Conduit system

Abstract

A catheter system comprising: a catheter adapter; a catheter extending distally from the catheter adapter; an extension tube extending from the catheter adapter; a needle assembly comprising a needle hub and an introducer needle, wherein a proximal end of the introducer needle is secured within the needle hub; a Y-adapter having a distal end, a first arm, and a second arm, wherein the distal end of the Y-adapter is coupled to the extension tube; a needleless connector coupled to the second arm and comprising a compression seal; and a vent cap coupled to the needleless connector and comprising a vent path and a gas permeable barrier within the vent path, wherein in response to movement of the vent cap from an unactuated position to a depressed position, the compression seal is compressed by the vent cap to allow fluid to pass through the vent path.

Description

[0001] This application is a divisional application of the invention patent application entitled "Catheter System", filed on August 7, 2019, with application number 201910725631.2. Technical Field

[0002] This invention relates to catheter systems. Background Technology

[0003] Infusion therapy, a common medical procedure, can be facilitated by vascular access devices. Hospitalized, home-care, and other patients receive fluids, medications, and blood products via vascular access devices inserted into the vascular system. Blood draw is another common medical procedure facilitated by vascular access devices.

[0004] Vascular access devices can be connected to a patient's peripheral or central vascular system. These devices can be left in place for short (days), medium (weeks), or long (months to years). Vascular access devices can be used for continuous infusion therapy or for intermittent therapy.

[0005] A common type of vascular access device is the on-needle peripheral venous catheter (PIVC). As the name suggests, an on-needle PIVC is mounted on an inserter needle with a sharp distal tip. The sharp distal tip is used to penetrate the patient's skin and vascular system. The PIVC is inserted into the vascular system after the needle has been inserted. The needle and PIVC are typically inserted into the patient's vascular system through the skin at a shallow angle, with the bevel of the needle facing away from the patient's skin.

[0006] To verify proper placement of the catheter needle and / or PIVC in the blood vessel, the user typically confirms the presence of a blood “flashback” in the annular space between the catheter and the needle or in the flashback chamber of the catheter assembly. Once a flashback has been confirmed, the user can temporarily occlude flow in the vascular system and remove the needle, leaving the catheter in place for future blood aspiration or fluid infusion.

[0007] In some markets, it is common practice to perfuse the PIVC before inserting it into the patient's vascular system. To perfuse the PIVC, the user may fill it with saline or other perfusion fluid to reduce or eliminate any cavitation within the PIVC. Saline may also fill all or part of the needle lumen. For example, saline may fill the notch near the needle and a portion distal to the notch, all the way to the distal tip of the catheter needle.

[0008] The subject matter claimed herein is not limited to embodiments that address any shortcomings or operate only in environments such as those described above. Rather, this background is provided merely to illustrate an exemplary technical field in which some implementations described herein may be practiced. Summary of the Invention

[0009] This disclosure generally relates to systems and methods for catheter insertion and blood flashback. In some embodiments, a method of placing a catheter into a patient's vein may include an infusion catheter system. In some embodiments, the catheter system may include a catheter adapter, a catheter extending distally from the catheter adapter, and an extension tube extending from the catheter adapter. In some embodiments, the catheter adapter may include a side port and / or the extension tube may extend from the side port. In some embodiments, the catheter adapter may include a proximal end and a distal end. In some embodiments, the extension tube may extend from the proximal end of the catheter adapter.

[0010] In some embodiments, the catheter system may further include a Y-adapter, which may include a distal end, a first arm, and a second arm. In some embodiments, the distal end of the Y-adapter may be coupled to an extension tube. In some embodiments, the catheter system may further include a vent cap, which may be coupled to the second arm. In some embodiments, the first arm may correspond to a central arm or a side arm of the Y-adapter. In some embodiments, the second arm may correspond to a central arm or a side arm of the Y-adapter. In some embodiments, perfusing the catheter system may include attaching an IV line to the first arm and delivering saline through the IV line into the catheter system such that the saline exits the distal end of the catheter. In some embodiments, after the catheter is perfused, the IV line may be clamped via roller clamps or other clamping devices on the IV line to block the saline flow in the IV line. In some embodiments, clamping the IV line to block the flow may cause fluid to shift distally and may result in an increase in system pressure within the catheter system. In some embodiments, the method may further include actuating the vent cap after perfusing the catheter system. In some embodiments, actuating the vent cap coupled to the second arm of the Y-adapter after the perfusing and clamping steps may release system pressure in the catheter system caused by the perfusing and clamping of the IV line. In some embodiments, the method may further include inserting a catheter into the patient's vein after actuating the ventilation cap.

[0011] In some embodiments, the infusion catheter system may include the removal of all air from the Y-adapter, except for air disposed within the second arm of the Y-adapter. In some embodiments, in response to insertion of the catheter into a patient's vein after actuation of the ventilation cap, air disposed within the second arm of the Y-adapter may exit the catheter system via the ventilation cap. This is because the ventilation cap allows air to escape from the catheter system as blood enters it.

[0012] In some embodiments, the catheter system may include an inserter needle that may include a distal notch. In some embodiments, a method of placing the catheter into a patient's vein may include collecting blood flashback in the space between the outer surface of the inserter needle and the inner surface of the catheter. In some embodiments, ventilating the second arm of the Y-adapter after perfusion may facilitate blood flashback, which may indicate to the user that the distal tip of the inserter needle and the distal tip of the catheter are positioned within the vein. In some embodiments, blood flashback may be enhanced compared to blood flashback when the catheter is inserted into the vein after perfusion but the ventilator cap is not actuated after perfusion.

[0013] In some embodiments, the catheter system may include a first connector coupled to a first arm and / or a second connector coupled to a second arm. In some embodiments, a ventilation cap may be coupled to the second connector. In some embodiments, the first and / or second connectors may include needleless connectors. In some embodiments, the first and / or second connectors may include a PRN adapter (from the Latin pro re nata (as needed, as the situation)).

[0014] Various types of vent caps can be used. In some embodiments, the vent cap may include multiple flexible arms that engage with the flange of a second connector via a snap-fit. In some embodiments, the first and / or second arm may include a Luer adapter. In some embodiments, the vent cap may be coupled to the Luer adapter of the second arm of a Y-shaped adapter. In some embodiments, the vent cap may be coupled to a second connector (which may include a pinless connector) that is coupled to the second arm of the Y-shaped adapter. In some embodiments, the vent cap may be coupled to the second connector in a first position that does not approach or open a valve of the second connector. In some embodiments, the vent cap may be actuated or moved to a second position that approaches or opens a valve of the second connector.

[0015] In some embodiments, the catheter system may not be perfused before the catheter is inserted into a patient's vein. In these embodiments, the method of placing the catheter into a patient's vein may include actuating a vent cap and inserting the catheter into the patient's vein after actuating the vent cap. In these embodiments, blood flashback may be enhanced compared to blood flashback when the catheter system is ventilated without using a vent cap after insertion into the patient's vein. In some embodiments, the catheter system may be perfused after actuating the vent cap and before inserting the catheter into the patient's vein. In these embodiments, the catheter system may be fully perfused because the actuated vent cap, coupled to the second arm of the Luer adapter, allows air to escape from the second arm and the entire catheter system compared to methods that perfuse before actuating the vent cap.

[0016] According to the present invention, a catheter system is provided, comprising: a catheter adapter; a catheter extending distally from the catheter adapter; an extension tube extending from the catheter adapter; and a needle assembly including a needle hub and an inserter needle, wherein the needle hub is coupled to a proximal end of the catheter adapter and includes a flashback chamber, wherein the proximal end of the inserter needle is fixed within the needle hub, and wherein the flashback chamber includes a ventilation feature movable between an actuated position in which the flashback chamber is ventilated and an inacted position in which the flashback chamber is not ventilated.

[0017] Preferably, the catheter system further includes an inserter needle with a distal notch.

[0018] Preferably, the catheter adapter includes a side port, from which an extension tube extends.

[0019] Preferably, the catheter adapter includes a proximal end and a distal end, wherein the extension tube extends from the proximal end of the catheter adapter.

[0020] Preferably, the catheter system further includes a Y-shaped adapter having a distal end, a first arm, and a second arm, wherein the distal end of the Y-shaped adapter is connected to an extension tube.

[0021] Preferably, the catheter system further includes a ventilator cap connected to the second arm in the first position or the unacted position.

[0022] Preferably, the ventilator can be actuated by moving the ventilator to a second position or an actuation position.

[0023] Preferably, the catheter system further includes a first connector connected to the first arm and a second connector connected to the second arm, wherein the vent cap is connected to the second connector.

[0024] Preferably, the first connector and the second connector include pinless connectors.

[0025] Preferably, the second connector includes a PRN adapter.

[0026] Preferably, the distal end of the vent cap includes a plurality of flexible engagement arms that engage with the flange of the second connector in a snap-fit ​​manner.

[0027] Preferably, the first arm includes a first Luer adapter, and the second arm includes a second Luer adapter.

[0028] Preferably, the vent cap includes a third Luer adapter connected to the second Luer adapter.

[0029] Preferably, the catheter system further includes an IV line attached to the first arm.

[0030] Preferably, the IV line is clamped by a clamp on the IV line.

[0031] According to the present invention, an improved catheter system is provided.

[0032] It should be understood that the foregoing general description and the following detailed description are exemplary and illustrative, and not intended to limit the claimed invention. It should be understood that the various embodiments are not limited to the arrangements and tools shown in the 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 considered limiting. Attached Figure Description

[0033] Exemplary embodiments will be described and explained with additional features and details using the accompanying drawings, in which:

[0034] Figure 1A This is a top perspective view of an exemplary catheter system according to some embodiments;

[0035] Figure 1B According to some embodiments Figure 1A The upper perspective view of the catheter system having an exemplary first connector and an exemplary second connector and being coupled to an exemplary IV line;

[0036] Figure 1C According to some embodiments Figure 1B The upper perspective view of the conduit system shows an exemplary roller clamp in the closed position and an exemplary vent cap in the unactuated position;

[0037] Figure 1D According to some embodiments Figure 1B The upper perspective view of the catheter system shows the ventilator cap in the actuated position;

[0038] Figure 1E It is connected to an exemplary blood collection device according to some embodiments. Figure 1B Top perspective view of the catheter system;

[0039] Figure 2A It is connected to another exemplary ventilator according to some embodiments. Figure 1B A cross-sectional view of a catheter system, which shows an exemplary needleless connector;

[0040] Figure 2B It is in the actuated position according to some embodiments. Figure 2A A cross-sectional view of the vent cap;

[0041] Figure 3 This is a cross-sectional view of an exemplary conduit adapter and an exemplary needle hub according to some embodiments;

[0042] Figure 4 This is a top perspective view of another exemplary ventilator according to some embodiments;

[0043] Figure 5A This is a top perspective view of another exemplary ventilator according to some embodiments;

[0044] Figure 5B According to some embodiments Figure 5A A cross-sectional view of a portion of the vent cap;

[0045] Figure 5C According to some embodiments Figure 5A The upper perspective view of another part of the vent cap;

[0046] Figure 5D This is a cross-sectional view of an exemplary pinless connector according to some embodiments;

[0047] Figure 6 This is a flowchart illustrating an exemplary method of placing a catheter into a patient's vein according to some embodiments;

[0048] Figure 7 This is a flowchart illustrating another exemplary method of placing a catheter into a patient's vein according to some embodiments;

[0049] Figure 8 This is a flowchart illustrating another exemplary method of placing a catheter into a patient's vein according to some embodiments. Detailed Implementation

[0050] This disclosure generally relates to systems and methods for catheter insertion and blood flashback. Reference is now made to... Figure 1A In some embodiments, the catheter system 10 may include: a catheter adapter 12, a catheter 14 extending distally from the catheter adapter 12, and an extension tube 16 extending from the catheter adapter 12. In some embodiments, the catheter adapter 12 may include a side port 18. In some embodiments, the extension tube 16 may extend from the side port 18. In some embodiments, the catheter adapter 12 may include a proximal end 20 and a distal end 22. In some embodiments, the extension tube may extend from the proximal end 20 of the catheter adapter 12.

[0051] In some embodiments, the catheter system 10 may further include a Y-shaped adapter 24, which may include a distal end 26, a first arm 28, and a second arm 30. In some embodiments, the first arm 28 may correspond to the central arm of the Y-shaped adapter 24, such as... Figure 1A As shown. In these embodiments, the second arm 30 may correspond to the side arm of the Y-shaped adapter 24, such as... Figure 1AAs shown. Conversely, in some embodiments, the first arm 28 may correspond to the side arm of the Y-shaped adapter 24, and the second arm 30 may correspond to the central arm of the Y-shaped adapter 24.

[0052] In some embodiments, the distal end 26 of the Y-shaped adapter 24 may be coupled to the extension tube 16. In some embodiments, the extension tube 16 may include a clamp 17 that can selectively close the extension tube 16 to prevent blood or another fluid from flowing through the extension tube 16.

[0053] In some embodiments, the catheter system 10 may include a needle assembly 32, which may include a needle hub 34 and an inserter needle 36. In some embodiments, the inserter needle 36 may include a distal notch (see, for example...). Figure 3 The distal notch 71 is shown.

[0054] In some embodiments, the catheter system 10 may include BD NEXIVA TM Closed IV catheter system, BD NEXIVA TM DIFFUSICS TM Closed IV catheter system, Becton Dickinson PEGASUS TM A secure closed IV catheter system or another integrated catheter system. In other embodiments, catheter system 10 may be non-integrated.

[0055] Now for reference Figure 1B In some embodiments, the catheter system 10 may include a first connector 40 coupled to a first arm 28 and / or a second connector 42 coupled to a second arm 30. In some embodiments, the first connector 40 and / or the second connector 42 may include a pinless connector or other suitable type of connector. In some embodiments, the first connector 40 and / or the second connector 42 may include a PRN adapter.

[0056] In some embodiments, the catheter system 10 may further include a ventilation cap 44, which can be coupled to the second arm 30. In some embodiments that include a PRN adapter, a blunt or piercing plastic or metal cannula may be incorporated at the distal end of the ventilation cap 44 to access and actuate a non-Luer connection of the PRN connector. In some embodiments, the ventilation cap 44 may be directly coupled to a Luer adapter of the second arm 30. In other embodiments, the ventilation cap 44 may be coupled to the second arm 30 via a second connector 42.

[0057] In some embodiments, the first arm 28 and / or the second arm 30 may include a Luer adapter, such as a sliding or threaded male or female Luer adapter, or other suitable connector. In some embodiments, the proximal and / or distal ends of the first connector 40 may include a Luer adapter, such as a sliding or threaded male or female Luer adapter. In some embodiments, the proximal and / or distal ends of the second connector 42 may include a Luer adapter, such as a sliding or threaded male or female Luer adapter.

[0058] In some embodiments, in response to insertion of the catheter needle 36 into a patient's vein, a flashback of blood may flow through the pointed distal end 38 of the catheter needle 36 and exit from the distal notch 71 into a portion of the catheter system 10. For example, the flashback may flow through the distal end 38 and exit from the distal notch 71 into the space between the outer surface of the catheter needle 36 and the inner surface of the catheter 14 (this may be referred to as a "first-order flashback"). In some embodiments, the flashback may flow into the extension tube 16 (this may be referred to as a "second-order flashback"). First-order and / or second-order flashbacks confirm that the catheter needle 36 is located within the patient's vein.

[0059] In some markets, it is common practice to perfuse a specific catheter system before insertion into a patient. To perfuse the catheter system 10, the user may fill the catheter system 10 with an perfusing solution or another perfusing fluid to reduce or eliminate cavitation within the specific catheter system. The perfusing solution may also fill a portion of the lumen of the inserter needle 36 near the notch 71 and distal to the notch 71, extending to the distal end 38 of the inserter needle 36. Therefore, when the distal end 38 of the inserter needle 36 enters the vascular system, blood flashback may be slowed, more visually difficult to see, and may not penetrate very far into the catheter system due to the presence of saline and diffusion. In some embodiments, this disclosure relates to a method for improving blood flashback after perfusing the catheter system 10.

[0060] In some embodiments, the infusion catheter system 10 may include: attaching an IV line 46 or other suitable infusion device to the first arm 28 and delivering an infusion solution to the catheter system 10 through the IV line 46, such that the infusion solution exits the distal end 48 of the catheter 14 and / or the distal end 38 of the cannula needle 36; and then clamping the IV line 46 via a roller clamp 50. In some embodiments, the infusion solution may include saline or other suitable solution. Figure 1BThe roller clamp 50 is shown in the open position, allowing the infusion solution to flow into the conduit system 10 for infusion. In some embodiments, the infusion conduit system 10 may include the removal of all air from the Y-adapter 24, except for air disposed within the second arm 30 of the Y-adapter 24. Air within the second arm 30 may not be able to escape due to lack of ventilation. In some embodiments, air may be present in the second arm 30 and / or the second connector 42 of the conduit system 10 after infusion.

[0061] Now for reference Figure 1C According to some embodiments, the roller clamp 50 is shown in the closed position. In some embodiments, when the roller clamp 50 moves to the closed position, fluid flow through the IV line 46 is prevented. In some embodiments, in response to the roller clamp 50 moving to the closed position after infusion and without actuation of the vent cap 44, fluid displacement may occur within the IV line 46, which may create residual pressure within the catheter system 10, causing the infusion solution to continue dripping slowly from the distal end 38 until the residual pressure is released. Depending on the size of the catheter 14 or other factors, the dripping of the infusion solution may take up to 30 seconds or longer. In some embodiments, continuous softening of the catheter 14 may occur during the time spent waiting for the residual pressure to be released, which may result in less favorable insertion conditions. In some cases, if the user does not wait until the dripping of the infusion solution has stopped, venous confirmation via blood flashback may be limited.

[0062] In some embodiments, air trapped within the second arm 30 and / or the second connector 42 may be utilized to release residual pressure and / or improve blood flashback after perfusion. More specifically, in some embodiments, the method may also include actuating a ventilation cap 44 after perfusion of the catheter system 10. An actuated ventilation cap 44 provides ventilation to the catheter system 10, while an unactuated ventilation cap 44 may not. In some embodiments, the method may also include inserting the catheter 14 into a patient's vein after actuating the ventilation cap 44.

[0063] After perfusion, actuating the vent cap 44 releases residual pressure and allows the user to insert the catheter into the patient's vein and visualize the blood flashback without waiting approximately 30 seconds or more for the perfusion solution drip to slow or stop. More specifically, in some embodiments, in response to inserting the catheter 14 into the patient's vein after actuating the vent cap 44, air disposed within the second arm 30 of the Y-adapter 24 can exit the catheter system 10 via the vent cap 44. In some embodiments, air can escape from the catheter system 10 via the vent plug 44 to release residual pressure and allow the venous pressure entering the catheter system 10 with the blood flashback to propel the perfusion solution proximally within the second arm 30 and / or the second connector 42.

[0064] In some embodiments, venting the second arm 30 of the Y-adapter 24 after perfusion can facilitate blood flashback, which can be inserted into a portion of the catheter 14, catheter adapter 12, and extension tube to indicate to the user that the distal end 38 of the cannula needle 36 and the distal end 48 of the catheter 14 are positioned within a vein. In some embodiments, blood flashback can be enhanced compared to blood flashback when the catheter 14 is inserted into a vein after perfusion but the vent cap 44 is not actuated after perfusion. In some embodiments, perfusing the catheter system 10 without actuating the vent cap 44 after perfusion can slow blood flashback in response to insertion of the catheter 14 into the patient's vein due to residual pressure from the closed roller clamp and slower diffusion of blood into the catheter system.

[0065] Now for reference Figure 1D In some embodiments, the IV line 46 may be detached from the catheter system 10 after the catheter system 10 has been perfused and / or the vent cap 44 has been actuated. In some embodiments, the catheter system 10 may be unperfused or unattached to the IV line 46 when it is desired to collect one or more blood samples using the catheter system 10. In these and other embodiments, the vent cap 44 may be actuated to allow blood to fill the unperfused catheter system 10 by venting a second arm 30 to which the vent cap 44 may be attached. In some embodiments, after the catheter 14 has been inserted into a vein and the extension tube has filled with blood, the vent cap 44 may be removed, and a blood collection device (such as, for example, a vacuum tube holder, syringe, or other device) may be attached to the first arm 28 or the second arm 30 to collect a blood sample via the blood collection device. In these and other embodiments, without perfusion, it may not be necessary to pull to discard the sample to remove saline from the extension tube 16 and / or the Y-adapter 24.

[0066] In some embodiments, the blood collection device may be connected to the first arm 28 before the catheter 14 is inserted into the patient and after the ventilation cap 44 is actuated. In some embodiments, the blood collection device may be connected to the first arm 28 before the catheter 14 is inserted into the patient and before the ventilation cap 44 is actuated. In some embodiments, the blood collection device may be actuated to collect a blood sample when the extension tube is filled with blood, without needing to discard the sample.

[0067] Now for reference Figure 1E In some embodiments, the blood collection device 51 may be coupled to the Y-adapter 24. In some embodiments, the blood collection device 51 may be coupled to the Y-adapter after the perfusion catheter system 10 or without the perfusion catheter system 10. In some embodiments, the blood collection device 51 may be coupled to the first arm 28 of the Y-adapter.

[0068] In some embodiments, the blood collection device 51 may include any suitable type of blood collection device. In some embodiments, the blood collection device 51 may include a reservoir. In some embodiments, the blood collection device 51 may include a vacuum tube, a test tube, or a syringe. In some embodiments, the blood collection device 51 may include an adapter configured to hold a test tube or syringe.

[0069] In some embodiments, various types of ventilation caps or similar ventilation devices may be used with the catheter system 10. Reference now. Figure 2A-2B Another exemplary ventilator cap 44 according to some embodiments is shown. Figure 2A Also shown, according to some embodiments, is an unfilled volume 49 and a perfusion solution channel 53, which may include cavitation.

[0070] In some embodiments, the vent cap 44 may be assembled to a second connector 42, which may include a pinless connector, and may be in a first, stored, or inactive position (e.g., Figure 2A (as shown in the image) and second, the active pressing position (e.g., in...) Figure 2B The pinless connector moves or shifts between the two positions. In the first position, the compression seal 52 of the pinless connector is uncompressed, thereby preventing fluid from passing through the venting path 54. In the second position, the compression seal 52 of the pinless connector is compressed, thereby allowing fluid to pass through the venting path 54.

[0071] In some embodiments, a ventilation barrier 56 may be positioned within a portion of the ventilation path 54. In some embodiments, the ventilation barrier 56 may include a breathable matrix that allows air or gas to escape when blood fills the ventilation path 54, but prevents perfusion fluid, saline, blood, or other fluids from completely passing through the ventilation passage 54. In some embodiments, the ventilation cap 44 may be made of a transparent or translucent material that allows blood to fill a portion of the ventilation path 54 during air expulsion, thereby providing the user with visual confirmation that the catheter 14 has been inserted into the patient's vein. This visual confirmation may be referred to as a secondary or tertiary blood flashback.

[0072] In some embodiments, the nose portion 58 may terminate in a push plate 60. In some embodiments, the push plate 60 may include a flange 62 configured to provide a surface area for push by a user when the ventilator cap 44 is manually moved between a first, stored position and a second, active-press position. In one embodiment, a portion of the ventilation path wall 63 may further define an eyelet 64. In some embodiments, the eyelet 64 may be configured to provide a fluid path for escaping air between the ventilation path 54 and the exterior of the ventilation path wall 63. In particular, in some embodiments, the eyelet 64 may provide a path for escaping air when the user seals the end of the ventilation path 54 with their fingers as the ventilator cap 44 is moved to the second, active-press position. In one embodiment, a portion of the ventilator cap 44 may include a mechanism configured to provide an audible click and / or tactile feedback when the ventilator cap 44 has been moved to the second, active-press position.

[0073] In some embodiments, various types of first connector 40 and / or second connector 42 may be used in system 10. In some embodiments, various types of pinless connectors may be used as the first connector 40 and / or second connector 42. Some non-limiting examples of pinless connectors are described in U.S. Patent No. 8,066,670, filed November 5, 2007, entitled “VASCULAR ACCESS DEVICE SEPTUM VENTING,” which is incorporated herein by reference. Furthermore, in some embodiments, various types of PRN adapters may be used as the first connector 40 and / or second connector 42.

[0074] exist Figure 2A In some embodiments, the second connector 42 includes an exemplary pinless connector. In some embodiments, the pinless connector may include one or more of the following: a tapered inner conduit 66 having one or more fluid path windows 68; a flexible compression seal 52 capable of selectively covering the inner conduit 66; and a housing 70 substantially surrounding the inner conduit 66 and the compression seal 52. In some embodiments, the exterior of the housing 70 may include a substantially smooth surface, wherein cracks are minimized to allow for easy wiping or cleaning to prevent the growth and / or presence of microorganisms. In some embodiments, the interior of the housing 70 may be configured to promote more uniform fluid flow to improve the flushability of the pinless connector. In one embodiment, the interior of the housing 70 may be shaped to reduce the occurrence of dead spaces or cavities, thereby reducing areas where microbial growth may occur.

[0075] In some embodiments, the needleless connector and / or PRN adapter prevent fluid leakage and / or contamination of the fluid path of the catheter system 10. In some embodiments, in a closed or sealed position, a compression seal 52 may extend over the fluid path window 68 of the inner catheter 66 to create a fluid seal to prevent fluid leakage from the extension tube 16, for example, as... Figure 2A As shown. Conversely, in some embodiments, such as Figure 2B As shown, when the vent cap 44 is actuated and inserted into the housing 70, the compression seal 52 can be displaced to the open position, thereby exposing the fluid passage window 68 to the fluid path 68 of the vent cap 44.

[0076] In some embodiments, the first connector 40 and / or the second connector 42 enable the catheter system 10 to function as a closed system when not connected to the IV line 46 or another medical device. In some embodiments, a specific needleless connector or a specific PRN adapter combined with a specific ventilation cap prevents blood from escaping from the catheter system 10, thereby maintaining a closed system.

[0077] Now for reference Figure 3 In some embodiments, the catheter system 10 may include a flashback chamber 72, which may be fluidly connected to the proximal end of the catheter needle 36. In some embodiments, when the catheter needle 36 is in the insertion position for insertion into a patient, the catheter needle 36 may extend through the septum 74, for example, as... Figure 3 As shown. In some embodiments, the flashback chamber 72 may include a ventilation feature that may be actuated if not activated during perfusion of the catheter system 10 and / or after perfusion of the catheter system 10 but before insertion of the catheter 14 into the patient. In some embodiments, the flashback chamber 72 may be used to release residual pressure generated by perfusion of the catheter system 10 and / or clamping of the IV line 46. More specifically, in some embodiments, perfusion of the catheter system 10 may leave cavitation within the flashback chamber 72. In some embodiments, ventilating the flashback chamber 72 after perfusion of the catheter system 10 may remove cavitation, reduce residual pressure, and allow blood flow into the flashback chamber 72 when the catheter system 10 is inserted into a vein.

[0078] In some embodiments, the venting feature may include a vent cap that is movable between an actuated and an inactive position. According to some embodiments, the vent cap may include any of the features of the vent cap described in this disclosure. In some embodiments, the venting feature may include a vent 59, which may include a hydrophobic membrane or other filter that allows air but not fluid. In some embodiments, the vent can be actuated by removing an airtight cap covering the vent. In some embodiments, the vent can be deactuated by covering the vent with a cap, for example, as... Figure 3 As shown.

[0079] In some embodiments, a flashback chamber 72 with ventilation features can reduce or eliminate false positives, wherein blood continues to fill a particular flashback chamber even when the catheter needle penetrates a vein. In some embodiments, the flashback chamber 72 may vary in its size and configuration. In some embodiments, the flashback chamber 72 may include one or more features disclosed in U.S. Patent Application No. 15 / 286,188, which is incorporated herein by reference in its entirety.

[0080] Now for reference Figure 4 In some embodiments, the vent cap 44 may be attached to the Y-adapter 24 and / or the second connector 42 via a tether 76. In some embodiments, the second arm 30 and / or the second connector 42 may be inserted into a hole or orifice of an attachment element 78 located at the distal end of the tether 76. In some embodiments, the conduit system 10 (including the vent cap 44) may be packaged together in a kit.

[0081] Now for reference Figures 5A-5C In some embodiments, the vent cap 44 may include a plurality of engaging arms 80 configured to grip a portion of the Y-adapter 24 or the second connector 42. In some embodiments, the engaging arms 80 may be made of an elastic material such that the engaging arms 80 tend to return to their original shape after temporary deformation. In some embodiments, the engaging arms 80 may be biased outward to snap onto the Y-adapter 24 or the second connector 42. In some embodiments, the ends of the engaging arms 80 may include flanges 82 that abut against the flanges of the Y-adapter 24 or the second connector 42 and prevent the vent cap 44 from moving proximally.

[0082] In some embodiments, the vent cap 44 may include one or more additional arms 84 disposed in one or more slots 86 of the movable part of the vent cap 44. In some embodiments, the arms 84 disposed in the slots may support the vent cap 44 when the vent cap moves between an actuated or distal position and an unactuated or proximal position.

[0083] Figure 5D Another exemplary pinless connector according to some embodiments is shown. Figures 5A-5B The second connector shown can correspond to Figure 5D The needleless connector. In some embodiments, the diaphragm 88 prevents blood from leaving the catheter system 10. Figure 5D The needleless connector is described in further detail in U.S. Patent No. 8,066,670, filed November 5, 2007, entitled “VASCULARACCESS DEVICE SEPTUM VENTING,” which is incorporated herein by reference.

[0084] Now for reference Figure 6According to some embodiments, a flowchart of an exemplary method 100 for placing a catheter into a patient's vein is shown. The method may begin at block 102. In block 102, an infusion catheter system may be introduced. In some embodiments, the infusion catheter system clamps an IV line, such as, for example, one or more IV lines 46 discussed in the foregoing figures. In some embodiments, the catheter system may include or correspond to a catheter system 10 as described with respect to one or more of Figures 1-5. In some embodiments, block 102 may be followed by block 104.

[0085] In block 104, an actuable ventilator cap for the catheter system is located. In some embodiments, the ventilator cap may include or correspond to a ventilator cap 44 as described with respect to one or more of Figures 1-5. In some embodiments, block 104 may be followed by block 106.

[0086] In box 106, after the actuation of the ventilation cap, the catheter of the catheterization system can be inserted into the patient's vein. Further description may be made with reference to one or more of Figures 1-5. Figure 6 The method. Further descriptions can be made regarding one or more of the figures in Figures 1-5. Figure 6 The various elements used in the method. Although shown as discrete boxes, depending on the desired implementation, the individual boxes of method 100 can be divided into additional boxes, combined into fewer boxes, or eliminated.

[0087] Now for reference Figure 7 According to some embodiments, a flowchart of another exemplary method 200 for placing a catheter into a patient's vein is shown. The method may begin at block 202. In block 202, a ventilation cap of the catheter system is actuated. In some embodiments, the catheter system may include or correspond to a catheter system 10 as described with respect to one or more of Figures 1-5. In some embodiments, the ventilation cap may include or correspond to a ventilation cap 44 as described with respect to one or more of Figures 1-5. Block 202 may be followed by block 204.

[0088] In box 204, the catheter system can be perfused after the actuation of the ventilation cap. Box 204 is followed by box 206. At box 206, the catheter of the catheter system can be inserted into the patient's vein after the actuation of the ventilation cap and the perfusion of the catheter. More specifically, in some embodiments, the catheter system can be perfused after the actuation of the ventilation cap and before insertion of the catheter into the patient's vein, which provides a fully ventilated and therefore fully perfused catheter system that prevents residual air from being delivered to the patient.

[0089] and Figure 7 Compared to the methods, Figure 6 This method can provide enhanced flashback. However, compared to methods that do not include an actuating vent plug at all, Figure 7The method can provide enhanced flashback. Further description is possible with reference to one or more of the figures in Figures 1-5. Figure 7 The method. Further descriptions can be made regarding one or more of the figures in Figures 1-5. Figure 7 The various elements used in the method. Although shown as discrete boxes, depending on the desired implementation, the individual boxes of method 100 can be divided into additional boxes, combined into fewer boxes, or eliminated.

[0090] Now for reference Figure 8 The following is a flowchart of another exemplary method 300 for placing a catheter into a patient's vein, according to some embodiments. The method may begin at block 302. In block 302, the ventilation cap of the catheter system may be actuated. Block 304 may follow block 302.

[0091] In box 304, after actuating the ventilation cap, the catheter of the catheter system can be inserted into the patient's vein. In some embodiments, the catheter system may not be perfused before insertion into the vein. Box 304 is followed by box 306.

[0092] At box 306, a blood sample can be collected after the catheter has been inserted into a vein. More specifically, the blood sample can be obtained via a blood collection device coupled to the catheter system. In some embodiments, a blood sample can be collected without obtaining a discarded sample.

[0093] Further descriptions of one or more of Figures 1-5 are possible. Figure 8 The method. Further descriptions can be made regarding one or more of the figures in Figures 1-5. Figure 8 The various elements used in the method. Although shown as discrete boxes, depending on the desired implementation, the individual boxes of method 100 can be divided into additional boxes, combined into fewer boxes, or eliminated. For example, box 306 can be removed.

[0094] It should be understood that in some embodiments, the catheter system may not be perfused before the catheter is inserted into the patient's vein. In these embodiments, the method of placing the catheter into the patient's vein may include actuating a ventilation cap and inserting the catheter into the patient's vein after actuating the ventilation cap. In these embodiments, blood flashback may be enhanced compared to blood flashback when the catheter system is ventilated without using a ventilation cap after insertion into the patient's vein.

[0095] All examples and conditional language used herein are intended for educational purposes to help readers understand the inventions and concepts contributed by the inventors to promote the technology, and should be interpreted as not being limited to these specific 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 catheter system, comprising: catheter adapter; The catheter extends distally from the catheter adapter; Extension tube extending from the conduit adapter; A needle assembly including a needle hub and a cannula needle, wherein the needle hub is coupled to the proximal end of a catheter adapter and includes a flashback chamber, wherein the proximal end of the cannula needle is fixed within the needle hub, wherein the flashback chamber includes a ventilation feature movable between a ventilation feature actuated position in which the flashback chamber is ventilated and a ventilation feature inactive position in which the flashback chamber is not ventilated. A Y-shaped adapter having a distal end, a first arm, and a second arm, wherein the distal end of the Y-shaped adapter is coupled to an extension tube, and wherein the first arm is configured to receive an IV line for delivering saline solution to the catheter system, such that the saline solution exits the distal end of the catheter or cannula needle, the IV line further including a clamp for selectively clamping the IV line; and A vent cap is attached to the second arm and is movable between an inactive position and an activated position, wherein in the inactive position air can be trapped within the second arm, and wherein in the activated position the trapped air exits the duct system via a venting path of the vent cap.

2. The catheter system according to claim 1, wherein, The catheter adapter includes a side port from which an extension tube extends.

3. The catheter system according to claim 1, wherein, The cannula needle includes a distal notch, and the catheter system also includes a space configured to collect blood flashback located between the outer surface of the cannula needle and the inner surface of the catheter.

4. The catheter system according to claim 1, wherein, The catheter adapter includes a proximal end and a distal end, wherein the extension tube extends from the proximal end of the catheter adapter.

5. The catheter system according to claim 1, wherein, The catheter system also includes a first connector connected to the first arm and a second connector connected to the second arm, wherein the vent cap is connected to the second connector.

6. The catheter system according to claim 5, wherein, The first connector and the second connector include pinless connectors.

7. The catheter system according to claim 6, wherein, The pinless connector includes a compression seal that is uncompressed in the unacted position and compressed in the actuated position.

8. The catheter system according to claim 7, wherein, When the compression seal is in an uncompressed state, fluid is prevented from passing through the venting path, and when the compression seal is in a compressed state, fluid is allowed to pass through the venting path.

9. The catheter system according to claim 5, wherein, The second connector includes a PRN adapter.

10. The catheter system according to claim 5, wherein, The distal end of the vent cap includes a plurality of flexible engagement arms that engage with the flange of the second connector in a snap-fit ​​manner.

11. The catheter system according to claim 1, wherein, The first arm includes a first Luer adapter, and the second arm includes a second Luer adapter.

12. The catheter system of claim 11, wherein, The vent cap includes a third Luer adapter connected to the second Luer adapter.

13. The catheter system according to claim 1, wherein, When the clamp clamps the IV line, the vent cap is moved to the actuated position.

14. The catheter system of claim 1, further comprising a blood collection device connected to the first arm.

15. The catheter system according to claim 1, wherein, The vent cap is removably attached to the second arm.

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