Fluid infusion system

Abstract

A valve assembly including a conduit; a first valve at least partially disposed in the conduit, the first valve defining a first fluid path and a second fluid path; and a second valve at least partially disposed in the conduit, the second valve defining a third fluid path and a fourth fluid path, wherein the first and second valves are configured to modify fluid flow through the conduit.

Description

FLUID INFUSION SYSTEMCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims priority to United States Provisional Patent Application No. 63 / 617,215 entitled “Fluid Infusion System” filed January 3, 2024, the disclosure of which is hereby incorporated by reference in its entirety.FIELD OF THE INVENTION

[0002] The present disclosure relates generally to fluid infusion systems and methods of use thereof.BACKGROUND OF THE INVENTION

[0003] Fluid infusion systems are used throughout healthcare settings to provide various fluids and medications directly into the blood stream of a patient. During preparation and delivery of intravenous fluids delivery, certain challenges are presented. For example, when priming an intravenous line with a hazardous medication (such a chemotherapy drug), the intravenous line may already be filled with saline, requiring delivery of the saline to the patient prior to receiving the medication. This can result in unwanted fluid being administered to the patient, and delay in delivering the intended medication.

[0004] Air drawn into an infusion system upon completion of fluid delivery poses another challenge and risk to the patient. After a bag of fluid or medication has been fully infused a patient and is emptied, air can be drawn into the fluid delivery line posing an air embolism risk. The air must be withdrawn from the system before the system can be used for subsequent infusion of fluids.

[0005] Residual medication remaining in an infusion system poses another concern. When medication is delivered and the medication bag empties, there may be medication remaining in the fluid lines. The residual medication requires an extra step of flushing or introducing additional fluids to ensure the patient receives the full dose. Alternatively, the residual medication in the fluid lines may not be delivered to the patient, resulting in a small but consistent under-dosing practice.

[0006] Still another challenge presented during the use of infusion systems is the need in certain circumstances to rapidly deliver rescue medication to the patient. For example, if a patient has an adverse reaction to receiving fluid or a medication, the fluid being delivered must be immediately stopped, and rescue medications need to be delivered without deliveringmore of the fluid or medication that caused the reaction. In such circumstances, the time it would typically take to flush or prime the infusion system to receive and deliver rescue medication could compromise the patient.

[0007] The present disclosure provides fluid infusion systems and components thereof that address and overcome these challenges.SUMMARY OF THE INVENTION

[0008] The present disclosure provides a valve assembly, including a conduit having a first opening and a second opening; a first valve at least partially disposed in the conduit, the first valve defining a first fluid path and a second fluid path, wherein the first valve is movable from (i) a first position where the first fluid path is in fluid communication with the first opening and the second fluid path is not in fluid communication with the first opening, to (ii) a second position where the first fluid path is not in fluid communication with the first opening and the second fluid path is in fluid communication with the first opening; and a second valve at least partially disposed in the conduit, the second valve defining a third fluid path and a fourth fluid path, wherein the second valve is movable from (i) a first position where the third fluid path is in fluid communication with the second opening and the fourth fluid path is not in fluid communication with the second opening, to (ii) a second position where the third fluid path is not in fluid communication with the second opening and the fourth fluid path is in fluid communication with the second opening.

[0009] In one configuration, when the first valve is in the first position and the second valve is in the first position, the first opening of the conduit is in fluid communication with the second opening. When either the first valve or the second valve is in the second position, the first opening of the conduit is not in fluid communication with the second opening.

[0010] The conduit may define a longitudinal axis, and the first valve may be rotatable with respect to the conduit about an axis substantially transverse to the longitudinal axis. The second valve may be rotatable with respect to the conduit about an axis substantially transverse to the longitudinal axis. The first valve may include a first section exterior to the conduit and configured to attach to a syringe, and the first section may include a first port. The first valve may include a second port movably positionable within the conduit, and the second flow path may include the first and second ports. The first valve may include a second section at least partially disposed within the conduit, where the second section defines a channel constituting the first flow path. The channel may extend around an exterior perimeter of the second section.

[0011] The second valve may include a first section exterior to the conduit and configured to attach to a syringe, where the first section includes a first port. The second valve may include a second port movably positionable within the conduit, and the fourth flow path may include the first and second ports. The second valve may include a second section at least partially disposed within the conduit, the second section defining a channel constituting the third flow path. The channel may extend around an exterior perimeter of the second section.

[0012] A drip chamber is provided, including a housing defining a first end, a passage at the first end, a second end opposite the first end, and an interior cavity in fluid communication with the passage; a ball movably disposed within the interior cavity; a stopper configured to limit a range of movement of the ball; an inlet proximate the second end and in fluid communication with the interior cavity; and an outlet proximate the second end and in fluid communication with the interior cavity, wherein at least a portion of the housing is configured to form a seal with the ball such that the inlet and outlet are not in fluid communication with passage. The drip chamber may include a spike at the first end, and the passage may extend through the spike. The housing may define a funnel-shaped section within the interior cavity configured to form the seal with the ball. The inlet may include a connector configured to attach to a syringe. The drip chamber may include a check valve adjacent to the inlet.

[0013] A fluid delivery system is disclosed, including a first fluid container containing a fluid therein; a drip chamber as set forth herein in fluid communication with and receiving the fluid from the first fluid container; a pump in fluid communication with and receiving the fluid from the drip chamber; and the valve assembly as set forth herein in fluid communication with and receiving the fluid from the pump.

[0014] A method of delivering fluid is disclosed, including placing a drip chamber in fluid communication with a fluid container; transferring a first fluid from the container through a passage of the drip chamber into an interior cavity of the drip chamber; placing a syringe in fluid communication with an inlet of the drip chamber, the syringe containing a second fluid; applying a negative pressure to an outlet of the drip chamber such that the first fluid is drawn out of the outlet, wherein the first fluid is drawn out of the outlet until a ball contained within the drip chamber forms a seal with a portion of the interior cavity, at which point the negative pressure draws the second fluid from the syringe towards and out of the outlet. The first fluid may be different than the second fluid. The first fluid may be a medication and the second fluid may be saline.BRIEF DESCRIPTION OF THE DRAWINGS

[0015] A more complete understanding of the present disclosure, and the attendant advantages and features thereof, will be more readily understood by reference to the following detailed description when considered in conjunction with the accompanying drawings, wherein:

[0016] FIG. 1 is an illustration of an example of a fluid infusion system constructed in accordance with the principles of the present disclosure;

[0017] FIG. 2 is a perspective view of an example of a valve assembly constructed in accordance with the principles of the present disclosure;

[0018] FIG. 3 is a side view of the valve assembly of FIG. 2;

[0019] FIG. 4 is a partial cross-sectional view of the valve assembly of FIG. 2;

[0020] FIG. 5 is a perspective view of the valve assembly of FIG. 2 in an alternative position;

[0021] FIG. 6 is a partial cross-sectional view of the valve assembly in the position shown in of FIG. 5;

[0022] FIG. 7 is another partial cross-sectional view of the valve assembly in the position shown in of FIG. 5;

[0023] FIG. 8 is a perspective view of the valve assembly of FIG. 2 in another alternative position;

[0024] FIG. 9 is a partial cross-sectional view of the valve assembly in the position shown in of FIG. 8;

[0025] FIG. 10 is a perspective view of another example of a valve assembly constructed in accordance with the principles of the present disclosure;

[0026] FIG. 11 is a perspective view of an example of a drip chamber without fluid therein constructed in accordance with the principles of the present disclosure;

[0027] FIG. 12 is a cross-sectional view of the drip chamber of FIG. 11;

[0028] FIG. 13 is a cross-sectional view of the drip chamber of FIG. 11 with fluid therein;

[0029] FIG. 14 is a top view of an interior portion of the drip chamber of FIG. 11;

[0030] FIG. 15 is another cross-sectional view of the drip chamber of FIG. 11;

[0031] FIG. 16 is a cross-sectional view of an assembly of the drip chamber of FIG. 11 with a syringe and syringe adapter coupled thereto;

[0032] FIG. 17 is an illustration of another example of a fluid infusion system constructed in accordance with the principles of the present disclosure; and

[0033] FIG. 18 is an illustration of another example of a fluid infusion system constructed in accordance with the principles of the present disclosure;DETAILED DESCRIPTION OF THE INVENTION

[0034] The following description is provided to enable those skilled in the art to make and use the described aspects contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.

[0035] As used herein, the singular form of “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise.

[0036] Spatial or directional terms, such as “left”, “right”, “inner”, “outer”, “above”, “below”, and the like, relate to the embodiments or aspects as shown in the drawing figures and are not to be considered as limiting as the embodiments or aspects can assume various alternative orientations.

[0037] All numbers used in the specification and claims are to be understood as being modified in all instances by the term “about”. By “about” is meant within plus or minus twenty- five percent of the stated value. However, this should not be considered as limiting to any analysis of the values under the doctrine of equivalents.

[0038] Unless otherwise indicated, all ranges or ratios disclosed herein are to be understood to encompass the beginning and ending values and any and all subranges or subratios subsumed therein. For example, a stated range or ratio of “1 to 10” should be considered to include any and all subranges or subratios between (and inclusive of) the minimum value of 1 and the maximum value of 10; that is, all subranges or subratios beginning with a minimum value of 1 or more and ending with a maximum value of 10 or less. The ranges and / or ratios disclosed herein represent the average values over the specified range and / or ratio.

[0039] The terms “first”, “second”, and the like are not intended to refer to any particular order or chronology, but refer to different conditions, properties, or elements.

[0040] All documents referred to herein are “incorporated by reference” in their entirety.

[0041] The term “at least” is synonymous with “greater than or equal to.”

[0042] As used herein, “at least one of’ is synonymous with “one or more of.” For example, the phrase “at least one of A, B, or C” means any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, “at least one of A, B, and C” includes A alone; or B alone; or C alone; or A and B; or A and C; or B and C; or all of A, B, and C.

[0043] The word “comprising” and “comprises”, and the like, does not exclude the presence of elements or steps other than those listed in any claim or the specification as a whole. In the present specification, “comprises” means “includes” and “comprising” means “including.”

[0044] As used herein, the terms “parallel” or “substantially parallel” mean a relative angle as between two objects (if extended to theoretical intersection), such as elongated objects and including reference lines, that is from 0° to 5°, or from 0° to 3°, or from 0° to 2°, or from 0° to 1°, or from 0° to 0.5°, or from 0° to 0.25°, or from 0° to 0.1°, inclusive of the recited values.

[0045] As used herein, the terms “perpendicular”, “transverse”, “substantially perpendicular,” or “substantially transverse” mean a relative angle as between two objects at their real or theoretical intersection is from 85° to 90°, or from 87° to 90°, or from 88° to 90°, or from 89° to 90°, or from 89.5° to 90°, or from 89.75° to 90°, or from 89.9° to 90°, inclusive of the recited values.

[0046] The present disclosure provides fluid infusion systems and methods of use thereof. Referring now to the figures in which like reference designations refer to like elements, examples of such a system 10 and the components thereof are shown. The system 10 may include a valve assembly 12 at or near a distal or patient-sided end of the fluid system 10. Referring to FIGS. 1-10, examples of the valve assembly 12 are shown. The valve assembly may generally define or include a conduit 14 configured or operable to convey fluid therethrough. The conduit 14 may include or define a first opening 16, a second opening 18, and a passageway 20 connecting or otherwise in fluid communication with the first and second openings. The conduit 14 may constitute or be constructed at least partially from a segment of tubing, piping, and / or as an integral component of a housing or overall body of the valve assembly 12. The conduit 14 and / or the passageway 20 may be substantially linear and extend along or substantially parallel to a first axis 22. In alternative examples, at least a portion of the conduit 14 and / or the passageway 20 may be arcuate, curved, pliably shapeable, or have other configurations while providing the fluid flow characteristics and features disclosed herein.

[0047] The valve assembly 12 may include a first valve 24 at least partially disposed within the passageway 20 of the conduit 14 and operable to modify a fluid flowpath therethrough. The first valve 24 may, for example, have a segment or portion thereof rotatably positioned within the passageway 20 to modify and / or direct fluid flow. The first valve 24 may generally include or define a body 26 including a first section 28 configured to attach or couple to a syringe, fluid source, or other medical device, and a second section 30 configured to interact with and modify fluid flow within the passageway 20 of the conduit 14.

[0048] The first section 28 of the first valve 24 may generally have an elongated length oriented along an axis 40 and generally define or include a first port 34 opening into or otherwise in fluid communication with an interior cavity 36. The first section 28 may include one or more attachment features 38 configured to releasably engage with a syringe and / or a syringe adapter, as described herein. For example, the first section 28 of the first valve 24 as shown in FIGS. 2-9 includes or constitutes a needle free connector, which may include a valve covering or adjacent the first port 34, threading, and / or other features to connect a compatible device thereto. In an alternative configuration as shown in FIG. 1 and FIG. 10, the first section 28 of the first valve 24 may include or constitute a closed system transfer connector (typically employed for transfer of hazardous drugs or substances), where the first port 34 may be accessed through a sealing membrane 40, and other interlocking features may be included such as cantilever locking arms, tabs, or the like. Examples of needle free connectors and closed system transfer devices are provided in United States Patent No. 10,744,315, the entirety of which is hereby incorporated by reference.

[0049] The second section 30 may generally have a cylindrically-shaped body having an elongated length oriented along an axis 42 substantially transverse to the axis 40 of the first section 28. The second section 30 may define or include a lumen 44 therein in fluid communication with the interior cavity 36 and first port 34 of the first section 28 of the first valve 24. The second section 30 may also define or include second port 46 in fluid communication with the lumen 44 (and thus the interior cavity 36 and first port 34), with the second port 46 also being selectively positionable into or out of fluid communication with the first opening 16 of the conduit 14. In the illustrated example, the lumen 44 may extend through a centerline of the second section 30 substantially parallel to the axis 42. The second port 46 may be defined by or constitute an opening in a sidewall of the second section 30 substantially perpendicular to the axis 42. The second section 30 and / or first valve 24 may be rotatable from a first position where the second port 46 is not in fluid communication with the passageway 20 and the first opening 16, as shown in FIGS. 1-4, to a second position where the second port 46 is in fluid communication with the passageway 20 and the first opening 16, as shown in FIGS. 5-7.

[0050] The second section 30 may also define or include a channel 48 that is selectively positionable to be either in or out of fluid communication with the first opening 16. The channel 48 is isolated from and not in fluid communication with the lumen 44 or interior cavity 36 of the first section 28. The channel 48 may be formed as an arcuate groove or segment around an exterior perimeter or circumference of the second section 30, and may be rotatablearound the axis 42 in conjunction with the rotation or movement of the second section 30. When the second section 30 is in the first position described above (e.g., where the second port 46 is not in fluid communication with the passageway 20 and the first opening 16, as shown in FIGS. 1-4), the channel 48 is in fluid communication with the passageway 20 and the first opening 16 to allow fluid flow between the first opening 16 and an intermediate section 20a of the passageway 20 and / or the second opening 18. When the second section 30 is in the second position described above (e.g., the second port 46 is in fluid communication with the passageway 20 and the first opening 16, as shown in FIGS. 5-7), the channel 48 is not in fluid communication with the first opening 16, and fluid flow is prevented between the first opening 16 and an intermediate section 20a of the passageway 20 and / or the second opening 18.

[0051] The valve assembly 12 may include a second valve 50 at least partially disposed within the passageway 20 of the conduit 14 and operable to modify a fluid flowpath therethrough. The second valve 50 may be positioned between the first valve 24 and the second opening 18 of the conduit 14, and may have substantially similar construction, operation, and features as the first valve 24. The second valve 50 may, for example, have a segment or portion thereof rotatably positioned within the passageway 20 to modify and / or direct fluid flow between the intermediate segment 20a of the passageway 20 and the second opening 18 of the conduit 14. The second valve 50 may generally include or define a body 52 including a first section 54 configured to attach or couple to a syringe, fluid source, or other medical device, and a second section 56 configured to interact with and modify fluid flow within the passageway 20 of the conduit 14.

[0052] The first section 54 of the second valve 50 may generally have an elongated length oriented along an axis 58 and generally define or include a first port 60 opening into or otherwise in fluid communication with an interior cavity 62. The first section 54 may include one or more attachment features 64 configured to releasably engage with a syringe and / or a syringe adapter, as described herein, including needle free connectors and / or closed system transfer connectors.

[0053] The second section 30 may generally have a cylindrically-shaped body having an elongated length oriented along an axis 66 substantially transverse to the axis 58 of the first section 54. The second section 56 may define or include a lumen 68 therein in fluid communication with the interior cavity 62 and first port 60 of the first section 54 of the second valve 50. The second section 56 may also define or include second port 70 in fluid communication with the lumen 68 (and thus the interior cavity 62 and first port 60), with the second port 70 also being selectively positionable into or out of fluid communication with thefirst opening 16 of the conduit 14. In the illustrated example, the lumen 68 may extend through a centerline of the second section 56 substantially parallel to the axis 66. The second port 70 may be defined by or constitute an opening in a sidewall of the second section 56 substantially perpendicular to the axis 66.

[0054] The second section 56 and / or second valve 50 may be rotatable from a first position where the second port 70 is not in fluid communication with the passageway 20 and the second opening 18, as shown in FIGS. 1-6, to a second position where the second port 70 is in fluid communication with the passageway 20 and the second opening 18, as shown in FIGS. 8-9.

[0055] The second section 56 may also define or include a channel 72 that is selectively positionable to be either in or out of fluid communication with the second opening 18. The channel 72 is isolated from and not in fluid communication with the lumen 68 or interior cavity 62 of the first section 54. The channel 72 may be formed as an arcuate groove or segment around an exterior perimeter or circumference of the second section 56, and may be rotatable around the axis 66 in conjunction with the rotation or movement of the second section 56. When the second section 56 is in the first position described above (e.g., where the second port 70 is not in fluid communication with the passageway 20 and the second opening 18, as shown in FIGS. 1-6), the channel 72 is in fluid communication with the passageway 20 and the second opening 18 to allow fluid flow between the second opening 18 and an intermediate section 20a of the passageway 20 and / or the first opening 16. When the second section 54 is in the second position described above (e.g., the second port 70 is in fluid communication with the passageway 20 and the second opening 18, as shown in FIGS. 8-9), the channel 72 is not in fluid communication with the second opening 18, and fluid flow is prevented between the second opening 18 and an intermediate section 20a of the passageway 20 and / or the first opening 16.

[0056] The valve assembly 12 may include one or more connectors, adapters, or other couplers 74 positioned on or about the first opening 16, second opening 18, and / or conduit 14 to integrate the valve assembly 12 into a fluid line, delivery system, or otherwise for use as described herein.

[0057] Now referring to FIG. 1 and FIGS. 11-6, the system 10 may include a drip chamber 76 facilitating controlled delivery of fluids and / or medications through the system 10. The drip chamber 76 may generally include or define a housing 78 with a first end 80, a second end 82, and an interior cavity 84 therein configured to receive, store, and deliver fluid to other segments of the system 10. The first end 80 of the housing may be configured or operable to attach to or engage a fluid container, such as an IV bag or the like. The first end 80 may include or definea spike 86 configured to pierce a seal, port, or other opening of the fluid container. The spike 86 may include an aperture or opening 88 at or adjacent to a tip thereof and a passage 90 leading from the aperture 88 into the interior cavity of the housing 78. The drip chamber 76 may include a drop former or other structure to regulate fluid flow through the passage 90 and into the interior cavity 84 of the housing 78.

[0058] The drip chamber 76 may include a ball 92 movably positioned within the interior cavity 84 of the housing 78. The ball 92 may be sufficiently buoyant such that it floats or is otherwise moved within the interior cavity 84 depending on the presence and level of fluid contained in the interior cavity 84. FIG. 13 illustrates an example of the position of the ball 92 in the interior cavity when fluid is present, while FIG. 14 illustrates an example of the position of the ball 92 in the interior cavity when fluid is significantly removed from the interior cavity. The drip chamber 786 may include a stopper 94 configured or operable to limit or restrict a range of movement of the ball 92 within the interior cavity 84. For example, the stopper 94 may physically limit the maximum height to which the ball 92 can travel within the interior cavity 84. The stopper 94 may attach to, extend from, and / or otherwise be integrated with one or more portions of a sidewall or surface of the interior cavity 84, and may be movably positionable with respect to the interior cavity 84 to allow manual adjustment of the range of movement of the ball 92. In the illustrated example shown in FIG. 14, the stopper 94 has an annular structure circumscribing a circumference or perimeter of the interior cavity 84, and has a plurality of protrusions 96 defining an inner diameter or width less than a width or diameter of the ball 92, thus preventing the ball from passing through or beyond the stopper 94. The stopper 94 presents an otherwise open configuration to allow fluid to freely flow through the stopper 94 within the interior cavity 84.

[0059] The drip chamber 76 includes an inlet 98 proximate the second end 82 of the housing 78 configured to introduce or infuse fluids into the drip chamber. The inlet 98 may be in fluid communication with the interior cavity 84 of the housing 78, and a check valve 100 may be positioned adjacent to or otherwise in fluid communication with the inlet 98 and thus the interior cavity 62 of the housing to allow fluid to flow one-way into the interior cavity, and to prevent nay backflow or leaks out of the inlet 98 or housing 78. The inlet 98 may include one or more attachment features 102 configured to releasably engage with a syringe and / or a syringe adapter, as described herein. For example, the inlet 98 may include or otherwise be attached to a needle free connector similar to those shown in FIGS. 2-9 with respect to the valve assembly 12 discussed above. In another configuration as shown in FIG. 1 and FIGS. 11-15, the inlet 98 may include or otherwise be attached to a closed system transfer connector104 (typically employed for transfer of hazardous drugs or substances), where the inlet 98 and thus the interior cavity 62 of the housing may be accessed through a sealing membrane 106 and a lumen 108 therethrough. The connector 104 may include interlocking features such as cantilever locking arms, tabs, or the like to attach to a syringe adapter as disclosed herein.

[0060] The drip chamber 76 may include an outlet 108 at, adjacent, or proximate the second end 82 of the housing 78. The outlet 108 is in fluid communication with the interior cavity 84 and is configured or operable to deliver fluids out of the interior cavity to other portions of the system 10. The outlet 108 may include one or more lengths of tubing, nozzles, valves, and / or connectors to facilitate attachment and fluid communication with other portions of the system 10.

[0061] The drip chamber 76 may be configured such that the ball 92 descends and seals a portion of the interior cavity 84 from the inlet 98 and outlet 108 when a volume or amount of liquid in the interior cavity 84 drops below a threshold level. The ball 92 is thus operable and configured to prevent air from being entrained into the outlet 108 when an attached fluid container or IV bag has emptied into the drip chamber 76 and the fluid has been sufficiently discharged through the outlet 108. The ball 92 may form a seal with the housing 78 adjacent to or in proximity of the second end 82. The housing 78 may define or include an annular rim or funnel-shaped region 110 having a width or dimeter less than a width or dimeter of the ball 92 such that, when a fluid level within the interior cavity 84 is sufficiently reduced, the ball 92 descends to contact the rim 110, thus forming a fluid- tight seal between an upper segment 112 of the interior cavity 84 and a lower segment 114 of the interior cavity in proximity to and in fluid communication with the inlet 98 and outlet 108. When the ball 92 forms the seal, there may be sufficient liquid remaining in the lower segment 114 of the interior cavity 84 to ensure air is not introduced into the lower segment 114 and the outlet 108. During operation, the ball 92 sealing the interior cavity 84 also places a vacuum or pressure differential onto a syringe adapter 116, syringe 118, and / or other fluid container attached to the inlet 98, as shown in FIG. 16, to draw the contents therein into the inlet 98 and towards the outlet 108 as described further herein.

[0062] Referring again to FIG. 1, the system 10 may include an IV bag or fluid container 120 attached to or otherwise suspended from a hanger or frame 122. The system 10 includes one or more segments of tubing, piping, or other fluid conduits to interconnect the components and provide the fluid circuit or path operable as described. The drip chamber 76 may be in fluid communication with the container 120 by positioning or inserting the spike 86 through a seal or port in the container 120 such that the interior cavity 84 receives fluid from the container120. A pump 124 may be in fluid communication with the outlet 108 of the drip chamber 76, and the valve assembly 12 may be in fluid communication with the pump 124. The first opening 16 of the valve assembly 12 may be attached to or otherwise configured to received fluid delivered by the pump 124, and the second opening 18 of the valve assembly 12 may be coupled to a medical device (not shown) such as in in-dwelling catheter or cannula providing fluid to a patient. The system 10 may include one or more syringe connectors / vents 126 therein, and may include one or more clamps 128 (such as roller and / or slide clamps) to adjust fluid flow through the system 10. The system 10 provides a single-line flow path from the container 120 to the drip chamber 76, out of the outlet 108 (including any additive or injection from the inlet 98), to and through the pump 124 and towards the valve assembly 12.

[0063] Now referring to FIG. 17, another example of the system 10 is shown similar to the system shown in FIG. 1, with the addition of multiple fluid sources. The system 10 includes a first fluid container 120a and a second fluid container 120b attached to or otherwise suspended from a hanger or frame 122. The drip chamber 76 may be in fluid communication with the first container 120a by positioning or inserting the spike 86 through a seal or port in the container 120 such that the interior cavity 84 receives fluid from the container 120. The outlet 108 of the drip chamber 76 may lead to a connector 130 to intersect with an outlet or line from a secondary drip chamber 132 attached to the second fluid container 120b. The pump 124 may be in fluid communication with both fluid containers 120a, 120b downstream of the connector 130, and the valve assembly 12 may be in fluid communication with the pump 124. The first opening 16 of the valve assembly 12 may be attached to or otherwise configured to received fluid delivered by the pump 124, and the second opening 18 of the valve assembly 12 may be coupled to a medical device (not shown) such as in in-dwelling catheter or cannula providing fluid to a patient.

[0064] Now referring to FIG. 18, another example of the system 10 is shown similar to the system shown in FIG. 17, with multiple pumps. The system 10 includes the first fluid container 120a and a second fluid container 120b attached to or otherwise suspended from a hanger or frame 122. The drip chamber 76 may be in fluid communication with the first container 120a by positioning or inserting the spike 86 through a seal or port in the container 120 such that the interior cavity 84 receives fluid from the container 120. The outlet 108 of the drip chamber 76 may lead to first pump 124a upstream of the connector 130, and a secondary pump 124b is connected between the second fluid container 120b and the connector 130. The valve assembly 12 may be in fluid communication with both pumps and fluid containers downstream of the connector 130.

[0065] The system 10 and components thereof provide fluid flow control capabilities at various stages of preparation and delivery to a patient. For example, to prime the system 10 for fluid delivery, a syringe adapter 116 and / or syringe 118 may be coupled to the inlet 98 of the drip chamber 76. The fluid contents of the syringe 118 may be injected through the check valve 100 and into the interior cavity 84 of the drip chamber to prime or fill the fluid circuit or lines leading out of the outlet 108, to the pump 124, to the valve assembly 12, and towards an in-dwelling cannula or catheter of a patient (not shown). Alternatively, to prime the line and / or to remove air contained in the system 10, the first valve 24 may be adjusted from the first position to the second position such that the first port 34 and second port 46 are in fluid communication with the first opening 16 of the conduit 14, and a syringe may be coupled to the first section 28 of the first valve 24 to withdraw air until fluid from the drip chamber 76 fills the fluid line or circuit for delivery. Once fluid has filled the fluid line and air has been removed, the first valve 24 may be returned to the first position enabling fluid to pass through the first and second openings of the conduit 14, and downstream to the patient. Any excess fluid or medication drawn into the syringe may be reintroduced into the system 10 through the inlet 98 to minimize waste during the priming process.

[0066] Once the system has been primed, the system 10 may deliver a full dose of medication to a patient. For example, the container 120 may contain a medication that passes through the passage 90 and into the interior cavity 84 of the drip chamber 76. The syringe 118 may be coupled to the inlet 98 of the drip chamber 76 directly or through the syringe adapter 116, or other intermediary connector. The syringe 118 may include saline or other flushing fluid therein. As medication in the interior cavity 84 of the drip chamber 76 received from the fluid container 120 is drawn down and delivered to the patient (via the pump 124 and valve assembly 12 for example), the ball 92 descends to form a seal with the sealing region 110 of the housing 78, ensuring that air is not entrained or passed through the outlet 108. Once the seal is formed, a portion of the medication from the container 120 will still remain in the lower segment 114 of the housing and in the fluid line(s) leading from the outlet 108 to the pump 124, the valve assembly 12, and to the patient. The pump 124 generates a negative pressure through the sealed lower segment 114 of the housing 78 sufficient to open the check valve 100 and pull the fluid contents from the syringe 118. The contents of the syringe 118 will thus enter the inlet 98, pass through the outlet 108, and continue towards the valve assembly 12, thereby delivering the remaining medication in the system 10 to the patient, and keeping the system 10 primed for subsequent infusion. The volume of the contents of the syringepreferably meets or exceeds the volumetric capacity of the fluid lines within the system 10 to ensure complete medication delivery.

[0067] In the event of an adverse reaction or other circumstance requiring immediate termination of infusion and the injection of one or more rescue medications or other fluids, the second valve 50 may be moved from the first position to the second position, which blocks further fluid flow from the first opening 16 of the conduit 14 (and thus the pump 124 and drip chamber 76) to the patient, and places the first and second ports 60, 70 in fluid communication with the second opening 18 of the conduit 14 and downstream to the patient. A syringe containing the rescue medication or other fluid may be attached to the first section 54 of the second valve 50 via the attachment features 64, and the contents of the syringe can be injected through the first port 60, out of the second port 70, through the second opening 18 of the conduit 14, and to the patient.

[0068] It will be appreciated by persons skilled in the art that the present disclosure is not limited to what has been particularly shown and described herein above. In addition, unless mention was made above to the contrary, it should be noted that all of the accompanying drawings are not to scale. Of note, the system components have been represented where appropriate by conventional symbols in the drawings, showing only those specific details that are pertinent to understanding the embodiments of the present disclosure so as not to obscure the disclosure with details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein. Moreover, while certain embodiments or figures described herein may illustrate features not expressly indicated on other figures or embodiments, it is understood that the features and components of the examples disclosed herein are not necessarily exclusive of each other and may be included in a variety of different combinations or configurations without departing from the scope and spirit of the disclosure. A variety of modifications and variations are possible in light of the above teachings without departing from the scope and spirit of the disclosure, which is limited only by the following claims.

Claims

WHAT IS CLAIMED IS:

1. A valve assembly, comprising: a conduit having a first opening and a second opening; a first valve at least partially disposed in the conduit, the first valve defining a first fluid path and a second fluid path, wherein the first valve is movable from (i) a first position where the first fluid path is in fluid communication with the first opening and the second fluid path is not in fluid communication with the first opening, to (ii) a second position where the first fluid path is not in fluid communication with the first opening and the second fluid path is in fluid communication with the first opening; and a second valve at least partially disposed in the conduit, the second valve defining a third fluid path and a fourth fluid path, wherein the second valve is movable from (i) a first position where the third fluid path is in fluid communication with the second opening and the fourth fluid path is not in fluid communication with the second opening, to (ii) a second position where the third fluid path is not in fluid communication with the second opening and the fourth fluid path is in fluid communication with the second opening.

2. The valve assembly of claim 1, wherein when the first valve is in the first position and the second valve is in the first position, the first opening of the conduit is in fluid communication with the second opening.

3. The valve assembly of claim 2, wherein when either the first valve or the second valve is in the second position, the first opening of the conduit is not in fluid communication with the second opening.

4. The valve assembly of claim 1, wherein the conduit defines a longitudinal axis, and wherein the first valve is rotatable with respect to the conduit about an axis substantially transverse to the longitudinal axis.

5. The valve assembly of claim 4, wherein the second valve is rotatable with respect to the conduit about an axis substantially transverse to the longitudinal axis.

6. The valve assembly of claim 1, wherein the first valve includes a first section exterior to the conduit and configured to attach to a syringe, the first section including a first port.

7. The valve assembly of claim 6, wherein the first valve includes a second port movably positionable within the conduit, and the second flow path includes the first and second ports.

8. The valve assembly of claim 7, wherein the first valve includes a second section at least partially disposed within the conduit, the second section defining a channel constituting the first flow path.

9. The valve assembly of claim 8, wherein the channel extends around an exterior perimeter of the second section.

10. The valve assembly of claim 1, wherein the second valve includes a first section exterior to the conduit and configured to attach to a syringe, the first section including a first port.

11. The valve assembly of claim 10, wherein the second valve includes a second port movably positionable within the conduit, and the fourth flow path includes the first and second ports.

12. The valve assembly of claim 11, wherein the second valve includes a second section at least partially disposed within the conduit, the second section defining a channel constituting the third flow path.

13. The valve assembly of claim 12, wherein the channel extends around an exterior perimeter of the second section.

14. A drip chamber, comprising: a housing defining a first end, a passage at the first end, a second end opposite the first end, and an interior cavity in fluid communication with the passage; a ball movably disposed within the interior cavity;a stopper configured to limit a range of movement of the ball; an inlet proximate the second end and in fluid communication with the interior cavity; and an outlet proximate the second end and in fluid communication with the interior cavity, wherein at least a portion of the housing is configured to form a seal with the ball such that the inlet and outlet are not in fluid communication with passage.

15. The drip chamber of claim 14, further comprising a spike at the first end, the passage extending through the spike.

16. The drip chamber of claim 14, wherein the housing defines a funnel- shaped section within the interior cavity configured to form the seal with the ball.

17. The drip chamber of claim 14, wherein the inlet includes a connector configured to attach to a syringe.

18. The drip chamber of claim 14, further comprising a check valve adj acent to the inlet.

19. A fluid delivery system, comprising: a first fluid container containing a fluid therein; a drip chamber according to claim 14 in fluid communication with and receiving the fluid from the first fluid container; a pump in fluid communication with and receiving the fluid from the drip chamber; and the valve assembly according to claim 1 in fluid communication with and receiving the fluid from the pump.

20. A method of delivering fluid, comprising: placing a drip chamber in fluid communication with a fluid container; transferring a first fluid from the container through a passage of the drip chamber into an interior cavity of the drip chamber; placing a syringe in fluid communication with an inlet of the drip chamber, the syringe containing a second fluid; andapplying a negative pressure to an outlet of the drip chamber such that the first fluid is drawn out of the outlet, wherein the first fluid is drawn out of the outlet until a ball contained within the drip chamber forms a seal with a portion of the interior cavity, at which point the negative pressure draws the second fluid from the syringe towards and out of the outlet.

21. The method of claim 20, wherein the first fluid is different than the second fluid.

22. The method of claim 21, wherein the first fluid is a medication and the second fluid is saline.

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