Device for fluid transfer through placed conduits

Abstract

An apparatus for transporting a fluid through a placed conduit is disclosed. The placed catheter has an inner diameter, and the device includes a thin catheter having an outer diameter that is smaller than the inner diameter. The device further comprises: a distal region adapted to be connected to a catheter hub, the catheter hub attached to the placed catheter; a proximal region for transferring fluid to or from the fluid collection device; and a collapsible envelope extending from a distal region to a proximal region. A thin catheter is disposed within the cuff and connected to the proximal region such that advancing the proximal region toward the distal region contracts the cuff and advances the thin catheter into the placed catheter.

Description

Technical Field

[0001] In general terms, the present invention relates to devices and methods for delivering fluids through a placed catheter. The device may be, but is not exclusively, a catheter that has become blocked, for example, by fibrin growth. Background Art

[0002] In medical treatment, it is common for patients to require regular blood testing. This typically involves either repeatedly inserting a new needle into the patient's body or inserting a catheter into the patient's vascular system. In the case of a catheter, the catheter is attached to a catheter hub on the patient's arm or other limb, and blood is collected by attaching a blood collection container to the catheter hub.

[0003] Due to the natural clotting process, fibrin can accumulate on the catheter tip. This fibrin buildup can clog the catheter, making blood collection more difficult. This difficulty results in increased force being used to draw blood. This increased force can lead to hemolysis or catheter kinking. Furthermore, if the catheter tip rests against the vessel wall, this force can cause the catheter tip to stick to the wall.

[0004] Furthermore, the increased forces exerted on the catheter hub increase the risk of dislodgement, leakage, contaminant infiltration, phlebitis, patient discomfort, accidental needle stick injuries, and tissue damage.

[0005] To draw blood in the presence of fibrin deposits, some devices insert a small catheter through a catheter hub and a placed catheter (which is already inserted into the vascular system). The small catheter either bypasses the fibrin deposit or pierces it, allowing the tip of the small catheter to extend from the tip of the placed catheter, enter the vascular system, and come into direct contact with the blood. However, these devices—see, for example, US2017 / 0216564—are elongated, rigid bodies attached to a catheter hub. While such devices enable controlled insertion of a small catheter through a placed catheter, the force applied to the elongated, rigid body of such devices is transmitted to the catheter hub. This can lead to displacement, mechanical phlebitis, tissue damage at the puncture site, and other problems.

[0006] It would be desirable to overcome or ameliorate at least one of the above-mentioned problems, or at least provide a useful alternative. Summary of the Invention

[0007] Disclosed herein is a device for fluid transfer through a placed catheter having an inner diameter, comprising:

[0008] a distal region adapted to connect to a catheter hub attached to a placed catheter;

[0009] a proximal region for transferring fluid to or from a fluid collection device;

[0010] a shrinkable envelope extending from the distal region to the proximal region; and

[0011] A thin catheter having an outer diameter smaller than the inner diameter is disposed within the cuff and connected to the proximal region such that advancing the proximal region toward the distal region collapses the cuff and advances the thin catheter into the placed catheter.

[0012] As used herein, the term "cuff" refers to a tube, sheath, sleeve, or any other shield, cover, or the like that surrounds a portion of a catheter between a proximal region and a distal region and thereby prevents access to that portion. The cuff can be collapsed by folding, telescoping, and / or creasing into an accordion.

[0013] The phrase "a placed catheter having an inner diameter" refers to the inner diameter of the placed catheter, not the inner diameter of the devices disclosed herein.

[0014] Advancing the proximal region toward the distal region can collapse the cuff and advance the cannula through the placed catheter, causing the distal tip of the cannula to extend from the placed catheter and into the patient's vasculature. The cannula can be secured to the proximal region so that the cannula moves with the proximal region when the proximal region moves, and moves relative to the distal region when the proximal region moves toward the distal region.

[0015] The envelope can be hermetically sealed to each of the proximal and distal regions. Thus, while air or fluid can enter the envelope through other locations—e.g., through openings in the distal region—air cannot pass through the seals or joints between the envelope and the proximal and distal regions.

[0016] The cuff may comprise a flexible material that contracts by accordion as the proximal region is advanced towards the distal region.

[0017] In some examples, the sleeve may include a first hollow body and a second hollow body, wherein when the sleeve is contracted, the second hollow body contracts into the first hollow body. The sleeve may be extendable to retract the thin catheter from the placed catheter, and when the sleeve is extended, the second hollow body is retracted from the first hollow body. The device may also include a length indicator for providing an indication of the length of the thin catheter that has been advanced into the placed catheter, the length indicator being provided on one or both of the first hollow body and the second hollow body. The length indicator may alternatively be located elsewhere on the device—for example, on the thin catheter. The length indicator may include a protrusion and a recess provided on the device, such as a protrusion and a recess provided on each of the first hollow body and the second hollow body, the recess engaging the protrusion to provide tactile feedback of the length of the thin catheter that has been advanced into the placed catheter. In this sense, "feedback" is feedback to the device user (such as a clinician or nurse). In some examples, the housing may include more than two retractable hollow bodies.

[0018] During retraction of the cuff, the distal tip may extend through the orifice in the distal region, and the cuff may extend such that the distal tip moves proximal to the distal region and out of the orifice.

[0019] The device for transmitting fluid can also include a length mark for providing an indication of the length of the thin catheter that has been advanced into the placed catheter to the user. The length mark can include an expanded or expanded diameter of the thin catheter adjacent to an abutment such as a surface or shoulder, so that the proximal region cannot be further advanced toward the distal region, for example, the thin catheter can be advanced through an orifice in the distal region that is sized to allow the normal diameter of the thin catheter to pass through, but is too small to allow the expanded or expanded diameter portion to pass through. The length mark can also or alternatively include at least two length marks, each length mark indicating a different length of the thin catheter that has been advanced into the placed catheter. If it includes an abutment, the abutment can limit the position at which the thin catheter is fully inserted into or passes through the placed catheter.

[0020] The device may also include an extension guide for indicating when the second hollow body is fully extended from the first hollow body. The extension guide may include a protrusion and a recess provided on a respective one of the first hollow body and the second hollow body, the recess engaging the protrusion to provide tactile feedback that the thin catheter has been fully retracted from the placed catheter. The extension guide may include: a protrusion and a recess provided on a first body, the first body being one of the first hollow body and the second hollow body; and a protrusion provided on a second body, the second body being the other of the first hollow body and the second hollow body. In use, when the cuff is retracted, the protrusions of the first hollow body and the second hollow body can move away from each other, and when the cuff is extended, the protrusions can move closer to each other. The protrusion of the second hollow body can abut the protrusion of the first hollow body during the extension of the cuff and move over the protrusion of the first hollow body into the recess to secure the first hollow body and the second hollow body in a fully extended state.

[0021] The distal region may include at least one of:

[0022] a male Luer connector for connecting to a female Luer piece of a catheter hub;

[0023] a female Luer connector for connecting to a male Luer piece of a catheter hub; and

[0024] Twist-lock fittings for threaded engagement with conduit hubs.

[0025] The proximal region may include a needle tip for connection to a fluid collection container (e.g., a vacutainer) and / or at least one of:

[0026] a male Luer connector for connecting to a female Luer piece of a fluid collection container;

[0027] a female Luer connector for connecting to a male Luer fitting of a fluid collection container; and

[0028] Holder for receiving vacuum blood collection tubes.

[0029] The proximal region may include a needle having a needle tip and a cover covering the needle tip, wherein the needle tip pierces the cover during connection of the fluid collection container. The needle tip may also pierce a rubber septum located on a vacuum blood collection tube.

[0030] Also disclosed herein is a device for fluid transfer through a placed catheter having an inner diameter, the device comprising:

[0031] a distal region adapted to connect to a catheter hub attached to a placed catheter;

[0032] a proximal region for transferring fluid to or from a fluid collection device;

[0033] a thin catheter having an outer diameter smaller than the inner diameter, the thin catheter being connected to the proximal region such that the proximal region is advanced toward the distal region such that the distal tip of the thin catheter protrudes from the placed catheter;

[0034] Therein, the device is configured to capture the distal tip within the device after the distal tip is moved proximally of the distal region.

[0035] Advantageously, by making the envelope collapsible, such as by folding the envelope or telescoping one portion of the envelope into another, the length and stiffness of the device are reduced when compared to some prior art devices. This reduces the likelihood of mechanical phlebitis and improves flexibility during operation.

[0036] Advantageously, by enabling the tip of the thin catheter to be retracted to a position proximal to the distal region, the tip can be captured within the sheath and thereby prevent inadvertent reuse of the device. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Embodiments of the invention will now be described, by way of non-limiting examples, with reference to the accompanying drawings, in which:

[0038] Figure 1 is a side view of an apparatus according to an embodiment of the present invention;

[0039] Figure 2 yes Figure 1 a cross-sectional view of the device shown;

[0040] Figure 3 yes Figure 1 a cross-sectional view of the device in a collapsed state, the device being attached to a catheter hub;

[0041] Figure 4 Components used to form an apparatus according to an embodiment of the present invention are illustrated;

[0042] Figure 5 and Figure 6 The diagram shows the Figure 4 the condition of the components when they are assembled into a device;

[0043] FIG. 7 , including FIG. 7A to FIG. 7D , shows a method for using Figure 1 progressive steps of the device;

[0044] 8A, 8B and 9 are partial views of alternative embodiments of devices according to the present invention;

[0045] Figure 10 is a side perspective view of an alternative embodiment of the apparatus according to the present invention;

[0046] Figure 11 yes Figure 10 a cross-sectional view of the device shown;

[0047] FIG. 12 , including FIG. 12A to FIG. 12E , shows a method for using Figure 11 Progressive steps of the device;

[0048] Figure 13 is a cross-sectional view of an alternative embodiment of a device according to the present teachings; and

[0049] Figure 14 and 15 is a cross-sectional view of an alternative embodiment of a device according to the present teachings. DETAILED DESCRIPTION

[0050] The detailed description provided below in conjunction with the accompanying drawings is intended to be a description of the present preferred embodiment of the device and method for transmitting fluid by placing a catheter provided according to aspects of the present invention, and is not intended to represent the only form that this device, system and method can be constructed or utilized. This description, in conjunction with the illustrated embodiments, has been set forth the features and steps of the embodiments for building and using this device, system and method. However, it should be understood that identical or equivalent functions and structures can be achieved through different embodiments, which are also intended to be included in the spirit and scope of this disclosure. As described elsewhere herein, identical element numbers are intended to indicate identical or similar elements or features.

[0051] The description of the technical features or aspects of an exemplary configuration of the present disclosure should generally be considered to be applicable and applicable to other similar features or aspects in another exemplary configuration of the present disclosure. Therefore, the technical features described herein according to one exemplary configuration of the present disclosure may be applicable to other exemplary configurations of the present disclosure, and therefore repeated descriptions may be omitted herein.

[0052] The devices disclosed herein attempt to introduce a thin (i.e., small) catheter into the lumen of a placed catheter, allowing the thin catheter to be pushed through or around an obstruction of the placed catheter. Furthermore, embodiments attempt to do this in various ways to reduce the likelihood of mechanical phlebitis and other conditions developing. Thin or small is understood to be relative to the placed catheter, and a device is considered thin or small if it is able to pass through the lumen of the placed catheter.

[0053] Figure 1 An apparatus 100 is shown for fluid delivery via a placed catheter 102 (see, e.g., Figure 3 ). The placed catheter 102 has an inner diameter that may become blocked by, for example, fibrin growth.

[0054] An apparatus 100 for delivering a fluid through a placed catheter according to aspects of the present invention generally comprises:

[0055] distal region 104;

[0056] proximal region 106;

[0057] Shrinkable cover 108; and

[0058] A thin catheter 110 has a body with a length and a lumen.

[0059] The distal region 104 is adapted to be connected to a catheter hub 112 (e.g., see Figure 3 ), the catheter hub 112 is attached to the placed catheter 102. The proximal region 106 is used to transfer fluid (e.g., blood) to or from a fluid collection device (see, for example, the evacuated blood collection tube 114 of FIG. 7C ). In typical use, when the capillary catheter 110 has been advanced through the placed catheter 102 and into the patient's vasculature, the fluid (i.e., blood) will travel upward along the capillary catheter 110 within the placed catheter 102, through the distal region 104, into the proximal region 106, and into a blood collection container (such as a evacuated blood collection tube). In other embodiments, the proximal region 106 may include a evacuated blood collection tube or another fluid collection device.

[0060] In one example, and as discussed further below, the distal region 104 includes a male connector for coupling to a catheter hub of a placed catheter, and the proximal region includes a holder having a needle within a lumen for piercing a septum of a vacutainer tube received therein. A thin catheter 110 is in fluid communication with the needle in the holder and is slidable relative to the lumen of the male connector in the distal direction 104 so that the thin catheter can be advanced into the lumen of the placed catheter.

[0061] In other embodiments, the device 100 is used to infuse or deliver fluid to a patient. Thus, the fluid flows in the opposite direction to that described above, from a container holding the fluid that is part of or connected to the proximal region 106 of the device 100 into a thin conduit for delivery to the patient.

[0062] The collapsible sleeve 108 extends from the distal region 104 to the proximal region 106. When the proximal region 106 is pushed toward the distal region 104 by the user, the collapsible sleeve 108—i.e., a sleeve that can be contracted to a shorter length, such as by folding and telescopically shortening—reduces the force transmitted from the proximal region 106 to the distal region 104. The sleeve 108 can be any suitable material and, in this embodiment, is a transparent, compressible, thin plastic sleeve. The sleeve has a length and two ends. One of the two ends can be connected to a retainer at the proximal region 106, and the other end can be connected to a male connector at the distal region 104.

[0063] The outer diameter θ of the thin catheter 110df Smaller than the inner diameter θ of the placed catheter 102 dp Inner diameter Θ dp 7A shows an end view of the tip 116 of the placed catheter 102. The thin catheter 110 is disposed within the cuff 108 and is connected to the proximal region 106. Advancing the proximal region 106 toward the distal region 104 of the device collapses the cuff 108 because the distal end of the cuff is secured to the connector in the distal region and advances the thin catheter 110 into the placed catheter 102. Although the placed catheter has a length with a lumen, typically, an obstruction typically occurs at the distal tip 116 of the placed catheter 102. Thus, in this context, advancing the thin catheter 110 through the placed catheter 102 typically means that the distal tip 124 ( Figure 2 and 7C) extend from the placed catheter 102—ie, distally of the distal tip 116 of the placed catheter—into the patient's vasculature.

[0064] The thin conduit 110 may be formed from any suitable material, such as fluorocarbon (due to its weight and less slack during use, low memory and more springy feel when compared to monofilament) or nanofiber.

[0065] Figure 2 The device 100 is shown in cross-section. The distal region 104 includes a male Luer fitting 118 adapted to connect to the female Luer fitting of the catheter hub 112. In one example, a threaded collar 120 is provided for threaded engagement with the catheter hub. In some examples, the threaded collar is a rotation lock 120 that is provided to lock or secure the device 100 to the catheter hub 112. As shown, the male Luer fitting 118 may also lock into the rotation lock 120, or may be otherwise formed with or attached to the rotation lock 120.

[0066] It will be appreciated that the distal region 104 can be configured for attachment to any desired catheter hub and is not limited to the illustrated embodiment. For example, the distal region 104 can include at least one of: Figure 3 The male Luer connector 122 shown is used to connect to the female Luer piece of the catheter hub 112; the female Luer connector is used to connect to the male Luer piece of the catheter hub; and Figure 3 A twist lock fitting 120 is shown for connection in a known manner to a corresponding twist lock fitting of the catheter hub 112. However, the distal region is not limited to a Luer-type fitting or lock and may be adapted to connect to any non-Luer-type fitting.

[0067] Similarly, the proximal region 106 may include at least one of: a female Luer connector 128 for connecting to a male Luer connector (not shown) of a fluid collection container; a female Luer connector for connecting to a male Luer member of a fluid collection container; or any other suitable connector, or a holder for receiving a vacuum blood collection tube.

[0068] When proximal region 106 is a holder for receiving an evacuated blood collection tube, the holder may include a needle 130 having a sharp tip for piercing the septum of the evacuated blood collection tube, and a sleeve or rubber cannula 139 for covering needle 130. The needle has a sharp tip for piercing the septum of the evacuated blood collection tube. The tip of needle 130 is configured to pierce sleeve 132 and then pierce the septum of the fluid collection chamber during connection of a fluid collection container (not shown). Specifically, the fluid collection chamber (e.g., an evacuated blood collection tube or vacuum bottle with a rubber septum, through which needle 130 pierces) can be pressed against sleeve or sleeve 132 and advanced toward needle 130. This causes needle 130 to pierce sleeve 132, which otherwise ensures the sterility of the needle and needle tip and prevents the risk of blood exposure, and pierce the container's rubber septum. When the evacuated blood collection tube has a predetermined vacuum or "suction," blood will flow freely into the fluid collection chamber. In some embodiments, sleeve 132 may be omitted. In some embodiments, other components, such as connectors or retainers 128, may also be omitted.

[0069] Proximal to or at the proximal end of the distal region 104, a male Luer fitting 122 is provided. Figure 2 ). The cuff 108 is attached to the distal region 104, for example, by gluing, ultrasonic welding, or any other suitable process. As shown, the distal end of the cuff is attached to the male Luer fitting 122 of the distal region 104. To reduce the possibility of contaminants being introduced into the lumen of the placed catheter 102 by the thin catheter 110, the seal at the connection between the cuff 108 and the distal region 104 (such as the seal with the male Luer fitting 122) can be an airtight seal.

[0070] The cuff 108 can be attached to the proximal region 106 using a method similar to that used to attach it to the distal region. In one example, the cuff 108 is attached to the male luer fitting 126 of the proximal region 106, such as using an adhesive, ultrasonic welding, or any suitable means. This attachment can also similarly form an airtight seal between the cuff 108 and the proximal region 106.

[0071] For illustration purposes, Figure 4The components of the device 100 are shown in an exploded view. The distal region 104 includes a fitting 133 having a Luer cone 134 and a Luer connector 136. The cuff 108 has a first end and a second end, wherein the first end is configured for connection to the Luer cone 134 of the distal connector. The proximal region 106 includes a male Luer cone 126 to which the second end of the cuff 108 is connected, and when the device 100 is assembled, the guide tube or thin catheter 110 is generally aligned with the orifice 138 through the distal region 104. To assemble, the guide tube or thin catheter 110 is first inserted into the cuff 108, as shown in FIG. Figure 5 As shown. The cuff is preferably made of a medical-grade plastic material. A double-ended connector at the distal end is attached to the threaded collar 120, such as a rotating lock collar. The needle 130 and cuff 132 are typically pre-assembled with the retainer 128 in the proximal region 106, unless the proximal region is a different connector, such as a female Luer fitting or a needleless connector. Then, the guide tube or thin conduit 110 is attached to the male Luer connector 126 at the proximal end, such as by gluing. Thus, the thin conduit 110 is fixed relative to the proximal region 106 and moves as a unit with the proximal region 106, and both move relative to the fitting 133 at the distal region. Then, the cuff 108 is attached to the proximal region 106, particularly the male Luer connector 126. The guide tube or thin conduit 110 is then inserted into the orifice 138 of the fitting 133, and then the cuff 108 is attached to the Luer taper 134, such as by gluing or ultrasonic welding. The device 100 is thus assembled.

[0072] 7A to 7D illustrate the device 100 in use with a placed catheter 102 connected to a catheter hub 112. As shown in FIG7A , when blood collection is required, or simply to avoid concerns about occlusion, the device 100 is connected to the catheter hub 112, which is attached to the placed catheter 102. The proximal region 106 of the device 100 is then advanced toward the distal region 104, the thin catheter 110 is slid relative to the distal region, and then the thin catheter 110 is extended from the fitting at the distal region 104 and into the placed catheter 102, as shown in FIG7B . A fluid collection container 114 (such as a vacutainer) is then attached to the holder at the proximal region 106, allowing the needle 130 to pierce the cuff 132 and then the rubber septum on the fluid collection container before entering the container 114 to allow fluid communication between the proximal region 106 and the container 114, and also between the container 114 and the patient's vasculature, as shown in FIG7C . After a fluid sample, such as blood, is collected in the container 114, or the contents of the container 114 have been infused into the patient, the proximal region 106 is retracted. As shown in FIG7D , this involves moving the proximal region in a proximal direction away from the distal region 104 to extend the cuff 108 from its compressed or collapsed configuration and retract the thin catheter 110 from the deployed catheter 102.

[0073] Refer again Figure 3 , the device 100 has a collapsed or retracted state as shown, wherein the proximal region 106 has been advanced toward the distal region 104. In this state, the thin catheter 110 is fully extended into or through the placed catheter 102, such that the tip 124 of the thin catheter 110 extends distally of the distal opening of the placed catheter, as shown in FIG7C . Figures 1 to 3 As shown, because the cuff 108 can be folded or bent upon itself into an accordion, the cuff is understood to be formed of a flexible material. The flexibility allows the cuff 108 or its material to collapse as the proximal region 106 is advanced toward the distal region 104. For example, compared to a cuff made of a rigid material that does not collapse or is difficult to collapse, this collapse ensures that little, if any, force is transmitted from the proximal region 106 to the distal region 104 during advancement of the thin catheter 110 into the placed catheter 102.

[0074] In other embodiments, there may be multiple collapsed or retracted states, such as Figure 11 As shown in the embodiment of FIG, the marking marks the different lengths of the thin catheter 110 extending into the placed catheter 102, and thus distinguishes different cuff contraction states. Figure 11 Various aspects of the embodiments.

[0075] Although after assembly of the device 100 as shown in Figures 7A to 7C, the distal tip 124 of the thin catheter 110 extends through the orifice 138 ( Figure 4 ), but as the cuff 108 is extended, the distal tip 124 moves proximally of the distal region 104. This causes the distal tip 124 to exit proximally from the orifice 138 and fall freely into the cuff 108. The tip 124 is thereby captured within the cuff 108. This configuration prevents unintentional reuse of the device 100. Other arrangements may also be used, such as a small metal biasing arm 140 (Figure 7D) (shown in phantom as it does not form part of this embodiment but is an alternative embodiment) which, after the distal tip 124 of the cuff moves proximally of the distal region 104, displaces the cuff 110 laterally of the longitudinal axis of the device 100 to prevent the cuff 110 from realigning and entering the orifice 138. The small metal biasing arm 140 may exert insufficient force to interfere with movement of the device 100 to the collapsed state, but may exert sufficient force to prevent the thin catheter 110 from re-entering the orifice 138 after it has been moved proximally of the orifice 138 .

[0076] FIG8A shows a close-up of the distal region 104 of this embodiment. As previously discussed, the distal region 104 of the device 100 includes attachment fittings for engaging the catheter hub of a placed catheter and for securing the first end of the cuff 108. FIG8B shows an alternative embodiment of the distal region 104 that employs a female Luer connector 142 to which the cuff 108 is attached. These figures illustrate that a variety of different arrangements can be used for the distal region 104, and that the distal region can be embodied in a range of configurations for attachment to the catheter hub and cuff and for allowing a thin catheter to pass therethrough, and that these options are intended to fall within the scope of the present disclosure.

[0077] FIG8C illustrates an alternative shape for the proximal region 106 of the device 100. The retainer 144 is configured for use with a fluid collection assembly, such as a vacuum blood collection tube, and the female connector 146 can be a female Luer connector. Other connector arrangements are also contemplated and can be used as desired and fall within the scope of the present invention, such as a needleless connector having an internally located compressible piston for controlling fluid flow through the needleless connector body.

[0078] Figure 10 An alternative embodiment of a device 150 for fluid transfer is shown that operates in a substantially similar manner to the device 100 discussed elsewhere herein. The device 150 of this alternative embodiment can be similarly used for fluid transfer through a placed catheter 102. The device 150 generally comprises:

[0079] distal region 152;

[0080] proximal region 154;

[0081] Shrinkable cover 156; and

[0082] Thin catheter 158 ( Figure 11 ), which has a body with a length and a tubular cavity.

[0083] The envelope 156 may be opaque (as shown), translucent, or transparent. Figure 2 Compared to the cover 108, the cover 156 is the main difference between the two devices 100, 150. Figure 11 , the envelope 156 of the device 150 includes a first hollow body 160 and a second hollow body 162. The cross-sections of the two bodies 160, 162 can be circular and tubular, although any suitable cross-section can be used as desired. Figure 2 Rather than a single body that collapses as with the sleeve 108 of the device 100 of the embodiment shown, the second hollow body 162 of the present embodiment collapses into the first hollow body 160 as the sleeve 156 collapses in a telescopic manner. In other examples, the second hollow body 162 can pass over the first hollow body 160, or the first hollow body can move into the second hollow body, as the proximal region advances toward the distal region.

[0084] The telescoping cuff 156 can be extended from a retracted position to an extended position to retract the thin catheter 158 from the deployed catheter 102. Thus, when the cuff 156 is extended, the second hollow body 162 moves away from the first hollow body 160.

[0085] In some embodiments, there may be more than two hollow bodies forming the cuff 158, such as three or more hollow bodies forming a collapsible cuff. The hollow bodies may be concentrically disposed or arranged in any desired manner to facilitate ease of use and reduce forces applied by the device to the catheter hub during use.

[0086] The cuff 156 can be integrally formed with one or both of the proximal region 104 and the distal region 102, such as by injection molding. Alternatively, the cuff 156 can be separately formed and attached to the proximal region and the distal region in a manner similar to that described above. Many features of the device 150 will be understood from the description of the device 100 and will not be repeated here.

[0087] The device 150 may include a length indicator 164. The length indicator 164 is configured to provide an indication to the user of the length of the thin catheter 158 that has been advanced into the placed catheter 102. Figure 11The length indicia is shown as being provided on both the first hollow body 160 and the second hollow body 162, although only one or the other may be implemented. In the embodiment shown, the device indicia may be a tactile feedback or "click" sound.

[0088] The length indicator 164 can include one or more protrusions, currently: two protrusions 170, 172, which are arranged continuously along the length of the second hollow body 162; and a recess 174 provided on the first hollow body 160. As the first and second hollow bodies are retracted or telescoped inwardly during advancement in the proximal region during use, the protrusions successively engage the recesses to indicate the advancement length of the thin catheter that has been advanced by the movement. The protrusions can be formed as circumferential ribs or small localized protrusions radially outward from the body, which are formed on the body. Similarly, the recess 174 can be a circumferential or annular groove, thereby eliminating the need to orient the first body 160 relative to the second body 162 during the process of retraction of the cuff 158 to ensure that the recess and the protrusion engage.

[0089] The length indicator 164 may similarly include more than two length indicator features, such as more than two sequentially positioned protrusions 170, 172 along the outer length of the second hollow body, each protrusion indicating a different length of the thin catheter 158 that has been advanced into the deployed catheter 102. If the recess 174 is a circumferential or annular recess, the multiple protrusions may be sequentially positioned along the length of the second hollow body, but may be radially positioned relative to each other and still engage the annular recess during advancement in the proximal region.

[0090] The length indicia may alternatively be simply an abutment, such as the distal end 166 of the first hollow body 160 abutting a wall or shoulder portion 168 of the distal region 104 and physically preventing the proximal region 154 from advancing further toward the distal region 152. Thus, the length indicia in this instance would relate to both the first hollow body 160 and the distal region 104. Figure 1 and 2 Length markers may be incorporated into the device 100. For example, the length markers may include one or more recesses or protrusions on the distal region 104 that are joined by corresponding one or more protrusions or recesses on the proximal region 106, on the cuff 108, or on the exterior of the thin catheter 110.

[0091] 12A to 12E illustrate Figure 1112A ). At this stage, the device 150 may be approximately 200 mm long, although other lengths are contemplated for different applications. At this stage, the tip of the thin catheter 158 is positioned within the lumen of the fitting at the distal region. The distal region 152 is then connected to the catheter hub 112, which is attached to the placed catheter 102 ( FIG. 12B ). The proximal region 154 is then advanced toward the distal region 152 to telescopically retract the second hollow body 162 into the first hollow body 160, as shown in FIG. 12C . As a result, the protrusion 172 on the second hollow body enters the recess 174 of the first hollow body ( FIG. 12B ). Figure 11 ). This provides tactile feedback of the length of the thin catheter 158 that has been advanced into the placed catheter 102.

[0092] If the proximal region 154 is further advanced, the recess 174 will move over the second protrusion 172 and over or engage with the first protrusion 170. This further advancement provides feedback that the thin catheter 158 has been further advanced into the placed catheter, the distance advanced being a known distance measured between the first protrusion 170 and the second protrusion 172. The user can interpret the length indication in the following example. For shorter placed catheters of the order of about 23 mm, the second protrusion 172 engaging the recess 174 can be adapted to ensure that the distal tip 176 of the thin catheter 158 extends beyond the distal tip of the placed catheter 102, and no further advancement of the proximal region is required. For longer placed catheters of the order of about 32 mm, the first protrusion 170 engaging the recess 174 can be adapted to indicate that the distal tip of the thin catheter has extended beyond the distal tip of the placed catheter.

[0093] When in a configuration suitable for approximately a 25 mm placed catheter, the device 150 for transferring fluids can be approximately 142 mm long. Once the proximal region is advanced toward the distal region, a container 178 can be attached to the proximal region 154 ( FIG. 12D ), or the device 150 can include a built-in evacuated blood collection tube or other container. Once the container 178 is filled, or its contents have been infused, the container can be removed and the cuff 156 returned to its extended configuration. That is, the second body 162 is telescoped out from the first body 160. This is generally illustrated in FIG. 12E , which shows the device 150 with a retainer 180 for mating with a evacuated blood collection tube.

[0094] 12E is shown with an extension guide 182. In the configuration of FIG12E, the thin conduit 158 ​​is configured to fill a container used with the device with a fluid (such as blood). When the proximal region is retracted, the tip 184 of the thin conduit 158 ​​can be pulled past the proximal end of the distal region 186, similar to the device 100 described above, to prevent reuse of the device. However, as an example, the tip 184 of the thin conduit 158 ​​can instead be retained within the distal region 186 of the device by incorporating a telescoping locking feature.

[0095] To prevent the catheter 158 from being reinserted or reused after a fluid has been infused into a patient or a sample has been removed from a patient, Figure 13 The device 180 may include an extension guide 182. In one example, the extension guide 182 may be sized and shaped to indicate when the second hollow body is fully extended from the first hollow body. Furthermore, the extension guide 182 may incorporate a structure that, after use, prevents inward telescoping movement between the first hollow body 188 and the second hollow body 190 after the device 180 has been moved to the fully extended position as shown.

[0096] In the example shown, the extension guide 182 includes a protrusion 192 and a recess 194 disposed on respective ones of the first hollow body 188 and the second hollow body 190. The recess 194, which may have an annular groove, engages the protrusion 192 to provide tactile feedback that the thin tube 158 has been fully retracted from the placed catheter 102.

[0097] The present extension guide 182 also includes a protrusion 196 located on the first hollow body 188. The protrusion 196 on the first hollow body 188 provides an indication that the device 180 is about to enter a fully extended condition, which is currently a tactile indication because the cover of the present device includes a lock and cannot be retracted inward again once fully extended and locked. This reduces the risk of the device 180 being unintentionally and irreversibly extended to a position such as Figure 13 The possibility of a fully extended state is shown, in which the protrusion 192 is irreversibly captured in the recess 194 and acts as a telescoping lock. As a result, in use, the protrusion 196 on the first hollow body 188 and the protrusion 192 on the second hollow body 190 move away from each other as the sleeve 198 contracts and move toward each other as the sleeve 198 extends, as shown. Figure 13 During extension, the protrusion 192 of the second hollow body 190 moves over the protrusion 196 of the first hollow body 188 and into the recess 194 to secure the first hollow body 188 and the second hollow body 190 in the fully extended state.

[0098] It will be appreciated that the protrusion and recess can be provided on the other of the first hollow body 188 and the second hollow body 190 without affecting the operation of the extension guide. It will also be appreciated that the engagement of the protrusion and recess, or other mechanisms employed in certain embodiments, can lock the relative positions of the proximal and distal regions (e.g., by locking portions of a cuff or sheath), thereby preventing reuse of the device.

[0099] For discussion purposes, Figure 14 An apparatus 200 for transferring fluid according to another aspect of the present invention is shown adjacent to Figure 13 In this embodiment, the device 200 has a proximal region 202 having a small adapter 204 for connecting to a blood collection or fluid infusion container. For example, the small adapter 204 can be a female Luer piece for receiving a male Luer tip of a syringe.

[0100] For discussion purposes, Figure 15 Shown is located Figure 13 150 . The device 206 has a distal region 208 that includes a flexible tube 210 extending between a cuff 212 and a connector 214. The connector can be a male luer for connecting to a catheter hub of a placed catheter (not shown), which can optionally be a rotary lock collar located around the fitting. During the process of retraction of the cuff 212, such as during advancement of the proximal region toward the distal region, the flexible tube 210 can reduce the force applied to the catheter hub by the proximal region 216. The flexible tube 210 also allows the device 206 to be used flexibly within a range of angles relative to the catheter hub without exerting unnecessary force on the catheter hub that could otherwise pull the placed catheter out of the patient.

[0101] Embodiments of devices for transferring fluids using thin catheters described herein can provide one or more functions or advantages, namely, reducing the risk of blood exposure, providing direct feedback of extension and contraction during use, obtaining blood samples with minimal hemolysis, allowing good stability throughout the procedure by reducing the forces applied to the catheter hub of the placed catheter, and preventing inadvertent reuse of the device.

[0102] Methods of using the device and making the device are within the scope of the present invention.

[0103] It will be appreciated that many further modifications and permutations of various aspects of the described embodiments are possible. Accordingly, the described aspects are intended to embrace all such alterations, modifications and variations that fall within the spirit and scope of the appended claims.

[0104] Throughout the specification and claims that follow, unless the context requires otherwise, the word "comprise" and variations such as "comprises" and "comprising" will be understood to imply the inclusion of a stated integer or step or groups of integers or steps but not the exclusion of any other integer or step or groups of integers or steps.

[0105] The following are numbered example embodiments of devices, systems, and methods for transferring fluids within a placed catheter. Examples 1-42 or any other embodiments disclosed herein may be combined in whole or in part. The elements of the examples disclosed herein are not limiting.

[0106] Example 1. A device for transferring fluid through a placed catheter having an inner diameter comprises: a distal region adapted to connect to a catheter hub attached to the placed catheter; a proximal region for transferring fluid to or from a fluid collection device; a collapsible cuff extending from the distal region to the proximal region; and a thin catheter having an outer diameter smaller than the inner diameter, the thin catheter disposed within the cuff and connected to the proximal region, such that advancing the proximal region toward the distal region collapses the cuff and advances the thin catheter into the placed catheter.

[0107] Example 2. The system, device, apparatus, and method for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein the cuff has a first length when extended and a second length shorter than the first length when retracted, corresponding to when the cannula is advanced through the deployed catheter such that the distal tip of the cannula protrudes from the distal opening of the deployed catheter.

[0108] Example 3. The systems, devices, apparatus, and methods for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein the envelope is hermetically sealed to the proximal region and the distal region.

[0109] Example 4. The systems, devices, apparatus, and methods for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein the cuff comprises a flexible material that contracts by accordion when the proximal region is advanced toward the distal region.

[0110] Example 5. The system, device, apparatus, and method for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein the envelope comprises at least a first hollow body and a second hollow body, the first hollow body and the second hollow body being retractable.

[0111] Example 6. The system, device, apparatus, and method for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein the second hollow body is configured to collapse into the first hollow body when the proximal region is advanced toward the distal region.

[0112] Example 7. The system, device, apparatus, and method for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein the cuff is extendable from a contracted condition to an extended condition to retract the thin catheter from the deployed catheter, and wherein when the cuff is extended, the second hollow body telescopes outwardly from the first hollow body.

[0113] Example 8. The system, device, apparatus, and method for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein the cuff is extendable to retract the thin catheter from the deployed catheter, and the device is configured to capture the distal tip within the device after the distal tip moves proximal to the distal region.

[0114] Example 9. The system, device, apparatus, and method for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein during retraction of the cuff, the distal tip extends through an orifice in the distal region, and the cuff is extendable such that the distal tip moves proximally of the distal region and out of the orifice.

[0115] Example 10. The system, device, apparatus, and method for fluid transfer according to any of Examples 1-42 or any other embodiment described herein further includes a length indicator for providing an indication of the length of the thin catheter that has been advanced into the placed catheter.

[0116] Example 11. The system, device, apparatus, and method for fluid transfer according to any of Examples 1-42 or any other embodiment described herein further includes a length indicator for providing an indication of the length of the thin catheter that has been advanced into the placed catheter, the length indicator being disposed on one or both of the first hollow body and the second hollow body.

[0117] Example 12. The system, device, apparatus, and method for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein the length indicator comprises a protrusion and a recess provided on respective ones of the first hollow body and the second hollow body, the recess engaging the protrusion to provide tactile feedback of the length of the thin catheter that has been advanced into the placed catheter.

[0118] Example 13. The systems, devices, apparatus, and methods for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein the length marker comprises at least one of: an abutment such that the proximal region cannot be advanced further toward the distal region; and at least two length markers, each indicating a different length of the thin catheter that has been advanced into the placed catheter.

[0119] Example 14. The system, device, apparatus, and method for fluid transfer of any of Examples 1-42 or any other embodiment described herein further includes an extension guide for indicating when the second hollow body is fully extended from the first hollow body.

[0120] Example 15. The system, device, apparatus, and method for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein the extension guide comprises a protrusion and a recess provided on respective ones of the first hollow body and the second hollow body, the recess engaging the protrusion to provide tactile feedback that the thin tube has been fully retracted from the placed catheter.

[0121] Example 16. The system, device, apparatus, and method for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein the extension guide comprises: a protrusion and a recess provided on a first body, the first body being one of a first hollow body and a second hollow body; and a protrusion provided on a second body, the second body being the other of the first hollow body and the second hollow body.

[0122] Example 17. The system, device, apparatus, and method for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein, in use, the protrusions of the first and second hollow bodies move away from each other when the envelope is contracted, and the protrusions move toward each other when the envelope is extended.

[0123] Example 18. The system, device, apparatus, and method for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein during extension of the cuff, the protrusion of the second hollow body abuts the protrusion of the first hollow body and moves over the protrusion of the first body into the recess to secure the first and second hollow bodies in the fully extended state.

[0124] Example 19. The systems, devices, apparatus, and methods for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein the distal region comprises at least one of: a male luer connector for connecting to a female luer piece of a catheter hub; a female luer connector for connecting to a male luer piece of a catheter hub; and a twist-lock fitting for threaded engagement with the catheter hub.

[0125] Example 20. The systems, devices, apparatus, and methods for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein the proximal region includes a needle tip for connecting to a fluid collection container, and at least one of: a male luer connector for connecting to a female luer fitting of the fluid collection container; a female luer connector for connecting to a male luer fitting of the fluid collection container; and a holder for receiving the fluid collection container.

[0126] Example 21. The system, device, apparatus, and method for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein the proximal region comprises a needle having a needle tip and a sheath covering the needle tip, the needle tip piercing the sheath during connection of the fluid collection container.

[0127] Example 22. A device for transferring fluid through a placed catheter having an inner diameter, the device comprising: a distal region adapted to connect to a catheter hub attached to the placed catheter; a proximal region for transferring fluid to or from a fluid collection device; a thin catheter having an outer diameter smaller than the inner diameter, the thin catheter connected to the proximal region such that the proximal region advances the thin catheter toward the distal region such that a distal tip of the thin catheter extends from the placed catheter; wherein the device is configured to capture the distal tip within the device after the distal tip moves proximally of the distal region after use.

[0128] Example 23. The system, device, apparatus, and method for fluid transfer of any of Examples 1-42 or any other embodiment described herein further includes: a retractable cuff extending from the distal region to the proximal region; the thin catheter disposed within the cuff and connected to the proximal region such that advancing the proximal region toward the distal region retracts the cuff and advances the thin catheter into the placed catheter.

[0129] Example 24. The systems, devices, apparatus, and methods for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein the device of claim 23, wherein the envelope is hermetically sealed to the proximal region and the distal region.

[0130] Example 25. The systems, devices, apparatus, and methods for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein the cuff comprises a flexible material that contracts by accordion when the proximal region is advanced toward the distal region.

[0131] Example 26. The system, device, apparatus, and method for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein the envelope comprises at least a first hollow body and a second hollow body that collapses into the first hollow body when the envelope collapses.

[0132] Example 27. The system, device, apparatus, and method for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein the cuff is extendable to proximally retract the thin catheter from the deployed catheter, and wherein when the cuff is extended, the second hollow body telescopes outward from the first hollow body.

[0133] Example 28. The systems, devices, apparatus, and methods for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein during retraction of the cuff, the distal tip extends through an orifice in the distal region, and the cuff is extendable such that the distal tip moves proximally of the distal region and out of the orifice.

[0134] Example 29. The systems, devices, apparatus, and methods for fluid transfer of any of Examples 1-42 or any other embodiment described herein further include a length indicator for providing an indication of the length of the thin catheter that has been advanced into the placed catheter.

[0135] Example 30. The system, device, apparatus, and method for fluid transfer according to any of Examples 1-42 or any other embodiment described herein further includes a length indicator for providing an indication of the length of the thin catheter that has been advanced into the placed catheter, the length indicator being disposed on one or both of the first hollow body and the second hollow body.

[0136] Example 31. The system, device, apparatus, and method for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein the length indicator comprises a protrusion and a recess provided on respective ones of the first hollow body and the second hollow body, the recess engaging the protrusion to provide tactile feedback of the length of the thin catheter that has been advanced into the placed catheter.

[0137] Example 32. The systems, devices, apparatus, and methods for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein the length marker comprises at least one of: an abutment that prevents the proximal region from being advanced further toward the distal region; and at least two length markers, each indicating a different length of the thin catheter that has been advanced into the placed catheter.

[0138] Example 33. The system, device, apparatus, and method for fluid transfer of any of Examples 1-42 or any other embodiment described herein further includes an extension guide for indicating when the second hollow body is fully extended from the first hollow body.

[0139] Example 34. The system, device, apparatus, and method for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein the extension guide comprises a protrusion and a recess provided on a respective one of the first hollow body and the second hollow body, the recess engaging the protrusion to provide tactile feedback that the thin tube has been fully retracted from the placed catheter.

[0140] Example 35. The system, device, apparatus, and method for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein the extension guide comprises: a protrusion and a recess disposed on a first body, the first body being one of a first hollow body and a second hollow body; and a protrusion disposed on a second body, the second body being the other of the first hollow body and the second hollow body.

[0141] Example 36. The system, device, apparatus, and method for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein, in use, when the envelope is retracted, the protrusions of the first and second hollow bodies move away from each other, and when the envelope is extended, the protrusions of the first and second hollow bodies move toward each other.

[0142] Example 37. The system, device, apparatus, and method for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein during extension of the cuff, the protrusion of the second hollow body abuts the protrusion of the first hollow body and moves over the protrusion of the first body into the recess to secure the first and second hollow bodies in the fully extended state.

[0143] Example 38. The systems, devices, apparatus, and methods for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein the distal region comprises at least one of: a male luer connector for connecting to a female luer piece of a catheter hub; a female luer connector for connecting to a male luer piece of a catheter hub; and a twist-lock fitting for threaded engagement with the catheter hub.

[0144] Example 39. The systems, devices, apparatus, and methods for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein the proximal region comprises a needle having a needle tip for connecting to a fluid collection container, and at least one of: a male luer connector for connecting to a female luer fitting of the fluid collection container; a female luer connector for connecting to a male luer fitting of the fluid collection container; and a holder for receiving the fluid collection container.

[0145] Example 40. The system, device, apparatus, and method for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein the proximal region comprises a needle having a needle tip and a sheath covering the needle tip, the needle tip piercing the sheath during connection of the fluid collection container.

[0146] Example 41. A method of forming a device for fluid transfer through a placed catheter having an inner diameter, the method comprising: forming a distal region adapted to connect to a catheter hub attached to the placed catheter; forming a proximal region having structure for transferring fluid to or from a fluid collection device; positioning a collapsible cuff between the distal region and the proximal region and securing the cuff to the proximal region and the distal region; and connecting a thin catheter to the proximal region, the thin catheter having an outer diameter smaller than the inner diameter and disposed within the cuff; and wherein the cuff collapses when the proximal region is advanced toward the distal region.

[0147] Example 42. The system, device, apparatus, and method for fluid transfer of any of Examples 1-42 or any other embodiment described herein, wherein the thin catheter is movable relative to the distal region as the proximal region is advanced toward the distal region.

[0148] Reference in this specification to any prior publication (or information derived therefrom) or any known content is not and should not be regarded as an admission or recognition or any form of implication that such prior publication (or information derived therefrom) or known content constitutes part of the common general knowledge in the field to which this specification relates.

Claims

1. A device for fluid transfer through a placed catheter having an inner diameter, comprising: a distal region adapted to connect to a catheter hub attached to a placed catheter; a proximal region for transferring fluid to or from a fluid collection device; a shrinkable envelope extending from the distal region to the proximal region; and A thin catheter having an outer diameter smaller than the inner diameter is disposed within the cuff and connected to the proximal region such that advancing the proximal region toward the distal region collapses the cuff and advances the thin catheter into the placed catheter.

2. The device according to claim 1, wherein The cuff has a first length when extended and a second length shorter than the first length when retracted, corresponding to when the catheter is advanced through the placed catheter such that the distal tip of the catheter protrudes from the distal opening of the placed catheter.

3. The device according to claim 1, wherein The envelope is hermetically sealed to the proximal and distal regions.

4. The device according to claim 1, wherein The cuff comprises a flexible material that contracts by accordion as the proximal region is advanced toward the distal region.

5. The device according to claim 1, wherein The envelope comprises at least a telescopic first hollow body and a second hollow body.

6. The device according to claim 2, wherein The cuff is extendable to retract the thin catheter from the deployed catheter, and the device is configured to capture the distal tip within the device after the distal tip moves proximal to the distal region.

7. The device according to claim 1, wherein Also included is a length indicator for indicating the length of the thin catheter that has been advanced into the placed catheter.

8. The device according to claim 5, wherein Also included is a length marker for providing an indication of the length of the thin catheter that has been advanced into the placed catheter, the length marker being disposed on one or both of the first hollow body and the second hollow body.

9. The device according to claim 8, wherein The length indicator includes a protrusion and a recess provided on respective ones of the first and second hollow bodies, the recess engaging with the protrusion to provide tactile feedback of the length of the thin catheter that has been advanced into the placed catheter.

10. The apparatus of claim 5, further comprising an extension guide for indicating when the second hollow body is fully extended from the first hollow body.

11. The device according to claim 10, wherein The extension guide includes a protrusion and a recess provided on respective ones of the first and second hollow bodies, the recess engaging with the protrusion to provide tactile feedback that the thin catheter has been fully retracted from the placed catheter.

12. The device according to claim 1, wherein The distal region includes at least one of: a male Luer connector for connecting to the female Luer piece of the catheter hub; a female Luer connector for connecting to the male Luer piece of the catheter hub; and Twist-lock fittings for threaded engagement with conduit hubs.

13. The device according to claim 1, wherein The proximal region includes a needle tip for connection to a fluid collection container, and at least one of: a male Luer connector for connecting to a female Luer piece of the fluid collection container; a female Luer connector for connecting to a male Luer piece of the fluid collection container; and A holder is provided for receiving the fluid collection container.

14. A method of forming a device for fluid transfer through a placed catheter having an inner diameter, comprising: forming a distal region adapted to connect to a catheter hub attached to a placed catheter; forming a proximal region having structure for transferring fluid to or from a fluid collection device; positioning a shrinkable sleeve between the distal region and the proximal region and securing the sleeve to the proximal region and the distal region; and connecting a thin catheter to the proximal region, the thin catheter having an outer diameter smaller than the inner diameter and disposed within the cuff; and wherein the envelope contracts as the proximal region advances toward the distal region.

15. The method according to claim 14, wherein When the proximal region is advanced toward the distal region, the thin catheter is movable relative to the distal region.

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