Infusion system, method for supplying infusion fluid, and system for controlling flow rate

Abstract

The automated closed-loop gravity infusion system includes a fluid supply source, a drop counter operatively engaging a drip chamber of the fluid supply source, a roller clamp operatively associated with the drop counter, a processor operatively associated with the roller clamp, and a human-machine interface (HMI) operatively connected to the processor. Patient data is accessed through the HMI. The gravity infusion system utilizes the patient data and data from the drop counter to determine the appropriate position of the roller clamp. The drop counter continuously monitors the drip rate of the drip chamber and transmits the data to the processor. The processor analyzes the data and automatically adjusts the position of the roller clamp to administer the appropriate volume of fluid to the patient. The HMI is operatively linked to a remote centralized computing system capable of simultaneously monitoring multiple systems used to infuse different patients.

Description

[Technical Field]

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 480,599, filed January 19, 2023, the entire disclosure of which is incorporated herein by reference. The present disclosure relates to medical devices. In particular, the present disclosure relates to medical devices used to deliver intravenous fluids to patients. Specifically, the present disclosure relates to a system including an infusion source, a drop counter operatively engaging a drip chamber of the infusion source, a roller clamp operatively associated with the drop counter, a processor operatively associated with the roller clamp, and a human-machine interface (HMI) operatively connected to the processor. Patient data is accessed through the HMI. The processor uses the patient data and real-time data from the drop counter to automatically determine and set the appropriate roller clamp position and automatically deliver the prescribed volume of fluid to the patient under gravity. The system is configured to mimic, as closely as possible, a typical human operation of a conventional roller clamp. [Background technology]

[0002] Intravenous (IV) fluid therapy is a widely used technique for administering fluids, nutrients, vitamins, and other substances directly into a patient's bloodstream. The fluids administered to a patient are contained in an infusion bag (IV bag) that is suspended from a pole. A drip chamber extends outward from the IV bag, and tubing extends from the drip chamber to a luer (i.e., a hollow tube / needle) that is inserted directly into the patient's vein. During use, gravity causes the fluid to drip from the bag into the drip chamber. The fluid then flows by gravity down the tubing to the luer and ultimately into the patient's bloodstream.

[0003] The flow rate of fluid delivered from an IV bag to a patient must be controlled. There are two main types of devices used for this purpose: infusion pumps and "gravity infusion systems," or "gravity IVs." Infusion pumps can deliver fluid to patients at precise flow rates, but they are relatively expensive and require specialized, disposable components (valves and pumps). These disposable components are designed specifically for a specific type of infusion pump and cannot be used with other types of disposable components (valves and pumps). The cost of infusion pumps and the specialized equipment required makes them difficult for financially disadvantaged medical facilities to implement. Gravity infusion systems, on the other hand, do not require specialized peripherals and are inexpensive to purchase and operate. The most basic flow control device used in gravity infusion systems is the roller clamp. The roller clamp engages the tubing between the drip chamber and the luer and can be adjusted along the tubing as needed. Roller clamps can be used with any type of IV bag, drip chamber, and tubing, and do not require specialized equipment. Therefore, roller clamps are suitable for any medical environment. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] AU2020250300 Summary of the Invention [Problem to be solved by the invention]

[0005] One of the challenges of intravenous infusion is the need for a safe and stable delivery of fluid from the IV bag to the luer, particularly at the flow rate prescribed by the physician. Currently known IV pumps and gravity infusion devices are open-loop systems, meaning they do not provide immediate feedback to healthcare professionals about how the system is actually functioning. The movement of fluid through the system is predetermined based on original design calculations. In other words, currently known IV pumps do not monitor the flow of fluid or provide feedback to the control unit. They operate solely based on pre-determined design values, not real-time data. Without manufacturing variations, IV pumps are highly accurate, and gravity infusion systems also maintain a certain degree of accuracy, but gravity infusion systems are not as precise as IV pumps. However, manufacturing variations in infusion systems, including IV pumps and gravity infusion devices, may prevent the calculated volume of fluid from being delivered to the patient. For example, even if an IV pump moves its motor 10 times, this does not necessarily mean that the dedicated disposable parts have delivered the correct volume of fluid. Manufacturing variations and tolerances in dedicated disposable components can adversely affect fluid flow and, consequently, fluid delivery to the patient. Currently known infusion systems do not have a mechanism for monitoring the actual fluid flow rate into the patient, so healthcare professionals may not realize that the correct volume of fluid is not being delivered to the patient.

[0006] Typically, a roller clamp includes a body with an internal passage through which the tubing passes. The roller wheel is operatively coupled to the body and extends at least partially within the passage to contact the tubing passing therethrough. The passage may be arranged along a path within the body such that the roller wheel moves toward or away from the tubing. Alternatively, the inner wall of the roller clamp defining the passage may be configured to narrow from the first end to the second end of the body. To control the flow of infusion fluid through the tubing, a healthcare professional adjusts the position of the roller wheel relative to the roller clamp body. The healthcare professional manually pushes and rotates the roller wheel along the passage in either a first or second direction. As the roller wheel moves in the first direction, it gradually narrows the diameter of the tubing passing through the passage, thereby reducing the flow rate of infusion fluid through the tubing. The roller wheel can also be moved sufficiently in the first direction to completely stop the flow of infusion fluid through the tubing. If the healthcare professional determines that the infusion rate needs to be increased, the roller wheel is moved in a second direction relative to the first end of the roller clamp body. This rotation and movement in the second direction reduces the tendency of the roller wheels to pinch or crush the tubing, causing the tubing diameter to expand, which tends to increase the flow rate of the infusion fluid through the tubing.

[0007] Typically, rolling the roller wheel of the roller clamp toward the first end of the roller clamp body, i.e., toward the IV bag, increases the flow rate through the tubing, while rolling the roller wheel toward the second end of the roller clamp body, i.e., along the tubing toward the luer end, decreases the flow rate through the tubing.

[0008] In currently known gravity infusion systems, the flow rate is set manually, as described above. A healthcare professional first calculates the required infusion rate based on the patient's prescription. The actual flow rate is then confirmed by physically counting the number of drops of fluid dripping from the IV bag into the drip chamber over a predetermined period of time using a clock or other timing device. The observed number of drops within the predetermined period of time is compared to the required or desired infusion rate. If too many drops drip into the drip chamber within that period of time, the healthcare professional rolls the rollers of the roller clamp toward the patient end (the luer end) of the tubing, thereby narrowing the inner diameter of the tubing and thereby slowing the rate of fluid flow through the tubing. If too few drops drip into the drip chamber within the predetermined period of time, the healthcare professional rolls the rollers of the roller clamp toward the IV bag, thereby widening the inner diameter of the tubing and thereby increasing the rate of fluid flow through the tubing.

[0009] As mentioned above, one advantage of gravity infusion systems is their relatively low cost. They are also easy to set up and operate. However, one disadvantage of gravity infusion systems is their relatively low accuracy. If a healthcare professional is in a hurry or slightly distracted, they may not accurately count the number of drops dripping into the drip chamber, resulting in an inadequate delivery rate. Furthermore, healthcare professionals rely on feel to set the roller wheel position, and if the roller wheel is not moved to the optimal position on the roller body, the infusion flow rate through the tubing will not be optimal. Even after initial setup, the roller position can change due to various factors, including patient movement, tubing creep, and changes in IV bag volume. Therefore, manual adjustment of the infusion flow rate from currently known gravity IV systems requires careful attention from healthcare professionals, and the flow rate may need to be monitored and adjusted repeatedly to ensure the prescribed volume of infusion is delivered to the patient.

[0010] Various infusion systems are described in the prior art. For example, AU2020250300 (Peret) describes a system, method, and apparatus for monitoring, regulating, or controlling the flow of infusion fluid. This document discloses a closed-loop system including a drop counter with an optical sensor that monitors the rate at which infusion fluid drips from an IV bag into a drip chamber. In one embodiment, the sensor sends data to a processor, which controls a motor to adjust the position of an interacting member relative to a roller clamp (referred to as a "valve" in the document). A flow sensor estimates the flow rate through the drip chamber using images and controls the valve (roller clamp) based on the estimated flow rate. This document discloses that a motor is connected to a lead screw mechanism and controls the roller clamp through cooperation with an interacting member. When the motor is activated, the interacting member moves, which in turn moves a roller wheel of the roller clamp. The movement of the interacting member pushes the roller wheel, which moves the roller wheel relative to the roller clamp body. This pushing action, which is repeated in adjustments to control the flow of infusion fluid through a tube, is prone to damage to the roller wheel and / or the roller clamp body. Roller clamps are designed to be operated and adjusted by humans, not by machines. Using machines to operate roller clamps places excessive strain on the roller wheel shaft and its housing, leading to premature failure of the roller clamp. If the roller clamp fails while administering fluids to a patient, this will obviously have a negative impact on the administration of the fluid and may cause harm to the patient.

[0011] AU2020250300 also discloses that the system can be remotely controlled using electronic devices such as smartphones or computers, and that the flow meter will issue an alarm if the system detects a free-flow condition, if the flow rate exceeds a predetermined threshold or is outside a predetermined range, or if abnormal behavior is detected. Because the disclosed system controls the infusion flow rate using images from the flow counter, it is unclear how the flow counter can distinguish between abnormal infusion flow through the tubing and backflow. Furthermore, AU2020250300 discloses the use of various novel disposable components to control the infusion flow rate, but these disposable components interact with the tubing of gravity infusion systems in novel ways. The interaction of these novel disposable components with the tubing increases uncertainty about exactly how the flow of infusion fluid through the tubing will change, requiring advanced engineering and testing to accurately predict and control the infusion flow rate in the disclosed system. [Means for solving the problem]

[0012] The closed-loop gravity infusion system and method disclosed herein provide a system and method for accurately and automatically administering fluid to a patient at a predetermined flow rate using various currently known roller clamp configurations. The loading and control mechanisms of the disclosed system are compatible with various roller clamp designs and are configured to mimic as closely as possible the typical human interaction with a conventional roller clamp. The disclosed system and method can transform the simplest gravity IV set from an inaccurate and imprecise gravity IV set to a precision gravity IV set without the need for a high-end IV pump or specialized peripheral equipment. Furthermore, the disclosed system does not introduce any new interactions between the roller clamp and the IV tubing to control fluid flow, thereby maintaining the well-understood infusion flow characteristics associated with conventional roller clamps. The gravity infusion system disclosed herein also monitors fluid flow in real time and provides immediate feedback to a control unit. Thus, the system can provide real-time feedback to healthcare professionals.

[0013] The disclosed system includes an infusion source and a drop counter operatively engaged with a drip chamber of the infusion source. The drop counter is configured to automatically count drops dripping from the infusion source into the drip chamber. The system further includes a conventional roller clamp held in a holster attached to the housing, the roller clamp operatively linked to the drop counter. A processor is operatively connected to the roller clamp, and a human-machine interface (HMI) is operatively associated with the processor. Patient-specific data, including the patient's infusion prescription, is entered into the HMI via the user interface or uploaded from a database. A program embedded in the processor is configured to use patient data obtained from the HMI and drip data obtained from the drop counter to calculate an infusion flow rate that meets the patient's prescription. The program is also configured to determine the appropriate position of a roller wheel within the roller clamp to achieve the desired flow rate, and then automatically adjust the position of the roller wheel relative to the tubing so that the infusion is delivered to the patient through the tubing at the desired flow rate. The drop counter continuously monitors the drip rate of the drip chamber in real time and transmits the data to the processor. The processor analyzes the transmitted data in real time and automatically adjusts the position of the roller wheels in the roller clamp in real time to provide the appropriate amount of infusion to the patient. The HMI may be operatively connected to a remote centralized computing system configured to simultaneously monitor multiple identical infusion systems, each used to infuse a different patient.

[0014] The disclosed automated gravity infusion system provides a cost-effective alternative to traditional gravity IVs and infusion pumps, providing a more accurate and cost-effective method of intravenous administration using conventional roller clamp systems. One of the reasons the disclosed infusion system provides greater accuracy than traditional gravity IVs is because it is a closed-loop system. The disclosed system provides immediate feedback to healthcare professionals, a feature not available in prior art infusion systems. Furthermore, the disclosed infusion system allows a single healthcare professional to monitor and control multiple infusion devices in real time from a remote, centralized computer system.

[0015] In one aspect, exemplary embodiments of the present disclosure may provide an infusion system comprising: a drop counter configured to be engageable with a drip chamber of an infusion fluid source configured to deliver infusion fluid under gravity through a tube into a patient's body; a roller clamp operatively associated with said drop counter; an adjustment assembly operatively engaged with a roller of the roller clamp, the adjustment assembly including at least one spring-loaded plunger that presses the roller against a tube; a programmed processor configured to automatically adjust the position of the roller relative to the roller clamp via the adjustment assembly in response at least in part to drop data collected by the drop counter; An infusion system may be provided comprising:

[0016] In one embodiment, the at least one spring-loaded plunger may include a first plunger and a second plunger, which may engage spaced apart on the roller. In one embodiment, the first plunger and the second plunger may each be independently operable. In one embodiment, the first plunger and the second plunger may each include a pin roller that contacts a circumferential surface of the roller. In one embodiment, an outer surface of the pin roller that contacts the circumferential surface of the roller may comprise an elastic material. In one embodiment, the first plunger and the second plunger may cooperate to move the roller relative to the roller clamp. In one embodiment, the first plunger and the second plunger may cooperate to press and rotate the roller relative to the roller clamp.

[0017] In one embodiment, the infusion system may further include strain gauges that measure the forces experienced by the first plunger and the second plunger. In one embodiment, the infusion system may further include at least one limit switch that limits the range of movement of the adjustment mechanism relative to the roller clamp. In one embodiment, the infusion system may further include a counter that counts the number of times the adjustment mechanism adjusts the position of the roller relative to the roller clamp. In one embodiment, the infusion system may further include a housing with a holster, the holster being configured to accept any of a variety of roller clamps with different configurations. In one embodiment, the infusion system may further include a jogging mechanism configured to move a deformed tubing section from the roller clamp and introduce a new, undeformed tubing section into the roller clamp.

[0018] In one embodiment, the infusion system may be a closed-loop system. In one embodiment, the infusion source may include an infusion bag adapted to contain a predetermined volume of infusion solution, the drip chamber may be operatively coupled to the infusion bag, and the drop counter may be configured to automatically count droplets falling from the infusion bag into the drip chamber and transmit the drop data to the processor in real time.

[0019] In one embodiment, the infusion system may further include a human-machine interface (HMI) operatively connected to the processor, the HMI configured to provide access to patient data. In one embodiment, the infusion system may further include a user interface on the HMI, the HMI may access the patient data by inputting information through the user interface. In one embodiment, the infusion system may further include a database storing patient data, the HMI may access the patient data by automatically retrieving the patient data from the database. In one embodiment, the infusion system may further include a remote computing system operatively connected to the HMI. In one embodiment, the infusion system may further include a camera on the drop counter, the camera configured to capture drip data and / or a liquid level in a drip chamber of the drop counter.

[0020] In another aspect, exemplary embodiments of the present disclosure include: an infusion bag configured to hold a predetermined volume of infusion fluid to be administered to a patient; a tube extending between the infusion bag and the patient's body; a drip chamber engaged with the tubing at a location between the infusion bag and the patient's body; a drop counter operatively engaged with the drip chamber and configured to automatically measure in real time the number of droplets entering the drip chamber from the infusion bag; a roller clamp disposed between the drip chamber and the patient's body; Equipped with the tube extends through a hole in the roller clamp; a roller provided in the roller clamp for pressing the tube passing through the hole in the roller clamp; a first plunger and a second plunger contacting the roller at spaced apart locations and operable to move the roller relative to the roller clamp; a processor operatively associated with the drop counter and the roller, the processor automatically controlling the movement of the roller relative to the tube and controlling the flow rate of the infusion solution through the tube in response to drop data provided by the drop counter; An infusion system may be provided comprising:

[0021] In one embodiment, the first plunger and the second plunger may be independently operable. In one embodiment, the infusion system further comprises a human-machine interface (HMI) operatively connected to the processor, the HMI configured to access patient data and provide the data to the processor. In one embodiment, the infusion system may further comprise a remote computing system operatively connected to the HMI. In one embodiment, the infusion system further comprises a camera mounted on the drop counter, the camera configured to capture images of the number of droplets entering a drip chamber of the drop counter and / or the liquid level within the drip chamber.

[0022] In another aspect, exemplary embodiments of the present disclosure include: 1. A method for controlling the flow rate of an infusion fluid delivered to a patient using an infusion system including tubing extending from an infusion bag, comprising: accessing patient data via a human-machine interface (HMI) of the infusion system; receiving, at a processor of the infusion system, drop rate data from the drop counter; analyzing the patient data and the drip rate data with the processor; determining, by the processor, a desired flow rate for the infusion based on a desired dose to be administered to the patient via the infusion system within a predetermined time period based on the analysis of the patient data and the drip rate data; automatically adjusting the position of the roller in the roller clamp by pressing and rotating the roller against the roller clamp using a drive mechanism operatively connected to the processor; A delivery method may be provided to deliver a desired dose of fluid to the patient through the tube.

[0023] In one embodiment, automatically adjusting the position of the roller clamp may include rotating a roller of the roller clamp in one of a first direction and a second direction, contacting a tubing extending through an aperture in the roller clamp with the roller, rotating the roller in one of the first direction and the second direction to change the size of the aperture in the tubing, and changing the size of the aperture to change the flow rate of the infusion solution through the tubing to a desired flow rate. In one embodiment, receiving drip rate data from the drop counter may include automatically counting the number of drops of infusion solution entering the drip chamber from the infusion bag in real time with a sensor in the drop counter, communicating the counted number of drops from the drop counter to a processor, determining the flow rate of the infusion solution moving from the drip chamber through the tubing with a program in the processor, and automatically adjusting the position of the roller relative to the clamp in real time without human intervention.

[0024] In one embodiment, receiving drip rate data from the drop counter may include capturing images of droplets entering a drip chamber of the drop counter with a camera. The drip rate data may then be calculated from the captured images. In one embodiment, the method may further include capturing an image of an actual level of the infusion solution in the drip chamber of the drop counter. This may include determining whether the level exceeds a predetermined height. In one embodiment, the method may further include determining that backflow has occurred in the drip chamber when the level exceeds the predetermined height and issuing an alarm. In one embodiment, issuing an alarm may include one or more of issuing an audible alarm, issuing a visual alarm, and sending a real-time image of the actual level of the infusion solution in the drip chamber to a display screen of the HMI. In one embodiment, the method may further include providing a sensor for detecting backflow, air bubbles in the infusion solution, air in the infusion solution, or a pressure change in the tubing, and issuing an audible alarm, a visual alarm, or both, when the sensor detects backflow, air bubbles in the infusion solution, air in the infusion solution, or a pressure change in the tubing. In one embodiment, accessing patient data via the HMI may include automatically retrieving patient data stored in a database. In one embodiment, accessing patient data via the HMI may include entering patient data through a user interface.

[0025] In another aspect, exemplary embodiments of the present disclosure include: A system for controlling the flow rate of an infusion fluid delivered to a patient through a tube extending from an infusion bag, comprising: a drop counter operatively engaged with a drip chamber disposed between the infusion bag and the tubing; a roller clamp having a hole through which the tube is inserted, a roller extending into the hole and contacting the tube, and a drive mechanism for pressing and rotating the roller in one of a first direction and a second direction, the roller clamp being in electronic communication with the drop counter; a processor in communication with the drive mechanism; a human machine interface (HMI) operatively connected to said processor; A system comprising: In one embodiment, the system may be an automated, closed-loop, gravity infusion system. [Brief explanation of the drawings]

[0026] Sample embodiments of the present disclosure are set forth in the following description, illustrated in the drawings, and particularly pointed out and described in the appended claims, wherein like numerals refer to like parts throughout. [Figure 1] 1 is a schematic front view of a gravity infusion system according to the present disclosure; [Figure 2] 2 is a top, front, right side isometric perspective view showing the intravenous pole, infusion bag, drip chamber, drop counter, and a portion of the housing assembly of the gravity infusion system of FIG. 1. FIG. [Figure 3] FIG. 2 is a partial front view showing the infusion bag, drip chamber, and part of the drop counter of the gravity infusion system of FIG. 1. [Figure 3A] FIG. 4 is an enlarged top, front, right side isometric perspective view of the drop counter and drip chamber shown in FIG. [Figure 4] FIG. 1 is an exploded top, front, right side isometric perspective view of the inner housing and roller clamp assembly of the housing assembly, with the outer housing of the housing assembly omitted for clarity of illustration. [Figure 4A] FIG. 5 is a front view of the inner housing and roller clamp assembly of the housing assembly shown in FIG. 4, the inner housing and roller clamp assembly shown assembled. [Figure 4B] FIG. 4B is a front / partial cross-sectional view of the assembled inner housing and roller clamp assembly with some components shown in FIG. 4A omitted for clarity of illustration. [Figure 5]FIG. 10 is a front view of a second embodiment of an inner housing and roller clamp assembly shown assembled. [Figure 5A] FIG. 10 is a front / partial cross-sectional view of the assembled inner housing and roller clamp assembly. [Figure 5B] FIG. 6 is an upper left front isometric perspective view of a portion of the adjustment assembly of the inner housing and roller clamp assembly of the second embodiment shown in FIG. [Figure 5C] FIG. 10 is a front view, partially in section, of the assembled inner housing and roller clamp assembly showing the positions of the first and second plungers as the pin roller moves the roller wheel of the roller clamp relative to the clamp body. [Figure 5D] FIG. 10 is a front view of the assembled inner housing and roller clamp assembly showing the tube movement mechanism positioned to contact the tube and move the tube up or down to bring a new portion of the tube into contact with the roller clamp assembly. [Figure 6] 1 is a flow chart illustrating a prior art method of infusing a patient using a gravity infusion system. [Figure 7] 1 is a flowchart illustrating an exemplary method of infusing a patient using a gravity infusion system according to the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0027] 1-4B are schematic diagrams of a gravity infusion system in accordance with the present invention, generally designated 10. Gravity infusion system 10 (hereinafter also referred to as "system 10") includes an IV stand 12 (FIG. 2), an infusion bag 14 suspended from IV stand 12, a drip chamber 16 operatively engaged with infusion bag 14, and tubing 18 extending outwardly from drip chamber 16. Tubing 18 terminates in an intravascular connector or luer (not shown) that is inserted into the bloodstream of a patient "P" so that IV bag 14 is in fluid communication with the patient's bloodstream. Infusion bag 14, drip chamber 16, and tubing 18 form part of an infusion supply that utilizes the force of gravity to pump infusion fluid into the patient's body. Intravenous drip stand 12 (hereinafter referred to as "IV stand 12" or "stand 12"), infusion bag 14 (hereinafter referred to as "IV bag 14" or "bag 14"), drip chamber 16, and tubing 18 with a luer (not shown) are all used in known infusion systems. Because IV stand 12, IV bag 14, drip chamber 16, tubing 18, and the luer attached to tubing 18 are known in the art, these components will not be described in detail below unless necessary.

[0028] According to one aspect of the present disclosure, a drop counter 20 is mounted to the IV stand 12 and operatively engaged with the drip chamber 16, as shown in FIGS. 2 and 3 (it will be understood that any suitable drop counter may be used with the gravity infusion system 10). A mounting bracket "MB" operatively engages the base 32 of the drop counter 20, the mounting bracket "MB" being configured to secure the drop counter 20 to the IV stand 12 and may be of any suitable configuration for positioning the drop counter at a desired location along the length of the IV stand 12. The drop counter 20 may frictionally engage the drip chamber 16, allowing the drop counter 20 to continuously monitor the rate at which droplets drip from the IV bag 14 into the drip chamber 16. In particular, the drop counter 20 counts the number of drops of infusion dripping from the infusion bag 14 into the drip chamber 16 under the influence of gravity within a fixed period of time. The structure and operation of the drop counter 20 will be described in more detail below.

[0029] System 10 further includes a housing assembly 22 configured to be supported on IV stand 12 a fixed distance below drop counter 20. Housing assembly 22 encloses and protects, among other components, a battery 23 (see FIG. 1), a roller clamp assembly 24, and a printed circuit board 26 (see FIG. 4). Printed circuit board 26 is hereinafter referred to as "PCB 26." As shown in FIG. 4, PCB 26 includes a processor 26a (or one or more microprocessors) with embedded programming configured to control the function of the various components of system 10. Battery 23 (FIG. 1) is operatively coupled to the various electronic components within housing assembly 22 and provides power as needed (it will be understood that in other embodiments, system 10 may be provided with other suitable power sources in place of battery 23). As described below, roller clamp assembly 24 is comprised of roller clamp 46, holster 48, and holder 50. It should be understood that roller clamp 46 may be any conventional, currently known roller clamp. Holster 48 is a component that can hold a roller clamp of any configuration and position the roller clamp to engage with adjustment assembly 54 provided within the housing. Holster 48 allows housing assembly 42 to be a universal component that can accept and secure a roller clamp of any configuration.

[0030] The processor 26a is operatively linked to the drop counter 20, the roller clamps 46 of the roller clamp assembly 24, and an input source 28 for inputting patient data into the system 10. As shown in the accompanying figures, the input source 28 is a human-machine interface 28 (hereinafter, HMI 28), which may be separate from the IV stand 12 and the equipment attached thereto. Ideally, however, the HMI 28 is a portable device that can be carried by a healthcare professional. The HMI 28 is operatively linked to at least a portion of the remainder of the system 10, as described herein. In other embodiments, instead of the HMI 28 being a portable device, the input source may be provided as an integral part of the drop counter 20 or as an integral part of either the housing assembly 22 or the roller clamp assembly 24. System 10 is designed so that drop counter 20, housing assembly 22 with roller clamp assembly 24, and HMI 28 can operatively engage any currently known IV system that must be manually operated by a medical professional and convert that currently known IV system into an automated gravity infusion system in accordance with the present disclosure. Patient data can be entered into system 10 through a user interface provided on the HMI. In other cases, patient data may be stored in a database that is accessed by the HMI to retrieve saved patient data associated with a particular patient.

[0031] The drop counter 20 continuously monitors the drip rate in the drip chamber and transmits the drip rate data to the processor 26a. The processor 26a analyzes the drip rate data and controls the drive mechanism of the roller clamp 46 of the roller clamp assembly 24 to automatically adjust the position of the rollers of the roller clamp 46 to provide the appropriate and desired volume of infusion to the patient "P." The system 10 continuously monitors the drip rate and automatically adjusts the roller clamp 46 until the infusion is complete. The structure and function of the housing assembly 22, the roller clamp assembly 24, the PCB 26, and all other components of the system 10 are described in detail below.

[0032] As shown in FIG. 1 , system 10 further includes a human-machine interface 28 (hereinafter HMI 28) operatively coupled to PCB 26 to allow a user to input information regarding patient "P" and the treatment to be provided to patient "P" via system 10. HMI 28 is additionally or optionally operatively coupled to a remote computing system 30. It should be noted that communication between medical personnel and system 10 is achieved through applications uploaded to HMI 28 or through programs hosted on remote centralized computing system 30. Remote centralized computing system 30 is configured to enable medical personnel to simultaneously monitor multiple substantially identical infusion systems 10. The structure and operation of HMI 28 and computing system 30 are described in more detail below.

[0033] It will be understood that the various components of system 10 are functionally linked to one another, i.e., they communicate electronically with one another. It will further be understood that one or more of the electronic components of system 10 may include one or more processors with programming that controls other components within system 10 and ultimately automatically controls the delivery of infusion fluid from IV bag 14 to patient "P" via tubing 18. In particular, the programming controls the flow rate of infusion fluid from IV bag 14 to patient "P" via tubing 18. The electronic communication between the various components of system 10 may be configured in any manner such that the delivery of infusion fluid from IV bag 14 to patient "P" is automatically controlled by programming uploaded to at least one of the processor of drop counter 20, processor 26a of PCB 26, processor of HMI 28, and processor of remote computing system 30. FIG. 1 illustrates two symbols, designated by the reference characters "EC," that represent electronic communication between the electronic components of system 10. The electronic communications "EC" symbol indicates wireless or wired communications between the various components of system 10 and should not be narrowly construed as limiting the nature of the communications possible between the various electronic components of system 10.

[0034] 3 and 3A, drip chamber 16 is shown to include a transparent vial 16a having an upper end 16b and a lower end 16c. A peripheral wall of vial 16a defines an interior region 16d. Upper end 16b of vial 16a includes an inlet 16b' configured to operatively engage with tubing 14a (FIG. 3) extending downwardly from IV bag 14. Lower end 16c of vial 16a is configured to operatively engage or become integral with tubing 18. FIG. 3 illustrates how infusion fluid "F" from IV bag 14 drips dropwise ("F1," "F2") into drip chamber 16 via tubing 14a and inlet 16b'. A volume of infusion fluid "F3" accumulates in interior region 16d of drip chamber 16, and this infusion fluid "F3" eventually flows into and passes through tubing 18.

[0035] The structure and function of the drop counter 20 will now be described in more detail with reference to Figures 2, 3, and 3A. The drop counter 20 comprises a body including a base 32 having a first surface 32a and an opposing second surface 32b. The base 32 further includes a first end 32c, a second end 32d, a first side 32e, and a second side 32f. The first surface 32a and the second surface 32b define a first lateral direction therebetween. The first end 32c and the second end 32d face each other and define a longitudinal direction therebetween. The first side 32e and the second side 32f face each other and define a second lateral direction therebetween.

[0036] As best shown in FIG. 3A , the first surface 32a defines a generally longitudinally oriented recess 32a'. The recess 32a' extends generally from the first end 32c to the second end 32d of the base 32. The recess 32a' provides an area of ​​the first surface 32a in which the drop counter 16 may be positioned. The recess 32a' may be slightly tapered in a direction from the first end 32c to the second end 32d of the base 32. The taper of the recess 32a' is similar in shape to the taper of the drip chamber 16 that operatively engages the drop counter 20.

[0037] The first arm 32g and the second arm 32h extend outward from the first surface 32a of the base 32. The first arm 32g is positioned near the first side 32e, and the second arm 32h is positioned near the second side 32f. Thus, the second arm 32h is laterally spaced apart from the first arm 32g and extends outward from the first surface 32a in the same direction as the first arm 32g. As shown in FIG. 3, the first arm 32g and the second arm 32h have inner surfaces 32g' and 32h', respectively. The inner surfaces 32g' and 32h' face each other. In one embodiment, the inner surfaces 32g' and 32h' are positioned parallel to each other, forming a gap 32j (FIG. 3A) between the inner surface 32g' of the first arm 32g and the inner surface 32h' of the second arm 32h.

[0038] The base 32 is provided with a U-shaped clamping member 32k. The clamping member 32k can be provided anywhere on the base 32 that allows at least a portion of the clamping member 32k to extend outward beyond the first surface 32a. As shown in FIGS. 2 through 3A, the clamping member 32k is disposed near the first end 32c of the base 32 and extends upward and outward beyond the first end 32c. The clamping member 32k includes a first jaw 32k' and a second jaw 32k'' that are laterally spaced apart from one another and define a channel 32m therebetween. The channel 32m is bounded and defined by the U-shaped inner surface of the clamping member 32k, which is defined by the inner surfaces of the first jaw 32k' and the second jaw 32k'', and a portion of the first surface 32a that spans the recess 32a'. The channel 32m is oriented longitudinally, aligned with an upper region of the recess 32a', and in fluid communication with the gap 32j. Channel 32m is shaped and sized to accommodate a portion of drip chamber 16. Clamping member 32k can be fabricated such that first jaw 32k' and second jaw 32k'' are bent slightly away from each other to receive drip chamber 16 into channel 32m and then return to their original position to clamp drip chamber 16 between first jaw 32k' and second jaw 32k''.

[0039] A camera 34 (FIGS. 2-3A) or other suitable optical scanner or sensor is provided on one of the first arm 32g and the second arm 32h of the drop counter 20. As shown, the camera 34 extends from the inner surface 32g' of the first arm 32g to the gap 32j. It will be understood that the camera 34 may alternatively be provided on the inner surface 32h' of the second arm 32h and extend from the second arm 32h to the gap 32j. The camera 34 is coupled to the PCB 26 and controlled by programming provided to a processor on the PCB 26. When activated by the programming, the camera 34 has a field of view 34a that intersects with the drip chamber 16 held in the gap 32m of the drop counter 20 by the clamping member 32k. The camera 34 is operated to obtain photographs, videos, or other scanned or read images of the infusion solution (e.g., droplets "F1" and "F2") dispensed from the infusion bag 14. In particular, camera 34 collects images and other data relating to droplets "F1," "F2" dispensed into infusion fluid "F3" within drip chamber 16.

[0040] The camera 34 is used to continuously visually monitor and report the status of the drip. Data collected by the camera 34 as images is electronically transmitted to the processor 26a. As described below, this data is then electronically transmitted from the PCB 26 to the HMI 28, and may also be electronically transmitted from the HMI 28 to the remote computing system 30. The data collected by the camera 34 may also be used to report the status of the drip to medical personnel and to issue warnings or alarms to medical personnel.

[0041] Prior art systems lack a means to monitor for backflow and require healthcare professionals to manually tape or draw a physical line on the outside of the drip chamber to indicate where the infusion should begin. The healthcare professional must then reference the tape or physical line to check the fluid level in the drip chamber to determine if backflow is occurring. When the fluid eventually rises above the tape or line, the healthcare professional knows that backflow is occurring. Currently, manufacturers are working toward adding a physical line to the drip chamber to make it easier for healthcare professionals to visually detect backflow.

[0042] In contrast, the presently disclosed system easily addresses monitoring for potential reflux issues by having the camera 34 capture images of the drip chamber 16, determine the fluid level in the drip chamber, and send those images to the processor 26a. The processor 26a is programmed to continuously monitor and compare images to determine if reflux is occurring. Thus, the presently disclosed system will detect potential reflux sooner than a medical professional who must continually check for a problem with the fluid level in the drip chamber 16. Furthermore, the system automatically provides a visual or audio alert to the medical professional so that corrective action can be taken immediately. Furthermore, the system can be programmed to automatically stop the infusion if reflux is detected.

[0043] As described above, the camera 34 is used to monitor and verify the status of the drip chamber 16 by reading the fluid level therein. A fluid level threshold is programmed into the processor 26a to establish a fluid level threshold for the drip chamber 16. The camera 34 functions as a fluid level sensor in that it substantially continuously observes and monitors the actual fluid level within the drip chamber 16 and provides relevant data to the processor 26a. If the actual fluid level within the drip chamber 16 rises to a level that exceeds a predetermined or programmed fluid level threshold, a backflow condition may occur within the drip chamber 16. If such a condition occurs, an automatic backflow alarm is activated within the system. The system notifies medical personnel with an automatic alarm or notification indicating a potential backflow problem in the drip chamber 16 that requires attention. The alarm may be in the form of an audible alarm emitted by an appropriate component within one or more of the drip chamber 16, the housing assembly 22, the HMI 28, and the computing system 30. The alert may additionally or alternatively be a visual alarm in the form of a text message displayed on the screen 28a of the HMI 28 and the screen of the computing system 30. The alert may additionally or alternatively be a visual alert in the form of a real-time image of the drip chamber 16 provided by the camera 34 and displayed on the screen 28a of the HMI 28 and / or the screen of the computing system 30. In particular, the visual image captured by the camera 34 will indicate the actual fluid level as well as the programmed fluid level threshold. The alert displayed on the screen 28a of the HMI 28 and / or the screen of the computing system 30 may include specific instructions for the healthcare professional to follow to resolve the potential reflux issue. As part of these instructions, the healthcare professional may be alerted to physically check the patient's condition. The system-provided instructions may also instruct the healthcare professional on how to adjust the infusion delivery parameters to address the reflux condition that may have triggered the alarm. In other cases, the healthcare professional may simply adjust the infusion delivery parameters according to their training.

[0044] It should be appreciated that in some embodiments, drip chamber 16 can be equipped with a non-contact liquid level sensor (not shown) separate from camera 34. If the actual liquid level in drip chamber 16 exceeds a predetermined (i.e., pre-programmed) height, a backflow alarm is activated based on data provided to processor 26a from the liquid level sensor. This alarm is similar to the backflow alarms and alerts described above when camera 34 is used as the liquid level sensor. If such an alarm is activated by the non-contact liquid level sensor, real-time video from camera 34 is provided to HMI 28 and / or computing system 30 to assist medical personnel in determining the most appropriate course of action.

[0045] As best shown in FIG. 3A , the drop counter 20 also includes a pair of infrared sensors 36 mounted in recesses 32n formed in the first and second jaws 32k′ and 32k″. The infrared sensors 36 individually detect droplets “F1” and “F2” that land in the interior region 16d of the drip chamber 16 and transmit information about the collected droplets “F1” and “F2” to the PCB 26. The PCB 26 activates the camera 34 to take a photograph or collect other data about each droplet when a droplet enters the camera's field of view 34a. The drop data collected by the infrared sensors 36 and / or the camera 34 is used to count the number of droplets “F1” and “F2” that enter the drip chamber 16 within a predetermined time period. The time can be monitored by appropriate components within the drop counter 20 or by programming within the processor 26a. The drop counter 20 communicates the number of counted drops within a preset time range to the processor 26a. In particular, drop counter 20 communicates electronically with processor 26a. Preferably, drop counting by drop counter 20 occurs in real time, and electronic communication "EC" with PCB 26 also occurs in real time. Instead of electronically communicating the number of drops counted within a preset time range to PCB 26, that information may additionally or alternatively be electronically communicated to HMI 28, or to remote computing system 30 if operation of system 10 is controlled by HMI 28 or remote computing system 30 rather than by processor 26a.

[0046] It should be further understood that, in addition to the camera 34, level sensor, and other sensors previously described, the system may also include one or more air bubble detection sensors (not shown) and associated programming integrated into the processor 26a. Each air bubble detection sensor serves to determine whether air bubbles are trapped in the fluid traveling through the tubing 18. The sensors may also be able to determine whether air is trapped in the fluid within the tubing 18. The system is configured to automatically issue an appropriate alert upon detection of air or bubbles in the fluid within the tubing 18, which may include an audible or visual alarm similar to that generated when backflow is detected. The audio alarm for bubbles or air may be generated in a different sound than the alarm generated by the system when backflow is detected. Upon receiving the alert, medical personnel can take corrective action to remove the air or bubbles from the fluid within the tubing 18. In addition to generating an automatic alert, the system may also be programmed to automatically stop the infusion upon detection of air or bubbles, allowing medical personnel time to take appropriate action.

[0047] Additionally, one or more pressure sensors (not shown) may be provided in various suitable locations within system 10, such as drip chamber 16, housing assembly 22, and / or roller clamp assembly 24. Processor 26a is configured with appropriate programming to respond to data provided by one or more pressure sensors. Each pressure sensor operates in conjunction with processor 26a and is configured to detect the actual pressure within tubing 18. The programming uses the data provided by the pressure sensors to determine whether the pressure within tubing 18 has increased or decreased relative to a predetermined or preprogrammed pressure. An increase in pressure may indicate a possible obstruction or blockage within tubing 18. A decrease in pressure may indicate a leak in tubing 18 or another portion of the system (e.g., drip chamber 16). If the pressure exceeds a first threshold or falls below a second threshold, the system is programmed to generate an alert or alarm and automatically stop the infusion to allow medical personnel time to take appropriate action. The audio alert or alarm generated by the system may be different from other alerts or alarms generated by the system upon detection of reflux, bubbles, or air. In some embodiments, only one audio alert may be generated for all problems detected by the system, and the healthcare professional determines the nature of the problem by viewing a visual alert on the HMI or by physically viewing the patient and various components of the system held on the IV stand.

[0048] As described below, photographs and / or other drip data collected through operation of the camera 34 and infrared sensor 36 are electronically transmitted to the processor 26a. The processor 26a is programmed to utilize patient data to calculate an infusion rate based on the total volume of fluid to be administered and the patient's prescription. The processor 26a's programming calculates a desired drip rate and uses this data to determine a desired position for the roller clamp 46. Once the desired drip rate is calculated, the drip is set up by hanging the IV bag 14 on the IV stand 12, connecting the drop counter 20 to the drip chamber 16, inserting the tubing 18 into the roller clamp 46, and inserting the luer into the patient's body. The drip process then begins. When fluid begins dripping from the IV bag 14 into the drip chamber 16, the drop counter 20 begins drip detection and monitoring. As described above, the drop counter 20 measures the drip rate and monitors the drip status. The drop counter 20 sends the drop data to the processor 26a, which uses the patient data and the drop data to determine the appropriate position for the roller clamp 46. Once the appropriate position for the roller clamp 46 is determined, the processor 26a activates the drive mechanism to move the roller clamp 46 to the determined position in real time. The real-time data and drop status can be sent back to the mobile HMI or remote centralized computing system 30 for the medical personnel.

[0049] It should be noted that programming for calculating the desired position of the roller clamp 46 may be provided on the HMI 28 rather than the PCB 26. In such cases, collected data may be transmitted directly from the drop counter 20 to the HMI 28 or from the PCB 26 to the HMI 28. Even if programming for calculating the desired position of the roller clamp 46 is uploaded to the processor 26a, collected photographs and other data may be transmitted directly to the HMI 28 or via the PCB 26 for storage or later analysis. Collected photographs and other data may additionally or alternatively be transmitted directly from the drop counter 20, PCB 26, or HMI 28 to the remote computing system 30. Collected photographs and other infusion data may be stored in the memory of the remote computing system 30 or analyzed to inform algorithms on how to more accurately and reliably control the system 10. In some embodiments, programming for controlling delivery of infusion fluid from the IV bag 14 to the patient “P” may be provided on the remote computing system 30 rather than on the processor or processor 26a of the drop counter 20 or on the HMI 28.

[0050] 1, 2, and 4B, the housing assembly 22 and the roller clamp assembly 24 are shown in greater detail. The housing assembly 22 includes an outer housing 40 (FIG. 2) that at least partially encloses and protects an inner housing 42 (FIG. 4). The outer housing 40 includes a first wall 40a and a second wall 40b opposite the first end 40c, a second end 40d opposite the first side 40e, and a second side 40f opposite the first side 40e. The outer housing 40 may have an opening or window 40g (FIG. 2) formed in the first wall 40a through which a portion of the inner housing 42 and the roller clamp assembly 24 are visible. Each of the first end 40c and the second end 40d defines an opening 40h through which the tubing 18 extends when the housing assembly 22 is engaged with the IV stand 12. The outer housing 40 is provided to enclose and protect the inner housing 42 and the roller clamp assembly 24, as will be described below. The outer housing 40 operatively engages the IV stand 12 via a mounting bracket "MB," only a portion of which is visible in Figure 2. It will be appreciated that any suitable type of mounting bracket "MB" may be engaged with the outer housing 40 to secure the outer housing 40 to the IV stand 12.

[0051] 4-4B, the inner housing 42 and roller clamp assembly 24 are shown in greater detail. The outer housing 40 has been omitted from these figures for clarity. The inner housing 42 is configured to be housed within an interior space (not shown) defined by the first wall 40a, the second wall 40b, the first end 40c, the second end 40d, the first side 40e, and the second side 40f of the outer housing 40. With particular reference to FIG. 4, the inner housing 42 comprises a frame having a first end 42a and a second end 42b longitudinally spaced apart from one another. A first support portion 42c and a second support portion 42d extend between the first end 42a and the second end 42b. The inner housing 42 is molded to include various recesses and openings necessary to accommodate the other components of the system 10. For example, the first end 42a, the second end 42b, the first support 42c, and the second support 42d define and form an opening 42e in the inner housing 42. The PCB 26 extends across the opening 42e and is secured to the first end 42a and the second end 42b in any suitable manner. The inner housing 42 further defines a channel 42f in each of the first end 42a and the second end 42b. These channels are aligned with one another and with a channel 40h defined in the outer housing 40 when the outer housing 40 is positioned around the inner housing 42. The purpose of the channels 40h, 42f will be explained below.

[0052] The inner housing 42 further defines slots 42g on the side surfaces of each of the first and second ends 42a, 42b. The slots 42g are aligned with each other, forming through-holes through which the rack support and rack move at the top end of the inner housing 42. A first recess 42h is defined in the first surface of each of the first and second ends 42a, 42b, and the first recesses 42h are aligned with each other. A second recess 42j is also defined in the first surface of each of the first and second ends 42a, 42b, and is laterally spaced from the first recess 42h. The purposes of the slots 42g, the first recess 42h, and the second recess 42j will be described below. Figure 4 shows a flange 42k extending outward from the second support portion 42d of the inner housing 42. The purpose of the flange 42k will be described below.

[0053] The roller clamp assembly 24 is housed within a space formed by the components that make up the frame of the inner housing 42. As noted above, with reference to FIG. 4, the roller clamp assembly 24 is comprised of a roller clamp 46, a holster 48, and a holder 50. It should be understood that the specific configuration of the roller clamp 46 shown in the accompanying figures is illustrative of a known type of roller clamp currently available on the market. Roller clamps of different configurations than those illustrated herein may be used in the infusion system 10, and the specific clamp configurations illustrated and described herein do not limit the scope of protection of the present disclosure.

[0054] As shown in FIGS. 4, 4A, and 4B, the case 48 is a generally U-shaped component when viewed from the front. The holster 48 includes a spine 48a, a first end region 48b, and a second end region 48c. The first end region 48b and the second end region 48c are located at opposite ends of the spine 48a. The first end region 48b is generally U-shaped when viewed from above (as shown in FIG. 4) and includes a first arm 48b' and a second arm 48b'' partially separated from each other by a gap 48b'''. The length of the first arm 48b' is shorter than the length of the second arm 48b''B. The gap 48b''' is positioned to at least partially align with channels 42f, 40h defined in the inner housing 42 and the outer housing 40, respectively. The second end region 48c of the holster 48 is U-shaped when viewed from above (see FIG. 4) and includes a first arm 48c' and a second arm 48c''. A gap 48c''' is formed between the first arm 48c' and the second arm 48c'', and this gap 48c''' is at least partially aligned with the gap 48b''' and the channels 42f, 40h formed in the inner housing 42 and the outer housing 40, respectively.

[0055] As shown in FIGS. 4A and 4B, the roller clamp 46 is configured to be received within and operatively engaged with a holster 48. FIGS. 4-4B illustrate the roller clamp 46, which includes a body having a first end 46a and a second end 46b. A hole 46c is defined by the body of the roller clamp 46 and extends from an opening in the first end 46a to an opening defined in the second end 46b. A slot 46d is formed in the body of the roller clamp 46. Specifically, the slot 46d is formed in a side of the roller clamp 46 that is located away from the spine 48a of the holster 48 when the roller clamp 46 is engaged with the holster 48. The slot 46d begins at a position close to the interior of the end surface 46a' of the first end 46a of the body and ends at a position close to the interior of the end surface 46b' of the second end 46b of the body. The slot 46d is in fluid communication with the hole 46c. The purpose of the slot 46d will be described below.

[0056] The body 46 includes a flange 46e that slides under the first end 48b of the holster 48 when the system 10 is assembled and the roller clamp 46 is engaged with the holster 48. When the roller clamp 46 is engaged with the holster 48, the first end 46a of the roller clamp 46 is positioned below the underside of the first end 48a of the holster 48, and the second end 46b of the roller clamp 46 is at least partially received within a gap 48c''' in the second end 48c of the holster 48. When the roller clamp 46 is engaged in the holster 48 in this manner, the holes 46c of the roller clamp 46 are at least partially aligned with the gaps 48b''' and 48c''' in the holster 48. This places the holes 46c at least partially in alignment with the channels 42f and 40h in the inner and outer housings 42 and 40, respectively.

[0057] At least a portion of the hole 46c formed in the roller clamp 46 is defined by an inner wall 46f (FIG. 4B). The inner wall 46f may be slightly inclined relative to the end surface 46b' of the second end 46b of the roller clamp 46. When the roller clamp 46 is engaged with the holster 48, the region of the inner wall 46f near the first end 46a of the roller clamp 46 is positioned closer to the spine 48a of the holster 48 than the region of the inner wall 46f near the second end 46b of the roller clamp 46. This positioning of the inner wall 46f causes the cross-section of the hole 46c to taper from the first end 46a to the second end 46b of the roller clamp 46. The reason for the slight inclination of the inner wall 46f, and therefore the tapering of the hole 46c, will be explained later. In other configurations of the roller clamp 46, a groove (not shown) extending outward from the inner wall 46f may be formed on the opposite side of the roller clamp 46. The groove is in fluid communication with the hole 46c and the slot 46d. The roller 46h is at least partially contained within the hole 46c, with a portion of the roller 46h protruding outward from the body of the roller clamp 46 through the slot 46d of the roller clamp 46. Figure 4 shows the roller 46h exploded from the roller clamp 46. Although not shown here, it should be understood that the circumferential surface of the roller 46h may be knurled, since the roller 46h will typically come into contact with a person's fingers when pressing and rotating the roller 46h against the body of the roller clamp 46.

[0058] When the roller clamp 46 is held within the holster 48, the tube 18 passes through the channel 40h in the first end 40c of the outer housing 40, through the channel 42f formed in the first end 42a of the inner housing 42, through the gap 48b''' in the holster 48, through the hole 46c in the roller clamp 46, exit through the gap 48c''' in the casting 48, through the channel 42f defined in the second end 42b of the inner housing 42, and through the channel 40h in the second end 40d of the outer housing 40. When the tube 18 is passed through the hole 46c in the roller clamp 46, its roller 46h contacts the outer surface of the tube 18.

[0059] The roller clamp 46 is engaged within the holster 48 as described above, and the holster 48 is held in position between the first end 42a and the second end 42b of the inner housing 42 by the holder 50. The holder 50 has a first end 50a and a second end 50b. The first end 50a and the second end 50b are configured to be received within a first recess 42h formed by the first end 42a and the second end 42b of the inner housing 42. The thumbscrew 52 passes through holes (not numbered) defined in the first end 50a and the second end 50b of the holder 50 and is inserted into a hole (not numbered) formed in the first end 42a and the second end 42b of the inner housing 42 that form the first recess 42h. With the thumbscrew 52 attached, the holster 48 cannot be removed from the inner housing 42, and the roller clamp 46 is secured within the holster 48. When a user wants to remove or replace roller clamp 46, they loosen thumbscrew 52, ​​remove holder 50 from inner housing 42, and then remove holster 48 from the space formed between first end 42a and second end 42b of inner housing 42. Once holster 48 is removed from inner housing 42, roller clamp 46 can be removed from holster 48.

[0060] Referring to FIG. 4, a drive assembly 54 is shown including a rack support 54a with a rack 54b engaged therewith. The rack support 54a is configured to include a first end (unnumbered) that is received within a slot 42g formed in the first end 42a of the inner housing 42 and a second end (unnumbered) that is received within a slot 42g formed in the second end 42b of the inner housing 42. The fastening members 42m and 42n are used to secure the first and second ends of the rack support 54a in place within the inner housing 42. Specifically, the rack support 54a is held within the slot 42g formed in the inner housing 42, allowing the rack support 54a to slide relative to the first and second ends 42a and 42b. The rack 54b has a plurality of teeth 54b' that are horizontally oriented when the rack support 54a is vertically received within the slot 42g.

[0061] The drive assembly 54 further includes a pair of laterally spaced legs 54c, 54d (FIG. 4) extending outward beyond the surface of the rack support 54a opposite the surface on which the rack 54b is mounted. The legs 54c, 54d are substantially identically configured and laterally aligned with one another. A pair of pin rollers 54f, 54g extend between the opposing inner surfaces of the legs 54c, 54d. Each pin roller 54f, 54g includes a bearing disposed within an opening defined in the respective leg 54c, 54d and a pin extending between the oppositely aligned bearings. When the housing assembly 22 is assembled, the pins of the pin rollers 54f, 54g contact the roller 46h of the roller clamp 46. The pin rollers 54f, 54g are used to move the roller clamp 46 in either a first or second direction when the drive assembly 54 is actuated (as described below). Bridge portion 54h (FIG. 4) extends between legs 54c, 54d, a fixed lateral distance from pin rollers 54f, 54g, and adjacent rack support 54a. When roller clamp 46 and drive assembly 54 are engaged with inner housing 42, the upper surface of bridge portion 54h is adjacent first end 42a of inner housing 42, and the lower surface of bridge portion 54h is adjacent second end 42b of inner housing 42.

[0062] 4-4B show that the drive assembly 54 further includes a pinion gear 54j attached to a flange 42k extending outward from the second support portion 42d of the inner housing 42. The pinion gear 54j includes teeth 54h' configured to mesh with the teeth 54b' of the rack 54b. The motor 56 is operatively engaged with the pinion gear 54j and can rotate the pinion gear 54j in a selected direction from a first direction "A" (FIG. 4A) and a second direction "B" via a drive shaft 56a. As the pinion gear 54j rotates in the first direction "A," the rack 54b, and therefore the rack support portion 54a, passes through the slots 42g in the first and second ends 42a and 42b of the inner housing 42 and moves downward in a direction "C" relative to the first and second ends 42a and 42b. Rotation of pinion gear 54j in an opposite second direction "B" moves rack 54b, and therefore rack support 54a, upward in direction "D" through slot 42g relative to first and second ends 42a, 42b of inner housing 42. As rack support 54a moves downward in direction "C," rollers 46h rotate in direction "E" (FIG. 4B) and move downward along tube 18, reducing the effective diameter of tube bore 18a. As rack support 54a moves upward in direction "D," rollers 46h rotate in direction "F" (FIG. 4B) and move upward along tube 18, increasing the effective diameter of tube bore 18a.

[0063] 4-4B show first limit switch 58 and second limit switch 60 engaged within second recess 42j defined by first end 42a and second end 42b of inner housing 42. First limit switch 58 is configured to contact the underside of bridge portion 54h extending between legs 54c and 54d when rack support 54a descends in direction "C" in response to rotation of pinion gear 54j in direction "A." Second limit switch 60 is configured to contact the upper surface of bridge portion 54h when rack support 54a ascends in direction "D" in response to rotation of pinion gear 54j in direction "B."

[0064] As described above, roller 46h is operatively engaged with legs 54c, 54d and is biased to rotate in a direction that engages roller clamp 46 by pin rollers 54f, 54g. Pin rollers 54f, 54g help roller 46h to rotate smoothly in both directions "E" and "F" about axis "X" (FIG. 4B). As tube 18 abuts inner wall 46f of roller clamp 46, legs 54c, 54d and pin rollers 54f, 54g provided thereon tend to urge roller 46h into contact with tube 18. As rack support 54a, and thereby legs 54c, 54d, move downward in direction "C" in response to rotation of gear 54j in direction "A," the angle of inclination of inner wall 46f causes roller 46h to compress tube 18, thereby narrowing bore 18a (FIG. 4B) through tube 18. As hole 18a narrows, the flow rate of infusion fluid "F3" traveling from drip chamber 16 through tubing 18 toward the luer at the patient end of tubing 18 decreases. Continued movement of rack support 54a in direction "C" may eventually completely stop all flow of infusion fluid through hole 18a in tubing 18. When limit switch 58 contacts bridge portion 54h of drive assembly 54, power from motor 56 is interrupted, stopping rotation of pinion gear 54j in direction "A." This stops movement of rack support 54a in direction "C."

[0065] Furthermore, as the rack support 54a, and thus the legs 54c and 54d of the adjustment assembly, move in direction "D" in response to rotation of the pinion gear 54j in direction "B," the tilt angle of the clamp's inner wall 46f causes the roller 46h to slightly compress the tubing 18. As a result, the flow rate of the infusion solution "F3" from the drip chamber 16 through the hole 18a in the tubing 18 tends to increase. As the rack support 54a continues to move in direction "D," the bridge 54h of the drive assembly 54 contacts the limit switch 60. This contact interrupts power from the motor 56 to the pinion gear 54j, stopping the rotation of the pinion gear 54j in direction "B." When the pinion gear 54j stops rotating, the movement of the rack support 54a in direction "D" also stops.

[0066] A healthcare professional can utilize the HMI 28 (FIG. 1) to set and / or adjust the desired flow rate of infusion fluid "F3" from the drip chamber 16 through the tubing 18 for a particular patient "P." Once patient data (including treatment data) is entered into the HMI 28, the system automatically operates to administer the appropriate volume of infusion fluid to the patient "P." The HMI 28 is an electronic device such as a smartphone, tablet, or other type of handheld computing system capable of communicating with a processor 26a (FIG. 4) on the PCB 26, as indicated by "EC" in FIG. 1. Communication "EC" is preferably achieved wirelessly, but may also be achieved via a wired connection in some cases. One or both of the HMI 28 and the processor 26a are provided with programming configured to control various components of the system 10. For example, an application or other programming configured to control the system 10 can be downloaded to the HMI 28. The healthcare professional then uses the user interface 28a of the HMI 28 to input the patient and treatment data into the application or programming. The patient data may include information such as the dosage of fluid to be delivered to the patient via system 10. The entered patient data is used to set the flow rate of fluid "F3" delivered to patient "P" so that the appropriate volume of fluid is delivered to the patient.

[0067] When the user sets the patient "P" flow rate on the HMI 28, that information is communicated via "EC" to the processor 26a on the PCB 26. Programming provided to the processor 26a (or programming in the HMI 28 accessible to the processor 26a via connection "EC") activates the drop counter 20, which counts the number of droplets "F1," "F2" (Figure 2), etc., that are dropped into the drip chamber 16 within a preset time period. The number of droplets counted by the drop counter 20 is wirelessly transmitted to the processor 26a. Programming in the processor 26a or HMI 28 (or programming in the computing system 30) activates the motor 56 as needed to position the roller 46h relative to the roller clamp 46 to achieve the desired flow rate at the patient-side luer of the tubing 18. If the flow rate of the infusion fluid through the tubing 18 needs to be reduced, the motor 56 rotates the gear 54j in the "A" direction (Figure 4B). As described above, rotation of the gear 54j in the "A" direction moves the rack support 54a in the "C" direction. This causes roller 46h to move downward in direction "C" along sloped inner wall 46f of roller clamp 46. As roller 46h moves in direction "C," roller 46h compresses tubing 18, slowing the flow of infusion fluid through tubing 18. Motor 56 rotates gear 54j in direction "A" to an extent that a desired flow rate of infusion fluid through the tubing is achieved, based on programming. Once the desired flow rate is achieved, motor 56 stops rotating gear 54j, thereby fixing the position of roller 46h relative to roller clamp 46 and maintaining the flow rate through tubing 18.

[0068] If the healthcare professional later determines that the flow rate of the infusion fluid through the tubing 18 needs to be increased or decreased, the healthcare professional operates the user interface 28a of the HMI 28 to adjust the flow rate accordingly. A signal is transmitted from the HMI 28 to the PCB 26 via "EC." The PCB 26 then activates the motor 56 to rotate in the required direction "A" or "B" to change the flow rate. For example, if the healthcare professional determines that the flow rate of the infusion fluid through the tubing 18 needs to be decreased, the PCB 26 activates the motor 56 to rotate the gear 54j in direction "A." As the gear 56j rotates in direction "A," the rack support 54a moves in direction "C." As the rack 54a moves in direction "C," the roller 46h rotates in direction "E," moving in direction "C" along the inner wall 46f of the clamp. This increases the compression of the tubing 18 by the roller 46h, effectively reducing the size of the hole 18a in the tubing 18. As a result, the flow rate of the infusion fluid through the tubing 18 decreases. On the other hand, if the medical professional determines that the flow rate of the infusion fluid through the tubing 18 should be increased, the PCB 26 drives the motor 56 to rotate the gear 54j in the "B" direction. As the gear 56j rotates in the "B" direction, the rack support 54a moves in the "D" direction. As the rack 54a moves in the "D" direction, the roller 46h rotates in the "F" direction and moves in the "D" direction along the inner wall 46f of the clamp. This reduces the compression of the tubing 18 by the roller 46h, effectively expanding the size of the hole 18a in the tubing 18. As a result, the flow rate of the infusion fluid through the tubing 18 increases. When the preset desired flow rate is reached, the PCB 26 sends a signal to the motor 56, turning it off. As a result, the position of the roller 46h relative to the roller clamp 46 is fixed, and the flow rate through the tubing 18 is maintained.

[0069] Programming allows for continuous real-time monitoring of the information provided by the drop counter 20. Additionally, programming allows for real-time adjustment of the position of the roller clamp 46 by selectively activating the motor 56 to selectively rotate the gear 54j in either direction "A" or "B" as needed. When the drop counter 20 detects an increased rate of dripping of droplets "F1" and "F2" from the IV bag 14 into the drip chamber 16, a signal is automatically sent from the PCB 26 to the motor 56, which activates the motor 56 to rotate the gear 54j in the required direction to maintain the flow rate from the tubing 18 at a preset rate. Activating the motor 56 changes the position of the roller 46h relative to the roller clamp 46, adjusting the flow rate through the tubing 18 as needed. Once the roller 46h is moved to its new relative position, the motor 56 is stopped, and the flow rate through the tubing is maintained at the desired rate. Upon initial input of patient data and the desired flow rate of fluid from the IV bag 14 into the HMI 28, the system 10 automatically monitors the flow rate and adjusts the position of the roller clamp 46 to meet the input desired flow rate.

[0070] If the IV bag 14 is substantially empty, or if some problem occurs with the IV bag that causes the drop counter 20 to no longer count drops, that information is sent via "EC" to the PCB 26 (or HMI 28, or remote computing system 30). The system 10 then automatically issues an alarm so that medical personnel are paged. This alarm may be a visual or audible alarm, or it may take the form of an electronic communication such as a text message, automated voice message, or the like.

[0071] It will be appreciated that the HMI 28 can be used to monitor and automatically control multiple infusion delivery systems for multiple different patients. Patient data and desired infusion flow rates for each patient are entered into the HMI 28 via the user interface 28a, and the HMI 28 or programming of the PCB 26 of each system 10 automatically monitors and controls the delivery of infusion fluids to the patients connected to that system. Thus, a single medical professional can be responsible for the delivery of infusion fluids to multiple patients in real time.

[0072] The remote computing system 30 can form part of a single system 10 or can be electronically connected to multiple identical systems. The remote computing system 30 can be utilized to provide programming for the various systems and control the operation of their components. Alternatively, or additionally, the remote computing system 30 can be utilized to store information about the patient and their desired infusion therapy. Alternatively, or additionally, the remote computing system 30 can include programming for analyzing data collected by drop counters, clamp positioning, etc., to ensure the system accurately and reliably delivers the desired infusion rate to the patient. The remote computing system 30 can also be utilized to monitor and instruct multiple healthcare professionals at different locations substantially simultaneously.

[0073] 5-5D, a second embodiment of a portion of a housing assembly for use in system 10 according to the present disclosure is shown. In particular, FIGS. 5-5D show an inner housing 142, a roller clamp assembly 124, and an adjustment assembly 154 according to the present disclosure. (It should be understood that, although not shown in these figures, the housing assembly of FIGS. 5-5D includes a processor similar to processor 26a shown in FIG. 4.) Inner housing 142 is identical in structure and function to inner housing 42 and will not be described in further detail here. Similarly, roller clamp assembly 124 is identical in structure and function to roller clamp assembly 24. Roller clamp assembly 124 will not be described in further detail here, other than to reiterate that the holster forming part of the housing assembly is a universal holster capable of receiving roller clamps of any configuration and serves to secure various roller clamps in place within the housing assembly in a position where the roller wheels of the retained roller clamps can be contacted and adjusted by adjustment assembly 154. Adjustment assembly 154 includes many components that are identical in structure and function to drive assembly 54, and therefore these components will not be described in further detail here.

[0074] 5-5D, adjustment assembly 154 includes rack support 154a having rack 154b mounted thereon. Rack support 154a is configured to include a first end (not numbered) that is received within slot 142g (FIG. 5A) formed in a first end of inner housing 142, and a second end (not numbered) that is received within opposite slot 142g formed in a second end of inner housing 142. Rack support 154a engages within inner housing 142 in the same manner that rack support 54a engages within inner housing 42. Fixing members 142m and 142n are used to secure the first and second ends of rack support 154a within inner housing 142, in the same way that fixing members 142m and 142n secure rack support 54 to the inner housing. Rack 154b includes a plurality of teeth 154b' that face horizontally when the housing assembly is engaged with the IV support and positioned beneath the IV bag 14 as shown in FIG. 1. In particular, the plurality of teeth 154b' face horizontally when rack support 154a is vertically received within slot 142g of inner housing 142. The structure and function of rack 154b are identical to those of rack 54b, and therefore will not be described in further detail here.

[0075] Adjustment assembly 154 differs from adjustment assembly 54 in several ways, which are described below.

[0076] First, instead of the rack support 54 being provided with a pair of laterally spaced legs 54c, 54d, the adjustment assembly 154 includes an adjustment housing 154k of a different configuration. The adjustment housing 154k extends outward from a surface of the rack support 154a opposite the surface on which the rack 154b is provided. The adjustment housing 154k extends from the rack support 154a toward the roller clamp 146. The roller clamp 146 and its roller 146h are substantially identical in structure and function to the roller clamp 46 and its roller 46h, and therefore will not be described in further detail herein. Of course, it will be understood that the specific configurations of the roller clamps 46, 146 and rollers 46h, 146h shown herein are merely exemplary, as the holsters 48, 148 provided in the housing assembly are configured to receive and secure any of a variety of different roller clamp configurations.

[0077] As best shown in FIGS. 5B and 5C, the adjustment housing 154k has a pair of slots 154k' that begin at an opening formed in the surface of the adjustment housing 154k opposite the roller clamp 46. The first plunger 154m is located in the first of the two slots 154k', and the second plunger 154m is located in the second of the two slots 154k'. The two slots 154k', i.e., the first and second plungers 154m, 154n, are vertically spaced apart and aligned with each other. A first coil spring 154p is located in the first slot 154k' to receive the first plunger 154m and bias the first plunger 154m toward the roller clamp 146. Similarly, a second coil spring 154q is provided in the second slot 154k' and biases the second plunger 154n toward the roller clamp 146. A first end cap 154m' is provided at the free end of the first plunger 154m, and a second end cap 154n' is provided at the free end of the second plunger 154n.

[0078] As shown in FIG. 5D, when the adjustment assembly 154 is viewed from above, the first end cap 154m' and the second end cap 154n' each have a U-shape. A first bearing assembly 154r is mounted on the first end cap 154m', and a second bearing assembly 154s is mounted on the second end cap 154n'. The first bearing assembly 154r and the second bearing assembly 154s are comprised of aligned bearings that fit into openings defined in opposite legs of the respective U-shaped caps and a pin that extends between the bearings and spans the distance between the bearings. In particular, the first cap 154m' includes a bearing 154r' and a pin roller 154r'', and the second end cap 154n' includes a bearing 154s' and a pin roller 154s''. The pin rollers 154r'' and 154s'' are covered with an elastic outer layer, which is best seen in FIG. 5A. In one embodiment, the elastic outer layer is comprised of rubber. The rubber is provided to improve the ability of each pin roller 154r″ and 154s″ to grip the circumferential surface of roller 146h. As shown in FIGS. 5-5D , pin rollers 154r″ and 154s″ contact the surface of roller 146h at spaced apart locations. In particular, pin rollers 154r″ and 154s″ contact the circumferential surface of roller 146h at spaced apart locations. Note that the distance between the legs of the U-shaped first end cap 154m′ and second end cap 154n′ is slightly greater than the width of roller 146h on roller clamp 146. When adjustment assembly 154k contacts roller 146h, a portion of the circumferential surface of roller 146h fits into the gap between the two legs of first end cap 154m′ and second end cap 154n′ and contacts the elastic outer layers of pins 154r″ and 154s″.

[0079] Springs 154p, 154q bias first and second plungers 154m, 154n into operative engagement with roller 146h, biasing roller 146h toward roller clamp 146. Springs 154p, 154q allow the contact points between plungers 154m, 154n and roller 146h to move vertically relative to roller clamp 146h to accommodate different exterior profiles of roller clamps of various configurations. When roller clamps 146 of different configurations are engaged with the housing assembly, first plunger 154m and second plunger 154n can be adjusted to extend further outward or retract further outward from adjustment assembly 154. Adjustment of first plunger 154m and second plunger 154n adjusts the relative positions of first pin roller 154r'' and second pin roller 154s''. The elastic outer layers of pins 154r″ and 154s″ directly contact roller 146h, allowing roller 146h to easily rotate about axis “X1” ( FIG. 5A ) when adjustment assembly 154 moves upward in the direction of arrow “D” or downward in the direction of arrow “C.” Due to the direct contact between pins 154r″ and 154s″ and roller 146h, roller 146h is also pushed (or carried) upward or downward as adjustment assembly 154 moves in directions “D” or “C.” As adjustment assembly 154 and roller 146h move upward or downward relative to roller clamp 146, different forces may be applied to first plunger 154m and second plunger 154n as roller 146h moves relative to roller clamp 146. Springs 154p, 154q are slightly compressed inward toward rack 154b and then can return to their original, uncompressed state when these different forces are applied. For example, Figure 5C shows that first end cap 154m on first plunger 154m is moved inward toward rack 154b in the direction indicated by arrow "G" as the associated spring 154p is slightly compressed by the force applied to first plunger 154m by contact with roller wheel 146h. It will be appreciated that when the adjustment assembly 154 is moved in the direction opposite arrow "D" to release that force, spring 154p returns to the uncompressed state shown in Figure 5B.Because the springs 154p, 154q are compressed based on the force experienced by the first plunger 154m and the second plunger 154n, the contact between the first and second plungers 154m, 154n and the roller wheel 146h feels more like the light and firm feel of a human finger pushing and rotating the roller wheel 146h than would be the case without the spring-loaded plunger mechanism.

[0080] As the roller 146h rotates and is forced upward by the first plunger 154m and the second plunger 154n toward the first end 146a of the roller clamp 146, the roller 146h moves further away from the tubing 18, allowing the infusion fluid to flow more freely through the tubing 18. As the roller 146h rotates and is forced downward by the first plunger 154m and the second plunger 154n toward the second end 146b of the roller clamp 146, the roller 146h moves closer to the tubing 18, deforming the tubing 18 and reducing the flow rate of the infusion fluid through the tubing 18. The engagement of the adjustment assembly 154 and its two independently operable plungers 154m, 154n closely mimics the soft yet firm feel of a human finger manipulating the roller 146h. This type of push and turn operation of roller 146h allows for precise adjustment of the position of roller 146h relative to roller clamp 146, thus allowing for more precise control of the flow rate of infusion fluid through tubing 18 than conventional systems that require manual operation of the roller clamp.

[0081] Limit switches 158, 160 are provided to limit the range of travel of adjustment assembly 154, functioning similarly to limit switches 58, 60 that limit the range of travel of adjustment assembly 54. Limit switches 158, 160 also help the processor determine the desired and actual positions of roller 146h. To more accurately map the forces within the system and identify the position of the rollers, the system may also be provided with strain gauges (not shown) to measure the forces on first plunger 154m and second plunger 154n. The purpose of the disclosed system is to provide finger-like control of roller 146h and prevent excessive stress on roller 146h and roller clamp 146.

[0082] Mechanically operating the roller 146h increases the likelihood of overuse. Therefore, to prevent overuse of the roller clamp 146, the system must count the number of times the roller 146h rolls up or down relative to the roller clamp 146. The roller 146h is not intended to rotate continuously. Therefore, the housing assembly shown in FIGS. 5-5D can be provided with a dedicated counter that counts the number of times the adjustment assembly 154 is used to position the roller 146h. This counter can be provided in any suitable location within the housing assembly, either as a programming function provided to the processor or as a physical counter attached to a physical component within the housing assembly. An optical sensor or other type of sensor can be used as part of the counter or in combination with the counter. If the number of times the roller has been rotated by the counter exceeds a predetermined threshold, the processor determines that there is a malfunction in the roller clamp 146 or a problem with the IV set. In such a case, the HMI can send an error message to a healthcare professional monitoring the system or sound an appropriate alert or alarm.

[0083] Another problem that regularly occurs with gravity infusion systems is that the rollers' contact with the tubing can cause the tubing to deform over time. This deformation is called creep. In conventional gravity IV sets, a healthcare professional monitoring the patient would release the roller clamp and adjust the roller clamp by sliding the tubing relative to the roller clamp until it was positioned adjacent to the undeformed tubing. The gravity infusion systems disclosed herein are contemplated to include a mechanism for temporarily releasing the rollers 46h, 146h from the tubing and then sliding or rocking the tubing relative to its respective housing assembly to move the undeformed length of tubing into the roller clamp hole 146d. For example, FIG. 5D shows a tube displacement mechanism, or "jogging mechanism," 156 utilized to displace the tubing 18 when the portion of the tubing engaged with the roller clamp assembly becomes deformed. The tube displacement mechanism 156 moves in the direction indicated by arrow "H" in FIG. 5D to engage or grip the tubing 18 above and below the roller clamp 146. Arrow "J" indicates the possible movement of the tube 18 relative to the inner housing 142 when the jogging mechanism 156 is activated. If creep or deformation of the tube 18 is determined to be occurring, the roller 146h is moved by the adjustment assembly 154 to a position where the roller 146h has little or no contact with the tube. The jogging mechanism 156 is activated to grasp the tube 18 and pull a length of the tube 18 up or down, as indicated by arrow "J," relative to the roller clamp 146 so that the undeformed portion of the tube 18 is positioned within the bore of the roller clamp 146. The jogging mechanism 156 then releases the tube 18 (moving in the direction opposite arrow "H"), and the adjustment assembly 154 is activated to re-engage the roller 146h with the tube 18 within the roller clamp 146. This jogging process is controlled by processor programming.

[0084] Referring now to FIG. 6, a prior art method for administering fluid to a patient is shown and generally indicated at 200. In the first step of the prior art method, 202, a medical professional manually calculates a drip rate based on the patient's prescription. In step 204, a physician attaches an IV bag containing the fluid to be administered to the patient to an IV stand. A drip chamber is placed under the IV bag, and a roller clamp is mated to the tubing extending from the drip chamber. In step 206, the medical professional connects the IV bag to the patient by inserting luers at the ends of the tubing extending from the drip chamber and the IV bag. In step 208, the medical professional estimates the drip rate of the fluid to be administered to the patient by using a timing device, such as a watch, to count the number of droplets dripping from the IV bag into the drip chamber within a certain period of time. Using the information determined in step 208, the medical professional manually adjusts the position of the roller clamp to change the drip rate so that it matches the drip rate calculated in step 202. The manual adjustment of the roller clamp position is indicated at 210. In step 212, the healthcare professional determines whether the desired drip rate has been achieved. If the answer to the question in step 212 is "no," the healthcare professional returns to step 208, where the healthcare professional re-estimates the drip rate by manually counting the number of drops dripping into the drip chamber, and repeats steps 210 and 212. If the answer to the question in step 212 is "yes," in rare cases, all of the fluid in the IV bag is delivered to the patient, and the infusion continues until complete in step 214. In most healthcare settings, if the answer to the question in step 212 is "yes," a period of time will pass, and then in step 216 the healthcare professional will again reconfirm the drip rate by observing and manually counting the drips from the IV bag into the drip chamber over a period of time. In the next step 218, the healthcare professional compares the drip rate observed in step 216 with the drip rate in step 212 to determine whether the actual drip rate has changed. If the answer to this question is "yes," meaning that the drip rate has changed, steps 210 and 212 will be repeated.That is, the healthcare professional manually adjusts the position of the roller clamp to change the drip rate, adjusting it to match the drip rate calculated in step 202, and determines whether the desired drip rate has been reached. After a further period of time, steps 216 and 218 are repeated.

[0085] If the answer to the question of whether the drip rate has changed in step 218 is "no," a period of time passes and the healthcare professional determines whether the desired total volume of infusion (VTBI) has been reached in step 220. If the answer to the question in step 220 is "yes," the infusion is complete, similar to step 214.

[0086] As is evident from the above description of the prior art method 200, this infusion method is time consuming and highly dependent on the accuracy of calculations, observations, and judgments of medical personnel. Thus, the prior art method 200 introduces the potential for human error into the infusion process.

[0087] 7 and 1, a method of infusing a patient using the gravity infusion system 10 of the present disclosure is shown and generally designated 300. Method 300 includes a first step 302 in which a healthcare professional inputs patient data into a human-machine interface (HMI) 28 (FIG. 1). The patient data input into HMI 28 includes, among other information, the patient's infusion prescription. Alternatively, although not shown in FIG. 7, HMI 28 may access a database storing patient information, such as patient prescriptions, to retrieve patient data associated with the particular patient being treated.

[0088] In step 304, the medical professional attaches the IV bag 14 containing the liquid to be administered to the patient to the IV stand 12. The drip chamber 16 is positioned below the IV bag 14, and the drop counter 20 is connected to the drip chamber 16. Additionally, the roller clamp assembly 24 is attached to the IV stand 12 and connected to the tubing 18 extending from the drip chamber 16. In step 306, the medical professional connects the IV bag 14 to the patient by inserting a luer (not shown) provided at the end of the tubing 18 extending from the drip chamber 16.

[0089] As shown in FIG. 7, in the next step 308, system 10 is powered up, and programming in processor 26a automatically calculates the desired drip rate based on the patient's prescription entered into HMI 28, and the infusion begins. In step 310, drop counter 20 counts the number of droplets that drip by gravity into drip chamber 16 within a set time period to determine the liquid drip rate. Drop counter 20 transmits the drip rate data to processor 26a. In step 312, programming in processor 26a determines whether the desired drip rate has been reached by comparing the drip rate measured by drop counter 20 with the prescribed drip rate calculated in step 308. If the answer to the question in step 312 is "no," two paths are possible, as described below.

[0090] In the first path, in step 314, processor 26a automatically adjusts the position of roller clamp 46 of roller clamp assembly 24 to achieve the appropriate drip rate. System 10 then automatically checks the effectiveness of the adjustment of roller clamp 46 position, as shown at 316. This check involves system 10 automatically repeating steps 310 and 312 until the desired drip rate is achieved at step 312. In other words, the automatic adjustment of the roller clamp and automatic checking of its effectiveness is repeated until the answer to the question at step 312 is "yes." Once this occurs, the desired drip rate has been achieved, and the infusion continues, and the system monitors whether the total volume of infusion (VTBI) has been reached at step 320. If the answer to this question is "no," system 10 automatically repeats steps 310, 312, and 318 until the answer to the question at step 320 is "yes." If the VTBI has been reached, an alarm / alert is generated at step 322 to notify medical personnel that the infusion is complete. The alarm may be an audible sound and / or a visual message or image displayed on the HMI 28 and / or computing system 30. When the medical personnel receives the alarm / alert, the tubing 18, i.e., the IV bag, is removed from the patient.

[0091] If the answer to the question in step 312 is "No," a second path is shown in step 318. If the desired drip rate is not reached or if any change occurs, this may be due to an underlying problem with the system 10 that cannot be resolved by adjusting the position of the roller clamp in step 314. Such potential problems include, but are not limited to, problems related to backflow, bubbles, air, and / or high pressure in the lines. In practice, the system 10 periodically and / or continuously monitors these potential problems during the infusion, regardless of whether the answer to the question in step 312 is "Yes" or "No." The liquid level in the drip chamber 16 is periodically or continuously monitored by the system 10. Specifically, the camera 34 or a non-contact liquid level sensor detects the liquid level in the drip chamber 16, and if the liquid level in the drip chamber 16 exceeds a preset limit, backflow is detected by the system. The camera 34 or other sensor can be used to monitor the presence of bubbles or air in the lines. The system can also be equipped with a pressure sensor to monitor pressure changes in the tubing 18. Such periodic and / or continuous monitoring of the infusion is also illustrated in step 318 of method 300. If no potential problems are detected during normal infusion monitoring, or if the answer to the question of whether reflux, bubbles, air in the line, and / or high pressure is detected in step 312 is "no," the method illustrated in Figure 7 returns to step 310, proceeds to step 312, and ultimately to steps 320 and 322 described above.

[0092] However, if backflow, bubbles or air in the piping, or high pressure is detected during routine monitoring of the system 10, or if the answer to the question in step 318 was "yes," an alert is issued in step 324. In step 326, a medical professional is notified of the detected problem on the HMI 28, and the medical professional makes a decision regarding the detected problem. Note that as part of the alert issued in 324, visual information about the system may be provided to the operator on the HMI 28. For example, if high pressure is detected in the line (i.e., tubing 18) in step 318, the operator may check the tubing 18 for a clog and, if a clog is found, clear the clog or replace the tubing. Once the medical professional makes the necessary decision and takes the necessary action in step 326, the method returns to step 31, then proceeds to step 312, and ultimately to steps 320 and 322 as previously described.

[0093] As can be seen from FIG. 7 , the first task performed by a healthcare professional in method 300 is to input patient data, set up the IV bag 14, drip chamber 16, tubing 18, drop counter 20, and roller clamp 46, and then begin the infusion process. If the input patient data is accurate, system 10 automatically administers the prescribed amount of fluid over a predetermined period of time. If reflux or other problems are detected during the infusion, system 10 alerts the healthcare professional and prompts them to take the necessary steps to resolve the detected issue. Otherwise, the next time the healthcare professional interacts with system 10 is when the tubing 18 is removed from the patient. Considering the above-described method 300, it can be seen that the accuracy of infusions using system 10 is significantly improved compared to prior art method 200, significantly reducing the likelihood of human error in the infusion process. Furthermore, method 300 of the present disclosure allows a single healthcare professional to monitor the administration of fluids to multiple patients nearly simultaneously.

[0094] In summary, a method for controlling the flow rate of fluid to a patient "P" using an infusion system 10 including tubing 18 extending from an infusion bag 14 includes the steps of inputting patient data into a human-machine interface (HMI) 28 of the infusion system 10, receiving the patient data from the HMI and drip rate data from a drop counter 20 of the infusion system 10 at a processor 26a of the infusion system 10, analyzing the patient data and the drip rate data using programming in the processor 26a, and determining, using the programming in the processor 26a, an appropriate volume of fluid to be administered to the patient "P," i.e., a desired flow rate of fluid to be administered to the patient "P" by the infusion system 10 over a period of time. The method further includes automatically adjusting the position of a roller clamp 46 of the infusion system 10 in real time using a drive mechanism 54 operatively linked to the processor 26a, and delivering the appropriate desired volume of fluid from the infusion bag 14 through the tubing 18 to the patient "P." The drop counter 20 continuously monitors the drip rate in the drip chamber 16 in real time and continuously transmits the drip rate data to the processor 26a. The processor 26a continuously analyzes this data in real time and automatically adjusts the position of the roller 46h of the roller clamp 46 in real time to deliver the appropriate amount of fluid to the patient in real time. The HMI 28 may be operatively linked to a remote centralized computing system 30 configured to simultaneously monitor multiple identical systems being used to infuse fluids to different patients.

[0095] Automatically adjusting the position of the roller 46h of the roller clamp 46 includes rotating the pinion gear 54j in direction "A" or direction "B" and subsequently moving the rack support 54a in direction "C" or direction "D" to rotate the roller 46h in either the first direction or the second direction and correspondingly move the rack support 54a in direction "C" or direction "D." The automatic adjustment of the roller 46h includes bringing the tube 18, which passes through the hole 46c of the roller clamp 46, into contact with the roller 46h, changing the size of the hole 18a in the tube 18 as the roller 46h rotates in either the first direction or the second direction, and changing the flow rate of the liquid passing through the tube 18 to a desired flow rate in accordance with the change in the size of the hole 18a.

[0096] Receiving drip rate data from the drop counter 20 involves counting the number of drops "F1," "F2" flowing from the infusion bag 14 into the drip chamber 16 within a predetermined time period, transmitting the number of drops "F1," "F2" counted by the drop counter 20 from the drop counter 20 to the processor on the PCB 26, determining the flow rate of the liquid flowing from the drip chamber 16 through the tubing 18 using a program programmed into the processor, and automatically adjusting the position of the roller 46h relative to the roller clamp 46 without human intervention. If the flow rate of the liquid from the infusion bag 14 into the drip chamber 16 changes, the rate of change is detected by the drop counter 20 and transmitted to the processor on the PCB 26. The processor analyzes the patient data against the drip rate data, recalculates the required flow rate through the tubing, and makes the necessary adjustments to the roller 46h to achieve or maintain the desired flow rate to the patient "P." When the programming determines that roller 46h needs to be moved up or down relative to roller clamp 46, drive mechanism 54 is activated, causing motor 56 to drive pinion gear 54j in the required first direction "A" or second direction "B." Rotation of pinion gear 54j causes rack support 54a of drive mechanism 54 to move in the associated direction "C" or direction "D," as needed, depending on rotation "A" or "B." Thus, roller 46h rotates to a calculated position, affecting the flow rate of liquid through tubing 18. Adjustment of the position of roller 46h relative to roller clamp 46 is automatic, without human intervention.

[0097] As described above, conventional gravity infusion systems require healthcare professionals to manually determine roller clamp settings to administer the desired volume of fluid to a patient. Traditional methods of dose control can result in human error, resulting in too much or too little fluid being administered to a patient. By automating gravity infusion, the system 10 disclosed herein can reduce the likelihood of human error in administering fluid to a patient. System 10 can also increase the likelihood that the correct volume of fluid is administered to a patient. The ability to simultaneously monitor and control multiple identical systems improves efficiency and accuracy, allowing healthcare professionals to more effectively care for multiple patients simultaneously.

[0098] System 10 allows for more accurate infusion than is possible with conventional gravity infusion systems. The drip rate from an IV bag constantly changes due to tubing creep, patient movement, and changes in the height of the infusion bag. As a result, conventional systems require a healthcare professional to continually check or monitor the drip rate and adjust the roller clamp position appropriately. In contrast, system 10 is a closed-loop system that continuously monitors the drip feed rate and automatically adjusts the position of roller clamp 46 based on the real-time drip rate. This continuous monitoring and adjustment allows system 10 to ensure accurate infusion rates.

[0099] As described herein, embodiments of the present disclosure may include one or more electrical, pneumatic, hydraulic, or other similar secondary components and / or systems. Accordingly, the present disclosure should be construed and understood to include all components necessary for its operation. For example, an electrical component is understood to include all wiring, fuses, etc. necessary for its proper operation. Similarly, a provided pneumatic system may include secondary or peripheral components such as air hoses, compressors, valves, meters, etc. Furthermore, it should be understood that connections between various components not explicitly described herein may be made by any suitable means, including mechanical fasteners or permanent connection means such as welding. Alternatively, where feasible and / or desirable, the various components of the present disclosure may be integrally formed as a single unit.

[0100] Various inventive concepts may be embodied as one or more methods, an example of which is shown. The actions performed as part of a method may be performed in any suitable order. As such, embodiments may be constructed in which actions are performed in an order different from that shown, which may include performing some of the actions shown as sequential in an example embodiment simultaneously.

[0101] While various embodiments of the present invention have been described and illustrated herein, those skilled in the art will readily conceive of numerous other means and / or structures for performing the functions and obtaining the results and / or one or more advantages described herein, and each such variation and / or modification is deemed to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are exemplary, and that the actual parameters, dimensions, materials, and / or configurations will depend on the specific application(s) to which the inventive concepts are applied. Those skilled in the art will recognize or be able to identify, using no more than routine trial and error, numerous equivalents to the specific inventive embodiments described herein. Accordingly, it should be understood that the above-described embodiments are illustrative only and that, within the scope of the appended claims and their equivalents, the inventive embodiments may be practiced otherwise than as specifically described and claimed. The inventive embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and / or method described herein. Furthermore, any combination of two or more such features, systems, articles, materials, kits, and / or methods, unless they are mutually inconsistent, is within the inventive scope of the present disclosure.

[0102] The above-described embodiments can be implemented in various ways. For example, embodiments of the technology disclosed herein can be implemented using hardware, software, or a combination thereof. If implemented in software, the software code or instructions can be executed on any suitable processor or collection of processors, whether on a single computer or distributed across multiple computers. Furthermore, the instructions or software code can be stored on at least one non-volatile computer-readable storage medium.

[0103] Additionally, a computer or smartphone used to execute software code or instructions via a processor may include one or more input / output devices. These devices may be used, among other things, to display a user interface. Examples of output devices that may be used to provide a user interface include a printer or display screen for visually displaying output, and a speaker or other sound-generating device for audibly displaying output. Examples of input devices that may be used for a user interface include pointing devices such as a keyboard, mouse, touchpad, or digital tablet. As another example, a computer may be configured to receive input information through voice recognition or other audible formats.

[0104] Such computers and smartphones may be interconnected by one or more networks of any suitable form, such as a local area network (LAN), a wide area network (WAN) such as an enterprise network, an intelligent network (IN), the Internet, etc. Such networks may be based on any suitable technology and operate according to any suitable protocol, and may include wireless networks, wired networks, fiber optic networks, etc.

[0105] The various methods or processes outlined herein may be coded as software / instructions executable on one or more processors employing any of a variety of operating systems or platforms. Further, such software may be written using a variety of suitable programming languages ​​and / or programming or scripting tools, and may be compiled as executable machine code or intermediate code that runs on a framework or virtual machine.

[0106] In this regard, the various inventive concepts may be embodied as a computer-readable storage medium (or multiple computer-readable storage media) (e.g., computer memory, one or more floppy disks, compact disks, optical disks, magnetic tapes, flash memory, USB flash drives, SD cards, circuitry in field programmable gate arrays or other semiconductor devices, or other non-volatile or tangible computer storage media). These media may have one or more programs encoded thereon that, when executed on one or more computers or other processors, may implement the various embodiments of the present disclosure described above. The computer-readable media may be transportable, and the programs stored thereon may be loaded onto one or more different computers or other processors to implement various aspects of the present disclosure, as described above.

[0107] As used herein, the terms "program," "software," and "instructions" are used generically to refer to any type of computer code or computer-executable instructions that can be used to program a computer or other processor to implement various aspects of the above-described embodiments. Furthermore, according to one aspect, it should be understood that one or more computer programs that, when executed, perform the methods of the present disclosure need not reside on a single computer or processor, but may be distributed in a modular manner among several different computers or processors to perform various aspects of the present disclosure.

[0108] Computer-executable instructions may take various forms, such as program modules, executed by one or more computers or other devices. Generally, program modules include routines, programs, objects, components, data structures, etc. that perform particular tasks or implement particular abstract data types. Typically, the functionality of the program modules may be combined or distributed as desired in various embodiments.

[0109] Additionally, data structures may be stored in any suitable format on a computer-readable medium. For ease of explanation, data structures may be depicted as having fields related by their location within the data structure. Such relationships may equally be achieved by assigning to the fields and configuring their storage locations within a computer-readable medium that indicate the relationship between the fields. However, any suitable mechanism may be used to establish the relationship between information within fields in a data structure, such as pointers, tags, or other mechanisms for establishing relationships between data elements.

[0110] All definitions and definitions used herein should be understood to apply in preference to dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0111] As used herein, "logic" includes, but is not limited to, hardware, firmware, software, and / or combinations of each for performing a function or action and / or causing a function or action from another logic, method, and / or system. For example, based on desired applications and needs, logic may include a software-controlled microprocessor, discrete logic such as a processor (e.g., a microprocessor), an application-specific integrated circuit (ASIC), a programmed logic device, a memory device that stores instructions, an electronic device with memory, etc. Logic may include one or more gates, combinations of gates, or other circuit components. Logic may also be embodied entirely as software. Where multiple logics are described, the multiple logics may be incorporated into a single physical logic. Similarly, where a single logic is described, the single logic may be distributed across multiple physical logics.

[0112] Furthermore, the logic presented herein for achieving the various methods of this system may be directed toward improving existing computer- or internet-centric technologies that may not have previous analog versions. The logic may provide specific functionality directly related to structures that address and solve some of the problems identified herein. The logic may also provide far more advantages for solving these problems by providing exemplary inventive concepts as functionality consistent with specific logical structures of methods and systems. Furthermore, the logic may provide specific computer-implemented rules that improve existing technological processes. The logic presented herein goes beyond simply collecting data, analyzing information, and displaying results. Furthermore, some or all of this disclosure may rely on underlying equations derived from specific arrangements of equipment or components described herein. Thus, portions of this disclosure related to specific arrangements of parts are not directed to abstract concepts. Furthermore, this disclosure and the appended claims present teachings that involve more than the performance of activities already known, well-understood, routine, and conventional in the industry. Some of the methods or processes of this disclosure may incorporate aspects of natural phenomena, where the process or method steps are novel and useful additional features.

[0113] The term "one" as used herein and in the claims should be understood to mean "at least one" unless specifically stated to the contrary. The term "and / or" as used herein and in the claims (if present) should be understood to mean "either one or both" of the elements so conjoined, i.e., elements conjointly present in some holsters and disjunctively present in other holsters. Multiple elements listed with "and / or" should be construed in the same manner, i.e., "one or more" of the elements so conjoined. Other elements can optionally be present other than the elements specifically identified in the "and / or" clause, whether related to those specifically identified elements or not. Thus, as a non-limiting example, a reference to "A and / or B," when used in combination with open-ended language such as "comprising," can refer in one embodiment to A only (optionally including elements other than B), in another embodiment to B only (optionally including elements other than A), in yet another embodiment to both A and B (optionally including other elements), etc. As used in this specification and in the claims, "or" should be understood to have the same meaning as "and / or" as defined above. For example, when separating items in a list, "or" or "and / or" should be interpreted as inclusive, i.e., the inclusion of at least one of a plurality of elements or lists, but also two or more, and optionally additional unlisted items. Only terms clearly indicated to the contrary, such as "only one of" or "exactly one of," or, as used in the claims, "consisting of," shall mean the inclusion of exactly one element of a plurality of elements or list of elements. In general, the term "or" as used herein should be interpreted as indicating exclusive alternatives (i.e., "either / or," "one of," "only one of," or "exactly one of." As used in the claims, "consisting essentially of" shall have its ordinary meaning as used in the field of patent law.

[0114] In this specification and claims, the phrase "at least one" when used in reference to a list of one or more elements should be understood to mean at least one element selected from any one or more elements in the list of elements, but not necessarily including at least one of each element specifically listed in the list of elements, and not excluding any combination of elements in the list of elements. This definition also allows for the optional presence of elements other than those specifically identified in the list of elements to which the phrase "at least one" refers, whether related to the specifically identified elements or not. Thus, as a non-limiting example, "at least one of A and B" (or, equivalently, "at least one of A or B" or, equivalently, "at least one of A and / or B") can refer in one embodiment to at least one (optionally multiple) A in the absence of B (and optionally including elements other than B); in another embodiment to at least one (optionally multiple) B in the absence of A (and optionally including elements other than A); in yet another embodiment to at least one (optionally multiple) A and at least one (optionally multiple) B (and optionally including other elements), etc.

[0115] As used herein and in the claims, the term "cause" or a phrase or claim element beginning with the term "cause" should be understood to mean to cause something to happen or bring about something. For example, causing an event to occur may be caused by the actions of a first party, even if a second party actually performed or caused the event to occur to the second party. In other words, "causing an event" refers to one party providing another party with the tools, objects, or resources to cause the event to occur. Thus, in this example, the claim element "causing an event to occur" means that the first party provides the second party with the tools or resources necessary to carry out the event, whereas in a positive single act, the first party is responsible for providing the tools or resources to cause the event to occur.

[0116] As used herein, when a feature or element is described as "on" another feature or element, the feature or element may be directly on top of the other feature or element, or there may be intervening features and / or elements present. In contrast, when a feature or element is described as "directly on" another feature or element, there are no intervening features or elements present. Also, when a feature or element is described as being "connected," "attached," or "coupled" to another feature or element, the feature or element may be directly connected, attached, or coupled to the other feature or element, or there may be intervening features or elements present. In contrast, when a feature or element is described as being "directly connected," "directly attached," or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or illustrated with respect to one embodiment, the features and elements so described or illustrated are applicable to other embodiments. Furthermore, those skilled in the art will appreciate that when referring to a structure or feature positioned "adjacent" to another feature, the structure or feature may overlap or underlie the adjacent feature.

[0117] Spatially relative terms, such as "below," "lower," "lower side," "up," "above," "behind," "in front," and the like, may be used herein for convenience to describe the relationship of one element or feature to another, as shown in the figures. It will be understood that spatially relative terms are intended to encompass various orientations of the device during use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures were inverted, an element described as "below" or "directly below" another element or feature would then be positioned "above" that other element or feature. Thus, the illustrative term "below" may encompass both an orientation of above and below. The device may be positioned in other orientations (rotated 90 degrees or at other orientations), and the spatially relative descriptions used herein should be interpreted accordingly. Similarly, terms such as "upward," "downward," "vertical," "horizontal," "sideways," "transverse," "portrait," and the like are used for descriptive purposes only and are not intended to be limiting unless expressly stated.

[0118] As used herein, the terms "first" and "second" may be used to describe various features / elements, but these features / elements should not be limited by these terms unless the context dictates otherwise. These terms may be used to distinguish one feature / element from another. Thus, a first feature / element discussed herein may be referred to as a second feature / element, and similarly, a second feature / element discussed herein may be referred to as a first feature / element, without departing from the teachings of the present disclosure.

[0119] An embodiment is an embodiment or example of the present disclosure. References herein to "an embodiment," "one embodiment," "some embodiments," "one particular embodiment," "exemplary embodiment," "other embodiments," and the like mean that a particular feature, structure, or characteristic described in connection with an embodiment is included in at least some, but not necessarily all, embodiments of the present disclosure. The various expressions, such as "an embodiment," "one embodiment," "some embodiments," "one particular embodiment," "exemplary embodiment," "other embodiments," and the like, do not necessarily all refer to the same embodiment.

[0120] When a component, feature, structure, or characteristic is described as "may include," "could include," or "could include," it does not necessarily mean that the component, feature, structure, or characteristic is included. Also, a reference to "an" element in the specification or claims does not imply that there is only one of that element. A reference to "additional" elements in the specification or claims does not exclude the presence of a plurality of those additional elements.

[0121] In this specification and claims (including use in the examples), unless expressly stated otherwise, all numerical values ​​should be construed as if preceded by the word "about" or "approximately," even if the word "about" or "approximately" is not explicitly stated in the context. The words "about" and "approximately" may be used when describing a size and / or location to indicate that the described value and / or location is within a reasonable range of values ​​and / or locations. For example, numerical values ​​may have various values, such as + / -0.1% of the stated value (or range of values), + / -1% of the stated value (or range of values), + / -2% of the stated value (or range of values), + / -5% of the stated value (or range of values), and + / -10% of the stated value (or range of values). Numerical ranges stated herein are intended to include all subranges therein.

[0122] Furthermore, methods embodying the present disclosure may be performed in an order different from that described herein. Thus, unless expressly limited, the order of the methods should not be construed as limiting. It should be understood that similar results may be achieved by performing some steps of the methods in a different order.

[0123] In the claims and the above specification, all transitional phrases such as "comprise," "include," "carry," "have," "contain," "accompany," "hold," "possess," "comprise," and the like, are to be understood in an open sense, i.e., meaning including but not limited to. Only the transitional phrases "consisting only of" and "consisting essentially of" are to be treated as closed or semi-closed transitional phrases.

[0124] The use of the term "invention" in the titles and sections of this specification is for formatting purposes in accordance with U.S. Patent and Trademark Office guidelines / requirements for Word document submissions and should not be construed as a disclaimer of subject matter in any manner.

[0125] In the above description, specific terms have been used for brevity, clarity, and ease of understanding. These terms have been used for descriptive purposes and are intended to be broadly construed, without implying unnecessary limitations beyond the requirements of the prior art.

[0126] Moreover, the description and illustration of each embodiment of the present disclosure is by way of example, and the present disclosure is not limited to the exact details shown or described.

Claims

1. 1. An infusion system comprising: a drop counter configured to be engageable with a drip chamber of an infusion fluid source configured to deliver infusion fluid under gravity through a tube into a patient's body; a roller clamp operatively associated with said drop counter; an adjustment assembly operatively engaged with a roller of the roller clamp, the adjustment assembly including at least one spring-loaded plunger that presses the roller against a tube; a programmed processor configured to automatically adjust the position of the roller relative to the roller clamp via the adjustment assembly in response at least in part to drop data collected by the drop counter; An infusion system comprising:

2. the at least one spring-loaded plunger includes a first plunger and a second plunger; 2. The infusion system of claim 1, wherein the first plunger and the second plunger respectively engage at spaced positions on the roller, and the first plunger and the second plunger cooperate to press and rotate the roller against the roller clamp.

3. 3. The infusion system of claim 2, wherein the first plunger and the second plunger are independently operable.

4. the first plunger and the second plunger each have a pin roller that contacts a circumferential surface of the roller; 3. The infusion system of claim 2, wherein the outer surface of the pin roller that contacts the circumferential surface of the roller includes an elastic material.

5. 10. The infusion system of claim 1, further comprising a housing having a holster configured to receive any of a variety of roller clamps having different shapes.

6. the fluid supply includes an infusion bag adapted to contain a predetermined volume of fluid; the drip chamber is in operative engagement with the infusion bag; 2. The infusion system of claim 1, further comprising: a drop counter configured to automatically count droplets falling from the infusion bag into the drip chamber and transmit the drop data to the processor in real time.

7. 10. The infusion system of claim 1, further comprising a human machine interface (HMI) operatively connected to the processor, the HMI configured to provide access to patient data.

8. a camera provided on the drop counter; 10. The infusion system of claim 1, wherein the camera is configured to capture at least one of drip data and a liquid level within a drip chamber of a drop counter.

9. 1. An infusion system comprising: an infusion bag configured to hold a predetermined volume of infusion fluid to be administered to a patient; a tube extending between the infusion bag and the patient's body; a drip chamber engaged with the tubing at a location between the infusion bag and the patient's body; a drop counter operatively engaged with the drip chamber and configured to automatically measure in real time the number of droplets entering the drip chamber from the infusion bag; a roller clamp disposed between the drip chamber and the patient's body; Equipped with the tube extends through a hole in the roller clamp; a roller provided in the roller clamp for pressing the tube passing through the hole in the roller clamp; a first plunger and a second plunger contacting the roller at spaced apart locations and operable to move the roller relative to the roller clamp; a processor operatively associated with the drop counter and the roller, the processor automatically controlling the movement of the roller relative to the tube and controlling the flow rate of the infusion solution through the tube in response to drop data provided by the drop counter; An infusion system comprising:

10. 10. The infusion system of claim 9, wherein the first plunger and the second plunger are independently actuable.

11. a human machine interface (HMI) operatively connected to the processor, the HMI configured to access patient data and provide the patient data to the processor; 10. The infusion system of claim 9, further comprising a remote computing system operatively linked to the HMI.

12. a camera provided on the drop counter; 10. The infusion system of claim 9, wherein the camera is configured to capture an image of at least one of the number of droplets entering the drip chamber of the drop counter and the liquid level in the drip chamber.

13. 1. A method for controlling the flow rate of an infusion fluid delivered to a patient using an infusion system including tubing extending from an infusion bag, comprising: accessing patient data via a human machine interface (HMI) of the infusion system; receiving, at a processor of the infusion system, drop rate data from a drop counter of the infusion system; analyzing the patient data and the drip rate data with the processor; determining, by the processor, a desired flow rate for the infusion based on a desired dose to be administered to the patient by the infusion system over a predetermined time period based on the analysis of the patient data and the drip rate data; automatically adjusting the position of the roller in the roller clamp by pressing and rotating the roller against the roller clamp using a drive mechanism operatively connected to the processor; A method of delivering a desired dose of fluid to the patient through the tube.

14. The step of automatically adjusting the position of the roller clamp includes: rotating the roller of the roller clamp in either a first direction or a second direction; contacting the roller with the tube extending through an aperture in the roller clamp; rotating the roller in either the first direction or the second direction to vary the size of the hole for the tube; The change in the size of the hole allows the flow rate of the infusion fluid through the tube to be changed to a desired flow rate.

14. The method of claim 13, comprising:

15. receiving the drop rate data from the drop counter; automatically counting the number of droplets entering the drip chamber from the infusion bag in real time using a sensor of the drop counter; communicating the number of counted drops from the drop counter to the processor; determining, via a program embedded in the processor, a flow rate of the infusion solution moving from the drip chamber through the tubing; automatically adjusting the position of the roller relative to the roller clamp without human intervention and in real time; 14. The method of claim 13, comprising:

16. receiving the drop rate data from the drop counter; capturing, by a camera, an image of a droplet entering a drip chamber of said drop counter; determining the drop rate data from the acquired images; 14. The method of claim 13, comprising:

17. acquiring an image of the actual liquid level in the drip chamber of said drop counter; and determining when the actual liquid level exceeds a threshold liquid level.

18. 14. The method of claim 13, further comprising determining that backflow has occurred in the drip chamber of the drop counter when the actual liquid level exceeds a threshold liquid level, and issuing an alarm.

19. providing a sensor for detecting any of backflow, bubbles in the infusion, air in the infusion, and pressure changes in the tube; 14. The method of claim 13, further comprising emitting an audio and / or visual alarm if the sensor detects reflux, bubbles in the infusion, air in the infusion, high pressure in the tubing, or low pressure in the tubing.

20. A system for controlling the flow rate of an infusion fluid delivered to a patient through a tube extending from an infusion bag, comprising: a drop counter operatively engaged with a drip chamber disposed between the infusion bag and the tubing; a roller clamp having a hole through which the tube is inserted, a roller extending into the hole and contacting the tube, and a drive mechanism for pressing and rotating the roller in one of a first direction and a second direction, the roller clamp being in electronic communication with the drop counter; a processor in communication with the drive mechanism; a human machine interface (HMI) operatively connected to said processor; A system that includes:

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