Extension set, related system and method

Abstract

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

Description

Technology Field

[0001] Catheters are commonly used in various infusion therapies. For example, catheters can be used to infuse fluids such as normal saline, various medications, and whole parenteral nutrition to patients. Catheters can also be used to draw blood from patients to obtain blood samples. Background Technology

[0002] A common type of catheter is the over-the-needle peripheral venous ("IV") catheter. As the name suggests, an over-the-needle catheter can be mounted over a guide needle with a pointed distal tip. The catheter and guide needle can be assembled so that the distal tip of the guide needle extends beyond the distal tip of the catheter, with the needle's bevel pointing away from the patient's skin. The catheter and insertion needle are typically inserted through the skin into the patient's vascular system at a shallow angle.

[0003] To verify the proper placement of the intravascular guide needle and / or catheter, clinicians typically check for a "flashback" of blood in the catheter assembly's flashback chamber. Once the needle position is confirmed, the clinician temporarily blocks vascular flow and removes the needle, allowing the catheter to be placed in position for future blood recovery, fluid infusion, or probe access. The problem to be solved

[0004] Blood retrieval or infusion using a catheter can be difficult for various reasons, particularly when the catheter remains in the patient for more than one day. For instance, leaving a catheter inserted in a patient for an extended period can lead to narrowing, deformation, kinking, blockage by debris (e.g., fibrin or platelet aggregation), and adhesion of the catheter tip to the vascular system. Consequently, while catheters can be frequently used to collect blood samples upon catheter placement, they are very rarely used to collect samples during the catheter's duration of stay. Therefore, when blood samples are required, an additional needle stick is used to provide venous access for collection, which can cause pain to the patient and increase material costs.

[0005] The essence claimed in the present invention is not limited to embodiments that resolve any disadvantages or operate only in environments such as those described above. Rather, this background is provided to describe an exemplary technical area in which any embodiments described in the present invention may be practiced. means of solving the problem

[0006] The present invention generally relates to an extension set comprising a tube capable of receiving an instrument, such as, for example, a probe or a tube. The instrument may access a patient's vascular system for drug and fluid delivery and / or blood acquisition during the residence time of a vascular access device, such as a catheter assembly. In some embodiments, the instrument may access the fluid pathway of the catheter assembly. In other embodiments, the instrument may extend through the catheter assembly to access the patient's vascular structure.

[0007] In some embodiments, the extension set may include a tube that may include a proximal end, a distal end, and an outer surface. In some embodiments, an instrument such as a probe or tube may be placed 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 any blood or other fluid 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.

[0008] In some embodiments, a translation handle may be attached 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 accordingly translate the distal end of the apparatus between a retracted position and an advanced position. In some embodiments, the distal end of the apparatus in the advanced position may extend beyond the distal end of the tube.

[0009] In some embodiments, the fluid path assembly may include an apparatus, a proximal end, and a distal end. In some embodiments, an extension tube may be coupled to the proximal end of the apparatus. In some embodiments, the proximal end of the fluid path assembly may include a proximal connector configured to be connected to a blood collection device. In some embodiments, the fluid path assembly may be extended through a tube.

[0010] In some embodiments, the distal end of the tube may include a terminal connector. In some embodiments, the distal end of the tube and / or the distal connector may include a fluid seal to seal the tube and create a closed fluid path.

[0011] In some embodiments, the mechanism may extend from a coupling element to the distal end to facilitate translation of the mechanism within the tube without requiring direct contact. In some embodiments, the extension tube may be coupled to the mechanism through a coupling element. In some embodiments, the tube may be axially compressible so that a 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 with the coupling element so that movement of the translation handle along the outer surface of the tube translates the distal end of the mechanism between a retracted position and a distal position.

[0012] In some embodiments, the coupling element and / or tube may include a lubricant to facilitate translation of the mechanism within the tube. In these and other embodiments, the translation handle may include rollers and / or bearings to provide local compression of the tube to engage with the coupling element through the tube.

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

[0014] In some embodiments, a method for providing access to a patient's vascular system may include the step of attaching an extension set to a catheter assembly. In some embodiments, the extension set may include a tube, a device disposed within the tube, and a translational handle attached to the outer surface of the tube. In some embodiments, attaching the extension set to the catheter assembly may include attaching the distal end of the tube to the catheter assembly. In some embodiments, the method may further include the step of moving the translational handle along the tube from a proximal position to a distal position. In some embodiments, at the distal position, the distal end of the device may extend beyond the distal end of the tube into the catheter assembly.

[0015] In some embodiments, the step of connecting the distal end of the tube to the catheter assembly may include the step of connecting the distal connector of the tube to the catheter assembly. In some embodiments, the catheter assembly may include a catheter extending from its distal end. In some embodiments, in response to the translational handle moving to a distal position, the apparatus may extend through the distal end of the catheter.

[0016] In some embodiments, the extension set may include a blood collection device. In some embodiments, after blood is collected in the blood collection device, the method may include the step of moving a translation handle from a distal position to a proximal position. In some embodiments, when the translation handle is moved to a proximal position, the distal end of the device may be retracted into a tube.

[0017] It should be understood that the foregoing general description and the following detailed description are all exemplary and illustrative and do not limit the invention as claimed. It should be understood that various embodiments are not limited to the configurations and means depicted in the drawings. Furthermore, it should be understood that embodiments may be combined or other embodiments may be utilized, and that structural modifications may be made without departing from the scope of the various embodiments of the invention unless otherwise claimed. Accordingly, the following detailed description should not be taken in a restrictive sense. Brief explanation of the drawing

[0018] Exemplary embodiments will be further described and explained in specific and detailed terms through the use of the accompanying drawings as follows: FIG. 1 is a top perspective view of an exemplary extension set illustrating an exemplary mechanism in an advanced position according to some embodiment. FIG. 2 is a top perspective view of an extension set coupled to an exemplary catheter assembly according to some embodiment. FIG. 3 is a partial cutaway view of an extension set illustrating a mechanism in a retracted position according to some embodiment. FIG. 4 is a partial cutaway view of an extension set illustrating a mechanism in an advanced position according to some embodiment. FIG. 5a is a cross-sectional view of an exemplary translational motion device according to some embodiment. FIG. 5b is a cross-sectional view of another exemplary translational device of an extension set according to some embodiment. FIG. 6 is a partial exploded view of an exemplary translational device of an extension set according to some embodiment. FIG. 7 is an upper perspective view of an extension set illustrating a mechanism in a retracted position according to some embodiment. FIG. 8 is an upper perspective view of an extension set illustrating a mechanism in an advanced position according to some embodiment. FIG. 9a is a top perspective view of an exemplary translational handle and an exemplary coupling element according to some embodiment. FIG. 9b is a cross-sectional view of the translational handle and coupling element of FIG. 9a according to some embodiment. Specific details for implementing the invention

[0019] As used herein, the terms "proximal" and "distal" may indicate directions closer and further, respectively, to the clinician who will place the catheter system in contact with the patient. Thus, for example, the end of the catheter system that first touches the patient's body becomes the distal end, while the opposite end of the catheter system becomes the proximal end.

[0020] An extension set according to some embodiments may provide access to the patient's vascular system. As described 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 vascular structure during the residence time of the catheter assembly for drug and fluid delivery and / or blood collection.

[0021] As previously mentioned, a catheter having a significant residence time within a patient's vascular system may be susceptible to stenosis, collapse, kinking, blockage by debris (e.g., fibrin or platelet aggregation), and adhesion of the catheter tip to the patient's blood vessels. Consequently, blood recovery using the catheter may be difficult. Preferably, in some embodiments, the extension set may include a device such as another catheter or probe placed within the tube. In some embodiments, the device may provide access to the patient's vascular system without an additional needle stick. Thus, in some embodiments, the extension set (100) may be used for needle-free blood collection and / or fluid infusion.

[0022] Now, referring to FIG. 1, in some embodiments, the extension set (100) may include a tube (102), which may include a proximal end (104), a distal end (106), and an outer surface (108). In some embodiments, the tube (102) may be flexible, rigid, or semi-rigid. In some embodiments, the apparatus (110) may be placed within the tube (102) and may include a proximal end (112) and a distal end (114). In some embodiments, the distal end (114) may be non-traumatic or blunt. In some embodiments, the extension set (100) may provide a non-body path through the tube (102) to shield the apparatus (110) from contaminants and the surrounding external environment. The non-body path may be configured so that blood drawn from the patient does not come into contact with the non-body path. In some embodiments, the extension set (100) may also separate blood or other fluids that may remain in the device (110) after use. Additionally, in some embodiments, the extension set (100) may provide support, alignment, and aseptic delivery of the device (110) through a catheter assembly and into the patient's vascular system.

[0023] In some embodiments, the translation handle (116) may be attached to the outer surface (108) of the tube (102) to facilitate movement of the apparatus (110) without requiring direct contact with the apparatus (110). In some embodiments, the translation handle (116) may be movable 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) may comprise an axially compressible, biocompatible, and elastomer or polymer material. In this way, in some embodiments, the translation handle (116) may create local compression of the tube (102).

[0024] As described in more detail below, in some embodiments, the compression portion of the tube (102) may engage with a coupling element (117) coupled to the proximal end (112) of the apparatus (110) so that the translation handle (116) can translate the distal end (114) of the apparatus (110) in the direction of movement of the translation handle (116). In some embodiments, the translation handle (116) may translate the distal end (114) of the apparatus (110) between a retracted position and an advanced position. In the advanced position (124), as illustrated in FIG. 1, the distal end (114) of the apparatus (110) may extend beyond the distal end (106) of the tube (102), for example, into a patient's catheter assembly or vascular system.

[0025] Now, referring to FIG. 2, in some embodiments, an extension set (100) may be coupled to a catheter assembly (200) that may include a distal end (204). In some embodiments, the apparatus (110) may be extended through the distal end (204) of the catheter assembly (200) in response to a translational handle (116) moving to a distal position.

[0026] In some embodiments, the device (110) may include a probe having one or more openings and / or sensors to provide intravenous patient and device monitoring. In some embodiments, the probe openings and / or sensors may be positioned toward the distal end (114). In some embodiments, the openings may function as fluid inlets and / or outlets. In some embodiments, the sensors may measure one or more parameters and / or detect one or more elements related, for example, diagnostic information, blood chemistry, pH, temperature, pressure, flow rate, drug identification, microorganisms, placement of implantable stents, intravenous catheter tip stabilization function, or other device or physiological measurements.

[0027] In some embodiments, the apparatus (110) may include a tube and may include elements of both a probe and a catheter and function as both. In some embodiments, the apparatus (110) may include a tube to provide fluid infusion and / or retrieval. In some embodiments, the tube may include a standard catheter tip or an asymmetric catheter tip. In some embodiments, a diffuser hole may be placed at the tip of the tube. In some embodiments, the tube may include polyurethane, FEP, Teflon, silicone, TPE, TPU, fluorinated polymer, polyimide, or any other suitable material or combination thereof. In some embodiments, the tube material may be hydrophilic, hydrophobic, and / or may include any other desired properties or features, such as an anti-fouling material. Some embodiments of the tube may include a coating, such as an antithrombotic coating, or other coatings to impart other desired properties to the tube.

[0028] In some embodiments, the extension tube (206) may be coupled to the proximal end of the translational handle (116) and / or the proximal end (112) of the apparatus (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 material. In some embodiments, the extension tube (206) may be substantially transparent and / or may include a marker that informs the clinician of the position of the apparatus (110) relative to the catheter or catheter feature. In some embodiments, the extension tube (206) may include a textured surface to reduce contact friction. The extension tube (206) of some embodiments may be ventilated by, for example, an open air path, a breathable filter membrane, a porous exhaust material, a microchannel, etc.

[0029] In some embodiments, the proximal connector (208) may be coupled or integrated, for example, to the proximal end of the extension tube (206) and connected to a blood collection device (210) (e.g., see FIG. 3), an infusion device, or a monitoring device. In some embodiments, the blood collection device is a VACUTAINER available from Becton Dickinson and Company of Franklin Lakes, New Jersey. ® or VACUTAINER ® Any suitable blood collection device such as LUER-LOK™ may be included. The proximal connector (208) may include, for example, a male or female Luer, a blunt cannula, or other suitable connector.

[0030] In some embodiments, the distal end (106) of the tube (102) may be coupled to or integrated with a distal connector (212) which may include a fluid seal (214) for sealing the tube (102) and creating a closed fluid path. In some embodiments, the distal connector (212) may include, for example, a male or female Luer, a blunt cannula, or other suitable connector.

[0031] In some embodiments, the extension tube (206) may be extended through a proximal connector (209) that is integrated with or coupled to the proximal end (104) of the tube (102). In some embodiments, there may be a tight fit or diaphragm between the extension tube (206) and the proximal connector (209), which may 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) may be moved from a proximal position to a distal position so that the distal end (114) of the apparatus (110) advances distally over the tube (102) and / or the proximal connector (208) moves closer to the proximal connector (209). In some embodiments, after blood is collected in the blood collection device (210), the translational handle (116) may be moved from a distal position to a proximal position so that the distal end (114) of the device (110) is retracted into the tube (102) and / or the proximal connector (208) is moved away from the proximal part. In some embodiments, the translation handle (116) may comprise any suitable translation handle, which is described in more detail, for example, in U.S. Patent Application No. 17 / 127,588 filed December 18, 2020 (Title of invention: "FLUSH INSTRUMENT WITH BLOOD EXPOSURE PROTECTION AND RELATED METHODS") and U.S. Patent Application No. 17 / 127,623 filed December 18, 2020 (Title of invention: "MULTI-LUMEN EXTENSION SYSTEM"), which are incorporated by reference in their entirety into the present invention.

[0032] In some embodiments, the extension set (100) can reduce hemolysis of blood samples collected through the fluid path. In some embodiments, the extension set (100) can provide an appropriate fluid flow rate. Blood cells undergo shear stress as they flow through the fluid path. The maximum shear stress is along the wall of the blood cell or is 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 follows:

[0033]

[0034] In the above equation, ΔP is the pressure drop along a path of length L and inner radius r. k is the contraction index.

[0035] The time required to fill a collection tube V of a specific volume with a flow rate Q can be simply evaluated as follows:

[0036]

[0037] In the above equation, μ is the dynamic viscosity of the fluid. Hemolysis is typically related to both wall shear stress and the time that blood cells are exposed to wall shear stress. In the literature, it is widely known that the hemolytic index can be approached as a function of the following:

[0038]

[0039] In the above equation, A, α, and β are coefficients.

[0040] In principle, the hemolytic index is related to the pressure gradient and cross-sectional characteristic dimensions:

[0041]

[0042] In some embodiments, the length of the extension set (100) may be selected based on one or more of the following: the gauge of a specific catheter, the configuration of a specific catheter assembly, or a clinical setting. In some embodiments, the extension set (100) may include a length (L). In some embodiments, the extension set (100) may include an inner diameter (D).

[0043] The fluid flow in the fluid path through the tubular extension set (100) can be analyzed using the Poiseuille equation:

[0044]

[0045] In the above equation, ΔP is the change in pressure gradient along the length of the fluid path, D and L are the inner diameter and length of the fluid path, respectively, and μ is the viscosity of the fluid, and is fluid resistance. Since μ is the fluid viscosity and is not part of the extended tube shape, the geometric factor Gf, Rf (fluid resistance) It is stipulated to be as, and at this time am.

[0046] In some embodiments, the fluid path through the extension set (100) may have multiple sections having lengths (L1, L2, L3) and inner diameters (D1, D2, D3), and the geometric factors are as follows:.

[0047]

[0048] In some embodiments, the fluid path through the extension set (100) may have an inner diameter that varies over the length of the extension set (100), and the geometric factors are as follows:

[0049]

[0050] In some embodiments, the fluid path through the extension set (100) may have a non-circular cross-section or a complex inner diameter profile. Next, the geometric modulus may be determined by measuring the flow rate (Q) at a given pressure (ΔP) with a fluid of known viscosity (μ):

[0051]

[0052] The Gf value of the fluid path through the extension set (100) represents the maximum shear stress for each catheter gauge, which was previously considered the gold standard for blood collection, the BD 21G VACUTAINER (available from Becton, Dickinson & Company of Franklin Lakes, New Jersey). ® UltraTouch ™ The value may be selected to be reduced to below the maximum shear stress of the push-button blood collection set. In some embodiments, the Gf value of the fluid path is the maximum shear stress for each catheter gauge (available from Becton, Dickinson & Company of Franklin Lakes, New Jersey) BD 25G VACUTAINER ® UltraTouch ™ It can be selected to reduce the maximum shear stress of the push button blood collection set to be less than or equal to the maximum shear stress.

[0053] In some embodiments, the fluid path of a blood collection system, which may include one or more of a blood collection device, an extension set (100), and a catheter assembly (200) (which may include an extension tube extending from a side port (224)), may include the entire blood collection path through which blood flows to or through the blood collection device during blood collection after leaving the vascular system. The system geometric factor Gfs for the fluid path of the blood collection system may be determined in a manner similar to the Gf value of the fluid path through the extension set (100) described above. In some embodiments, the system geometric factor Gfs is 7.34E+06 (1 / in when the device (110) is in the advanced position. 3 ) may be greater than or equal to. In some embodiments, Gfs may include other values. In some embodiments, the system geometric factor Gfs is 7.34E+06(1 / in 3 ) It 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, Gfs may include other values ​​that can be selected based on the gauge and / or length of the catheter (223).

[0054] In some embodiments, a distal connector (212) may connect an extension set (100) to a 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 therefrom. 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 connected 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 connected to the proximal end (222) of the catheter adapter (220), the side port (224), the adapter, or another part 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 a 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 peripheral insertion center catheter.

[0055] 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 that may be placed 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 other suitable materials or combinations thereof. In some embodiments, the catheter (223) material may include any other desired properties or characteristics, such as hydrophilic, hydrophobic, and / or antifouling materials. Some embodiments of the catheter (223) may include a coating, such as an antithrombotic coating or other coatings, to impart other desired properties to the catheter (223).

[0056] Referring to FIGS. 3 and 4, in some embodiments, the fluid seal (214) may allow the advance and / or retraction of the mechanism (110) through it while maintaining a closed fluid path. 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 opening, a slit, etc., to receive the mechanism (110) through it.

[0057] In some embodiments, the compression portion (302) of the tube (102) is engaged with a coupling element (117) so that the movement of the translational handle (116) along the outer surface (108) of the tube (102) translates the distal end (114) of the furniture (110) between the retracted position shown in FIG. 3 and the forward position shown in FIG. 4. In some embodiments, the coupling element (117) may be joined to the mechanism (110) and / or the extension tube (206), for example by a press fit, adhesive, or both. In some embodiments, the extension tube (206) and the mechanism (110) may be formed monolithically as a single unit and extended through the coupling element (117).

[0058] Referring to FIGS. 5A and 5B, in some embodiments, the coupling element (117) may be engaged with one or more features of the translational handle (116) through a tube (102) or otherwise engaged so as to allow translation of the mechanism (110) without any direct contact between the coupling element (117) and the translational handle (116) that is coupled to the mechanism (110). For example, in some embodiments, as shown in FIG. 5A, the coupling element (117) may include a disc or ellipsoidal shape (506) having a flat or concave central portion (504). The flat or concave central portion (504) may be aligned with opposing features (500) of the translational handle (116) to facilitate flexible translation. In some embodiments, the features (500) may include rollers, ball bearings, low-friction sliding surfaces, etc. In some embodiments, the features (500) may be round, angular, spherical, or cylindrical.

[0059] In some embodiments, the distance between opposing features (500) may be smaller than the outer diameter of the tube (102) so that the tube (102) is sandwiched between the feature portions (500) and the coupling element (117). In some embodiments, as illustrated in FIG. 5B, the coupling element (117) may include a disc or ellipsoidal shape having a tapered end (508). The tapered end (508) may accommodate the feature portion (500) of the translation handle (116) to facilitate flexible translation.

[0060] In some embodiments, the feature (500) may be coupled to the translational handle (116) to provide local compression of the tube (102). In some embodiments, the feature (500) may be coupled to the coupling element (117) through the tube (102) to facilitate smooth translation of the tube (102). In some embodiments, the feature (500) may be coupled to the inner edge of the translational handle (116). In some embodiments, the surface of the coupling element (117) interfacing with the feature (500) may be substantially concave. This facilitates flexible bilateral movement along the outer surface (108) of the tube (102).

[0061] According to various embodiments, the coupling element (117) may include a tapered end (508) to improve the ability to round the 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 perforations, ribs, or channels to facilitate fluid flow, such as air and / or liquid. In some embodiments, air may flow around the coupling element (117), for example, through perforations, ribs, or channels, so that the vacuum is reduced or removed in response to moving the coupling element (117) distal or proximal. In other embodiments, the coupling element (117) may include a bore to receive fluid flow, for example, fluid injected into the patient's vascular system or blood aspirated from the patient's vascular system. In some embodiments, the coupling element (117) may include one or more colors or patterns to increase visibility.

[0062] In some embodiments, a longitudinal rib may be formed on the outer surface of the coupling element (117) to maintain the coupling element (117) oriented parallel to the tube (102), thereby facilitating unhindered bidirectional movement of the coupling element (117) through the tube (102). In some embodiments, the longitudinal rib may contact an opposing feature on the inner surface of the tube (102) to prevent the coupling element (117) from rotating within the tube (102).

[0063] In some embodiments, the inner surface of the coupling element (117) and / or the tube (102) may contain a lubricant (304) to facilitate translational movement of the mechanism (110) within the tube (102). In some embodiments, the lubricant (304) may be placed around the coupling element (117) and / or inside the non-body path lumen (510) of the tube (102). In other embodiments, the lubricant (304) may be applied outside the non-body path lumen (510) around the feature portion (500) of the translational handle (116). In some embodiments, the coupling element (117) may contain a lubricating material to facilitate movement within the non-body path lumen (510). In these and other embodiments, the extension set (100) may include ventilation to maintain atmospheric pressure and allow air movement within the non-body. In some embodiments, the non-body path lumen (510) may include a vent to allow airflow in and out of the non-body path lumen (510), which may facilitate the operation of the translational handle (116) and the coupling element (117). In some embodiments, one or more vents for providing a vent may be reduced in size to allow air movement while maintaining excellent sterile protection of the apparatus (110) and / or other parts of the extension set (100).

[0064] Now, referring to FIGS. 6 through 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 a device (110) that may include a tube, such as a microtube, for example. In some embodiments, the tube may include a polymer material, polyimide, or other 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 device (110) and through the extension tube (206) to a blood collection device.

[0065] In some embodiments, the non-body path extension assembly (602) may provide support, alignment, and aseptic delivery of the device (110) through a catheter (e.g., catheter (223) in FIG. 2)) within the vascular system. In some embodiments, most of the non-body path extension assembly (602) or part of the non-body path extension assembly (602) adjacent to the fluid seal (214) may not come into contact with blood recovered from the patient through the extension set (100). In some embodiments, part of the non-body path extension assembly distal to the fluid seal (214) may have some contact with blood or saline that may be in the fluid path of the catheter. In some embodiments, the non-body path extension assembly (602) may include one or more of a tube (102), a translation handle (116), a distal connector (212) at the distal end (106), and a proximal connector (209) placed 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 the distal end of the non-fluid path extension assembly (602). In some embodiments, the fluid seal (214) may form a seal around the apparatus (110) and may extend through it. Preferably, the extension set (100) according to some embodiments may be easy to adjust in length based on, for example, the size or length of the catheter (123) or catheter assembly (200).

[0066] Now, referring 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 transparently in FIG. 9b for exemplary purposes. In some embodiments, the collar (900) may extend completely or partially around the tube (102). In some embodiments, the collar (900) may move in both directions along the tube (102). In some embodiments, the collar (900) and the connecting element (117) may be magnetically attracted to each other through the tube (102) to facilitate movement of the mechanism (110) without direct contact. These and other embodiments of the collar (900) may include a feature (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, a push tab, or other protrusions, to provide easy handling.

[0067] In some embodiments, the feature (500) may include one, two, or three ball bearings radially symmetrically distributed with respect to 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 adjust contact between the collar (900) and the outer surface (108) of the tube (102). In other embodiments, any number of feature (500) may exist and may be arranged in various symmetric and asymmetric configurations.

[0068] All examples and conditional language cited in this invention are intended for educational purposes to help the reader understand the invention and to aid in the concept that the invention contributes to the advancement of technology, and are not limited to the specifically cited examples and conditions. Although embodiments of the invention have been described in detail, it should be understood that various modifications, substitutions, and changes may be made without departing from the spirit and scope of the disclosed embodiments.

Claims

Claim 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 outer surface; a device disposed within the tube and including a proximal end and a distal end; and a translational handle coupled to the outer surface of the tube, wherein the translational handle is configured to move along the outer surface of the tube between a proximal position and a distal position to translate the distal end of the device between a retracted position and an advanced position, and in response to the distal end of the device being in an advanced position, the distal end of the device extends beyond the distal end of the tube, wherein the device comprises a coupling element, and the translational handle compresses a portion of the tube between the coupling element and the translational handle, and the portion of the tube engages with the coupling element so that the movement of the translational handle along the outer surface of the tube translates the distal end of the device between a retracted position and an advanced position. Claim 2 In paragraph 1, the device is an extension set including a tube. Claim 3 An extension set according to claim 1, further comprising a fluid path assembly including a device, a proximal end, and a distal end, wherein an extension tube is coupled to the proximal end of the device, and the proximal end of the fluid path assembly is configured to be connected to a blood collection device. Claim 4 In claim 1, the distal end of the tube comprises an extension set including a terminal connector. Claim 5 In paragraph 4, the distal end or terminal connector of the tube comprises an extension set including a fluid seal for sealing the tube. Claim 6 delete Claim 7 An extension set according to claim 1, wherein at least one of the coupling element and the tube comprises a lubricant that facilitates the translational movement of the mechanism within the tube. Claim 8 In claim 1, the translational motion handle comprises at least one of a roller and a bearing to provide local compression of the tube so as to engage with a coupling element through the tube, an extension set. Claim 9 A fluid path assembly comprising an extension set for providing access to a patient's vascular system, the extension tube, and a proximal connector configured to be coupled to a blood collection set; a tube comprising a proximal end, a distal end, and an outer surface, wherein a translational handle is coupled to the outer surface and configured to move between the proximal end and the distal end, wherein the extension set comprises an extension set comprising an extension set having a proximal end and a distal end, wherein the proximal end of the extension set is configured to engage with a translational handle and move between a proximal position and a distal position, wherein in response to the translational handle moving to the distal end of the tube, the distal end of the extension set extends beyond the distal end of the tube, wherein the proximal end of the extension set comprises a coupling element, wherein the translational handle compresses a portion of the tube between the coupling element and the translational handle, and the portion of the tube engages with a coupling element such that the movement of the translational handle along the outer surface of the tube translates the distal end of the extension set between a retracted position and an advanced position. Claim 10 In paragraph 9, the above apparatus is an extension set including a tube. Claim 11 In claim 9, the fluid path assembly extends through a tube, and the mechanism is configured to move relative to the tube between a retracted position and an advanced position, an extension set. Claim 12 In claim 9, the distal end of the tube comprises an extension set including a terminal connector. Claim 13 In paragraph 12, the distal end or terminal connector of the tube comprises an extension set including a fluid seal for sealing the tube. Claim 14 delete Claim 15 In claim 9, an extension set wherein at least one of the coupling element and the tube comprises a lubricant that facilitates the translational movement of the mechanism within the tube. Claim 16 In claim 9, the translational motion handle comprises at least one of a roller and a bearing to provide local compression of the tube so as to engage with a coupling element through the tube, an extension set. Claim 17 delete Claim 18 delete Claim 19 delete Claim 20 delete

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