KR20190019916A - Devices for Monitoring Infusion Sets - Google Patents

Abstract

A device provided for monitoring the delivery of fluids through a drip chamber. The device includes an electromagnetic radiation (EMR) source and an EMR detector. The device body is used to position the source and detector around the drip chamber so that the source and detector define a light path across the drip chamber. The processor device is used to detect fluid droplets from differences between detector signal values separated by the lag time. The device connects to a monitor that may continuously monitor the detected points.

Description

Devices for Monitoring Infusion Sets

The present application claims the benefit of U.S. Patent Application No. 14 / 188,669, filed February 24, 2014, now U.S. Patent No. 9,199,036, which claims the benefit of U.S. Published Patent Application No. 61 / 769,109, filed February 25, Filed on October 26, 2015 and now U.S. Patent No. 9,533,095, which is a continuation-in-part of U.S. Serial No. 14 / 923,427, filed on November 28, 2016, U.S. Serial No. 15 / 362,646, , The present application also claims benefit of U.S. Provisional Patent Application No. 62 / 323,051, filed April 15, 2016, each of which is incorporated by reference.

This disclosure generally relates to the delivery of intravenous fluids, and more particularly to the monitoring of delivery of intravenous fluids to a subject.

In various settings, it may be useful to ensure accurate delivery of intravenous fluids. One mode of intravenous fluid delivery is a gravity injection set. One problem with using gravity injection sets is the difficulty of (a) establishing an initial flow rate and (b) monitoring the flow rate over time.

Devices for establishing and monitoring the flow rate may be in the form of an all-in-one device having an infrared light source and photodiode, a microprocessor, a battery, and a display. Such a device may also be attached directly to a drip chamber and may provide continuous monitoring of flow rate during gravity injection. The infrared light source and photodiode may be mounted on opposing sides of the drip chamber so as to traverse the path of the spot where the beam falls. The microprocessor may periodically measure the light sensed by the photodiode and may detect that the droplet has fallen by sensing a change in the detected light. By measuring the elapsed time between detected droplets, the microprocessor can measure the droplet velocity and then display it.

Two factors that contribute to the successful monitoring of gravity injection through optical beam droplet detection are (a) the proper alignment of the sensing element on the drip chamber body and (b) the secure attachment of the monitoring device to the drip chamber. If any one of these factors is compromised, incomplete or inaccurate monitoring may occur because the beam may not be properly aligned to sense each falling droplet or the device may be out of alignment. The all-in-one device may be subject to user misalignment on the drip chamber. In addition, design considerations for all-in-one devices may be complicated by aspects used to safely attach the device to a wide variety of user-supplied drop chambers, which can vary considerably in the materials and geometry of the components It is possible.

The present disclosure provides devices, methods, and systems for providing real-time monitoring of fluid flow rate and cumulative total volume through a drip chamber.

Various embodiments of the presently disclosed fluid flow monitoring devices include a source capable of emitting electromagnetic radiation (EMR), a detector capable of generating a detector signal, a source, and at least one of the drip chambers to define a light path across the detector chamber A device body constructed and arranged to position a source and a detector around one outer surface, wherein the fluid between the source and the detector inhibits movement of the EMR along the optical path; A device body configured and arranged to position a source and a detector around at least one outer surface of a docking chamber to define a source and a detector traversing the docking chamber, wherein the fluid between the source and the detector has an EMR The device according to claim 1, And a processor device for executing the instructions to perform the actions. The actions include detecting a fluid droplet based on at least a difference between a plurality of detector signal values temporally separated by a predetermined delay time and determining a flow rate of the fluid based on at least a predetermined pointing factor and detecting a plurality of fluid droplets do.

In some embodiments, detecting the fluid droplet may be further based on a comparison of a plurality of temporally ordered difference values, and the plurality of difference values may be based on differences in a plurality of detector signals that are temporally separated by a delay time . Additionally, the actions may further include rejecting the detection of the second fluid droplet if the time difference between the detection of the second fluid droplet and the detection of the first fluid droplet is below a predetermined lockout time.

In at least one of the various embodiments, detecting the fluid droplet is to generate a droplet waveform based on sampled detector signal values at a plurality of temporally ordered times, wherein the droplet waveform is controlled by a fluid droplet, Generating a droplet waveform; generating a retarded time difference waveform based on a plurality of differences in the droplet waveform corresponding to at least the retard time and the different times; and generating a delay time difference waveform based on at least the signal contained in the delay time difference waveform, And may further include detecting droplets.

In some embodiments, the source may be a light emitting diode (LED). In some embodiments, the detector may be a photodiode. In at least one of the various embodiments, the source may also emit an EMR within the wavelength window, wherein the wavelengths in the wavelength window are longer than the visible light wavelengths and the sensitivity of the detector is greater than the wavelength in the wavelength window Lt; / RTI >

In some embodiments, the actions include detecting a first fluid droplet at a first detection time, adding a first detection time to the droplet history buffer, wherein the droplet history buffer includes at least a plurality of different detection times, Each of the times corresponding to a previously detected fluid droplet, adding the first detection time to the droplet history buffer, removing at least one of the other detection times from the droplet history buffer, Determining the average droplet velocity based on the detection times, and determining the point stability based on a comparison of a plurality of temporal distances between detection times included in the droplet history buffer. In some embodiments, the device may comprise a battery. In some embodiments, the power provided to at least one of the detector and the source is pulsated. The provided power may include a bias current. In at least one of various embodiments, the bias current provided to the detector and sources is pulsated at a predetermined frequency.

Preferred and alternative examples of the present invention are described in detail below with reference to the following drawings.
BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 A shows a flow monitoring device adjacent to a gravity feed infusion set comprising a drip chamber according to embodiments of the present disclosure.
1B shows a flow monitoring device attached to a drip chamber included in a gravity feed infusion set according to embodiments of the present disclosure.
Figure 2 shows a plan view of a flow monitoring device attached to a drip chamber in accordance with embodiments of the present disclosure.
3 shows an exploded view of a flow monitoring device having a dock chamber positioned in the optical path between the source and the detector in accordance with embodiments of the present disclosure;
4 shows a block level diagram of electronic components included in various embodiments of the flow monitoring device described in this disclosure.
Figures 5A and 5B show a time series of waveforms generated based on EMR detection signals as described in this disclosure.
Figure 6 illustrates embodiments of methods of operating a monitoring device.
Figure 7 shows an embodiment of a clip-style monitoring device body in accordance with embodiments of the present disclosure.
8A, 8B, and 8C illustrate various views of a monitoring device in accordance with embodiments of the present disclosure.
Figure 9 is an enlarged perspective view of a preferred monitoring system with a drip chamber having a separate monitoring device and sensor housing.
10 is a front elevational view of a drip chamber having an attached flow sensor housing;
Figure 11 is a perspective view of the sensor housing and the preferred drip chamber attached to the monitoring device.
12 is a schematic diagram of a sensor housing and a preferred drop chamber having a connector and a wired tether configured for attachment to a separate monitoring device.
13 is a schematic diagram of a preferred drip chamber and sensor housing for wireless communication with one or more discrete monitoring devices.
14 is a schematic diagram of an alternative preferred drip chamber and sensor housing having a connector and a wired tether configured for attachment to a separate monitoring device.
15 is a schematic diagram of an alternative preferred drip chamber and sensor housing for wireless communication with one or more discrete monitoring devices.
Figure 16 is a block diagram of components in a preferred drop chamber sensor device body and a separate monitoring unit.
Figure 17 is a schematic view of an alternative preferred drip chamber and sensor housing.

A preferred monitoring system may consist of a disposable gravity point set and mechanical or electrical interface comprising the point sensing elements, and a monitoring unit mechanically or electrically interfaced with the point set. In this system, the monitoring unit may receive sensor values and perform continuous or other monitoring of the injection. The system may at least partially mitigate both sensor alignment and secure attachment issues that may be seen with all-in-one injection monitoring devices.

The terms defined herein have the same meaning as commonly understood by one of ordinary skill in the art in the context of the present disclosure. Terms such as "a", "an", "an", "the", "the", "the", "the", "the", "are" and are not intended to be construed as limiting the invention to the particular embodiments disclosed. Although the terminology herein is used to describe certain embodiments of the disclosure, its use is not intended to be limited to the present disclosure, except as summarized in the claims.

As used herein, the term " electromagnetic radiation " (EMR) is not intended to be limiting. In contrast, as used throughout this disclosure, EMR may refer to electromagnetic waves and / or any form of energy associated with propagation of photons. The term EMR is not limited to wavelengths within the electromagnetic spectrum or a specific range of frequencies. Rather, the EMR may include any other such wavelengths or frequencies of radio wave, microwave, infrared (IR), visible, ultraviolet (UV) radiation, X-ray, gamma ray, or EMR as used herein .

As used herein, the terms " EMR source " and " source " are not intended to be limiting. In contrast, as used throughout this disclosure, both an " EMR source " and a " source " may refer to any device that may emit an EMR. Non-limiting examples of sources include light emitting diodes (LEDs), lasers, bulbs, and the like.

As used herein, the terms " EMR detector " and " detector " are not intended to be limiting. In contrast, as used throughout this disclosure, both an " EMR detector " and a " detector " may refer to any device that may generate a signal in the presence of an EMR. In some embodiments, the nature of the signal may be electrical, optical, mechanical, or a combination thereof. The nature of the generated electrical signal may be analog or digital. Some detectors may be referred to as photodetectors or optical sensors. Non-limiting examples of detectors include photodiodes, reverse biased LEDS, active-pixel sensors (APS), avalanche photodiodes (APDs), charge coupled devices (CCDs), photo resistors, photomultiplier tubes, Photovoltaic cells, and the like.

As used herein, the term " processor device " is not intended to be limiting. Rather, as used throughout this disclosure, a processor device may refer to one or more devices that may execute instructions to perform an action. In some embodiments, the processor device may receive an input and provide a corresponding output in response to the received input. In some embodiments, the processor device may include a programmable microcontroller. In some embodiments, the processor device may comprise a microprocessor. The processor device may include a field programmable gate array (FPGA). In other embodiments, the processor device may comprise an application specific integrated circuit (ASIC). In some embodiments, the processor device may comprise a computer and / or a mobile device. In some embodiments, the processor device may include a processing core, memory, input / output peripherals, logic gates, analog-to-digital converters (ADCs) In some embodiments, the processor devices may comprise a plurality of processor devices communicating with one another over a network or bus.

Briefly, various embodiments of the devices, methods, and systems included herein are directed to monitoring the flow rate and total volume or cumulative fluid dose of a fluid delivered to a target via an infusion set, It is not limited. The target may be a medical patient, or fluids may be delivered intravenously.

A handheld monitoring device may be attached to the drip chamber included in the infusion set. By using a built-in EMR source and a built-in EMR detector, individual droplets falling in the drip chamber may be detected and counted in real time. Also, the time between each successive droplet may be determined. The fluid flow rate may be determined by monitoring the velocity of droplets falling within the drip chamber and applying a suitable drip factor. In addition, the total volume or cumulative dose of fluid delivered to the target may be determined.

The determined flow rate and total cumulative fluid dose may be provided to the user in real time via the user interface. The user interface may include a display unit, input buttons or an alphanumeric keypad, and an audible speaker. In some embodiments, user input and output functions may be enabled through a touch-sensitive display device.

The user may provide a variety of input information through the user interface, such as a pointing factor, target fluid flow rate, target total dose, target flow stability, and the like. The user may also provide corresponding tolerances and / or ranges associated with these target parameters via the user interface.

If the flow becomes unstable, the device may provide various alerts to the user if the monitored flow rate is outside the tolerance range, the total volumetric dose is achieved or exceeded, or the flow is interrupted. These alerts may include audio alerts provided by the speakers. The alerts may include visual alerts provided by the display device. In some embodiments, at least some of the alerts may be provided in real time to remote devices including, but not limited to, servers / clients, mobile devices, desktop computers, and the like.

The portable device may also be attached or attached to the drip chamber with a spring loaded clip. In other embodiments, a trench or channel included in the monitoring device may enable " snapping " the device to the clip chamber. The device may be powered by a battery or may be powered via an external source, such as a wall socket. Some embodiments may include a backup battery. In at least one of various embodiments, the power may be supplied to the monitoring device by using a solar battery.

In some embodiments, the device may be networked to remote devices, such as a remote computer, a smartphone, or a tablet. Through the network means, the device may provide real time information to these remote devices. The remote user can remotely operate the user interface. In some embodiments, the device may be operated and monitored through an application, such as an app, running on a mobile device.

The device may also generate log files that include monitored flows, corresponding stability, and total delivered fluid doses. The log files may also include other operational parameters, such as the input provided by the user. These log files may be included in the patient ' s medical history files. In some embodiments, a remote networking computer may monitor the device and generate log files. The log files may be provided and stored by other systems, such as cloud-based storage systems.

While many of the embodiments contained herein are described in the context of delivering fluids through an infusion set, it should be understood that the invention is not so limited. The present invention can be used in any situation where fluids are transported in the form of discrete droplets, for at least a portion of the total distance over which the fluid is transported. For example, the present invention may be used in any situation where fluid droplets may be detected. Examples include, but are not limited to, fluids that flow through a drip chamber, nozzles, valves, apertures, and the like. This situation includes, but is not limited to, industrial, government / academic / industrial research, and the like.

FIG. 1A illustrates one embodiment of a flow monitoring device 100 adjacent to an infusion set 190. FIG. In some embodiments, the infusion set 190 may be a gravity feed infusion set, although the invention is not so limited. For example, other means for directing droplet flow through the path, such as a pump, may be used in various embodiments. In at least one of various embodiments, the flow monitoring device 100 may be a portable device. The flow monitoring device 100 includes a display unit 102. The display unit 102 may provide real time data to the user based at least on the monitored flow of fluid through the infusion set 190. Although not shown in FIG. 1A, some embodiments may also include an audio interface, such as an audio speaker. The audio interface may also provide the user with audio information, such as an audible alarm, if the monitored flow rate is outside a certain range.

The monitoring device 100 includes a user input interface 106. The user input interface 106 allows the user to input inputs such as target flow rate, tolerance ranges, drop factors, delay times, lockout times, stability ranges, alarm functions, display units, fluid types, And the like. In some embodiments, the input interface 106 may include buttons, alphanumeric keypads, and the like. In some embodiments, the input interface 106 may be integrated with the display unit 102 by using a touch sensitive display unit. Although not shown, in at least some embodiments, the monitoring device 100 may include an audio input device such as a microphone. Some embodiments may include speech recognition software such that a user may provide inputs via an audio input device. The monitoring device 100 includes a coupler 104. Coupler 104 allows attachment or attachment of monitoring device 100 to implant set 190.

The infusion set 190 includes a fluid source 191. The fluid source 191 may be an IV back. The infusion set 190 may include suspension means 193 such as a loop or hook attached to a fluid source 191. The infusion set 190 may be suspended in the gravitational field by using the suspension means 193. Suspension of the infusion set 190 allows gravity to induce fluid flow through the infusion set 190. The monitoring device 100 may be suspended along the infusion set 190 when attached to the infusion set 190. In at least one of various embodiments, the coupler 104 may include a clip.

The injection set 190 may comprise a drip chamber 192. Due to gravity, fluid flows from the fluid source 191 through the drip chamber 192. The infusion set 190 may also allow fluid flowing through the drip chamber 192 to be in the form of discrete fluid droplets as long as the flow rate through the infusion set 190 is below a threshold. If the fluid flow rate exceeds the threshold value, the fluid flowing through the drip chamber may be a continuous stream of fluid.

Some elements of the injection set 190 may be characterized by a dot factor. The pointing factors depend on the physical characteristics of the specific elements of the same injection set 190, such as the tubing components such as the pointing chamber 192 and the fluid outlet 198, and combinations thereof. The pointing factors correspond to the volume of fluid in each individual fluid droplet flowing through the drip chamber of a particular injection set. Dotting factors may be expressed in units of droplets per gtt / ml or milliliters (ml) of fluid. For example, if 1 ml of fluid flows through the infusion set with a dotting factor of 10 gtt / ml, 10 separate fluid droplets must flow through the drip chamber. Exemplary, but non-limiting, dot factor values corresponding to combinations of various elements of injection set 190 may include 10, 15, 20 and 60 gtt / ml. Throughout this disclosure, references to a dot factor of an injection set may refer to a value of a dot factor corresponding to a combination of various injection set elements on which the dot factor depends.

In some embodiments, the pointing factors may be expressed in alternative units such as ml / gtt. In other embodiments, if the density of the fluid is known, the pointing factor may be expressed in terms of unit mass or droplet weight. In addition, the drop factors may be expressed in mass or weight per droplet. It is to be understood that the disclosure is not limited to these example pointing factors and may accommodate any other suitable values, units, or alternate ways of representing or measuring pointing factors.

The flow rate of the droplets through the drip chamber 192 can be converted to a fluid flow rate based on the pointing factor corresponding to the infusion set 190 and vice versa. Additionally, the total number of droplets or the cumulative flow of the fluid may be determined by integrating or determining the sum of the respective fluid flow rates or the sum of the flow rates of the droplets over successive time points.

The infusion set 190 includes a user handle 194 and a roller clamp 196. The combination of the user handle 194 and the roller clamp 196 allows the user to adjust the flow rate of the individual fluid droplets through the drip chamber 192 by varying the position of the roller clamp 196 along the edge of the user handle 194. [ Thus allowing control of the flow rate of the fluid through the infusion set 190. [ The infusion set 190 includes a fluid output 198. Fluid output 198 transfers fluids originating from fluid source 191 to the intended target and to a flow rate corresponding to the position of roller clamp 196.

1B shows a flow monitoring device 100 attached to an infusion set 190 by using a coupler 104. FIG. In some embodiments, the monitoring device 100 may be attached to the implant set 190 by attaching or attaching the monitoring device 100 to a drip chamber that is obscured by the monitoring device 100 and is not visible.

In some embodiments, including at least the embodiments discussed in Figures 8A, 8B and 8C, at least a portion of the drip chamber may be visible to the user when the monitoring device is attached to the infusion set. Providing user visibility to at least a portion of the drip chamber during operation of the monitoring device allows the user to visually inspect fluid droplets in the channel. In at least one of various embodiments, the monitoring device is attached to the chamber by using a trench or channel that provides user visibility to at least a portion of the drip chamber. In some embodiments, when the implant set 190 is suspended or otherwise repositioned, the monitoring device 100 remains attached to the drip chamber.

Figure 2 shows a top view of one embodiment of a flow monitoring device 200 attached to the drip chamber 292. [ The monitoring device 200 includes a device body 250. The monitoring device (200) includes a cavity (258). In some embodiments, the cavity 258 may be a cavity, a hole, a trench, a recess, or an aperture in the device body 250. In some embodiments, the cavity 258 may include at least one inner surface.

When the monitoring device 200 is attached to the drip chamber 292, the drip chamber 292 may be positioned within the cavity 258. In at least one embodiment, the cavity 258 may be configured and arranged to receive at least a portion of the drip chamber 292. At least one interior surface of the cavity 258 may provide gripping or otherwise frictional forces to grip the exterior surface of the drip chamber 292. This gripping force may also stabilize the monitoring device 200 around the drip chamber 292.

In some embodiments, the fit between the outer surface of the drip chamber 292 and the inner surface of the cavity 258 may or may not be clear. 2, in some embodiments, when the monitoring device 200 is attached to the drip chamber 292, at least some of the inner surface of the cavity 258 and the outer surface of the drip chamber 292 There may be gaps between them. In some embodiments, the monitoring device 200 may provide at least one of a compressible gripping material, a camming device, or a textured portion to the interior surface of the cavity 258, Lt; RTI ID = 0.0 > and / or < / RTI >

The monitoring device 200 includes a source 210 and a detector 212. Source 210 may also emit an EMR. In some embodiments, the operation of the source 210 may enable at least the timing and / or intensity of the emission of the EMR from the source 210 to be controlled. Detector 212 detects the EMR emitted by source 210 and generates a corresponding signal. In some embodiments, the source 210 may be an LED. In some embodiments, the source 210 may emit an EMR within a certain range of wavelengths or frequencies. In some embodiments, the source 210 may be an infrared emitting diode (IRED).

In various embodiments, the detector 212 may be a photodiode. The detector 212 may detect a specific range of frequencies or frequencies of the EMR emitted by the source 210. In some embodiments, the detector 212 may be more sensitive to a particular range of wavelengths emitted by the source 210 than to other wavelengths. For example, if the source 210 emits an IR EMR, the detector 212 may produce a more sensitive signal in the presence of IR EMR than in the presence of other wavelengths of EMR, such as visible light.

In some embodiments, the source 210 and the detector 212 may be opposite, along the interior surface of the cavity 258. The source 210 and the detector 212 form optical paths that cross the cavity 258. In contrast, The EMR emitted by the source 210 and traveling along the optical path may be detected by the detector 212. This optical path is shown as a dotted line across the cavity 258.

In some embodiments, the drip chamber 292 may be at least partially transparent, semi-transmissive, or translucent to the wavelengths of the EMR emitted by the source 210. When the monitoring device 200 is attached to the drip chamber 292, a light path traversing the drip chamber 292 is formed. If there is no fluid in the light path, at least a portion of the EMR emitted by the source 210 is detected by the detector 212. A portion of the EMR emitted by source 210 and detected by detector 212 may generate a baseline detector signal, as described below in connection with Figures 5A and 5B.

At least a portion of the device body 250 may be configured as a clip, such as a tension- or spring loaded clip. The spring loaded clip may be opened by overcoming the tension with an external force such as a user opening the clip. In the absence of such an external force, the clip may be in the closed state. The tension or spring force of the clip may provide a stabilizing force to attach the monitoring device 200 to the drip chamber 292 when the drip chamber 292 is positioned within the cavity 258. [

One or more clip handles 252 may be included in the device body 250 to provide leverage to the user to assist in opening the clip. In some embodiments, the spring 256 may provide at least a portion of the force that closes the clip and attaches the device 200 to the drip chamber 292. During opening and closing of the clip, at least a portion of the clip may pivot about the hinge 254.

Figure 3 provides an exploded view of the flow monitoring device 300 in which a drop chamber 392 is located within the optical path 320 between the source 310 and the corresponding detector (not shown in the figure). The dotted line represents the optical path 320.

The drip chamber 392 is constructed and arranged such that the fluid entering the drip chamber 392 drops as individual droplets and forms a fluid pool at the bottom of the drip chamber 392. [ The fluid in the pool then flows out of the drip chamber 392 and into the fluid outlet 398. Fluid flowing through fluid outlet 398 is eventually delivered to the target.

During steady-state operation of the infusion set, the volume of the fluid pool at the bottom of the drip chamber 392 remains approximately constant. In this steady state operation, the velocity of the fluid delivered to the target through the fluid outlet 398 (in units of milliliters per unit of time) falls within the drip chamber 392 per unit time for the appropriate drop factor in units of gtt / Can be determined based on the ratio of the number of fluid droplets. Similarly, the cumulative volume of fluid delivered to the target can be determined based on the ratio of the total number of fluid droplets that have remained in the drip chamber 392 to the pointing factor.

The three separate fluid droplets are shown at various points falling from the top of the drip chamber 392 towards the fluid pool at the bottom of the drip chamber 392. The amount of time it takes for an individual droplet to initially reach dropping from the top of the drop chamber 392 to reach the pool at the bottom of the drop chamber 392 may be referred to as droplet dropping time.

The monitoring device 300 is constructed and arranged such that when attached to the drip chamber 392 each fluid droplet passing through the drip chamber 392 passes through the optical path 320 during a portion of the dripping time of the droplet. Fluid droplet 393 is shown in optical path 320. The period during which the droplet is in the optical path 320 may be referred to as the line of sight of the droplet. The length of the line-of-sight period of the droplet may be referred to as the line-of-sight time of the droplet.

In some embodiments, the fluid droplets 393 passing through the drip chamber are not completely transparent to at least some of the EMR wavelengths emitted by the source 310. At least the combination of the walls of the drip chamber 392 and the fluid droplet 393 is less permeable to the EMR emitted than the walls of the drip chamber 392 without the fluid droplet 393 in the optical path 320. Thus, during the top line period of the droplet, the fluid droplet 393 will at least partially inhibit the EMR emitted from the source 310 from moving across the optical path 320. For example, fluid droplet 393 may partially obstruct or refract the EMR within optical path 320 during its corresponding line of sight line.

Since the EMR emitted from the source 310 will be at least partially suppressed during the line of sight of the fluid droplet 393, the response of the detector will change so that a signal different from the signal generated when the fluid is not in the optical path 320 . If the fluid is not in optical path 320, the signal generated by the detector may be referred to as the baseline signal of the detector.

The monitoring device 300 is configured to detect each individual fluid droplet in real time as it passes through the dock chamber 392, as provided in more detail below with respect to Figures 5A and 5B, May be used. Based on at least the detection of each individual fluid droplet, the monitoring device 300 may determine the total number of fluid droplets that have passed through the drop chamber 392. [ By applying a suitable pointing factor to convert the number of droplets to the volume of the fluid, the monitoring device 300 may determine the total volume of fluid delivered to the target through the fluid outlet 398.

In various embodiments, the monitoring device 300 may determine the amount of time between each successive detected fluid droplet in the drop chamber 392. By detecting a plurality of discrete droplets over time, the monitoring device 300 may determine a fluid drop rate, such as the number of droplets per unit time. By applying a suitable pointing factor, the monitoring device 300 may determine the volumetric fluid flow rate delivered to the target via the fluid outlet 398. As provided in more detail in connection with FIG. 6, the monitoring device 300 may determine the rolling average and associated stability of the volume of fluid and the number of droplets per unit time per unit of time.

In at least one of various embodiments, the monitoring device 300 may determine whether the determined droplet or volume flow rate is outside of a specific range, such as nominal or ± 10% of the target value. These instabilities may occur if the patient changes position, the position of the IV bag changes, the tubing pressure changes, the position of the roller clamp changes accidentally, the infusion set becomes clogged, or the IV bag becomes depleted.

The monitoring device 300 may provide these decisions and additional information to the user by using the display unit 302. In some embodiments, the monitoring device 300 may provide alerts to the user. These alerts may be triggered when determinations such as instabilities in the droplet or fluid flow rate do not match the target value within a certain range. Alarms may be provided if the cumulative total target volume of fluid has been delivered or the total target volume has been exceeded. The alerts may be provided through the display device 302 and / or through an audio interface such as a speaker. In at least some embodiments, alerts provided to the user may include visual alerts, such as LEDs emitting at least EMRs of optical frequencies, or alerts provided by these other light sources, including bulbs or light lasers. Alarms may be provided by rapid pulsating audio or visual signals such as strobe lights or sirens. Users may provide the monitoring device 300 with target values for such metrics to be monitored, via user input interfaces, such as the user input interface 106 of FIGS. 1A and 1B.

Some embodiments may be networked to remote devices and may supply such information and alerts to users of remote devices. Some embodiments of the monitoring device 300 may include non-volatile memory devices that may generate log files that include one or more metrics that are determined and monitored by the monitoring device 300. The log files may include values of user inputs such as target volume or target flow rates. The log files include other data such as the amount of time the fluid has flowed through the drip chamber, the time stamp for each individually detected droplet, droplet waveforms, and other diagnostics, acquired data, and operating conditions It is possible.

By using a networked monitoring device, data can be provided to remote devices. This provided data may be used by remote devices to generate a log file. These log files may be kept for future access and may be part of the patient's medical history. These log files may be used as input data for clinical tests or other research or industrial purposes. For example, log files may be used in the production of energy sources such as biofuels or in related research.

Figure 4 shows a block level diagram of components included in various embodiments of flow monitoring devices described throughout this disclosure. One such monitoring device may be the monitoring device 100 of FIG. In some embodiments, the monitoring device may comprise a processor device. In at least one of various embodiments, the processor device may include a programmable microcontroller such as microcontroller 416. [

The monitoring device includes a source. In some embodiments, the source may include an LED 410. LED 410 may be an infrared (IR) LED, such as an IRED. At least one terminal of the LED 410 may be grounded. The monitoring device may include a detector. In some embodiments, the detector may comprise a photodiode 412. The photodiode 412 may have greater sensitivity to IR wavelengths than wavelengths in the visible light spectrum. In some embodiments, a sense resistor 414 may be used with the photodiode 412. The sense resistor may be between the photodiode 412 and ground.

In some embodiments, microcontroller 416 may control the operation of at least one of LED 410 and photodiode 412. These controls may include controlling the pulsation of the biasing currents used in operation of the LED 410 and the photodiode 412. The microcontroller 416 monitors one or more signals from the photodiode 412 in response to the detection of the EMR emitted from the LED 410 and at least including the EMR detection signal generated by the photodiode 412. [ You may.

The EMR detection signal may be a digital signal. However, in at least some embodiments, the EMR signal may be an analog signal. If the EMR detection signal is an analog signal, the EMR detection signal may be digitized before being provided to the microcontroller 416. [ In other embodiments, the EMR detection signal may be provided to the microcontroller 416 as an analog signal. In some embodiments, a consumer-amplification of the EMR detection signal may not be required before being provided to microcontroller 416. [ In these embodiments, the ability to provide an EMR detection analog signal to the microcontroller 416 without pre-amplification reduces the total number of components required for the manufacture of the monitoring device. This reduction in component count may reduce the cost and / or complexity of the monitoring device.

At least one of the LED 410 and the photodiode 412 may be operated at 100% duty cycle during operation of the monitoring device. In some embodiments, the monitoring device may operate in a " continuous mode & . In these " continuous mode " embodiments, fluid droplet detection measurements may be made continuously.

In order to reduce the operating power requirement, at least one of the LED 410 and the photodiode 412 may be operated with a duty cycle of less than 100%. In these " sample mode " embodiments, the fluid droplet detection measurements may be made periodically rather than continuously or in a sample. Thus, the sample measurements may be of a predetermined frequency.

The amount of time that an individual fluid droplet, such as fluid droplet 393 of FIG. 3, is within the optical path of the monitoring device, e.g., light path 320, may be referred to as the line of sight of the droplet. In some embodiments, the time between successive samples or the sample period may be less than the line of sight of the droplet. In at least one of various embodiments, the sample period may be significantly less than the line of sight of the droplet. Using a sample period that is significantly less than the line of sight of the droplet, as shown in connection with Figures 5A and 5B, may allow for the generation of a waveform or time profile of the droplet.

In some embodiments, LED 410 and photodiode 412 are operated for only a portion of the sample period for each sample measurement. For example, for a sample frequency of 1 kHz, a sample measurement is obtained every 1 millisecond (ms). In some embodiments, 1 ms is significantly less than the line-of-sight time of any individual droplet. To sample the transparency of optical path 320 during a single sample measurement, a bias current is applied to LED 410 and photodiode 412 for a length of time referred to as operating time. The operating time may be less than the sample period. For example, for a 1 ms sample period, the bias current may be supplied to LED 410 and photodiode 412 for only about 10 microseconds. An operating time of 10 microseconds results in an operating duty cycle of 1% or (10 microseconds) / (1 ms).

The " sample mode " embodiments may allow the monitoring devices to have significantly lower power consumption requirements, since the biasing currents are only supplied to the source and detector during a small portion of time. The operating times include the source and detector rise and fall times, the operating speed of the process device, the optical transmittance of the fluid and / or dummy chamber walls, the length of the drip chamber, the response times of various components and / May be based on one or more of the same features.

It is understood that the values of sample frequency, sample period, operating time, as well as all other numerical values used herein are for exemplary purposes only, and that the disclosure is not limited by the values provided herein. Rather, these values are chosen for their exemplary purposes. In some embodiments, sample periods, etc. may be varied to account for detector response times, length of drop chambers, fluid characteristics, characteristics of sources / detectors such as rise / fall times, and the like.

In some embodiments, the microcontroller 416 may control the pulsation of the biasing currents for the LED 410 and the photodiode 412. Some embodiments may operate in both a " continuous " mode and a " sample " mode. In such embodiments, the user may select which mode to operate and may also provide programmable operating parameters such as sampling frequency, duty cycle, and the like.

Various embodiments may include a power supply. The power supply may power various components such as microcontroller 416 and other components. In some embodiments, the power supply may be an internal power supply, such as battery 418. The battery 418 may be replaceable. Moreover, the battery 418 may be rechargeable. Some embodiments may include more than one battery to provide redundancy. Some embodiments may describe an external power supply, such as wall-mounted sockets. Some embodiments may utilize both external and internal power supplies depending on the needs and operational circumstances of the user. For example, some monitoring devices may be powered by a wall socket, and may also include a backup battery in the event of a power loss to a wall socket. In at least one of the various embodiments, the power source may comprise a photovoltaic cell, such as a solar cell.

The monitoring devices may include a display unit 402. The display unit 402 may be used to provide information to the user. This information may include determined fluid flow rates, fluid drop rates, percentage or absolute amount of battery power remaining, the pointing factor currently used by the monitoring device, total cumulative droplets, total cumulative fluid flow, It is not limited. The microcontroller 416 may control at least a portion of the display unit 402.

The monitoring devices may include a user input interface. The user input interface may include button inputs 406. The button inputs 406 may be used by a user to provide various user inputs to the device, such as a drop factor, a target fluid drop rate, a target fluid flow rate, a target total cumulative fluid flow, and the like. In some embodiments, a user may toggle between " continuous mode " and " sample mode " of operation by using button inputs 406. [ In some embodiments, the user may provide the target duty cycle or other such input information to the monitoring device by using the button inputs 406. [

The monitoring device may include an audio interface, such as an alarm transducer 408. [ The alert transducer 408 may be a speaker used to provide audio alerts and other audio information to the user. Microcontroller 416 may communicate with display unit 402, button inputs 406, and alert transducer 408 and may provide inputs and outputs to these and other devices.

Although not shown, it is understood that various other components, such as charge pumps, may be used in the embodiments. The digital memory device may be included in various embodiments. The memory devices may be volatile or non-volatile memory devices. The memory device may include, but is not limited to, RAM, ROM, EEPROM, FLASH, SRAM, DRAM, optical disk, magnetic hard drive, solid state drives, or any other such non-temporary storage medium. Memory devices may be used to store various information, including, but not limited to, programmable user inputs, monitored metrics, log files, or operational parameters.

Although not shown, it is understood that the various embodiments of the monitoring device may include a network transceiver device. These network transceivers may communicate with other devices via a wired network or wireless network. These transceivers may be enabled with Wi-Fi, Bluetooth, cellular, or other data transmission and networking capabilities. In such an embodiment, the monitoring devices may communicate with other devices. These other devices may include remote computer devices such as servers, clients, desktops, and mobile devices.

Users may supply inputs to the monitoring device by remote use of these networked computer devices. Moreover, users may monitor the information provided by the monitoring devices in real time, through the use of remote computing devices. Healthcare providers can remotely monitor patients from a distance. For example, doctors or nurses may remotely monitor IV dots for patients located in different areas of the hospital in one area of the hospital. Mobile devices, such as tablets or smartphones, may be used for such remote, real-time monitoring.

Networking capabilities may also allow data logs for patients to be generated and stored. These data logs or log files may be part of the patient's medical history. Moreover, these log files may be used as evidence of the care standard provided to the patient.

Figures 5A and 5B show time series plots of waveforms generated based on EMR detection signals. In some embodiments, the waveform may comprise a plurality of points ordered in time, each corresponding to a detector signal. Each point in the waveform may include time coordinates and detector signal coordinates. Since points are ordered in time, the characteristics of points such as previous, current, and subsequent points are well defined. Also, the distance between points, e.g. the time distance between points, is well defined.

5A and 5B, the unprocessed EMR detection signals may be analog signals from a detector such as the photodiode 412 of FIG. The analog signals may be digitized prior to generation of the waveforms. In some embodiments, digitization may occur within a processor device, such as the microcontroller 416 of FIG. The digitization process may use an analog-to-digital converter (ADC) in the microcontroller 416. FIG. 5A shows preprocessed droplet waveform 522. FIG. The x-axis represents the time of the sampled detector read in milliseconds. The y-axis represents the ADC value based on the signal generated by the detector at each sampled time.

In Fig. 5A, the start of a fluid droplet, such as the fluid droplet 393 of Fig. 3, entering the light path, such as light path 320 of Fig. 3, is displayed at about 20 ms. Also, the time the fluid droplet exits the optical path is shown at about 36 ms. Thus, the droplet line of sight time is about 16 ms.

Notice the change in the value of waveform 522 during the line of sight line. The two peak structures may be characteristic of some fluid droplets. Note the two peak structures in waveform 522, where the first peak is displayed at about 27 ms and the second peak is displayed at about 29 ms. This change in the digitized signal value is due to fluid droplets that inhibit the EMR emitted by the source, such as LED 410, from flowing across the light path.

Also note the baseline signal with an ADC count of about 183, corresponding to the unrestrained flow of the EMR across the optical path. Noise variations also appear in the droplet waveform 522. In some embodiments, these noise variations may be filtered using hardware and / or software based filters.

In some embodiments, droplets may be detected by using a processor device, such as microcontroller 416 of FIG. 4, to analyze droplet waveforms, such as exemplary droplet waveform 522, in real time. Some embodiments may use a method of analyzing droplet waveforms, including a comparison of the waveform of each sample to an absolute threshold, such as an average or filtered value of a baseline signal or a scaling threshold, as shown in waveform 522. [

Other embodiments may compare at least a portion of the points of waveform 522 to other points of waveform 522. In these embodiments, the detector signal at various sample times may be used to generate the difference waveforms. These differential waveforms may result in differential signals characterized by the detection of fluid droplets. For example, the detector signal (or ADC count) in each sample may be compared to the detector signal (or ADC count) from the previous sample. The amount of time between the time corresponding to the current sample and the time corresponding to the previous sample may be referred to as a delay time.

By first generating a pre-processed waveform, such as waveform 522, a delay time difference waveform can be determined. After the generation of the pre-processed waveform 522, a difference between each point included in at least a portion of the points of the pre-processed waveform 522 and the previous point of the pre-processed waveform 522 is determined Where the two points used to generate the difference are separated by the same time distance as the lag time.

5B shows the delay time difference waveform 524, which is a simple difference waveform. The simple difference waveform 524 was generated using a delay time equivalent to the sample period. In other words, each example of the detector signal is compared to the previous sample. For the simple difference waveform 524, the sample period is the same as the lag time (1 ms) and the droplet line of sight time is about 16 ms. Detecting fluid droplets from the simple difference waveform may prove difficult, as long as the absolute values of the time derivative of the pre-processed waveform 522 are not large enough so that the liquid drop signal resulting from the simple difference waveform is a simple difference waveform (524). ≪ / RTI >

Other choices of delay time may be more beneficial. To create a better signal-to-noise ratio, larger delay times may be used. These larger delay times can produce differential signals that further characterize fluid droplets, so that false positive and false negative fluid droplet detections are suppressed. Some embodiments may utilize a delay time that is approximately equal to one-half of the visible line time of the droplet. These values may result in a larger time difference signal. These values may enhance the likelihood of successful detection of fluid droplets. This is because the peak structure of the unprocessed waveform is compared to the baseline signal of the waveform, resulting in a larger temporal difference signal representing the fluid droplet.

For example, delay time difference waveform 526 was generated from waveform 522 by using a delay time of 8 ms. Note the amplitude of the signals in the delay time difference waveform 526 with the simple difference waveform 524. The larger signal amplitude of the time difference waveform 526 may result in better droplet detection. Also notice both positive and negative structures of waveform 526. The negative and positive peaks of retarded time difference waveform 526 result from a comparison of the peak structure of pre-processed waveform 522, which is compared to the baseline detector signal before and after each line of sight of the droplet. This contiguous negative and positive peak structure associated with a suitable choice of lag time may be a characteristic signal of fluid droplet detection. Thus, this proper selection of lag time may result in better signal-to-noise ratio and / or increased droplet detection accuracy, including suppressing both false positive and false false detections.

Waveform 526 may not be sensitive to long-term changes in signal value, but usually maintains a high signal-to-noise ratio of waveform 522. Waveform 522 may show a large signal difference between the signal baseline and the speech peak. However, the specific ADC count values of the baseline and peak will vary based on various factors including, but not limited to, source brightness, shape, and concentration in the drip chamber, ambient light, drip position, and drip chamber . Any single threshold for detecting the dot will not be robust to changes in these environmental factors.

Since the waveforms 524 and 526 are not sensitive to long term variations in the signal value, the factors do not affect the signal. However, the signal-to-noise ratio of waveform 524 is low, which may result in false positive and negative problems. Waveform 526 is not sensitive to long-term changes in signal value, but usually maintains a high signal-to-noise ratio of waveform 522.

In some embodiments, the delay time is selected to be longer than the fall and / or rise time of the detector. In at least one of the various embodiments, the delay time used is longer than several sample periods, but is shorter than the droplet line of sight. For example, as shown in waveform 526, the delay time of 8 ms is shorter than the 16 ms visible line time (and approximately half of the visible line time of the droplet) but longer than the 1 ms sample period. Delay times longer than the droplet line of sight may fail to detect fluid droplets. In some embodiments, the delay time may vary depending on the particular use of the monitoring device. In some embodiments, a user may provide a delay time to use during a particular operation.

In some embodiments, delayed time difference waveforms, such as delayed time difference waveform 526, generated based on a suitable delayed time value may be used to detect each individual droplet. By using at least a processor device, such as the microcontroller 416 of FIG. 4, droplet detection may be performed in real time when the droplet falls off the drip chamber. Lag time differential waveforms may be analyzed to detect fluid droplets. In various embodiments, droplet detection may be based on the shape of a plurality of retarded time difference waveforms by using an appropriate retarded time value.

Some embodiments may use a lockout method to reject false positive droplet detections. The detector signal can represent the droplet profile in real time at more than one instant. For example, if the time difference between the detection of the first droplet and the second droplet is below the lockout threshold, at least one of the detections is determined as spurious detection. A false detection case may trigger a rejection of at least one of the two droplet detections.

In some embodiments, waveforms corresponding to rejected or lockout detections may be included in the log file for future analysis. In some embodiments, the detection of a plurality of lockout events within a minimal amount of time may signal that the dropping rate is unstable, or that dropping or flowing into the drop chamber is too rapid to allow individual drop detection. Some embodiments may provide an audio or visual alert to a user in the event of one or more lockout events.

The lockout threshold or period may be chosen to be longer than the droplet line of sight, but shorter than the average drop rate. In some cases, the user may supply a lockout threshold. In some embodiments, the lockout threshold may be changed to account for the current average dropping rate.

6 shows embodiments of a method 630 of operating a monitoring device. Methods such as method 630 may be performed by a process device such as microcontroller 416 of FIG. The process device may execute instructions to perform actions. At block 631, a droplet is detected at time t in a drip chamber, such as the drip chamber 392 of Fig. The droplet may be detected using a variety of methods, including, but not limited to, the various embodiments discussed with reference to Figures 5A and 5B. If the droplet is rejected as a lockout event, the method 630 may proceed to block 632.

At block 632, the detected droplet is added to the droplet history buffer. In some embodiments, the buffer may be stored in at least a memory device included in the monitoring device. The memory device may be a volatile or non-volatile memory device. Adding a detected droplet to the droplet history buffer may include adding a detection time to the buffer. In some embodiments, the droplet line of sight time corresponding to the added droplet may be added to the buffer. In at least one of various embodiments, at least a portion of the detector signal associated with the added droplet may be added to the buffer. At least one waveform, such as any of 522, 524 or 526 in Figures 5A and 5B, may be added to the buffer. A total droplet count associated with the detected droplet may be added to the buffer. In some embodiments, the buffer includes a plurality of previously detected droplets.

If the monitoring device is operated in the manual transition mode, the method 630 branches to the manual transition method 633 and proceeds to block 635. If the monitoring device is operated in the automatic transition mode, the method 630 branches to the automatic transition method 641 and proceeds to block 642. In at least one of various embodiments, a user may select a manual transition mode or an automatic transition mode by using a user input interface, such as the user input interface 106 of FIGS. 1A and 1B.

At blocks 635 and 642, the droplet history buffer is trimmed to a specific time period. The particular time period may depend on the available size of the buffer, such as the amount of memory allocated to the buffer. The buffer size may be resized to accommodate a specific time period. If the addition of the detected droplet to the buffer leads to a buffer overflow at block 631, then at least one droplet may be removed from the buffer. The buffer may be a first-in, first-out (FIFO) buffer so that the removed droplet is the least recent droplet of the droplet history buffer. The buffer may be trimmed or enlarged so that a certain maximum or minimum number of droplets are included in the history buffer.

At block 636 and block 643, a check is performed to ensure that minimum intervals are available for further decisions. For example, if a rolling drop rate average is determined, a check may be performed to ensure that a minimum number of droplets are included in the buffer. In some embodiments, a check may be performed to ensure that there is a minimum time between the most recent and least recent droplets in the buffer. In some embodiments, a check may be performed to ensure that there is a minimum time between consecutive droplets in the buffer. These and other checks may be performed to ensure statistical significance or stability of further decisions.

In some embodiments, a rolling average may be determined. In at least one of the various embodiments, the rolling average may be based on a ratio of the total number of detected droplets of the buffer to the total amount of time between detections. For example, the total amount of time between detections may be based on the difference between the time of detection of the most recent droplet in the buffer and the time of detection of the least recent droplet in the buffer. In some embodiments, the rolling average may be determined in various units. For example, the rolling average may be determined by the droplet per unit time, or the time between droplets. In at least one of the various embodiments, the rolling average may be determined by the fluid volume per unit time or time per unit volume. It should be appreciated that other methods for determining the rolling average may be used.

If the user has indicated a measurement of the drop rate, the method 633 proceeds to block 638. [ For example, the user may indicate to measure the loading rate by activating the measurement mode via a user interface, such as the user interface 106 of FIGS. 1A and 1B. At block 638, the determined rolling average may be displayed. The display of the rolling average may be made possible by using a display unit such as the display unit 102 of Figs. 1A and 1B.

If the user has not indicated to measure the drop rate, the method 633 proceeds to block 640. [ At block 640, the most recent time interval may be displayed. The most recent time interval may be based on at least detection times of the two most recent droplets of the droplet history buffer.

At decision block 644, a determination is made based at least on dot stability. The dot stability may be determined based on a comparison of a plurality of distances between detection times of consecutive droplets contained in the droplet history buffer. If the dotted stability is less than the predetermined threshold, the method 641 proceeds to block 648. [ An exemplary but non-limiting or non-limiting value of the stability threshold has a change of 12.5%. At block 648, as in block 640, the most recent time interval may be displayed. Otherwise, the method 641 proceeds to decision block 645. [

At block 645, a determination is made based on whether the droplet history buffer spans a predetermined length of time. If the buffer does not span a predetermined length of time, the method 641 proceeds to block 648. Otherwise, the method 641 proceeds to decision block 646. [

At block 646, a determination is made based on whether the buffer has a predetermined minimum threshold of intervals. If the buffer does not have a predetermined threshold of interval, the method 641 proceeds to block 648. [ Otherwise, the method 641 proceeds to block 647. At block 647, the determined rolling average is displayed.

Figure 7 illustrates one embodiment of a device body 750 included in some embodiments of a monitoring device. The device body 750 may be opened and closed. As shown in Fig. 7, the device body 750 is in the open state. At least a portion of the device body 750 is enabled as a clip that may be opened by application of a force. The clip handles 752 may be actuated by an actuating force to open the device body 750. The clip handles 752 may provide leverage to provide the operating force required by the user to open the device body 750. During opening or closing operations, portions of the device body 750 may pivot about the hinge 754.

If no actuating force is applied to the clip handles 752, the device body 750 may be in its closed state. Spring 756 may also provide force to close the device. The device body 750 may include a first wing 760 and a second wing 762. The first wing 760 and the second wing 762 may be attached around the hinge 754. The first wing 760 may include a first trench 764. The second wing 762 may include a second trench 766.

When the device body 750 is in the closed state, the first trench 764 and the second trench 766 may be aligned to form a cavity such as the cavity 257 of FIG. When the device body 750 is attached to a drip chamber such as the drip chamber 292 of Fig. 2, at least a portion of the drip chamber is defined by a cavity formed by the alignment of the first trench 764 and the second trench 766 May be accepted. At least one of the first trench 764 and the second trench 766 may comprise a textured material to enable gripping of the drop chamber.

8A, 8B, and 8C illustrate various views of an embodiment of a flow monitoring device 800. FIG. The monitoring device 800 may include a display unit 802, a user input interface 806, and a user audio interface 808.

The monitoring device 800 may include an outer case with a channel. Some embodiments may include trenches 864. When the monitoring device 800 is attached to a drip chamber such as the drip chamber 192 of Fig. 1, at least a portion of the drip chamber may fit snugly into the trench 864. At least one inner surface of the trench 864 may include a tectzchured material 868 to assist in gripping the drip chamber. In some embodiments, at least one inner surface of the trench 864 may include a camming device 870 to assist gripping of the drip chamber. In some embodiments, the textured material 868 and the camming device 870 may be opposed. In at least one embodiment, the textured material 868 may be a compressible material that expands and contracts to accommodate drip chambers of various dimensions. In some embodiments, the camming device 870 may accommodate drip chambers of various dimensions. The camming device 870 may include ridges or teeth that enhance drop chamber gripping and friction.

The monitoring device 800 may include a source 810. The source 810 may be positioned along at least the inner surface of the trench 864. Although not shown, the monitoring device 800 may include a detector. The source 810 and the detector may be along the inner surface of the trench 864 to form a light path across the drip chamber when the monitoring device 800 is attached to the drip chamber.

In at least one of various embodiments, the channel or trench 864 may receive a portion of the drip chamber when the monitoring device 800 is attached to the drip chamber. In some embodiments, at least a portion of the drip chamber may be visible to the user during operation of the monitoring device 800, since at least a portion of the channel or trench 864 is open. The user may visually or manually inspect the drop of individual fluid droplets during the monitoring of the fluid flow rate. Because at least a portion of the drip chamber may be visible to the user, some embodiments may provide the user with visual feedback of detected fluid droplets. In response to the visual feedback and in response to the determined fluid flow rate provided by the monitoring device, the user is prompted for a flow rate, such as the manual operation of a roller clamp or other adjustment means, such as the roller clamp 196 of FIGS. 1A and 1B, May be precisely adjusted or changed.

8A shows a monitoring device 800 with a front side view from a square. 8B shows a monitoring device 800 as a front view. 8C shows the monitoring device 800 in plan view.

9-11 illustrate an alternative of the monitoring device 900 and the sensor device body 950, interconnected in Fig. 11, separated from each other in Fig. 9, and illustrating the sensor device body alone in Fig. Version. In one version of this alternative embodiment, the sensor device body 950 includes an infrared light emitting diode 951, or IRED, and photodiode 952, or PD (see FIG. 10) The droplets 954 falling from the top to bottom of the tubing 953 are positioned about the tubing set 953 in this manner to at least partially obstruct or refract the beam 955 extending along the field of view from the PD to the IRED. Most preferably, the IRED and PD form a sensor device body and are attached to a housing 956 that surrounds the tubing set or at least extends along opposite portions of the tubing set. In some versions, the sensor device body need not have a separate housing, but rather may have various components mounted on the tubing set and may include the tubing set itself. The sensor device body components (e. G., IRED and PD) are exposed on the outside of the tubing set and preferably include contacts 957 formed on a tab or protrusion 958 extending outwardly from the housing Or the like). The tubing set contacts 957 are configured to align with the docking chambers and the receiving contacts 910 mounted on a separate monitoring device 900 attached to the sensor device body. As discussed further below, contacts 957 facilitate transfer of power to the housing, and data associated with PDs or other aspects within the sensor device body may be exchanged with the monitoring device.

For simplicity of illustration, the embodiments of Figures 9-11 are illustrated without a fluid source. The tubing set and sensor device body is illustrated with an exemplary upper receiving tube 963 having a top in the form of a spike for insertion into a fluid source, such as fluid source 191, as illustrated in FIG.

In one version, the housing 956 is configured to be received within the mating channels 911, 912 of the monitoring device, thereby allowing alignment of the monitor contacts 910 and the sensor device body contacts 957, And a pair of side fins 960, 961 to ensure a snug fit of the housing to the housing. Thus, most preferably, the sensor device body includes structural features that allow it to be mounted on the monitoring device, and wherein the IRED and PD are mounted on the sensor device body rather than on the monitoring device. In this version, the alignment of the components around the drop tube does not receive movement or defective attachment by the user because they are mounted at the appropriate locations, oppositely fixed to each other. The monitoring device 900 may include a display 913, a plurality of buttons 914 or other input / output interface devices, a trench 915 for receiving a set of tubing, May be substantially similar to, or identical to, the different versions of the above-described monitoring devices having a processor and memory. The monitoring device may also be secured in place with mechanical latches, magnets, and other mechanical features.

Most preferably, as noted above, in the embodiment as shown in Figures 9-11, at least the emitter and the detector are fixedly mounted on the tubing set such that their alignment can not be changed by the user. Thus, for example, the emitter, detector and power source may be bonded or molded to the drip chamber or mounted to the housing, which may be permanently bonded to the tubing set so that the alignment is held in place, Lt; / RTI > As used herein, mountings using screws or bolts are within the meaning of " permanently attached ", as they do not require a tool for removal, for example, Because it can not simply be removed.

In one embodiment, as illustrated in Figure 12, a wired tether is used to connect a set of tubing to a monitoring device. One end of the tether may be interfaced with the form factor and connector of the tubing set, and the other end may be connectable to the monitoring device. Thus, the tether acts as an " extension cord " allowing the sensor and the monitoring device to be separated by some spacing. These wired interfaces may use serial, e.g., RS232, connection, USB connection, Ethernet connection, 12C connection, SPI interface, or the like.

As an example, the sensor device body 950 includes a wire 964 extending from the sensor housing 956 and terminating in a coupler 967. The coupler is configured to mate with the monitoring device 900 and in one version the coupler is formed with an outer shape corresponding to the sensor housing as described above, corresponding to the pair of side fins 960, 961. As a result, the coupler is configured to be received within the mating channels 911, 912 of the monitoring device. The coupler further includes contacts, such as those corresponding to the tubing set contacts 957, as described above, which are configured to align with the receiving contacts 910 mounted on the separate monitoring device 900. The tethered coupler instead allows the monitoring device to be positioned a distance from the tubing set and the sensor housing, which is limited only by the length of the cord or cable 964. [

13, a radio embedded in a set of tubing, or, more preferably, in a sensor device body 950 or its housing 956, may also be coupled to the monitoring device 900 and wireless Lt; / RTI > In one version, the monitoring device as described above may include its own receiver, transmitter, or transceiver to transmit signals wirelessly to the sensor device body 950 or to receive signals from the sensor device body. Similarly, the sensor device body 950 preferably includes a transceiver or equivalent components to enable such communication within the housing 956. In this configuration, the sensor device body may transmit data relating to monitoring of the points to the monitoring device, and the monitoring device may thereafter store, analyze and display the data at the remote location.

In one version, the monitoring device may be the same as or substantially similar to the monitoring device as described above, in addition to including the components for enabling wireless communication. In alternate versions, the monitoring device may be configured differently to exclude, for example, a set of tubing and trenches, contacts, and other features for direct acceptance of the sensor device body. In one such case, the monitoring device may be in the form of a personal computer or tablet 920 that includes stored programming instructions that enable reception and analysis of data as described above. In other embodiments, the monitoring device 920 may be a smart phone or other wireless-enabled device that runs software for interfacing wirelessly with a set of tubing and sensor device bodies.

As illustrated in FIG. 13, the sensor device body 950 and the monitoring devices 900, 920 appear to communicate wirelessly with each other in a direct manner, for example, by using Bluetooth or other protocols. For example, the wireless link may include a USB link, a Bluetooth link, a low power Bluetooth link, a ZigBee link, an NFC link, and so on. It should be appreciated that the connection may be less direct, such as over a Wi-Fi or other wireless network, or even more remote over the Internet or other networks.

The devices in Figures 12 and 13 illustrate tethered and wireless connections between the sensor device body and the monitoring device, wherein the sensor device body is permanently attached to the tubing set. In other versions, the wireless or tethered connections may be separate sensor devices designed to clip or otherwise attach on the outside of the standard tubing sets, such as the versions illustrated and described above with reference to Figures 2 and 3, Lt; / RTI > The removable device may include a droplet sensor and may have components that are connected to a tether (see FIG. 14) or that allow it to communicate wirelessly with a separate monitoring device (see FIG. 15). Such a removable device may generally be lighter than the all-in-one devices discussed above, wherein the monitoring device and the display are integrated into the sensor device body and are cumulatively attached to the tubing set. In addition, such a device may enable safer attachment and better sensor alignment when compared to an all-in-one device.

Certain embodiments of the present technology also include other flow techniques or droplet sensing other than infrared beam detection, including, but not limited to, RF, optical, and capacitive sensing techniques.

In some embodiments, after receipt of the flow data by the monitoring device via wired or wireless means, the data may be remotely located via a long-distance network or elsewhere in the facility via wired or wireless communication methods Which may be further transmitted to the remote monitoring station. For example, as noted above, any of the monitoring devices 900, 920 may be remotely located or communicating with the sensor device body 950 via a wireless network, which may include the Internet.

In further embodiments, the same electromechanical or wireless interface may be used with sensors above dribble velocity measurement, such as pulse oximeters, respiratory or electrocardiograph monitors, as well as IV flow controllers, pumps, or SCDs Devices). ≪ / RTI > Thus, the sensor device body may be integrated into a device other than the tubing set, wherein the sensors monitor and transmit data in the manner described above.

In some versions, these electromechanical or wireless interfaces may include facilities that allow these attachments (including the tube sets discussed above-discussed above) to " self-describe " to the monitoring device, And may display appropriate control and status information according to the nature of the attached sensor or intervening device.

Figure 16 illustrates a block diagram of internal components that form the preferred sensor device body 950 and the electrical circuitry of the monitoring device 900. The sensor device body includes a source, which may be in the form of an LED 410. At least one terminal of the LED 410 may be grounded. A detector, preferably a photodiode 412, is also provided. The photodiode 412 may have greater sensitivity to IR wavelengths than for wavelengths in the visible light spectrum. The resistor 414 may be used in connection with the photodiode 412, which is connected between the photodiode 412 and the ground.

In the illustrated example, microcontroller 416 may control operation of at least one of LED 410 and photodiode 412. However, in some versions, the microcontroller may be omitted from the sensor device body 950. This may be achieved, for example, when the sensor device body is connected to the monitoring device 900 with its own microcontroller or microprocessor either directly (as in Figure 11) or via optional tether 964 (as in Figure 12) Lt; / RTI > In this description, the term " processor " generally encompasses processors, microprocessors, and microcontrollers. When the processor is omitted from the sensor device body 950, the components of the sensor device body preferably communicate through the contacts 910, 957, as described above, to signal communication with the processor in the monitoring device 900, Lt; / RTI >

The processor may control the pulsation of the biasing currents used in operation of LED 410 and photodiode 412 (either in sensor device body 950 or in monitoring device 900) ≪ / RTI >

As illustrated, the sensor device body includes a power source 418, which may include a power supply in the form of an internal power supply, such as a cord for AC power or a battery. However, in some versions, the power source 418 may be provided from a separate monitoring device 900 and its internal power supply 930. In such a case, the power is preferably transmitted to the sensor device body through the contacts as described above, and may be transmitted via the tether 964. [

In the case of a wireless version of the sensor device body, a transceiver 420 is provided. The transceiver may alternatively be a transmitter, without the separate ability to receive signals from the monitoring device. Although not shown, the transceiver or transmitter includes an antenna.

Preferably, the sensor device body includes a memory 421, which may be used as a cache for data detected by the detector for programming commands operable by the microcontroller or for other purposes. The memory can also be transmitted to or read by the monitoring device and then interpret and display the identification information to determine the type of sensor device body in use and the particular number of devices that have been identified, And may include the same identification information. The memory may further include a pointing factor (gtt / ml) of the tubing set, stored information such as sensor configuration, or other information that may be communicated to the monitoring unit.

The monitoring device may include a display unit 402 such as an LCD or LED screen. The display unit 402 may be used to provide the user with information including the information described above with reference to Fig.

The processor 422 allows the monitoring device to control the sensor device body, retrieve data from the sensor device body, read data from the memory in the sensor device body, analyze and store the data detected by the system Along with a memory 424 that contains stored programming instructions that are operable by the processor to control the display 402. The memory 424 includes a memory 424,

The monitoring devices may include a user input interface, or an I / O device 423, which may be in the form of button inputs as described above, or alternatively may be in the form of a touch screen or other interface . The monitoring devices may include an audio interface as part of the I / O subsystem, such as speakers used to provide audio alerts or other audio information to a user.

A power supply 930, which may be in the form of batteries, AC power, or others, is provided.

The monitoring device further includes a transceiver 425 which indirectly communicates data to and from the sensor device body, or from a remote computer and from a remote computer, either directly or via various communication channels as described above And may be configured with an antenna to transmit and receive.

A further alternative embodiment of a device for monitoring fluid through a drip chamber is illustrated in Fig. In this version, the device has an exemplary top receiving tube 963 having an upper end in the form of a spike for insertion into a fluid source, such as fluid source 191 as illustrated in FIG. 1, Set and a sensor device body. In an alternative embodiment, the sensor device body 950 is preferably configured such that droplets falling from the top to bottom of the tubing set at least partially obstruct or refract the beam 955 extending along the line of sight from the PD to the IRED An infrared light emitting diode 951, or an IRED, and a photodiode 952, or a PD (see Fig. 10), which are positioned around the tubing set 953 with a tubing set 953. As summarized above, the IRED and PD may alternatively be any other type of sensor configured to detect drops falling through the sensor device body.

Most preferably, the IRED and PD form a sensor device body and are attached to a housing 956 that surrounds the tubing set or at least extends along opposite portions of the tubing set. In some versions of this alternative embodiment, the sensor device body need not have a separate housing, but rather may comprise the tubing set itself, having various components mounted on the tubing set. Most preferably, the components are permanently attached to the drip set by gluing, molding, sonic welding, or other such methods.

The alternative embodiment of FIG. 17 may, in some implementations, act as a standalone device, without a separate or remote monitoring unit or display. Accordingly, the sensor device body includes microcontroller 416 (attached to housing 956 or otherwise to the tubing set) to control at least the operation of the LED and PD, as well as the related components discussed with reference to Fig. do. The processor may control the operation of the LED and PD and may perform other services as described above.

The sensor device body also includes a power source 418 (see FIG. 16), not illustrated in FIG. 17 but provided in the housing 956 or otherwise attached to the device. The power supply may be in the form of an internal power supply such as a battery, or may be a cord for AC power, a solar array strip, or some other form.

Most preferably, this alternate version of the invention includes a display panel 941, which may be in the form of an LED or LCD display, which may, for example, display text messages, icons, or other images do. In other versions, the display panel may be one or more LEDs or other indicators that may convey messages through simpler, e.g., blinking, illumination, display of a specific color, or other formats. In the illustrated example, the display panel is provided on the exterior surface of the housing 956. The display panel is controlled by a microcontroller as described above.

The version of Figure 17 also preferably includes a user input device in the form of a button 942 provided on the housing 956 in the illustrated example and communicating with the microcontroller 416. The button allows the user to toggle the device on or off, scroll, and select various possible commands to control the device. Some versions may include multiple buttons or switches attached to the device, or may incorporate a touch screen within the display panel 941 to act as both a display and a user input device.

The version of Figure 17 is suitable for serving as a disposable unit, having all of the necessary components built in and embedded in the device in some implementations. This version may optionally include a transceiver 420 (see FIG. 16) to enable it to communicate with the remote monitoring unit. The device may also optionally be configured for direct connection with the monitoring unit, which enables the user to selectively use the device in a stand-alone manner, via physical attachment to the monitoring device, or via wireless communication with the remote monitoring device, Or a tether.

Preferably, the sensor device body comprises a memory 421 as described above, which may be used as a cache for data detected by the detector for programming purposes, or for other purposes as described above, ).

Although the preferred embodiments of the present invention have been illustrated and described above, many changes can be made without departing from the spirit and scope of the present invention. Therefore, the scope of the present invention is not limited by the disclosure of the preferred embodiments. Instead, the invention should be determined entirely with reference to the following claims.

Claims (30)

A device for monitoring a fluid through a drip chamber,
An emitter mounted to the drip chamber and positioned to emit electromagnetic radiation across the drip chamber;
The detector mounted to the drip chamber and positioned to define a path across the drip chamber between the emitter and the detector, the detector also configured to generate a detector signal in response to electromagnetic radiation received from the emitter And wherein, when the fluid is in the path between the emitter and the detector, the fluid inhibits the electromagnetic radiation from moving along the path; And
Wherein the interface is configured to communicate data representative of the detector signal from the device to a remote monitoring device. The method according to claim 1,
Wherein the interface further comprises a first plurality of contacts mounted on the device and configured to pair with a second plurality of contacts positioned on the remote monitoring device. 3. The method of claim 2,
Wherein the interface further comprises a wired tether and a connector,
Wherein the wired tether extends from the device to the connector and the first plurality of contacts are positioned on the connector. The method of claim 3,
Wherein the connector includes one or more protruding surfaces configured to be received in one or more corresponding channels in the remote monitoring device, whereby the connector is configured to receive the one or more protruding surfaces from the remote monitoring device when the one or more protruding surfaces are positioned within the one or more corresponding channels. A device for monitoring a fluid that is removably retained within a remote monitoring device. The method of claim 3,
Wherein the emitter and the detector are permanently mounted to the drip chamber. 6. The method of claim 5,
Further comprising a housing mounted on the device,
The wired tether also extends from the housing. 6. The method of claim 5,
Wherein the first plurality of contacts are connected to an electrical circuit on the device, the electrical circuit is connected to the emitter and the detector, and the electrical circuit further comprises a second plurality of contacts, Is configured to be controlled by a processor on the remote monitoring device. 8. The method of claim 7,
Wherein the electrical circuit is configured to be powered by a power source of the remote monitoring device and wherein the power is delivered from the second plurality of contacts to the device with the first plurality of contacts, . 3. The method of claim 2,
Further comprising a housing mounted on the device and in the drip chamber, the first plurality of contacts being mounted on the housing. 10. The method of claim 9,
Wherein the housing includes one or more protruding surfaces configured to be received in one or more corresponding channels in the remote monitoring device whereby the housing is configured to receive the one or more protruding surfaces when the one or more protruding surfaces are positioned within the one or more corresponding channels. A device for monitoring a fluid that is removably retained within a remote monitoring device. 10. The method of claim 9,
Wherein the emitter and the detector are permanently mounted to the drip chamber. 10. The method of claim 9,
Wherein the first plurality of contacts are connected to an electrical circuit on the device, the electrical circuit is connected to the emitter and the detector, and the electrical circuit further comprises a second plurality of contacts, Is configured to be controlled by a processor on the remote monitoring device. 13. The method of claim 12,
Wherein the electrical circuit is configured to be powered by a power source of the remote monitoring device and wherein the power is delivered from the second plurality of contacts to the device with the first plurality of contacts, . The method according to claim 1,
Wherein the device further comprises a transceiver configured for wireless communication with the remote monitoring device. A system for monitoring fluid through a drip chamber,
A sensor device body; And
And a remote monitoring device physically separated from the sensor device body,
The sensor device body comprises:
An emitter mounted to the drip chamber and positioned to emit electromagnetic radiation across the drip chamber;
The detector mounted to the drip chamber and positioned to define a path across the drip chamber between the emitter and the detector, the detector also configured to generate a detector signal in response to electromagnetic radiation received from the emitter And wherein, when the fluid is in the path between the emitter and the detector, the fluid inhibits the electromagnetic radiation from moving along the path; And
An electrical circuit comprising the emitter and the detector, the electrical circuit further comprising an interface configured to communicate data indicative of the detector signal,
The remote monitoring device comprising:
An outer case;
display;
A processor; And
The memory including stored programming instructions operable by the processor to cause the processor to receive data representative of the detector signal from the sensor device body; . 16. The method of claim 15,
Wherein the sensor device body is detachably attachable to the outer case of the remote monitoring device. 17. The method of claim 16,
Wherein the electrical circuit is in signal communication with the processor and is configured to be controlled by the processor on the remote monitoring device when the sensor device body is detachably attached to the remote monitoring device. 16. The method of claim 15,
Wherein the sensor device body further comprises a wired tether and a connector, wherein the connector is configured for an attachment removable to the remote monitoring device. 19. The method of claim 18,
Wherein the electrical circuit is in signal communication with the processor and is configured to be controlled by the processor on the remote monitoring device when the connector is detachably attached to the remote monitoring device. 16. The method of claim 15,
Wherein the electrical circuit further comprises a transceiver configured for wireless communication with the remote monitoring device. A device for monitoring fluid through a drip chamber,
An emitter positioned to permanently mount in the drip chamber and positioned to emit electromagnetic radiation across the drip chamber;
The detector being positioned to permanently mount in the drip chamber and to define a path across the drip chamber between the emitter and the detector, the detector further configured to detect a detector signal in response to electromagnetic radiation received from the emitter Wherein the fluid inhibits movement of electromagnetic radiation along the path when the fluid is in the path between the emitter and the detector.
A microcontroller mounted on the device and a power source mounted on the device, the microcontroller communicating with the detector signal; the microcontroller and the power source; And
A user interface permanently mounted to the device, the user interface having a user input device and a display panel, the microcontroller being further configured to cause the display panel to present a display in response to the detector signal, A device for monitoring fluid, comprising a user interface. 22. The method of claim 21,
And wherein the microcontroller is permanently mounted to the drip chamber. 23. The method of claim 22,
Wherein the power source is permanently mounted to the drip chamber. 22. The method of claim 21,
Further comprising a housing,
Wherein the microcontroller and the battery are permanently contained within the housing. 25. The method of claim 24,
Wherein the user input device and the display panel are mounted on the housing. 22. The method of claim 21,
Wherein the emitter and the detector are bonded to the drip chamber. 22. The method of claim 21,
Wherein the emitter and the detector are molded in the drip chamber. 22. The method of claim 21,
Wherein the display panel comprises one or more light emitting diodes. 22. The method of claim 21,
Wherein the user input device comprises a button attached to the device. 22. The method of claim 21,
Wherein the user input device and the display panel are configured as a touch-sensitive display panel, and wherein the touch-sensitive display panel is mounted to the device.

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