The tube 102 is shown as transparent 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 coupler 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 grips, such as ribs, textured surfaces, push tabs, or other protrusions, to provide ease of handling.

[0069] In some embodiments, the feature 500 may include one, two, or three ball bearings distributed radially symmetrically about the longitudinal axis of the tube 102. In some embodiments, the feature 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, any number of features 500 may be present and may be arranged in various symmetric and asymmetric configurations.

[0070] Referring now to FIGS. 10A - 11C, the translational handle 116 may include a housing 1000 that may include a distal opening 1002 and a proximal opening 1004. In some embodiments, the tube 102 may extend through the distal opening 1002 and the proximal opening 1004. In some embodiments, the housing 1000 may extend around the tube 102. In some embodiments, the housing 1000 may move bidirectionally along the tube 102. In some embodiments, the housing 1000 and the coupler element 117 may be magnetically attracted to each other through the tube 102 to facilitate movement of the instrument 110 without direct contact of the instrument 110 by the user.

[0071] In some embodiments, the translational handle 116 may compress a portion of the tube 102 between the coupler element 117 and the translational handle 116. In some embodiments, a portion of the tube 102 may engage the coupler element 117, and movement of the translational handle 116 along the outer surface 108 of the tube 102 may translate the coupler element 117 within the tube 102 such that the distal end 114 of the instrument 110 may be moved between a retracted position and a forward position.

[0072] In some embodiments, the housing 1000 may include features 500 to improve movement of the translational handle 116 along the outer surface 108 of the tube 102. In some embodiments, the features 500 may be coupled to the inner surface of the housing 1000 to mediate contact between the housing 1000 and the outer surface 108 of the tube 102. In other embodiments, any number of features 500 may be present and may be arranged in various symmetric and asymmetric arrangements.

[0073] In some embodiments, feature 500 may include a ball bearing, a wheel, a low friction slider, or other suitable feature for providing a local compression of tube 102 to engage with coupler element 117. In some embodiments, feature 500 may be coupled to translational handle 116. In some embodiments, feature 500 may be directly coupled to translational handle 116. In some embodiments, feature 500 and translational handle 116 may be molded together or formed monolithically as a single unit. In some embodiments, feature 500 and translational handle 116 may be integrated or attached together.

[0074] In some embodiments, feature 500 may include a pinch mechanism and may be arranged to pinch or compress outer surface 108 of tube 102. In some embodiments, one or more of features 500 may be opposite or on the opposite side of tube 102 relative to one or more of the other ones of features 500. In some embodiments, the inner surface of tube 102 within translational handle 116 may be small enough to allow coupler element 117 to pass therethrough. In some embodiments, housing 1000 may be rigid or semi-rigid, which may provide more support to the user for one-handed advancement of instrument 110 by the user.

[0075] For example, as shown in FIGS. 11A-11B, feature 500 may include a wheel 1100 rotatably coupled to translational handle 116. In some embodiments, shaft 1102 may extend through feature 500. In some embodiments, feature 500 may be a slider and may include a slider configured of smooth and / or plastic and slidable along tube 102. In some embodiments, the slider may be stationary or fixed relative to translational handle 116.

[0076] As illustrated, for example, in FIG. 11C, feature 500 may include a ball bearing, which may be rotatable within a socket formed in the translational handle 116. In some embodiments, each of the sockets may include a protrusion or ridge around the circumference of the socket, which may limit contact of the ball bearing with the socket and reduce friction. In some embodiments, the ball bearing may have a protrusion or ridge that may be disposed between the ball bearing and the housing 1000. In some embodiments, the ridges may be equally spaced around the circumference. In some embodiments, a lubricant may be applied to the coupler element 117 and / or the feature to reduce friction.

[0077] In some embodiments, the outer surface of the housing 1000 may include one or more grips 1006, such as ribs, textured surfaces, push tabs, protrusions, or indentations, for example, which may facilitate handling. In some embodiments, the grip 1006 may be disposed on the side surface of the housing 1000, as shown in FIGS. 10A-10D, for example. In some embodiments, the grip 1006 may be disposed on the side surface and / or the top of the housing 1000, as shown in FIG. 10C, for example. In some embodiments, the housing 1000 may include various shapes, such as rectangular, square, cylindrical, elliptical, or another suitable shape, for example. In some embodiments, the central portion of the housing 1000 may have a diameter that is less than the diameter of the first end of the housing 1000 and / or the diameter of the second end of the housing 1000 that is opposite the first end. In these and other embodiments, the shape of the housing 1000 may facilitate gripping of the housing 1000 by the user.

[0078] In some embodiments, the coupler element 117 may include apertures, ribs, or channels for facilitating the flow of fluids such as air and / or liquid. Thus, in some embodiments, the tube 102 may be in fluid communication with the proximal connector 209. In some embodiments, the proximal connector 209 may be coupled to a needleless connector 1104 that may include a septum. In some embodiments, the blood collection device may be coupled to the needleless connector 1104, and blood may be drawn proximally through one or more of the tube 102, coupler element 117, proximal connector 209, and needleless connector 1104. In some embodiments, the needleless connector 1104 may be coupled to the proximal connector 209 via a luer adapter. In some embodiments, the needleless connector 1104 may be permanently connected to the proximal connector 209, which may include a luer adapter, with an adhesive or another suitable means to prevent intentional or unintentional removal by the user.

[0079] Referring now to FIGS. 12A-12F, the coupler element 117 may include various shapes. In some embodiments, the coupler element 117 may include a distal end 1200, and the instrument 110 may extend from the distal end 1200. For example, as shown in FIG. 12A, the coupler element 117 may include a cylinder or barrel shape. For example, as shown in FIGS. 12B-12D, the coupler element 117 may include a tapered exterior. For example, as shown in FIGS. 12C-12D, the coupler element 117 may have one or more rounded protrusions to improve its ability to round corners. In some embodiments, the coupler element 117 may include fins to assist the coupler element 117 in moving down the tube 102. In some embodiments, the coupler element 117 may include an aperture within the coupler element 117 to allow fluid to flow around the coupler element 117. In some embodiments, the flow path around the coupler element 117 may be selected such that the hydraulic diameter is larger than the inner diameter of the blood collection device or the tube 102 to reduce shear stress during blood collection.

[0080] For example, as shown in FIG. 12F, in contrast to four, the coupler element 117 can include a dog bone or bow shape so as to be used with two pinch points, two ball bearings, or two wheels. In some embodiments, the coupler element 117 can be attached to the instrument 110 by interference fit, adhesive, or both. In some embodiments, the instrument 110 can be tapered such that the large outer diameter end of the instrument 110 functions as a coupler element 117 or wedge. In some embodiments, the coupler element 117 can be colored to increase visibility.

[0081] Referring now to FIG. 13A, in some embodiments, the blood collection device can be coupled to the proximal connector 209 and / or a needleless connector coupled to the proximal connector 209. In some embodiments, the instrument 110 can include a tube, and the channel 1300 can extend through the coupler element 117. In some embodiments, the tube can create a closed circuit for blood flow and prevent blood contamination due to drug adsorption within the VAD. In some embodiments, the instrument 110 can be colored to enhance visibility.

[0082] In some embodiments, such as FIGS. 13A - 13B, the fluid path can be disposed between the outer surface of the instrument 110 and the inner surface of the tube 102 and can extend through the distal connector 212 and the proximal connector 209. Thus, in some embodiments, the distal end 106 may not include a fluid seal 214. In some embodiments, blood can flow proximally through the instrument 110 and / or the fluid path between the outer surface of the instrument 110 and the inner surface of the tube 102. In some embodiments, the blood within the fluid path can flow to a blood collection device coupled to the proximal connector 209. In some embodiments, the blood collection device can be directly coupled to the proximal connector 209 or can be coupled to the proximal connector 209 via a needleless connector or another suitable device. In some embodiments, during infusion, the fluid can flow distally through the fluid path between the outer surface of the instrument 110 and the inner surface of the tube 102 and can pass through the distal connector 212.

[0083] In some embodiments, the extension set can be coupled to various parts of a particular catheter assembly, and the instrument 110 can access the patient's vasculature via various routes. As an example, the instrument 110 can be advanced through an adapter such as a Y adapter or a T adapter, and / or through other extension tubing. In some embodiments, the instrument 110 can be advanced through a particular side port of the catheter adapter. In some embodiments, the path of the instrument 110 can be linear and can be aligned with the longitudinal axis of a particular catheter assembly. In some embodiments, blood can flow into the blood sampling device via various routes through one or more of an adapter, other extension tubing, and side ports.

[0084] In some embodiments, for fluid to flow through the fluid path between the outer surface of the instrument 110 and the inner surface of the tube 102, the fluid can flow around and / or through the coupler element 117. In some embodiments, one or more windows, ribs, or other channels can facilitate the flow of fluid from the distal side of the coupler element 117 to the proximal side of the coupler element 117.

[0085] Referring now to FIG. 13B, in some embodiments, the instrument 110 can include a guide wire and / or a spring that can be constructed of metal or another suitable material. In some embodiments, the spring can have a pitch that varies along its length. For example, the pitch of the spring distal to the tip of the catheter can allow for more blood flow and can increase the flow rate. In some embodiments, the spring can have a smaller pitch near the tip of the catheter to prevent thrombus from entering the VAD, yet still allow blood flow through. In some embodiments, the spring can include a guide wire through the center of the spring or along one or more sides of the spring for additional stiffness to facilitate insertion.

[0086] Referring now to FIGS. 14A - 14C, in some embodiments, the distal connector 1400 may include a blunt cannula 1400 that may form a distal opening 1402. In some embodiments, the cap 1406 may surround the blunt cannula 1400. In some embodiments, the cap 1406 may include one or more protrusions 1408 that may facilitate gripping of the cap 1406 by the user prior to removal of the cap 1406 from the blunt cannula 1400 by the user. As illustrated, for example, in FIGS. 14B - 14C, the distal end 1410 of the cap 1406 may be closed. For example, as shown in FIG. 14C, the cap 1406 may be adjacent or proximate to the proximal end of the blunt cannula 1400, which may prevent the instrument 110 from moving distally to the blunt cannula 1400 during shipping and / or priming. In some embodiments, the cap 1406 may include one or more ventilation holes that extend through the cap 1406 proximal to the distal end 1410.

[0087] All examples and conditional language recited herein are intended for educational purposes to aid in understanding the invention and the concepts provided by the inventors to promote the art, and are to be construed as not being limited to specifically recited examples and conditions. Although embodiments of the present disclosure have been described in detail, it should be understood that various changes, substitutions, and alternatives can be made to the present specification without departing from the spirit and scope of the disclosed embodiments.

Claims

1. An extension set for providing access to a patient's vasculature, a tube having a proximal end, a distal end, and an outer surface, an instrument disposed within the tube, the instrument having a proximal end and a distal end and configured such that fluid flows through the tube between the outer surface of the instrument and the inner surface of the tube, a translation handle coupled to the outer surface of the tube and 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 a forward position, and in response to the distal end of the instrument being in the forward position, the distal end of the instrument extends beyond the distal end of the tube, a translation handle; a coupler element, wherein the translation handle compresses a portion of the tube between a portion of the coupler element and the translation handle, the portion of the tube engages the coupler element, and 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 forward position, a coupler element; An extension set comprising.

2. The extension set according to claim 1, wherein the instrument comprises one or more of a tube, a spring, and a guide wire.

3. Further comprising a fluid path assembly having an instrument, a proximal end, and a distal end, an extension tube being coupled to the proximal end of the instrument, and the proximal end of the fluid path assembly comprising a proximal connector configured to connect to a blood sampling device, the extension set according to claim 1.

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

5. The extension set according to claim 1, wherein at least one of the coupler element and the tube comprises a lubricant to facilitate translation of the instrument within the tube.

6. The translation handle includes a plurality of ball bearings, wheels, or low friction sliders and locally compresses the tube to engage with the coupler element through the tube, the extension set according to claim 5.

7. An extension set for providing access to a patient's vasculature, A fluid path assembly comprising a proximal connector configured to couple to an instrument, an extension tube, and a blood collection set, A tube having a proximal end, a distal end, and an outer surface, with a translation handle coupled to the outer surface and configured to move between the proximal end and the distal end, and fluid configured to flow through the tube between the outer surface of the instrument and the inner surface of the tube, An instrument disposed within the tube and having a proximal end and a distal end, the proximal end of the instrument engaging with the translation handle and configured to move between a proximal position and a distal position, and in response to movement of the translation handle towards the distal end of the tube, the distal end of the instrument extending beyond the distal end of the tube, comprising, The proximal end of the instrument includes a coupler element, the translation handle compresses a portion of the tube between the coupler element and the translation handle, a portion of the tube engages with the coupler element, and movement of the translation handle along the outer surface of the tube translates the distal end of the instrument between a retracted position and a forward position, the extension set.

8. The extension set according to claim 7, wherein the instrument comprises a tube.

9. The extension set according to claim 7, wherein the fluid path assembly extends through the tube and the instrument is configured to move between the retracted position and the forward position relative to the tube.

10. The extension set according to claim 7, wherein the distal end of the tube comprises a distal connector.

11. The distal end of the tube or the distal connector, the extension set according to claim 10, comprising a fluid seal for sealing the tube.

12. The extension set according to claim 7, wherein at least one of the coupler element and the tube comprises a lubricant that facilitates translation of the instrument within the tube.

13. The extension set according to claim 7, wherein the translation handle comprises a plurality of ball bearings, wheels, or low friction sliders that locally compress the tube to engage the coupler element through the tube.

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