Devices used at the catheter insertion site
Patent Information
- Application Number
- JP2023538813
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2020-12-23
- Filing Date
- 2021-12-22
- Publication Date
- 2024-12-27
- Estimated Expiration
- Not applicable · inactive patent
AI Technical Summary
Conventional catheter stabilization techniques fail to adequately prevent dislodgment, kinking, and contamination, leading to reduced catheter residence time, increased infection risk, and vein damage due to inappropriate angulation and adhesive use.
A catheter stabilization device that secures the catheter hub without direct adhesive contact, using a membrane with arms to minimize movement, provides an airtight seal, and incorporates antimicrobial features to reduce contamination and allow visibility of the insertion site.
Extends catheter residence time, reduces contamination risk, minimizes skin irritation, and maintains catheter angulation, thereby decreasing replacement frequency and associated costs.
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Abstract
Description
[Technical Field]
[0001] [Incorporation by reference to priority application] This application claims the benefit of U.S. Provisional Application No. 63 / 130,215, entitled "Catheter Anchoring, Stabilizing, and Antimicrobial Device," filed December 23, 2020, which is incorporated herein by reference in its entirety.
[0002] Generally, the present disclosure relates to catheter stabilization devices, systems, and methods. [Background technology]
[0003] Intravenous catheterization has been available to patients for over a century. Peripherally inserted central catheters (PIVCs) and peripherally inserted central catheters (PICCs) are commonly used to provide medications, nutrition, and / or fluids to patients in hospitals or nursing homes. After irrigating the catheter insertion site, a needle is inserted into the patient's vein, and then the catheter is inserted into the vein. Such catheters are typically coupled with a catheter hub. [Prior art documents] [Patent documents]
[0004] [Patent Document 1] US Patent Application Publication No. 2019 / 0388652 Summary of the Invention
[0005] It is very important to stabilize the catheter when inserted into the catheter insertion site. Phlebitis (inflammation of the veins) is usually caused by catheter movement against the blood vessel wall. Conventional techniques for stabilizing a catheter involve applying one or more adhesive film bandages directly to the catheter hub connected to the catheter, the patient's skin, and the catheter insertion site. However, such techniques have various drawbacks. For example, they do not adequately prevent the catheter from becoming dislodged (e.g., due to patient movement) or being pushed further into the patient's arm (or other body part). The adhesive bandages used in such techniques can harbor and cultivate germs and bacteria at the insertion site, potentially leading to various infections and complications. Frequent changes of such adhesive bandages and catheters can increase the risk of bacterial infection and cause inflammation and trauma at the insertion site, especially in elderly patients. Furthermore, conventional techniques inhibit normal skin respiration and ventilation and increase humidity and temperature at and near the insertion site, which can promote microbial growth.
[0006] Another drawback of traditional catheter stabilization techniques is that applying tape directly to the catheter hub (connected to the catheter) over the catheter insertion site can cause the catheter tip to be at an improper angle within the vein, potentially leading to catheter tip erosion and damage to the vein and / or vein wall. This erosion and other damage can be exacerbated by patient movement. Such techniques also obscure the catheter insertion site, hindering assessment of catheter status and / or complications. Catheter "kinking" is also a common problem with traditional catheter stabilization techniques. Generally accepted practice calls for catheter removal after a dwell time of 72 to 96 hours. Therefore, even under the best circumstances, traditional approaches result in relatively short catheter lifespans and the need for frequent adjustments and / or migration. Catheter failure and frequent catheter migration can lead to expensive catheter replacements, increased costs due to extended patient treatment times, and ultimately, the potential for venous depletion. Venous depletion requires more invasive, riskier, and more expensive venous access devices.
[0007] The present disclosure provides devices, systems, and methods for stabilizing a catheter at a catheter insertion site. The disclosed devices, systems, and methods can reduce or eliminate problems associated with conventional techniques for securing a catheter hub and catheter at a catheter insertion site, such as those described above. The disclosed devices, systems, and methods can extend catheter dwell times beyond current standard dwell periods.
[0008] Some embodiments of the devices, systems, and methods disclosed herein provide various disinfecting and / or sterilizing functions for a catheter insertion site and / or a portion of the catheter and / or catheter hub. For example, some embodiments of the disclosed catheter housing devices can be supplied with a sterilizing inert gas capable of asphyxiating microorganisms or other contaminants around the catheter insertion site, the catheter, the catheter hub coupled to the catheter, the Luer connector coupled to the catheter hub, portions of connected fluid tubing, and / or portions within the interior defined by the catheter housing device when secured to a subject. The catheter housing devices (or portions thereof) discussed herein can be coated with an antimicrobial coating to aid in disinfecting and / or sterilizing near the catheter insertion site and / or within or around the catheter housing device. Various components of the disclosed catheter housing devices can be structured to form an airtight seal that can advantageously inhibit or prevent microorganisms or other contaminants from entering portions of the catheter housing device. Some embodiments of the disclosed catheter housing devices can include a gas port for supplying sterilizing or other gases. Sedatives, antiseptics, anesthetics, and / or similar vapor agents can be provided in gaseous form to a catheter insertion site via the disclosed catheter containment devices to aid in healing or reconstruction within and around the catheter insertion site. Some embodiments of the disclosed catheter containment devices include one or more UV SMD ("surface mounted") LEDs that can provide active sterilization and / or disinfection of areas within or near the catheter insertion site, the catheter, a catheter hub coupled to the catheter, a region of the luer, a connector connected to the catheter hub, a portion of connected fluid tubing, and / or portions of the interior defined by the catheter containment device when secured to a subject. Such UV SMD LEDs can also illuminate interior areas within the catheter containment device, such as at or near the catheter insertion site.
[0009] The disclosed catheter containment device and method avoids applying direct pressure to the needle, insertion site, and / or catheter, avoids catheter kinking, significantly reduces the likelihood of contamination in and / or around the catheter insertion site, and / or allows the insertion site to remain easily visible to the caregiver. Some embodiments of the disclosed catheter containment device mechanically isolate the catheter and / or catheter hub from patient movement and hold the catheter and / or catheter hub at a proper (e.g., "natural") insertion angle. Some embodiments of the disclosed catheter containment device provide a catheter stabilization system that is highly skin-breathable, allows patient comfort, and reduces skin irritation or trauma. A catheter containment device and method for securing it to a subject are described in commonly owned U.S. Patent Application Publication No. 2019 / 0388652, which is incorporated herein in its entirety.
[0010] As used herein, the term "catheter hub" (also referred to as a "catheter device" or "catheter hub device") refers to a device coupled to a catheter (which may be referred to herein as a "venous catheter," "IV catheter," "cannula," or "intravenous line"). The catheter hubs discussed herein may include one or more cylindrical sections coupled to a portion of the catheter and may be directly connected to a Luer connector, and such Luer connectors (e.g., male Luer connectors) may indirectly connect the catheter hub to a fluid tubing. The catheter containment devices described herein (also referred to herein as "catheter stabilization devices," "catheter housings," and "housings") may stabilize a catheter by securing one or more portions of the catheter hub and / or by securing Luer connectors connected to such catheter hubs. For example, the catheter containment devices discussed herein may secure (or at least partially secure) one or more cylindrical sections of the catheter hub, Luer connectors configured to connect to such catheter hubs, and / or portions of fluid tubing connected to such Luer connectors. Such fixation may thus position and / or stabilize a catheter coupled to the catheter hub when the catheter is inserted into a catheter insertion site (e.g., extending through a subject's skin and into a vein). The fluid tubes (also referred to herein as "tubes" and "tubing") described herein can deliver fluids (including medicinal, nutritional, and / or other fluids) to the catheter and, in turn, to the subject.
[0011] Disclosed herein is a catheter containment device configured for use at a catheter insertion site of a subject, the catheter containment device comprising a hub and a cover. The hub is configured to be placed at the catheter insertion site and comprises a membrane including an opening, the membrane configured to be secured to the subject's skin so that the catheter insertion site is located within the opening, and at least one arm coupled to the membrane and extending partially across the opening, the at least one arm configured to rest on the subject's skin when the membrane is secured to the subject's skin, the free end of the at least one arm spaced inward from the periphery of the opening and configured to secure a catheter hub connected to the catheter to minimize movement of the catheter when inserted into the catheter insertion site. The cover is removably secured to the hub and configured to surround the catheter insertion site of the subject.
[0012] In some embodiments, the at least one arm comprises a pair of opposing arms, the free ends of which are spaced apart by a gap and configured to secure the catheter hub during use of the catheter containing device. In some embodiments, the catheter containing device further comprises a frame connected to the membrane along at least a portion of the periphery of the opening (e.g., all or less than the entire periphery of the opening). In some embodiments, the at least one arm comprises: a first arm extending outward from a first portion of the frame partially across the opening, the first arm having a connected end connected to the first portion of the frame and a free end opposite the connected end of the first arm; and a second arm extending outward from a second portion of the frame partially across the opening toward the first arm, the second arm having a connected end connected to the second portion of the frame and a free end opposite the connected end of the second portion of the frame. In some embodiments, the free ends of the first and second arms are spaced inward from the periphery of the opening, spaced apart by a gap, and configured to secure the catheter hub during use of the catheter containing device. In some embodiments, the second portion of the frame is opposite the first portion of the frame.
[0013] In some embodiments, the free ends of the first and second arms are configured to secure the catheter hub in an inclined position relative to the subject's skin during use. In some embodiments, the free ends of the first and second arms are spaced apart on a plane extending along the bottom surface of the membrane. In some embodiments, each of the first and second arms includes a first section extending outward from the frame and a second section at the free end, the second section connected to the first section and configured to contact the catheter hub when the catheter hub is secured by the free ends of the first and second arms. In some embodiments, the second section is transverse to the first section. In some embodiments, the second section is generally perpendicular to the first section. In some embodiments, the second section is at least partially curved to conform to and surround a portion of the catheter hub when the catheter hub is secured by the free ends of the first and second arms. In some embodiments, the facing surfaces of the second sections of the first and second arms have matching curvatures. In some embodiments, the first arm and the second arm are mirror images of each other.
[0014] In some embodiments, each of the first and second arms comprises a generally T-shaped structure having a stem connected to the first or second portion of the frame and a flange connected to the stem and spaced from the frame, and at least a portion of the flange is curved to conform to and surround a portion of the catheter hub when the catheter hub is secured by the first and second arms. In some embodiments, the frame comprises a first material and the membrane comprises a second material different from the first material. In some embodiments, the second material is more flexible than the first material. In some embodiments, the first material is more rigid than the second material. In some embodiments, the frame has an annular shape.
[0015] In some embodiments, when the catheter hub is secured by the first and second arms during use, no portion of the catheter containing device is located between the first and second arms and the subject's skin. In some embodiments, when the catheter hub is secured by the first and second arms during use, no portion of the cover contacts the catheter hub. In some embodiments, when the catheter hub is secured by the first and second arms during use, no portion of the membrane contacts the catheter hub. In some embodiments, when the catheter hub is secured by the first and second arms during use, the catheter hub is spaced inwardly from the periphery of the opening.
[0016] In some embodiments, the catheter hub includes a first end connected to the catheter and a second end opposite the first end of the catheter hub, and when the catheter hub is secured by the first and second arms, the second end of the catheter hub does not contact the subject's skin. In some embodiments, when the catheter hub is secured by the first and second arms, only the first end of the catheter hub contacts the subject's skin. In some embodiments, when the catheter hub is secured by the first and second arms, no portion of the catheter hub contacts the subject's skin. In some embodiments, the free ends of the first and second arms are spaced apart above a plane extending along the bottom of the frame.
[0017] In some embodiments, the catheter containing device further comprises a moisture wicking element coupled to the membrane and configured to contact the subject's skin when the membrane is secured to the subject's skin and surround the catheter insertion site, the moisture wicking element configured to wick moisture away from the catheter insertion site during use of the catheter containing device, hi some embodiments, the membrane comprises a plurality of openings spaced around the opening.
[0018] In some embodiments, the catheter containing device further comprises one or more adhesive substrates coupled to the bottom surface of the membrane and configured to secure the membrane to the skin of the subject. In some embodiments, the membrane further comprises a plurality of recesses, each recess disposed adjacent one of the plurality of openings in the membrane and recessed inwardly from a plane extending along the bottom surface of the membrane, the recesses configured to allow an adhesive removal solution to flow beneath the bottom surface.
[0019] In some embodiments, the cover comprises a top and a wall extending outwardly from the top to define an interior, the wall of the cover configured to be removably secured to a frame of the hub, hi some embodiments, the frame comprises one or more latch legs, and the wall of the cover comprises one or more latch protrusions configured to be removably secured to the one or more latch legs of the frame.
[0020] In some embodiments, the one or more latch legs extend from the frame in a direction generally perpendicular to the first and second arms. In some embodiments, the wall comprises at least one latch protrusion at a first end of the wall and at least one latch protrusion at a second end of the wall opposite the first end of the wall. In some embodiments, the cover further comprises an opening extending through a portion of the wall, the opening in the cover configured to allow a fluid tube to pass through the wall and connect to the catheter hub. In some embodiments, the fluid tube connects to the catheter hub via a male Luer connector. In some embodiments, the frame is permanently secured to the membrane.
[0021] Disclosed herein is a catheter containment device configured for use at a catheter insertion site of a subject, the catheter containment device comprising a hub and a cover. The hub is configured to be placed at the catheter insertion site, the hub comprising: a membrane with an opening configured to be secured to the subject's skin such that the catheter insertion site is located within the opening; a frame connected to the membrane along a periphery of the opening; a first arm extending outward from a first portion of the frame and partially across the opening, the first arm having a first end connected to the first portion of the frame and a second end opposite the first end of the first arm; and a second arm extending outward from a second portion of the frame and partially across the opening toward the first arm, the second arm having a first end connected to the second portion of the frame and a second end opposite the first end of the frame. The second ends of the first and second arms are spaced inward from the periphery of the opening and separated from each other by a gap, and are configured to secure the catheter hub connected to the catheter to minimize movement of the catheter when inserted into the catheter insertion site. The cover is removably secured to the frame of the hub and is configured to surround a catheter insertion site in a subject.
[0022] In some embodiments, the second portion of the frame is opposite the first portion of the frame. In some embodiments, the second ends of the first and second arms are configured to secure the catheter hub in an inclined position relative to the subject's skin during use. In some embodiments, the second ends of the first and second arms are spaced apart above a plane extending along the bottom surface of the membrane.
[0023] In some embodiments, each of the first and second arms includes a first section extending outward from the frame and a second section at the second end, the second section connected to the first section and configured to contact the catheter hub when the catheter hub is secured by the second ends of the first and second arms. In some embodiments, the second section is transverse to the first section. In some embodiments, the second section is generally perpendicular to the first section. In some embodiments, the second section is at least partially curved to conform to and surround a portion of the catheter hub when the catheter hub is secured by the second ends of the first and second arms. In some embodiments, facing surfaces of the second sections of the first and second arms have matching curvatures. In some embodiments, the first arm and the second arm are mirror images of each other.
[0024] In some embodiments, each of the first and second arms comprises a generally T-shaped structure having a stem connected to the first or second portion of the frame and a flange connected to the stem and spaced from the frame, at least a portion of the flange curved to conform to and surround a portion of the catheter hub when the catheter hub is secured by the first and second arms. In some embodiments, the frame comprises a first material and the membrane comprises a second material different from the first material. In some embodiments, the second material is more flexible than the first material. In some embodiments, the first material is more rigid than the second material. In some embodiments, the frame has an annular shape.
[0025] In some embodiments, when the catheter hub is secured by the first and second arms during use, no portion of the catheter containing device is located between the first and second arms of the hub and the subject's skin. In some embodiments, when the catheter hub is secured by the first and second arms during use, no portion of the cover contacts the catheter hub. In some embodiments, when the catheter hub is secured by the first and second arms during use, no portion of the membrane contacts the catheter hub.
[0026] In some embodiments, when the catheter hub is secured by the first and second arms during use, the catheter hub is spaced inward from the periphery of the opening. In some embodiments, the catheter hub has a first end connected to the catheter and a second end opposite the first end of the catheter hub, and when the catheter hub is secured by the first and second arms of the hub, the second end of the catheter hub does not contact the subject's skin. In some embodiments, when the catheter hub is secured by the first and second arms of the hub, only the first end of the catheter hub contacts the subject's skin. In some embodiments, when the catheter hub is secured by the first and second arms of the hub, no portion of the catheter hub contacts the subject's skin.
[0027] In some embodiments, the second ends of the first and second arms are spaced apart above a plane extending along the bottom of the frame. In some embodiments, the catheter containment device further comprises a moisture-wicking element connected to at least one of the membrane and the frame and configured to contact the subject's skin and surround the catheter insertion site when the membrane is secured to the subject's skin, the moisture-wicking element configured to wick moisture away from the catheter insertion site during use of the catheter containment device. In some embodiments, the membrane comprises a plurality of openings spaced apart from the periphery of the opening. In some embodiments, the catheter containment device further comprises one or more adhesive substrates coupled to the bottom surface of the membrane and configured to secure the membrane to the subject's skin. In some embodiments, the membrane further comprises a plurality of recesses, each recessed adjacent to one of the openings in the membrane and recessed inwardly from a plane extending along the bottom surface of the membrane, the recesses configured to allow adhesive removal liquid to flow beneath the bottom surface.
[0028] In some embodiments, the cover comprises a top and a wall extending outward from the top to define an interior. In some embodiments, the wall of the cover is configured to be removably secured to the frame of the hub. In some embodiments, the frame comprises one or more latch legs, and the wall of the cover comprises one or more latch protrusions configured to be removably secured to the one or more latch legs of the frame. In some embodiments, the one or more latch legs extend from the frame in a direction generally perpendicular to the first and second arms. In some embodiments, the wall comprises at least one latch protrusion at a first end of the wall and at least one latch protrusion at a second end of the wall opposite the first end of the wall. In some embodiments, the cover further comprises an opening extending through a portion of the wall, the opening in the cover configured to allow a fluid tube to pass through the wall and connect to the catheter hub. In some embodiments, the fluid tube connects to the catheter hub via a male Luer connector. In some embodiments, the frame is permanently secured to the membrane.
[0029] The catheter stabilization system disclosed herein includes a hub, a fluid tube assembly, and a cover. The hub is configured to be secured to the subject's skin around a catheter insertion site, the hub including an opening configured to be positioned over the catheter insertion site, and the hub is further configured to secure a catheter hub connected to the catheter to minimize movement of the catheter when inserted into the catheter insertion site. The fluid tube assembly is configured to deliver fluid to the subject, and may include a fluid tube having a first end and a second end opposite the first end, a catheter hub connector coupled to the first end of the fluid tube and configured to connect to the catheter hub to provide fluid communication between the fluid tube and the catheter connected to the catheter hub, a fluid tube locking connector coupled to the fluid tube, and a cover including a cover opening configured to receive the fluid tube and the cover connector adjacent to the cover opening. The cover is removably secured to the hub and configured to surround the catheter insertion site of the subject. When the fluid tube locking connector and the cover connector are disconnected, movement of the fluid tube locking connector and the cover along the fluid tube is permitted. When the fluid tube locking connector and the cover connector are connected, the fluid tube locking connector and the cover are prevented from moving along the fluid tube.
[0030] In some embodiments, the fluid tube assembly further comprises a sleeve coupled to the fluid tube, wherein the sleeve prevents movement of the fluid tube locking connector and the cover along the fluid tube when the fluid tube locking connector and the cover connector are connected to each other. In some embodiments, pressure is applied to the sleeve when the fluid tube locking connector and the cover connector are connected to each other. In some embodiments, the sleeve has a tubular shape. In some embodiments, the sleeve has a length that is shorter than the fluid tube.
[0031] In some embodiments, the fluid tube locking connector and the cover connector are configured to threadably connect to one another. In some embodiments, the fluid tube locking connector and the cover connector are configured to connect to one another via a snap-fit engagement. In some embodiments, the cover includes a top and a wall extending outwardly from the top to define an interior, and the cover connector extends outwardly from the wall of the cover. In some embodiments, the fluid tube locking connector includes a body having a threaded interior and an opening configured to receive a fluid tube, and the cover connector includes a threaded portion configured to threadably engage with the threaded interior of the body. In some embodiments, the fluid tube locking connector includes a notch recessed from an outer surface of the body, and the cover connector further includes a latch arm configured to snap into the notch when the threaded portion is threaded into the threaded interior of the body.
[0032] In some embodiments, the fluid tubing assembly further comprises a stopper permanently secured to a portion of the fluid tubing and configured to be disposed between the catheter hub connector and the cover opening, the stopper configured to prevent the fluid tubing from being withdrawn through the cover opening. In some embodiments, the stopper has an annular shape extending around an entire cross section of the portion of the fluid tubing. In some embodiments, the stopper has a circular cross section. In some embodiments, the stopper is spaced from the catheter hub connector by a gap, thereby defining a flexible coupling.
[0033] In some embodiments, when the fluid tube locking connector and the cover connector are disconnected from one another, the fluid tube locking connector and the cover are permitted to slide along the fluid tube, and when the fluid tube locking connector and the cover connector are connected, the fluid tube locking connector and the cover are prevented from sliding along the fluid tube. In some embodiments, the catheter hub connector is a male Luer connector. In some embodiments, a wall of the cover is configured to removably connect to the hub.
[0034] In some embodiments, the hub further comprises: a membrane configured to contact and secure against the subject's skin, the membrane including an opening configured to be positioned over a catheter insertion site; and at least one arm coupled to the membrane and extending partially across the opening, the at least one arm configured to rest on the subject's skin when the membrane is secured to the subject's skin, the free end of the at least one arm spaced inwardly from the periphery of the opening and configured to secure a catheter hub connected to a catheter to minimize movement of the catheter when inserted into the catheter insertion site. In some embodiments, the at least one arm comprises a pair of opposing arms, the free ends of the pair of opposing arms spaced apart from one another by a gap and configured to secure the catheter hub during use of the catheter containment device.
[0035] In some embodiments, the hub further comprises a frame connected to the membrane along at least a portion of the periphery of the opening (e.g., all or less than all of the periphery of the opening). In some embodiments, the at least one arm comprises: a first arm extending outward from a first portion of the frame and partially across the opening, the first arm having a connected end connected to the first portion of the frame and a free end opposite the connected end of the first arm; and a second arm extending outward from a second portion of the frame and partially across the opening toward the first arm, the second arm having a connected end connected to the second portion of the frame and a free end opposite the connected end of the second arm, the free ends of the first and second arms being spaced inward from the periphery of the opening and spaced apart by a gap and configured to secure the catheter hub during use of the catheter containing device. In some embodiments, the free ends of the first and second arms are configured to secure the catheter hub in an inclined position against the subject's skin during use. In some embodiments, the free ends of the first and second arms are spaced apart on a plane extending along the bottom surface of the membrane. In some embodiments, each of the first and second arms comprises a generally T-shaped structure having a stem connected to the first or second portion of the frame and a flange connected to the stem and spaced apart from the frame, at least a portion of the flange being curved to conform to and surround a portion of the catheter hub when the catheter hub is secured by the first and second arms. In some embodiments, each of the first and second arms comprises a first section extending outward from the frame and a second section connected at a free end to the first section and configured to contact the catheter hub when the catheter hub is secured by the free ends of the first and second arms. In some embodiments, the second section is transverse to the first section. In some embodiments, the second section is at least partially curved to conform to and surround a portion of the catheter hub when the catheter hub is secured by the free ends of the first and second arms.In some embodiments, the facing surfaces of the second sections of the first and second arms have matching curvatures.
[0036] Disclosed herein is a method for stabilizing a catheter hub connected to a catheter inserted into a catheter insertion site of a subject to minimize catheter movement, the method comprising the steps of obtaining a hub having a membrane having an opening, a frame connected to the membrane along a periphery of the opening, a first arm extending outward from a first portion of the frame and partially across the opening, and a second arm extending outward from a second portion of the frame and partially across the opening toward the first arm, positioning the opening in the membrane over the catheter insertion site and securing the membrane to the subject's skin, securing the catheter hub at the first and second arms of the hub, and enclosing the catheter insertion site by securing a cover to the hub.
[0037] In some embodiments, the hub further comprises at least one positioning indicator, and positioning the membrane opening over the catheter insertion site further comprises aligning the at least one positioning indicator with the catheter insertion site. In some embodiments, the hub further comprises two positioning indicators, and positioning the membrane opening over the catheter insertion site further comprises aligning an axis extending between the two positioning indicators with the catheter insertion site. In some embodiments, the at least one positioning indicator extends outwardly from the frame.
[0038] In some embodiments, the method further includes securing a male luer connector to a catheter hub to provide fluid communication between the catheter hub and a fluid tubing coupled to the male luer connector. In some embodiments, the step of enclosing the catheter insertion site by securing the cover to the hub occurs after the step of securing the male luer connector to the catheter hub. In some embodiments, the cover includes a cover opening that receives a fluid tubing, and the method further includes moving the cover along the fluid tubing toward the hub before securing the cover to the hub.
[0039] In some embodiments, the cover further comprises a cover connector adjacent the cover opening, and the method further comprises securing the fluid tube locking connector coupled to the fluid tube to the cover connector to prevent the fluid tube locking connector and the cover from moving along the fluid tube. In some embodiments, a sleeve is disposed around the fluid tube and within at least a portion of the fluid tube locking connector, and securing the fluid tube locking connector to the cover connector causes the sleeve to grip the fluid tube and prevent the fluid tube locking connector and the cover from moving along the fluid tube. In some embodiments, the fluid tube locking connector comprises a body having a threaded interior and an opening disposed around the fluid tube, the cover connector comprising a threaded portion, and securing the fluid tube locking connector to the cover connector comprises engaging the threaded portion of the cover connector with the threaded interior of the body of the fluid tube locking connector. In some embodiments, the fluid tube locking connector comprises a notch recessed from an outer surface of the body, and the cover connector further comprises a latch arm, and the step of securing the fluid tube locking connector to the cover connector further comprises engaging a threaded portion of the cover connector with a threaded interior of the body of the fluid tube locking connector until the latch arm clicks into engagement with the notch.
[0040] In some embodiments, the cover comprises a top and a wall extending outwardly from the top to define an interior, the wall comprising the cover opening, and securing the cover to the hub comprises securing the wall of the cover to a frame of the hub. In some embodiments, the frame comprises one or more latch legs, the wall of the cover comprises one or more latch protrusions, and securing the wall of the cover to the frame of the hub comprises engaging the one or more latch legs with the one or more latch protrusions.
[0041] In some embodiments, securing the membrane to the subject's skin includes securing the membrane to the subject's skin using an adhesive layer disposed on a bottom surface of the membrane. In some embodiments, the method further includes removing a release liner from the adhesive layer disposed on the bottom surface of the membrane before securing the membrane to the subject's skin. In some embodiments, the method further includes removing a first portion of a release liner from a first portion of an adhesive layer disposed on the bottom surface of the membrane, securing the first portion of an adhesive layer to the subject's skin, removing a second portion of the release liner from the second portion of an adhesive layer, and securing the second portion of an adhesive layer to the subject's skin.
[0042] In some embodiments, the first arm has a first end connected to the first portion of the frame and a second end opposite the first end of the first arm, and the second arm has a first end connected to the second portion of the frame and a second end opposite the first end of the second arm, the second ends of the first and second arms being spaced inwardly from the periphery of the opening and spaced apart from each other by a gap, and securing the catheter hub to the first and second arms of the hub includes positioning the catheter hub between the first and second ends of the second arms. In some embodiments, the second portion of the frame is opposite the first portion of the frame. In some embodiments, securing the catheter hub to the first and second arms of the hub includes securing the catheter hub in an inclined position relative to the subject's skin. In some embodiments, the second ends of the first and second arms are spaced apart above a plane extending along the bottom surface of the membrane.
[0043] In some embodiments, each of the first and second arms comprises a first section extending outward from the frame and a second section connected to the first section at a second end, and configured to contact the catheter hub when the catheter hub is secured by the second ends of the first and second arms, the second section being at least partially curved, and securing the catheter hub to the first and second arms of the hub includes securing the catheter hub between the at least partially curved second sections of the first and second arms.
[0044] In some embodiments, the step of securing the catheter hub to the first and second arms of the hub includes securing the catheter hub to the first and second arms such that no portion of the hub is located between the first and second arms and the subject's skin. In some embodiments, no portion of the cover contacts the catheter hub when the catheter hub is secured by the first and second arms of the hub. In some embodiments, no portion of the membrane contacts the catheter hub when the catheter hub is secured by the first and second arms of the hub.
[0045] In some embodiments, securing the catheter hub to the first and second arms of the hub includes securing the catheter hub to the first and second arms such that the catheter hub is spaced inward from a perimeter of the opening. In some embodiments, the catheter hub includes a first end connected to the catheter and a second end opposite the first end of the catheter hub, and securing the catheter hub to the first and second arms of the hub includes securing the catheter hub to the first and second arms such that the second end of the catheter hub does not contact the subject's skin. In some embodiments, securing the catheter hub to the first and second arms of the hub further includes securing the catheter hub to the first and second arms such that only the first end of the catheter hub contacts the subject's skin. In some embodiments, the catheter hub has a first end connected to the catheter and a second end opposite the first end of the catheter hub, and securing the catheter hub to the first and second arms of the hub includes securing the catheter hub to the first and second arms such that no portion of the catheter hub contacts the subject's skin.
[0046] In some embodiments, the membrane comprises a plurality of openings spaced apart from a periphery of the openings, a bottom surface and an adhesive layer disposed on the bottom surface, and a plurality of recesses, each recess disposed adjacent one of the plurality of openings and recessed inwardly from a plane extending along the bottom surface of the membrane. The method may further include allowing an adhesive removal liquid to flow through the plurality of openings and along the subject's skin beneath the plurality of recesses. In some embodiments, the adhesive removal liquid comprises alcohol. In some embodiments, the method further includes removing at least a portion of the bottom surface of the membrane from the subject's skin after flowing the adhesive removal liquid through the plurality of openings and along the subject's skin beneath the plurality of recesses.
[0047] Disclosed herein is a fluid tube locking system for use with a fluid tube, the system comprising: a first connector configured to be coupled to the fluid tube; and a second connector configured to be coupled to the fluid tube and further configured to be removably connected to the first connector, wherein when the first and second connectors are disconnected from each other, movement of at least one of the first connector and the second connector relative to the fluid tube is permitted, and when the first and second connectors are connected to each other, movement of the first and second connectors relative to the fluid tube is prevented.
[0048] In some embodiments, the first and second connectors are configured to threadably connect to one another. In some embodiments, the first and second connectors are configured to connect to one another via a snap-fit engagement. In some embodiments, the first connector comprises a body and an opening configured to receive the fluid tube, the body having a threaded interior, and the second connector comprising a threaded portion configured to threadably engage with the threaded interior of the body of the first connector. In some embodiments, the first connector comprises a notch recessed from an outer surface of the body, and the second connector further comprises a latch arm configured to snap-engage with the notch when the threaded portion of the second connector threads into the threaded interior of the body. In some embodiments, the fluid tube locking system further comprises a sleeve configured to be coupled to the fluid tube, and when the first and second connectors are connected to one another, movement of the first and second connectors relative to the fluid tube is prevented by the sleeve.
[0049] In some embodiments, when the first and second connectors are connected to each other, pressure is applied to the sleeve. In some embodiments, the sleeve is operably positioned by the first connector. In some embodiments, the sleeve is disposed within a body of the first connector. In some embodiments, the sleeve has a tubular shape. In some embodiments, the sleeve has a length shorter than the fluid tube. In some embodiments, the fluid tube locking system further comprises the fluid tube. In some embodiments, when the first and second connectors are disconnected from each other, sliding of the first and second connectors along the fluid tube is permitted, and when the first and second connectors are connected to each other, sliding of the first and second connectors along the fluid tube is prevented.
[0050] In some embodiments, the fluid tube lock system further comprises a cover configured to be placed over a catheter insertion site of a subject to enclose the catheter insertion site, the cover comprising the second connector. In some embodiments, the cover comprises an upper portion and a wall extending outwardly from the upper portion to define an interior, the second connector extending outwardly from the wall of the cover. In some embodiments, the cover comprises a wall opening configured to receive the fluid tube.
[0051] Disclosed herein is a catheter housing configured to surround a catheter insertion site of a user, the catheter housing comprising a hub, a cover, and an expansion set. The hub is configured to be positioned around the catheter insertion site of a user and comprises a membrane configured to be secured to the user's skin, the membrane having an opening configured to surround the catheter insertion site during use of the catheter housing. The cover is configured to at least partially surround the catheter insertion site and comprises an upper portion, a wall extending transversely to the upper portion to define a perimeter of the cover, and an opening extending through a portion of the wall. The expansion set is configured to be secured to a catheter device coupled to the cover and catheter to facilitate fluid communication between the catheter and a tubing of the expansion set. The expansion set comprises: a tube configured to be received through the opening in the cover, the tube having a first end and a second end opposite the first end; a first connector configured to secure to the first end of the tube and to a portion of the catheter device; and a second connector disposed along the tube and configured to engage a portion of the cover at the opening to secure the expansion set to the cover.
[0052] In some embodiments, the cover and the hub are permanently coupled. In some embodiments, at least one of the cover and the hub is configured to slide along the tube when the second connector secures the expansion set to the cover. In some embodiments, the catheter housing further comprises a third connector, wherein the second and third connectors are configured to be secured to one another and sandwich a portion of the cover around the opening. In some embodiments, the cover further comprises a rim protruding outward from the wall surrounding the opening, and the second connector is configured to engage the edge of the cover to secure the expansion set to the cover. In some embodiments, the second connector comprises a flange and a stem, wherein the stem has a smaller cross-section than the flange and is configured to extend through at least a portion of the opening in the cover, and the flange is configured to contact the cover when the stem is positioned at least partially through the opening in the cover. In some embodiments, the expansion set further comprises a third connector configured to secure to the stem of the second connector. In some embodiments, when the third connector is secured to the stem of the second connector, the second and third connectors sandwich a portion of the cover around the opening. In some embodiments, the second connector further comprises a body connected to and disposed between the stem and the flange, the body having a smaller cross-section than the flange and further comprising one or more protrusions extending outward from a surface of the body, the cover further comprising a rim protruding outward from a wall around the opening, the rim comprising one or more notches configured to allow the one or more protrusions to pass through. In some embodiments, the second connector comprises an opening extending through a center of the second connector, the opening of the second connector configured to receive a tube. In some embodiments, the cover further comprises a bridge extending outward from an inner surface of an upper portion of the cover, the bridge configured to surround a portion of the first connector. In some embodiments, the bridge is configured to surround less than the entire circumference of the cross-section of the first connector. In some embodiments, the first connector is a male luer connector.
[0053] Although certain aspects, advantages, and novel features of embodiments of the invention have been described herein, it is to be understood that not necessarily all such advantages can be achieved in accordance with any particular embodiment of the invention disclosed herein. Thus, the inventions disclosed herein may achieve one advantage or group of advantages taught herein, or may be embodied or carried out in selected ways, without necessarily achieving other advantages that may be taught or suggested herein. [Brief explanation of the drawings]
[0054] Certain features of the present disclosure are described below with reference to the drawings. The illustrated embodiments are for illustrative purposes only and are not intended to be limiting. Various features of different disclosed embodiments can be combined to form additional embodiments that are part of this disclosure.
[0055] [Figure 1A] 1 shows a top perspective view of a catheter housing device according to aspects of the present disclosure. [Figure 1B] 1 shows a top perspective view of a catheter housing device according to aspects of the present disclosure. [Figure 1C] 1A-1B show bottom perspective views of the catheter-containing device of FIGS. 1A-1B, according to an embodiment of the present disclosure. [Figure 1D] 1A-1B, showing another top perspective view of the catheter-containing device of FIGS. 1A-1B, with the cover of the catheter-containing device shown as transparent, according to an embodiment of the present disclosure. FIG. [Figure 1E] 1A-1B in use on the skin of a subject, according to an embodiment of the present disclosure. FIG. [Figure 1F] FIG. 1C shows a top perspective view of a cover of the catheter-containing device of FIGS. 1A-1B, according to an embodiment of the present disclosure. [Figure 1G] FIG. 1C shows a top perspective view of a cover of the catheter-containing device of FIGS. 1A-1B, according to an embodiment of the present disclosure. [Figure 1H] FIG. 1F shows a top view of the cover of FIGS. 1F-1G according to an embodiment of the present disclosure. [Figure 1I] FIG. 1F shows a bottom view of the cover of FIGS. 1F-1G according to an embodiment of the present disclosure. [Figure 1J] FIG. 1F shows a side view of the cover of FIGS. 1F-1G according to an embodiment of the present disclosure. [Figure 1K] FIG. 1F shows a side view of the cover of FIGS. 1F-1G according to an embodiment of the present disclosure. [Figure 1L] FIG. 1F illustrates a rear view of the cover of FIGS. 1F-1G according to an embodiment of the present disclosure. [Figure 1M] FIG. 1F shows a front view of the cover of FIGS. 1F-1G according to an embodiment of the present disclosure. [Figure 1N] 1F-1G according to an embodiment of the present disclosure. [Figure 1O] FIG. 1C shows a top perspective view of a hub of the catheter-containing device of FIGS. 1A-1B, according to an embodiment of the present disclosure. [Figure 1P] FIG. 1C shows a bottom perspective view of the hub of the catheter-containing device of FIGS. 1A-1B, according to an embodiment of the present disclosure. [Figure 1Q] 1A-1B show an expanded set of catheter-containing devices according to an embodiment of the present disclosure. [Figure 1R] 1A-1B show a portion of an expansion set of the catheter housing device of FIGS. 1A-1B, according to an embodiment of the present disclosure. [Figure 1S] 1A-1B show a portion of an expansion set of the catheter housing device of FIGS. 1A-1B, according to an embodiment of the present disclosure. [Figure 1T] 1A-1B show a portion of an expansion set of the catheter housing device of FIGS. 1A-1B, according to an embodiment of the present disclosure. [Figure 1U] 10A-10C illustrate alternative embodiments of covers for catheter containing devices in accordance with aspects of the present disclosure. [Figure 1V] 10A-10C illustrate alternative embodiments of covers for catheter containing devices in accordance with aspects of the present disclosure. [Figure 1W] 10A-10C illustrate alternative embodiments of covers for catheter containing devices in accordance with aspects of the present disclosure. [Figure 1X] 10A-10C illustrate alternative embodiments of covers for catheter containing devices in accordance with aspects of the present disclosure. [Figure 1Y]10A-10C illustrate alternative embodiments of covers for catheter containing devices in accordance with aspects of the present disclosure. [Figure 1Z] 10A-10C illustrate alternative embodiments of covers for catheter containing devices in accordance with aspects of the present disclosure. [Figure 2A] 1 shows a perspective view of a catheter containing device according to aspects of the present disclosure. [Figure 2B] 1 shows a perspective view of a catheter containing device according to aspects of the present disclosure. [Figure 2C] 1 shows a perspective view of a catheter containing device according to aspects of the present disclosure. [Figure 2D] 2A-2C according to an embodiment of the present disclosure. [Figure 2E] 2A-2C according to an embodiment of the present disclosure. FIG. [Figure 2F] 2A-2C in use on the skin of a subject, according to an embodiment of the present disclosure. FIG. [Figure 2G] 2A-2C show exploded views of the catheter housing device according to an embodiment of the present disclosure. [Figure 2H] 2A-2C, according to an embodiment of the present disclosure. FIG. [Figure 2I] 2A-2C, according to an embodiment of the present disclosure. FIG. [Figure 2J] 2A-2C, according to an embodiment of the present disclosure. FIG. [Figure 2K] 2A-2C, according to an embodiment of the present disclosure. FIG. [Figure 2L] 2A-2C, according to an embodiment of the present disclosure. FIG. [Figure 2M] 2A-2C, according to an embodiment of the present disclosure. FIG. [Figure 2N] 2A-2C, according to an embodiment of the present disclosure. FIG. [Figure 2O]2A-2C, according to an embodiment of the present disclosure. FIG. [Figure 2P] 2A-2C, according to an embodiment of the present disclosure. FIG. [Figure 2Q] 2A-2C, according to an embodiment of the present disclosure. FIG. [Figure 2R] 2A-2C, according to an embodiment of the present disclosure. FIG. [Figure 2S] 2A-2C, according to an embodiment of the present disclosure. FIG. [Figure 2T] 2A-2C, according to an embodiment of the present disclosure. FIG. [Figure 2U] 2A-2C, according to an embodiment of the present disclosure. FIG. [Figure 2V] 2A-2C, according to an embodiment of the present disclosure. FIG. [Figure 2W] 2A-2C, according to an embodiment of the present disclosure. FIG. [Figure 2X] 2A-2C, according to an embodiment of the present disclosure. FIG. [Figure 2Y] 2S-2X according to an embodiment of the present disclosure. [Figure 2Z] 2S-2X show cross-sectional views through the hub of FIGS. 2S-2X according to an embodiment of the present disclosure. [Figure 2AA] 2S-2X show cross-sectional views through the hub of FIGS. 2S-2X according to an embodiment of the present disclosure. [Figure 2BB] 2A-2C illustrate an exemplary method of using the catheter containing device of FIGS. 2A-2C according to an embodiment of the present disclosure. [Figure 2CC] 2A-2C illustrate an exemplary method of using the catheter containing device of FIGS. 2A-2C according to an embodiment of the present disclosure. [Figure 2DD] 2A-2C illustrate an exemplary method of using the catheter containing device of FIGS. 2A-2C according to an embodiment of the present disclosure. [Figure 2EE] 2A-2C illustrate an exemplary method of using the catheter containing device of FIGS. 2A-2C according to an embodiment of the present disclosure. [Figure 2FF] 2A-2C illustrate alternative implementations of a hub for the catheter-containing device of FIGS. 2A-2C, according to an embodiment of the present disclosure. [Figure 2GG] 2A-2C illustrate alternative implementations of a hub for the catheter-containing device of FIGS. 2A-2C, according to an embodiment of the present disclosure. [Figure 2HH] 2A-2C illustrate alternative implementations of a hub for the catheter-containing device of FIGS. 2A-2C, according to an embodiment of the present disclosure. [Figure 2II] 2A-2C illustrate alternative implementations of a hub for the catheter-containing device of FIGS. 2A-2C, according to an embodiment of the present disclosure. [Figure 2JJ] 2FF-2II show cross-sectional views of the hub of FIGS. 2FF-2II according to an embodiment of the present disclosure. [Figure 2KK] 1A-1C illustrate exemplary implementations of one or more release liners for a catheter-containing device according to aspects of the present disclosure. [Figure 2LL] 1A-1C illustrate exemplary implementations of one or more release liners for a catheter-containing device according to aspects of the present disclosure. [Figure 2MM] 1A-1C illustrate exemplary implementations of one or more release liners for a catheter-containing device according to aspects of the present disclosure. [Figure 3A] 1 shows a perspective view of a catheter containing device according to aspects of the present disclosure. [Figure 3B] 1 shows a perspective view of a catheter containing device according to aspects of the present disclosure. [Figure 3C] 1 shows a perspective view of a catheter containing device according to aspects of the present disclosure. [Figure 3D] 3A-3C according to an embodiment of the present disclosure. [Figure 3E] 3A-3C according to an embodiment of the present disclosure. FIG. [Figure 3F] 3A-3C in use on the skin of a subject, according to an embodiment of the present disclosure. FIG. [Figure 3G] 2A-2C show exploded views of the catheter housing device according to an embodiment of the present disclosure. [Figure 3H] 3A-3C according to an embodiment of the present disclosure. FIG. [Figure 3I] 3A-3C according to an embodiment of the present disclosure. FIG. [Figure 3J] 3A-3C according to an embodiment of the present disclosure. FIG. [Figure 3K] 3A-3C according to an embodiment of the present disclosure. FIG. [Figure 3L] 3A-3C show perspective views of an expansion set of the catheter-containing device according to an embodiment of the present disclosure. [Figure 3M] 3A-3C, according to an embodiment of the present disclosure. FIG. [Figure 3N] 3A-3C, according to an embodiment of the present disclosure. FIG. [Figure 3O] 3A-3C, according to an embodiment of the present disclosure. FIG. [Figure 3P] 3A-3C, according to an embodiment of the present disclosure. FIG. [Figure 3Q] 3A-3C, according to an embodiment of the present disclosure. FIG. [Figure 3R] 3M-3Q show exploded views of the hub according to an embodiment of the present disclosure. [Figure 3S] 3M-3Q show cross-sectional views through the hub of FIGS. 3M-3Q according to an embodiment of the present disclosure. [Figure 3T] 3M-3Q show cross-sectional views through the hub of FIGS. 3M-3Q according to an embodiment of the present disclosure. [Figure 3U] 3M according to an embodiment of the present disclosure. FIG. [Figure 3V] 3M-3Q show the catheter, catheter hub, male luer connector, and tubing secured by the hub, according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION
[0056] Various features and advantages of the disclosed technology will become more fully apparent from the following description of several specific illustrated embodiments. These embodiments are intended to illustrate the principles of the present disclosure. However, the present disclosure should not be limited to only the illustrated embodiments. Features of the illustrated embodiments can be modified, combined, removed, and / or substituted, as will be apparent to those skilled in the art in light of the principles disclosed herein.
[0057] 1A-1T illustrate a catheter housing 100 (which may also be referred to as a "catheter housing device," "catheter stabilizing device," or "catheter stabilizing system") and various aspects and / or portions thereof, as further described below. The catheter housing 100, or portions thereof, may be similar or identical in some or many respects to any of the catheter housings (or portions thereof) discussed in commonly owned U.S. Patent Application Publication No. 2019 / 0388652, the entirety of which is incorporated herein by reference.
[0058] The catheter housing 100 may include a cover 120, which is shown with other portions / components of the catheter housing 100 in Figures 1A-1E and shown alone in Figures 1F-1N. Additionally, the catheter housing 100 may include a hub 160, which is shown with other portions / components of the catheter housing 100 in Figures 1A-1E and shown alone in Figures 1O-1P. Additionally, the catheter housing 100 may include an extension set 140, which is shown with other portions / components of the catheter housing 100 in Figures 1A-1E and shown alone in Figures 1Q-1R. Some embodiments of the catheter housing 100 do not include the extension set 140. In some embodiments, the cover 120 and hub 160 form a unitary structure and are coupled to the tube 147 of the extension set 140 such that the cover, hub 160, and extension set 140 form a unitary structure. The catheter housing 100 can be used, for example, in a manner similar or identical to that discussed in U.S. Patent Application Publication No. 2019 / 0388652 to stabilize a catheter as it is inserted into a catheter insertion site in a subject. As described in more detail below, stabilization of the catheter can be achieved by engagement with a catheter hub connected to such a catheter. Additionally, or alternatively, in some embodiments, stabilization of the catheter is achieved by engagement with a male luer connector connected to the catheter hub.
[0059] 1A-1B show a top perspective view of the catheter housing 100, and FIG. 1C shows a bottom perspective view of the catheter housing 100. FIG. 1D shows a top perspective view of the catheter housing 100 with the cover 120 shown as transparent to better show the interior of the cover 100, the catheter 141, the catheter hub 142, and the connector 143 (also referred to herein as the "catheter hub connector"). FIG. 1E shows a cross-sectional view of a portion of the catheter housing 100, which is described further below. FIG. 1E illustrates an exemplary manner in which the catheter housing 100 may be positioned and / or secured to a subject's skin during use. FIG. 1E shows a partial cross-sectional view through the cover 120 and the hub 260 to better show the components within the interior area defined by the cover 120, the hub 260, and the subject's skin. FIG. 1E further shows the connector 146 and the tubing 147 (also referred to as "tubing" or "fluid tubing"), each of which is described further below.
[0060] 1F-1N show various views of cover 120. Cover 120 may be similar or identical in some or many respects to any of the covers discussed in U.S. Patent Application Publication No. 2019 / 0388652. Cover 120 may include an upper portion 123a and a wall 123b extending outward from upper portion 123a, where such wall 123b may define an interior of cover 120. Such upper portion 123a and wall 123b may form a body of cover 120. In some embodiments, such as those shown in FIGS. 2H-2Q, cover 120 includes only a single wall (wall 123b) extending from upper portion 123a, where such single wall 123b defines the interior of cover 120. Wall 123b may extend laterally (e.g., generally vertically) through such upper portion 123a. Wall 123b may define a perimeter of cover 120. Cover 120 can be made of a variety of materials, including plastics such as polyphenyl ether (PPE), polycarbonate (PC), among others. In some embodiments, the cover is transparent or translucent. In some embodiments, cover 120 is made of a material that is more rigid than hub 160 or portions of hub 160. For example, in some embodiments, cover 120 is made of a material that is more rigid than membrane 162 of hub 160.
[0061] In some embodiments, cover 120 includes one or more wings 122 that may extend outward from wall 123b and / or top 123a. Wings 122 extend outward from wall 123b and / or top 123a and may be utilized to secure tubing 147 during use. For example, to reduce the likelihood that tubing 147 will interfere with an IV procedure and / or be inadvertently pulled, tubing 147 may be secured to wings 122 and wrapped around a portion of cover 120 during use. Wings 122 may include openings 122a (which may also be referred to as "slots") that allow viewing of a portion of tubing 147, for example, to determine whether fluid is present in tubing 147 and / or whether fluid is flowing through tubing 147 to a subject. Such openings 122a may further facilitate removal of tube 147 from wing(s) 122 by, for example, allowing a finger or tool to be inserted through opening 122a to push tube 147 out of engagement with wing(s) 122. Wing 122 may include one or more ribs 122b (e.g., 1, 2, 3, 4, 5, or 6 or more ribs 122b), which may be spaced apart from one another to aid a user in grasping and / or handling cover 120 and / or catheter housing 100.
[0062] Wall 123b may define a perimeter of cover 120. In some embodiments, cover 120 includes a flange 179 (also referred to herein as a "bottom flange") extending outwardly from wall 123b (e.g., the lower end of wall 123b opposite top portion 123a). With reference to at least FIGS. 1F-1G, 1E, and 1O, flange 179 may be disposed within slot 169 of hub 160 during manufacturing of catheter housing 100, as described further below, to permanently seal and / or secure cover 120 to hub 160. In some variations, flange 179 has a non-uniform shape and / or perimeter (such as the illustrated flower shape), which may provide space for a sealant / material to be disposed between flange 179 and a portion of slot 169 of hub component 160 to facilitate bonding.
[0063] As shown in FIGS. 1G and 1L, cover 120 includes opening 133 (also referred to herein as a "cover opening"). Opening 133 may be positioned at or near an end of cover 120. Opening 133 may extend through wall 123b. Cover 120 may include a rim 131 (also referred to herein as a "connector" or "cover connector") that extends outward from the inner and / or outer surface of cover 120 (e.g., wall 123b) around opening 133. Rim 131 may extend outward from the outer surface of cover 120 around opening 133 a distance greater than, equal to, or less than the distance it extends inward from the inner surface of cover 120 around opening 133 (see, for example, FIG. 1N). Rim 131 may be cylindrical, among other shapes. The rim 131 may include one or more notches 135, e.g., one, two, three, four, five, or six or more notches 135. The rim 131 may include multiple notches 135 spaced apart from one another, e.g., radially spaced apart from one another along and / or around the outer periphery and / or circumference of the rim 131 and / or radially spaced apart from one another with respect to an axis extending through the center of the opening 133. In some embodiments, four notches 135 are disposed at 90 degrees from one another along the rim 131 (see FIG. 1L). The rim 131 may be sized and / or shaped to receive and / or secure the connectors 144 and / or 146 of the expansion set 140, as described further below (see FIGS. 1E and 1R-1T). The fixation between rim 131 and connectors 144 and / or 146 may advantageously prevent movement of cover 120 and / or hub 160 along tube 147, for example, to keep cover 120 and / or hub 160 in place when secured to the subject's skin.
[0064] 1I and 1N, the cover 120 may include an arm 126 (also referred to as a "stabilizing arm" or "stabilizing portion" or "mechanical stabilizing device") that may help stabilize the catheter 141 when inserted into a catheter insertion site by engaging a connector 143 that may connect to a catheter hub 142 connected to the catheter 141. While the arm 126 is shown and described as engaging with the connector 143, in some variations, the arm 126 may be configured to engage with the catheter hub 142. The arm 126 may advantageously facilitate stabilization of the catheter 141 by holding, securing, and / or aligning the connector 143, which may advantageously minimize movement of the catheter 141 when inserted into a catheter insertion site. As described elsewhere herein, arm 126 may cooperate with connector 144, opening 133, connector 146, and / or tube 147 to stabilize catheter 141 (e.g., by positioning and stabilizing catheter 141, catheter hub 142 in an appropriate inclined position relative to catheter hub 142).
[0065] Arms 126 may extend from an inner surface of cover 120. For example, as shown, arms 126 may extend from an inner surface of cover 120 opposite an outer surface of cover 120 at and / or along top 123a of cover 120, and at least partially toward the subject's skin. The size, shape, and / or configuration of arms 126 of cover 120 may be similar or identical in some or many respects to those discussed with respect to any of the locks and / or bridges of the covers described in U.S. Patent Application Publication No. 2019 / 0388652 (Patent Document 1).
[0066] The arm 126 may extend laterally (e.g., vertically) from the cover 120 (e.g., from the inner surface of the upper portion 123a of the cover 120). The arm 126 may have a first end connected to the upper portion 123a (e.g., the inner surface of the upper portion 123a) and a second end including a recess opposite the first end. Such a recess may be sized and / or shaped to surround a portion of the connector 143 (and / or the catheter hub 142 with which the arm 126 is configured to engage). Such a recess may be, for example, round and / or circular, or arcuate, among other shapes. Such a recess may span less than the entire cross-sectional circumference of the connector 143 when the catheter housing 100 is in use, e.g., less than about 80%, less than about 70%, less than about 60%, less than about 50%, less than about 40%, or less than about 30% of the entire cross-sectional circumference of the connector 143. Such a configuration allows the cover 120 to more easily engage and disengage with the connector 143, thereby facilitating easier assembly of the catheter housing 100 onto the subject.
[0067] In some embodiments, the catheter housing 100 includes one or more UV light sources that, when the catheter housing 100 is in use, illuminate and / or disinfect the catheter insertion site where the catheter 141 is inserted into the subject's body, and / or the interior of the cover 120 and / or the area around the various components housed within the cover 120. With reference to FIGS. 1I and 1N, the cover may include one or more light source housings 177, such as one, two, three, or four or more light source housings 177. The light source housings 177 may extend from a portion of the cover 120, such as the inner surface of the top portion 123a of the cover 120. The light source housings 177 may include a recess and / or cavity for receiving and / or securing a UV light source. The light source housing 177 and / or the recess / cavity defined thereby may be sized, shaped, and / or otherwise configured to direct light emitted from the UV light source toward the catheter insertion site, the patient's skin, the catheter 141, the catheter hub 142, the connector 143, and / or a portion of the tube 147 located at an interior area at least partially defined by the cover 120 (see FIG. 1E ). In some embodiments, the light source housing 177 and / or the recess / cavity defined thereby may be sized, shaped, and / or otherwise configured to direct light emitted from the UV light source at an angle toward the catheter insertion site, the patient's skin, the catheter 141, and / or the catheter hub 142. For example, the light source housing 177 and / or the recess / cavity defined thereby may be angled as shown in FIGS. 1N and 1E so that the emitted light is directed primarily toward the catheter insertion site. The UV light source may be a UV surface-mounted LED (SMD LED) and / or a UV-C light source. In some embodiments, the UV light source may include a UV LED. In some embodiments, the cover 120 includes two light source housings 177 spaced apart from one another, extending from the inner surface of the top 123a of the cover 120, and positioned adjacent to opposing sides / portions of the wall 123b of the cover 120 (see FIG. 1I).
[0068] The UV light source may be controlled by a controller (e.g., a 4-bit processor) that can implement a variety of user-selectable schemes by controlling not only the exposure time but also the intensity of the emitted light. The controller allows for a variety of advanced disinfection schemes based on the patient type and / or condition. For example, the UV light source may be turned on intermittently, periodically at a predetermined on-time, or as needed based on a measure of site infection. One measure is the dose of UV light required to inactivate a particular type of bacteria or virus that may be present on the skin. This may be controlled by the intensity and duration of the UV light source. In some embodiments, the UV light source is configured to automatically turn off when the cover 120 and / or hub 160 are moved (e.g., removed from the patient's skin). The controller may include a processor and / or memory and be integrated into one or more printed circuit boards. In some embodiments, such a controller may be mounted as part of the catheter housing 100. However, in some variations, such a controller may be included in a separate device and communicate (e.g., wirelessly) with a communications module mounted on the catheter housing 100 that is coupled to the UV light source.
[0069] The UV light source can be operated continuously or periodically / intermittently. For example, the UV light source can be configured to turn on and / or off according to a timing protocol, such as every 30 minutes, hour, 2 hours, 3 hours, or 4 hours, among others. The UV light source can be configured to irradiate the catheter insertion site and / or the surrounding skin with various wavelengths. The UV light source can be configured to emit light at wavelengths bounded by between about 100 and about 500 nm, between about 200 and about 400 nm, between about 200 and about 300 nm, between about 210 and about 290 nm, between about 220 and about 280 nm, between about 230 and about 270 nm, between about 240 and about 260 nm, between about 200 and about 250 nm, between about 220 and about 230 nm, or between about 220 and about 350 nm, or any value or range therebetween, or any combination of these values or ranges, although values outside these values or ranges can also be used in some cases. In some configurations, the UV light source can be configured to emit light at a wavelength of approximately 220 nm. The UV light source can be configured to irradiate the catheter insertion site and / or surrounding skin with short-wavelength ultraviolet light. In some configurations, the radiation exposure time of the UV light source can be selected to provide beneficial disinfection of the catheter insertion site and / or surrounding skin while minimizing the time the skin is exposed to radiation. For example, the UV light source can be configured to emit light for a short period of time, such as limited by 0.1 seconds, 0.2 seconds, 0.3 seconds, 0.4 seconds, 0.5 seconds, 1 second, 1.5 seconds, 2 seconds, 3 seconds, 4 seconds, or any value or range therebetween, or any combination of these values or ranges, although values outside these values or ranges can also be used in some cases.
[0070] With reference to at least FIGS. 1E, 1I, 1N, and 1O, a UV light source (which may be mounted within a light source housing 177) may be configured to emit light through the opening 163 in the hub 160 / membrane 162 and around the catheter insertion site. With reference to FIG. 1E, the UV light source may emit light toward the catheter insertion site, and in some embodiments, the housing 177 is angled so that the UV light source emits light having a triangular shape on the subject's skin. The angle defined by the vertices / corners of such a triangle of emitted light may define an angle of less than 90 degrees to adequately focus the emitted light at and around the catheter insertion site. Such an angle may be, for example, less than 85 degrees, less than 80 degrees, less than 75 degrees, less than 70 degrees, less than 65 degrees, less than 60 degrees, less than 55 degrees, or less than 50 degrees, or bounded by any value or range therebetween, or any combination of values or ranges therebetween. 1E, in some cases, the catheter 141 and / or catheter hub 142 may block some of such emitted light, casting a shadow on the patient's skin underneath. In some configurations, the UV light source is a wide-source UV light source that can better illuminate such "hidden" areas of the skin, and / or one or more UV light sources are positioned and / or spaced apart within the cover 120 to illuminate such hidden areas of the skin. As another example, one or more mirrors may be incorporated within the catheter housing 100 (e.g., on the interior surface of the cover 120) to help redirect the emitted light to illuminate hidden areas of the skin.
[0071] 1O-1P show a hub 160 of a catheter housing 100. The hub 160 may be similar or identical in some or many respects to any of the hubs discussed in U.S. Patent Application Publication No. 2019 / 0388652. The hub 160 may include and / or be defined by a membrane 162. The membrane 162 may include one or more perforations 162a (also referred to herein as "apertures") to facilitate breathability of the subject's skin when the membrane 162 is secured thereto. The membrane 162 may include a plurality of perforations 162a spaced along and around the opening 163 of the membrane 162, for example, 1 or more, 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, 10 or more, or 11 or more, 10 to 50, or 50 to 100 perforations 162a, although in some embodiments there may be different amounts of perforations 162a.
[0072] The membrane 162 may be made of a flexible material. The membrane 162 may be made of a different material than the cover 120. The membrane 162 may include, for example, a thermoplastic elastomer (TPE), a thermoplastic polyurethane (TPU), and / or polyvinyl chloride (PVC), among other materials. In some embodiments, the membrane 162 includes a material that is more flexible than the material comprised by the cover 120. In some embodiments, the membrane 162 and the cover 120 include the same material.
[0073] The membrane 162 may include an opening 163 that may be positioned over the site where the needle and / or catheter 141 is (or has been) inserted into the patient. In some embodiments, such as the illustrated embodiment, such opening 163 is not separated and / or divided by any portion of the membrane 162. The opening 163 may have a round shape. For example, the opening 163 may comprise a rectangular shape that is not separated and / or divided by any portion of the membrane 162. In some embodiments, when the catheter housing 100 is assembled and secured to the subject's skin, no portion of the membrane 162 is located between the catheter hub 142 and / or connector 143 and the subject's skin. In some embodiments, the hub 160 and / or membrane 162 (and / or cover 120) may be made of a transparent or translucent material, thereby allowing inspection of the catheter insertion site, catheter 141, catheter hub 142, and connector 143 during use of the catheter housing 100.
[0074] As described above, the cover 120 and the hub 160 may be permanently secured to one another to form a unitary structure. Referring to FIG. 1O, the hub 160 may include a raised portion 167 extending above and / or outward from a portion of the membrane 162 around the opening 163. Such raised portion 167 may include a slot 169 (also referred to as a "channel") that may be sized and / or shaped to receive a flange 179 of the cover 120. Such a slot 169 may extend around the opening 163, as shown in FIG. 1O. During manufacturing, the flange 179 may be inserted into the slot 169 and permanently secured (e.g., glued) to the hub 160. Such permanent securing may be achieved by adhesive and / or ultrasonic welding, among other methods. Such permanent securing may advantageously reduce the number of components of the catheter housing 100, thereby making it easier for caregivers to assemble and / or use the catheter housing 100. In some variations, the cover 120 and the hub 160 may be integrally formed during manufacturing, for example, via an overmolding process. In some such cases, the cover 120 does not include the flange 179 and the hub 100 does not include the slot 169 (and / or the raised portion 167).
[0075] In some embodiments, the catheter housing 100 includes one or more sensors used to measure various physiological parameters and / or conditions of the patient. Such one or more sensors may include a temperature sensor (e.g., a local temperature sensor), a blood pressure sensor, a blood oxygen saturation sensor, a fluid and blood leakage sensor, and / or a skin moisture sensor. Such sensors may be positioned at various locations on the membrane 162. For example, with reference to FIG. 1P, the membrane 162 may include cavities 183 recessed from a surface (e.g., a bottom surface) of the membrane 162 and / or shaped to receive one or more sensors. The membrane 162 may include one, two, three, four, five, six, seven, eight, or more cavities 183. The membrane 162 may include multiple cavities 183 spaced apart from one another and arranged around the opening 163. The cavities 183 may include a round shape, such as a circle, among others. In some cases, the catheter housing 100 includes electrodes positioned within the cavities 183. In some variations, such electrodes can be used for electrotherapy purposes to apply electrical energy to the wearer of the catheter housing 100 at and / or around the catheter insertion site, which may provide benefits such as pain relief.
[0076] 1Q-1R illustrate various components that may together form the expansion set 140 of the catheter housing 100. FIG. 1Q shows the expansion set 140 detached / disconnected from the cover 120 and hub 160 to better illustrate aspects of the expansion set 140. FIG. 1R illustrates an exploded view of the expansion set 140, as well as the catheter hub 142 and connected catheter 141. The expansion set 140 and / or portions thereof may be coupled to the catheter 141 and catheter hub 142 to transfer fluid from a location external to the catheter housing 100, such as from a fluid source (such as an IV bag), to the catheter 141. In some variations, the expansion set 140 may be utilized to transfer fluid (e.g., blood) from a subject to a fluid collection container via the catheter 141. However, FIG. 1R illustrates connector 143 (which may be a male Luer connector), connector 144, annular ring 145, connector 146, tubing 147, and connector 148 (which may be a female Luer connector). Connectors 143 and 148 may be connected to opposite ends of tubing 147. Connector 148 may be configured to connect to a fluid source. Tube 147, connector 143, and / or connector 148 may be similar to or identical to any of the tubing and / or connectors described in U.S. Patent Application Publication No. 2019 / 0388652.
[0077] Connector 144 of expansion set 140 may include opening 198 (see FIG. 1S) sized to accommodate tubing 147. Connector 144 may advantageously secure expansion set 140 to cover 120, alone and / or in combination with connector 146, as described further below. Connector 146 may secure connector 144 to cover 120, for example, at rim 131 and opening 133 of cover 120, as described further below. In some embodiments, expansion set 140 includes an annular ring 145 that may be positioned (e.g., "sandwiched") between a portion of connector 144 (e.g., flange 196) and rim 131 within cover 120. Expansion set 140 may be coupled to catheter hub 142 and catheter 141, for example, via fastening connector 143 to the end of catheter hub 142, as described further below.
[0078] 1S-1T show perspective and side views (respectively) of connector 144. Connector 144 may advantageously allow expansion set 140 to couple with cover 120 to form a unitary structure with cover 120 and / or hub 160. Additionally, in some embodiments, securing connector 144 to connector 146 on either side of rim 131 of cover 120 can prevent cover 120 from moving along tube 147, which may be advantageous when cover 120 and hub 160 are secured to the subject's skin. Connector 144 may include a first end 190 and a second end 191 opposite first end 190. Connector 144 may include a flange 196 (e.g., end 191), a body 194, and a stem 192. Body 194 may be sized and / or shaped to be received within rim 131 and / or through opening 133 in cover 120. The body 194 may have a cylindrical or partially cylindrical shape and / or a circular cross-section. The body 194 may include one or more protrusions 197 extending away from the surface of the body 194 and / or along the length of the body 194. For example, the body 194 may include one, two, three, or more than three protrusions 197. In some embodiments, the number of protrusions 197 corresponds to the number of notches 135 on the rim 131 of the cover 120. The body 194 may include multiple protrusions 197 spaced apart from one another (e.g., radially spaced apart from one another along the circumference of the body 194). In some embodiments, the connector 144 includes four protrusions 197 spaced apart from one another at 90 degrees relative to an axis extending through the center of the connector 144. The protrusions 197 may be sized and / or shaped to fit within and / or through the notches 135 of the cover 120 described above. Referring to FIG. 1T, the protrusion 197 may include a sloped portion 197a having a linearly increasing / decreasing height (measured from the surface of the main body 194) and a non-sloped portion 197b having a uniform height (measured from the surface of the main body 194).In some embodiments, the protrusion 197 extends along the surface of the body 194 from the first end of the body 194 toward the second end of the body 194, stopping before reaching the second end of the body 194 such that a gap "g" exists between the end of the protrusion 197 and the flange 196 (see FIG. 1T). Such a gap may be sized and / or shaped to fit within the annular ring 145. The connector 144 may include a stem 192 extending outwardly from the body 194. The stem 192 may be sized and / or shaped to fit within an opening extending through the connector 146. The stem 192 includes a cylindrical or partially cylindrical shape and / or a circular cross-section. The stem 192 may include threads / threads 195 extending along the surface of the stem 192, which may be configured to secure to threads / threads in the connector 146. The flange 196 of the connector 144 may have a cross-section that is larger than the cross-section of one or both of the body 194 and the stem 192. Such a configuration may ensure that the flange 196 "seats" inside the cover 120 against a portion (end) of the rim 131 of the cover 120. As shown in FIG. 1S, the connector 144 may include an opening 198 that extends the length of the connector 144. Such opening 198 may be sized and / or shaped to receive the tube 147 such that the tube 147 can extend through the connector 144. The opening 198 may have a circular cross-section and may be sized to receive the tube 147.
[0079] 1E shows a cross-sectional view of catheter housing 100 and further illustrates how expansion set 140, cover 120, and hub 160 can form a unitary structure that can be coupled with catheter hub 142 and catheter 141 when catheter 141 is inserted into a catheter insertion site (e.g., through the skin and into a subject's vein). Cover 120 and hub 160 can be secured together (e.g., permanently coupled) via securing flange 179 within slot 179, as described above.
[0080] Expansion set 140 may be secured to cover 120 and hub 160 in various ways (e.g., via direct fastening to cover 120) to form a unitary structure, for example, during manufacture of catheter housing 100. Various ones of connector 143, connector 144, annular ring 145, connector 146, and / or connector 148 may be disposed along (e.g., on) and / or secured to a portion of tube 147 before or after tube 147 is inserted through opening 133 in cover 120. Connector 144 (e.g., via opening 198), annular ring 145, and / or connector 146 may be disposed around and / or along tube 147. Connector 144 (e.g., via opening 198), annular ring 145, and / or connector 146 may be configured to slide along tube 147, for example, longitudinally along an axis extending through tube 147. Such a configuration may advantageously allow connector 144, annular ring 145, and / or connector 146 to be positioned at or near rim 131 and / or opening 133 of cover 120. Stem 192 and body 194 of connector 144 may be positioned within and / or through (or partially within and / or through) opening 133 and / or rim 131 of cover 120, such that flange 196 contacts a portion (e.g., an end) of rim 131 on the interior of cover 120, e.g., by inserting one or more protrusions 197 into one or more notches 135 in rim 131 (see FIG. 1E ). Contact between flange 196 and that portion of rim 131 may prevent connector 144 from moving further through rim 131. In some cases where expansion set 140 includes an annular ring 145 , such annular ring 145 may be disposed (eg, sandwiched) between flange 196 and such portion of rim 131 .In some embodiments, protrusion 197 can be inserted through notch 135, and connector 144 can be rotated relative to rim 131 (e.g., an axis extending through the center of rim 131 and / or opening 133) such that protrusion 197 is not aligned with notch 135 after such rotation. In such a case, rim 131 may contact connector 144 and / or prevent connector 144 from exiting opening 133. After connector 144 is positioned within and / or through (or partially through) opening 133 and / or rim 131 of cover 120, connector 146 can be secured (e.g., screwed) to connector 144, for example, via engagement between threads of connector 146 and threads 195 of stem 192. When such securing occurs, flange 196 of connector 144 and connector 146 can sandwich rim 131 of cover 120. Such fastening may advantageously couple the expansion set 140 to the cover 120 and the hub 160 .
[0081] In some cases, once coupled along tube 147, cover 120 and / or hub 160 can slide along tube 147, for example, longitudinally along an axis extending through tube 147. Connector 143 can be secured to one end of tube 147, and connector 148 can be secured to the opposite end of tube 147. In some embodiments, once connectors 144 and 146 are disconnected from one another, cover 120 and hub 160 can move along tube 147 toward and / or away from connector 143. This configuration advantageously allows a caregiver to quickly and efficiently secure catheter housing 100 to catheter hub 142 and catheter 141. For example, after a caregiver inserts catheter 141 into a patient (e.g., into the patient's vein), the caregiver can move cover 120 and hub 160 (which are disposed along tube 147) away from connector 143 along a portion of the length of tube 147, and then secure (e.g., screw) connector 143 of expansion set 140 to the end of catheter hub 142. The caregiver can then move (e.g., slide) cover 120 and hub 160 toward male connector 143, catheter hub 142, and catheter 141 to position and secure cover 120 and hub 160 to the skin surrounding the catheter insertion site. Such positioning can include engaging connector 143 with arm 126 so that connector 143 is positioned within a recess in arm 126, as described above. After cover 120 and hub 160 are placed and / or secured to the skin, a caregiver can secure connector 146 to connector 144 (e.g., as described above) to minimize or prevent movement of cover 120 and hub 160 relative to tube 147. Referring to FIG. 1E , when connector 146 is secured to connector 144 in this manner, connectors 144, 146 can pinch a portion of cover 120 around opening 133, such as rim 131.Advantageously, securing the expansion set 140 by the cover 120 at the openings 133 and / or rim 131, alone and / or in combination with the arms 126, provides strong stabilization of the catheter hub 142 and connector 143, among other components, preventing or reducing the likelihood of movement of the catheter 141 when inserted into a patient. Furthermore, securing the expansion set 140 to the cover 120 at the openings 133 and / or rim 131 in this manner prevents or reduces problems that can arise when the tube 147 is pulled in various directions relative to the cover 120.
[0082] 1C-1E, in some configurations, cover 120 and / or hub 160 can be secured to extension set 140 in such a manner that connector 143 is spaced from connector 144 and / or rim 131, e.g., by a gap (interior of cover 120) along tube 147. Such a gap can be seen by the portion of tube 147 visible within the interior area enclosed by cover 120 in FIG. 1E. Such a gap may advantageously allow a portion of tube 147 (interior of cover 120) to function as a flexible coupling (e.g., if tube 147 comprises a flexible material), which may minimize or prevent forces on the cover 120, hub 160, connector 146, connector 144, and / or portions of tube 147 outside of cover 120 from transferring to connector 143, i.e., catheter hub 142 and / or catheter 141. For example, if a force is applied to outer cover 120 laterally (e.g., "inside" or "outside" the page in the illustration shown in FIG. 1E ) to a portion of cover 120, hub 160, or tube 147, such a gap between connector 143 and connector 144 (and / or opening 133, rim 131, or other portions of cover 120) can provide a flexible joint that minimizes or prevents such force from being transmitted to connector 143, catheter hub 142, and / or catheter 141. Such a result can significantly reduce the likelihood of catheter "kinking" and / or other problems that may arise when catheter 141 is moved against a patient's vein and / or skin at or near the catheter insertion site.
[0083] 1U-1X show an alternative design for cover 120′. Cover 120′ may be used with catheter housing 100 in a manner similar to cover 120. Cover 120′ may be identical in all respects to cover 120, except that it further includes ports 121a′ and 121b′. Ports 121a′ and 121b′ may be similar or identical in some or many respects to ports 521a and 521b discussed and illustrated in U.S. Patent Application Publication No. 2019 / 0388652 (Patent Document 1). Ports 121a′ and 121b′ may be used to allow gas to flow into and / or out of the interior of cover 120′. Port 121a′ may be a gas inlet port configured to secure a tube and allow gas from the tube to be inserted through a portion of cover 520′ toward a catheter insertion site. For example, sterilizing gas and / or anesthetic gas may be inserted through port 121a′. Port 121b' may be a gas exit port configured to allow gas to exit catheter housing 100 through a portion of cover 120'. Port 121b' may include a relief valve, for example, to allow gas to escape from the interior of cover 120' and / or catheter housing 100 once a certain pressure has been achieved. The relief valve may be configured to open when gas is inserted through gas inlet port 121a'. In some embodiments, ports 121a', 121b' do not include a valve and / or are fully open.
[0084] The ports 121a′, 121b′ may extend through various portions of the cover 120′. For example, one or both of the ports 121a′, 121b′ may extend through a top portion 123a′ of the cover 120′, with a wall 123b′ extending therefrom. The ports 121a′, 121b′ may define an opening on an inner surface of the cover 120′. The cover 120′ may include a chamber 121c′ surrounding the periphery of the opening defined by the port 121a′. The chamber 121c′ may be cylindrical, for example. One or both of the ports 121a′, 121b′ may be positioned proximate a wall 123b′ of the cover 120′. The ports 121a′, 121b′ may be positioned near the opposite side / surface of the wall 123b′. Port 121a' and / or port 121b' may be configured to secure the tube via a snap fit, a friction fit, a press fit, or another type of securement.
[0085] Gas ports 121a′, 121b′ may protrude outward and / or along top 123a′ of cover 120′. Ports 121a′, 121b′ may define a chamber along the length of such extension, which may be sized and / or shaped to receive and / or secure to a tube. Ports 121a′, 121b′ may include a round shape. Ports 121a′, 121b′ may include a cylindrical or partially cylindrical cross-section along their length. Ports 121a′, 121b′ may have a first end 121d′ defining an opening and a second end 121e′ opposite first end 121d′. Second end 121e′ may be sloped or tapered in cross-section to transition the fluid passage defined by ports 121a′, 121b′ to an opening in the cover 120′. For example, the chamber defined by ports 121a', 121b' may transition from a direction parallel to an axis passing through an opening in end 121d' (see FIG. 1V) to a direction perpendicular to such axis near an opening through a portion of cover 120' (see FIG. 1X).
[0086] FIG. 1Y shows an alternative design for cover 120″, which may be used with catheter housing 100 in a manner similar to cover 120. Cover 120″ is identical in all respects to cover 120, except that cover 120″ includes a plurality of holes 197″ extending through the top of cover 120. Such holes 197″ allow the interior of catheter housing 100 and / or the catheter insertion site to be ventilated (e.g., fluidly communicate with the ambient air). In some variations, holes 197″ may be covered on the exterior and / or interior surface of cover 120 with a semipermeable film, which may be transparent. Such a semipermeable film may be secured to the interior surface of cover 120″ adjacent to (e.g., below) holes 197″. Such a semipermeable film may be a polyurethane plastic sheet adhered to the interior surface of cover 120″ via an acrylic adhesive or other type of adhesive. The inclusion of a semi-permeable film near holes 197" may advantageously provide ventilation while reducing the likelihood of objects and / or fluids passing through cover 120" through holes 197". Although cover 120" is shown as opaque in FIG. 1Y, cover 120" may comprise a transparent or translucent material.
[0087] FIG. 1Z shows an alternative design for cover 120′″. Cover 120′″ may be used with catheter housing 100 in a manner similar to cover 120. Cover 120′″ may be identical in all respects to cover 120′″ except that cover 120′″ includes a recess 199′″ recessed from the top exterior surface of cover 120′″. In some variations, a camera may be placed and / or secured in recess 199″. Although cover 120′″ is shown as opaque in FIG. 1Z, cover 120″ may comprise a transparent or translucent material. Such a configuration advantageously allows a camera mounted in such recess 199" to view the catheter insertion site and / or other components contained within the catheter housing 100, such as the catheter 141, the catheter hub 142 coupled to the catheter 141, the connector 143, etc., which may be in contact between the connector 143 and the arm 126 of the cover 120 during use. Such a configuration also advantageously allows a caregiver to determine whether the catheter 141 is inserted (and / or inserted correctly) into the catheter insertion site and / or whether the catheter hub 142 is properly aligned, angled, and / or positioned. The recess 199" may have, among other things, a circular cross-section.
[0088] 2A-2EE illustrate a catheter housing 200 (which may also be referred to as a "catheter housing device," "catheter stabilizing device," or "catheter stabilizing system") and various aspects and / or portions thereof, as further described below. The catheter housing 200 may be advantageously used to stabilize a catheter as it is inserted into a catheter insertion site in a subject, for example, in a manner similar to that described elsewhere herein with reference to the catheter housing 100. As described in detail below, stabilization of the catheter 241 may be achieved by engagement with a catheter hub 242 connected to such catheter 241. Additionally, or alternatively, in some variations, stabilization of the catheter 241 is achieved by engagement with a male Luer connector 243 connected to the catheter hub 242. As shown, the catheter housing 200 may include a cover 220, a hub 260, and an extension set 240 (also referred to herein as a "fluid tubing assembly"). 2A-2B show a top perspective view of the catheter housing 200, FIG. 2C shows a bottom perspective view of the catheter housing 200, and FIGS. 2D-2E show top and bottom views of the catheter housing 200. Each of FIGS. 2C and 2E shows a catheter hub 242 (connected to a catheter 241) secured by the catheter housing 200, as described further below. The catheter 241 and / or catheter hub 242 may be similar to or identical to any of the catheters and / or catheter hubs described herein. FIG. 2F shows a cross-sectional view of the catheter housing 200 (see FIG. 2D) in use, with the catheter housing 200 secured to the subject's skin. While not shown, it should be understood that the catheter 241 may be at least partially positioned within a subject's vein according to conventional catheter insertion techniques so that the catheter 241 can deliver fluid to the subject. Stabilization of the catheter 241 (e.g., by securing the catheter hub 242) is described in more detail below.2G is an exploded view of the catheter housing 200, showing the cover 220, hub 260, and expansion set 240 separated from each other and from the catheter 241 and catheter hub 242. Some embodiments of the catheter housing 200 do not include the expansion set 240.
[0089] 2H-2J show a top perspective view of cover 220, FIG. 2K shows a bottom perspective view of cover 220, FIGS. 2L-2M show top and bottom views of cover 220, FIGS. 2N-2O show side views of cover 220, and FIGS. 2P-2Q show front and back views of cover 220, respectively. Cover 220 may include an upper portion 223a and a wall 223b extending outward from upper portion 223a, where such wall 223b may define the interior of cover 220. Such upper portion 223a and wall 223b may form the main body of cover 220. In some embodiments, such as those shown in FIGS. 2H-2Q, cover 220 includes only a single wall 223b extending from upper portion 223a, where such single wall 223b defines the interior of cover 220. Wall 223b may extend laterally (e.g., generally vertically) through such upper portion 223a. Wall 223b may define a perimeter of cover 220. Cover 220 may be made of a variety of materials, including plastics such as polyphenyl ether (PPE), polycarbonate (PC), among others. In some embodiments, cover 220 is transparent or translucent. In some embodiments, cover 220 is made of a material that is more rigid than hub 260 or portions of hub 260. For example, in some embodiments, cover 220 is made of a material that is more rigid than membrane 262 of hub 260.
[0090] In some embodiments, cover 220 includes one or more wings 222 extending outwardly from top 223a and / or wall 223b, which can be used to secure tube 247 during use. Wings 222 can be similar or identical in some or many respects to wings 122. In some embodiments, wings 222 include one or more ribs 222a (e.g., 1, 2, 3, 4, 5, or more than 6 ribs 222a), which can be similar or identical in some or many respects to ribs 122b.
[0091] In some embodiments, cover 220 includes one or more gas ports configured to allow gas to be delivered within an interior region of cover 220 and further to and / or toward a catheter insertion site enclosed by cover 220 and / or hub 260 when cover 220 is coupled with hub 260 and secured to a subject (see FIG. 2F ). For example, cover 220 may include gas ports 237a and 237b. Gas port 237b may be configured to allow gas to flow into such interior region (e.g., through wall 223b), and gas port 237a may be configured to allow gas to flow out of such interior region (e.g., through wall 223b). In some variations, gas port 237a is configured to allow gas to flow into such interior region (e.g., through wall 223b), and gas port 237b is configured to allow gas to flow out of such interior region (e.g., through wall 223b). The gas port 237b may be configured to be secured to a gas supply tube that allows gas (e.g., sterilizing gas and / or anesthetic gas) to be inserted through the wall 223b toward the catheter insertion site. Such a configuration, when secured to a subject's skin, can advantageously allow gas to flow to and / or around the catheter insertion site, catheter 241, catheter hub 242, and luer connector 243 (also referred to herein as the "catheter hub connector") within the interior region defined by the catheter housing 200. In some embodiments, such as the one illustrated, the gas ports 237a, 237b extend in opposite directions from the cover 220 (e.g., from the wall 223b) and / or outward from opposite ends of the cover 220. Such an implementation can advantageously provide a desired gas flow (e.g., "flushing") into the interior region defined by the catheter housing 200 during use.
[0092] 2K, in some implementations, the cover 220 includes one or more UV light sources that, when the catheter housing 200 is in use, illuminate and / or disinfect the catheter insertion site where the catheter 241 is inserted into the subject, and / or the interior of the cover 220 and / or the area around the various components housed within the cover 220. In such embodiments, the cover 220 may include one or more light source housings 277 that may be similar to or identical to the light source housings 177 described above with respect to the cover 120. The placement and / or utilization of any such light source housings 277 and the UV light sources mounted therein may be similar to or identical to the placement and / or utilization described above with respect to the light source housings 177.
[0093] The cover 220 may be configured to be removably secured to the hub 260. In some embodiments, the cover 220 includes a protrusion 239a (see FIGS. 2H-2I and 2K-2P). The protrusion 239a is configured to engage with a latch arm 273a of the hub 260 (see FIGS. 2S-2T and 2Y), and such engagement may secure the cover 220 and the hub 260 to one another. Additionally, or instead, the cover 220 may include one or both of the protrusions 239b shown in FIGS. 2K and 2M. The protrusion 239b is configured to engage with a latch arm 273b of the hub 260 (see FIGS. 2S-2T and 2Y), and such engagement may secure the cover 220 and the hub 260 to one another. As shown, the protrusion 239a may extend from an outer surface of the wall 232a, and the protrusion 239b may extend from an inner surface of the wall 232a. Protrusions 239a, 239b are also referred to herein as "latch protrusions." Latch arms 273a, 273b of hub 260 are also referred to herein as "latch legs." In some embodiments, protrusions 239a, 239b include a tapered profile.
[0094] The engagement between protrusion 239a and latch arm 273a and / or protrusion 239b and latch arm 273b can be, for example, a snap-fit engagement. For example, in some cases, cover 220 can be secured to hub 260 by moving cover 220 onto hub 260 (e.g., from above) so that protrusion 239a engages with latch arm 273a and / or protrusion 239b engages with latch arm 273b. Protrusion 273a presses latch arm 273a outward (e.g., away from the interior or center of hub 260) until it contacts and / or passes the tapered end of latch arm 273a, at which point such tapered end of latch arm 273a can have a tapered surface that can snap into and secure protrusion 239a. Protrusion 239b may have a tapered surface that contacts the tapered end of latch arm 273b such that protrusion 239b pushes latch arm 273b inward (e.g., toward the interior or center of hub 260) until protrusion 239b passes the tapered end of latch arm 273b, at which point such tapered end of latch arm 273b may snap onto protrusion 239b. To remove cover 220 from hub 260, latch arm 273a may be pushed outward, thereby removing an end (e.g., "front") of cover 220. Protrusion 239b may then be disengaged from latch arm 273b, and cover 220 may be separated from hub 260.
[0095] 2K and 2Q, cover 220 includes opening 233 that allows tube 247 (also referred to as "tube" or "fluid tube") to extend through cover 220, allowing tube 247 to deliver fluid. Once cover 220 is secured to subject's hub 260, catheter 241 is inserted through catheter hub 242. Opening 233 (also referred to herein as "cover opening") may be located at or near an end of cover 220. Opening 233 may, for example, extend through wall 223b as shown.
[0096] In some embodiments, cover 220 includes a connector (also referred to as a “connector portion”) configured to facilitate connection to expansion set 240. For example, cover 220 may include connector 231 (also referred to herein as a “cover connector”). Connector 231 may extend from wall 223 b of cover 220 around opening 233. Connector 231 may be secured to connector 246 (also referred to herein as a “fluid tube locking connector”), as described further below. Also, as described further below, when connectors 231, 246 are connected to one another, they may inhibit (e.g., prevent) movement (e.g., sliding) of cover 220 and / or connector 246 relative to tube 247, whereas when connectors 231, 246 are not connected to one another, they may otherwise allow movement (e.g., sliding) of cover 220 and / or connector 246 relative to tube 247. Such a connection may advantageously prevent movement of catheter 241, catheter hub 242, luer connector 243, and / or portions of tubing 247 housed within cover 220 due to pulling tubing 247 from a position outside cover 220. Connector 231 and connector 246 may be configured to threadably connect to one another, for example, via their threads and / or via a snap-fit engagement. Connector 231 may extend from wall 223b at an end (e.g., the "front" end) of cover 220. Connector 231 may include a connector body 231a extending outwardly from wall 223b and a threaded portion 231b extending outwardly from connector body 231a. Connector body 231a and / or threaded portion 231b may have a generally cylindrical shape and have an opening aligned with opening 233 to allow tubing 247 to pass therethrough. In some embodiments, threaded portion 231b has a smaller cross-section than connector body 231a. In some embodiments, connector 231 additionally or alternatively includes a latch arm 231c (also referred to herein as a "latch" or "cover connector latch") that extends outwardly from wall 223b and / or connector body 231a and can be positioned adjacent connector body 231a.2DD-2EE, the latch arm 231c may engage with a notch 246b of the connector 246. The latch arm 231c may be resilient to allow the latch arm 231c to flex during engagement with the connector 246 and the notch 246b, as described below.
[0097] FIG. 2R shows an enlarged perspective view of expansion set 240 (also referred to herein as a "fluid tubing assembly"). Expansion set 240 may include connector 243 (which may be a male Luer connector), stopper 245, sleeve 249, connector 246 (also referred to herein as a "fluid tubing lock connector"), tubing 247, and / or connector 248 (which may be a female Luer connector). Connectors 243, 248, and / or tubing 247 may be similar to or identical to connectors 143, 148, and / or tubing 147 (respectively) described above with respect to expansion set 140. Connectors 243, 248 may be connected to opposite ends of tubing 247 as shown. Connector 248 may be configured to connect to a fluid source holding fluid for providing infusion therapy to a subject. Connector 243 may be configured to connect to catheter hub 242, for example, as shown in FIGS. 2C, 2E, and 2F.
[0098] As mentioned above, connector 246 may be advantageously utilized with connector 231 of cover 220 to inhibit (e.g., prevent) movement of cover 220 and / or connector 246 relative to tube 247. Connector 246 may include body 246a, which may include an interior having threads configured to secure to threaded portion 231b of connector 231 of cover 220. Body 246a may include an opening that allows connector 246 to be coupled to tube 247, for example, so that connector 246 can move (e.g., slide) along tube 247. In some embodiments, connector 246 includes notch 246b recessed from an outer surface of body 246a, which may be configured to engage latch arm 231c of connector 231 of cover 220, as described above and in more detail below. Notch 246b may be sized and / or shaped to accommodate a portion of latch arm 231c. 2CC, expansion set 240 and cover 220 are configured such that tube 247 extends through connector 231 (e.g., through connector body 231a and threaded portion 231b) and through opening 233 in wall 223b of cover 220, and cover 220 (e.g., wall 223b of cover 220) is positioned along tube 247 between connector 243, stopper 245, and connectors 246, 248. In such a configuration, cover 220 and connector 246 may be configured to slide along tube 247 (e.g., along the longitudinal axis of tube 247) before connecting connector 246 to connector 231, as described below.
[0099] Figure 2F shows catheter housing 200 assembled as described above and secured to the skin of a subject. Figure 2F shows connector 246 secured to connector 231 of cover 220. Connector 246 can be connected to connector 231 via engagement between threads on body 246a of connector 246 and threaded portion 231b of connector 231. As described above, in some embodiments, connector 231 includes latch arm 231c, and in such embodiments, latch arm 231c can engage notch 246b of connector 246. For example, latch arm 231c can engage notch 246b after body 246a is threadedly secured to threaded portion 231b. 2DD, connector 246 can be threaded (e.g., by rotation) onto threaded portion 231b. During such threading, body 246a (e.g., the outer surface of body 246a) of connector 246 can press against latch arm 231c, causing latch arm 231c to bend away from connector body 231a. After continued threading (via rotation of connector 246), latch arm 231c can snap into notch 246b of connector 246, thereby “locking” connector 231 to connector 246 (see FIG. 2EE). Disconnection of connectors 231, 246 from one another is achieved by bending latch arm 231c (e.g., away from connector body 231a) so that latch arm 231c is disengaged from notch 246b, allowing connector 246 to be rotated in the opposite rotational direction to that used to secure connector 246 by threading it onto threaded portion 231b. As described above, expansion set 240 may include sleeve 249. Sleeve 249 may be operably positioned by connector 246 such that pressure is applied to sleeve 249 when connectors 246, 231 are secured together (see FIG. 2F ). When connectors 246, 231 are connected together, movement of connector 246 and cover 220 along tube 247 may be inhibited (e.g., prevented) via a gripping force applied to tube 247 by sleeve 249 caused by pressure applied to sleeve 249 by connectors 246, 231, for example.With this configuration, connectors 246, 231 can "lock" a portion of tubing 247 so that a force applied to tubing 247 outside cover 220 is not transmitted to the portion of tubing 247 inside cover 220 and / or connector 243, catheter hub 242, and catheter 241. This can advantageously prevent dislodgment of catheter 241 and / or catheter hub 242 and prevent trauma to the catheter insertion site. Sleeve 249 can include a tubular shape and / or can include the same material as tubing 247. Sleeve 249 can be movable (e.g., slidable) along tubing 247, for example, when connectors 246, 231 are not secured to one another. Sleeve 249 can have a shorter length than tubing 247. Sleeve 249 can be made of a variety of materials, such as polyvinyl chloride (PVC), latex-free materials, and / or other materials.
[0100] In some embodiments, the expansion set 240 includes a stopper 245 (see FIGS. 2F, 2G, and 2R). Referring to FIG. 2E, the stopper 245 is coupled to the tube 247 and may be positioned between the connector 243 and the opening 233 and / or wall 223a of the cover 220 when the cover 220 and the expansion set 240 are secured to one another (and / or the cover 220 and the expansion set 240 are secured to the hub 260). The stopper 245 may have an annular (e.g., circular) shape. The stopper 245 may have a length that is shorter than the length of the tube 247. The stopper 245 may be permanently adhered to a portion of the tube 247. 2F , stopper 245 can prevent tube 247 from being pulled out of cover 220 and / or can isolate a portion of tube 247 (inside cover 220), connector 243, catheter hub 242, and / or catheter 241 from forces exerted on tube 247 outside cover 220. For example, if a force is applied to a portion of tube 247 outside cover 220 in a direction along the longitudinal axis of tube 247 and / or transversely (e.g., perpendicular) to that axis, stopper 245 can engage wall 223a and prevent such force from causing movement of connector 243, catheter hub 242, and / or catheter 241. Stopper 245 can be utilized alone or in combination with sleeve 249. In some cases, stopper 245 can be engaged if the force applied to tube 247 exceeds the ability of sleeve 249 to resist the force.
[0101] Figures 2S-2T show top perspective views of hub 260, Figures 2U-2V show bottom perspective views, and Figures 2W-2X show top and bottom views (respectively). Figure 2Y shows an exploded perspective view of hub 260, and Figures 2Z-2AA show cross-sectional views through a portion of hub 260 (see Figure 2W). Hub 260 may be configured to be secured to a subject's skin around a catheter insertion site. Hub 260 (e.g., membrane 262) may include an opening 263 configured to be positioned over the catheter insertion site when hub 260 is secured to the subject's skin. Hub 260 may be configured to secure catheter hub 242 connected to catheter 241 to minimize movement of catheter 241 when inserted into the catheter insertion site. Securing catheter hub 242 with hub 260 (e.g., as opposed to cover 220) may advantageously allow a caregiver to visualize the catheter insertion site, catheter 241, catheter hub 242, and / or other components before enclosing the catheter insertion site with cover 220. This allows the caregiver to conveniently assess whether catheter hub 242 is properly secured and / or positioned, for example, to operatively position catheter 241 at the proper angle relative to the subject's skin and / or vein into which catheter 241 is to be inserted.
[0102] The hub 260 may include a membrane 262 and a frame 264. The membrane 262 may include one or more perforations 262a (also referred to herein as "apertures") to facilitate breathability of the subject's skin when the membrane 262 is secured thereto. The number, arrangement, and characteristics of the perforations 262a may be similar to or identical to the perforations 162a described above with respect to the membrane 162. The membrane 262 may include openings 263 at which the needle and / or catheter 241 may be positioned over a site at which the needle and / or catheter 241 is inserted (or is being inserted) into the subject (e.g., patient). In some embodiments, such as the one shown, such openings 163 are not separated and / or divided by any portion of the membrane 262. The openings 263 may have a round shape. For example, the openings 263 may include a rectangular shape that is not separated and / or divided by any portion of the membrane 262. In some embodiments, as shown in FIG. 2F , when the catheter housing 200 is assembled and secured to the subject's skin, no portion of the membrane 262 is located between the catheter hub 242 (and / or connector 243) and the subject's skin. In some embodiments, the hub 260 and / or membrane 262 (and / or cover 220) may be made of a transparent or translucent material to allow inspection of the catheter insertion site, catheter 241, catheter hub 242, and connector 243 during use of the catheter housing 200. The membrane 262 may be made of a flexible material. The membrane 262 may be made of a different material than the cover 220. The membrane 262 may include, for example, a thermoplastic elastomer (TPE), a thermoplastic polyurethane (TPU), and / or polyvinyl chloride (PVC), among other materials. In some embodiments, the membrane 262 comprises a material that is more flexible than the material comprised by the cover 220. The membrane 262 may be more flexible than the frame 264. In some embodiments, membrane 262 is transparent or translucent. In some variations, hub 260 does not include frame 264. In such variations, features of frame 264 (such as arm 274, latch arms 273a, 273b, and / or indicator 275) are part of membrane 262.
[0103] In some embodiments, one or more substrates (also referred to as "layers") are disposed on the bottom surface of membrane 262 to enable membrane 262 to be secured to the subject's skin. In some embodiments, one or more adhesive layers are secured to the bottom surface of membrane 262. In some embodiments, a top layer (e.g., comprising an adhesive material such as a rubber-based adhesive) is adhered to the bottom surface of membrane 262, a middle layer (e.g., comprising a foam, rubber-based, or acrylic-based adhesive material) is secured to the top layer, and a bottom layer (e.g., comprising an adhesive material such as an acrylic adhesive) is secured to the middle layer. Such middle layers may connect the top layer (intended to be secured to membrane 262) and the bottom layer (intended to be secured to the subject's skin). In some embodiments, one or more release liners (also referred to as "release layers") are secured to membrane 262 (e.g., to one or more adhesive layers disposed on the bottom surface of membrane 262). Such release liners may be removed prior to securing membrane 262 to the subject's skin. Exemplary release liner configurations are shown and described with reference to FIGS. 2JJ-2LL. 2U-2V and 2X, in some embodiments, membrane 262 includes one or more recesses 272b positioned adjacent opening 262a. Recesses 272b may be recessed from the bottom surface of membrane 262 and extend inward from opening 262a, for example, toward the center of membrane 262. Recesses 272b may advantageously allow an adhesive removal solution (e.g., including alcohol) passing through opening 262a to flow under the bottom surface of membrane 262 to loosen the adhesive's engagement with the skin. Such a configuration may advantageously allow membrane 262 (and hub 260) to be more easily removed from a subject's skin.
[0104] FIG. 2Y shows membrane 262 separated from frame 264. Membrane 262 may include a raised portion 267 extending above and / or outward from a portion of membrane 262 (e.g., spaced inward from the periphery of membrane 262) and extending around the periphery of opening 263. Such raised portion 267 may include a slot 269 (also referred to as a "channel") that may extend around opening 263. Slot 269 may be sized and / or shaped to receive flange 272 of frame 264, as described further below. During manufacturing, flange 272 may be inserted into slot 269 and permanently secured (e.g., glued) to membrane 262. Such permanent securing may be achieved by adhesive and / or ultrasonic welding, among other methods. In some cases, membrane 262 may be overmolded onto frame 264. In such a case, flange 272 can include one or more openings 272a (e.g., 1, 2, 3, 4, 1-20 openings 272a) that allow the overmolded material of membrane 262 to pass through, thereby forming a secure bond therethrough. Thus, while slot 269 is shown as open in FIG. 2Y, it should be understood that slot 269 can be filled (and thus absent) when membrane 262 is overmolded onto frame 264. In some embodiments, membrane 262 includes notch 267a configured to receive latch arm 273a, as shown in FIGS. 2S and 2Y.
[0105] In some embodiments, hub 260 includes a moisture wicking element configured to wick moisture away from the catheter insertion site and / or all or a portion of the subject's skin surrounded by opening 263. For example, in some embodiments, the moisture wicking element is disposed on membrane 262 along all or less than the entire perimeter of opening 263. Such a moisture wicking element may have, for example, an annular shape corresponding to the shape of opening 263 and extend all or less than the entire perimeter of opening 263. Such a moisture wicking element may include a tricot fabric. Such a moisture wicking element may include, for example, nylon and spandex, or polyester and spandex. Additionally or alternatively, such a moisture wicking element may include a hydrocolloid.
[0106] The frame 264 may be made of a variety of materials. For example, the frame 264 may be constructed of plastic. The frame 264 may include, among others, polyphenylether (PPE) and / or polycarbonate (PC). In some embodiments, the frame 264 is transparent or translucent. In some embodiments, the frame 264 and the cover 220 are made of the same material. In some embodiments, the frame 264 is made of a material that is stiffer than the membrane 262. With continued reference to FIG. 2Y , the frame 260 may include a frame body 270 and a flange 272 extending outwardly from the frame body 270, e.g., along a portion of the entire perimeter of the frame body 270. The frame body 270 may have, among others, an annular and / or rectangular shape. The frame 264 may be connected to the membrane 262 along the entire or less than the entire perimeter of the opening 263 in the membrane 262. In some embodiments, the latch arm 273a and / or the latch arm 273b (described above) extend outwardly from the flange 272. In some variations, latch arm 273a and / or latch arm 273b extend outward from frame body 270. In some embodiments, such as shown in FIG. 2Y, latch arm 273b is located at an opposite end of frame 264 (e.g., frame body 270) from latch arm 273a.
[0107] The hub 260 may include one or more indicators that may advantageously help position the hub 260 relative to the catheter insertion site and / or relative to the catheter 241 and / or catheter hub 242. For example, the frame 264 may include an indicator 275 extending outward from the surface of the frame body 270. In some cases, the frame 264 includes two indicators 275 located on opposite sides of the frame body 270 and / or one indicator 275 located along the end of the frame body 270. Such indicators 275 may be aligned with the catheter insertion site so that the hub 260 can be properly secured in place, e.g., so that the frame 264 (e.g., arms 274) can be operably positioned to secure the catheter hub 242. In some embodiments, the frame body 270 includes a groove 276 extending around all or part of the circumference of the frame body 270. Such groove 276 may be sized and / or shaped to receive an annular member 279. 2Z-2AA show annular member 279 secured within groove 276, and FIG. 2F shows annular member 279 secured within groove 276 and cover 220 and hub 260 secured together. Annular member 279 may be utilized to seal the interior region defined between catheter housing 200 and the subject's skin when cover 220 and hub 260 are secured together. Such a seal may inhibit (e.g., prevent) gas from entering or exiting the interior region along the connection point or region of cover 220 and hub 260. Annular member 279 may be, for example, an O-ring.
[0108] As previously described, the hub 260 can be configured to secure the catheter hub 242 to minimize movement of the catheter 241 when inserted into the catheter insertion site. The hub 260 can include one or more arms configured to secure the catheter hub 242 to minimize movement of the catheter 241 when inserted into the catheter insertion site. For example, as shown in FIGS. 2S-2Y, the hub 260 (e.g., the frame 264) can include an arm 274. The arm 274 can extend outward from a portion of the frame 264 and across (e.g., partially across) the opening in the frame 264 and / or the opening 263 when the frame 264 and the membrane 262 are coupled together. FIG. 2Z shows a cross-sectional view of the hub 260. In some embodiments, as shown, the arm 274 does not extend completely across the opening 263. The arms 274 may include a first end (also referred to herein as a “connected end”) connected to a portion of the frame 264 (e.g., a portion of the frame body 270) and a second end (also referred to herein as a “free” end or “cantilever” end) opposite such first end. The arms 274 extend outward from a portion of the frame 264, and such “free” ends may be spaced apart from one another by a gap represented by “d1” in FIG. 2X. Such second or “free” ends of the arms 274 may be spaced apart inward from the frame body 270, the periphery of the opening in the frame 264, and / or the periphery of the opening 263. As previously mentioned, the frame 264 (e.g., the frame body 270) may be connected to the membrane 262 along all or part of the periphery of the opening 263. In some embodiments, the arms 274 may each include a generally T-shaped structure.
[0109] 2Z, arm 274 may include a first section 274a (also referred to as a "stem" or "first segment") extending outward from a portion of frame 264 (e.g., a portion of frame body 270) and a second section 274b (also referred to as a "flange" or "second segment") connected to the end of first section 274a (which may be the "free" end of arm 274). Second section 274b may be spaced apart from the portion of frame 264 from which first section 274a extends (e.g., spaced apart from frame body 270). In some embodiments, second section 274b is transverse (e.g., generally perpendicular) to first section 274a. In some embodiments, second sections 274b are at least partially curved (see FIG. 2Z) (e.g., curved toward each other). For example, surfaces of second sections 274b of arms 274 facing each other may be curved toward each other. The second section 274b may be at least partially curved to conform to and / or surround a portion of the catheter hub 242 when the catheter hub 242 is secured by the arms 274. In some embodiments, the surfaces of the second sections 274b of the arms 274 facing each other include matching curvatures. In some embodiments, the arms 274 are mirror images of each other. In some embodiments, as shown in FIG. 2AA, the second sections 274b are angled relative to a plane extending along the top of the frame body 270, a plane extending along the bottom surface of the membrane 262, and / or the subject's skin (when the hub 260 is secured to the subject's skin). Such an embodiment allows the arms 274 to secure the catheter hub 242 at an oblique angle relative to the subject's skin (e.g., at the angle shown in FIG. 2F) when the hub 260 is in use.
[0110] Arms 274 (or portions thereof) may be sized and / or shaped to secure any of various types of catheter hubs, such as any of the catheter hubs discussed herein, among others. In some embodiments, frame 264 and arms 274 comprise a rigid material, and in such embodiments, arms 274 may provide rigid fixation to catheter hub 242. However, in some variations, frame 264 and / or arms 274 comprise a flexible material (e.g., similar to or the same as the material described above with respect to membrane 262). In some variations, arms 274 may comprise a more flexible material than frame body 270 from which they extend.
[0111] In some embodiments, during use, when catheter hub 242 is secured by arm 274 and hub 260 is secured to the subject's skin, no portion of catheter containing device 200 is located between arm 274 and the subject's skin, no portion of cover 220 contacts catheter hub 242, and / or no portion of membrane 262 contacts catheter hub 242. Referring to FIG. 2F , catheter hub 242 may have a first end connected to catheter 241 and a second end connected to connector 243. In some embodiments, during use, when catheter hub 242 is secured by arm 274 and hub 260 is secured to the subject's skin, such second end of catheter hub 242 does not contact the subject's skin, only the first end of catheter hub 242 contacts the subject's skin, and / or no portion of catheter hub 242 contacts the subject's skin. 2Z and 2AA, in some embodiments, arms 274 are spaced apart from (e.g., positioned above) a plane extending along the bottom surface of membrane 262. Such a configuration may allow arms 274 to be spaced apart from (e.g., above) the subject's skin during use of hub 260, thereby advantageously inhibiting (e.g., preventing) arms 274 from potentially causing irritation to the subject's skin.
[0112] 2S-2M show two arms 274, in some variations, the hub 260 (e.g., frame 264) includes a different number of arms 274. For example, in some variations, the hub 260 (e.g., frame 264) includes one arm 274 extending outward from a portion of the frame 264 configured to secure the catheter hub 242 to minimize movement of the catheter 241 when inserted into the catheter insertion site.
[0113] 2BB-2EE illustrate exemplary methods by which the catheter housing 200 may be assembled and secured to a subject. The catheter 241 may be inserted into a catheter insertion site according to conventional techniques. After the catheter 241 is inserted, the hub 260 may be positioned over the catheter insertion site so that the opening 263 is located over the portion of the catheter 241 outside the skin and / or over the catheter hub 242 connected to the catheter 241. The hub 260 may be secured to the subject's skin, for example, by adhesively securing the membrane 262 to the skin. In some embodiments, an indicator 275 (which may optionally be included in the hub 260) is utilized to position and / or align the hub 260 with the insertion site, the catheter 241, and / or the catheter hub 242. The catheter hub 242 may then be secured by the arm 274 in an inclined position relative to the subject's skin, as shown in FIG. 2BB, for example, with the arm 274 configured for that position. Referring to FIG. 2CC, the connector 243 may then be connected to the catheter hub 242. As shown in FIG. 2CC above, when cover 220 is coupled to tube 247, cover 220 may move along tube 247 toward hub 260. Cover 220 may be secured to hub 260, for example, by engagement of protrusions 239a, 239b of cover 220 with latch arms 273a, 273b, as described elsewhere herein. Securing cover 220 to hub 260 may thus enclose catheter insertion site, catheter hub 242, and / or connector 243. Referring to FIGS. 2CC-2DD, connector 246 may move along tube 247 toward cover 220 and secure to connector 231 of cover 220, as described elsewhere herein. As previously described, connector 246 may be threadably secured to connector 231 (e.g., via engagement between threads of connector 246 and threaded portion 231b). As also previously mentioned, connector 246 may be secured to connector 231 in a snap fit engagement via engagement of latch 231c with notch 246b.Such a connection may, for example, "lock" the tube 247 relative to the cover 220 and connector 246 to prevent movement of the cover 220 and / or connector 246 relative to the tube 247, as described above. Assembling the catheter housing 200 in this manner may be a simple yet effective way to stabilize the catheter 241 and surround the catheter insertion site. However, the catheter housing 200 may be assembled and secured to the subject in other ways than those described above, and the above methods are not intended to be limiting.
[0114] Figures 2FF-2II show an alternative implementation of hub 260'. Hub 260' may be similar or identical in some or many respects to hub 260. Hub 260' includes a frame 264' and a membrane 262'. Figure 2II shows an exploded view of hub 260'. Frame 264' and membrane 262' may be similar or identical in some or many respects to frame 264 and membrane 262 (respectively).
[0115] The membrane 262′ may include one or more perforations 262a′ (also referred to herein as “openings”) to facilitate breathability of the subject's skin when the membrane 262′ is secured to the subject's skin. The number, arrangement, and characteristics of the perforations 262a′ may be similar to or identical to the perforations 162a and / or 262a described above. The membrane 262′ may include openings 263′ that may be positioned over sites where the needle and / or catheter 241 is (or has been) inserted into the subject (e.g., patient). In some embodiments, such as the illustrated embodiment, such openings 263′ are not separated and / or divided by any portion of the membrane 262′. The openings 263′ may have a round shape. For example, the openings 263′ may include a rectangular shape that is not separated and / or divided by any portion of the membrane 262′. In some embodiments, the hub 260′ (e.g., the frame 264′ and / or the membrane 262′) is made of a transparent or translucent material. Membrane 262′ and / or frame 264′ may be made from, among other materials, any of the materials discussed herein with respect to membrane 262 and frame 264 (respectively). One or more substrates and / or release liners may be disposed on the bottom surface of membrane 262′, such as any of those described above with respect to membrane 262.
[0116] Continuing with reference to FIG. 2II, membrane 262′ may include a slot 269′ (also referred to as a “channel”) that may extend around opening 263′. Slot 269′ may be sized and / or shaped to receive a portion of frame body 270′. During manufacturing, a portion of frame body 270′ may be inserted into slot 269′ and permanently secured (e.g., glued) to membrane 262′. Such permanent securing may be achieved via adhesive and / or ultrasonic welding, among others. In some cases, membrane 262′ is overmolded onto frame 264′. In such cases, frame body 270′ may include one or more openings 272′ (e.g., 1, 2, 3, 4, or between 1 and 20 openings 272′) to allow overmolding material of membrane 262′ to pass through, thereby forming a secure bond therethrough. Reference numeral 268′ in the cross-sectional view shown in FIG. 2JJ indicates a portion of membrane 262′ that extends through opening 272′ in frame body 270′ to form a secure bond between frame 264′ and membrane 262′ after membrane 262′ is overmolded onto frame 264′. While slot 269′ is shown as open in FIG. 2Y, it should be understood that slot 269′ may be filled (and thus absent) when membrane 262′ is overmolded onto frame 264′. In some embodiments, membrane 262′ includes notch 267a′ configured to accommodate latch arm 273a′. In some embodiments, membrane 262′ includes notch 265′ sized to accommodate a portion of arm 274′ along the portion of membrane 262′ proximate opening 263′.
[0117] Arms 274' extend outwardly toward each other from portions of frame 264' (e.g., from opposite sides of frame body 270') and may be similar to or identical to arms 274. Thus, the above description of arms 274 is equally applicable to arms 274'.
[0118] The frame 264′ includes a frame body 270′ and latch arms 273a′, 273b′ extending outwardly from the frame body 270′. The latch arms 273a′, 273b′ may be configured to engage with the protrusions 239a, 239b of the cover 220 in a manner similar or identical to that described above with respect to the latch arms 273a, 273b. The frame body 270′ may be similar or identical to the frame body 270 in some or many respects. The frame body 270′ may include, among other things, an annular (e.g., rectangular) shape. The frame 264′ may be connected to the membrane 262′ along all or part of the perimeter of the opening 263 in the membrane 262. One difference between the frame 264′ and the frame 264 is that the frame 264′ does not include the flange 272. In some embodiments, frame body 270' includes a groove 276', which may be similar to or identical to groove 276 of frame body 270, and such groove 276' is configured to receive an annular member 279' (which may be similar to or identical to annular member 279).
[0119] Figures 2JJ-2LL show exemplary implementations of release liners that can be used with any of the catheter containment devices disclosed herein. Figures 2KK-2MM show bottom views of a hub 260′ having a first release liner configuration (Figure 2KK), a second release liner configuration (Figure 2LL), and a third release liner configuration (Figure 2MM). Any of the catheter containment devices disclosed herein can include one or more release liners disposed on one or more adhesive layers bonded to the bottom surface of the hub (e.g., the bottom surface of the membrane of such a hub). While Figures 2KK-2MM show hub 260′, the release liner configurations described with reference to Figures 2KK-2MM and hub 260′ are equally applicable to any of the other hubs described herein (e.g., hubs 160, 260, and / or 360). Figure 2KK shows a release liner with a single cut or slit 291 through which the release liner can be removed in the direction indicated by the arrow (prior to securing hub 260′ to the subject's skin). Such slits 291 allow release liners to be removed from hub 260′, connected covers (e.g., cover 220), and expansion sets (such as expansion set 240). Figure 2LL shows two release liners separated by two slits 292 (oriented perpendicular to the long axis of hub 260′), where such release liners are removed sequentially (in the direction indicated by the arrows), e.g., a first portion of the bottom surface of hub 260′ is pressed down and secured to the subject's skin before a second portion of the bottom surface of hub 260′. Figure 2MM shows two release liners separated by two slits 293 (oriented parallel to the long axis of hub 260′), where such release liners are removed sequentially (in the direction indicated by the arrows), e.g., a first portion of the bottom surface of hub 260′ is pressed down and secured to the subject's skin before a second portion of the bottom surface of hub 260′.
[0120] 3A-3V illustrate catheter housing 200 (which may also be referred to as a "catheter housing device," "catheter stabilizing device," or "catheter stabilizing system") and various aspects and / or portions thereof, as described further below. Catheter housing 300 may be advantageously used to stabilize a catheter as it is inserted into a catheter insertion site in a subject, e.g., in a manner similar to that described elsewhere herein with reference to catheter housings 100 and / or 200. As described in more detail below, stabilization of catheter 341 may be achieved by engagement with a catheter hub 342 connected to such catheter and / or by engagement with a connector 343 connected to catheter hub 342.
[0121] As shown, the catheter housing 300 can include a cover 320, a hub 360, and an extension set 340 (also referred to herein as a "fluid tubing assembly"). Figures 3A-3B show a top perspective view of the catheter housing 300, Figure 3C shows a bottom perspective view, and Figures 3D-3E show top and bottom views of the catheter housing 300. Each of Figures 3C and 3E shows a catheter hub 342 (connected to a catheter 341) and a connector 343 secured by the catheter housing 300, as described further below. The catheter 341 and / or catheter hub 342 can be similar to or identical to any of the other catheters and / or catheter hubs described herein. Some embodiments of the catheter housing 300 do not include the extension set 340.
[0122] Figure 3F shows a cross-sectional view of the catheter housing 300 (see Figure 3D) in an in-use configuration in which the catheter housing 300 is secured to the subject's skin. Although not shown, it should be understood that the catheter 341 may be at least partially positioned within the subject's vein according to conventional catheter insertion techniques so that the catheter 341 can deliver fluid to the subject. Stabilization of the catheter 341 is described in more detail below. Figure 3G shows the cover 320, hub 360, and extension set 340 separated from each other and from the catheter 341 and catheter hub 342.
[0123] Figures 3H-3I show top and side perspective views of cover 320, Figure 3J shows a bottom perspective view, and Figure 3K shows a top view of cover 320. Cover 320 may be similar to or identical to covers 120 and / or 220 in some or many respects. Cover 320 may include top 323a and wall 323b, which may be similar to or identical to top 123a, 223a and wall 123b, 223b, respectively. Cover 320 may include wing 322 with slot 322a, which may be similar to or identical to wing 122 with slot 122a of cover 120. Cover 320 may include protrusions 339a and 339b, which may be identical to protrusions 239a and 239b (respectively) of cover 220. The cover 320 may include gas ports 337a, 337b, which may be similar to or identical to gas ports 237a, 237b or any of the other gas ports described herein. As shown, the gas ports 337a, 337b may extend outward from the same end of the cover 320, e.g., in the same direction from wall 323b, and / or may be located at the same end of the cover 320 where the connector 331 and / or opening 333 are located. Referring to FIG. 3J , the cover 320 may include one or more light source housings 377, which may be similar to or identical to the light source housings 177, 277 of the covers 120, 220. In some embodiments in which the catheter housing 300 includes one or more UV light sources (e.g., housed within the light source housing 377), the catheter housing 300 may include a battery configured to power such UV light sources. In some embodiments, the catheter housing 300 includes a battery housing 329 connected to and / or extending outward from the upper portion 323a. Cover 320 may be made from any of the materials described above with respect to covers 120 and / or 220, among other materials. In some embodiments, cover 320 is transparent or translucent. In some embodiments, cover 320 is made from a material that is more rigid than hub 360 or portions of hub 360. For example, in some embodiments, cover 320 is made from a material that is more rigid than membrane 362.
[0124] The cover 320 includes an opening 333 (also referred to herein as a "cover opening") that may be similar to or identical to the opening 133 in some or many respects. The cover 320 includes a rim 331 (sometimes referred to herein as a "connector" or "cover connector") that may extend outward from the inner and / or outer surface of the cover 320 (e.g., of the wall 323b) around the opening 333. The rim 331 may be similar to or identical to the rim 131 in some or many respects. For example, the rim 331 includes one or more notches 335, the number, placement, and characteristics of which may be similar to or identical to the notches 135. The rim 331 may be secured to connectors 344 and 346, as described further below. As shown, the cover 320 may include a tab 331a extending outward from the rim 331, e.g., extending outward from the outer surface of the rim 331. Tab 331a may be utilized when rim 331 is secured to connector 346, as described further below.
[0125] FIG. 3L shows expansion set 340 (also referred to herein as a “fluid tube assembly”). Expansion set 340 may be similar in some or many respects to expansion set 140. Expansion set 340 may include connector 343 (which may be similar to or identical to connectors 143 and / or 243), tubing 347 (which may be similar to or identical to tubing 147, 247), connector 348 (which may be similar to or identical to connectors 148, 248), and sleeve 349 (which may be similar to or identical to sleeve 249). Expansion set 340 may include connector 344 that is similar to or identical to connector 144. Connector 344 may engage with rim 331 in a manner similar to or identical to that described above with respect to connector 144 and rim 131. Rings 345 a, 345 b may be included in expansion set 340 and secured to connector 344 as shown. 3F, connector 344 may be partially inserted through opening 333 (and rim 331) in cover 320 and secured to connector 346 in a manner similar to that described above with respect to connector 144, opening 133 (and rim 131), and connector 146. Sleeve 349 may be operably positioned by connector 346 and may engage tube 347 to prevent relative movement of cover 320 and / or connector 346 with respect to tube 347 in a manner similar or identical to that described above with respect to sleeve 249, cover 220, and connector 246. Referring to FIG. 3L, connector 346 may include a body 346a having an opening for receiving tube 347 and fingers 346b extending from body 346a, such fingers 346b may contact tabs 331a on cover 320 when connector 346 is threaded onto threads of connector 344 (which may be similar or identical to the threads of connector 144 described above). In some cases, tab 331a is tapered so that when connector 346 is threaded into connector 144 a given amount of rotation, fingers 346b slide over the tapered portion of tab 331a (e.g., bend outward from opening 333), and once reached after such amount of rotation, fingers 346b snap inward toward opening 333.Such positioning of fingers 346b against tabs 331a may prevent connector 346 from being removed from connector 144 and rim 331 because tabs 331a may interfere with the fingers. Body 346a has a cylindrical shape as shown and may include threads therein that can be mated with threads of connector 344 (which may be similar to or identical to threads 195).
[0126] Figures 3M-3N show a top perspective view, Figure 3O shows a bottom perspective view, Figures 3P-3Q show top and bottom views of hub 360, and Figure 3R shows an exploded view of hub 360. Figures 3S-3T show cross-sectional views through hub 360 (see Figure 3P). Figure 3U shows an enlarged view of a portion of hub 360 shown in Figure 3M. Hub 360 may be similar or identical in some or many respects to hub 260. Hub 360 may include a frame 364 and a membrane 362. Frame 364 may be similar or identical in some or many respects to frame 264. Frame 364 includes latch arms 373a and 373b, which may be similar or identical in some or many respects to latch arms 273a and 273b (respectively), and frame 364 may be secured to protrusions 339a, 339b of cover 320 in a manner similar or identical to that described above with respect to latch arms 273a, 273b of frame 264 and protrusions 239a, 239b of cover 220. Frame 364 includes latch arms 373a and 373b, which may be similar or identical in some or many respects to latch arms 273a and 273b (respectively), and frame 364 may be secured to protrusions 339a, 339b of cover 320 in a manner similar or identical to that described above with respect to latch arms 273a, 273b of frame 264 and protrusions 239a, 239b of cover 220. The frame 364 may include a flange 372 and / or an opening 372a similar to or identical to the flange 272 and opening 272a of the frame 264. The frame 364 and / or the membrane 362 may include materials similar to or identical to any of the materials described herein, particularly with respect to the frames 164, 264 and membranes 162, 262. The membrane 362 may include one or more perforations 362a, which may be similar to or identical to one or more perforations 162a, 262a of the membranes 162, 262. The membrane 362 may include a slot or channel 369 in the membrane 262, which may be similar to or identical to the slot or channel 269 in the membranes 162, 262.The fastening of flange 372 and slot 369 and / or the manufacturing (e.g., by overmolding) of frame 364 and membrane 362 can be similar to or identical to that described with reference to flange 272, slot 269, frame 264, and membrane 262. Membrane 362 can include opening 363 that is similar to or identical to opening 263. Hub 360 can include annular member 379 that can be similar to or identical to annular member 279. Frame body 370 includes groove 376 that can be similar to or identical to groove 276 of frame 264, and groove 376 can receive annular member 379 in a manner similar to or identical to that described with respect to annular member 279 and groove 276. In some embodiments, frame 364 includes indicator 375 defined as a notch along frame body 370 (see FIG. 3N). Indicator 375 can be used in a manner similar to that described above with respect to indicator 275.
[0127] The hub 360 includes structures configured to secure the catheter hub 342 and / or connector 343, which act to stabilize the catheter 341 as it is inserted into the catheter insertion site, minimizing movement of the catheter 341. Such structures may extend across the opening 363 (e.g., completely across the opening 363) and connect to the frame 364. Referring to Figures 3M-3R, the hub 360 may include mounting structures 380 and / or 390. The mounting structure 380 may be configured to secure the catheter hub 342, and the mounting structure 390 may be configured to secure a connector 343 (which may be a male Luer connector) connectable to the catheter hub 342. Figure 3V shows a top perspective view of the hub 360 with the catheter hub 342 and connector 343 secured by the mounting structures 380, 390. As shown, in some embodiments, connector 343 may be retained by and between mounting structures 380, 390. In some variations, hub 360 includes only one of mounting structures 380 or 390. For example, in some variations, hub 360 includes mounting structure 380 but not mounting structure 390, or includes mounting structure 390 but not mounting structure 380. Mounting structures 380, 390 may be connected to frame 364 and extend across opening 363. For example, mounting structures 380, 390 may connect to and extend between opposite sides of frame body 370 of frame 364. In some embodiments, mounting structures 380 and / or 390 are integrally formed with frame 364. As shown, mounting structures 380, 390 may be spaced apart from one another.
[0128] 3S, the mounting structure 380 may include a base 382 extending across the opening 363 between the frame bodies 370. The base 382 may be spaced a distance d2 from the bottom of the hub 360 (e.g., the bottom surface of the membrane 362). Such a configuration may inhibit or prevent the mounting structure 380 from contacting the subject's skin during use of the hub 360, thereby advantageously inhibiting (e.g., preventing) the mounting structure 380 from causing potential irritation to the subject's skin. The mounting structure 380 may include arms 384 (also referred to as "sidewalls") extending outward from the base 382. The arms 234 may extend transversely (e.g., perpendicularly) to the base 382, as shown. The arms 384 are spaced apart from one another, and such spacing may be sized to receive the catheter hub 342. As shown in FIG. 3S, the mounting structure 380 may include a surface 385 configured to face and / or contact the catheter hub 342 when the catheter hub 342 is secured by the mounting structure 380. Such surface 385 may be defined between the arms 384. The surface 385 may have a rounded cross-section that conforms to the cross-sectional shape of the catheter hub 342. For example, the surface 385 may have a circular cross-section. As shown in at least FIGS. 3S and 3U, the surface 385 may be sloped, for example, such that a first end of the surface 385 proximal to the mounting structure 390 is higher than a second end of the surface 385 opposite such first end. Such a configuration may advantageously slope the catheter hub 342 when secured by the mounting structure 380 (see FIG. 3V). In some embodiments, the mounting structure 380 includes protrusions 386 extending from the arms 384 toward each other. Such protrusions 386 may be located at or near the ends of the arms 384 (e.g., at the "free" or "cantilever" ends of the arms 384). Such protrusions 386 may act to prevent the catheter hub 342 from being removed from the mounting structure 380. In some cases, the catheter hub 342 may be removed from the mounting structure 380 by bending the arms 384 away from each other, thereby moving the protrusions 386 away from each other.In some cases, such bending of the arms 384 may occur when sufficient removal force is applied to the catheter hub 382 (eg, in the "upward" direction in the view shown in FIG. 3S).
[0129] Referring to FIG. 3T, the mounting structure 390 may include a base 392 extending across the opening 363 between the frame bodies 370. The base 392 may be spaced a distance d3 from the bottom of the hub 360 (e.g., the bottom surface of the membrane 362). Such a configuration may inhibit or prevent the mounting structure 390 from contacting the subject's skin during use of the hub 360, thereby advantageously inhibiting (e.g., preventing) the mounting structure 390 from causing potential irritation to the subject's skin. The mounting structure 390 may include arms 394 (also referred to as "side walls") extending outward from the base 392. The arms 394 may extend transversely (e.g., perpendicularly) to the base 392, as shown. The arms 394 are spaced apart from one another, and such spacing may be dimensioned (sized) to receive the catheter hub 342. As shown in FIG. 3T, the mounting structure 390 may include a surface 395 configured to face and / or contact the connector 343 when the connector 343 is secured by the mounting structure 390. The surface 395 may be defined between the arms 394. The surface 395 may have a rounded cross-section that conforms to the cross-sectional shape of the connector 343. For example, the surface 395 may have a circular cross-section. As shown in at least FIGS. 3T and 3U, the surface 395 may be sloped, for example, such that a first end of the surface 395 proximate the mounting structure 380 is lower than a second end of the surface 395 opposite such first end. Such a configuration may advantageously slope the connector 343 when secured by the mounting structure 390 (see FIG. 3V). In some embodiments, the mounting structure 390 includes a rear wall 397 adjacent such second end of the surface 395 and intersecting (e.g., perpendicular to) the arms 394. 3V, the rear wall 397 may help retain the connector 343 and inhibit (e.g., prevent) the connector 343 from moving laterally away from the catheter hub 342 (e.g., away from the mounting structure 380). In some embodiments, the rear wall 397 includes a groove 397a along the edge of the rear wall 397.Groove 397a may have a rounded shape (eg, circular) that matches the shape of a portion of connector 343 (eg, the portion of connector 343 that mates with the end of tube 247, as shown in FIG. 3V).
[0130] The catheter housing 300 may be assembled and secured to the subject in a manner similar to that described above with reference to the catheter housing 200 and Figures 2BB-2EE. For example, after a caregiver inserts the catheter 341 into the insertion site according to a conventional approach, the hub 360 may be positioned over the catheter insertion site so that the opening 363 is positioned over the portion of the catheter 341 outside the skin and / or over the catheter hub 342. The hub 360 may be secured to the subject's skin, for example, by adhesively securing the membrane 362 to the skin. The catheter hub 342 and / or connector 343 may then be secured by attachment structures 380, 390, as shown, for example, in Figure 3V. Note that the connector 343 may be connected to the catheter hub 342 before or after securing the catheter hub 342 by the attachment structure 380. As previously described, cover 320 may be coupled to extension set 340, for example, where cover 320 is coupled to tube 347 and connector 344 extends through opening 333 and engages rim 331 of cover 320. After connector 343 and catheter hub 342 are secured to one another and secured by mounting structures 380, 390, cover 320 may be secured to hub 360, for example, via engagement of protrusions 339a, 339b on cover 320 with latch arms 373a of hub 360. Thus, securing cover 320 to hub 360 may enclose the catheter insertion site, catheter hub 342, and / or connector 343. Connector 346 (which may be referred to as a "fluid tube locking connector") may be moved along tube 347 toward cover 320 and secured to connector 244 (e.g., via engagement between threads on connector 346 and connector 244). As described above, connector 346 may include fingers 346b that may be obstructed by tabs 331a on cover 320. The connection between connector 346 and connector 344 at rim 331 may "lock" tube 347 relative to cover 320 and connector 346, for example, to prevent movement of cover 320 and / or connector 346 relative to tube 347.Assembling the catheter housing 300 in this manner can be a simple and effective method for stabilizing the catheter 341 and surrounding the catheter insertion site, however, the catheter housing 300 can be assembled and secured to the subject in ways other than those described above, and the above-described methods are not intended to be limiting.
[0131] Any of the catheter housings described herein (e.g., catheter housing 100, 200, 300) or portions thereof (e.g., hub 160, 260, 260′, 360 and / or cover 120, 120′, 120″, 220, 320) may include various sensors, such as biosensors, that can measure, collect, and transmit patient medical condition data. The biosensors may include a microprocessor. For example, the biosensors may include an illuminated LCD monitor for detecting, measuring, storing, and / or displaying a patient's vital functions, including venous and arterial blood pressure, heart rate, blood oxygen level, systemic and local temperature, local tissue humidity, and / or venous blood flow velocity. Measurements and / or calculations performed and / or obtained by these sensors may be stored in flash storage memory attached to the catheter housing. Alternatively, sensor measurements may be wirelessly (or wired) transmitted to a patient monitoring system for display to a healthcare provider or user.
[0132] [Additional Considerations and Terminology] While the present disclosure has been described in connection with specific embodiments, it will be understood by those skilled in the art that the present disclosure extends beyond the specifically disclosed embodiments to other alternatives and / or uses of the present disclosure, as well as obvious modifications and equivalents thereof. Moreover, while many variations of the present disclosure have been illustrated and described in detail, other variations that are within the scope of the present disclosure will be readily apparent to those skilled in the art based on this disclosure. It is also contemplated that various combinations or subcombinations of specific features and aspects of the embodiments may be made and still fall within the scope of the present disclosure. Accordingly, it should be understood that various features and aspects of the present disclosure can be combined with or substituted for one another in order to form varying modes of the present disclosure.
[0133] It should be understood that features, materials, properties, or groups described in connection with a particular embodiment or example are applicable to other embodiments or examples described in this section or elsewhere in this specification, unless inconsistent. All features disclosed in this specification (including the accompanying claims, abstract, and drawings), and / or all steps of any method or process so disclosed, may be combined in any combination, except combinations in which at least some of such features and / or steps are mutually exclusive. This protection is not limited to the details of the device or system examples described above. This protection extends to novel or novel combinations of features disclosed in this specification (including the accompanying claims, abstract, and drawings), or novel or novel combinations of steps of methods or processes so disclosed.
[0134] Furthermore, certain features that are described in this disclosure in the context of separate implementations may also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation may also be implemented in multiple implementations separately or in any suitable subcombination. Furthermore, while features may be described above as acting in a particular combination, one or more features from a claimed combination may in some cases be deleted from the combination, and the combination may be claimed as a subcombination or a variation of the subcombination.
[0135] Furthermore, while operations may be shown in the figures or described in the specification in a particular order, such operations need not be performed in the particular order shown or sequential order, or even all of the operations, to achieve desirable results. Other operations not shown or described may be incorporated into the example methods and processes. For example, one or more additional operations may be performed before, after, simultaneously with, or between any of the described operations. Furthermore, operations may be rearranged or reordered in other embodiments. Those skilled in the art will appreciate that the actual steps performed in the illustrated and / or disclosed processes may differ from those shown. In some systems, some of the steps may be omitted, or other steps may be added. Furthermore, the features and attributes of the specific examples described above may be combined in various ways to form additional example systems, all of which are within the scope of the present disclosure. Also, the separation of various system components in the implementations described above should not be understood as requiring such separation in all implementations, and it should be understood that the described components and systems may generally be integrated together in a single product or packaged in multiple products.
[0136] As used herein, conditional language, particularly terms such as "can," "can be," "may," "may," "may," "for example," and the like, is generally intended to convey that certain features, elements, and / or steps are optional, unless otherwise specified or understood otherwise within the context in which it is used. Thus, such conditional language is not intended to imply that the features, elements, and / or steps are somehow required, or that one or more embodiments necessarily include logic for determining whether those features, elements, and / or steps are included or should always be performed, regardless of the presence or absence of other input or prompting. Terms such as "comprises," "includes," and "having" are synonymous and are used inclusively, open-ended, and do not exclude additional elements, features, acts, operations, etc. Additionally, the term "or" is used in an inclusive (rather than exclusive) sense; for example, when used to connect listed elements, the term "or" means one, some, or all of the elements in the list. Furthermore, the term "respectively" as used herein, in addition to its ordinary meaning, may also mean any subset of the set of elements to which the term "respectively" applies.
[0137] Certain terminology is used in the following description for reference purposes only and is not intended to be limiting. For example, terms such as "top" and "bottom" refer to directions within the referenced drawings. Terms such as "proximal," "distal," "anterior," "posterior," "rear," and "side" describe the orientation and / or location of parts of components or elements within a consistent but arbitrary frame of reference. Reference to the text and associated drawings describing the component or element under discussion will clarify the content. Such terminology may include words specifically mentioned above, derivatives thereof, and words of similar import.
[0138] Conjunctions such as "at least one of X, Y, Z," unless otherwise specified, are understood in the context in which they are used to generally convey that an item, term, etc. is either X, Y, or Z. Thus, such conjunctions are not generally intended to imply that a particular embodiment requires the presence of at least one of X, at least one of Y, and at least one of Z.
[0139] As used herein, terms expressing degrees, such as "approximately," "about," "generally," and "substantially," refer to values, amounts, or characteristics that are close to a stated value, amount, or characteristic that still functions and achieves a desired function or result. For example, the terms "approximately," "about," "generally," and "substantially" can refer to an amount that is within 10%, 5%, 1%, 0.1%, or 0.01% of a stated amount. As another example, in certain embodiments, the terms "approximately parallel" and "substantially parallel" refer to a value, amount, or characteristic that deviates from strictly parallel by no more than 10 degrees, 5 degrees, 3 degrees, or 1 degree. As another example, in certain embodiments, the terms "approximately perpendicular" and "substantially perpendicular" refer to a value, amount, or characteristic that deviates from exactly perpendicular by no more than 10 degrees, 5 degrees, 3 degrees, or 1 degree.
[0140] While the foregoing detailed description illustrates, describes, and points out novel features, it should be understood that various omissions, substitutions, and changes in the form and details of the illustrated devices or systems may be made without departing from the spirit of the disclosure. As will be recognized, some features can be used or practiced separately from other features, and therefore certain portions of the description herein may be embodied in a form that does not provide all of the features and advantages described herein. The scope of the specific embodiments disclosed herein is indicated by the appended claims, rather than the foregoing description. All changes that come within the meaning and range of equivalency of the claims are intended to be embraced within their scope. [Explanation of symbols]
[0141] 100, 200, 300 catheter housing 120, 120´, 120″, 120´´´, 220, 320 Cover 121a´, 121b´ Port 121c´ Chamber 121d´ First end 121e´ Second end 122, 222 Wing 122a opening 122b Rib 123a, 223a, 323a upper part 123b, 123b´, 223b, 232a, 323b Wall 126 Arm 131, 331 rims 133, 163, 198, 233, 263, 333 Openings 135, 246b notch 140, 240, 340 Expansion Set 141, 241, 341 catheter 142, 242, 342 catheter hub 143, 243 male luer connector 144, 146, 231, 246, 346 Connectors 145 Annular Ring 147, 247, 347 tubes 148, 248, 348 Female Luer Connector 160, 260, 260´, 360 hubs 162, 262, 262´, 362 membrane 162a, 262a, 262a´, 362a perforation 167, 267 raised part 169, 269, 269´, 369 slots 177, 377 Light source housing 179, 196 flange 183 Cavity 192 stem 194 Main Unit 197 Protrusion 197a Sloped section 197b Non-slope section 197″, 197´´´ holes 199" recess 231a Connector body 231b Threaded part 231c, 273a, 273b latch arms 237a, 237b, 337a, 337b Gas Port 239a, 239b, 339a, 339b protrusion 243 Luer Connector 245 Stopper 246a, 346a main body 249 Sleeve 262a, 263, 263´, 272´ opening 264, 264´, 364 frames 270, 270´, 370 frame body 272b Recess 234, 274, 274´ Arms 274a First Section 274b Second Section 275, 375 indicator 276´ 376 Groove 279, 279´, 379 Annular members 291, 292, 293 Slits 331a Tab 345a, 345b ring 346b Finger 380, 390 mounting structure 382, 392 base 384, 394 Arm 385, 395 surface 386, 396 protrusion 397 Back wall 397a Groove
Claims
1. a hub configured for placement at a catheter insertion site; a cover configured to at least partially surround a catheter insertion site; 1. A device adapted for use at a catheter insertion site of a subject, comprising: The hub includes: a membrane having an opening configured to be secured to a subject's skin such that the catheter insertion site is located within the opening; a frame connected to the membrane along at least a portion of a periphery of the opening; a mounting structure extending across the membrane opening and connected to the frame, a portion of the mounting structure configured to secure a catheter hub connected to a catheter configured to be inserted into the catheter insertion site, a portion of the mounting structure spaced inwardly from a periphery of the opening and spaced above the membrane opening; The device comprises:
2. The device described in claim 1, wherein at least a portion of the mounting structure and the frame are integrated.
3. An apparatus as described in claim 1 or 2, wherein a portion of the mounting structure configured to be secured to the catheter hub is rounded to fit within a cylindrical portion of the catheter hub.
4. An apparatus as described in any one of claims 1 to 3, wherein the frame comprises a first material and the membrane comprises a second material, the first material being more rigid than the second material.
5. An apparatus as described in any one of claims 1 to 4, wherein a portion of the mounting structure is configured to fix the catheter hub in an inclined position relative to the subject's skin during use.
6. An apparatus as described in any one of claims 1 to 5, wherein the cover is configured to be removably secured to the hub of the apparatus.
7. The device of claim 6, wherein the frame has a latch arm configured to engage a portion of the cover to removably secure the cover to the frame of the hub of the device.
8. The apparatus of claim 7, wherein the frame further comprises a first end, a second end opposite the first end, a first side, and a second side opposite the first side, and the latch arm extends from the first end of the frame.
9. An apparatus as described in any one of claims 1 to 8, wherein a portion of the mounting structure configured to be secured to the catheter hub comprises a first arm and a second arm, the first arm and the second arm being spaced apart from one another and configured to fit over and surround a portion of the catheter hub.
10. The device of claim 9, wherein the first arm and the second arm are configured to fit within and surround a cylindrical portion of the catheter hub.
11. The apparatus described in claim 9, wherein the mounting structure further comprises a base extending across the opening in the membrane between opposing sides of the frame, the first arm and the second arm being connected to the base.
12. The device described in claim 1, wherein the mounting structure further comprises a base extending across the opening in the membrane between opposing sides of the frame, and a portion of the mounting structure configured to secure the catheter hub is connected to the base.
13. The device of claim 1, wherein the cover has a cover opening configured to allow a fluid tube to extend through the cover opening and be fluidly connected to the catheter hub via a connector.
14. The device described in claim 1, wherein the membrane has a plurality of perforations surrounding the frame and the opening in the membrane.
15. The frame includes an annular shape having a first end, a second end opposite the first end, a first side, and a second side opposite the first side; The apparatus of claim 1 , wherein the mounting structure is spaced from both the first end and the second end and is connected to a first side and a second side of the frame.