Drip chamber with automatic vent and shutoff, and related systems and methods

Abstract

A drip chamber assembly for automatically setting and maintaining a fluid level in the drip chamber assembly is described. The dnp chamber assembly includes a drip chamber body, a fluid inlet, a fluid outlet, and an air vent. The fluid intake opening of a fluid outlet conduit of the fluid outlet and an air exhaust opening of the air vent are disposed at least proximate to the longitudinal axis of the drip chamber body.

Description

DRIP CHAMBER WITH AUTOMATIC VENT AND SHUTOFF, AND RELATED SYSTEMS AND METHODSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 618,534 filed on January' 8, 2024, the disclosure of which is incorporated herein, in its entirety , by this reference.BACKGROUND

[0002] Intravenous (IV) therapy refers to the delivery of a liquid substance (e.g., a glucose solution, saline solutions, medication in liquid form, an aqueous physiologically acceptable fluid, and blood or plasma) directly into a vein. One method of administering IV fluids is through gravity assisted infusion and is commonly referred to as an IV drip. Sometimes, IV fluids may be administered with the assistance of a pressurized cuff designed to maintain the rate of IV fluid delivery to the patient. While IV therapy has been widely available since the mid- 1900s, commercially available IV infusion sets have remained mostly unchanged for decades and many risks and inefficiencies associated with them remain largely unaddressed. For example, a significant risk associated with IV therapy is air embolism, which can result from air passing through the fluid line into the circulatory system of the patient and causing a blood vessel blockage. To reduce the risk of this, the IV bag is typically held at least 3 feet above the IV site and the drip chamber is held vertical at all times, which may be difficult to achieve in certain scenarios, such as in emergency response scenarios. Priming the IV tube set through conventional means may also have shortcomings largely unaddressed by IV tube sets currently in wide use. Thus, designers and manufacturers of IV tube sets continue to seek improvements thereto and embodiments described herein may address some of the limitations of existing solutions.SUMMARY

[0003] Assemblies for automatically setting a fluid level and maintaining the fluid level setting in a drip chamber are disclosed. In an embodiment, a drip chamber assembly for IV fluid or blood infusion is disclosed. The drip chamber assembly includes a drip chamber body having a distal region, a proximal region, and a longitudinal axis extending between the proximal region and the distal region. The drip chamber body defines an internal volume within an interior of the drip chamber body. The drip chamber assembly includes a fluid inlet having an inlet conduit disposed at the distal region of the drip chamber body and configured to dripthe IV fluid into the interior of the drip chamber. The drip chamber assembly includes a fluid outlet including a fluid intake opening disposed in the internal volume of the drip chamber body, a fluid exhaust opening at the proximal region of the drip chamber body, and a fluid outlet conduit extending between the fluid intake opening and the fluid exhaust opening such that the fluid outlet conduit is in fluid communication with the internal volume of the drip chamber body and configured to allow the IV fluid to flow out of the drip chamber body. The drip chamber assembly includes an air vent configured to automatically set and maintain an air pocket of predetermined size within the interior of the drip chamber body. The air vent includes an air intake opening in the internal volume positioned to define the predetermined size of the air pocket, an air exhaust opening at the proximal region of the drip chamber body, and an air conduit extending between the air intake opening and the air exhaust opening. The fluid intake opening of the fluid outlet conduit and the air exhaust opening of the air vent are disposed at least proximate to the longitudinal axis of the drip chamber body.

[0004] In an embodiment, a drip chamber assembly for IV fluid or blood infusion is disclosed. The drip chamber assembly includes a drip chamber body having a distal region, a proximal region, and a longitudinal axis extending between the proximal region and the distal region, the drip chamber body defining an internal volume that narrows proximally in the proximal region from a maximum width within an interior of the drip chamber body. The drip chamber assembly also includes a fluid inlet including an inlet conduit disposed at the distal region of the drip chamber body and configured to drip the IV fluid into the interior of the drip chamber body. The drip chamber assembly also includes a fluid outlet including a fluid intake opening aligned in the internal volume of the drip chamber body with the maximum width of the internal volume, a fluid exhaust opening at the proximal region of the drip chamber body, and a fluid outlet conduit extending between the fluid intake opening and the fluid exhaust opening such that the fluid outlet conduit is in fluid communication with the internal volume of the drip chamber body and configured to allow the IV fluid to flow out of the drip chamber body. The drip chamber assembly also includes an air vent configured to automatically set and maintain an air pocket of predetermined size within the interior of the drip chamber body. The air vent includes an air intake opening in the internal volume positioned between the maximum width of the internal volume and the fluid inlet to define the predetermined size of the air pocket, an air exhaust opening at the proximal region of the drip chamber body, and an air conduit extending between the air intake opening and the air exhaust opening.

[0005] In an embodiment, a method of manufacturing a drip chamber assembly for IV fluid or blood infusion is disclosed. The method includes providing a first part having a fluid inlet including an inlet conduit. The method also includes providing a second part including: a fluid outlet including a fluid intake opening, a fluid exhaust opening, and a fluid outlet conduit extending between the fluid intake opening and the fluid exhaust opening; and an air vent including an air intake opening, an air exhaust opening, and an air conduit extending between the air intake opening and the air exhaust opening. The method also includes securing the first part to the second part such that the first part and the second part form a proximal region and a distal region, respectively, of a drip chamber body that defines an internal volume within an interior of the drip chamber body with the fluid intake opening disposed in the internal volume of the drip chamber body and configured to drip IV fluid into the interior of the drip chamber. The fluid outlet is in fluid communication with the internal volume of the drip chamber body and configured to allow the IV fluid to flow out of the drip chamber body. The air vent is configured to automatically set and maintain an air pocket of predetermined size within the interior of the drip chamber. The air intake opening is positioned in the internal volume to define the predetermined size of the air pocket. The fluid intake opening of the fluid outlet conduit and the air exhaust opening of the air vent are disposed at least proximate to a longitudinal axis of the drip chamber body.

[0006] In an embodiment, a drip chamber assembly for IV fluid or blood infusion is disclosed. The drip chamber assembly includes a drip chamber body having a distal region, a proximal region, and a longitudinal axis extending between the proximal region and the distal region. The drip chamber body defines an internal volume within an interior of the drip chamber body. The drip chamber assembly includes a fluid inlet including an inlet conduit disposed at the distal region of the drip chamber body and configured to drip the IV fluid into the interior of the drip chamber. The drip chamber assembly includes a fluid outlet including a fluid intake opening disposed in the internal volume of the drip chamber body, a fluid exhaust opening at the proximal region of the drip chamber body, and a fluid outlet conduit extending between the fluid intake opening and the fluid exhaust opening such that the fluid outlet conduit is in fluid communication with the internal volume of the drip chamber body and configured to allow the IV fluid to flow out of the drip chamber body. The longitudinal axis extends through the fluid intake opening, the fluid exhaust opening, and the fluid outlet conduit. The drip chamber assembly includes an air vent configured to automatically set and maintain an airpocket of predetermined size within the interior of the drip chamber body. The air vent includes an air intake opening in the internal volume positioned to define the predetermined size of the air pocket and aligned with the longitudinal axis, an air exhaust opening at the proximal region of the drip chamber body and offset from the longitudinal axis, and an air conduit extending between the air intake opening and the air exhaust opening, the air conduit including a curved and / or angled section between the air intake opening and the air exhaust opening.

[0007] Features from any of the disclosed embodiments may be used in combination with one another, without limitation. In addition, other features and advantages of the present disclosure will become apparent to those of ordinary skill in the art through consideration of the following detailed description and the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate examples of the disclosure and, together with the general description given above and the detailed description given below, serve to explain the principles of these examples.

[0009] FIG. 1 shows a top isometric view of a drip chamber assembly, according to an embodiment.

[0010] FIG. 2 shows a bottom isometric view of the drip chamber assembly of FIG. 1.

[0011] FIG. 3 shows a cross-sectional view of the drip chamber assembly of FIG. 1.

[0012] FIG. 4 is an exploded view of a drip chamber assembly, according to an embodiment.

[0013] FIG. 5 is a cross-sectional view of the drip chamber assembly of FIG. 4.

[0014] FIG. 6 is a flow diagram of a method of forming a drip chamber assembly according to an embodiment.

[0015] FIG. 7 is a cross-sectional view of a drip chamber assembly, according to an embodiment.DETAILED DESCRIPTION

[0016] Generally, the embodiments described herein relate to IV infusion systems, and more particularly to IV tube sets and apparatuses associated with the same. In typical embodiments, a fluid infusion set (e.g., an IV tube set) includes a drip chamber, which may be, but need not be, an emboli-reducing drip chamber (also referred to as all position drip chamber). Examples of an all position drip chamber are described in U.S. Pat. No. 10,485,921, entitled “Drip chamber assembly that functions irrespective of orientation,’7which is incorporated herein by reference in its entirety for any purpose.

[0017] A drip chamber is connected in the fluid path between the IV bag and the IV site in the patient, and serves the primary function of enabling a user (e.g., the clinician or person administering the IV fluid) to confirm the drip rate, such as by counting the number of drops per minute. The drip chamber is configured to be connected to an IV bag. As used herein, the terms proximal and proximally are used to describe a position or direction closer to the patient during use, while the terms distal and distally refer to the relative position or direction which is relatively farther from the patient during use. While IV fluid is being administered, the fluid flows from the bag into the drip chamber and toward the IV site in the patient, thus the distal and proximal direction or position may also be described as upstream and downstream, respectively, in reference to the direction of fluid flow. For confirming the drip rate, an inlet tube (e.g., fluid inlet) providing the IV fluid into the drip chamber is configured to drip the fluid into the drip chamber. The term configured to drip implies that the proximal diameter of the inlet tube is sufficiently small such that the liquid flows into the drip chamber at a drip rate rather than as a continuous stream. The drip chamber is further configured, such that during use, an air pocket remains in its upper portion, above the fluid, to enable the drops to be seen and counted.

[0018] A sealed IV bag typically contains a certain amount of gas, typically air, sealed with the fluid in the bag. This air, or a portion thereof, may and often is transferred to the drip chamber during priming of the drip chamber and administration of fluid. While a certain amount of air is useful in the drip chamber to establish / maintain an air pocket for counting the drops, as described above, too much air in the drip chamber increases the risk of air embolism. A drip chamber with a self-regulating air pocket is described herein. Embodiments of the present disclosure automatically establish an air pocket within the drip chamber and protect the size of the air pocket during fluid administration, e.g., using an automatic vent shut-offassembly according to the present disclosure. Apparatuses for automatically setting and maintaining a fluid level in a drip chamber are described.

[0019] FIG. 1 shows a top isometric view of a drip chamber assembly 100, according to an embodiment, FIG. 2 shows a bottom isometric view of the drip chamber assembly 100 of FIG. 1, and FIG. 3 shows a cross-sectional view of the drip chamber assembly 100 of FIG. 1. The drip chamber assembly 100 may include a drip chamber body 105, a fluid inlet 108, a fluid outlet 128, and an air vent 164. The drip chamber body 105 may include a distal region 101, a proximal region 103, and a longitudinal axis 104 extending between the proximal region 103 and the distal region 101. The drip chamber body 105 also defines an internal volume 150 within an interior of the drip chamber body 105. In some embodiments, the internal volume 150 of the drip chamber body 105 may narrow proximally in the proximal region 103 from a maximum width of the internal volume 150 and / or the drip chamber body 105. In some embodiments, the drip chamber body 105 includes an upper portion 110 including the distal region 101 and a lower portion 120 including the proximal region 103. The lower portion 120 may include a generally hemispherical shape. The upper portion 110 may include a first portion including the distal region 101 and a second portion disposed between the first portion of the upper portion 110 and the lower portion 120. The first portion of the upper portion 110 may be substantially cylindrical and the second portion of the upper portion may be semi-spherical in shape complementary to the low er portion 120.

[0020] The fluid inlet 108 includes an inlet conduit 106 disposed at the distal region 101 of the drip chamber body 110 and is configured to drip the IV fluid into the internal volume 150 (or interior) of the drip chamber body 105. In some embodiments, the drip chamber assembly 100 includes a chamber cap 102 having the fluid inlet 108 defining the inlet conduit 106. The chamber cap 102 may be detachably or fixedly secured to the distal region 101 of the drip chamber body 105. For example, in some embodiments, the chamber cap 102 is secured to the substantially cy lindrical portion of the upper portion 110 of the drip chamber body 105. In some embodiments, the inlet conduit 106 is substantially aligned with the longitudinal axis 104 of the drip chamber body 105 such that the longitudinal axis 104 extends (e.g, continuously) through the inlet conduit 106.

[0021] In many embodiments, the fluid outlet 128 includes a fluid intake opening 156 disposed in the internal volume 150 of the drip chamber body 105, a fluid exhaust opening 126 at the proximal region 103 of the drip chamber body 105, and a fluid outlet conduit 154extending between the fluid intake opening 156 and the fluid exhaust opening 126. Accordingly, the fluid outlet conduit 154 may be in fluid communication with the internal volume 150 of the drip chamber body 105 and configured to allow the IV fluid to flow out of the internal volume of the drip chamber body 105. In some embodiments, the fluid outlet conduit 154 is generally linear. As provided above, in some embodiments, the internal volume 150 of the drip chamber body 105 narrows proximally in the lower portion 120 and / or the proximal region 103 from a maximum width of the internal volume 150 and / or drip chamber body 105. In these and other embodiments, the fluid exhaust opening 126 is positioned on the proximal region 103 generally opposite to the fluid inlet 108, and the fluid outlet 128 extends distally from the fluid exhaust opening 126 partially into the internal volume 150. For example, the fluid intake opening 156 may be generally aligned with the maximum width of the internal volume 150. More particularly, in embodiments of the drip chamber body 105 having a hemispherical lower portion 120 and semispherical upper portion 110, the fluid intake opening 156 may be substantially aligned with an intersection of the lower portion 120 and the upper portion 110. In some embodiments, the fluid outlet conduit 128 extends distally from the bottom of the proximal region 103 about 20 mm to about 50 mm. about 20 mm to about 40 mm, about 30 mm to about 50 mm, about 20 mm to about 30 mm, about 25 mm to about 35 mm, about 30 mm to about 40 mm, about 35 mm to about 45 mm, or about 40 mm to about 50 mm into the internal volume 150 of the drip chamber body 105.

[0022] The air vent 164 is configured to automatically set and maintain an air pocket153 of predetermined size within the interior of the drip chamber body 105, according to an embodiment. The air vent 164 includes an air intake opening 168 in the internal volume 150 positioned to define the predetermined size of the air pocket 153, an air exhaust opening 122 at the proximal region 103 of the drip chamber body 105, and an air conduit 162 extending between the air intake opening 168 and the air exhaust opening 122. In many embodiments, the air intake opening 168 is positioned within the cylindrical portion of the upper portion 110 of the drip chamber body 105. Accordingly, the air intake opening may be spaced about 20 mm to about 50 mm, about 20 mm to about 40 mm, about 30 mm to about 50 mm, about 20 mm to about 30 mm, about 25 mm to about 35 mm, about 30 mm to about 40 mm, about 35 mm to about 45 mm. or about 40 mm to about 50 mm from the fluid intake opening 156.

[0023] In some embodiments, the fluid intake opening 156 of the fluid outlet conduit154 and the air exhaust opening 122 of the air vent 164 are disposed at least proximate to thelongitudinal axis 104 of the drip chamber body 105. For example, the fluid intake opening 156 and the air exhaust opening 122 may both be positioned within about 5 mm, within about 4 mm, within about 3 mm. about 2 mm to about 5 mm, about 2 mm to about 4 mm, about 3 mm to about 5mm, about 2 mm to about 3 mm, about 3 mm to about 4 mm, about 4 mm to about 5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, or about 5 mm from the longitudinal axis 104 of the drip chamber body 105. In some embodiments, one of the fluid intake opening 156 or the air exhaust opening 122 is aligned with the longitudinal axis 104 and the other of the fluid intake opening 156 or the air exhaust opening 122 is positioned proximate to the longitudinal axis 104 (e.g, any of the distances provided above). In the embodiment illustrated in FIG. 3, the air exhaust opening 122 is aligned with the longitudinal axis 104 of the drip chamber body 105 and the fluid intake opening 156 is positioned about 3.8 mm from the longitudinal axis 104. Furthermore, as the fluid outlet conduit 154 and the air conduit 162 are substantially linear in the embodiment illustrated in FIG. 3, the longitudinal axis 104 extends through all of the air exhaust opening 122, the air conduit 162, and the air intake opening 168, while the axis of the fluid outlet conduit 154, the fluid intake opening 156, and the fluid exhaust opening 126 is spaced about 3.8 mm from the longitudinal axis. In some embodiments (such as but not limited to the drip chamber 400 described below), the longitudinal axis 104 may extend through the fluid exhaust opening 126, the fluid outlet conduit 154, and the fluid intake opening 156, while the air intake opening 168, the air conduit 162, and the air exhaust opening 122 of the air vent 164 may be positioned proximate to the longitudinal axis 104 (e.g, any of the distances provided above).

[0024] In many embodiments, the drip chamber assembly 100 may include a filter 123 extending across the air intake opening 168. For example, the drip chamber assembly 100 may include an aquaphobic filter 123 stretched across the air intake opening 168 and configured to substantially prevent the IV fluid from passing therethrough and entering the air conduit 162. The filter 123 may include any filter that resists or substantially blocks the passage of a fluid through the pickup tube air intake opening 168 and air conduit 162, while permitting the passage of air therethrough. In some embodiments, the permeability (or porosity) of the material of the filter 123 is selected to allow gases to pass through but not w ater. In some embodiments, the filter material selected for the filter 123 is additionally or alternatively, aquaphobic, thereby allowing air to pass through while resisting or substantially blocking the IV fluid (typically an aqueous solution) from passing through it. In cases in which the dripchamber is designed for use with non-aqueous IV solution, a different type of filter 123 of suitable configuration to resist or effectively block the passage of the non-aqueous fluid through the vent may be used. In some embodiments, the filter 123 may include a GVS 1-2 micron filter.

[0025] Placing the filter 123 near the air vent intake ensures that liquids (e.g., the IV fluid) are substantially prevented from passing into the pickup tube air conduit 162, while air can be vented out when the level of the liquid (e.g., IV fluid) in the drip chamber falls below the fill level (e.g.. the lower limit of the pocket 153). As such, the auto-vent functions to automatically set the size of the air pocket 153 and to automatically control or regulate the size of the pocket 153 to the desired size during use of the drip chamber assembly 100. This configuration that automatically sets and regulates the size of the air pocket 153 in the drip chamber assembly 100, reduces the need for increased care by the user and / or the risk associated with user error when priming and operating the infusion system because the size of the air pocket is regulated or managed in a manner outside of the user’s control. The auto vent not only sets and prevents the fluid level in the drip chamber assembly 100 from rising above the desired fill line but may also facilitate the introduction of additional fluid in the drip chamber assembly 100 when the fluid level drops below the desired fill line.

[0026] Accordingly, the drip chamber assembly 100 is configured to vent air out of the internal volume 150 while IV fluid is dripped into internal volume 150 through the fluid inlet 108, but automatically stop venting air out of the internal volume 150 when the internal volume 150 is filled to a predetermined fill level (e.g., the bottom of the pocket 153). For example, as IV fluid is dripped into the internal volume 150 through the fluid inlet 108, air is automatically pushed through the air intake opening 168 within the drip chamber assembly 100, through the air conduit 162, and out through the air exhaust opening 122 at the proximal region 103. If / when IV fluid reaches the air intake opening 168 and / or the filter 123, no more air is pushed through the filter 123, and no more fluid enters the internal volume 150 of the drip chamber assembly 100, resulting in the air pocket 153 in the upper portion 110 of the drip chamber body 105. In some embodiments, a visual indicator of the fill level (e.g. , lower limit of the air pocket 153) is provided, for example on the cylindrical portion of upper portion 110 of the drip chamber body 105.

[0027] In some embodiments, air vent 164 may include a filter support 169 having the filter 123 secured thereto. The filter support 169 may be detachably or fixedly secured to adistal end of the air vent 164. The filter support 169 may be in fluid communication with the air conduit 162 or form a portion of the air conduit 162 and, therefore, may define the air intake opening 168. In some embodiments, the filter support 169 may include a cap 170 secured thereto and having a cover spaced from the filter 123. For example, the cap 170 may include one or more prongs or arms extending distally from the filter support 169 to a cover that is spaced from the filter 123 and also positioned between the filter support 169 and the fluid inlet 108. The prongs or arms are configured, sized, and positioned to allow fluid communication between the internal volume 150 and the filter 123, while also supporting the cover of the cap over the filter 123. In some embodiments, the cover of the cap 170 may be substantially conical in shape. Accordingly, as IV fluid enters the internal volume 150 through the fluid inlet 108, the IV fluid contacts the cover of the cap 170 before moving to the proximal region 103 or fluid line in the internal volume 150. This positioning results in the filter 123 remaining dry, thereby allowing air to exit the internal volume 150 through the filter 123 and air conduit 162.

[0028] In some embodiments, the drip chamber assembly 100 may be configured to allow a user to use the drip chamber assembly 100 with either IV fluid or blood. More specifically , the drip chamber assembly 100 may be selectively adjustable between an IV fluid configuration and blood configuration shown in FIG. 3. In some embodiments, the filter support 169, filter 123, and cap 170 may remain in use in either the IV fluid configuration or the blood configuration (e.g, the filter 123 is configured to prevent both IV fluid and blood from entering the air conduit 162, while allowing air to enter the air conduit 162). In these and other embodiments, a blood screen may be positioned on the fluid intake opening 156 for the blood configuration.

[0029] FIG. 3, for example, shows a drip chamber assembly 100 in a blood configuration with a blood filter fitment 172 detachably secured to a boss 171 at the proximal region 103 of the drip chamber assembly 100. In the IV fluid configuration, the blood filter fitment 172 is removed and absent from the interior region of the drip chamber assembly 100. The blood filter fitment 172 may be sized to slide at least partially over the boss 171 and secure to the boss with a friction fit. In some embodiments, the blood filter fitment 172 may be threadedly secured to the boss 171.

[0030] The blood filter fitment 172 may include a blood screen 175 configured and positioned on the blood filter fitment 172 to filter blood in the internal volume 150 before the blood enters the fluid intake opening 156 of the fluid outlet 128. In the embodiment shown inFIG. 3, the blood screen 175 extends longitudinally at least partially (e.g., entirely) between a distal end 177 of the blood filter fitment 172 and the boss 171. In other embodiments, the distal end 177 of the blood filter fitment 172 may include a distal blood screen 175, either with or without the blood screen 175 extending longitudinally at least partially (e g., entirely) between the distal end 177 of the blood filter fitment 172 and the boss 171. The blood screen may be configured to filter out contaminants, undesirable objects, clots, etc., in the blood from entering the fluid outlet 128.

[0031] The distal end 177 of the blood filter fitment 172 may include an opening 179 or conduit sized to allow7the air vent 164 to extend therethrough. For example, the distal end 177 of the blood filter fitment 172 may include an opening 179 or conduit sized to allow at least a distal portion of the air vent 164 to be inserted through the opening or conduit as the blood filter fitment 172 is secured to the boss 171 to adjust the drip chamber assembly 100 to a blood configuration. The opening 179 or conduit in the distal end 177 may be sized complementary to the air vent 164 such that blood is substantially prevented from entering interior region of the blood filter fitment 172 through the opening 179 or conduit in the distal end 177 of the blood filter fitment 172. In some embodiments, the distal end 177 includes a seal at the opening 179 or conduit effective to prevent fluid from entering the interior region of the blood filter fitment 172 through the opening 179 between the air vent 164 and the distal end 177. The blood filter fitment 172 may be included or adapted for use with any of the drip chamber assemblies disclosed herein.

[0032] Turning ahead in the drawings, FIG. 4 is an exploded view7a drip chamber assembly 400, according to an embodiment, and FIG. 5 is a cross-sectional view of the drip chamber assembly 400 of FIG. 4. Unless otherwise noted, the drip chamber assembly 400 may include any aspect of the drip chamber assembly 100. For example, the drip chamber assembly 400 may include a chamber cap 402, a longitudinal axis 404, a fluid inlet conduit 406, a fluid inlet 408, a distal region 401, an air vent 464, an air conduit 462, an upper portion 410, a lower portion 420, a proximal region 403, an air exhaust opening 422, a fluid outlet 428, a fluid exhaust opening 426, a fluid outlet conduit 454, a fluid intake opening 456, a blood filter fitment 472, and an internal volume 450 that, unless otherwise noted, may include any aspect of the chamber cap 102, the longitudinal axis 104, the fluid inlet conduit 106, the fluid inlet 108, the distal region 101, the air vent 164, the air conduit 162, the upper portion 110, the lower portion 120, the proximal region 103, the air exhaust opening 122. the fluid outlet 128, the fluidexhaust opening 126, the fluid outlet conduit 154, the fluid intake opening 156, the blood filter fitment 172, and the internal volume 150 of the drip chamber assembly 100.

[0033] In the drip chamber assembly 400, the fluid outlet 428 is generally aligned with the longitudinal axis 404 such that the longitudinal axis 404 extends through the fluid outlet conduit 454, the fluid exhaust opening 426, and the fluid intake opening 456 of the fluid outlet 428. The air conduit 462 and the air exhaust opening 422 of the air vent 464, accordingly, may be positioned at least proximate to the longitudinal axis 404. For example, the air conduit 462 and the air exhaust opening 422 of the air vent 464 may be positioned within about 5 mm, within about 4 mm, within about 3 mm, about 2 mm to about 5 mm, about 2 mm to about 4 mm, about 3 mm to about 5mm, about 2 mm to about 3 mm, about 3 mm to about 4 mm, about 4 mm to about 5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, or about 5 mm from the longitudinal axis 404. In the embodiment illustrated in FIG. 5. the fluid outlet 428 is aligned with the longitudinal axis 404 and the air conduit 462 and air exhaust opening 422 are positioned about 3.8 mm from the longitudinal axis 404.

[0034] Similar to the drip chamber assembly 100, in some embodiments, the internal volume 450 of the drip chamber assembly 400 narrows proximally in the lower portion 420 and / or the proximal region 403 from a maximum width of the internal volume 450 and / or the drip chamber assembly 400. In these and other embodiments, the fluid exhaust opening 426 is positioned on the proximal region 403 generally opposite to the fluid inlet 408, and the fluid outlet 428 extends distally from the fluid exhaust opening 426 partially into the internal volume 450. For example, the fluid intake opening 456 may be generally aligned with the maximum width of the internal volume 450. More particularly, in embodiments of the drip chamber assembly 400 having a hemispherical lower portion 420 and semispherical upper portion 410, the fluid intake opening 456 may be substantially aligned with an intersection of the lower portion 420 and the upper portion 410. In some embodiments, the fluid outlet conduit 428 extends distally from the bottom of the proximal region 403 about 20 mm to about 50 mm, about 20 mm to about 40 mm, about 30 mm to about 50 mm, about 20 mm to about 30 mm, about 25 mm to about 35 mm, about 30 mm to about 40 mm, about 35 mm to about 45 mm, or about 40 mm to about 50 mm into the internal volume 450 of the drip chamber body 405.

[0035] The air vent 464 is configured to automatically set and maintain an air pocket of predetermined size within the internal volume 450, according to an embodiment. The air vent 464 includes an air intake opening 468 in the internal volume 450 positioned to define thepredetermined size of the air pocket 453, an air exhaust opening 422 at the proximal region 403 of the drip chamber assembly 400, and an air conduit 462 extending between the air intake opening 468 and the air exhaust opening 422. In many embodiments, the air intake opening 468 is positioned within the cylindrical portion of the upper portion 410 of the drip chamber assembly 400. Accordingly, the air intake opening 468 may be spaced about 20 mm to about 50 mm, about 20 mm to about 40 mm, about 30 mm to about 50 mm, about 20 mm to about 30 mm, about 25 mm to about 35 mm. about 30 mm to about 40 mm, about 35 mm to about 45 mm, or about 40 mm to about 50 mm from the fluid intake opening 456.

[0036] The drip chamber assembly 400 also may include a cap 470 secured to the air vent 464 at a distal region of the air vent 464. The cap 470 includes a curved conduit and the air intake opening 468 in fluid communication with the air conduit 462 of the air vent 464. The air intake opening 468 may be oriented towards the proximal region 403 and / or away from the fluid inlet 408 in the distal region 401. For example, in the drip chamber assembly 400 illustrated in FIG. 5, the curved conduit in the cap 470 curves 180 degrees from the air conduit 462 such that the air intake opening 468 is oriented towards the proximal region 403 of the drip chamber assembly 400. In other embodiments (not shown), the curved conduit in the cap 470 may curve about 95 degrees to about 180 degrees, about 95 degrees to about 135 degrees, about 95 degrees to about 115 degrees, about 105 degrees to about 125 degrees, about 115 degrees to about 135 degrees, about 125 degrees to about 145 degrees, about 135 degrees to about 155 degrees, about 145 degrees to about 165 degrees, or about 155 degrees to about 175 degrees from the air conduit 462. In some embodiments, the filter (e.g., filter 123) is absent from the cap 470, as the curved conduit in the cap 470 may Apically eliminate the need for the filter. In some embodiments, the filter 123 may be included with the cap 470. The curve of the cap 470 and resulting orientation of the air intake opening 468 prevents fluid entering the internal volume from the fluid inlet 408 from entering the air conduit 162. The air intake opening 468 also establishes the predetermined fill line and the resulting pocket in the internal volume, similar to the drip chamber assembly 100.

[0037] Turning ahead, FIG. 7 is a cross-sectional view of a drip chamber assembly 700. according to an embodiment. Unless otherwise noted, the drip chamber assembly 700 may include any aspect of the drip chamber assembly 100, 400. For example, the drip chamber assembly 700 may include a longitudinal axis 704, a distal region 701, an air vent 764, an air conduit 762, an upper portion 710, a lower portion 720. a proximal region 703, an air exhaustopening 722, a fluid outlet 728, a fluid exhaust opening 726, a fluid outlet conduit 754, a fluid intake opening 756, and an internal volume 750 that, unless otherwise noted, may include any aspect of the longitudinal axis 104, the distal region 101, the air vent 164, the air conduit 162. the upper portion 110, the lower portion 120, the proximal region 103, the air exhaust opening 122, the fluid outlet 128, the fluid exhaust opening 126, the fluid outlet conduit 154, the fluid intake opening 156, and the internal volume 150 of the drip chamber assembly 100. The drip chamber assembly 700 also may include the chamber cap 102 and the cap 170 of the drip chamber assembly 100.

[0038] In the drip chamber assembly 700, the fluid outlet 728 is generally aligned with the longitudinal axis 704 such that the longitudinal axis 704 extends through the fluid outlet conduit 754, the fluid exhaust opening 726, and the fluid intake opening 756 of the fluid outlet 728. At least some of the air conduit 762 and the air exhaust opening 722 of the air vent 764, accordingly, may be positioned at least proximate to the longitudinal axis 704. For example, at least some (e.g, a proximal region) of the air conduit 762 and the air exhaust opening 722 of the air vent 764 may be positioned within about 5 mm, within about 4 mm, within about 3 mm, about 2 mm to about 5 mm, about 2 mm to about 4 mm, about 3 mm to about 5mm, about 2 mm to about 3 mm, about 3 mm to about 4 mm, about 4 mm to about 5 mm. about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, or about 5 mm from the longitudinal axis 704. In the embodiment illustrated in FIG. 7, the fluid outlet 428 is aligned with the longitudinal axis 704 and a proximal region of the air conduit 762 and air exhaust opening 722 are positioned about 3.8 mm from the longitudinal axis 704.

[0039] In some embodiments, the air intake opening 768 is substantially aligned with the longitudinal axis 704 while the air exhaust opening 722 is positioned proximate to the longitudinal axis 704. For example, both the air intake opening 768 and the fluid intake opening 756 may be substantially aligned with the longitudinal axis 704, with the air intake opening 768 positioned distally over the fluid intake opening 756 with a space therebetween.

[0040] To accommodate both the air intake opening 768 and the fluid intake opening 756 substantially aligned with the longitudinal axis 704, the air conduit 764 includes a curved and / or angled section between the air intake opening 768 and the air exhaust opening 722. In some embodiments, the air vent 764 includes a first (proximal or lower) portion 764a defining a first (proximal or lower) region of the air conduit 762 and a second (distal or upper) portion 764b defining a second (distal or upper) region of the air conduit 762. The first portion 764amay be shaped and configured such that the region of the air conduit 762 defined by the first portion 764a is generally linear. The second portion 764b may be shaped and configured such that the region of the air conduit 762 defined by the second portion 764b curves or angles to align the distal end of the air conduit 762 with the longitudinal axis 704 while also not blocking fluid communication between the fluid intake opening 756 and the internal volume 754.

[0041] Similar to the drip chamber assembly 100, in some embodiments, the internal volume 750 of the drip chamber assembly 700 narrows proximally in the low er portion 720 and / or the proximal region 703 from a maximum width of the internal volume 750 and / or the drip chamber assembly 700. In these and other embodiments, the fluid exhaust opening 726 is positioned on the proximal region 703 generally opposite to the fluid inlet 708, and the fluid outlet 728 extends distally from the fluid exhaust opening 726 partially into the internal volume 750. For example, the fluid intake opening 756 may be generally aligned with the maximum width of the internal volume 750. More particularly, in embodiments of the drip chamber assembly 700 having a hemispherical lower portion 720 and semispherical upper portion 710, the fluid intake opening 756 may be substantially aligned with an intersection of the lower portion 720 and the upper portion 710. In some embodiments, the fluid outlet conduit 728 extends distally from the bottom of the proximal region 703 about 20 mm to about 50 mm, about 20 mm to about 40 mm, about 30 mm to about 50 mm, about 20 mm to about 30 mm, about 25 mm to about 35 mm, about 30 mm to about 40 mm, about 35 mm to about 45 mm, or about 40 mm to about 50 mm into the internal volume 750 of the drip chamber body 705.

[0042] In some embodiments, the second portion 764b of the air vent 764 is detachably secured to the first portion 764a of the air vent 764. The first portion 764a of the air vent 764 may be formed integrally with the fluid outlet 128. In some embodiments, the terminating distal end of the first portion 764a of the air vent 764 may be positioned at a height in the internal volume 750 that is the same as or similar to the fluid intake opening 756, and the second portion 764b of the air vent may extend therefrom to the cylindrical region of the upper portion 710 of the drip chamber assembly 700.

[0043] The air vent 464 is configured to automatically set and maintain an air pocket of predetermined size within the internal volume 450, according to an embodiment. The air vent 464 includes an air intake opening 468 in the internal volume 450 positioned to define the predetermined size of the air pocket 453, an air exhaust opening 422 at the proximal region 403 of the drip chamber assembly 400, and an air conduit 462 extending between the air intakeopening 468 and the air exhaust opening 422. In many embodiments, the air intake opening 468 is positioned within the cylindrical portion of the upper portion 410 of the drip chamber assembly 400. Accordingly, the air intake opening 468 may be spaced about 20 mm to about 50 mm, about 20 mm to about 40 mm, about 30 mm to about 50 mm, about 20 mm to about 30 mm, about 25 mm to about 35 mm, about 30 mm to about 40 mm, about 35 mm to about 45 mm, or about 40 mm to about 50 mm from the fluid intake opening 456.

[0044] Turning back in the drawings, FIG. 6 is a flow diagram of a method 600 of manufacturing a drip chamber for IV fluid and / or blood infusion. The method 600 may include a method to manufacture any of the drip chamber assemblies 100, 400, 700 described herein. In an embodiment, the method 600 includes an act 605 of providing a first part having a fluid inlet including an inlet conduit. The method 600 also may include an act 610 of providing a second part. The second part may include a fluid outlet including a fluid intake opening, a fluid exhaust opening, and a fluid outlet conduit extending between the fluid intake opening and the fluid exhaust opening. The second part also may include an air vent including an air intake opening, an air exhaust opening, and an air conduit extending between the air intake opening and the air exhaust opening. The method 600 also may include an act 615 of securing the first part to the second part such that the first part and the second part form a proximal region and a distal region, respectively, of a drip chamber body that defines an internal volume within an interior of the drip chamber body with the fluid intake opening disposed in the internal volume of the drip chamber body and configured to drip IV fluid and / or blood into the interior of the drip chamber. The fluid outlet may be in fluid communication with the internal volume of the drip chamber body and configured to allow the IV fluid and / or blood to flow out of the drip chamber body. The air vent may be configured to automatically set and maintain an air pocket of predetermined size within the interior of the drip chamber. The air intake opening may be positioned in the internal volume to define the predetermined size of the air pocket. The fluid intake opening of the fluid outlet conduit and the air exhaust opening of the air vent may be disposed at least proximate to a longitudinal axis of the drip chamber body.

[0045] In some embodiments of the method 600, the fluid intake opening, the fluid exhaust opening, and the fluid outlet conduit are substantially aligned with the longitudinal axis of the drip chamber body, with the fluid outlet conduit extending at least 20 mm into the internal volume of the drip chamber. In these and other embodiments of the method 600, the air exhaust opening is disposed within about 5 mm of the longitudinal axis of the drip chamberbody, the air intake opening is substantially aligned with the longitudinal axis of the drip chamber body such that the air intake opening is positioned distally over the fluid intake opening with a space therebetween, and the air conduit includes a curved and / or angled section between the air intake opening and the air exhaust opening.

[0046] In some embodiments of the method 600, the air exhaust opening, the air intake opening, and the air conduit are substantially aligned with the longitudinal axis of the drip chamber body. In these and other embodiments of the method 600, the fluid intake opening, the fluid exhaust opening, and the fluid outlet conduit are substantially disposed within about 5 mm of the longitudinal axis of the drip chamber body, the fluid outlet conduit extending at least 20 mm into the internal volume of the drip chamber.

[0047] In some embodiments of the method 600, the fluid outlet conduit is generally linear and the air vent conduit is generally linear. In some embodiments, the method 600 further comprises securing an aquaphobic filter stretched across the air intake opening. The aquaphobic filter may be configured to substantially prevent the IV fluid from passing therethrough. In some embodiments, the method 600 further comprises securing a blood filter to the air vent at least proximate to the air intake opening, the blood filter being configured to substantially prevent blood from passing therethrough.

[0048] In some embodiments of the method 600, the air vent includes a cap secured to include the air intake opening. The cap may be positioned at a distal region of the air vent between the fluid inlet of drip chamber body and the fluid intake opening such that a portion of the cap covers the air intake opening while also being spaced from the air intake opening.

[0049] In some embodiments, the method 600 further comprises securing a cap to a distal region of the air vent. In these and other embodiments of the method 600, the cap may include a curved conduit and the air intake opening in fluid communication with the air conduit of the air vent, with the air intake opening being oriented towards the proximal region and / or away from the fluid inlet in the distal region. In these and other embodiments of the method 600, the fluid intake opening, the fluid exhaust opening, and the fluid outlet conduit may be substantially aligned with the longitudinal axis of the drip chamber body, and the fluid outlet conduit may extend at least 20 mm into the internal volume of the drip chamber. Furthermore, the air exhaust opening and the air conduit may be disposed within about 5 mm of the longitudinal axis of the drip chamber body.

[0050] In some embodiments of the method 600, the internal volume defined by the second part narrows proximally from a maximum width of the internal volume. When the first part is secured to the second part, the fluid exhaust opening may be positioned on the proximal region generally opposite to the fluid inlet and the fluid outlet extends distally from the fluid exhaust opening partially into the internal volume such that fluid intake opening is generally aligned with the maximum width of the internal volume. Also when the first part is secured to the second part, the air exhaust opening may be positioned on the proximal region generally opposite to the fluid inlet and the air vent may extend distally from the air exhaust opening into the internal volume such that the air intake opening is positioned between the maximum width of the internal volume and the fluid inlet. In these and other embodiments of the method 600, the second part may be generally hemispherical in shape and the first part may include a first portion and a second portion disposed between the first portion of the first part and the second part. The first portion may be substantially cylindrical and the second portion being generally semi-spherical in shape complementary to the second part.

[0051] As used herein, the term “about” or “substantially” refers to an allowable variance of the term modified by “about” by ±10% or ±5%. Further, the terms “less than,” “or less,” “greater than”, “more than,” or “or more” include as an endpoint, the value that is modified by the terms “less than,” “or less,” “greater than,” “more than,” or “or more.”

[0052] While various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated. The various aspects and embodiment disclosed herein are for purposes of illustration and are not intended to be limiting.

Claims

CLAIMSWe claim:

1. A drip chamber assembly for intravenous (IV) fluid or blood infusion, the drip chamber assembly comprising: a drip chamber body having a distal region, a proximal region, and a longitudinal axis extending between the proximal region and the distal region, the drip chamber body defining an internal volume within an interior of the drip chamber body; a fluid inlet including an inlet conduit disposed at the distal region of the drip chamber body and configured to drip the IV fluid into the interior of the drip chamber; a fluid outlet including a fluid intake opening disposed in the internal volume of the drip chamber body, a fluid exhaust opening at the proximal region of the drip chamber body, and a fluid outlet conduit extending between the fluid intake opening and the fluid exhaust opening such that the fluid outlet conduit is in fluid communication with the internal volume of the drip chamber body and configured to allow the IV fluid to flow out of the drip chamber body; and an air vent configured to automatically set and maintain an air pocket of predetermined size within the interior of the drip chamber body, wherein the air vent includes an air intake opening in the internal volume positioned to define the predetermined size of the air pocket, an air exhaust opening at the proximal region of the drip chamber body, and an air conduit extending between the air intake opening and the air exhaust opening, wherein the fluid intake opening of the fluid outlet conduit and the air exhaust opening of the air vent are disposed at least proximate to the longitudinal axis of the drip chamber body.

2. The drip chamber assembly of claim 1, wherein: the fluid intake opening, the fluid exhaust opening, and the fluid outlet conduit are substantially aligned with the longitudinal axis of the drip chamber body, the fluid outlet conduit extending at least 20 mm into the internal volume of the drip chamber; and the air exhaust opening is disposed within about 5 mm of the longitudinal axis of the drip chamber body, the air intake opening is substantially aligned with the longitudinal axis of the drip chamber body such that the air intake opening is positioned distally over the fluid intake opening with a space therebetween, and the air conduit includes a curved and / or angledsection between the air intake opening and the air exhaust opening.

3. The drip chamber assembly of claim 1, wherein: the air exhaust opening, the air intake opening, and the air conduit are substantially aligned with the longitudinal axis of the drip chamber body; and the fluid intake opening, the fluid exhaust opening, and the fluid outlet conduit are substantially disposed within about 5 mm of the longitudinal axis of the drip chamber body, the fluid outlet conduit extending at least 20 mm into the internal volume of the drip chamber.

4. The drip chamber assembly of claim 3, wherein the fluid outlet conduit is generally linear and the air vent conduit is generally linear.

5. The drip chamber assembly of claim 1, further comprising an aquaphobic filter stretched across the air intake opening and configured to substantially prevent the IV fluid from passing therethrough.

6. The drip chamber assembly of claim 1, wherein the air vent includes a cap secured to including the air intake opening, the cap being positioned at a distal region of the air vent between the fluid inlet of drip chamber body and the fluid intake opening such that a portion of the cap covers the air intake opening while also being spaced from the air intake opening.

7. The drip chamber assembly of claim 1, wherein: the air vent includes a cap secured to the air vent at a distal region of the air vent, the cap comprising a curved conduit and the air intake opening in fluid communication with the air conduit of the air vent, the air intake opening being oriented towards the proximal region and / or away from the fluid inlet in the distal region; and wherein the fluid intake opening, the fluid exhaust opening, and the fluid outlet conduit are substantially aligned with the longitudinal axis of the drip chamber body, the fluid outlet conduit extending at least 20 mm into the internal volume of the drip chamber; and wherein the air exhaust opening and the air conduit are disposed within about 5 mm of the longitudinal axis of the drip chamber body.

8. The drip chamber assembly of claim 1, further comprising a blood filter secured to the air vent at least proximate to the air intake opening and configured to substantially prevent blood from passing therethrough.

9. The drip chamber assembly of claim 1, wherein: the internal volume of the drip chamber body narrows proximally in the proximal region from a maximum width of the internal volume; the fluid exhaust opening is positioned on the proximal region generally opposite to the fluid inlet and the fluid outlet extends distally from the fluid exhaust opening partially into the internal volume such that the fluid intake opening is generally aligned with the maximum width of the internal volume; and the air exhaust opening is positioned on the proximal region generally opposite to the fluid inlet and the air vent extends distally from the air exhaust opening into the internal volume such that the air intake opening is positioned between the maximum width of the internal volume and the fluid inlet.

10. The drip chamber assembly of claim 9, wherein the drip chamber body includes an upper portion including the distal region and a lower portion including the proximal region, the lower portion including a generally hemispherical shape and the upper portion including a first portion that is substantially cylindrical and a second portion that is generally semi-spherical in shape complementary to the lower portion, the second portion being spaced between the first portion of the upper portion and the lower portion.

11. The drip chamber assembly of claim 1 , wherein one of the fluid intake opening or the air exhaust opening is aligned with the longitudinal axis and the other of the fluid intake opening or the air exhaust opening is spaced less than about 5 mm from the longitudinal axis of the drip chamber body.

12. A drip chamber assembly for intravenous (IV) fluid or blood infusion, the drip chamber assembly comprising: a drip chamber body having a distal region, a proximal region, and a longitudinal axis extending between the proximal region and the distal region, the drip chamber body defining an internal volume that narrows proximally in the proximal region from a maximum widthwithin an interior of the drip chamber body; a fluid inlet including an inlet conduit disposed at the distal region of the drip chamber body and configured to drip the IV fluid into the interior of the drip chamber body; a fluid outlet including a fluid intake opening aligned in the internal volume of the drip chamber body with the maximum width of the internal volume, a fluid exhaust opening at the proximal region of the drip chamber body, and a fluid outlet conduit extending between the fluid intake opening and the fluid exhaust opening such that the fluid outlet conduit is in fluid communication with the internal volume of the drip chamber body and configured to allow the IV fluid to flow out of the drip chamber body; and an air vent configured to automatically set and maintain an air pocket of predetermined size within the interior of the drip chamber body, wherein the air vent includes an air intake opening in the internal volume positioned between the maximum width of the internal volume and the fluid inlet to define the predetermined size of the air pocket, an air exhaust opening at the proximal region of the drip chamber body, and an air conduit extending between the air intake opening and the air exhaust opening.

13. The drip chamber assembly of claim 12, further comprising an aquaphobic filter stretched across the air intake opening and configured to substantially prevent the IV fluid from passing therethrough.

14. The drip chamber assembly of claim 12, further comprising a blood filter secured to the air vent at least proximate to the air intake opening and configured to substantially prevent blood from passing therethrough.

15. The drip chamber assembly of claim 12. wherein the air vent includes a cap secured to the air intake opening, the cap being positioned at a distal region of the air vent between the fluid inlet of drip chamber body and the fluid intake opening such that a portion of the cap covers the air intake opening while also being spaced from the air intake opening.

16. The drip chamber assembly of claim 12, wherein: the air vent includes a cap secured to the air vent at a distal region of the air vent, the cap comprising a curved conduit and the air intake opening in fluid communication with the air conduit of the air vent, the air intake opening being oriented towards the proximal regionand / or away from the fluid inlet in the distal region; and wherein the fluid intake opening, the fluid exhaust opening, and the fluid outlet conduit are substantially aligned with the longitudinal axis of the drip chamber body, the fluid outlet conduit extending at least 20 mm into the internal volume of the drip chamber; and wherein the air exhaust opening and the air conduit are disposed within about 5 mm of the longitudinal axis of the drip chamber body.

17. The drip chamber assembly of claim 12, wherein the drip chamber body includes an upper portion including the distal region and a lower portion including the proximal region, the lower portion including a generally hemispherical shape and the upper portion including a first portion that is substantially cylindrical and a second portion that is generally semi-spherical in shape complementary to the lower portion, the second portion being spaced between the first portion of the upper portion and the lower portion.

18. The drip chamber assembly of claim 12, wherein the fluid outlet conduit is generally linear and the air vent conduit is generally linear.

19. The drip chamber of claim 12, wherein the fluid intake opening of the fluid outlet conduit and the air exhaust opening of the air vent are disposed at least proximate to the longitudinal axis of the drip chamber body.

20. The drip chamber assembly of claim 19, wherein: the fluid intake opening, the fluid exhaust opening, and the fluid outlet conduit are substantially aligned with the longitudinal axis of the drip chamber body; and the air exhaust opening is disposed within about 5 mm of the longitudinal axis of the drip chamber body, the air intake opening is substantially aligned with the longitudinal axis of the drip chamber body such that the air intake opening is positioned distally over the fluid intake opening with a space therebetween, and the air conduit includes a curved and / or angled section between the air intake opening and the air exhaust opening.

21. The drip chamber assembly of claim 19, wherein: the air exhaust opening, the air intake opening, and the air conduit are substantially aligned with the longitudinal axis of the drip chamber body; andthe fluid intake opening, the fluid exhaust opening, and the fluid outlet conduit are substantially disposed within about 5 mm of the longitudinal axis of the drip chamber body.

22. The drip chamber assembly of claim 21, wherein the fluid outlet conduit is generally linear and the air vent conduit is generally linear.

23. A method of manufacturing a drip chamber assembly for intravenous (IV) fluid or blood infusion, the method comprising: providing a first part having a fluid inlet including an inlet conduit; providing a second part including: a fluid outlet including a fluid intake opening, a fluid exhaust opening, and a fluid outlet conduit extending between the fluid intake opening and the fluid exhaust opening; and an air vent including an air intake opening, an air exhaust opening, and an air conduit extending between the air intake opening and the air exhaust opening; and securing the first part to the second part such that the first part and the second part form a proximal region and a distal region, respectively, of a drip chamber body that defines an internal volume within an interior of the drip chamber body with the fluid intake opening disposed in the internal volume of the drip chamber body and configured to drip IV fluid into the interior of the drip chamber, the fluid outlet is in fluid communication with the internal volume of the drip chamber body and configured to allow the IV fluid to flow out of the drip chamber body, the air vent is configured to automatically set and maintain an air pocket of predetermined size within the interior of the drip chamber, the air intake opening is positioned in the internal volume to define the predetermined size of the air pocket, and the fluid intake opening of the fluid outlet conduit and the air exhaust opening of the air vent are disposed at least proximate to a longitudinal axis of the drip chamber body.

24. The method of claim 23, wherein: the fluid intake opening, the fluid exhaust opening, and the fluid outlet conduit are substantially aligned with the longitudinal axis of the drip chamber body, the fluid outlet conduit extending at least 20 mm into the internal volume of the drip chamber; and the air exhaust opening is disposed within about 5 mm of the longitudinal axis of the drip chamber body, the air intake opening is substantially aligned with the longitudinal axis ofthe drip chamber body such that the air intake opening is positioned distally over the fluid intake opening with a space therebetween, and the air conduit includes a curved and / or angled section between the air intake opening and the air exhaust opening.

25. The method of claim 23, wherein: the air exhaust opening, the air intake opening, and the air conduit are substantially aligned with the longitudinal axis of the drip chamber body; and the fluid intake opening, the fluid exhaust opening, and the fluid outlet conduit are substantially disposed within about 5 mm of the longitudinal axis of the drip chamber body, the fluid outlet conduit extending at least 20 mm into the internal volume of the drip chamber.

26. The method of claim 25, wherein the fluid outlet conduit is generally linear and the air vent conduit is generally linear.

27. The method of claim 23, further comprising securing an aquaphobic fdter stretched across the air intake opening, the aquaphobic filter being configured to substantially prevent the IV fluid from passing therethrough.

28. The method of claim 23, further comprising securing a blood filter to the air vent at least proximate to the air intake opening, the blood filter being configured to substantially prevent blood from passing therethrough.

29. The method of claim 23, wherein the air vent includes a cap secured to the air intake opening, the cap being positioned at a distal region of the air vent between the fluid inlet of drip chamber body and the fluid intake opening such that a portion of the cap covers the air intake opening while also being spaced from the air intake opening.

30. The method of claim 23, further comprising: securing a cap to a distal region of the air vent, the cap comprising a curved conduit and the air intake opening in fluid communication with the air conduit of the air vent, the air intake opening being oriented towards the proximal region and / or away from the fluid inlet in the distal region; and wherein the fluid intake opening, the fluid exhaust opening, and the fluid outlet conduitare substantially aligned with the longitudinal axis of the drip chamber body, the fluid outlet conduit extending at least 20 mm into the internal volume of the drip chamber; and wherein the air exhaust opening and the air conduit are disposed within about 5 mm of the longitudinal axis of the drip chamber body.

31. The method of claim 23, wherein: the internal volume defined by the second part narrows proximally from a maximum width of the internal volume: when the first part is secured to the second part, the fluid exhaust opening is positioned on the proximal region generally opposite to the fluid inlet and the fluid outlet extends distally from the fluid exhaust opening partially into the internal volume such that fluid intake opening is generally aligned with the maximum width of the internal volume; and when the first part is secured to the second part, the air exhaust opening is positioned on the proximal region generally opposite to the fluid inlet and the air vent extends distally from the air exhaust opening into the internal volume such that the air intake opening is positioned between the maximum width of the internal volume and the fluid inlet.

32. The method of claim 31, wherein the second part is generally hemispherical in shape and the first part includes a first portion and a second portion disposed between the first portion of the first part and the second part, the first portion being substantially cylindrical and the second portion being generally semi-spherical in shape complementary to the second part.

33. A drip chamber assembly for intravenous (IV) fluid infusion, the drip chamber assembly comprising: a drip chamber body having a distal region, a proximal region, and a longitudinal axis extending between the proximal region and the distal region, the drip chamber body defining an internal volume within an interior of the drip chamber body; a fluid inlet including an inlet conduit disposed at the distal region of the drip chamber body and configured to drip the IV fluid into the interior of the drip chamber; a fluid outlet including a fluid intake opening disposed in the internal volume of the drip chamber body, a fluid exhaust opening at the proximal region of the drip chamber body, and a fluid outlet conduit extending between the fluid intake opening and the fluid exhaust opening such that the fluid outlet conduit is in fluid communication with the internal volumeof the drip chamber body and configured to allow the IV fluid to flow out of the drip chamber body, wherein the longitudinal axis extends through the fluid intake opening, the fluid exhaust opening, and the fluid outlet conduit; and an air vent configured to automatically set and maintain an air pocket of predetermined size within the interior of the drip chamber body, wherein the air vent includes an air intake opening in the internal volume positioned to define the predetermined size of the air pocket and aligned with the longitudinal axis, an air exhaust opening at the proximal region of the drip chamber body and offset from the longitudinal axis, and an air conduit extending between the air intake opening and the air exhaust opening, the air conduit including a curved and / or angled section between the air intake opening and the air exhaust opening.

34. The drip chamber assembly of claim 33, further comprising a blood filter secured to the air vent at least proximate to the air intake opening and configured to substantially prevent blood from passing therethrough.

35. The drip chamber assembly of claim 33. wherein: the internal volume of the drip chamber body narrows proximally in the proximal region from a maximum width; the fluid exhaust opening is positioned on the proximal region generally opposite to the fluid inlet and the fluid outlet extends distally from the fluid exhaust opening partially into the internal volume such that fluid intake opening is generally aligned with the maximum width of the internal volume; and the air exhaust opening is positioned on the proximal region generally opposite to the fluid inlet and the air vent extends distally from the air exhaust opening into the internal volume such that the air intake opening is positioned between the maximum width of the internal volume and the fluid inlet.

36. The drip chamber assembly of claim 35, wherein the proximal region is generally hemispherical in shape and the distal region includes a first portion and a second portion disposed between the first portion of the distal region and the proximal region, the first portion being substantially cylindrical and the second portion being generally semi-spherical in shape complementary to the proximal region.

37. The drip chamber assembly of claim 33, wherein the air exhaust opening is spaced less than about 5 mm from the longitudinal axis of the drip chamber body.

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