Multi-Lumen Extension System

Abstract

The multi-lumen extension system may include a first lumen forming a fluid pathway within the multi-lumen extension system, a second lumen forming a non-fluid pathway within the multi-lumen extension system, a patency device housed within the second lumen, a seal between the first lumen and the second lumen that prevents fluid from entering the second lumen from the first lumen, and a grip formed along the second lumen and operably coupled to the patency device housed within the second lumen for selectively advancing the patency device along the second lumen.

Description

[Background technology]

[0001] Patency is the state or quality of an unobstructed fluid pathway within a patient's body. Intravenous (IV) devices, in particular, may have a certain level of patency when fluids, such as blood or medications, may pass through the IV device. During use of an IV device, the IV device is inserted into a patient's blood vessel, and in some embodiments, the needle is withdrawn from the catheter while the catheter remains in the patient's blood vessel. In some situations, the IV device remains in the patient's blood vessel for 30 days or more. This allows a physician or other healthcare provider (HCP) fluid access to the patient's bloodstream during care. This continuous fluid access to the patient's blood vessel allows the physician or other HCP to perform one or more blood draws or administer one or more fluids, such as normal saline solution, various medications, and total parenteral nutrition, at appropriate times.

[0002] While the IV device is in the patient's blood vessels, however, the patency of the IV device may be at risk. A blockage may remain and the IV device may prevent further administration of the IV device into the patient's body. This may cause trauma to the patient and may lead to other medical problems such as inflammation of the blood vessels, among other medical problems.

[0003] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in the environments as described herein. Rather, this background is provided to describe the environments in which the presently described embodiments may operate. Summary of the Invention

[0004] The present disclosure generally relates to a multi-lumen extension system used as an interface with an IV device that provides a fluid pathway to the IV device while also providing a patency device that is used to periodically check or improve the patency of the IV device while the IV device is in a patient's blood vessel. In some embodiments, the multi-lumen extension system comprises: a first lumen that forms a fluid pathway within the multi-lumen extension system; a second lumen that forms a non-fluid pathway within the multi-lumen extension system; a patency device housed within the second lumen that prevents fluid from entering the second lumen from the first lumen; a seal between the first lumen and the second lumen, and a grip formed along the second lumen and operably coupled to the patency device housed within the second lumen for selectively advancing the patency device along the second lumen.

[0005] In some embodiments, the grip is not physically and non-directly coupled to the patency device, thereby allowing the patency device to remain in a sealed environment during use and avoiding any contamination due to introduction. In some embodiments, during operation, a physician or other HCP may withdraw blood from a patient's bloodstream and provide fluid infusions, such as normal saline solution, various medications, and total parenteral nutrition, into the patient's bloodstream without manipulating the IV device itself. This is because the multi-lumen extension systems described herein interface with the proximal end of the IV device while the distal end of the multi-lumen extension system is coupled thereto. This allows the IV device to be secured to the patient's body, for example, via medical tape or a securement bandage, to prevent movement of the IV device while using the multi-lumen extension system. Thus, the multi-lumen extension system is positioned remotely from the IV device while the physician withdraws blood from the IV device through the first lumen, injects fluids such as normal saline solution, various medications, and total parenteral nutrition into the patient's bloodstream through the first lumen, and introduces a patency device into the IV device through the second lumen.

[0006] In some embodiments, the first lumen and the second lumen of the multi-lumen extension system may be formed coaxially within the multi-lumen tube, which may provide an alignment of the first and second lumens to form lumens for easy physician access.

[0007] In some embodiments, the grip of the multi-lumen extension system may comprise a ring formed coaxially around the second lumen and a plurality of ball bearings or another type of roller for a low friction slider formed between the ring and the outer wall of the second lumen having a patency device with a surface that engages the plurality of ball bearings, such that movement of the ring moves the patency device within the second lumen. In some embodiments described herein, the second lumen may comprise a gas vent that allows gas to escape from the second lumen upon movement of the patency device.

[0008] In some embodiments, the multi-lumen extension system may include a Luer Lock Access Device (LLAD) operably coupled to the proximal end of the first lumen, which may allow for selective engagement of a Luer Lock on the proximal end of the multi-lumen extension system for blood collection. More specifically, in some embodiments, the proximal end of the first lumen may include a coupling device such that at least any type of blood infusion or blood sampling device may be coupled thereto for administration of infusion of fluids such as normal saline solution, various medications, and total parenteral nutrition, or for blood collection, respectively.

[0009] In some embodiments, the grip of the multi-lumen extension system can include a magnetic hub formed at the proximal end of the patency device, and with this magnetic hub, the grip of the multi-lumen extension system can include a permanent magnetic ring formed coaxially around the second lumen and magnetically coupled to the magnetic hub such that movement of the permanent magnetic ring moves the patency device within the second lumen.

[0010] In some embodiments, the grip of the multi-lumen extension system is mechanically coupled to the proximal end of the patency device via a passageway formed through the multi-lumen tube coaxially formed around the first lumen and the second lumen, and in this embodiment, the mechanically coupled grip may comprise a passageway through which the first lumen passes.

[0011] In some embodiments, the multi-lumen extension system may include a second lumen that is generally perpendicular or non-parallel to the main axis of the first lumen at the distal end, allowing a physician to access the first and second lumens at a location separate from the IV device to which the multi-lumen extension system is coupled.

[0012] As described herein, the multi-lumen extension system may include a second lumen with a patency device therein. In these embodiments, the patency device may be coaxially formed within the second lumen. In some embodiments, the patency device is a guidewire or other patency-enhancing structure that is coaxially formed within the second lumen and that is moved within the second lumen using a grip, as described herein.

[0013] It is to be understood that both the following general description and the detailed description are exemplary and explanatory and are not restrictive of the present invention, as defined in the claims. It is to be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. It is to be understood that the embodiments may be combined or utilized in different ways, and structural changes may be made, unless otherwise stated in the claims, without departing from the scope of the present invention. Therefore, the following detailed description is not to be construed as limiting. [Brief explanation of the drawings]

[0014] Exemplary embodiments will be described and explained in more detail and through the use of accompanying drawings.

[0015] [Figure 1] FIG. 1 is a perspective view of a multi-lumen extension system according to an embodiment of the present disclosure. [Figure 2] FIG. 2 is a side cross-sectional view of a multi-lumen extension system according to an embodiment of the present disclosure. [Figure 3] FIG. 3 is a front cross-sectional view of a multi-lumen extension system according to an embodiment of the present disclosure. [Figure 4] FIG. 4 is a front cross-sectional view of a multi-lumen extension system according to an embodiment of the present disclosure. [Figure 5] FIG. 5 is a side cross-sectional view of a multi-lumen extension system according to an embodiment of the present disclosure. [Figure 6] FIG. 6 is a perspective view of a multi-lumen extension system according to an embodiment of the present disclosure. [Figure 7] FIG. 7 is a cross-sectional perspective view of a multi-lumen extension system according to an embodiment of the present disclosure. [Figure 8] FIG. 8 is a front cross-sectional view of a multi-lumen extension system according to an embodiment of the present disclosure. [Figure 9] FIG. 9 is a side view of a rigid multi-lumen extension system according to an embodiment of the present disclosure. [Figure 10] FIG. 10 is a side cross-sectional view of a rigid multi-lumen extension system according to an embodiment of the present disclosure. [Figure 11] FIG. 11 is a side cross-sectional view of a rigid multi-lumen extension system according to an embodiment of the present disclosure. [Figure 12] FIG. 12 is a side cross-sectional view of a rigid multi-lumen extension system according to an embodiment of the present disclosure. [Figure 13] FIG. 13 is a front view of a multi-lumen extension system according to an embodiment of the present disclosure. [Figure 14] FIG. 14 is a side view of a grip according to an embodiment of the present disclosure. [Figure 15] FIG. 15 is a perspective view of a multi-lumen extension system according to an embodiment of the present disclosure. [Figure 16] FIG. 16 is a top plan view of a multi-lumen extension system according to an embodiment of the present disclosure. [Figure 17] FIG. 17 is a top plan view of a multi-lumen extension system according to an embodiment of the present disclosure. [Figure 18] FIG. 18 is a side view of a patency device extending out of the distal end of an IV catheter, according to an embodiment of the present disclosure. [Figure 19] FIG. 19 is a side view of a patency device according to an embodiment of the present disclosure. [Figure 20] FIG. 20 is a side view of a patency device according to an embodiment of the present disclosure. [Figure 21] FIG. 21 is a side view of a patency device according to an embodiment of the present disclosure. [Figure 22] FIG. 22 is a side view of a patency device according to an embodiment of the present disclosure. [Figure 23] FIG. 23 is a side view of a patency device according to an embodiment of the present disclosure. [Figure 24] FIG. 24 is a side view of a patency device extending out of the distal end of a catheter according to an embodiment of the present disclosure. [Figure 25] FIG. 25 is a side view of a patency device extending out of the distal end of a catheter according to an embodiment of the present disclosure. [Figure 26] FIG. 26 is a flow chart illustrating a method of making a multi-lumen extension system according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0016] As used herein, the term "proximal" refers to the location on the needle of an intravenous treatment system that, in use, is closest to the physician using the intravenous treatment system and farthest from the patient to whom the device is connected. Conversely, the term "distal" refers to the location on the needle of an intravenous treatment system that, in use, is furthest from the physician using the intravenous treatment system and nearest to the patient to whom the intravenous treatment system is connected.

[0017] As used herein, the terms "top," "above," or "upward" refer to a location on the needle of an intravenous treatment system that is radially away from the longitudinal axis of the intravenous treatment system and away from the patient's skin during use. Conversely, the terms "bottom," "below," or "downward" refer to a location on the needle of an intravenous treatment system that is radially away from the longitudinal axis of the device and toward the patient's skin during use.

[0018] As used herein, the terms "in" or "inwardly" refer to a position relative to the needle of the intravenous treatment system that is toward the inside of the intravenous treatment system during use. Conversely, the terms "out" or "outwardly" refer to a position relative to the needle of the intravenous treatment system that is toward the outside of the intravenous treatment system during use.

[0019] As used herein, the term "formed" refers to the construction, creation, production, arrangement, or placement of a component part.

[0020] The drawings may be used to refer to components in different embodiments. While the embodiments described herein are used in conjunction with an intravenous treatment system for receiving a blood sample or introducing medication into a patient's body, it should be understood that the intravenous treatment system may also be applied to other medical devices suitable for needles and / or catheters inserted into a patient's blood vessels. Furthermore, while the intravenous treatment system may be implemented in many different forms, there are several embodiments that are within the scope of the disclosure, as shown in the drawings and described in detail herein.

[0021] FIG. 1 is a perspective view of a multi-lumen extension system 100 according to an embodiment of the present disclosure. As described herein, the multi-lumen extension system 100 may include a first lumen 105 and a second lumen 110. In some embodiments, the first lumen 105 may be a fluid pathway through which blood, fluid agents, infusion fluids such as normal saline solution, various medications, and / or total parenteral nutrition may pass. In some embodiments, the first lumen 105 may be fluidly coupled to a fluid source at a proximal end 135 of the first lumen 105. In the particular embodiment shown in FIG. 1, the proximal end 135 of the first lumen 105 may be coupled to a Luer Lock Access Device (LLAD) 130. The LLAD 130 may include a needle 155 for interfacing with a blood sample tube, such as a VACUTAINER® blood sample collection tube manufactured by Becton, Dickinson and Company of Franklin Lakes, NJ. Although the present description describes the first lumen 105 as being fluidly connected to the LLAD 130, the present description contemplates that any fluid sampling device or fluid storage container may be connected to the proximal end 135 of the first lumen 105 for sampling blood or providing infusion fluids, such as normal saline solution, various medications, and / or total parenteral nutrition, respectively.

[0022] In some embodiments, the first lumen 105 may be fluidly coupled to an IV device at the distal end 140 of the multi-lumen extension system 100 via the distal end 150 of the first lumen 105. The distal end 140 of the multi-lumen extension system 100 may comprise a connector used to connect the multi-lumen extension system 100 to an IV device. In the particular embodiment shown in FIG. 1 , the distal end 140 of the multi-lumen extension system 100 comprises a male adapter used to interface with a female component on an IV device. The male adapter may allow the distal end 150 of the first lumen 105 to exit into a hollow space formed within the male adapter.

[0023] The distal end 140 of the multi-lumen extension system 100 may further include a number of connection mechanisms for connecting the distal end 140 of the multi-lumen extension system 100 to an IV device. While Figure 1 shows the distal end 140 including a male adapter and a connection mechanism used to interface with a female adapter on an IV device, the present description contemplates that other types of adapters (including female adapters) may be used to connect the distal end 140 of the multi-lumen extension system 100 to an IV device.

[0024] The multi-lumen extension system 100 may also include a second lumen 110. In the embodiment shown in FIG. 1, the second lumen 110 is generally parallel to the first lumen 105. In an alternative embodiment, as described herein, the first lumen 105 and the second lumen 110 are formed generally perpendicular to one another, with the distal end 150 of the first lumen 105 and the distal end 140 of the multi-lumen extension system 100 bisecting the length of the first lumen 105 and / or the second lumen 110. In embodiments in which the second lumen 110 is generally parallel to the first lumen 105, a multi-lumen tube 145 may be used to house the first lumen 105 and the second lumen 110. The multi-lumen tube 145 may be coaxially formed around the first lumen 105 and the second lumen 110, allowing the lumens 105, 110 to be configured in a single location for access by a physician or other HCP. The multi-lumen tube 145, in this embodiment, may form part of a structure used to connect the first lumen 105 and the second lumen 110 to the distal end 140 of the multi-lumen extension system 100 and to a proximal end of the multi-lumen extension system 100, such as the proximal end 135 of the first lumen 105.

[0025] The multi-lumen extension system 100, in some embodiments, may include a grip 115. The grip 115 may be any device operably coupled to a patency device 125 formed within the second lumen 110. The grip 115 may be manipulated by a physician or other HCP to selectively advance the patency device 125 within the second lumen 110 and cause a portion of the patency device 125 to extend out of the distal end 140 of the multi-lumen extension system 100. As described herein, the multi-lumen extension system 100 may be coupled to an IV device disposed within a patient's blood vessel. Advancement of the patency device 125 by manipulation of the grip 115 may cause the patency device 125 to extend out of the second lumen 110 and through any fluid pathway formed in the IV device to clear any obstructions or check the patency of the IV device. During operation of the multi-lumen extension system 100, the physician may selectively pull the grip 115 toward the distal end 140 of the multi-lumen extension system 100 to extend the patency device 125 out of the multi-lumen extension system 100. The physician may selectively pull the grip 115 toward the second lumen 110 and the proximal end of the multi-lumen extension system 100 to retract the patency device 125 back into the second lumen 110, after which the physician may check patency or move fluid through the multi-lumen extension system 100 via the first lumen 105. Further pulling the grip 115 toward the second lumen 110 and the proximal end of the multi-lumen extension system 100 causes the patency device 125 to be enclosed within the second lumen 110 such that the patency device 125 remains within the second lumen 110 before disconnecting the multi-lumen extension system 100 from the IV device. This reduces the risk of blood exposure from the patency device 125 outside of the multi-lumen extension system 100.

[0026] In some embodiments, the multi-lumen extension system 100 may include a seal 120. The seal 120 may be used to fluidly seal the second lumen 110 from fluid passing through the first lumen 105 and through the distal end 140 of the multi-lumen extension system 100. As described herein and shown in FIG. 1 , the first lumen 105 and the second lumen 110 may be connected together at a single point at the distal end 140 of the multi-lumen extension system 100. In some embodiments, the distal end 150 of the first lumen 105 may be fluidly connected to the interior volume of a male adapter used to interface with a female adapter of an IV device. In some embodiments, the seal 120 may prevent any fluid contained within the interior volume of the male adapter from entering the second lumen 110, since the second lumen 110 serves as a non-fluidic path for the patency device 125 contained therein. In another embodiment, the multi-lumen extension system 100 does not include a seal 120, and the second lumen 110 may be used as a fluid pathway, for example, for passing a blood sample therethrough or for passing infusion fluids such as normal saline solution, various medications, and total parenteral nutrition.

[0027] In some embodiments, the second lumen 110 may include a number of markers that indicate the position of the patency device 125 relative to the IV catheter. In certain embodiments, the markers may indicate to the physician where along the length of the second lumen 110 the grip 115 should be positioned to cause the patency device 125 to pass fully or partially through a fluid pathway formed within the IV catheter 200.

[0028] First lumen 105 may be adapted to reduce hemolysis during blood collection. The inner diameter of first lumen 105 and / or second lumen 110 may be adapted to provide a sufficient fluid flow rate. In some embodiments, the length and inner diameter of first lumen 105 and / or second lumen 110 may be selected based on one or more of the following: The gauge and / or length of the particular IV device, the shape of the particular IV device, or the physician's setup.

[0029] Fluid flow in a lumen having a cylindrical fluid path therethrough can be analyzed using the Poiseuille equation:

[0030]

number

[0031] where ΔP is the change in pressure gradient across the length of the lumen of a cylindrical fluid path through the lumen, where D and L are the internal diameter and length, respectively; μ is the viscosity of the fluid; and

[0032]

number

[0033] is the flow resistance. μ is the viscosity of the fluid, and since it is not a part of the lumen shape, the geometric factor G f is R f (flow resistance) is

[0034]

number

[0035] where:

[0036]

number

[0037] It is defined to be:

[0038] In some embodiments, first lumen 105 and / or second lumen 110 may comprise lumens having a cylindrically shaped fluid path.

[0039] In some embodiments, the first lumen 105 and / or the second lumen 110 may have a cylindrical cross section with lengths (L1, L2, L3) and inner diameters (D1, D2, D3), where the view factor is:

[0040]

number

[0041] In some embodiments, the first lumen 105 and / or the second lumen 110 may have an inner diameter that varies over the length of the lumen, and then the view factor is:

[0042]

number

[0043] In some embodiments, first lumen 105 and / or second lumen 110 may have a non-circular cross-section. In this case, the view factor can be determined by measuring the flow velocity (Q) at a given pressure (ΔP) of a fluid with known viscosity (μ):

[0044]

number

[0045] This G f The value may be selected to reduce the maximum shear stress for each IV device gauge to less than or equal to the maximum shear stress of the BD 21G VACUTAINER® UTLRATOUCH™ push-button blood collection set (available from Becton, Dickinson and Company, Franklin Lakes, NJ), which was previously the gold standard for blood collection. f is 3.83E+06 (1 / in) when the IV device is equipped with an 18G catheter. 3) or greater, which may reduce wall shear stress and reduce hemolysis. f is 3.27E+06 (1 / in) when the IV device is equipped with a 20G catheter. 3 ) or greater, which may reduce wall shear stress and reduce hemolysis. f is 3.33E+06 (1 / in) when the IV device is equipped with a 22G catheter. 3 ) or greater, which may reduce wall shear stress and reduce hemolysis. f is 1.50E+07 (1 / in) when the IV device is equipped with a 24G catheter. 3 ) or greater, which may reduce wall shear stress and reduce hemolysis. f may have other values. In some embodiments, G f may be selected to reduce the maximum shear stress for each catheter gauge to less than or equal to the maximum shear stress of the BD 25G VACUTAINER® ULTRATOUCH™ push button blood collection set (available from Becton, Dickinson and Company, Franklin Lakes, New Jersey).

[0046] In some embodiments, the blood collection system may include one or more of the following: an IV device (which may include extension tubing), a multi-lumen extension system 100, and a needle 155. In some embodiments, the multi-lumen extension system 100 may include a first lumen 105 and / or a second lumen 110. In some embodiments, the fluid path of the blood collection system may include the entire blood collection path through which blood flows during blood collection. The system's view factor G for the fluid path of the blood collection system is fs can be determined in a similar manner as described above. In some embodiments, the system view factor G fs is 7.34E+06 (1 / in) when the patency device 125 may or may not be in the extended position. 3) or more. In some embodiments, G fs may include other values. In some embodiments, the system view factor G fs is 7.34E+06 (1 / in 3 ) may be plus or minus 10%, plus or minus 25%, plus or minus 50%, plus or minus 75%. fs may include other values, which may be selected based on the gauge and / or length of the catheter.

[0047] The multi-lumen extension system 100 may minimize hemolysis during blood collection while also connecting the patency of the IV catheter to the multi-lumen extension system 100. The multi-lumen extension system improves placement of the IV catheter in the patient's blood vessel while optimizing blood flow rates during the blood collection process.

[0048] While this disclosure describes an IV catheter, this specification considers the IV catheter to be a peripheral IV catheter (PIVC). In some embodiments, the PIVC may include a needleless access connector (NAC) attached to a patient-proximal access luer port on a multi-lumen extension system. In some embodiments, the PIVC may include a NAC attached to a patient-proximal access luer port with a non-integrated VAD.

[0049] In some embodiments, the second lumen 110 may include a vent to allow air to escape. In some embodiments, air may be compressed as a grip is used to pass the patency device 125 therethrough. With a vent, the compressed air may escape from the second lumen 110.

[0050] FIG. 1 also depicts section line "A." Section line "A," as shown, depicts the configuration of the multi-lumen extension system 100 in FIG. 2, in one embodiment. FIG. 2 is a side cross-sectional view of the multi-lumen extension system 100, in accordance with an embodiment of the present disclosure. This configuration in FIG. 2 depicts the grip 115 at least partially enclosed around the first lumen 105 and the second lumen 110 of the multi-lumen extension system 100. In the side cross-sectional view of the multi-lumen extension system 100 depicted in FIG. 2, the grip 115 may be positioned at any distance along the first lumen 105 and the second lumen 110. The configuration depicted in FIG. 1 depicts the placement of the grip 115 at the proximal-most end of the multi-lumen extension system 100. However, it should be understood that the placement of the grip 115 in FIG. 1 is merely an example location relative to the first lumen 105 and the second lumen 110, and that the situation shown in FIG. 2 may be along any location of the first lumen 105 and the second lumen 110. In certain embodiments, the multi-lumen tube 145 may include spaces along the length of the multi-lumen extension tube 145 that form the first lumen 105 and the second lumen 110. However, it is understood that the multi-lumen tube 145 may also be separate tubing formed around or coaxial with the first lumen 105 and the second lumen 110, both of which have separate tubing, as described above in connection with FIG. 1. Section line "A" indicates that the patency device 125 moves coaxially within the second lumen 110. The first lumen 105 also moves generally parallel to the second lumen 110 and its patency device 125.

[0051] The grip 115 may include a number of fingers 160 protruding from the grip 115. The fingers 160 may be interfaced well with the grip 115 such that the physician may use the grip 115 toward or away from the distal end 140 of the multi-lumen extension system 100 to selectively extend and retract the patency device 125 disposed within the second lumen 110.

[0052] FIG. 2 also depicts section line "B." Section line "B" depicts the state of the multi-lumen extension system 100 in FIG. 3, as shown, in one embodiment. FIG. 3 is a front cross-sectional view of a multi-lumen extension system in accordance with an embodiment of the present disclosure. FIG. 3 particularly depicts a cross-sectional view of the second lumen 110, which houses the patency device 125 therein. Because the patency device 125 is maintained within the second lumen 110 in this embodiment, the grip 115 may be configured to interface with the patency device 125 through the outer wall of the second lumen 110. In the particular embodiment depicted in FIG. 3, the patency device 125 comprises a hub 165 having a surface that interfaces or engages with a plurality of ball bearings 170. While the embodiments depicted herein describe the use of ball bearings 170, the present disclosure contemplates the use of other types of devices, such as rollers and other low-friction sliding surfaces, and the present disclosure contemplates the use of these various alternative devices without departing from the scope of the principles described herein. In the embodiment shown in FIG. 3, the surface of the hub 165 of the patency device 125 that interfaces with the ball bearing 170 may include a recessed portion adapted to interface with the ball bearing 170.

[0053] In one embodiment, ball bearing 170 is disposed along the outer wall of second lumen 110 such that ball bearing 170 presses against the outer wall of second lumen 110 via compression from grip 115, which is coaxially formed around at least second lumen 110. The surface of hub 165 disposed around patency device 125 may conform to the spherical surface of ball bearing 170 such that movement of ball bearing 170 along the outer wall of second lumen 110 by grip 115 moves the surface of hub 165 and attached patency device 125 within second lumen 110. The direction of movement of grip 115, ball bearing 170, surface of hub 165, and patency device 125 may be in the direction indicated by bidirectional arrow 175. As described herein, second lumen 110 may include a vent to allow air to escape from second lumen 110 as hub 165 passes through second lumen 110. In some embodiments, the interface between the second lumen and the ball bearing 170 may form a seal with the grip 115. Upon movement of the seal between the hub 165 and the ball bearing 170, air may be compressed within the second lumen 110, and the air may escape through the vent.

[0054] In some embodiments, grip 115 may include a quantity of lubricant disposed near ball bearing 170 to facilitate movement of grip 115 along second lumen 110. In certain embodiments, lubricant may be disposed along the interface between ball bearing 170 and the outer wall of second lumen 110 and / or the interface between ball bearing 170 and the inner surface of grip 115. In some embodiments, lubricant may be disposed between hub 165 and the inner diameter of second lumen 110.

[0055] Figure 4 is a front cross-sectional view of a multi-lumen extension system according to an embodiment of the present disclosure. Similar to Figure 3, Figure 4 is a front cross-sectional view of a multi-lumen extension system according to an embodiment of the present disclosure taken along section "B" shown in Figure 2. In this embodiment shown in Figure 4, grip 115 may include more ball bearings than shown in Figure 3; specifically, four ball bearings 170.

[0056] The surface of the hub 165 of the patency device 125 shown in Figure 4 is interfaced with four ball bearings 170, with the ball bearings 170 surrounding the surface rather than being located within a recessed portion as shown in Figure 3. Figure 4 shows the patency device 125 interface as being recessed, such that the ball bearings 170 surround the surface of the hub 165 of the patency device 125.

[0057] In one embodiment, ball bearing 170 is disposed along the outer wall of second lumen 110 such that ball bearing 170 presses against the outer wall of second lumen 110 via compression from grip 115, which is coaxially formed around at least second lumen 110. The surface of hub 165 disposed around patency device 125 may conform to the spherical surface of ball bearing 170 such that movement of ball bearing 170 along the outer wall of second lumen 110 by grip 115 moves the surface of hub 165 and attached patency device 125 within second lumen 110. The direction of movement of grip 115, ball bearing 170, surface of hub 165, and patency device 125 may be in the direction indicated by bidirectional arrow 175.

[0058] In some embodiments, grip 115 may include a quantity of lubricant disposed near ball bearing 170 to facilitate movement of grip 115 along second lumen 110. In certain embodiments, lubricant may be disposed along the interface between ball bearing 170 and the outer wall of second lumen 110 and / or the interface between ball bearing 170 and the inner surface of grip 115.

[0059] FIG. 5 is a side cross-sectional view of a multi-lumen extension system according to an embodiment of the present disclosure. Similar to FIG. 2, FIG. 5 is a cross-sectional view according to an embodiment of the present disclosure. In the side cross-sectional view of the multi-lumen extension system 100 shown in FIG. 5, the grip 115 may be positioned at any distance along the first lumen 105 and the second lumen 110. The state shown in FIG. 1, for example, illustrates the placement of the grip 115 at the proximal-most end of the multi-lumen extension system 100. However, it should be understood that the placement of the grip 115 in FIG. 1 is merely an exemplary location relative to the first lumen 105 and the second lumen 110, and that the state shown in FIG. 5 may be along any location of the first lumen 105 and the second lumen 110. In the embodiment shown in FIG. 5, the patency device 125 may include a surface of the hub 165 having three separate concave portions, each interfacing with a ball bearing 170. In this embodiment, the surface of hub 165 may form a three-lobed surface of hub 165 that retains ball bearings 170 between grip 115 and the outer wall of second lumen 110. However, the present disclosure contemplates that any number of ball bearings 170 may be interfaced in any manner with the surface of hub 165 of patency device 125 through the outer wall of second lumen 110.

[0060] 6 is a perspective view of a multi-lumen extension system 100 according to an embodiment of the present disclosure. In this embodiment, the grip 115 may include a concave surface that allows a physician or other HCP to engage the grip 115 to move the grip 115, hub 165, ball bearing 170, and patency device 125 along the length of the second lumen 110.

[0061] 6, the surface of hub 165 of patency device 125 may be concave to receive ball bearing 170 as described herein. In some embodiments, a quantity of lubricant may be disposed near ball bearing 170 to facilitate movement of grip 115 along second lumen 110. In certain embodiments, lubricant may be disposed along the interface between ball bearing 170 and the outer wall of second lumen 110 and / or the interface between ball bearing 170 and the inner surface of grip 115.

[0062] 6 illustrates an embodiment in which the grip 115 completely and coaxially surrounds the second lumen 110. In this embodiment, the first lumen 105 may be spaced apart from the second lumen 110 with a non-multi-lumen tube 145 formed coaxially around the first lumen 105 and the second lumen 110. However, the present description contemplates that the grip 115 may be formed partially around the second lumen 110, with the second lumen 110 generally aligned parallel to the first lumen 105, and housed within the multi-lumen tube 145 as described in some embodiments herein.

[0063] 7 is a cross-sectional perspective view of a multi-lumen extension system 100 according to an embodiment of the present disclosure. FIG. 7 shows a grip 115 interfacing with a surface of the hub 165 via a ball bearing 170 and passing through the second lumen 110. In this embodiment, the grip 115 coaxially surrounds the second lumen 110. Similar to FIG. 6, the first lumen 105 may be spaced apart from the second lumen 110 with a non-multi-lumen tube 145 formed coaxially around the first lumen 105 and the second lumen 110.

[0064] 7 illustrates the placement of lubricant 180 by hub 165 of patency device 125 in one embodiment. In this embodiment, lubricant 180 may spread throughout the hollow space of second lumen 110 upon movement of hub 165 and patency device 125 within second lumen 110. In this embodiment, a seal (not shown) is disposed at the distal end of second lumen 110 to prevent any lubricant disposed within the hollow space of second lumen 110 from escaping second lumen 110 and contaminating blood samples received at the distal end of second lumen 110 or infusion fluids, such as normal saline solution, various medications, and total parenteral nutrition, exiting the distal end of first lumen 105. In one embodiment, lubricant 180 may be disposed on or around ball bearing 170 disposed between the outer surface of second lumen 110 and grip 115. In this embodiment, any number of seals may be coupled to grip 115 to contain lubricant 180 between the grip and ball bearing 170, with little or no lubricant 180 spreading along the outer surface of second lumen 110 during actuation of grip 115 by the physician. Lubricant 180 may be located in multiple locations to facilitate easy movement of grip 115 along the length of second lumen 110, and this description contemplates these multiple locations.

[0065] 8 is a front cross-sectional view of a multi-lumen extension system 100 according to an embodiment of the present disclosure. In this embodiment, the hub 165 of the patency device 125 is magnetized and, in some embodiments, may be made from a ferromagnetic material that is magnetized and secured to the proximal end of the patency device 125. In this embodiment, the hub 165 may be maintained in position within the second lumen 110 through the use of a grip 115 that is also magnetized or formed from a magnetized ferromagnetic material.

[0066] In one embodiment, grip 115 may be a ring of ferromagnetic material that is magnetized to attract or repel magnetized hub 165 in all directions coaxially from hub 165. Because magnetized hub 165 attracts or repels hub 165 in all coaxial angles from hub 165, hub 165 may be maintained in a central position within second lumen 110 where hub 165 has a radial dimension smaller than the inner hollow of second lumen 110, as shown in FIG. 8. Movement of hub 165 and patency device 125 may be achieved through movement of grip 115 in the direction indicated by the double arrow, as described herein.

[0067] 9 is a side view of a rigid multi-lumen extension system 200 according to an embodiment of the present disclosure. In one embodiment, the rigid multi-lumen extension system 200 includes a first lumen 205 and a second lumen 210. Unlike FIG. 1 , the rigid multi-lumen extension system 200 is constructed from a rigid material such that the first lumen 205 and the second lumen 110 are formed therethrough. The first lumen 205 may be formed along the entire length of the rigid multi-lumen extension system 200 from the proximal end of the rigid multi-lumen extension system 200 to the distal end of the rigid multi-lumen extension system 200, where, in one embodiment, the first lumen 205 is fluidly coupled to an IV device, for example, via a male connector as described herein. The embodiments shown herein may refer to the rigid multi-lumen extension system 200 as being constructed from a rigid material. However, this specification contemplates the use of a variety of other materials, whether rigid, semi-rigid, or flexible, without going beyond the scope of the principles described herein.

[0068] The rigid multi-lumen extension system 200, in the embodiment shown in FIG. 9, includes an open second lumen 210. Unlike FIG. 1, the rigid multi-lumen extension system 200 is made from a rigid material, so the walls of the open second lumen 210 may remain in place so that they do not collapse thereon. The open second lumen 210 may be a non-fluidic path that allows a grip (not shown) to access a patency device 125 (not shown) formed within the second lumen 210. In this embodiment, the grip may be mechanically coupled to the patency device such that movement of the grip along the length of the second lumen 210 also moves the patency device within the second lumen 210. The rigidity of the rigid multi-lumen extension system 200 may allow a physician to hold the rigid multi-lumen extension system 200 with one hand while actuating the grip 215.

[0069] To allow for mechanical coupling of a grip to the hub of the patency device, the second lumen 210 may include a via 905 formed longitudinally through the second lumen 210. The via 905 may be sized for an arm to pass therethrough that couples the grip to the hub.

[0070] 10 is a side view of a rigid multi-lumen extension system 200 according to an embodiment of the present disclosure. The rigid multi-lumen extension system 200 in this embodiment may include a grip 215 that surrounds the length of the rigid multi-lumen extension system 200. In the embodiment of FIG. 10, the rigid multi-lumen extension system 200 includes a first lumen 205 and a second lumen 210. The first lumen 205 may be formed along the entire length of the rigid multi-lumen extension system 200 from the proximal end of the rigid multi-lumen extension system 200 to the distal end of the rigid multi-lumen extension system 200, where in some embodiments, the first lumen 205 is fluidly coupled to an IV device, for example, via a male connector, as described herein.

[0071] 10 shows an open second lumen 210 with a via 1005. In this embodiment, the grip 215 has an arm 1010 extending through the via 1005 and is attached to the hub 265 of the patency device (not shown). The arm 1010 may, in some embodiments, form part of an integrally formed grip 215 that includes the patency device, the hub 265 of the patency device, the arm 1010, and the grip 215 as one piece, as shown in FIG.

[0072] The grip 215 and the rigid multi-lumen extension system 200 may have a generally oval shape when viewed in cross section as shown in Figure 10. However, the present description contemplates that other shapes and configurations of the hub 265 and the rigid multi-lumen extension system 200 may be formed.

[0073] 11 is a side cross-sectional view of a rigid multi-lumen extension system 200 according to an embodiment of the present disclosure. In this embodiment, the rigid multi-lumen extension system 200 may include a grip 215 that surrounds the length of the rigid multi-lumen extension system 200. In the embodiment of FIG. 11, the rigid multi-lumen extension system 200 includes a first lumen 205 and a second lumen 210. The first lumen 205 may be formed along the entire length of the rigid multi-lumen extension system 200 from the proximal end of the rigid multi-lumen extension system 200 to the distal end of the rigid multi-lumen extension system 200, where, in some embodiments, the first lumen 205 is fluidly coupled to an IV device, for example, via a male connector, as described herein.

[0074] Figure 11 shows the via 11 11 shows an open second lumen 210 with a via 1105. In this embodiment, grip 215 has arms 1110 extending through vias 1105 and attached to a hub 265 of a patency device (not shown). Arms 1110 may, in some embodiments, form part of an integrally formed grip 215 comprising the patency device, patency device hub 265, arms 1110 and grip 215 as one piece, as shown in FIG.

[0075] The grip 215 and the rigid multi-lumen extension system 200 may have a generally circular shape when viewed in cross section as shown in Figure 11. However, the present description contemplates that other shapes and configurations of the hub 265 and the rigid multi-lumen extension system 200 may be formed.

[0076] 12 is a side cross-sectional view of a rigid multi-lumen extension system 200 according to an embodiment of the present disclosure. In this embodiment, the rigid multi-lumen extension system 200 may include a grip 215 that partially surrounds the length of the rigid multi-lumen extension system 200. In the embodiment of FIG. 12, the rigid multi-lumen extension system 200 includes a first lumen 205 and a second lumen 210. The first lumen 205 may be formed along the entire length of the rigid multi-lumen extension system 200 from the proximal end of the rigid multi-lumen extension system 200 to the distal end of the rigid multi-lumen extension system 200, where, in some embodiments, the first lumen 205 is fluidly coupled to an IV device, for example, via a male connector, as described herein.

[0077] 12 shows an open second lumen 210 with a via 1205. In this embodiment, the grip 215 has an arm 1210 extending through the via 1205 and is attached to the hub 265 of the patency device (not shown). The arm 1210 may, in some embodiments, form part of an integrally formed grip 215 that includes the patency device, the hub 265 of the patency device, the arm 1210, and the grip 215 as one piece, as shown in FIG.

[0078] The grip 215 and the rigid multi-lumen extension system 200 may have a generally square shape when viewed in cross section as shown in Figure 11. However, the present description contemplates that other shapes and configurations of the hub 265 and the rigid multi-lumen extension system 200 may be formed.

[0079] 13 is a front view of a multi-lumen extension system 200 in accordance with an embodiment of the present disclosure. In the embodiment shown in FIG. 13, the rigid multi-lumen extension system 200 is coupled to the LLAD 230 at the proximal end of the rigid multi-lumen extension system 200, and is fluidly coupled to the proximal end 135 of the first lumen 105. Again, the embodiment shown herein may be referred to as a rigid multi-lumen extension system 200 made from a rigid material. However, this specification contemplates the use of a variety of other materials, whether rigid, semi-rigid, or flexible, without departing from the scope of the principles herein.

[0080] As disclosed herein, the multi-lumen extension system 200 may include a first lumen 205 and a second lumen 210. In some embodiments, the first lumen 205 may be a fluid pathway through which blood, fluid medication, normal saline solution, various medications, and / or infusion fluids such as total parenteral nutrition may pass. In some embodiments, the first lumen 205 may be fluidly coupled at a proximal end 235 of the first lumen 205 to a fluid source or LLAD 230, as described herein. The LLAD 230 may include a needle 255 for interfacing with a blood sample tubing, such as a VACUTAINER® blood sample collection tubing manufactured by Becton, Dickinson & Company. Although this description describes first lumen 205 as being fluidly connected to LLAD 230, this description contemplates that any fluid sampling device or fluid storage container may be connected to proximal end 235 of first lumen 205 so long as it samples blood or provides infusion fluids such as normal saline solution, various medications, and total parenteral nutrition, respectively.

[0081] In some embodiments, the first lumen 205 may be fluidly coupled to an IV device at the distal end 240 of the multi-lumen extension system 200 via the distal end 250 of the first lumen 205. The distal end 240 of the multi-lumen extension system 200 may comprise a connector used to couple the multi-lumen extension system 200 to an IV device. In some embodiments, the distal end 240 of the multi-lumen extension system 200 comprises a male adapter used to interface with a female component on an IV device. The male adapter may allow the distal end 250 of the first lumen 205 to exit into a hollow space formed within the male adapter. The distal end 240 of the multi-lumen extension system 200 may further comprise a number of coupling mechanisms for coupling the distal end 240 of the multi-lumen extension system 200 to an IV device, as described herein.

[0082] The multi-lumen extension system 200 may also include a second lumen 210. In embodiments such as that shown in FIG. 13, the second lumen 210 is generally parallel to the first lumen 205. In some embodiments, a multi-lumen tube 245 may be used to house the first lumen 205 and the second lumen 210. This multi-lumen tube 245 may be coaxially formed around the first lumen 205 and the second lumen 210, and these lumens 205, 210 may be configured in one location for access by a physician or other HCP. In this embodiment, the multi-lumen tube 245 may form part of a structure used to connect the first lumen 205 and the second lumen 210 to the distal end 240 of the multi-lumen extension system 200 and to a proximal end of the multi-lumen extension system 200, such as the proximal end 235 of the first lumen 205.

[0083] The multi-lumen extension system 200, in some embodiments, may include a grip 215. The grip 215 may be any device formed on the patency device 225 and operably coupled to a hub 265 coaxially disposed within the second lumen 210. The grip 215 may be manipulated by a physician or other HCP to selectively advance or move the patency device 225 within the second lumen 210 and cause a portion of the patency device 225 to extend out of the distal end 240 of the multi-lumen extension system 200. As described herein, the multi-lumen extension system 200 may be coupled to an IV device disposed within a patient's blood vessel. Advancement of the patency device 225 by manipulation of the grip 215 may cause the patency device 225 to extend out of the second lumen 210 and through any fluid pathways formed in the IV device to clear any obstructions or check the patency of the IV device. During operation of the multi-lumen extension system 200, the physician may selectively pull the grip 215 toward the distal end 240 of the multi-lumen extension system 200 to extend the patency device 225 out of the multi-lumen extension system 200. The physician may selectively pull the grip 215 toward the second lumen 210 and the proximal end 235 of the multi-lumen extension system 200 to retract the patency device 225 back into the second lumen 210 and then check patency or allow fluid movement through the multi-lumen extension system 200 via the first lumen 205.

[0084] In some embodiments, the multi-lumen extension system 200 may include a seal 220. The seal 220 may be used to fluidly seal the second lumen 210 from fluid passing through the first lumen 205 and through the distal end 240 of the multi-lumen extension system 200. As described herein and shown in FIG. 13 , the first lumen 205 and the second lumen 210 may be coupled together at a single point at the distal end 240 of the multi-lumen extension system 200. In some embodiments, the distal end 250 of the first lumen 205 may be fluidly coupled to the interior volume of a male adapter used to interface with a female adapter of an IV device. In some embodiments, the seal 220 may prevent any fluid contained within the interior volume of the male adapter from entering the second lumen 210, since the second lumen 210 serves as a non-fluidic path for the patency device 225 contained therein. In another embodiment, the multi-lumen extension system 200 does not include a seal 220, and the second lumen 210 may be used as a fluid pathway, for example, for passing a blood sample therethrough or for passing infusion fluids such as normal saline solution, various medications, and total parenteral nutrition.

[0085] As shown in FIG. 13 , the grip 215 may physically couple the first lumen 205 to the second lumen 210. This embodiment is shown in more detail in FIGS. 14 and 15 . FIG. 14 is a side view of the grip 215 according to an embodiment of the present disclosure. FIG. 15 is a perspective view of a multi-lumen extension system 200 according to an embodiment of the present disclosure. The grip 215 may include a first via 1415 through which the first lumen 205 may pass. The diameter of the first via 1415 may be sufficient to allow the first lumen 205 to slide therethrough without adding a sufficient amount of friction to increase the difficulty of moving the grip 215 along the first lumen 205.

[0086] Grip 215 may include a second via 1420. Second via 1420 may be sized to allow second lumen 210 to pass therethrough. The diameter of second via 1420 may be sufficient to allow second lumen 210 to slide therethrough without adding a sufficient amount of friction to increase the difficulty of moving grip 215 along second lumen 205.

[0087] Grip 215 may comprise a patency coupling device to allow a physician or other HCP to move patency device 225 within the second lumen. As shown in FIG. 15 , first lumen 205 and second lumen 210 are shown passing through first via 1415 and second via 1420, respectively. Grip 215 may be physically or operably coupled to patency device 225 within second lumen 210 as described herein. In this embodiment, grip 215 operatively secures first lumen 205 to second lumen 210 such that movement of grip 215 occurs only when both first lumen 205 and second lumen 210 pass through first via 1415 and second via 1420, respectively. Again, movement of the grip 215 causes the patency device 225 to move within the second lumen 210 and out of the rigid multi-lumen extension system 200, as described herein.

[0088] FIG. 16 is a front view of a multi-lumen extension system 100 having a patency device 125 disposed in a first state according to an embodiment of the present disclosure. FIG. 17 is a top plan view of a multi-lumen extension system 100 having a patency device 125 disposed in a second state according to an embodiment of the present disclosure. With reference to FIGS. 16 and 17 , the multi-lumen extension system 100 includes a first lumen 105 and a second lumen 110. In some embodiments, the first lumen 105 may be a fluid pathway through which blood, fluid medication, normal saline solution, various medications, and / or infusion fluids such as total parenteral nutrition may pass. In some embodiments, the first lumen 105 may be fluidly coupled to a fluid source at a proximal end 135 of the first lumen 105. In some embodiments, the proximal end 135 of the first lumen 105 may be coupled to an LLAD 130. The LLAD 130 may include a needle 155 for interfacing with a blood sample tube, such as, for example, a VACUTAINER® blood sample collection tube manufactured by Becton, Dickinson & Co. Although the present description describes the first lumen 105 as being fluidly connected to the LLAD 130, the present description contemplates that any fluid sampling device or fluid storage container may be connected to the proximal end 135 of the first lumen 105 so long as it samples blood or provides infusion fluids, such as normal saline solution, various medications, and total parenteral nutrition, respectively.

[0089] In some embodiments, the first lumen 105 may be fluidly coupled to an IV device at the distal end 140 of the multi-lumen extension system 100 via the distal end 150 of the first lumen 105. The distal end 140 of the multi-lumen extension system 100 may comprise a connector used to connect the multi-lumen extension system 100 to an IV device. In the particular embodiment shown in Figures 16 and 17, the distal end 140 of the multi-lumen extension system 100 comprises a male adapter used to interface with a female component on an IV device. The male adapter may allow the distal end 150 of the first lumen 105 to exit into a hollow space formed within the male adapter.

[0090] The distal end 140 of the multi-lumen extension system 100 may further comprise a number of mechanisms for connecting the distal end 140 of the multi-lumen extension system 100 to an IV device. While Figures 16 and 17 show the distal end 140 comprising a male adapter and a connection mechanism used to interface with a female adapter on a V device, the present description contemplates that other types of adapters (including female adapters) may be used to connect the distal end 140 of the multi-lumen extension system 100 on a V device.

[0091] The multi-lumen extension system 100 may also include a second lumen 110. In embodiments such as those shown in FIGS. 16 and 17, the second lumen 110 is generally parallel to the first lumen 105. In the embodiment shown in FIGS. 16 and 17, the distal ends of the first lumen 105 and the second lumen 110 may intersect at a location distal to a seal 120 formed at the distal end of the second lumen 110. In this embodiment, the patency device 125 may extend distally beyond the seal 120 rather than out of the multi-lumen extension system 100 in the first state shown in FIG. 16. In the second state shown in FIG. 17, the grip 115 may be moved toward the distal end 140 of the multi-lumen extension system 100, as described herein, so that the patency device 125 extends out of the multi-lumen extension system 100. The non-parallel or perpendicular arrangement of the first lumen 105 relative to the second lumen 110 may allow for manipulation of the multi-lumen extension system 100 to multiple locations. In this embodiment, a physician may manipulate the patency device 125 from a first location remote from the IV equipment coupled to the multi-lumen extension system 100 while simultaneously or subsequently manipulating the LLAD 130 and fluid first lumen 105 at a second location remote from the IV equipment. Each of the first lumen 105 and second lumen 110 may be secured to the patient's body via, for example, medical tape or another securement bandage.

[0092] The multi-lumen extension system 100, in some embodiments, may include a grip 115 formed in the second lumen 110. The grip 115 may be any device operably coupled to a patency device 125 formed within the second lumen 110 such that it can be manipulated by a physician or other HCP to check patency. The grip 115 may be manipulated by a physician or other HCP to selectively advance the patency device 125 within the second lumen 110, such that a portion of the patency device 125 extends out the distal end 140 of the multi-lumen extension system 100 and into an IV device positioned within a patient's blood vessel. Advancement of the patency device 125 by manipulation of the grip 115 may cause the patency device 125 to extend out of the second lumen 110 and through any fluid pathway formed in the IV device to clear any obstructions or check the patency of the IV device. During operation of the multi-lumen extension system 100, the physician may selectively pull the grip 115 toward the distal end 140 of the multi-lumen extension system 100 to extend the patency device 125 out of the multi-lumen extension system 100. The physician may pull the grip 115 toward the first lumen 105 and the proximal end 135 of the multi-lumen extension system 100 to retract the patency device 125 back into the second lumen 110, and then check patency or move fluid through the multi-lumen extension system 100 via the first lumen 105.

[0093] As described herein, grip 115 may be operably coupled to a hub (not shown) of patency device 125. In some embodiments, grip 115 may be magnetically coupled to the hub of patency device 125 through the use of ferromagnetic materials used for the hub and grip 115. In some embodiments, grip 115 may be physically advanced through the use of multiple ball bearings that interface with the surface of the hub. In this embodiment, multiple ball bearings may be positioned between grip 115 and the outer surface of second lumen 110 to interface with the surface of the hub and pull patency device 125 coaxially through the hub and second lumen 110, as described herein.

[0094] In some embodiments, second lumen 110 may be made from a clear plastic tube that allows a physician to view the advancement of patency device 125 through second lumen 110. Patency device 125, in some embodiments, may be made from a resilient, pliable material, such as a metal, that can bend to pass through second lumen 110 and into the fluid and mechanical pathways formed within the IV device.

[0095] In some embodiments, the multi-lumen extension system 100 may include a seal 120 disposed at the distal end of the second lumen 110. The seal 120 may be used to fluidly seal the second lumen 110 from fluid passing through the first lumen 105 and through the distal end 140 of the multi-lumen extension system 100. In certain embodiments, the distal end 150 of the first lumen 105 may be fluidly connected to the interior volume of a male adapter used to interface with a female adapter of an IV device. In certain embodiments, the seal 120 may prevent any fluid contained within the interior volume of the male adapter from entering the second lumen 110 because the second lumen 110 serves as a non-fluidic path for the patency device 125 to be contained therein. In another embodiment, the multi-lumen extension system 100 does not include a seal 120, and the second lumen 110 may be used as a fluid pathway, for example, for passing a blood sample therethrough or for passing infusion fluids such as normal saline solution, various medications, and total parenteral nutrition.

[0096] In certain embodiments, the second lumen 110 may include a coupling device 1600 that selectively secures the second lumen 110, including its patency device 125, to the remainder of the multi-lumen extension system 100. This coupling device 1600 may allow a physician to selectively use the patency device 125, release the coupling of the patency device 125 from the multi-lumen extension system 100, and replace the second lumen 110 with a fluid stop device or another type of non-fluid or fluid lumen. This increases the versatility of the multi-lumen extension system 100 by allowing a physician to interface with IV devices coupled with the multi-lumen extension system 100 in a myriad of ways.

[0097] In one embodiment, the first lumen 105 may be interfaced with a clamping device 185 that selectively prevents fluid from passing through the first lumen 105. In this embodiment, the clamping device 185 may be used to maintain pressure within the multi-lumen extension system 100 to prevent blood from flowing into the first lumen 105 or into the hollow space within the male adapter formed at the distal end 140 of the multi-lumen extension system 100.

[0098] 17 illustrates a second state of the multi-lumen extension system 100 with the patency device 125 extending out from the distal end 140 of the multi-lumen extension system 100, in accordance with an embodiment of the present disclosure. During operation of the multi-lumen extension system 100, the patency device 125 does not come into contact with the ambient air and may instead be delivered through a fluid and mechanical path formed within an IV device coupled to the male connector of the multi-lumen extension system 100. Because the patency device 125 is used to enter a patient's bloodstream or through a fluid path fluidly connected to a patient's blood vessel, the patency device 125 is maintained within the second lumen 110 until use with the IV device to prevent contamination of the patency device 125.

[0099] 18 is a side view of a patency device 125 extending from the distal end of an IV catheter 200 in accordance with an embodiment of the present disclosure. In this embodiment, the patency device 125 may include an end cap 190 and a spring wrap 195. In this example, the spring wrap 195 may be coaxially formed around the gate wire. While the embodiment shown herein depicts a certain type of gate wire and spring wrap 195, the present disclosure contemplates the use of any device that creates a fluid path in the catheter and improves patency, and the present disclosure contemplates the use of a variety of these other devices without departing from the scope of the principles described herein.

[0100] End cap 190 and spring wrap 195 may be formed over a portion of patency device 125 and may be used to remove objects from within IV catheter 200 during a patency check procedure. In one embodiment, when patency device 125 is deployed, spring wrap 195 allows any fluid to flow through IV catheter 200 and the patient's blood vessel, while end cap 190 may break up any blockages. Multiple spring wraps 195 of different types may be used, as described herein.

[0101] In some embodiments, the IV catheter 200 may include multiple diffusion ports 205 formed therein. In this embodiment, the diffusion ports 205 may allow fluid to flow through the IV catheter 200 while the patency device 125 is in place. While the spring winding 195 may allow fluid to flow through the IV catheter 200, the inclusion of the diffusion ports 205 may allow for the rapid infusion of infusion fluids such as normal saline solution, various medications, and total parenteral nutrition, or the passage of blood. Additionally, the diffusion ports 205 may allow fluid to flow outwardly from the central axis of the IV catheter 200 and the patency device 125.

[0102] The IV catheter 200 may be any type of catheter device that fluidly connects a patient's blood vessel to the multi-lumen extension system 100. In one embodiment, the IV catheter 200 is a BD Nexiva™ manufactured by Becton, Dickinson and Company. In one embodiment, the distal end of the IV catheter 200 may be asymmetric, symmetric, or any other shape that allows the patency device 125 to pass therethrough.

[0103] 19-25 are each a side view of a patency device 125 in accordance with an embodiment of the present disclosure. The illustrated embodiments of the patency device 125 each include a spring wrap 195 formed coaxially around the patency device 125. In the illustrated embodiment, the patency device 125 may include, among other configurations, a fixed spring wrap 195 whose pitch cannot be varied along the length of the patency device 125, a variable end cap 190 whose pitch can be varied along the length of the spring wrap 195, and a repeatable spring wrap 195 whose pitch repeats along the length of the spring wrap 195. When the patency device 125 exits the distal end of the IV catheter 200, each of these types of spring wraps 195 may allow fluid to pass therethrough in varying amounts through the IV catheter 200.

[0104] The embodiments of the patency device 125 shown in FIGS. 19-25 may or may not include an end cap 190. In some embodiments, the end cap 190 may prevent initial fluid flow through the IV catheter 200 until the end cap 190 is fully advanced out of the distal end of the IV catheter 200. In embodiments in which the patency device 125 does not include an end cap 190, fluid may be allowed to flow through the IV catheter 200 despite the presence of the patency device 125 within the IV catheter 200. This description contemplates that the patency device 125 may include any type of spring wrap 195 or end cap 190 arrangement to provide the features of the patency device 125 described herein. The embodiments shown in FIGS. 19-25 are merely illustrative and are not intended to limit the arrangement and features of the spring wrap 195, end cap 190, or patency device 125 described herein.

[0105] FIG. 26 is a flowchart illustrating a method 2600 of manufacturing a multi-lumen extension system according to an embodiment of the present disclosure. Method 2600 may include, at block 2605, forming a fluidic first lumen from a male vascular access device (VAD) coupler to a female Luer Lock Access Device (LLAD) at the distal end of the first lumen. As described herein, the first lumen is a fluidic lumen that allows for the substitution of a blood sample and / or the administration of fluids infused via an IV catheter into a patient's bloodstream, such as normal saline solution, various medications, and total parenteral nutrition. This specification describes a male VAD coupler formed at the distal end of the multi-lumen extension system. Alternative coupling devices are contemplated by this disclosure, and the embodiments shown herein are intended to be non-limiting examples. Furthermore, this disclosure describes an LLAD coupled to the proximal end of the first lumen. Again, alternative devices may be coupled to the proximal end of the first lumen, and these embodiments shown herein are intended to be non-limiting examples. For example, alternative devices may include a fluid delivery device and a sensor device.

[0106] Method 2600 may further include forming a non-fluidic lumen from the male VAD coupler to a female Luer Lock Access Device (LLAD) at block 2610. In some embodiments, the non-fluidic lumen may be physically coupled to the LLAD such that the fluidic lumen and the non-fluidic lumen are aligned parallel to one another. In some embodiments, the non-fluidic lumen may not be physically coupled to the LLAD such that the non-fluidic lumen is not aligned parallel to the fluidic lumen.

[0107] Method 2600 may further include forming a patency check device coaxially within the non-fluidic lumen at block 2615. The patency check device may be any type of device that may pass through the second lumen and through the fluid and mechanical pathways formed within the IV device. In one embodiment, the patency check device may be made from a guidewire that is coaxially formed within a spring winding and capped with an end cap.

[0108] Method 2600 begins at block 26. 20 A grip may be formed along the non-fluidic lumen and operably coupled to the patency check device to selectively advance the patency check device along the non-fluidic lumen. The grip may comprise any number of devices for operably coupling the grip to a hub formed on the proximal end of the patency device, which may comprise a magnetic device, a ball bearing, or a physically coupled arm used to move the patency device within the second lumen.

[0109] Again, it is understood that the embodiments of this application may be combined. For example, the embodiments of Figures 1-29 may be arranged to fit a particular use based on the type of activity being performed.

[0110] The presently described multi-lumen extension systems may enable the collection of blood samples, the delivery of fluid infusions into a patient's bloodstream, such as normal saline solution, various medications, and total parenteral nutrition, and the checking of the patency of an IV catheter that is fluidly and mechanically coupled to the multi-lumen extension system. The multi-lumen extension systems described herein improve the patency of the underlying VAD, optimize blood flow rates during collection, optimize the quality of sampled blood, improve workflow, and reduce the operational risks associated with IV catheters.

[0111] The multi-lumen extension systems described herein may provide a flexible extension tube with a dedicated fluid path lumen optimized for blood collection and a second lumen with atraumatic guidewire devices to improve patency of the indwelling catheter. The multi-lumen extension system may be scaled in length in embodiments where a non-rigid lumen is used. Furthermore, the dedicated fluid path may be optimized for use with catheters of a given length that require longer devices to extend beyond the tip of the catheter, and therefore a longer extension set. Having a flexible design also reduces the likelihood of IV catheter migration and complications related to site manipulation.

[0112] Multi-lumen extension systems are relatively more compact and have many of the advantages of extension sets when used with IV catheters. In some embodiments, multi-lumen extension systems may eliminate rigid housings and maintain flexibility when used, reducing the potential for catheter complications. In some embodiments, multi-lumen extension systems may include an integrated LLAD to improve workflow and reduce steps during blood collection. Multi-lumen extension systems may reduce medical waste (fewer components and less volume) and may fit more easily into sharps containers or medical waste containers.

[0113] All specific examples and conditional language used herein are intended for educational purposes to aid the reader in understanding the invention and the concepts of the inventor's contributions beyond the prior art, and should be construed without limitation to such specific examples and conditions. Although embodiments of the invention have been described in detail, it should be understood that various changes, substitutions, and alterations can be made without departing from the spirit and scope of the invention.

Claims

1. 1. A multi-lumen extension system comprising: a first lumen forming a fluid pathway within the multi-lumen extension system; a multi-lumen tube having a first lumen and a parallel second lumen that form a non-fluid pathway within the multi-lumen extension system; a patency device housed within the second lumen; a seal between the first lumen and the second lumen to prevent fluid from entering the second lumen from the first lumen; and a grip formed along the second lumen and operably coupled to the patency device housed within the second lumen for selectively moving the patency device along the second lumen; The grip includes a ring coaxially formed around the second lumen; a low-friction sliding surface formed between the ring and the outer wall of the second lumen; A multi-lumen extension system, wherein the patency device comprises a surface that engages a plurality of ball bearings such that movement of the ring causes movement of the patency device within the second lumen.

2. 10. The multi-lumen extension system of claim 1, wherein the first lumen and the second lumen are coaxially formed within the multi-lumen tube.

3. 3. The multi-lumen extension system of claim 2, wherein the second lumen comprises a gas vent for allowing gas to escape from the second lumen upon movement of the patency device.

4. 10. The multi-lumen extension system of claim 1, further comprising a Luer Lock Access Device (LLAD) operably coupled to the proximal end of the first lumen.

5. 10. The multi-lumen extension system of claim 1, wherein the patency device comprises a magnetic hub formed on a proximal end of the patency device.

6. 6. The multi-lumen extension system of claim 5, wherein the grip comprises a permanent magnetic ring coaxially formed around the second lumen and magnetically coupled to the magnetic hub such that movement of the permanent magnetic ring moves the patency device within the second lumen.

7. 10. The multi-lumen extension system of claim 1, wherein the grip is mechanically coupled to the proximal end of the patency device via a passage formed through the multi-lumen tube formed coaxially around the first lumen and the second lumen.

8. 8. The multi-lumen extension system of claim 7, wherein the grip comprises a passageway through which the first lumen passes.

9. The multi-lumen extension system of claim 1 , wherein a distal end of the second lumen is oriented non-parallel to a major axis of the first lumen.

10. 10. The multi-lumen extension system of claim 1, wherein the patency device is a guidewire coaxially formed within the second lumen.

11. 1. A method of manufacturing a multi-lumen extension system, comprising: forming a fluid lumen from a male vascular access device (VAD) connector to a female Luer Lock Access Device (LLAD) at the distal end of the multi-lumen tubing; forming a non-fluid lumen parallel to the fluid lumen within a multi-lumen tube extending from the male VAD connector to the female Luer Lock Access Device (LLAD) connector; forming a patency check device coaxially within the non-fluid lumen; and forming a grip along the multi-lumen tube that is movable along the multi-lumen tube, and operably connecting the grip to a patency check device such that any movement of the grip causes a corresponding movement of the patency check device along the non-fluid lumen; Forming a grip is forming a ring coaxially around the non-fluid lumen; and The method further comprising forming a plurality of ball bearings between the ring and an outer wall of the non-fluid lumen.

12. The method of claim 11 , wherein the fluid lumen and the non-fluid lumen are coaxially formed within a multi-lumen tube.

13. 12. The method of claim 11, further comprising forming a hub on the patency check device to engage a plurality of ball bearings such that movement of the ring moves the patency check device within the non-fluid lumen.

14. Forming a grip is forming a permanent magnetic ring coaxially around the non-fluid lumen; and The method of claim 11 , further comprising forming a magnetic hub at the proximal end of the patency check device.

15. 1. A vascular access device (VAD), comprising: an intravenous (IV) catheter insertable into a patient's blood vessel; 1. A multi-lumen extension system connectable to an IV catheter, comprising: a first lumen forming a first pathway within the multi-lumen extension system; a multi-lumen tube comprising a second lumen parallel to the first lumen, forming a second pathway within the multi-lumen extension system; a connector at a distal end of the multi-lumen tubing configured to connect the multi-lumen extension system to the IV catheter; a patency device housed within the second lumen; a grip formed along the second lumen and operably coupled to the patency device contained within the second lumen for selectively advancing the patency device along the second lumen and into the IV catheter; and a multi-lumen extension system comprising a Luer Lock Access Device (LLAD) operably coupled to the proximal end of the first lumen; The grip includes a ring coaxially formed around the second lumen; a plurality of ball bearings formed between the ring and the outer wall of the second lumen; A vascular access device (VAD), wherein the patency device comprises a surface that engages a plurality of ball bearings such that movement of the ring causes movement of the patency device within the second lumen.

16. 16. The vascular access device (VAD) of claim 15, wherein the grip comprises a permanent magnetic ring coaxially formed around the second lumen and magnetically coupled to the magnetic hub such that movement of the permanent magnetic ring moves the patency instrument within the second lumen.

17. 16. The vascular access device (VAD) of claim 15, wherein the patency device is a guidewire coaxially formed within the second lumen.

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