Venting device and related method

Abstract

The present invention provides a venting device for exhausting gases from medical equipment lines that contain gases to be removed. [Solution] There are various types of venting devices 100 for exhausting gas from a medical device line that has a gas to be removed. The venting device may include an inlet 102 that communicates with the inside of the line during use, and an outlet 104 that communicates with the air outside the line or is exposed to the outside air. The inlet and outlet define opposing ends of a flow path configured to exhaust gas from the inside of the line to the outside of the line and to restrict the flow of fluid from the inside of the line out of the outlet of the venting device.

Description

Technical Field

[0001] The present invention generally relates to a venting device for removing gas from medical devices such as tubing lines. In some cases, the present invention can be used for gas venting from a peripheral intravenous catheter or other medical instruments.

Background Art

[0002] Venous air embolism occurs when one or more air bubbles enter the vein and restrict blood supply to specific human organs such as the heart, lungs, and brain. Arterial air embolism is the same event and occurs in the artery.

[0003] Air embolism can cause heart attacks, strokes, and respiratory failure, and in neonatal patients in particular, 0.02 mL of air can cause ischemia or restriction of blood supply to tissues in the neonatal patient, which can be fatal.

[0004] Air embolism can occur not only as a result of compression such as compressive injury, pulmonary trauma, and scuba diving, but also during injections and surgical procedures, which can occur during neurosurgery and during infusion therapy when air trapped within the infusion line is not properly vented prior to drug injection.

[0005] Currently, medical personnel are trained to identify and remove air embolism. This is more of a reactive measure rather than a proactive one, and thus is not very desirable. Also, in some cases, a syringe is used to vent air from the infusion line. The operator can aspirate the trapped air by connecting the syringe to the needleless connector. In this case, the operator needs to identify the trapped air and remove all of it.

[0006] The aforementioned remedies do not eliminate or reduce the likelihood of the problem occurring, but rather require the practitioner to identify and resolve the problem.

[0007] Current air suction techniques require additional steps, making them more time-consuming. This is undesirable in emergencies where the practitioner may already be preoccupied with other symptoms or treatments. Furthermore, the use of syringes and the time spent by the practitioner add to the waste and cost.

[0008] It is desirable to overcome or improve at least one of the aforementioned problems, or at least provide a useful alternative. [Overview of the project]

[0009] Disclosed is a venting device for exhausting gas from a line, the device comprising, when in use, an inlet communicating with the inside of the line and an outlet communicating with the outside air of the line, wherein the inlet and outlet define opposing ends of a flow path configured to exhaust gas from the inside of the line to the outlet and to suppress the flow of liquid from the inside of the line to the outlet.

[0010] The flow path may contain a gas-permeable hydrophobic material.

[0011] The apparatus may further include a housing, the inlet being in the distal region of the housing, the outlet being in the proximal region of the housing, and the flow path forming a conduit within the housing. The outlet may contain a hydrophobic material. The housing may include one or more proximal outlet openings, and the outlet may be formed as a strip of hydrophobic material crossing one or more outlet openings. The strip may cover one or more outlet openings.

[0012] The hydrophobic material may be embodied as an insert and placed within the housing, positioned between the inlet and outlet.

[0013] The inlet may include one or more inlet openings formed in the distal region of the housing.

[0014] The channel can be formed by a hydrophobic material body. The outlet is defined by the proximal region of the body, and the inlet is defined by the distal region of the body.

[0015] The device may include a distal region that at least partially includes an inlet, a proximal region that includes an outlet, and an intermediate region between the distal and proximal regions. The distal region may have a first thickness, and the intermediate region may have a second thickness that is smaller than the first thickness. The proximal region may have a third thickness that is larger than the second thickness.

[0016] The proximal region may be configured as a grip. The outer surface of the proximal region may be textured. The textured surface increases friction between the device and the user's fingers.

[0017] The distal region may have a first width, and the proximal region may have a second width that is greater than the first width.

[0018] The line may be part of an intravenous catheter (IVC) or a peripheral intravenous catheter (PIVC). The venting device may be sized to be received through a needleless connector of the IVC or PIVC. In this regard, being sized to be received through a needleless connector may include only the portion that is inserted into or through the needleless connector being of such size. Any portion of the device that does not need to be inserted may be of a suitable size so as to be grasped by the user.

[0019] Advantageously, when the device is connected to a line containing the gas to be removed, such as via a needleless connector, it can passively allow air to pass from the device to the surroundings along the flow path. Furthermore, since the flow path, which may include hydrophobic materials, is configured to restrict the passage of liquid from the outlet, there is virtually no risk of blood leaking from the device or through the connector to which the device connects to the line.

[0020] A venting device for exhausting gases from a medical device is disclosed. The venting device, when in use, An entrance that communicates with the inside of the medical device, This may include an outlet that is open to the outside air of the medical device, The inlet and outlet define opposite ends of a flow path configured to exhaust gases from inside the medical device through the outlet and to restrict the flow of liquids from inside the medical device to the outlet.

[0021] The venting device according to claim 1, wherein the flow path includes a gas-permeable hydrophobic material.

[0022] The venting device may further include a housing, with the inlet located in the distal region of the housing and the outlet in the proximal region of the housing, and the flow path forming a conduit within the housing. For example, the housing may be a two-part housing with a seam, and an insert is placed within the cavity of the housing to define the venting device.

[0023] Hydrophobic materials can be placed at the outlet.

[0024] The housing may include one or more proximal outlet openings, the hydrophobic material may be located at the outlet, or the strip of hydrophobic material may be located across one or more outlet openings.

[0025] A strip of hydrophobic material can cover one or more outlet openings such that gases flowing out from one or more openings must flow through the strip of hydrophobic material.

[0026] The hydrophobic material can be formed as an insert, which can be positioned within the cavity of the housing and disposed between the inlet and the outlet.

[0027] The inlet may include one or more inlet openings formed in the distal region of the housing.

[0028] The flow path can be formed by the body of the hydrophobic material.

[0029] The vent device can have a generally flat profile with a length and a thickness, and the length is at least 20 times the thickness. For example, the length can be 25 times, 30 times, 35 times, 40 times, or 60 times the thickness.

[0030] The vent device may include a distal region that at least partially includes the inlet, a proximal region that includes the outlet, and an intermediate region intermediate between the distal region and the proximal region.

[0031] The distal region can have a first thickness, and the intermediate region can have a second thickness that is smaller than the first thickness.

[0032] The proximal region can have a third thickness that is greater than the second thickness.

[0033] The proximal region of the vent device can be configured as a grip.

[0034] The outer surface of the proximal region can be textured to improve gripping.

[0035] The distal region can have a first width, and the proximal region can have a second width that is greater than the first width.

[0036] The line can be part of an intravenous catheter (IVC) or a peripheral intravenous catheter (PIVC).

[0037] The inlet can be located within the receiving end of a port or connector.

[0038] During use, the gas is exhausted through the venting device without the first part of the venting device acting relative to the second part of the venting device, and the venting device does not contain first and second parts that are movable relative to each other for operation.

[0039] A method for forming a venting device for exhausting gas from a line containing gas to be removed is disclosed. The steps include forming a body from a hydrophobic material having a distal region, a proximal region, and an intermediate region between the distal and proximal regions, In order to form a thin profile, the body is provided with a length at least 20 times greater than the thickness of the body, The process includes the steps of forming a first width W1 in the distal region and a second width W2 in the proximal region, wherein the second width W2 is greater than the first width W1. The method is further, The steps include forming a first thickness H1 in the distal region, a second thickness H2 in the intermediate region, and a third thickness H3 in the proximal region, The procedure includes the step of providing a tapered edge in the distal region to facilitate the insertion of the venting device.

[0040] The first thickness H1 can be greater than the second thickness H2. [Brief explanation of the drawing]

[0041] Hereinafter, embodiments of the present invention will be described with reference to the drawings as non-limiting examples.

[0042] [Figure 1] Figure 1 is a rear perspective view of the apparatus according to one embodiment of this teaching. [Figure 2] Figure 2 is a front perspective view of the device. [Figure 3] Figure 3 is a side view of the device. [Figure 4] Figure 4 is another perspective view of the device. [Figure 5] Figure 5 is a side elevation view of the apparatus. [Figure 6] Figure 6 is a top view of the apparatus. [Figure 7] Figure 7 is an exploded view of the device, showing the two components: the housing and the insert. [Figure 8] Figure 8 is an end-face cross-sectional view of the assembled device shown in Figure 7. [Figure 9] Figure 9 shows an apparatus according to one embodiment of this teaching, the proximal region of the apparatus is equipped with grips for various texture change examples. [Figure 10] Figure 10 is a front perspective view of an alternative device according to one embodiment of this teaching. [Figure 11] Figure 11 is a rear perspective view of an alternative apparatus according to one embodiment of this teaching. [Figure 12] Figure 12 is a front perspective view of an alternative device according to one embodiment of this teaching. [Figure 13] Figure 13 shows PIVC before it is connected to the patient's vascular system. [Figure 14] Figure 14 shows the PIVC assembly from Figure 13 after it has been connected to the patient's vascular system. [Figure 15] Figure 15 shows an apparatus according to one embodiment of this teaching, which is inserted through a port or connector and attached to the PIVC, and is in fluid communication with the PIVC. [Figure 16] Figure 16 shows an apparatus according to one embodiment of this teaching, which is connected to a connector housing to access the line in order to exhaust gas from the line. [Figure 17] Figure 17 shows the connector or valve contact area of ​​the device according to one embodiment of this teaching, where the device is received by the connector or valve. [Modes for carrying out the invention]

[0043] The detailed description below, in relation to the accompanying drawings, is intended to describe currently preferred embodiments of the venting apparatus provided according to the embodiments of the Apparatus, System, and Method, and is not intended to represent the only forms in which the Apparatus, System, and Method may be constructed or used. This specification specifies features and steps for constructing and using embodiments of the Apparatus, System, and Method in relation to the illustrated embodiments. However, it should be understood that identical or equivalent functions and structures may also be achieved by different embodiments intended to be covered within the spirit and scope of this disclosure. As shown elsewhere in this specification, similar element numbers are intended to indicate similar or similar elements or features.

[0044] Generally speaking, practitioners must identify trapped air in infusion sets, catheter systems, etc., or identify and correct the presence of embolism after delivering air to a patient. However, in emergency situations, this puts pressure on practitioners who may be distracted and fail to identify trapped air before delivering air to the patient. Embodiments of the present invention enable passive exhaust of air from lines of medical devices such as peripheral intravenous catheters (PIVCs) and intravenous catheters (IVCs) without the need to inspect for trapped air or for practitioner intervention. Embodiments of the present invention can also prevent blood and fluids from leaking from the venting device along the air path.

[0045] Referring to Figure 1, a vent or venting device 100 is shown, which includes an inlet 102, an outlet 104, and a flow path 106 between the inlet and the outlet. In other words, the flow path 106 has an inlet and an outlet at opposite ends of the flow path.

[0046] In the embodiment shown in Figure 1, the exhaust port or vent device 100, or simply the device, includes a housing 108. The inlet 102 is located in the distal region 110 of the housing 108, and the outlet 104 is located in the proximal region 112 of the housing 108. Thus, the flow path 106 (shown as a dashed line because it is inside the device 100) forms a conduit within the housing 108.

[0047] The distal region 110 of the housing 108 may be the portion of the housing 108 that communicates with the gas (e.g., air) in the lines, systems, or chambers of the medical device during use of the venting device 100. The shape of the device 100 is not limited to the illustrated shape and can be adjusted as needed. For example, the distal region 110 may be any portion of the housing 108 that can communicate with the gas in the lines. As shown, the housing 108 has a flat profile in that the width of the housing is substantially greater than or greater than the thickness of the housing. The flat profile allows the housing 108 to be inserted into the body of a connector having a complementary narrow opening profile. In other embodiments, the housing 108 may have a distal region having a cylindrical shape for insertion into a complementary bore-shaped inlet opening. For example, the housing 108 of the venting device 100 may have a male luer tip for insertion into the female luer of a connector to exhaust air from the connector side to the outside of the venting device.

[0048] When the venting device 100 is used to remove gas from a medical device, such as from a line that is part of an IVC or PIVC, the inlet 102 communicates with the inside of the line, as shown in Figures 16 and 17. The venting device 100 may be supplied separately from the medical device line, system, or assembly, or it may be supplied on-site with the medical device, such as during packaging, to allow for quick passive use of the venting device 100 without separate connection steps.

[0049] Referring to Figure 2, the inlet 102 is configured here as a plurality of openings 114, only some of which are provided by reference number for clarity in Figure 2. The openings 114 are formed in the distal region 110 of the housing 108. It will be understood that a single opening, or any desired number of openings such as two, three, four, or more, may be provided in a given embodiment to suit the purpose for which the device 100 is intended to be used. The distal region 110 of the vent device has a distal edge 155, i.e., the tip end. The tip end 155 may be solid or at least not have an opening for the inlet gas flow. As shown, the plurality of openings 114 of the inlet are located proximal to the distal edge 155. In a particular embodiment, at least one opening 114 is provided on the side edge of the distal region, and optionally at least one opening is provided on the side edge of the intermediate region. The side edges of the distal and intermediate regions may be angled with respect to the distal edge 155. In a further embodiment, at least one opening 114 is provided on each of the two lateral edges of the distal region, and each of the two lateral edges is angled with respect to the distal edge. In another embodiment, at least one opening 114 is provided on each of the two lateral edges of the intermediate region, and each of the two lateral edges is angled with respect to the distal edge. If there are two or more openings 114, the two or more openings may have the same or different opening sizes, including the same or different opening types.

[0050] The proximal region 112 of the housing 108 (Figure 1) forms the portion of the housing 108 that communicates with the surrounding environment during use. For example, the proximal region 112 can be exposed to or opened to the ambient atmosphere in order to directly exhaust the gas removed through the device into the ambient atmosphere. Thus, the gas exhausted from the exhaust port 104 of the proximal region 112 can be exhausted into the atmosphere.

[0051] Figure 1 further shows an outlet 104 configured as a plurality of openings 116, only some of which are provided by reference numerals for clarity in Figure 1. It will be understood that a single opening, or any desired number of openings such as two, three, four, six, or more, may be provided in a given embodiment so that the device is suitable for the intended purpose. The proximal region 112 of the vent device has a proximal edge 153, i.e., the rearmost edge. The proximal edge 153 has an exhaust port 104 positioned therefor for exhaust gas flow. In one embodiment, at least two or more spaced-apart openings 116 are provided as outlets for gas outflow. If two or more openings 116 are present in the proximal region, the two or more openings may have the same or different sizes, including the same or different types of openings. Each of the at least two or more spaced-apart openings 116 in the proximal region may have an opening that defines a plane, where the plane is at an angle to the plane of the opening in the distal region. As a result, the internal flow path of the housing 108 of the venting device of the present invention is nonlinear in that the gas flow entering the flow path through the housing must change direction at least once between entering from the inlet and exiting from the outlet.

[0052] As shown in Figures 1 and 2, the housing 108 has an inlet 102 in the distal region 110 and an outlet 104 in the proximal region, which respectively form the inlet and outlet of the flow path 106 formed inside the housing 108. Both the inlet and outlet may have one or more openings, one or more of which may span a joint 105 extending through the housing.

[0053] Thus, one aspect of the present invention is understood to include a venting device used with medical devices such as Luer adapters, IVCs, and PIVCs, and configured to remove gas from the medical devices. The venting device may be configured to remove gas without operating the venting device or moving any internal components of the venting device to enable venting. In its simplest form, the venting device may simply be positioned to fluidly communicate with a medical device having the gas to be removed without operating or moving any internal components of the venting device, such as by moving one part of the venting device relative to another part of the venting device.

[0054] While the housing 108 has a distal region 110 and a proximal region 112, some embodiments of the venting device according to aspects of the present invention do not include the housing 108. For example, as will be further described later, Figure 12 shows an alternative venting device 100 having a distal region and a proximal region, and allowing gas to flow through or across the device without a separate housing. Thus, referring to Figure 3, without the housing 108, the venting device 100 may have a distal region 118, a proximal region 120, and an intermediate region 122 having a valve contact region 123 located between the distal region 118 and the proximal region 120. Thus, the venting device 100 can embody an insert that is placed within the housing 108, or the venting device may have its own utility without being placed within a housing. Thus, the venting device can be used with a connector for removing or exhausting gas without a separate housing. Alternatively, the venting device can be formed as an insert placed within the housing 108, and the combination of the insert and the housing is used to remove gas from the medical device line.

[0055] The distal region 118 includes an inlet 102 formed here as a plurality of openings 114. In some embodiments, the entire inlet 102 may be formed in the distal region 118 of the device 100, while in other embodiments, as shown, the inlet 102 may be on or partially located in the intermediate region 122. In other words, a plurality of openings functioning as inlets may be present in the distal and intermediate regions of the device.

[0056] As shown in Figure 4, the proximal region 120 of the device includes an outlet 104, which is configured here as a plurality of openings 116. The openings may extend to the proximal end of the proximal region or be arranged at intervals. One or more openings may optionally be located at the corners of the proximal edge and at the lateral edges of the proximal region. In yet another example, one or more openings may be located at the lateral edges of the proximal region.

[0057] For illustrative purposes, Figures 3 and 4 include arrows indicating the direction of gas inflow and outflow through the device 100. In particular, Figure 3 shows the inflow of gas from a medical device line, as indicated by arrow X pointing into the opening 114 of the inlet 102. Similarly, Figure 4 shows the outflow or exhaust of gas from the device 100, and by extension from the line, as indicated by arrow Y extending from the opening 116 of the outlet 104. Thus, for example, gas from a line can be exhausted through the vent device 100 by flowing into the inlet 102, passing through one or more flow paths within the device body, and outflowing from the outlet 104.

[0058] As shown in Figures 5 and 6, the distal region 118 of this embodiment has a first thickness H1. The intermediate region 122 has a second thickness H2, where H2 is smaller than H1. Similarly, in this embodiment, the proximal region 120 has a third thickness H3, which is larger than H2. In some cases, H1 and H3 may have the same thickness or different thicknesses. In other embodiments, H3 may have the same thickness as H2. In some examples, H1 is equal to H2, or H1 is smaller than H2. When these alternative thicknesses are incorporated, the distal region may have alternative structures to resist the removal of the device from the port or connector. For example, the distal region may include strips or bumps to increase the thickness of the distal region at specific locations within the distal region.

[0059] The transition section 117 is provided between two adjacent regions, such as between the distal region and the intermediate region, and between the intermediate region and the proximal region. The transition section 117 can embody the tapered thickness portion of the vent device and can be provided on one side of the device or on both sides of the device, as shown in the side elevation view of Figure 5.

[0060] In one embodiment, the venting device 100 can be incorporated into the connector housing, and the combination of the housing and the venting device can be connected to a port having a line containing the gas to be removed, as shown in Figures 14 to 17. In an alternative embodiment, the port having a line containing the gas to be removed may have a receiving flap with an opening that can directly receive the venting device 100. Thus, a venting device according to an aspect of the present invention can be connected directly to a port on a medical device adapter to remove gas from a medical device without first being assembled into a connector having a tip for inserting the tip into the port on the medical device adapter.

[0061] In one embodiment, the connector that grips the device 100 so that the combination can be used with the port may be a resilient member described for illustrative purposes only as a rubber septum. The rubber septum of the connector may be sized and shaped to grip the intermediate region 122 of the venting device 100. Thus, by increasing the size of the distal region 118, such as making the thickness H1 of the distal region greater than the thickness H2 of the intermediate region, the device 100 is less likely to accidentally slip off the rubber septum and detach from the line. A thicker distal region H1 creates a point of interference or restriction with the rubber septum if the device 100 accidentally slides proximal to the connector. In this way, the opening in the rubber septum provides a clamp-like function with a gap, and the relatively thicker distal region of the device 100 is restricted from coming out of the smaller gap in the rubber septum in the proximal direction.

[0062] To remove the device 100 from the line, the rubber septum must be compressed along the lateral direction of the receiving end to increase the size of the gap at the receiving end, allowing the distal region 118 to pass away from the rubber septum. In one embodiment, the receiving end of a connector or port having gas to be exhausted generally has an elongated or slotted opening. Therefore, to open the receiving end of the connector or port, the two short sides of the opening or slot are compressed together to open the gap of the elongated or slotted opening. In another embodiment, the rubber septum has a first hardness value, and the venting device has a second hardness value that is harder than the first hardness value, and when the venting device is grasped and retracted to remove it from the rectangular opening, the rubber septum is deformed by the venting device, causing the venting device to detach from the rubber septum.

[0063] The proximal region 120 can have any suitable thickness. In this embodiment, it is larger than the thickness of the intermediate region 122, allowing the operator to easily grasp it and, if desired, to facilitate the removal of the device 100 from the connector and, consequently, from the line. However, the thickness of the proximal region may be smaller than that of the intermediate region to allow the operator to grasp and pull it. In yet another embodiment, the proximal region may be provided with an enlarged gripping block or gripping surface to facilitate grasping. For example, a strip of material such as a hydrophilic material can be attached to the proximal end to provide an enlarged surface for grasping.

[0064] Referring to Figure 6, the distal region 118 has a first width W1, and the proximal region 120 has a second width W2, where W2 is greater than W1. The device 100 also has a variable width region 133 between the proximal and distal regions. In some embodiments, the variable width region 133 is instead an abrupt or single-angle riser in the transition between the smaller and larger widths. While some parts or sections of the device 100 may have a constant width, the most distal end of the distal region 118 may have a width with a narrowing or tapering profile, such as a change in width, to ensure and facilitate insertion of the tip into a port or connector to access the line having the gas to be removed. The proximal region 120 can be large enough to facilitate easy gripping and removal of the device 100 from the line when desired.

[0065] The inlet 102 and outlet 104 define the opposite ends of the flow path 106, as previously described. Furthermore, the flow path 106 is configured to exhaust gas from inside the line containing the gas to be removed through the outlet 104, but not to exhaust liquid flow from inside the line through the outlet 104. In some embodiments, restricting the liquid flow through the venting device can be achieved by placing a hydrophilic material inside the housing 108 that closes the valve diaphragm or similar flow path when it swells. Thus, when the liquid penetrates the housing 108, the hydrophilic material swells, preventing the liquid from flowing out of the housing. Alternatively, in the illustrated embodiment, the flow path may be made of a gas-permeable hydrophobic material.

[0066] In this specification, the term “gas permeability” generally refers to “air permeability.” This term is intended to refer to a material that allows gases of a nature that would be trapped in a medical line to pass through. Furthermore, the term “hydrophobic” is generally intended to mean blood-repellent, such that the material inhibits or prevents the passage of blood from outlet 104 when the device 100 is in use, but allows the passage of gases.

[0067] Referring to Figure 7, the venting device 100 comprises a housing 108 which may be formed in two parts 124, 126, and an insert 128 made of a hydrophobic material which is located within the cavity of the housing when the two parts 124, 126 are assembled together. The two housing parts 124, 126 have cut-outs or surface features which, when the two housing parts are assembled, form a notable inlet 102 and outlet 104, each having one or more openings. For example, the upper housing part 124 may have a semicircular or semirectangular cut-out, and the lower housing part 126 may have a complementary semicircular or semirectangular cut-out, and when the upper and lower housing parts 124, 126 are assembled, the two semi-cut-outs join to form a circular opening. Each housing part may have two or more cut-outs at the inlet and outlet to form two or more openings at the inlet and outlet.

[0068] The hydrophobic material insert 128 can be placed within the cavity of a two-part housing 108, and the two housing parts are fixed together by welding, adhesive, detent, or a combination thereof. The insert 128 can be placed between the inlet 102 and outlet 104 of the housing, for example, functioning as a physical presence between the inlet and outlet. The insert 128 may have a plurality of projections 130 along its edge so as to occupy the opening 114 of the inlet 102 and the opening 116 of the outlet 104. In other embodiments, the projections 130 can be omitted, and the outer circumference of the insert 128 is held firmly against the side edge of the housing 108 in the assembled state, with some interference or compression. In yet another embodiment, the insert may have a plurality of projections 130 and may also be held firmly against the side edge of the housing when assembled within the housing. For clarity in the drawing, only a portion of the projections 130 are labeled.

[0069] In one embodiment, each of the two housing portions 124, 126 has a housing contour that is complementary to the contour of the insert 128. In other embodiments, the insert may have a contour different from the contours of the two housing portions. For example, an insert made of a hydrophobic material may embody a first insert portion that occupies a cavity in the distal region of the housing and covers the inlet in the distal and intermediate regions. Another second insert occupies the proximal region of the housing and covers the outlet in the proximal region. In one embodiment, the first insert may be spaced apart from the second insert. Referring to Figures 6 and 7, as shown, the venting device 100 may have a body with a generally flat profile such that the length of the body is at least 20 times (20X) the thickness of the body. The length can be about 25 times, for example 30 times, 35 times, 50 times, or more than the thickness of the body. A large ratio of length to thickness defines a thin profile for insertion into slotted or elongated openings, as opposed to round openings of ports or connectors.

[0070] Figure 8 is a cross-sectional view of the assembled housing 108, showing an insert 128 of a hydrophobic, gas-permeable material that occupies substantially the entire internal cavity 132 formed by two parts 124, 126 of the housing 108.

[0071] To remove the device 100 from the line from which the gas is removed, a small amount of force is required to pull the distal region of the device 100 through a connector or valve. To assist in the application of this force to pull the device 100, the proximal region 120 of the device is configured as a grip, as shown in Figure 9. This configuration can be achieved by making the proximal region 120 sufficiently large or by shaping it in a way that makes it easily graspable in other ways. In one example, the outer surface 134 of the device in the proximal region 120 may be textured. Two of the many possible choices of textures 136, 138 that can be incorporated into the outer surface 134 of the device 100 are illustrated. In some examples, the outer surfaces 134 on both sides of the device may be textured.

[0072] Figure 10 shows an alternative venting device 140 in which the outlet 142 contains a hydrophobic material. As described above, since the outlet 142 is inside the device 140, it defines the end of the flow path 144, which is shown by a dashed line. Thus, by incorporating or using a hydrophobic material in the outlet 142, the flow path 144, which is partially defined by the outlet, is configured to restrict the flow of liquid.

[0073] The housing 146 of the apparatus 140 includes one or more proximal outlet openings (not shown), such as those used for the outlet 104 of the apparatus 100 discussed elsewhere in this specification. However, in this embodiment, the outlet 142 includes a strip 143 of hydrophobic material positioned across one or more outlet openings. Thus, the strip 143 covers one or more outlet openings. The internal flow channels 144 of the housing 146 may also include inserts 128 made of hydrophobic material, or they may be hollow cavities or conduits within the housing without strips. When the strip 143 of hydrophobic material is incorporated into the housing and covers one or more outlet openings on the housing, a distal opening 145 can be provided in the distal region. The distal opening 145 may be an elongated slot along the varying width of the distal region. The distal opening may be formed at the distal edge of the distal region.

[0074] Figure 11 shows a rear perspective view of the device 140, with a strip 142 attached to the housing by adhesive, ultrasonic welding or any other suitable process, covering the outlet. In one embodiment, another hydrophobic material strip may also be attached to the distal region of the housing 146 to cover the inlet in the distal region. In an alternative embodiment, the distal region of the vent device 140, which may embody an insert located inside the housing 146, may contain hydrophobic material to restrict the flow of liquid at the inlet, but the distal region of the housing 146 itself, unlike the proximal region, does not have a strip.

[0075] The flow path of the device 100 may be formed by a body of hydrophobic material, or may substantially coincide with a body of hydrophobic material. For example, the flow path may include a cavity in a housing that is entirely occupied by an insert of hydrophobic material, and the gas flows across the material of the insert.

[0076] Figure 12 shows a further embodiment in which the device 148 itself is formed by a body 150 of a hydrophobic material. The vent device 148 of Figure 12 can be used to vent gas from a medical device line without first inserting the body of the device into a complementary housing. In this embodiment, the outlet is defined by the proximal region 152 of the body 150, and the inlet is defined by the distal region 154 of the body 150. Thus, wherever gas from a line having the gas to be removed enters the body 150 of the insert, i.e., wherever gas flows into the distal region 154, it is considered an inlet, and wherever the gas escapes from the body 150 into the surrounding environment, it is considered an outlet. In one embodiment, the distal region 154 of the vent device 148 is inserted into the receiving end of a port or adapter of a medical device having the gas to be removed, and the gas can foreseeably enter all exposed surface areas of the insert located within the port or adapter. In that particular example, the entire distal region of the insert into which the gas enters is considered an inlet.

[0077] The distal region 154 can extend all the way to the proximal region 152, but for illustrative purposes, the device 148 is thought to include, to reiterate, a distal region 154 that at least partially constitutes an inlet, a proximal region 152 that constitutes an outlet, and an intermediate region 156 between the distal region 154 and the proximal region 152.

[0078] The same description as above relating to the relative thickness and width of various regions of the device 100 also applies to the device 148 of this embodiment, which can have various thicknesses and can be used without first being inserted into a complementary housing.

[0079] Figure 13 shows a prior art peripheral intravenous catheter (PIVC) access assembly 160 with a needleless connector 162 before insertion of a needle 164 with a catheter tube into the patient's vascular system 166. The tubular line 168 of the assembly 160 between the side port of the catheter hub and the adapter is empty or blood-free before use. Figure 14 shows the same assembly as in Figure 13, but after insertion of the needle 164 into the vascular system. Blood 170 is shown advancing up the needle 164 into the tube 168. In particular, an air pocket 172 is formed by the advancing blood at the adapter junction 174, including inside the needleless connector 162. Typically, the practitioner must remove the air pocket 172 by inserting the Luer tip of a medical instrument such as a syringe into the needleless connector 162 and deflating it to prevent the air pocket 172 from being injected into the vascular system 166 as a bubble and causing air embolism.

[0080] Figure 15 shows the venting device 100 according to this teaching, inserted through a needleless connector 176 to communicate with the inside of line 178. Notably, blood 180, having traveled up the needle 182, into line 178, and proceeded to the joint 184, is replaced or pushed out by any air from the joint 184 through the venting device 100, but the blood does not proceed through the device 100 because the flow path of the device is configured to prevent the blood from escaping through the outlet of the device 100. For example, as previously described, the device 100 itself can be made from a hydrophobic material, or one or more strips made from a hydrophobic material can be placed at the inlet of the insert, the inlet of the housing having the insert, the outlet of the housing having the insert, or a combination thereof, so that gas passes through the device but blood does not.

[0081] Figure 16 is a schematic diagram of a venting device 100 according to a further embodiment of the present invention, inserted into a housing 200 of a connector 176 having a luer tip 205 and a threaded collar 207 surrounding the tip 205. In some embodiments, the collar can be omitted, and the device is called a luer slip. The luer tip 205 of the connector 176 can be used with a connector having a female luer, for example, a needleless valve having a female luer receptacle.

[0082] As shown in the figure, the housing 200 of the connector 176 has a receiving end 202 which includes a flap or valve 204 having a slit or opening sized and shaped to receive the distal region 118 of the venting device 100. The receiving end 202 can receive the distal region 118 and at least a portion of the intermediate region of the device 100, but cannot receive the proximal region 120 of the device 100 that extends outside the housing 200. Thus, by making the proximal region 120 too wide and long to fit into the connector 176, the proximal region 120 prevents the entire device 100 from being inadvertently pushed through the housing 200 into the adapter joint 184. Furthermore, a transitional region with variable width or abrupt change in width between the intermediate and proximal regions can be sized and shaped to prevent insertion of the housing 200 into the receiving end 202.

[0083] Figure 17 shows the same apparatus 100 and needleless connector 176 as in Figure 16, but rotated 90° from Figure 16 to show the thickness instead of the width of the apparatus 100. As shown, the intermediate region 122 is held by the periphery of the opening of the flap 204 of the connector 176. The thicker distal region 118 is further located within the housing 200 of the connector 176 and communicates with the interior of the line in the direction indicated by arrow Z.

[0084] Methods of use and manufacture of vascular access assemblies, including venting devices and components of vascular access assemblies, as shown and described herein, are understood to be within the scope of the present invention.

[0085] It will be understood that many further modifications and permutations of various aspects of the embodiments described are possible. Accordingly, the embodiments described are intended to encompass all such modifications, alterations, and variations that fall within the spirit and scope of the appended claims.

[0086] Throughout this specification and the subsequent claims, unless otherwise required by context, the word “includes” is understood to mean including any integer or step or group of integers or steps described, but not to mean excluding any other integer or step or group of integers or steps.

[0087] References in this specification to prior publications (or information derived therefrom) or publicly known matters do not constitute an acknowledgment or suggestion that such prior publications (or information derived therefrom) or publicly known matters form part of the general knowledge in the field of effort to which this specification relates.

[0088] While this specification specifically describes and illustrates limited embodiments of venting devices, connectors, and vascular access assemblies and their components, many modifications and variations will be apparent to those skilled in the art. Therefore, it should be understood that venting devices, connectors, and vascular access assemblies and their components, constructed according to the principles of the disclosed devices, systems, and methods, may be embodied in ways other than those specifically described herein. This disclosure is also defined in the following claims.

Claims

1. A venting device for exhausting gases from medical equipment, The venting device is When in use, there is an inlet that communicates with the inside of the medical device, Includes an outlet exposed to the outside air of the medical device, The inlet and outlet define the opposing ends of a flow path configured to exhaust gas from the inside of the medical device to the outlet and to suppress the flow of liquid from the inside of the medical device to the outlet. Vent device.

2. The channel contains a gas-permeable hydrophobic material. The venting device according to claim 1.

3. Including the housing, The inlet is located in the distal region of the housing, the outlet is located in the proximal region of the housing, and the flow path forms a conduit within the housing. The venting device according to claim 1 or 2.

4. A hydrophobic material is placed at the outlet. The venting device according to claim 3.

5. The housing includes one or more proximal exit openings. A hydrophobic material is located at the outlet, or a strip of hydrophobic material is arranged across one or more outlet openings. The venting device according to claim 4.

6. A strip of hydrophobic material may cover one or more outlet openings, and gases flowing out of one or more openings must flow through the strip of hydrophobic material. The venting device according to claim 5.

7. The hydrophobic material is formed as an insert. The insert is located in the cavity within the housing and is positioned between the inlet and outlet. The venting device according to claim 3.

8. The entrance includes one or more entrance openings formed in the distal region of the housing. A venting device according to any one of claims 3 to 7.

9. The channel is formed by the hydrophobic material body. The venting device according to claim 2.

10. It has a generally flat profile with length and thickness, where the length is at least 20 times the thickness. The venting device according to claim 8.

11. It includes a distal region that includes at least a partial entrance, a proximal region that includes an exit, and an intermediate region between the distal and proximal regions. A venting device according to any one of claims 1 to 10.

12. The distal region has a first thickness, and the intermediate region has a second thickness that is smaller than the first thickness. The venting device according to claim 11.

13. The proximal region has a third thickness greater than the second thickness. The venting device according to claim 11 or 12.

14. The proximal region is composed of grips. A venting device according to any one of claims 11 to 13.

15. The outer surface of the proximal region is textured. The venting device according to claim 14.

16. The distal region has a first width, and the proximal region has a second width that is greater than the first width. A venting device according to any one of claims 11 to 15.

17. The line is part of an intravenous catheter (IVC) or peripheral intravenous catheter (PIVC). A venting device according to any one of claims 1 to 16.

18. The inlet is located within the receiving end of the port or connector. The venting device according to claim 17.

19. The gas is exhausted through the venting device without activating the first part of the venting device relative to the second part of the venting device. The venting device according to claim 1.

20. A method for forming a venting device for exhausting gas from a line having gas to be removed, The method is, The steps include forming a body from a hydrophobic material having a distal region, a proximal region, and an intermediate region between the distal and proximal regions, In order to form a thin profile, the body is provided with a length at least 20 times greater than the thickness of the body, The first width W in the distal region １ A second width W in the proximal region ２ The steps include forming a second width W ２ The first width W １ Larger, The method is further, Distal region has a first thickness H １ A second thickness H is added to the intermediate region. ２ A third thickness H in the proximal region ３ The steps of forming, A method comprising the step of providing a tapered edge in the distal region to facilitate the insertion of a venting device.

21. The first thickness H １ is greater than the second thickness H ２ ​ The method according to claim 20.

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