Multi-lumen extension system

Abstract

A multi-lumen extension system can include a first lumen forming a fluid passageway within the multi-lumen extension system, a second lumen forming a non-fluid passageway within the multi-lumen extension system, an access 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 handle formed along the second lumen and operatively coupled to the access device housed within the second lumen to selectively move the access device along the second lumen. The present application also relates to a method of manufacturing the multi-lumen extension system and a vascular access device.

Description

Technical Field

[0001] This application relates to the field of medical devices, and in particular to a multi-cavity extension system and its manufacturing method, as well as a vascular access device. Background Technology

[0002] Patency is the state or quality of fluid pathways within a patient's body that are not obstructed. Specifically, an intravenous (IV) device can have a degree of patency when fluids, such as blood or medications, can pass through it. During the use of an IV device, it is inserted into the patient's blood vessel, and in some embodiments, the needle is removed from the catheter while the catheter remains in the patient's blood vessel. In some cases, the IV device is left in the patient's blood vessel for up to 30 days or more. This is done to provide the clinician or other healthcare provider (HCP) with a continuous flow of blood to the patient during care. This continuous flow of blood to the patient allows the clinician or other healthcare provider to aspirate one or more blood samples or administer one or more infusion fluids, such as saline solution, various medications, and total parenteral nutrition, as appropriate.

[0003] However, the patency of an intravenous device can be compromised when it is placed inside a patient's blood vessel. Any blockage can persist and cause the device to malfunction, necessitating the insertion of another device. This can increase the trauma experienced by the patient and lead to other medical problems, such as inflammation of the blood vessels, and other complications.

[0004] The subject matter claimed herein is not limited to embodiments that address any shortcomings or operate only in environments such as those described herein. Rather, this background is provided to describe the environments in which the embodiments currently described may operate. Summary of the Invention

[0005] This disclosure generally relates to a multi-lumen extension system for engaging with an intravenous device, the multi-lumen extension system providing a fluid path to the intravenous device while also providing a patency instrument used to periodically check or improve the patency of the intravenous device while it is in a patient's blood vessel. In some embodiments, the multi-lumen extension system may include: a first lumen forming a fluid passage within the multi-lumen extension system; a second lumen forming a non-fluid passage within the multi-lumen extension system; a patency device housed within the second lumen; a seal between the first and second lumens to prevent fluid from entering the second lumen from the first lumen; and a handle formed along the second lumen and operatively coupled to the patency device housed within the second lumen to selectively displace the patency device along the second lumen.

[0006] In some embodiments, the handle is not physically and directly coupled to the patency device, thereby allowing the patency device to remain in a sealed environment during use and preventing the introduction of any contaminants. In some embodiments, during operation, a clinician or other healthcare provider can aspirate blood from the patient's bloodstream and provide infusion fluids, such as saline solution, various medications, and total parenteral nutrition, into the patient's bloodstream without manipulating the intravenous device itself. This is because the multi-lumen extension system described herein engages with the proximal end of the intravenous device while the distal end of the multi-lumen extension system is coupled to the intravenous device. This allows the intravenous device to be secured to the patient's body via, for example, medical tape or a fixation dressing, so that the intravenous device remains stationary when using the multi-lumen extension system. Therefore, the multi-lumen extension system will be placed outside the intravenous device while still allowing clinicians to aspirate blood from the intravenous device through the first lumen, inject infusion fluids such as saline solution, various drugs, and total parenteral nutrition into the patient's bloodstream through the first lumen, and introduce patency instruments into the intravenous device through the second lumen.

[0007] In some embodiments, the first and second lumens of the multi-lumen extension system are coaxially formed within the multi-lumen tube. This allows for a side-by-side arrangement of the first and second lumens to facilitate the organization of multiple lumens for easy access by the clinician.

[0008] In some embodiments, the handle of the multi-cavity extension system may include a ring coaxially formed around the second cavity and a plurality of ball bearings or other types of rollers formed between the ring and the outer wall of the second cavity for low-friction sliding, wherein the patency device includes a surface that engages the plurality of ball bearings to allow the patency device to move within the second cavity when the ring moves. In some embodiments described herein, the second cavity includes a vent hole that allows gas to escape from the second cavity when the patency device moves.

[0009] In some embodiments, the multi-lumen extension system may further include a Luer lock access device (LLAD) operatively coupled to the proximal end of the first lumen. This allows the Luer lock to be selectively engaged to the proximal end of the multi-lumen extension system for blood aspiration. Furthermore, in some embodiments, the proximal end of the first lumen may at least include a coupling device to allow the coupling of any type of blood infusion device or blood sampling device for administering, for example, saline solutions, various medications, and total parenteral nutrition infusion fluids, or for blood aspiration.

[0010] In some embodiments, the handle of the multi-cavity extension system may include a magnetic base formed at the proximal end of the patency device. With this magnetic base, the handle of the multi-cavity extension system may also include a permanent magnet ring formed coaxially around the second cavity and magnetically coupled to the magnetic base to move the patency device within the second cavity when the permanent magnet ring moves.

[0011] In some embodiments, the handle of the multi-cavity extension system is mechanically coupled to the proximal end of the patency device via a channel formed through a multi-cavity tube coaxially formed around the first and second cavities. In this embodiment, the mechanically coupled handle may include a channel through which the first cavity passes.

[0012] In one embodiment, the multi-lumen extension system may include a second lumen, which is generally perpendicular to or not parallel to the distal end of the main axis of the first lumen. This allows clinicians to access the first and second lumens from different locations separate from the intravenous device to which the multi-lumen extension system is connected.

[0013] As described herein, the multi-cavity extension system includes a second cavity in which a patency-enhancing device is contained. In these embodiments, the patency-enhancing device may be coaxially formed within the second cavity. In one embodiment, the patency-enhancing device is a guidewire or other patency-enhancing structure coaxially formed within the second cavity and moved within the second cavity using a handle as described herein.

[0014] It should be understood that the foregoing general description and the following detailed description are illustrative and explanatory, and do not limit the invention as claimed. It should be understood that the various embodiments are not limited to the arrangements and means shown in the accompanying drawings. It should also be understood that embodiments may be combined, other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the invention, unless so claimed. Therefore, the following detailed description should not be construed as restrictive. Attached Figure Description

[0015] Exemplary embodiments will be described and explained in further detail with reference to the accompanying drawings, wherein:

[0016] Figure 1 A perspective view of a multi-cavity extension system according to an embodiment of the present disclosure;

[0017] Figure 2 A side sectional view of a multi-cavity extension system according to an embodiment of the present disclosure;

[0018] Figure 3 A front sectional view of a multi-cavity extension system according to an embodiment of the present disclosure;

[0019] Figure 4 A front sectional view of a multi-cavity extension system according to an embodiment of the present disclosure;

[0020] Figure 5 A side sectional view of a multi-cavity extension system according to an embodiment of the present disclosure;

[0021] Figure 6 A perspective view of a multi-cavity extension system according to an embodiment of the present disclosure;

[0022] Figure 7 A cross-sectional perspective view of a multi-cavity extension system according to an embodiment of the present disclosure;

[0023] Figure 8 A front sectional view of a multi-cavity extension system according to an embodiment of the present disclosure;

[0024] Figure 9 A side view of a rigid multi-cavity extension system according to an embodiment of the present disclosure;

[0025] Figure 10 A side sectional view of a rigid multi-cavity extension system according to an embodiment of the present disclosure;

[0026] Figure 11 A side sectional view of a rigid multi-cavity extension system according to an embodiment of the present disclosure;

[0027] Figure 12 A side sectional view of a rigid multi-cavity extension system according to an embodiment of the present disclosure;

[0028] Figure 13 A front view of a multi-cavity extension system according to an embodiment of the present disclosure;

[0029] Figure 14 A side view of a handle according to an embodiment of the present disclosure;

[0030] Figure 15 A perspective view of a multi-cavity extension system according to an embodiment of the present disclosure;

[0031] Figure 16 A top view of a multi-cavity extension system according to an embodiment of the present disclosure;

[0032] Figure 17 A top view of a multi-cavity extension system according to an embodiment of the present disclosure;

[0033] Figure 18 A side view of a patency device extending from the distal end of an intravenous catheter according to an embodiment of the present disclosure;

[0034] Figure 19 A side view of a traversable device according to an embodiment of the present disclosure;

[0035] Figure 20 A side view of a traversable device according to an embodiment of the present disclosure;

[0036] Figure 21 A side view of a traversable device according to an embodiment of the present disclosure;

[0037] Figure 22 A side view of a traversable device according to an embodiment of the present disclosure;

[0038] Figure 23 A side view of a traversable device according to an embodiment of the present disclosure;

[0039] Figure 24 A side view of a patency device extending from a conduit according to an embodiment of the present disclosure;

[0040] Figure 25 A side view of a patency device extending from a conduit according to an embodiment of the present disclosure; and

[0041] Figure 26 A flowchart illustrating a method for manufacturing a multi-cavity extension system according to an embodiment of the present disclosure. Detailed Implementation

[0042] When used herein, the term "proximal" refers to the location on the needle of the intravenous therapy system that is closest to the clinician using the intravenous therapy system and furthest from the patient using the device during use. Conversely, the term "distal" refers to the location on the needle of the intravenous therapy system that is furthest from the clinician using the intravenous therapy system and closest to the patient using the intravenous therapy system during use.

[0043] When used herein, the terms “top,” “upward,” or “upward” refer to a position on the needle of the intravenous therapy system that is radially away from the longitudinal axis of the intravenous therapy system and away from the patient’s skin during use. Conversely, when used herein, the terms “bottom,” “downward,” or “downward” refer to a position on the needle of the intravenous therapy system that is radially away from the longitudinal axis of the device and towards the patient’s skin during use.

[0044] When used herein, the terms “in” or “inward” refer to the position of the needle relative to the intravenous therapy system, which during use faces inward toward the interior of the intravenous therapy system. Conversely, when used herein, the terms “outward” or “outwardly” refer to the position of the needle relative to the intravenous therapy system, which during use faces outward toward the exterior of the intravenous therapy system.

[0045] When used in this document, the term “formed” refers to the construction, creation, production, arrangement, or placement of an element.

[0046] In different embodiments, the same reference numerals may be used for the same elements in the accompanying drawings. Although the embodiments described herein are combined for use as intravenous therapy systems to receive blood samples or deliver medications into a patient's body, it should be understood that this intravenous therapy system can be applied to other medical devices in which it is desirable to insert needles and / or catheters into a patient's blood vessels. Furthermore, while many different forms of embodiments satisfy the embodiments of the described intravenous therapy system, certain embodiments are shown in the accompanying drawings and described in detail herein within the scope of this disclosure.

[0047] Figure 1 This is a perspective view of a multi-cavity extension system 100 according to an embodiment of the present disclosure. As described herein, the multi-cavity extension system 100 may include a first cavity 105 and a second cavity 110. In one embodiment, the first cavity 105 may be a fluid channel through which infusion fluids such as blood, flushing agents, saline solutions, various medications, and / or total parenteral nutrition can pass. In one embodiment, the first cavity 105 may be fluidly coupled to a fluid source at its proximal end 135. Figure 1In the specific example shown, the proximal end 135 of the first cavity 105 can be coupled to a Luer lock access device (LLAD) 130. The Luer lock access device 130 may include a needle 155 for engagement with, for example, a blood sample tube, such as those manufactured by Bickon, Dickinson and Company of Franklin Lake, New Jersey. Blood sample collection tube. Although this specification describes the first chamber 105 as fluidly connected to the Luer lock access device 130, it is contemplated that any fluid sampling device or fluid reservoir can be connected to the proximal end 135 of the first chamber 105 to sample blood or provide infusion fluids such as saline solution, various medications, and total parenteral nutrition.

[0048] In one embodiment, the first lumen 105 may be fluidly coupled to an intravenous device at the distal end 140 of the multi-lumen extension system 100 via its distal end 150. The distal end 140 of the multi-lumen extension system 100 may further include a connector for coupling the multi-lumen extension system 100 to the intravenous device. Figure 1 In the specific example shown, the distal end 140 of the multi-lumen extension system 100 includes a male adapter for engaging with a female member on an intravenous device. The male adapter allows the distal end 150 of the first lumen 105 to enter a hollow portion formed within the male adapter.

[0049] The distal end 140 of the multi-lumen extension system 100 may further include a plurality of connecting mechanisms for connecting the distal end 140 of the multi-lumen extension system 100 to an intravenous device. Although Figure 1 The distal end 140 is shown to include a male adapter for engaging with a female adapter on an intravenous device and a connection mechanism; however, this specification 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 intravenous device.

[0050] The multi-cavity extension system 100 also includes a second cavity 110. Figure 1In the illustrated embodiment, the second cavity 110 is generally parallel to the first cavity 105. In alternative embodiments, as described herein, the first cavity 105 and the second cavity 110 may be formed generally perpendicular to each other, wherein the distal end 150 of the first cavity 105 and the distal end 140 of the multi-cavity extension system 100 bisect the length of the first cavity 105 and / or the second cavity 110. In embodiments where the second cavity 110 is generally parallel to the first cavity 105, a multi-cavity tube 145 may be used to accommodate the first cavity 105 and the second cavity 110. This multi-cavity tube 145 may be formed coaxially around the first cavity 105 and the second cavity 110 such that the first cavity 105 and the second cavity 110 can be organized in a single location for access by a clinician or other healthcare provider. In this embodiment, the multi-cavity tube 145 may form part of a structure for connecting the first cavity 105 and the second cavity 110 to the distal end 140 of the multi-cavity extension system 100 and the proximal end of the multi-cavity extension system 100 (e.g., the proximal end 135 of the first cavity 105).

[0051] In some embodiments, the multi-lumen extension system 100 may include a handle 115. The handle 115 can be any device operatively coupled to a patency device 125 formed within a second lumen 110. The handle 115 can be actuated by a clinician or other healthcare provider to selectively advance the patency device 125 within the second lumen 110 and to extend a portion of the patency device 125 from the distal end 140 of the multi-lumen extension system 100. As described herein, the multi-lumen extension system 100 can be coupled to an intravenous device placed within a patient's blood vessel. Actuation of the handle 115 advances the patency device 125, thereby extending it from the second lumen 110 and through any fluid passages formed within the intravenous device to remove any obstructions or check patency within the vein. During operation of the multi-lumen extension system 100, the clinician can selectively drag the handle 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 clinician can also drag the handle 115 toward the second lumen 110 and the proximal end of the multi-lumen extension system 100 to retract the patency device 125 into the second lumen 110, allowing for subsequent patency checks or fluid transfer through the multi-lumen extension system 100 via the first lumen 105. Additionally, by dragging the handle 115 toward the second lumen 110 and the proximal end of the multi-lumen extension system 100, the patency device 125 is enclosed within the second lumen 110, ensuring that the patency device 125 remains within the first lumen 100 before dissociation of the multi-lumen extension system 100 from the intravenous device. This reduces the risk of blood from the patency device 125 being exposed to the outside of the multi-lumen extension system 100.

[0052] In one embodiment, the multi-cavity extension system 100 may include a seal 120. The seal 120 can be used to fluidly seal the second cavity 110 from fluid passing through the first cavity 105 and through the distal end 140 of the multi-cavity extension system 100. As described herein and in Figure 1 As shown, the first cavity 105 and the second cavity 110 can be joined together at a single point at the distal end 140 of the multi-cavity extension system 100. In one embodiment, the distal end 150 of the first cavity 105 can be fluidly coupled to the internal volume of a male adapter for engagement with a female adapter of an intravenous device. In one embodiment, because the second cavity 110 serves as a non-fluid channel for accommodating the patency device 125 therein, the seal 120 can prevent any fluid contained within the internal volume of the male adapter from entering the second cavity 110. In a separate embodiment, the multi-cavity extension system 100 does not include the seal 120, and the second cavity 110 can also be used as a fluid channel, for example, for the passage of blood samples or for the passage of infusion fluids such as saline solutions, various medications, and total parenteral nutrition.

[0053] In one embodiment, the second lumen 110 may include a plurality of markers indicating the position of the patency device 125 relative to the intravenous catheter. In a particular embodiment, the markers may indicate to the clinician where the handle 115 is positioned along the length of the second lumen 110 such that the patency device 125 passes completely or partially through the fluid passage formed within the intravenous catheter 200.

[0054] The first lumen 105 can be optimized to reduce hemolysis during blood aspiration. The inner diameter of the first lumen 105 and / or the second lumen 110 can be optimized to provide a sufficient flow rate of fluid. In one embodiment, the length and inner diameter of the first lumen 105 and / or the second lumen 110 can be selected based on one or more of the following: the specifications and / or length of a particular intravenous device, the construction of a particular intravenous device, or clinical settings.

[0055] The Poiseuille equation can be used to analyze fluid flow in a cavity with a tubular fluid passage running through it:

[0056]

[0057] Where ΔP is the change in pressure gradient over the entire length of the cavity, D and L are the diameter and length of the tubular fluid passage through the cavity, respectively, and μ is the viscosity of the fluid. For fluid resistance. Since μ is the viscosity of the fluid rather than part of the cavity geometry, the geometry factor G is defined. f So that R f (fluid resistance) is in In some embodiments, the first cavity 105 and / or the second cavity 110 may contain a cavity with a tubular fluid passage.

[0058] In some embodiments, the first cavity 105 and / or the second cavity 110 may have multiple tubular segments having lengths (L1, L2, L3) and inner diameters (D1, D2, D3), thus the geometric factors are:

[0059]

[0060] In some embodiments, the first cavity 105 and / or the second cavity 110 may have an inner diameter that varies along the length of the cavity, thus the geometric factor is:

[0061]

[0062] In some embodiments, the first cavity 105 and / or the second cavity 110 may have a non-circular cross-section. In this case, the geometric factors can be determined by measuring the flow rate (Q) using a fluid of known viscosity (μ) at a given pressure (ΔP).

[0063]

[0064] You can choose G f The value is designed to reduce the maximum shear stress of each intravenous device specification to be equal to or less than BD 21G (specification 21 from Becton Dickinson). UTLRATOUCH TM The maximum shear stress of the button blood collection device (available from Becton Dickinson & Company, Franklin Lake, New Jersey), which was previously considered the gold standard for blood aspiration. In some embodiments, when the intravenous device includes a catheter of specification 18 (18G), G f It can be equal to or greater than 3.83E+06(1 / in) 3 This can reduce wall shear stress and thus reduce hemolysis. In some embodiments, when the intravenous device includes a catheter of specification 20 (20G), G f It can be equal to or greater than 3.27E+06(1 / in) 3 This can reduce wall shear stress and thus reduce hemolysis. In some embodiments, when the intravenous device includes a catheter of specification 22 (22G), G f It can be equal to or greater than 3.33E+06(1 / in) 3 This can reduce wall shear stress and thus reduce hemolysis. In some embodiments, when the intravenous device includes a catheter of specification 24 (24G), G fIt can be equal to or greater than 1.50E+07(1 / in) 3 This can reduce wall shear stress and thus reduce hemolysis. In some embodiments, G f It can include another value. In some embodiments, G can be selected. f The value is set to reduce the maximum shear stress for each catheter specification to be equal to or less than BD 25G (specification 25 from Becton Dickinson). UTLRATOUCH TM Maximum shear stress of the button blood collection device (available from Becton Dickinson & Company, Franklin Lake, New Jersey).

[0065] In some embodiments, the blood collection system may include one or more of the following: an intravenous device (which may include an extension tube), 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 passage of the blood collection system may encompass the entire blood collection passage through which blood flows during blood collection. The system geometry factor G of the fluid passage of the blood collection system can be determined in a manner similar to that previously described. fs In some embodiments, the system geometry factor G is determined when the access device 125 may or may not be in the extended position. fs It can be equal to or greater than 7.34E+06(1 / in) 3 In some embodiments, G fs It may contain another value. In some embodiments, the system geometry factor G fs It can be 7.34E+06(1 / in) 3 Add or subtract 10%, 25%, 50%, or 75%. In some embodiments, G fs Another value can be included, selected based on the catheter's specifications and / or length.

[0066] The multi-lumen extension system 100 minimizes hemolysis during blood aspiration while also ensuring the patency of intravenous catheters connected to the multi-lumen extension system 100. The multi-lumen extension system optimizes blood flow rate during the blood collection process while improving the condition of intravenous catheters placed in the patient's vein.

[0067] Although this disclosure describes intravenous catheters, this specification contemplates that the intravenous catheter is a peripheral intravenous catheter (PIVC). In one embodiment, the peripheral intravenous catheter includes a needleless access connector (NAC) attached to a proximal patient access Luer port on a multi-lumen extension system. In another embodiment, the peripheral intravenous catheter includes a needleless access connector attached to a proximal patient access Luer port via a non-integrated vascular access device.

[0068] In one embodiment, the second chamber 110 may include a vent hole allowing air to pass through. In some embodiments, air may be compressed when the handle is used to pass the access device 125 through it. With the vent hole included, compressed air can escape from the second chamber 110.

[0069] Figure 1 Section line "A" is also shown. Section line "A" shows... Figure 2 A view depicted in one embodiment of the multi-cavity extension system 100. Figure 2 This is a side sectional view of a multi-cavity extension system 100 according to an embodiment of the present disclosure. Figure 2 The view shows a handle 115 that at least partially surrounds the first cavity 105 and the second cavity 110 of the multi-cavity extension system 100. Figure 2 In the side sectional view of the multi-cavity extension system 100 shown, the handle 115 can be placed at any distance along the first cavity 105 and the second cavity 110. Figure 1 The illustrated view shows the placement of the grip 115 at the nearest side end of the multi-cavity extension system 100. However, Figure 1 The placement of the handle 115 is merely an exemplary position relative to the first cavity 105 and the second cavity 110, and it should be understood that... Figure 2 The view shown can be anywhere along the first cavity 105 and the second cavity 110. In this particular example, the multi-cavity tube 145 includes a cavity forming the first cavity 105 and the second cavity 110 along the length of the multi-cavity tube 145. However, this specification contemplates that the multi-cavity tube 145 can be a separate tube formed around and coaxial with the first cavity 105 and the second cavity 110, which are combined as described above. Figure 1 All described herein contain separate tubes. Section line “A” shows that the patency device 125 extends coaxially within the second cavity 110. Moreover, the first cavity 105 extends generally parallel to the second cavity 110 and its patency device 125.

[0070] The handle 115 may also include a plurality of fingers 160 protruding from the handle 115. Clinicians can use the fingers 160 to better engage with the handle 115 so that clinicians can drag the handle 115 toward or away from the distal end 140 of the multi-cavity extension system 100 to selectively extend and retract the patency device 125 placed in the second cavity 110.

[0071] Figure 2 Section line "B" is also shown. Section line "B" shows... Figure 3 A view depicted in one embodiment of the multi-cavity extension system 100. Figure 3 This is a front sectional view of a multi-cavity extension system 100 according to an embodiment of the present disclosure. Figure 3 Specifically, the section of the second cavity 110 that houses the patency device 125 is shown. Because the patency device 125 is held within the second cavity 110 in this embodiment, the handle 115 is formed to engage the patency device 125 through the outer wall of the second cavity 110. Figure 3 In the specific example shown, the general-purpose device 125 includes a seat 165 that includes surfaces that connect and engage with a plurality of ball bearings 170. Although the embodiments presented herein describe the use of ball bearings 170, this specification contemplates the use of other types of devices, such as rollers and other low-friction sliding surfaces, without departing from the principles described herein. Figure 3 In the embodiment shown, the surface of the seat 165 of the general-purpose device 125 that engages with the ball bearing 170 may include a concave portion, which is mounted to engage with the ball bearing 170.

[0072] In one embodiment, the ball bearing 170 is positioned along the outer wall of the second cavity 110 such that the ball bearing 170 is pressed against the outer wall of the second cavity 110 by a push from a handle 115 formed at least coaxially around the second cavity 110. The surface of a seat 165 positioned around the facilitator 125 may conform to the spherical surface of the ball bearing 170 such that movement of the ball bearing 170 along the outer wall of the second cavity 110 by the action of the handle 115 causes movement of the surface of the seat 165 and the facilitator 125 to which the seat 165 is attached within the second cavity 110. The direction of movement of the handle 115, the ball bearing 170, the surface of the seat 165, and the facilitator 125 may be in the direction indicated by the double-headed arrow 175. As described herein, the second cavity 110 may include a vent that allows air to escape from the second cavity 110 as the seat 165 passes through it. In one embodiment, the interface between the second cavity and the ball bearing 170 can form a seal at the handle 115. As the seal moves between the seat 165 and the ball bearing 170, air may be compressed within the second cavity 110 and may escape through a vent.

[0073] In one embodiment, the handle 115 may contain a quantity of lubricant placed near the ball bearing 170 to allow the handle 115 to move along the second cavity 110. In a particular embodiment, the lubricant may be placed along the interface between the ball bearing 170 and the outer wall of the second cavity 110 and / or the interface between the ball bearing 170 and the inner surface of the handle 115. In one embodiment, the lubricant may also be contained between the seat 165 and the inner diameter of the second cavity.

[0074] Figure 4 This is a front sectional view of a multi-cavity extension system according to an embodiment of the present disclosure. Similar to... Figure 3 , Figure 4 According to embodiments of this disclosure Figure 2 The front sectional view of section line "B" shown. Figure 4 In the embodiment shown, the handle 115 may include a larger... Figure 3 The additional ball bearings 170 shown: specifically, four ball bearings 170.

[0075] Figure 4 The surface of the seat 165 of the facilitator 125 shown engages with four ball bearings 170, wherein the ball bearings 170 surround the surface rather than as shown Figure 3 The image shown is placed within the concave portion. Figure 4 The interface of the facilitator 125 shown is concave, such that the ball bearing 170 surrounds the surface of the seat 165 of the facilitator 125.

[0076] In one embodiment, the ball bearing 170 is positioned along the outer wall of the second cavity 110 such that the ball bearing 170 is pressed against the outer wall of the second cavity 110 by a push from a handle 115 formed at least coaxially around the second cavity 110. The surface of the seat 165, which is positioned around the dredging device 125, may conform to the spherical surface of the ball bearing 170 such that movement of the ball bearing 170 along the outer wall of the second cavity 110 via the handle 115 causes movement of the seat 165 and the dredging device 125 to which the seat 165 is attached within the second cavity 110. The direction of movement of the handle 115, the ball bearing 170, the seat 165, and the dredging device 125 may be as indicated by the double-headed arrow 175.

[0077] In one embodiment, the grip 115 may contain a certain amount of lubricant placed near the ball bearing 170 to allow the grip 115 to move along the second cavity 110. In a particular embodiment, the lubricant may be placed along the interface between the ball bearing 70 and the outer wall of the second cavity 110 and / or the interface between the ball bearing 170 and the inner surface of the grip 115.

[0078] Figure 5 This is a side sectional view of a multi-cavity extension system 100 according to an embodiment of the present disclosure. Similar to... Figure 2 , Figure 5 This is a cross-sectional view according to an embodiment of the present disclosure. Figure 5 In the side sectional view of the multi-cavity extension system 100 shown, the handle 115 can be positioned at any distance along the first cavity 105 and the second cavity 110. For example, Figure 1 The view shown illustrates the placement of the grip 115 at the nearest side end of the multi-cavity extension system 100. However, Figure 1 The placement of the handle 115 is merely an exemplary position relative to the first cavity 105 and the second cavity 110, and it should be understood that... Figure 5 The view shown can be taken at any position along the first cavity 105 and the second cavity 110. Figure 5 In the illustrated embodiment, the access device 125 may include a surface of a seat 165 having three separate concave portions, each engaging a ball bearing 170. In this embodiment, the surface of the seat 165 may be formed as a three-lobed surface that holds the ball bearing 170 between the handle 115 and the outer wall of the second cavity 110. However, this disclosure contemplates that any number of ball bearings 170 may be used to engage the surface of the seat 165 of the access device 125 in any manner through the outer wall of the second cavity 110.

[0079] Figure 6This is a perspective view of a multi-cavity 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 clinician or other healthcare provider to interact with the grip 115 to allow the grip 115, seat 165, ball bearing 170, and descent device 125 to move along the length of the second cavity 110.

[0080] exist Figure 6 In the illustrated embodiment, the surface of the seat 165 of the general-purpose device 125 may also be concave to receive the ball bearing 170 as described herein. In one embodiment, a quantity of lubricant may be placed near the ball bearing 170 to allow the handle 115 to move along the second cavity 110. In a particular embodiment, the lubricant may be placed along the interface between the ball bearing 170 and the outer wall of the second cavity 110 and / or the interface between the ball bearing 170 and the inner surface of the handle 115.

[0081] Figure 6 An embodiment is shown in which the handle 115 is coaxially and completely surrounding the second cavity 110. In this embodiment, the first cavity 105 may be separately disposed from the second cavity 110, wherein a multi-cavity tube 145 is not formed coaxially around the first cavity 105 and the second cavity 110. However, this specification contemplates that the handle 115 may be formed partially around the second cavity 110, wherein the second cavity 110 is generally parallel to the first cavity 105 and is received within the multi-cavity tube 145, as described in some embodiments herein.

[0082] Figure 7 This is a cross-sectional perspective view of a multi-cavity extension system 100 according to an embodiment of the present disclosure. Figure 7 The grip 115 is shown via a ball bearing 170 and through the surface of the engagement seat 165 of the second cavity 110. In this embodiment, the grip 115 is coaxially positioned around the second cavity 110. Similar to... Figure 6 The first cavity 105 can be set separately from the second cavity 110, wherein a multi-cavity tube 145 is not formed coaxially around the first cavity 105 and the second cavity 110.

[0083] In one embodiment, Figure 7The illustration shows the application of lubricant 180 via a seat 165 of the patency device 125. In this embodiment, lubricant 180 can spread throughout the entire hollow portion of the second cavity 110 as the seat 165 and the patency device 125 move within the second cavity 110. In this embodiment, a seal (not shown) is positioned at the distal end of the second cavity 110 to prevent any lubricant placed within the hollow portion of the second cavity 110 from escaping the second cavity 110 and from contaminating blood samples received at the distal end of the first cavity or infusion fluids exiting from the distal end of the first cavity, such as saline solutions, various medications, and total parenteral nutrition. In one embodiment, lubricant 180 may be applied at or around a ball bearing 170 positioned between the outer surface of the second cavity 110 and the handle 115. In this embodiment, any number of seals can be attached to the grip 115 to accommodate lubricant 180 between the grip 115 and the ball bearing 170, wherein little or no lubricant propagates along the outer surface of the second cavity 110 during actuation of the grip 115 by a clinician. The lubricant 180 can be disposed at multiple locations to facilitate easy movement of the grip 115 along the length of the second cavity 110, and such multiple locations are contemplated in this specification.

[0084] Figure 8 This is a front sectional view of a multi-cavity extension system 100 according to an embodiment of the present disclosure. In this embodiment, the seat 165 of the access device 125 is magnetized, and in one embodiment, it may be made of a ferromagnetic material, which is magnetized and fixed to the proximal end of the access device 125. In this embodiment, the seat 165 can be held in position within the second cavity 110 by using a handle 115 formed of a magnetized or also magnetized ferromagnetic material.

[0085] In one embodiment, the handle 115 may be a ring made of a ferromagnetic material, which has been magnetized to repel or attract the magnetized seat 165 in all directions coaxial with the seat 165. Due to the equal repulsion or attraction to the seat 165 at all coaxial angles from the seat 165, the magnetized seat 165 can be maintained in a central position within the second cavity 110, wherein the seat 165 has a radial dimension smaller than the internal hollow portion of the second cavity 110, such as... Figure 8 As shown in the diagram. The movement of the seat 165 and the access device 125 can be achieved by the movement of the handle 115 in the direction depicted by the double-headed arrow 175, as described herein.

[0086] Figure 9 This is a side view of a rigid multi-cavity extension system 200 according to an embodiment of the present disclosure. In one embodiment, the rigid multi-cavity extension system 200 includes a first cavity 205 and a second cavity 210. Figure 1Unlike other systems, the rigid multi-cavity extension system 200 is made of a rigid material such that the first cavity 205 and the second cavity 110 are formed of rigid material. The first cavity 205 can be formed along the entire length of the rigid multi-cavity extension system 200 from its proximal end to its distal end, wherein in one embodiment, the first cavity 205 is fluidly coupled to an intravenous device via, for example, a male connector as described herein. The embodiments presented herein may be referred to as the rigid multi-cavity extension system 200 being made of a rigid material. However, this specification contemplates that the use of various other rigid, semi-rigid, or flexible materials is not beyond the scope of the principles described herein.

[0087] exist Figure 9 In the illustrated embodiment, the rigid multi-cavity extension system 200 may include an open second cavity 210. Figure 1 Unlike other systems, the rigid multi-cavity extension system 200, being made of a rigid material, allows the walls of the second cavities 210 to remain in place without collapsing. The open second cavities 210 can be non-fluid channels that allow a handle (not shown) to approach a patency device (not shown) formed within the second cavity 210. In this example, the handle can be mechanically coupled to the patency device such that movement of the handle along the length of the second cavity 210 causes movement of the patency device within the second cavity 210 as well. The rigidity of the rigid multi-cavity extension system 200 allows a clinician to grip the rigid multi-cavity extension system 200 with one hand while actuating the handle 215.

[0088] To allow the handle to be mechanically attached to the seat of the access device, the second cavity 210 may include a through-hole 905 formed longitudinally through the second cavity 210. The through-hole 905 may be sized to allow an arm for attaching the handle to the seat to pass through it.

[0089] Figure 10 This is a side view of a rigid multi-cavity extension system 200 according to an embodiment of the present disclosure. In this embodiment, the rigid multi-cavity extension system 200 includes a handle 215 extending along the length of the rigid multi-cavity extension system 200. Figure 10 In one embodiment, the rigid multi-cavity extension system 200 includes a first cavity 205 and a second cavity 205. The first cavity 205 may be formed along the entire length of the rigid multi-cavity extension system 200 from the proximal end to the distal end of the rigid multi-cavity extension system 200, wherein in one embodiment the first cavity 205 is fluidly coupled to an intravenous device via, for example, a male connector as described herein.

[0090] Figure 10An open second cavity 210 including a through-hole 1005 is shown. In this embodiment, the handle 215 includes an arm 1010 that extends through the through-hole 1005 and is attached to a seat 265 of a facilitator (not shown). In one embodiment, the arm 1010 may be part of an integrally formed handle 215, which, as a single component, includes the facilitator, the seat 265 of the facilitator, the arm 1010, and the handle 215, as shown. Figure 10 As shown in the image.

[0091] When in such Figure 10 When viewed in the cross-sectional view shown, the handle 215 and the rigid multi-cavity extension system 200 may have an overall elliptical shape. However, this specification contemplates that other shapes and forms may be formed for the seat 265 and the rigid multi-cavity extension system 200.

[0092] Figure 11 This is a side sectional view of a rigid multi-cavity extension system 200 according to an embodiment of the present disclosure. In this embodiment, the rigid multi-cavity extension system 200 includes a handle 215 extending along the length of the rigid multi-cavity extension system 200. Figure 11 In one embodiment, the rigid multi-cavity extension system 200 includes a first cavity 205 and a second cavity 210. The first cavity 205 may be formed along the entire length of the rigid multi-cavity extension system 200 from the proximal end to the distal end of the rigid multi-cavity extension system 200, wherein in one embodiment, the first cavity 205 is fluidly coupled to an intravenous device via, for example, a male connector as described herein.

[0093] Figure 11 An open second cavity 210 including a through-hole 1105 is shown. In this embodiment, the handle 215 includes an arm 1110 that extends through the through-hole 1105 and is attached to a seat 265 of a facilitator (not shown). In one embodiment, the arm 1110 may be part of an integrally formed handle 215, which, as a single component, includes the facilitator, the seat 265 of the facilitator, the arm 1110, and the handle 215, as shown. Figure 11 As shown in the image.

[0094] When in such Figure 11 When viewed in the cross-sectional view shown, the handle 215 and the rigid multi-cavity extension system 200 can have a generally circular shape. However, this specification contemplates that other shapes and forms can be formed for the seat 265 and the rigid multi-cavity extension system 200.

[0095] Figure 12This is a side sectional view of a rigid multi-cavity extension system 200 according to an embodiment of the present disclosure. In this embodiment, the rigid multi-cavity extension system 200 includes a handle 215 that partially surrounds the length of the rigid multi-cavity extension system 200. Figure 12 In one embodiment, the rigid multi-cavity extension system 200 includes a first cavity 205 and a second cavity 210. The first cavity 205 may be formed along the entire length of the rigid multi-cavity extension system 200 from the proximal end to the distal end of the rigid multi-cavity extension system 200, wherein in one embodiment, the first cavity 205 is fluidly coupled to an intravenous device via, for example, a male connector as described herein.

[0096] Figure 12 An open second cavity 210 including a through-hole 1205 is shown. In this embodiment, the handle 215 includes an arm 1210 that extends through the through-hole 1205 and is attached to a seat 265 of a facilitator (not shown). In one embodiment, the arm 1210 may be part of an integrally formed handle 215, which, as a single component, includes the facilitator, the seat 265 of the facilitator, the arm 1210, and the handle 215, as shown. Figure 12 As shown in the image.

[0097] When in such Figure 12 When viewed in the cross-sectional view shown, the grip 215 and the rigid multi-cavity extension system 200 can have a generally square shape. In this embodiment, the first cavity 205 can extend outside the surrounding grip 215. However, this specification contemplates that other shapes and forms can be formed for the seat 265 and the rigid multi-cavity extension system 200.

[0098] Figure 13 This is a front view of a multi-cavity extension system 200 according to an embodiment of the present disclosure. Figure 13 In the illustrated embodiment, the rigid multi-cavity extension system 200 is coupled to the Luer lock passage device 230 at its proximal end and fluidly coupled to the proximal end 135 of the first cavity 105. Again, the embodiments presented herein may be referred to as the rigid multi-cavity extension system 200 being made of a rigid material. However, this specification contemplates the use of various other rigid, semi-rigid, or flexible materials without departing from the principles described herein.

[0099] As described herein, the multi-lumen extension system 200 may include a first lumen 205 and a second lumen 210. In one embodiment, the first lumen 205 may be a fluid channel through which blood, flushing agents, such as saline solutions, various medications, and / or total parenteral nutrition infusion fluids may pass. In one embodiment, the first lumen 205 may be fluidly coupled at its proximal end 235 to a fluid source or Luer lock access device 230, as described herein. The Luer lock access device 230 may include a needle 255 for engagement with, for example, a blood sample tube, such as those manufactured by Beckton Dickinson. Blood sample collection tube. Although this specification describes the first chamber 205 as fluidly connected to the Luer lock access device 230, this specification contemplates that any fluid sampling device or fluid reservoir may be connected to the proximal end 235 of the first chamber 205 to sample blood or provide infusion fluids such as saline solution, various medications, and total parenteral nutrition.

[0100] In one embodiment, the first lumen 205 may be fluidly coupled to an intravenous device at the distal end 240 of the multi-lumen extension system 200 via its distal end 250. The distal end 240 of the multi-lumen extension system 200 may also include a connector for coupling the multi-lumen extension system 200 to the intravenous device. In one example, the distal end 240 of the multi-lumen extension system 200 includes a male adapter for engaging a female member on the intravenous device. The male adapter may allow the distal end 250 of the first lumen 205 to enter a hollow portion formed within the male adapter. As described herein, the distal end 240 of the multi-lumen extension system 200 may further include a plurality of coupling mechanisms for coupling the distal end 240 of the multi-lumen extension system 200 to the intravenous device.

[0101] The multi-cavity extension system 200 also includes a second cavity 210. Figure 13 In the illustrated embodiment, the second lumen 210 is generally parallel to the first lumen 205. In one embodiment, a multi-lumen tube 245 may be used to accommodate the first lumen 205 and the second lumen 210. This multi-lumen tube 245 may be formed coaxially around the first lumen 205 and the second lumen 210 so that these lumens 205 and 210 can be organized in a single location for access by a clinician or other healthcare provider. In this embodiment, the multi-lumen tube 245 may form part of a structure for connecting the first lumen 205 and the second lumen 210 to the distal end 240 and the proximal end (e.g., the proximal end 235 of the first lumen 205) of the multi-lumen extension system 200.

[0102] In some embodiments, the multi-lumen extension system 200 may include a handle 215. The handle 215 may be any device operatively coupled to a seat 265 formed on the patency device 225 and coaxially disposed within the second lumen 210. The handle 215 may be actuated by a clinician or other healthcare provider to selectively advance or move the patency device 225 within the second lumen 210 and to extend a portion of the patency device 225 from 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 intravenous device placed within a patient's blood vessel. Actuating the handle 215 to advance the patency device 225 causes it to extend from the second lumen 210 and through any fluid passages formed in the intravenous device to remove any obstructions or check patency within the vein. During operation of the multi-chamber extension system 200, the clinician can selectively drag the handle 215 toward the distal end 240 of the multi-chamber extension system 200 to extend the patency device 225 out of the multi-chamber extension system 200. The clinician can also drag the handle 215 toward the first chamber 205 and the proximal end 235 of the multi-chamber extension system 200 to retract the patency device 225 into the second chamber 210 to allow subsequent patency checks or fluid delivery through the first chamber 205 via the multi-chamber extension system 200.

[0103] In one embodiment, the multi-cavity extension system 200 may include a seal 220. The seal 220 can be used to fluidly seal the second cavity 210 from fluid passing through the first cavity 205 and through the distal end 240 of the multi-cavity extension system 200. As described herein and Figure 13 As shown, the first cavity 205 and the second cavity 210 can be joined together at a location at the distal end 240 of the multi-cavity extension system 200. In one embodiment, the distal end 250 of the first cavity 205 can be fluidly coupled to the internal volume of a male adapter for engagement with a female adapter of an intravenous device. In one embodiment, because the second cavity 210 serves as a non-fluid channel for accommodating the patency device 225, the seal 220 can prevent any fluid contained within the internal volume of the male adapter from entering the second cavity 210. In a separate embodiment, the multi-cavity extension system 200 does not include the seal 220, and the second cavity 210 can also be used as a fluid channel, for example, for the passage of blood samples or infusion fluids such as saline solutions, various medications, and total parenteral nutrition.

[0104] like Figure 13 As shown, the handle 215 can physically connect the first cavity 205 to the second cavity 210. Figure 14 and 15 The embodiment is shown in further detail below. Figure 14A side view of a handle 215 according to an embodiment of the present disclosure. Figure 15 This is a perspective view of a multi-cavity extension system 200 according to an embodiment of the present disclosure. The handle 215 may include a first through-hole 1415 through which a first cavity 205 may pass. The diameter of the first through-hole 1415 may be sufficient to allow the first cavity 205 to slide through it without significantly increasing the amount of friction that could make it more difficult to move the handle 215 along the first cavity 205.

[0105] The handle 215 also includes a second through-hole 1420. The size of the second through-hole 1420 can be configured to allow the second cavity 210 to pass through it. The diameter of the second through-hole 1420 can be sufficient to allow the second cavity to slide through it without increasing a significant amount of friction that could make it more difficult to move the handle 215 along the second cavity.

[0106] The handle 215 may also include a patency coupling device that allows a clinician or other healthcare provider to move the patency device 225 within the second cavity. For example... Figure 15 As shown, the first cavity 205 and the second cavity 210 are shown passing through the first through-hole 1415 and the second through-hole 1420, respectively. As described herein, the handle 215 can be physically or operatively coupled to the descent device 225 within the second cavity 210. In this example, the handle 215 functionally secures the first cavity 205 to the second cavity 210 such that movement of the handle 215 occurs solely by allowing both the first cavity 205 and the second cavity 210 to pass through the first through-hole 1415 and the second through-hole 1420, respectively. Again, movement of the handle 215 causes the descent device 225 to move within the second cavity 210 and out of the rigid multi-cavity extension system 200, as described herein.

[0107] Figure 16 This is a top view of a multi-cavity extension system 100 according to an embodiment of the present disclosure, wherein the facilitator 125 is placed in a first state. Figure 17 This is a top view of a multi-cavity extension system 100 according to an embodiment of the present disclosure, wherein the facilitator 125 is positioned in a second state. (See reference...) Figure 16 and 17The multi-chamber extension system 100 may include a first chamber 105 and a second chamber 110. In one embodiment, the first chamber 105 may be a fluid channel through which infusion fluids such as blood, flushing agents, saline, various medications, and / or total parenteral nutrition can pass. In one embodiment, the first chamber 105 may be fluidly coupled to a fluid source at its proximal end 135. In one embodiment, the proximal end 135 of the first chamber 105 may be coupled to a Luer lock access device 130. The Luer lock access device 130 may include a needle 155 for engagement with, for example, a blood sample tube, such as those manufactured by Beckton Dickinson. Blood sample collection tube. Although this specification describes the first chamber 105 as fluidly connected to the Luer lock access device 130, this specification contemplates that any fluid sampling device or fluid reservoir may be connected to the proximal end 135 of the first chamber 105 to sample blood or provide infusion fluids such as saline solution, various medications, and total parenteral nutrition.

[0108] In one embodiment, the first lumen 105 may be fluidly coupled to an intravenous device (not shown) at the distal end 140 of the multi-lumen extension system 100 via its distal end 150. The distal end 140 of the multi-lumen extension system 100 may also include a connector for coupling the multi-lumen extension system 100 to the intravenous device. Figure 16 and 17 In the specific example shown, the distal end 140 of the multi-lumen extension system 100 includes a male adapter for engaging with a female member on an intravenous device. The male adapter allows the distal end 150 of the first lumen 105 to enter a hollow portion formed within the male adapter.

[0109] The distal end 140 of the multi-lumen extension system 100 may further include a plurality of connecting mechanisms for connecting the distal end 140 of the multi-lumen extension system 100 to an intravenous device. Although Figure 16 and 17 The distal end 140 is shown to include a male adapter for engaging with a female adapter on an intravenous device and a connection mechanism; however, this specification 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 intravenous device.

[0110] The multi-cavity extension system 100 further includes a second cavity 110. Figure 16 and 17 In the embodiment shown, the second cavity 110 is generally perpendicular to the first cavity 105. Figure 16 and 17In the example shown, the distal ends of the first cavity 105 and the second cavity 110 may intersect at a position distal to the seal 120 formed at the distal end of the second cavity 110. In this embodiment, the unobstructed access device 125 is in Figure 16 In the first state shown, it can extend beyond the seal 120 by a certain distance but does not extend out of the multi-cavity extension system 100. Figure 17 In the second state shown, as described herein, the patency device 125 extends from the multi-lumen extension system 100 when the handle 115 moves toward the distal end 140 of the multi-lumen extension system 100. The non-parallel or perpendicular orientation of the first lumen 105 relative to the second lumen 110 allows operation of the multi-lumen extension system 100 from multiple positions. In this embodiment, a clinician can operate the patency device 125 from a first position outside the intravenous device attached to the multi-lumen extension system 100, while simultaneously or sequentially operating the Luer lock access device 130 and the fluid first lumen 105 from a second position outside the intravenous device. Each of the first lumen 105 and the second lumen 110 can be secured to the patient's body via, for example, medical tape or other fixation dressings.

[0111] In some embodiments, the multi-lumen extension system 100 may include a handle 115 formed at a second lumen 110. The handle 115 can be any device operatively coupled to a patency device 125 formed within the second lumen 110 to allow patency checks by a clinician or other healthcare provider. The handle 115 can be actuated by a clinician or other healthcare provider to selectively advance the patency device 125 within the second lumen 110 and to extend a portion of the patency device 125 from the distal end 140 of the multi-lumen extension system 100 into an intravenous device placed within a patient's blood vessel. Actuation of the handle 115 advances the patency device 125, thereby extending it from the second lumen 110 and through any fluid passages formed within the intravenous device to remove any obstructions or check the patency of the intravenous device. During operation of the multi-chamber extension system 100, the clinician can selectively drag the handle 115 toward the distal end 140 of the multi-chamber extension system 100 to extend the patency device 125 out of the multi-chamber extension system 100. The clinician can also drag the handle 115 toward the first chamber 105 and the proximal end 135 of the multi-chamber extension system 100 to retract the patency device 125 into the second chamber 110 to allow subsequent patency checks or fluid transfer through the first chamber 105 into the multi-chamber extension system 100.

[0112] As described herein, the handle 115 is operatively coupled to a seat (not shown) of the access device 125. In one embodiment, the handle 115 may be magnetically coupled to the seat of the access device 125 using a ferromagnetic material for both the seat and the handle 115. In another embodiment, the handle 115 may be physically advanced using a plurality of ball bearings that engage with the surface of the seat. In this embodiment, as described herein, the plurality of ball bearings may be positioned between the handle 115 and the outer surface of the second cavity 110 to engage with the surface of the seat and to coaxially drag the seat and the access device 125 through the second cavity 110.

[0113] In one embodiment, the second lumen 110 may be made of a transparent plastic tube that allows a clinician to view the progress of the patency device 125 through the second lumen 110. In one embodiment, the patency device 125 may be made of a flexible material, such as metal, that can bend as it passes through the second lumen 110 and enters the fluid and mechanical channels formed within the intravenous device.

[0114] In one embodiment, 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 one embodiment, the distal end 150 of the first lumen 105 may be fluidly coupled to the internal volume of a male adapter for engagement with a female adapter of an intravenous device. In one embodiment, because the second lumen 110 serves as a non-fluid passage for housing the patency device 125, the seal 120 may prevent any fluid contained within the internal volume of the male adapter from entering the second lumen 110. In a separate embodiment, the multi-lumen extension system 100 may not include the seal 120, and the second lumen 110 may also serve as a fluid passage, for example, for the passage of blood samples or infusion fluids such as saline solutions, various medications, and total parenteral nutrition.

[0115] In one embodiment, the second lumen 110 may include a coupling device 1600 that selectively attaches the second lumen 110 and its patency device 125 to the remainder of the multi-lumen extension system 100. This coupling device 1600 allows clinicians to selectively: use the patency device 125; disconnect the patency device 125 from the multi-lumen extension system 100; and replace the second lumen 110 with a fluid-stopping device or other types of non-fluid or fluid lumens. This increases the versatility of the multi-lumen extension system 100 by allowing clinicians to engage intravenous devices connected to the multi-lumen extension system 100 in a variety of ways.

[0116] In one embodiment, the first cavity 105 may engage with a clamping device 185 that selectively prevents fluid from flowing through the first cavity 105. In this embodiment, the clamping device 185 may be used to maintain pressure within the multi-cavity extension system 100 so that blood does not flow into the first cavity 105 or into the hollow portion formed in the male adapter at the distal end 140 of the multi-cavity extension system 100.

[0117] Figure 17 The second state of the multi-lumen extension system 100 is shown, wherein the patency device 125 extends from the distal end 140 of the multi-lumen extension system 100. During operation of the multi-lumen extension system 100, the patency device 125 is not exposed to ambient air, but is fed through fluid and mechanical channels formed in the intravenous device connected to the male connector of the multi-lumen extension system 100. Because the patency device 125 is to be used to enter a patient's blood vessel or through the fluid channels fluidly connected to the patient's blood vessel, the patency device 125 is held within the second lumen 110 until use at the intravenous device to prevent contamination of the patency device 125.

[0118] Figure 18 This is a side view of a patency device 125 extending from the distal end of an intravenous catheter 200 according to an embodiment of the present disclosure. In this embodiment, the patency device 125 may include an end cap 190 and a spring winding 195. In this example, the spring winding 195 may be formed coaxially around a guidewire. Although the embodiments presented herein illustrate certain types of guidewires and spring windings 195, this specification contemplates that any device forming a fluid path into the catheter and improving patency may be used, and this specification contemplates the use of these various other devices without departing from the scope of the principles described herein.

[0119] End cap 190 and spring winding 195 may be formed on a portion of patency device 125 and can be used to remove objects from intravenous catheter 200 during patency testing procedures. In one embodiment, when patency device 125 is deployed, end cap 190 can break any obstruction while spring winding 195 allows flow of any fluid within intravenous catheter 200 and the patient's blood vessels. Various different types of spring winding 195 can be used as described herein.

[0120] In one embodiment, the intravenous catheter 200 may include a plurality of diffuser ports 205 formed therein. In this embodiment, the diffuser ports 205 allow fluid to pass through the intravenous catheter 200 when the patency device 125 is deployed. Although the spring winding 195 allows fluid to flow out of the intravenous catheter 200, the inclusion of diffuser ports 205 allows for faster infusion of infusion fluids such as saline solution, various medications, and total parenteral nutrition, or the passage of blood. Additionally, the diffuser ports 205 can induce outward flow of fluid away from the central axis of the intravenous catheter 200 and the patency device 125.

[0121] The intravenous catheter 200 can 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 intravenous catheter 200 is a BDNexiva manufactured by Becton Dickinson. TM In one embodiment, the distal end of the intravenous catheter 200 may be asymmetrical, symmetrical, or any other shape that allows the patency device 125 to pass through it.

[0122] Figures 19 to 25 Side views of a patency device 125 according to an embodiment of the present disclosure are shown. Each illustrated example of a patency device 125 includes a spring winding 195 coaxially formed around the patency device 125. In the illustrated embodiment, the patency device 125 may include: a fixed spring winding 195 with a constant pitch along the length of the patency device 125; a variable end cap 190 with a variable pitch along the length of the spring winding 195; and a repeating variable spring winding 195 with a repeating pitch along the length of the spring winding 195, and other configurations. Each of these types of spring windings 195 can allow fluid passing through the intravenous catheter 200 in various amounts as the patency device 125 exits the distal end of the intravenous catheter 200.

[0123] Figures 19 to 25 Embodiments of the patency device 125 shown may or may not include an end cap 190. In some embodiments, the end cap 190 may prevent initial flow of fluid through the intravenous catheter 200 until the end cap 190 has completely advanced away from the distal end of the intravenous catheter 200. In embodiments where the patency device 125 does not include an end cap 190, fluid flow through the intravenous catheter 200 may be permitted despite the presence of the patency device 125 within the intravenous catheter 200. This specification contemplates that the patency device 125 may include any type of spring winding 195 or end cap 190 configuration to provide the features of the patency device 125 as described herein. Figures 19 to 25The examples presented herein are merely illustrative and are not intended to limit the orientation and features of the spring winding 195, end cap 190, or facilitator 125 as described herein.

[0124] Figure 26 This is a flowchart illustrating a method 2600 for manufacturing a multi-lumen extension system according to an embodiment of the present disclosure. Method 2600 may include, at block 2605, forming a fluid first lumen from a posterior vascular access device (VAD) connector at the distal end of a first lumen to a posterior lumen lock access device (LLAD). As described herein, the first lumen is a fluid lumen that allows for the retrieval of blood samples via an intravenous catheter and / or the administration of infusion fluids such as saline solution, various medications, and total parenteral nutrition into the patient's bloodstream. This specification describes a posterior vascular access device connector formed at the distal end of the multi-lumen extension system. Alternative connectors are also contemplated in this disclosure, and the embodiments presented herein are non-limiting examples. Additionally, this disclosure describes a lumen lock access device 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 presented herein are non-limiting examples. For example, alternative devices may include fluid delivery devices and sensor devices.

[0125] Method 2600 may further include forming a non-fluidic cavity at block 2610 from the male vascular access device connector to the female Luerlock access device (LLAD) connector. In one embodiment, the non-fluidic cavity may be physically coupled to the Luerlock access device such that the fluid cavity and the non-fluidic cavity are parallel to each other. In one embodiment, the non-fluidic cavity is not physically coupled to the Luerlock access device, thereby allowing the non-fluidic cavity to be non-parallel to the fluid cavity.

[0126] Method 2600 may further include forming a patency testing device coaxially within a non-fluid cavity at block 2615. The patency testing device can be any type of device that can pass through the second cavity and through fluid and mechanical channels formed within the intravenous device. In one embodiment, the patency testing device may be made of a guidewire coaxially formed within a spring winding and covered by an end cap.

[0127] Method 2600 may include forming a handle along a non-fluid cavity at block 2620 and operatively coupling the handle to a patency testing device to selectively advance the patency testing device along the non-fluid cavity. The handle may include any number of devices for operatively coupling the handle to a seat formed at a proximal end of the patency testing device. This may include a magnetic device, a ball bearing, or a physically coupled arm for moving the patency testing device within a second cavity.

[0128] Again, it should be understood that embodiments of the present invention can be combined. As an example, Figure 1-26 Implementations can be arranged to suit a specific purpose based on the type of action being performed.

[0129] The currently described multi-lumen extension system allows for the collection of blood samples, the delivery of infusion fluids such as saline solution, various medications, and total parenteral nutrition into the patient's bloodstream, and the patency testing of intravenous catheters fluidly and mechanically connected to the multi-lumen extension system. The multi-lumen extension system described herein improves the patency of indwelling vascular access devices, optimizes blood flow rate during collection, optimizes the quality of collected blood samples, improves workflow, and reduces the risk of manipulation associated with intravenous catheter complications.

[0130] The multi-lumen extension system described herein can provide a flexible extension tube with a dedicated fluid path lumen optimized for blood collection, and a second lumen containing a non-invasive guidewire instrument to improve the patency of indwelling catheters. In embodiments that do not use rigid lumens, the length of the multi-lumen extension system can be scaled proportionally. Additionally, the dedicated fluid path can be optimized for use with catheters of a given length that require longer instruments beyond the catheter tip and therefore necessitate longer extension devices. This flexible design also reduces the likelihood of intravenous catheter movement and site-related manipulation complications.

[0131] When used with intravenous catheters, multi-lumen extension systems are also relatively more compact and offer many of the advantages of extension devices. In some embodiments, multi-lumen extension systems can eliminate a rigid housing and remain flexible to reduce the likelihood of catheter complications during use. In some embodiments, multi-lumen extension systems may include an integrated Luer lock access device to improve workflow and reduce steps during blood aspiration. Multi-lumen extension systems also reduce medical waste (fewer components and less volume) and can be more easily installed in sharps containers or medical waste containers.

[0132] All examples and conditional language cited herein are intended for pedagogical purposes to aid the reader's understanding of the invention and the concepts contributed by the inventors to advance the art, and should be interpreted as not being limited to such specifically enumerated examples and conditions. Although embodiments of the invention have been described in detail, it should be understood that various changes, substitutions, and modifications can be made thereto without departing from the spirit and scope of the invention.

Claims

1. A multi-cavity extension system, comprising: A multi-lumen tube, the multi-lumen tube comprising: A first cavity, which forms a fluid channel for conveying fluid within the multi-cavity extension system; and The second cavity forms a non-fluid channel within the multi-cavity extension system, and the second cavity and the first cavity are parallel and laterally offset within the multi-cavity tube; A patency device contained within the second cavity; A seal between the first cavity and the second cavity to prevent fluid from entering the second cavity from the first cavity; and A handle formed along the multilumen tube and at least partially surrounding the multilumen tube, the handle being operatively coupled to a patency device received within a second cavity to selectively move the patency device along the second cavity, wherein the handle is capable of independent and separate movement along the outer surface of the multilumen tube, i.e., the handle is not physically and directly coupled to the patency device. When the handle is pushed by the user, the handle engages with the patency device through the multi-lumen tube, thereby causing the patency device to move accordingly as the handle moves distally or proximally along the multi-lumen tube.

2. The multi-cavity extension system according to claim 1, characterized in that, The handle includes: A ring coaxially formed around the second cavity; and A low-friction sliding surface is formed between the ring and the outer wall of the second cavity; The patency device includes a surface that engages with the low-friction sliding surface to allow the patency device to move within the second cavity during ring movement.

3. The multi-cavity extension system according to claim 2, characterized in that, The second chamber includes an exhaust port that allows gas to escape from the second chamber during movement of the circumferential apparatus.

4. The multi-cavity extension system according to claim 1, characterized in that, The multi-cavity extension system further includes a Luer lock passage device operatively coupled to the proximal end of the first cavity.

5. The multi-cavity extension system according to claim 1, characterized in that, The patency device includes a magnetic base formed at the proximal end of the patency device.

6. The multi-cavity extension system according to claim 5, characterized in that, The grip includes a permanent magnet ring that is coaxially formed around the second cavity and magnetically connected to the magnetic base to allow the traversing instrument to move within the second cavity when the permanent magnet ring moves.

7. The multi-cavity extension system according to claim 1, characterized in that, The handle is mechanically connected to the proximal end of the patency device via a channel formed through the multi-lumen tube, which is coaxially formed around the first and second lumens.

8. The multi-cavity extension system according to claim 7, characterized in that, The grip includes a channel through which the first cavity passes.

9. The multi-cavity extension system according to claim 1, characterized in that, The distal end of the second cavity is oriented to be non-parallel to the main axis of the first cavity.

10. The multi-cavity extension system according to claim 1, characterized in that, The patency testing device is a guidewire coaxially formed within the second cavity.

11. A vascular access device, comprising: An intravenous catheter that can be inserted into a patient's blood vessels; A multi-cavity extension system, comprising: A multi-lumen tube, the multi-lumen tube comprising: A first cavity, wherein the first cavity forms a first fluid channel for conveying fluid within the multi-cavity extension system; and The second cavity forms a second channel within the multi-cavity extension system, and the second cavity and the first cavity are parallel and laterally offset within the multi-cavity tube; A patency device contained within the second cavity; A handle, formed along and at least partially surrounding the multi-lumen tube, operatively coupled to a patency device received within a second lumen to selectively advance the patency device along the second lumen, wherein the handle is independently and separately movable along the outer surface of the multi-lumen tube, i.e., the handle is not physically and directly coupled to the patency device; when the handle is pushed by a user, the handle engages with the patency device through the multi-lumen tube, thereby causing distal or proximal movement of the handle along the multi-lumen tube to cause corresponding movement of the patency device; and A Luer lock passage device is operatively connected to the proximal end of the first cavity.

12. The vascular access device according to claim 11, characterized in that, The handle includes: A ring coaxially formed around the second cavity; and Multiple ball bearings are formed between the ring and the outer wall of the second cavity; The patency device includes a surface that engages with the plurality of ball bearings to allow the patency device to move within the second cavity during ring movement.

13. The vascular access device according to claim 11, characterized in that, The grip includes a permanent magnet ring that is coaxially formed around the second cavity and magnetically coupled to a magnetic base to allow the traversing instrument to move within the second cavity when the permanent magnet ring moves.

14. The vascular access device according to claim 11, characterized in that, The patency testing device is a guidewire coaxially formed within the second cavity.

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