Micro-droplet Drop Chamber
The drip chamber uses a droplet former with a sharp point and optional ultrasonic or gas injection to form smaller droplets, enhancing accuracy in IV therapy systems for precise flow rate measurement, addressing limitations in existing drip chambers.
Patent Information
- Application Number
- JP2023204375
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2018-10-15
- Filing Date
- 2023-12-04
- Publication Date
- 2025-07-09
- Estimated Expiration
- 2039-09-05
AI Technical Summary
Existing drip chambers in IV therapy systems are limited in accuracy for measuring low flow rates, particularly for neonates and patients with fluid restrictions, and manual counting methods are prone to errors, while automatic pumps increase complexity and cost.
The drip chamber incorporates a droplet former with a solid pin or wire terminating in a sharp point, optionally using ultrasonic energy, gas injection, or a piezoelectric sensor to facilitate smaller droplet sizes and accurate flow rate measurement, allowing for precise control without additional complexity or cost.
Enables more accurate metering and measurement of low flow rates by forming smaller droplets, reducing human error, and providing precise flow rate control without the need for costly automatic pumps.
Smart Images

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Abstract
Description
Technical Field
[0001] The disclosed embodiments relate to, for example, drip chambers for intravenous (IV) therapy.
Background Art
[0002] Medical procedures often involve the use of IV therapy in which a liquid such as saline, blood, and / or a drug is administered directly into a patient's vein. The IV systems used for IV therapy generally use a drip chamber, which allows a clinician (e.g., a nurse) to determine the rate at which the IV fluid is being administered by manually counting the number of droplets over a given period. Drip chambers may be classified as macro droplets or micro droplets based on a droplet coefficient defined as the number of drops per milliliter (mL) of the IV fluid provided. For example, macro droplet drip chambers generally use a drip factor of about 20 gtts / mL (or drops / mL), while micro droplet drip chambers generally use a drip factor of about 60 gtts / mL.
Brief Description of the Drawings
[0003]
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Mode for Carrying Out the Invention
[0004] In one or more implementations, not all of the components shown in each figure may be required, and one or more implementations may include additional components not shown in the figures. Changes in the arrangement and type of components may be made without departing from the scope of the present disclosure. Additional components, different components, or fewer components may be utilized within the scope of the present disclosure.
[0005] The detailed description set forth below is intended as a description of various implementations and is not intended to represent the only implementation in which the subject technology may be practiced. As will be understood by those skilled in the art, the described implementations may be varied in various different ways without departing from the scope of the present disclosure. Thus, the drawings and the specification are to be regarded essentially as illustrative rather than restrictive.
[0006] The drip chamber of an intravenous therapy system may be limited in accuracy such that the flow rate can be measured based on its drip factor, which results in restricting the range of flow rates that can be accurately delivered to a patient. For example, neonates, diabetics, or other patients with fluid restrictions may require infusion or IV fluid delivery at slow rates on the order of 1 mL or a few mL per hour. Even in the case of a micro-drop drip chamber with a drip factor of 60 drops / mL, this may result in a slow drip rate of 1 drop per minute, which may not allow for accurate or practical measurement by a clinician counting the number of drops using a stopwatch. Further, at such low flow rates, even small errors can have a large impact on the treatment. Automatic pumps can control the flow rate more accurately, but increase cost and complexity and may not be practical in certain markets and environments.
[0007] In some embodiments disclosed herein, the drip chamber, as well as IV therapy systems and methods that use the drip chamber, can allow for smaller droplet sizes in order to enable more accurate metering of low flow rates and / or facilitate more accurate flow rate measurements as compared to existing technologies. In some embodiments, the drip chamber can use a solid pin, wire, or other liquid former structure that allows the IV fluid to carry down the outer surface of the liquid former. The liquid former can terminate in a sharp solid point in order to reduce the surface area and drop droplets from the liquid former in a smaller volume. Additionally or alternatively, electronics such as an ultrasonic or other acoustic energy source can be used to stimulate the formation or release of droplets from the droplet former. Additionally or alternatively, a gas inlet port can be included to allow other gases to be injected into the drip chamber to disperse the flow and induce droplet release from the droplet former. Additionally or alternatively, a piezoelectric sensor can be utilized to detect the impact of the falling droplets and enable smaller droplets to fall at a faster rate than may be reliably counted by the human eye.
[0008] These embodiments and other embodiments are discussed below with reference to FIGS. 1-9. However, those skilled in the art will understand the various changes and other embodiments that can be made using the principles of the present disclosure without departing from the scope and spirit of the concepts disclosed herein. As a result, it is understood that the detailed figures and discussions provided herein are for illustrative purposes only and should not be construed as limiting.
[0009] FIG. 1 is a schematic diagram of an exemplary IV therapy system 101 that can be used to administer fluid to a patient. The IV therapy system 101 includes an IV bag 102 that contains a reservoir of fluid 104 to be administered to the patient 106, a catheter 108 that is inserted into the patient's vein to deliver the IV fluid, and an IV line 110 that provides a tube for transporting the fluid from the IV bag 102 to the catheter 108. A drip chamber 150 is coupled between the IV bag 102 and the catheter 108 to form droplets of the fluid 104 at a known droplet coefficient. Droplet formation in the drip chamber 150 can provide a measurement for determining the flow rate, for example, by enabling the counting or measurement of the number of droplets over a period of time. A control mechanism 112, such as a roller clamp coupled to the IV line, can be used to adjust the flow rate based on the flow rate determined from the drip chamber as needed.
[0010] FIG. 2 is a diagram of an exemplary IV administration set 200. The IV set 200 is a specific example of an apparatus that includes a drip chamber and other operable components of a fluid administration system. The IV set 200 includes a modular design that allows for insertion into and removal from an IV system as needed. The IV set 200 can be used, for example, with the IV therapy system 101 or any other suitable fluid administration system.
[0011] As shown in FIG. 2, the IV set 200 includes a drip chamber 250, an IV line 210, a luer lock fitting 232, and a roller clamp 212. The drip chamber 250 has a container for holding IV fluid. The proximal end of the drip chamber 250 can include an inlet port for receiving fluid from a fluid reservoir, while the distal end of the drip chamber 250 can include an outlet port for providing fluid downstream to a patient through the IV line 210. The drip chamber 250 can be configured to receive fluid using gravity supply from a fluid reservoir, and in a gravity reference system, the proximal end of the drip chamber 250 corresponds to the upper end (or top end), and the distal end corresponds to the lower end (or bottom end). The droplet former 220 is suspended from the upper end of the drip chamber 250 and can extend downwardly into the interior cavity of the container partially from the upper end. The droplet former 220 can be manufactured from, for example, plastic, metal, and / or any other suitable material, and the droplet former 220 can include, for example, a tube, a pin, a wire, a cylinder, a flare tip, or other structures that can form droplets of IV fluid that can fall into the container below. During operation, the drip chamber 250 can be initially filled with IV fluid (e.g., up to about half level) to allow air or other gas to disperse and not enter the IV line 210 below upon impact of droplets of the IV fluid, which is liquid, from the droplet former 220.
[0012] The IV set 200 includes a spike 226 at its proximal end, which includes an inlet port therein and can be coupled to an IV bag (e.g., the IV bag 102 of FIG. 1). The IV bag can include a liquid reservoir that can provide a source of liquid to be delivered to the patient. The IV set 200 shown in FIG. 2 is implemented with a spike type drip chamber, and the spike 226 is included in the cap at the upper end of the drip chamber 250 such that the drip chamber itself can be directly attached to the bottom of the IV bag via the spike 226. The protective cover 228, shown removed from the spike 226 in FIG. 2, can cover the spike 226 during initial delivery or transport prior to use. At the distal end of the IV set 200 on the opposite side, there is a male luer fitting 232 disposed at the end of a segment of the IV line 210. The male luer fitting 232 provides a connector for coupling to a downstream or distal component such as a catheter or an additional IV line segment through which fluid is delivered to the patient.
[0013] A roller clamp 212 is included in the IV set 200 along the IV line. The roller clamp 212 provides a control mechanism that enables manual adjustment of the flow rate by a user (e.g., a clinician). The drip chamber 250 can include an outer surface that is sufficiently transparent to enable the user to see the droplets falling from the droplet former 220 such that the drip rate of the droplets provides a visual check for the user to determine the flow rate. For example, the user can use a stopwatch to count the number of droplets over a set period and determine the flow rate based on the number of counted droplets, the period, and the known droplet factor of the drip chamber 250. Additionally or alternatively, the drip chamber 250 can include a sensor such as a piezoelectric sensor to count and otherwise detect the droplets falling into the drip chamber. Then, the user can adjust the flow rate up or down as appropriate by operating the roller clamp 212 based on the desired treatment of the patient.
[0014] FIG. 3 is a diagram of an exemplary IV set 300. The IV set 300 is another example of an apparatus that includes a drip chamber and other operable components of a fluid administration system. The IV set 300 includes an in-line drip chamber 350 that is arranged along an IV line, rather than being configured to couple directly to an IV bag as is the drip chamber 250 of FIG. 2. The IV set 300 can be used, for example, in an IV therapy system 101 or any other suitable fluid administration system.
[0015] The top or cap of the in-line drip chamber 350 can include an inlet port coupled to the proximal or upstream segment of the IV line 310 between the drip chamber 350 and the IV bag. The IV set 300 shown in FIG. 3 includes, at its proximal end, a pair of connectors for coupling to respective fluid reservoirs (e.g., an IV bag for saline and a separate IV bag for blood, or other suitable combinations of fluids to be delivered to a patient). Unlike the example of FIG. 2 where a spike is included directly in the upper side or cap of the drip chamber 250, the IV set 300 of FIG. 3 includes a pair of spikes 326 disposed at the ends of a pair of IV line segments at the proximal end of the IV set 300.
[0016] A pair of roller clamps 312 are provided to each of a pair of IV line segments, enabling individual adjustment of the flow rate of each respective fluid reservoir. The roller clamp 312 is proximal and upstream to the drip chamber 350 and provided between the drip chamber 350 and the fluid reservoir, in contrast to the IV set 200 of FIG. 2 where the roller clamp 212 (FIG. 2) is distal and downstream to the drip chamber 250 (FIG. 2) and disposed between the drip chamber and the patient. The IV set 300 also includes various additional components to provide additional functionality. For example, an additional fluid transfer device (e.g., a disposable syringe or other component) is coupled to the IV line 310 for delivery of additional fluid to the patient and, optionally, removed from the IV line 310 for removal of additional fluid from the patient, and an access connector 334 disposed along the IV line 310 is shown. A slider clamp 336 disposed along the IV line 310 is also shown to provide an additional control mechanism for stopping or starting the flow rate.
[0017] FIG. 4 is a cross-sectional view of an exemplary drip chamber 450. The drip chamber 450 is a particular example of a drip chamber that uses a solid pin, wire, or other droplet former structure that provides an outer surface for the IV fluid to descend. The droplet former structure can terminate at a small point to encourage droplets or a series of droplets to fall from the outer surface and be released in a smaller volume from the tip of the droplet former. In some embodiments, the drip chamber 450 can share common features with any one or more of the drip chambers shown in FIGS. 1-3.
[0018] The drip chamber 450 includes a container 444, a cap 446, and an internal cavity 442 that is within the container and closed by the cap 446. The container 444 can have a substantially cylindrical body or any other suitable structure that enables holding IV fluid in an internal cavity of the container body. The cap 446 is disposed at the upper or proximal end of the container 444 and includes a spike 426 that can be configured to couple to an IV bag containing fluid (e.g., by inserting the spike into the bottom end or port of the IV bag). The inlet port 456 is included at the proximal end of the container and can be configured to receive fluid from the IV bag. As shown in FIG. 4, the inlet port 456 extends through the spike 426 and the cap 446 and is coupled to the droplet former 420 at the upper or proximal end of the droplet former. The inlet port 456 is disposed above the droplet former to enable the IV fluid to descend to the droplet former. Although shown as including a lumen that extends through the cap, in various configurations, the inlet port can have any suitable opening, channel, or other structure to enable receipt of the IV fluid flowing into the drip chamber. Further, although the drip chamber 450 is shown as including a spike 426 that can be used for direct connection to an IV bag, the drip chamber 450 can alternatively or additionally be implemented as an in-line drip chamber having an inlet port configured to couple to, for example, an upstream segment of an IV line without using the spike 426.
[0019] The droplet former 420 is suspended from the cap 446 and extends partially downward in a distal direction into the internal cavity 442 from the cap 446. The droplet former 420 is configured to form droplets of fluid received from the inlet port 456 and is configured to discharge droplets at a constant rate into the internal cavity 442 and the container 444 in order to enable the measurement or estimation of the flow rate by counting the droplets. The droplet former 420 can be implemented, for example, as a solid pin, wire, or other elongated member. The droplet former 420 can terminate at its lower or distal end with a lower tip 421 (or "distal tip") that provides a discharge point for the droplets of the IV fluid 452 to fall into the container 444.
[0020] The outer surface 423 between the proximal and distal ends of the droplet former 420 can be directly or indirectly coupled to the inlet port 456 to receive the IV fluid 452 from the inlet port 456. The outer surface 423 can extend downward and terminate at the distal tip 421 to allow the IV fluid 452 to descend along the outer surface 423 toward the small discharge point of the distal tip 421. The outer side surface of a pin, wire, or other elongated member can provide the outer surface 423 for the fluid to descend. The small solid point of the lower tip 421 below the outer surface 423 can enable the formation and discharge of smaller droplets that can be smaller than the droplets formed by a pure tube-type drip chamber having an internal resistance that limits the droplet size to 60 droplets / mL. By way of example, the droplet former 420 can be configured (e.g., based on its dimensions) to form droplets on the order of 200 - 300 droplets / mL or any other desired size.
[0021] The droplet former 420 can have a uniform diameter over its entire length. Alternatively, the droplet former 420 can taper to a smaller diameter at the distal tip, such as a pin implementation where the distal (lower) tip of the pin has a smaller diameter or size than the proximal (upper) portion of the pin. The droplet former 420 can have a solid structure throughout its length without a lumen or internal fluid path provided throughout the extent of the droplet former, or the liquid former 420 can have a solid structure only in a distal section that terminates at a distal tip 421 that provides, for example, a point of release for droplets of fluid 452.
[0022] The droplet former 420 can be coupled to a fluid source and can be coupled to the inlet port 456 through a small hole 462 or pinhole included in a cap 462 between the upper end of the inlet port 456 and the lower end of the droplet former 420. The size of the hole can be made small enough so that the surface tension of the fluid prevents gravity from enabling free fall of the fluid through the hole 462. In this example, the droplet former 420 includes a proximal section disposed in the hole 462 that enables the droplet former 420 to carry fluid through the hole 462 by capillary action, in a wire-like shape that carries a liquid similar to, for example, a candle wick. Alternatively, the liquid former 420 can be coupled to the inlet port 456 through any other suitable structure or arrangement that enables the fluid to descend along the outer surface 423 of the liquid former 420.
[0023] The outlet port 458 is included at the distal end of the container 444. The outlet port 458 is configured to couple to the IV line 410 to enable fluid to be provided downstream to a patient through the IV line 410 from the internal cavity 442 of the drip chamber 450. In FIG. 4, a drip chamber 450 is shown after the IV fluid 452 has been placed to approximately the mid-level of the container. All or part of the container can be made sufficiently transparent to enable droplets falling from the droplet former 420 to be visible from outside the drip chamber 450. For example, the container 444 can be manufactured of a transparent plastic, in whole or in part, to enable the formation and / or release of droplets to be visible to a user (e.g., a clinician) from outside the drip chamber 450 to enable manual counting of the droplets by the user.
[0024] FIG. 5 is a cross-sectional view of an exemplary drip chamber 550. The drip chamber 550 is a particular example of a drip chamber that uses an electronic device, such as an acoustic emitter, to energize a droplet former to stimulate the ejection or release of small droplets from the droplet former. In some embodiments, the drip chamber 550 can share common features with any one or more of the drip chambers shown in FIGS. 1-4.
[0025] The drip chamber 550 includes a droplet former 520 that can be suspended from the cap 446 and configured to release droplets of the intravenous fluid 452 into the internal cavity 442 of the container 444. The droplet former 520 is shown in FIG. 5 as including a tubular structure having an inner lumen through which fluid from the inlet port 456 passes to the distal tip of the tubular structure. Additionally or alternatively, the droplet former 520 can use any suitable structure for forming and ejecting drops, such as a pin or wire having a solid distal tip, as shown, for example, in FIG. 4.
[0026] The drip chamber 550 includes an electronic component 566 housed within the cap 446. The electronic component 566 is operably coupled to the droplet former 520 and is configured to stimulate droplet formation and / or ejection therefrom. The electronic component 566 may be operably coupled to the droplet former directly or via an intervening component such as a cap, so long as the electronic component is sufficiently coupled to enable interaction with the droplet former 520. The electronic component 566 can include, for example, an acoustic emitter, which can be operably coupled to the droplet former 520 via any suitable physical or mechanical coupling that allows sound waves or other signals emitted from the component 566 to reach the surface of the droplet former 520. Additionally or alternatively, the electronic component can include a circuit, a power source (e.g., a battery), wires, and / or other electronics to facilitate providing energy to the droplet former 520.
[0027] The acoustic energy or mechanical vibrations generated or otherwise provided by the electronic component 566 can be configured to induce the ejection of droplets that, without overcoming the fluid resistance or surface tension of the droplet former, might fall only depending on gravity or a pressure differential. The electronic component 566 can be configured to periodically stimulate the droplet former 520, for example, by being fixed or being user-programmable to generate bursts of acoustic energy in synchronization with a predetermined droplet velocity.
[0028] The electronic component 566 can be housed within a housing of a cap 446 that is sealed and otherwise insulated from the fluid path of the fluid 452 (e.g., insulated from the inlet port 456 and the internal cavity 442). This can enable insulating the electronic component 566 from the sterile components and / or enable removing the electronic component 566 from the cap 446 for reuse in other drip chambers, while the remaining structure of the drip chamber 550, such as the container 544 and / or the droplet former 520, can be discarded after each process of use. The electronic component 566 is shown in FIG. 5 as an annular structure that at least partially surrounds the inlet fluid path, but the electronic component 566 can alternatively or additionally be implemented as one or more individual structures having any other suitable size or shape.
[0029] FIG. 6 is a cross-sectional view of an exemplary drip chamber 650. FIGS. 7A-7C are diagrams of a sequence of operating a droplet former 620 included in the drip chamber 650. The drip chamber 650 is a particular example of a drip chamber that uses ultrasonic energy to energize a droplet former to stimulate the ejection or release of small droplets from the droplet former. In some embodiments, the drip chamber 650 can share common features with any one or more of the drip chambers shown in FIGS. 1-5.
[0030] The drip chamber 650 includes electronic components housed within the cap 446. In particular, the electronic component is implemented as, or otherwise includes, an ultrasonic emitter 666 operably coupled to a droplet former 620 suspended from the cap 446. The ultrasonic emitter 666 can include, for example, a piezoelectric, capacitive, or other suitable transducer capable of emitting ultrasonic waves to the surface of the droplet former 620. The droplet former 620 includes a lateral outer surface 673 at the distal or lower tip of the droplet former. The lateral outer surface 673 extends substantially orthogonally downward, or more generally, laterally with respect to the direction in which droplets are emitted from the droplet former 620. This allows droplets to be emitted from the droplet former 620 in a direction generally perpendicular to the outer surface 673. The lateral outer surface 673 may be provided using a flare structure, as shown in FIG. 6, where the distal lower end of the droplet former is flared radially outward such that the diameter increases at its lower end. Alternatively, the droplet former 620 may be implemented as a solid cylindrical structure (such as a large gauge wire) that provides a lateral surface at the distal lower tip having a surface area sufficient for the ultrasonic emitter to generate droplets in the manner described herein.
[0031] FIG. 6 also shows an external coupling connector 677 that can enable the coupling of the ultrasonic emitter 666 to external electronic components, such as an external power source and / or an external ultrasonic generator configured to provide a vibration signal to the ultrasonic emitter 666 housed within the drip chamber 650, for example. The drip chamber 650 is shown including both the internal ultrasonic emitter 666 and the external coupling connector 677, although in alternative embodiments, only one or the other may be used. For example, in some embodiments, all of the electronics used to emit waves to the droplet former 620 can be fully housed within the cap 446. Alternatively, all of the electronics including the ultrasonic emitter 666 can be provided externally and coupled to the droplet former via one or more external coupling connectors.
[0032] The ultrasonic emitter 666 can be configured to generate a standing wave of the IV fluid 452 at the surface of the droplet former 620 in order to enable the generation of very small droplets or drops that can have a diameter smaller than the lateral surface 673. FIGS. 7A-7C show an exemplary sequence of droplet generation in the droplet former 620 using ultrasonic electronics to energize the droplet former and generate a standing wave at the lateral surface 673. In FIGS. 7A-7C, the droplet former 620 is shown in an inverted form to better illustrate the surface 673 and wave generation.
[0033] FIG. 7A shows the droplet former 620 with the IV fluid stationary on the surface 673 when no ultrasonic or energy is provided to the surface. In this state, the fluid can form relatively large masses. In FIG. 7B, the ultrasonic waves are coupled to the surface 673 to cause the formation of a standing wave that generally separates the mass of the IV fluid 452 into smaller sections or smaller hills and valleys. In this state, the IV fluid 452 has not yet been released from the droplet former. In FIG. 7C, the wave reaches its peak after sufficiently increasing to cause the release of one or more small droplets or drops of the IV fluid 452, the amplitude of which can generally have a diameter smaller than the diameter of the lateral surface 673 at the tip of the droplet former 620. In FIGS. 7A-7C, waves having generally circular or annular patterns are shown, but in various implementations, the waves and / or droplets emitted from the ultrasonic droplet former 620 can generally have any suitable size, shape, or pattern as needed. For example, the use of ultrasonic electronics may also enable fine-tuning of the size, pattern, or velocity of droplet generation by adjusting the waveform provided to the lateral outer surface 673 (e.g., by adjusting the shape, frequency, and / or amplitude of the ultrasonic waves).
[0034] FIG. 8 is a cross-sectional view of an exemplary drip chamber 850. The drip chamber 850 is a particular example of a drip chamber that uses injected air to stimulate the release of droplets from a droplet former. In some embodiments, the drip chamber 850 can share common features with any one or more of the drip chambers shown in FIGS. 1-7.
[0035] The drip chamber 850 includes a gas inlet port 881 coupled to a droplet former 820 via a fluid path to enable an injected gas 883 (e.g., sterile air or another gas) to stimulate the release of small droplets from the droplet former 820, where the injected gas 883 can receive IV fluid from a liquid inlet port 456. A gas injection component 887 can be coupled to the gas inlet port 881 to inject gas into the interior of the drip chamber, which can stimulate the surface of the droplet former to induce the release of droplets of the IV fluid 452. The gas injection component 887 can include, for example, a compressed gas cartridge, or a tubing segment coupled to a pressurized gas tank, pump, or other gas source at a facility (e.g., a hospital).
[0036] The gas inlet port 881 can be operably coupled to the droplet former via a fluid path that enables the injected gas 883 to reach the droplet former. For example, a gas orifice 889 can be provided in a cap immediately above the droplet former to enable the gas 883 injected through the gas inlet port 881 to reach the droplet former 820. Alternatively, other structures may be used to operably couple the gas inlet port 881 to the droplet former to enable the release of droplets therefrom. In some embodiments, the injected gas may be delivered in a series of bursts that are timed in synchronization with a predetermined drop rate that may be fixed or user-programmable. For example, a small disposable compressed gas cartridge may be provided in the drip chamber 850 and configured to meter the gas injected through the gas inlet port in a series of small bursts. This may enable the compressed gas contained within the compressed gas cartridge to also last for the duration of the use of the drip chamber 850 while enabling the desired drop rate.
[0037] Figure 9 is a cross-sectional view of an exemplary drip chamber 950. The drip chamber 950 is a particular example of a drip chamber that uses a piezoelectric sensor to detect the drop rate of droplets falling within the drip chamber, which may enable, for example, counting the droplets at a rate faster than can be reliably seen by the human eye. In some embodiments, the drip chamber 950 can share common features with any one or more of the drip chambers shown in FIGS. 1-8.
[0038] The drip chamber 950 includes a piezoelectric sensor 991 coupled to the container 444 for detecting droplets falling within the container. The piezoelectric sensor 991 can include a passive piezoelectric material 992 that functions as a microphone, for example, to detect the impact of droplets of the IV fluid 452 falling from the droplet former 920 into the container 444. In the example shown in FIG. 9, the piezoelectric sensor 991 includes one or more electrodes 993 coupled to the piezoelectric material 992. The piezoelectric material 992 can be, for example, a passive piezoelectric material. The electrodes 993 can be coupled to a detection circuit 995 configured to determine a flow rate by measuring a signal and / or counting the number of droplets falling into the container 444. The detection circuit 995 can generally include any one or more analog and / or digital circuits, processors, microcomputers, and / or other circuits suitable for processing the signal received from the piezoelectric sensor 992. The detection circuit 995 can be included, for example, within the same physical module or sensor package as the piezoelectric sensor 991, or can be physically separated and communicatively coupled to the piezoelectric sensor 991 via one or more wired and / or wireless interconnects.
[0039] The piezoelectric sensor 991 can be disposed outside of the container 444 and the internal cavity 442 to insulate the piezoelectric sensor 991 from physical contact with the IV fluid 452 being delivered to the patient. The piezoelectric sensor 991 can be attached to the sidewall of the container 444 to facilitate pickup of the signal from the impact of droplets falling within the cavity 442 by the sensor 991. The piezoelectric sensor 991 can also be disposed below the fluid level where the IV fluid was first placed, for example, below the midpoint of the container body. This may also facilitate pickup of the signal of each droplet at the time of impact picked up by the sensor since the IV fluid 452 can function as a transmission medium for the acoustic or mechanical impact of the falling droplets.
[0040] FIG. 10 is a cross-sectional view of an exemplary drip chamber 1050. The drip chamber 1050 is a particular example of a drip chamber that uses a charged electrode to attract polar molecules (e.g., water molecules) of the IV fluid 452 and move droplets of the IV fluid 452 in a smaller volume than might be possible with gravity alone. In some embodiments, the drip chamber 1050 can share common features with any one or more of the drip chambers shown in FIGS. 1-9.
[0041] The drip chamber 1050 includes an electrode 1099 that is positioned sufficiently close to the droplet former 1020 to attract polar molecules of the IV fluid 452 based on the charge applied to and otherwise retained by the electrode 1099. For example, as shown in FIG. 10, the electrode 1099 can be negatively charged, which can attract the positive ends of water molecules within the droplet former to effect the release of droplets. As another example, in some embodiments, the electrode 1099 can be positively charged to attract the negative ends of water molecules or other polar molecules of the IV fluid 452. In the example shown in FIG. 10, the electrode 1099 is disposed within the internal cavity 442 of the container 444 and is suspended from the cap 446 in a region near the tip of the droplet former 1020. However, implementations are contemplated where the electrode 1099 can be positioned at any other suitable location to enable the electrode to attract polar molecules of the IV fluid 452. For example, in some embodiments, the electrode 1099 can be implemented as all or part of the container 444 itself. The droplet former 1020 is shown in FIG. 10 as having a tubular structure, but in various embodiments, any suitable structure for forming and releasing droplets can be used, such as a pin or wire having a solid distal tip as shown in FIG. 4.
[0042] In the example shown in FIG. 10, the electrode 1099 is coupled to the wire 1097 to connect the electrode 1099 to a power source 1098 that applies a charge to the electrode (e.g., by applying a voltage to the electrode 1099). The power source 1098 can be disposed outside the container 444 and the cap 446 as, for example, part of a pump system used to pump fluid through an IV system, or any other suitable electronic system of a facility, etc. Alternatively, the power source 1098 can be, for example, a battery housed within the cap 446. In any case, the wire 1097 coupled to the electrode 1099 can extend at least partially through the cap to provide, for example, a signal path for charging the electrode 1099.
[0043] Various examples of aspects of the present disclosure are described below as convenience clauses. These are provided as examples and do not limit the subject technology. By way of example, some of the clauses described below are shown in FIGS. 1-10.
[0044] Clause 1 A container configured to hold intravenous (IV) fluid, A droplet former suspended over the container, the droplet former having an upper end, a lower tip, and an outer surface extending between the upper end and the lower tip, An inlet port disposed over the droplet former and configured to receive IV fluid from a reservoir A drip chamber comprising: The inlet port is coupled to the outer surface to enable the IV fluid to descend along the outer surface.
[0045] Clause 2 Further comprising a cap disposed over an upper side of the container, The droplet former is suspended from the cap, The droplet former includes a solid pin or wire extending downwardly, An outer side of the solid pin or wire provides the outer surface, The drip chamber of claim 1 or any other claim herein, wherein the outlet port is disposed at the lower end of the container and the outlet port is configured to couple to an IV line for delivering IV fluid to a patient.
[0046] Claim 3 The drip chamber of claim 1 or any other claim herein, wherein the droplet former includes a solid pin.
[0047] Claim 4 The drip chamber of claim 1 or any other claim herein, wherein the droplet former includes a wire.
[0048] Claim 5 The drip chamber of claim 1 or any other claim herein, wherein the droplet former extends downwardly and terminates at a solid point at the lower tip.
[0049] Claim 6 A cap disposed on the upper side of the container, wherein the inlet port is disposed in the cap and the droplet former is suspended from the cap, the cap and, A hole disposed in the container below the inlet port, wherein the outer surface of the droplet former is coupled to the inlet port through the hole for carrying IV fluid through the hole, the hole and The drip chamber of claim 1 or any other claim herein, further comprising.
[0050] Claim 7 The drip chamber of claim 1 or any other claim herein, further comprising a piezoelectric sensor coupled to the container for detecting droplets falling from the droplet former into the container.
[0051] Claim 8 The drip chamber of claim 1 or any other claim herein, further comprising an electrode disposed sufficiently close to the droplet former for attracting polar molecules of the IV fluid based on the charge held by the electrode.
[0052] Claim 9 A container configured to hold an IV fluid, a droplet former suspended above the container and coupled to an inlet port to receive IV fluid from a reservoir, and an acoustic emitter operably coupled to the droplet former to stimulate the release of droplets of the IV fluid from the droplet former comprising a drip chamber.
[0053] Clause 10 further comprising a cap disposed on an upper side of the container, wherein the droplet former is suspended from the cap, wherein the acoustic emitter is an ultrasonic emitter housed within the cap, and an outlet port disposed at a lower end of the container, the outlet port being configured to couple to an IV line to deliver the IV fluid to a patient, a drip chamber of Clause 9 or any other clause of this specification.
[0054] Clause 11 The acoustic emitter is an ultrasonic emitter configured to generate a standing wave of the IV fluid at a surface of the droplet former, a drip chamber of Clause 9 or any other clause of this specification.
[0055] Clause 12 further comprising a cap disposed on an upper side of the container, wherein the droplet former is suspended from the cap, wherein the acoustic emitter is housed within the cap, a drip chamber of Clause 9 or any other clause of this specification.
[0056] Clause 13 A drip chamber of Clause 9 or any other clause of this specification, wherein a lower tip of the droplet former is flared outwardly.
[0057] Clause 14 The droplet former has a solid cylindrical structure, a drip chamber of Clause 9 or any other clause of this specification.
[0058] Clause 15 The droplet former has a lateral outer surface that extends downward and across the downward direction, and the acoustic emitter is an ultrasonic emitter configured to generate droplets having a diameter smaller than the diameter of the lateral outer surface, the drip chamber of clause 9 or any other clause of this specification.
[0059] Clause 16 A container configured to hold IV fluid, A droplet former suspended above the container and coupled to an inlet port to receive IV fluid from a reservoir, A piezoelectric sensor coupled to the container to detect droplets falling from the droplet former into the container The drip chamber comprising.
[0060] Clause 17 Further comprising a cap disposed above the container, The droplet former is suspended from the cap, An outlet port is disposed at the lower end of the container, and the outlet port is configured to be coupled to an IV line to deliver IV fluid to a patient, The piezoelectric sensor is attached to the sidewall of the container below the midpoint of the container, the drip chamber of clause 16 or any other clause of this specification.
[0061] Clause 18 The piezoelectric sensor is disposed outside the container below the fluid level of the container, the drip chamber of clause 16 or any other clause of this specification.
[0062] Clause 19 The drip chamber of clause 16 or any other clause of this specification further comprising a detection circuit coupled to the piezoelectric sensor and configured to determine a flow rate by counting the number of droplets falling into the container.
[0063] Clause 20 The piezoelectric sensor comprises a piezoelectric material and an electrode coupled to the piezoelectric material, the drip chamber of clause 16 or any other clause of this specification.
[0064] Clause 21 The droplet former is a drip chamber of Clause 16 or other clauses of this specification, comprising at least one of a tube, a pin, a wire, a cylinder, and a flare tip.
[0065] Clause 22 A container configured to hold IV fluid, A droplet former suspended over the container and coupled to a liquid inlet port to receive IV fluid from a reservoir, A gas inlet port coupled to the droplet former via a fluid path to enable an injected gas to stimulate the release of droplets of IV fluid from the droplet former and a drip chamber comprising the same.
[0066] Clause 23 Further comprising a cap disposed on the upper side of the container, The droplet former is suspended from the cap, The gas inlet port is disposed on the cap, An outlet port is disposed at the lower end of the container, and the outlet port is configured to be coupled to an IV line to deliver IV fluid to a patient, and a drip chamber of Clause 22 or other clauses of this specification.
[0067] Clause 24 Further comprising a tubing segment coupled to the gas inlet port and configured to convey an injected gas from a source to the gas inlet port, and a drip chamber of Clause 22 or other clauses of this specification.
[0068] Clause 25 Further comprising a compressed gas cartridge coupled to the gas inlet port and configured to inject a gas injected through the gas inlet port, and a drip chamber of Clause 22 or other clauses of this specification.
[0069] Clause 26 The compressed gas cartridge is a drip chamber of clause 25 or other clauses of this specification configured to meter the gas injected through the gas inlet port in a series of bursts synchronized with a predetermined drip rate.
[0070] Clause 27 A container configured to hold IV fluid, A droplet former suspended above the container and coupled to an inlet port to receive IV fluid from a reservoir, An electrode disposed sufficiently close to the droplet former to attract polar molecules of the IV fluid based on the charge held by the electrode A drip chamber comprising the same.
[0071] Clause 28 Further comprising a cap disposed above the container, The droplet former is suspended from the cap, The electrode is suspended from the cap and coupled to a wire that extends at least partially through the cap to connect the electrode to a power source, An outlet port is disposed at the lower end of the container, and the outlet port is configured to couple to an IV line to deliver the IV fluid to a patient. A drip chamber of clause 27 or other clauses of this specification.
[0072] Clause 29 The electrode is disposed in the container. A drip chamber of clause 27 or any other clause of this specification.
[0073] Clause 30 The electrode is at least part of the container. A drip chamber of clause 27 or any other clause of this specification.
[0074] Clause 31 The electrode is negatively charged. A drip chamber of clause 27 or any other clause of this specification.
[0075] Clause 32 The electrode is a drip chamber of clause 27 or any other clause of this specification that is positively charged.
[0076] Clause 33 The electrode is a drip chamber of clause 27 or any other clause of this specification that is coupled to a power source configured to apply a charge to the electrode.
[0077] Clause 34 A cap disposed on the upper side of the container, the power source being outside the cap and the container, further comprising the cap, a drip chamber of clause 33 or any other clause of this specification.
[0078] Clause 35 A cap disposed on the upper side of the container, the power source being a battery housed within the cap, further comprising the cap, a drip chamber of clause 33 or any other clause of this specification.
[0079] Clause 36 A spike configured to couple to an IV bag containing a reservoir of IV fluid, An IV line segment disposed distally of the spike, the IV line segment having a distal end terminating in a luer fitting, A drip chamber coupled between the IV line segment and the spike, the drip chamber being configured according to any of the drip chambers of clauses 1 - 35 An IV administration set comprising.
[0080] Clause 37 An IV bag containing a reservoir of IV fluid, A catheter configured to deliver IV fluid to a patient's vein, A drip chamber coupled between the IV bag and the catheter, the drip chamber being configured according to any of the drip chambers of clauses 1 - 35 An IV therapy system comprising.
[0081] References to elements in the singular are not intended to mean “only one” unless specifically stated otherwise, but rather “one or more.” For example, the “a” module may refer to one or more modules. Elements preceded by “a,” “an,” “the,” or “said” do not exclude the presence of additional same elements without further limitation.
[0082] Titles and subtitles, if any, are used only for convenience and do not limit the present invention. The word “exemplary” is used to mean serving as an example or instance. To the extent terms such as “include,” “have,” etc. are used, such terms are intended to be as inclusive as the term “comprise” as interpreted when “comprise” is used as a transitional term in the claims. Relative terms such as “first” and “second” may be used to distinguish one entity or action from another without necessarily requiring or implying any actual such relationship or order between such entities or actions.
[0083] Phrases such as aspects, the aspect, another aspect, some aspects, one or more aspects, implementations, the implementation, another implementation, some implementations, one or more implementations, embodiments, the embodiment, another embodiment, some embodiments, one or more embodiments, configurations, the configuration, another configuration, some configurations, one or more configurations, the subject technology, the disclosure, the present disclosure, other variations thereof, etc. are for convenience only and do not mean that the disclosure related to such phrases is essential to the subject technology or that such disclosure applies to all configurations of the subject technology. The disclosure related to such phrases may apply to all configurations or one or more configurations. The disclosure related to such phrases may provide one or more examples. Phrases such as an aspect or some aspects may refer to one or more aspects and vice versa, which applies equally to the other aforementioned phrases.
[0084] The phrase "at least one" before a series of items modifies the list as a whole, rather than each member of the list, with the terms "and" or "or" that separate any of the items. The phrase "at least one" does not require the selection of at least one item; rather, this phrase allows for the meaning of including at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. By way of example, each of the phrases "at least one of A, B, and C" or "at least one of A, B, or C" refers to only A, only B, or only C, any combination of A, B, and C, and / or at least one of each of A, B, and C.
[0085] It is understood that the specific order or hierarchy of the disclosed steps, operations, or processes are examples of exemplary approaches. Unless specifically stated otherwise, it is understood that the specific order or hierarchy of steps, operations, or processes may be performed in a different order. Some steps, operations, or processes may be performed simultaneously. Where present, the appended method claims present the various steps, operations, or process elements in a sample order and are not meant to be limited to the specific order or hierarchy presented. These may be performed sequentially, linearly, simultaneously, or in a different order. It should be understood that the instructions, operations, and systems described are generally integrated together in a single software / hardware product or packaged in multiple software / hardware products.
[0086] In one aspect, terms such as "coupled" may refer to being directly coupled. In another aspect, terms such as "coupled" may refer to being indirectly coupled.
[0087] This disclosure is provided so that those skilled in the art can implement the various aspects described herein. In some cases, well-known structures and components are shown in block diagram form to avoid obscuring the concepts of the technology being addressed. This disclosure provides various examples of the technology being addressed, and the technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the principles described herein may be applied to other aspects.
[0088] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure, whether known or later become known to those skilled in the art, are expressly incorporated herein by reference and are intended to be included within the scope of the claims. Moreover, what is disclosed herein is not intended to be dedicated to the public whether or not such disclosure is expressly recited in the claims. The claims are not to be construed under the provisions of 35 U.S.C. § 112, paragraph (f) or paragraph 6 of 35 U.S.C. § 112, unless an element is expressly recited using the phrase "means for" or, in the case of a method claim, the element is recited using the phrase "step for."
[0089] Accordingly, the title of the invention, background art, brief description of the drawings, summary, and drawings are incorporated herein and provided as examples to aid in the description of this disclosure, not as limiting descriptions. They are submitted with the understanding that they are not to be used to limit the scope or meaning of the claims. Additionally, it can be seen herein that this specification provides examples to aid in the description and that various features are grouped together in various implementations for the purpose of streamlining this disclosure. The methods of this disclosure are not to be construed as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the claims reflect, the subject matter of the invention lies in less than all of the features of a single disclosed configuration or operation. Accordingly, the claims are incorporated herein and each claim stands on its own as a separately asserted subject matter.
[0090] The claims are not intended to be limited to the aspects described in this specification, but should be given the full scope that is consistent with the language of the claims and should include all legal equivalents. Nevertheless, none of the claims is intended to cover, and should not be construed to cover, subject matter that fails to meet the requirements of the applicable patent law.
Claims
1. A container configured to hold an intravenous (IV) fluid, a droplet former suspended over the container and coupled to a liquid inlet port to receive the IV fluid from a reservoir, a gas inlet port coupled to the droplet former via a fluid path to enable an injected gas to cause the release of droplets of the IV fluid from the droplet former, and a compressed gas cartridge coupled to the gas inlet port and configured to inject the injected gas through the gas inlet port. A drip chamber comprising the above.
2. The drip chamber further comprising a cap disposed on an upper side of the container, wherein the droplet former is suspended from the cap, the gas inlet port is disposed in the cap, and an outlet port is disposed at a lower end of the container and configured to be coupled to an IV line to deliver the IV fluid to a patient, as claimed in claim 1.
3. The drip chamber as claimed in claim 1, further comprising a tubing segment coupled to the gas inlet port and configured to convey the injected gas from a source to the gas inlet port.
4. The drip chamber as claimed in claim 1, wherein the compressed gas cartridge is configured to meter the injected gas through the gas inlet port in a series of bursts synchronized with a predetermined drip rate.
5. The droplet former comprises a tubular structure having an inner lumen, and the IV fluid from the liquid inlet port passes through the inner lumen to a distal tip of the tubular structure, as claimed in claim 1.
6. The droplet former comprises one of a pin having a solid distal tip and a wire having a solid distal tip, as claimed in claim 1.
7. The drip chamber as claimed in claim 1, further comprising a piezoelectric sensor coupled to the container and configured to detect droplets falling into the container.
8. A spike configured to be coupled to an IV bag containing a reservoir of IV fluid, an IV line segment disposed distally of the spike and having a distal end terminated with a luer fitting, and the drip chamber as claimed in claim 1 An IV administration set comprising the above.
Citation Information
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