Infusion device, components of infusion device, and method for determining flow rate

Abstract

Infusion devices, their components, and methods for obtaining fluid measurements provided by the infusion device. Special fluid chambers are configured to achieve optimal optical image clarity when a camera images the fluid within or flowing into the chamber.

Description

Cross - Reference to Related Applications

[0001] This application claims priority under 35 USC 119(e) based on U.S. Provisional Patent Application No. 63 / 490265, filed on March 15, 2023, entitled "Infusion Device, Infusion Device Components, and Method of Determining Flow Rate", which is hereby incorporated by reference in its entirety.

Technical Field

[0002] The present invention generally relates to infusion devices, each component of an infusion device, and a method for obtaining fluid measurement values provided by an infusion device.

Background Art

[0003] Infusion devices are well - known in the art and include a variety of variations, designs, and methods for administering and controlling a selected fluid to a patient, such as gravity infusion sets and pump - driven sets. In one design, a single camera system is used to image the droplets passing through a drip chamber and process the images of the droplets to determine the size, growth, and volume of each droplet. A combination of these measurements enables an on - board computer to process and calculate the flow rate.

[0004] As described above, conventionally, infusion devices take one of two forms: a gravity - based infusion set or a pump - driven infusion set. Gravity infusion sets allow the flow of fluid due to the action of gravity. Thus, the fluid source is always at a position higher than the position of the patient receiving the infusion. The higher the infusion bottle, the stronger the gravity acting on the fluid flow. Conversely, pump - driven infusion sets use the force from a pump to extrude the fluid flow. Gravity infusion devices are preferred because pump - driven sets can complicate the infusion process and cause medical problems by supplying the selected fluid at an excessive flow rate.

[0005] Conventionally, an infusion device comprises at least one fluid container (e.g., an IV bag) arranged to contain a selected infusion fluid (e.g., water, drugs or electrolytes, nutrients, and / or blood); a drip chamber that functions as a field for determining the fluid flow rate and is in fluid communication with the at least one fluid container; and a flow regulator (or flow control valve) located downstream (i.e., distal) of the drip chamber and arranged to control the flow of fluid from the drip chamber to the infusion site in the patient. All of the aforementioned components are in fluid communication via conventional flexible tubing.

[0006] Currently, drop chambers are constructed from flexible materials and are therefore flexible. These drop chambers are designed with curved walls. While such material selection has advantages, such as the ability to physically reduce the air pressure from the drop chamber (e.g., by squeezing it out), flexible materials deform easily, making it difficult to provide sufficient images for fluid measurement processing and / or calculations when imaging the drop chamber via a camera. Even when the flexible drop chamber is not deformed, the curved shape can cause image distortion.

[0007] Traditionally, images captured by cameras have been used to determine flow rates, fluid volumes, etc., but there is no way to directly measure flow rates. As a result, the supply of selected fluids becomes inaccurate, the reliability of detecting flow interruptions decreases (e.g., under-detection, over-detection, and / or detection delay), and critical and catastrophic hardware failures and / or malfunctions cannot be detected.

[0008] During the process of intravenous fluid delivery, when the fluid container becomes empty, it becomes necessary to disconnect the IV line (e.g., tubing) from the patient to remove air from the line. This disconnection from the patient inevitably extends the total time required for fluid delivery, necessitates additional intervention by healthcare workers, and increases the potential risk of infection during the disconnection and reconnection process.

[0009] Therefore, the following have been needed for a long time. 1. A device configured for a gravity-type infusion set, which enables the introduction of pressure into a fluid line and increases the fluid flow rate, 2. A drop chamber made of a material that is non-flexible, has flat walls, and allows for distortion-free imaging of the fluid and / or fluid droplets within the drop chamber with high resolution and / or high quality, 3. A device for an infusion set configured to allow excess air to be released from the drip chamber without disconnecting and reconnecting the connection to the patient, 4. A method for directly measuring the amount of fluid flowing into the drip chamber of an infusion system, 5. A method for directly calculating the flow rate of fluid injected in an infusion system. [Overview of the project]

[0010] The present invention relates to an infusion device with various sub-devices connected internally, comprising a device configured to release air pressure from the fluid chamber and a device that allows a pump to be manually operated to increase the flow rate. Furthermore, the present invention also includes a method for directly measuring the amount of fluid flowing into the fluid chamber and the flow rate of the fluid. In addition, the present invention relates to a fluid chamber or drip chamber having a combination of a transparent, rigid structure and "flat walls" to optimize the clarity of optical imaging of the internal fluid and / or fluid droplets.

[0011] In general, the present invention aims to provide a device configured for a gravity-type infusion set that enables the introduction of pressure into a fluid line and increases the flow rate of the fluid.

[0012] Another object of the present invention is to provide a drop chamber made of a material that is non-flexible, has flat walls, and allows for distortion-free imaging of the fluid and / or fluid droplets within the drop chamber with high resolution and / or high quality.

[0013] A further object of the present invention is to provide a device for an infusion set configured to allow excess air to be released from the drip chamber without disconnecting and reconnecting the connection to the patient.

[0014] Another object of the present invention is to provide a method for directly measuring the amount of fluid flowing into the drip chamber of an infusion system.

[0015] Another object of the present invention is to provide a method for directly calculating the flow rate of a fluid injected in an infusion system.

[0016] These and other objects, features, and advantages of the present invention will become readily apparent upon consideration of the following detailed description of the invention in view of the drawings and claims. [Brief explanation of the drawing]

[0017] Various embodiments are disclosed only as examples, with reference to the accompanying schematic diagrams in which the corresponding reference symbols indicate the corresponding parts. [Figure 1] Figure 1 is a schematic diagram showing one embodiment of the infusion device of the present invention. [Figure 2] Figure 2 is a perspective view of the outside of the infusion device. [Figure 3A] Figure 3A is a perspective view of the outside of the fluid chamber. [Figure 3B] Figure 3B shows a perspective view of the fluid chamber shown in Figure 3A, with a portion of the outside of the chamber cut away. [Figure 4A] Figure 4A is a diagram showing a typical cross-section of the fluid chamber shown in Figure 3A, and represents the overall flow pattern of a typical fluid within the fluid chamber. [Figure 4B] Figure 4B is a diagram showing a typical cross-section of the fluid chamber shown in Figure 3A, and represents the overall flow pattern of a typical fluid within the fluid chamber. [Figure 4C] Figure 4C is a diagram showing a typical cross-section of the fluid chamber shown in Figure 3A, and represents the overall flow pattern of a typical fluid within the fluid chamber. [Figure 4D] Figure 4D is a diagram showing a representative cross-section of the fluid chamber shown in Figure 3A, and is a diagram showing the representative fluid flow pattern in the fluid chamber as a whole. [Figure 4E] Figure 4E is a diagram showing a representative cross-section of the fluid chamber shown in Figure 3A, and is a diagram showing the representative fluid flow pattern in the fluid chamber as a whole. [Figure 4F] Figure 4F is a diagram showing a representative cross-section of the fluid chamber shown in Figure 3A, and is a diagram showing the representative fluid flow pattern in the fluid chamber as a whole. [Figure 4G] Figure 4G is a diagram showing a representative cross-section of the fluid chamber shown in Figure 3A, and is a diagram showing the representative fluid flow pattern in the fluid chamber as a whole. [Figure 4H] Figure 4H is a diagram showing a representative cross-section of the fluid chamber shown in Figure 3A, and is a diagram showing the representative fluid flow pattern in the fluid chamber as a whole. [Figure 5] Figure 5 is a diagram showing a representative camera assembly operably coupled to the fluid chamber. [Figure 6] Figure 6 is a diagram showing a representative method for determining the flow of fluid volume through the infusion device. Terminology Explanation

[0018] The following terms and / or phrases used in this specification should be interpreted as follows.

[0019] "Downstream", and / or terms equivalent thereto, are intended to mean the direction in which the fluid flows. Synonyms such as "distal", e.g., "distal side outlet", should be interpreted similarly with respect to the fluid interaction with a particular component and taking into account the spatial relationship.

[0020] The terms "upstream" and / or equivalent are intended to mean the direction opposite to the direction of fluid flow. Synonyms such as "proximal," for example, "component X is located proximal to component Y," should be interpreted similarly in relation to the fluid's interaction with a particular component, and should take spatial relationships into consideration.

[0021] The aforementioned terms "downstream" and "upstream" can be used interchangeably to describe the properties, arrangement, and interactions of components, but they should still be interpreted according to the definitions given above. For example, "Component X is located upstream of component Y" means that the fluid flows from "Component X" to "Component Y," and conversely, "Component Y is located downstream of component X" can also be expressed as "Component Y is located downstream of component X," which similarly means that the fluid flows from "Component X" to "Component Y."

[0022] It should be noted that the terms “upstream” and “downstream” as used herein are not inconsistent with the known understanding of pressure interactions in fluids and / or gases. For example, if a component is pressurized with a gas, and then depressurized upstream of that component, the gas will then flow upstream.

[0023] The aforementioned terms "distal" and "proximal" should be understood in light of the definitions of "downstream" and "upstream," but they also imply spatial relationships between components. For example, "Component X includes a proximal port and a distal port," the proximal port is located above the distal port, and the fluid flows from the proximal port to the distal port.

[0024] The terms "fluid connection," "fluidically connected," "fluidally in communication," and equivalent expressions mean that two or more components are connected so that a substance, such as a gas or liquid, can flow between and / or through those components.

[0025] The terms "electrically connected," "electrically connected," "electrically connected," "in an electrically connected state," and / or equivalent expressions mean either data communication between two components, electric current between two components, or a combination of these between two components. (Detailed explanation)

[0026] First, please understand that similar drawing numbers shown in different drawings identify identical or functionally similar components. Please also understand that the claims are not limited to the disclosed embodiments.

[0027] Furthermore, this disclosure is not limited to the specific methodologies, materials, and modifications described herein, and is naturally subject to change. It should also be understood that the terminology used herein is intended to describe specific aspects only and is not intended to limit the scope of the claims.

[0028] Unless otherwise defined, all technical and scientific terms used herein have the same meanings as those generally understood by those skilled in the art to which this disclosure pertains. Methods, apparatus, or materials similar or equivalent to those described herein may be used in the implementation or testing of the exemplary embodiments.

[0029] The term "substantially" is synonymous with terms such as "nearly," "very nearly," "about," "approximately," "around," "bordering on," "close to," "essentially," "in the neighborhood of," and "in the vicinity of," and such terms may be used interchangeably as they appear in the specification and claims. The term "proximate" is synonymous with terms such as "nearby," "close," "adjacent," "neighboring," "immediate," and "adjoining," and such terms may be used interchangeably as they appear in the specification and claims. "Approximately" means a value within 10% of the specified value.

[0030] It should be understood that the use of "or" in this application, unless otherwise specified, refers to a "non-exclusive" arrangement. For example, when we say "Item X is A or B," it is understood to mean one of the following: (1) Item X is either A or B only. (2) Item X is both A and B. Note that the word "or" does not define an "exclusive OR" arrangement. For example, the "exclusive OR" arrangement for the sentence "Item X is A or B" requires that x can be either A or B only. Furthermore, as used herein, "and / or" is intended to mean a grammatical connection used to indicate that one or more of the mentioned elements or conditions may be included or occur. For example, a device consisting of a first element, a second element and / or a third element is intended to be interpreted as one of the following structural arrangements: A device containing the first element, a device containing the second element, a device containing the third element. A device containing the first and second elements. A device containing the first and third elements. An apparatus comprising a first element, a second element, and a third element. Or, an apparatus comprising a second element and a third element.

[0031] Furthermore, when the phrases “including at least one” and “consisting of at least one” as used herein are combined with a system or element, it means that the system or element includes one or more of the elements listed after the phrase. For example, a device including at least one of “the first element,” “the second element,” and “the third element” is intended to be interpreted as any of the following structural configurations: a device including the first element, a device including the second element, a device including the third element, a device including the first and second elements, a device including the first and third elements, a device including the first element, the second and third elements, or a device including the second and third elements. A similar interpretation applies when the phrase “used in at least one” is used herein.

[0032] Referring to the drawings, Figure 1 shows an infusion device 10 having an infusion supply device 120, a pneumatic release device 130, or both.

[0033] Figure 1 shows an infusion device 10 of the present invention, which generally comprises a fluid container 100, such as an IV bag or other container used in a medical setting to hold an infusion fluid 11; a fluid chamber 110, which is in fluid communication with the fluid container 100 and located downstream of the fluid container 100; and an outlet line located downstream of the fluid chamber 110. The outlet line is preferably located to be in fluid communication with the patient, for example, at a venipuncture site 147 or a similar IV line connection site. The infusion device 10 also comprises at least one camera 140 electrically connected to at least one processor 145. That is, the camera 140 may be electrically connected to a primary processor 145A and a secondary processor 145B, etc.

[0034] The camera 140 is positioned so that the fluid chamber 110 is fully within its field of view, i.e., so that a single image and / or video can be captured, and is located within the external container portion 25 of the infusion device 10, as shown in Figure 2. The image and / or video 146 is configured to be transmitted to a processor 145, which is configured to be programmed by computing software 148 that uses the image and / or video 146 to perform a number of different fluid measurements related to the fluid chamber 110.

[0035] In some embodiments, the fluid chamber 110 is a dropping chamber comprising at least a fluid inlet 122 for the fluid 11, a droplet-forming section 123 that is in fluid communication with the inlet 122, an internal cavity 160 that is in fluid communication with the droplet-forming section 123 and is defined by the main body 161, as shown in Figures 3A to 3B, and a fluid outlet 113 that is in fluid communication with the internal cavity 160. The droplet-forming section 123 is configured to allow the fluid 11 from the fluid container 100 to flow into the fluid chamber 110 in one drop at a time through the fluid inlet 122 having a dropping chamber cap 166.

[0036] In some embodiments, the infusion device 10 can fluidly communicate with a pneumatic release device 130 located between the fluid container 100 and the fluid chamber 110, i.e., downstream of the fluid container 100 and upstream of the fluid chamber 110. In other embodiments, the infusion device 10 can fluidly communicate with an infusion supply device 120 located between the fluid container 100 and the fluid chamber 110, i.e., downstream of the fluid container 100 and upstream of the fluid chamber 110. In yet another embodiment, the infusion device 10 can include both the pneumatic release device 130 and the infusion supply device 120. That is, the infusion supply device 120 may be located in the position where the pump 126 is normally indicated in the pneumatic release device 130.

[0037] The pneumatic release device 130 is configured to fluidize the fluid container 100 and the fluid chamber 110 in the downstream line and fill the fluid chamber 110 via the pump 126. However, since the device is also configured to allow fluid to flow downstream by gravity, it should be noted that the pump 126 is not an essential component. Nevertheless, Figures 4A to 4H show a typical embodiment of the operation method including the fluid chamber 110 and the pump 126.

[0038] In general and typical embodiments, the pneumatic release device 130 comprises an infusion device 10 having a fluid container 100 having a proximal end 101 and a distal end 109; a fluid pump 126 located downstream of the fluid container 100 and in fluid communication with the fluid container 100; and a fluid chamber 110 having a proximal end 111 and a distal end 119, located downstream of the fluid pump 126 and in fluid communication with the fluid pump 126, with a fluid inlet 122 located at the proximal end 111 of the fluid chamber and in fluid communication with the fluid pump 126, and a fluid inlet 122 having a first check valve located upstream 125A, the fluid chamber The fluid chamber 110 comprises: an air outlet 137 located at the proximal end 111 of the fluid chamber and in fluid communication with the distal end 109 of the fluid container, the air outlet 137 having an air control valve 135 located downstream of the fluid container 100 and further upstream of the fluid chamber 110; a fluid outlet 113 located at the distal end 119 of the fluid chamber and further having a fluid control valve 500, the fluid outlet 113 having fluid communication with a fluid outlet line 114 located downstream of the fluid control valve 500; and a camera 140 electrically connected to at least one processor 145 and having a view of the fluid chamber 110.

[0039] In general and typical embodiments, the infusion device 10 and air pressure release device 130 described above automatically fill the fluid outlet line 114 leading to the fluid chamber 110 and the fluid chamber 110 itself by pumping fluid into the drip chamber, releasing the generated air pressure by opening the valve, and the released air moving upstream and returning to the fluid container 100. Generally, this involves closing the fluid outlet 113 of the fluid chamber 110 and the air outlet 137 of the fluid chamber 110, then using the pump 126 to move the fluid 11 from the fluid container 100 through the pump 126 and into the fluid chamber 110 via the fluid inlet 122, and operating until the amount of fluid 11 in the fluid chamber 110 reaches the desired amount. When the amount of fluid 11 in the chamber reaches the desired amount, the air pressure in the fluid chamber 110 increases by closing the inlet 122 of the fluid chamber 110. Next, the air control valve 135 is opened, thereby releasing the pressurized air (through pressure) into the upstream fluid container 100. Alternatively, in an alternative embodiment, the pressurized air is released into a secondary container that is in fluid communication with the air control valve 135, and in yet another embodiment, the pressurized air is released into an open external environment.

[0040] Therefore, the fluid inlet 122 of the fluid chamber 110 includes a fluid control valve 500 which may be a (unidirectional) check valve 125 or a controllable valve (such as mechanical or electric). The air outlet 137 of the fluid chamber 110 includes an air control valve 135 which is a controllable valve (such as mechanical or electric). The fluid outlet 113 of the fluid chamber 110 preferably includes a fluid control valve 500 which is a controllable valve (such as mechanical or electric). The controllable valve is configured to be electrically connected to a processor 145, and programmable software 149 may be configured to automatically control the operation of the valve in accordance with the level of fluid 11 measured via the processor 145 and a camera 140 of the fluid chamber 110.

[0041] The fluid control valve 500 is described in detail in U.S. Patent Application Publication No. 2022 / 0316605, filed on 31 March 2022 and published on 6 October 2022, the application in its entirety being incorporated herein by reference.

[0042] In general and typical embodiments, the aforementioned infusion device 10 may be included in the infusion supply device 120. Depending on the embodiment, the infusion supply device 120 includes a fluid container 100 having a tubular section 102 that is in fluid communication with the fluid container 100 and extends from its distal end, a first check valve 125A located downstream of the container and positioned in the tubular section 102, a pump 126, a pump bulb 128, a diaphragm 129 configured to increase the pressure in the downstream tubular section 102 when manually operated, and a diaphragm that is in fluid communication with the pump 126 The system includes a second check valve 125B located downstream of the pump 126, which allows the fluid 11 to flow passively downstream by gravity through the second check valve 125B; a pressurizing device capable of introducing pressure to the pump 126; a depressurizing device capable of releasing pressure from the pump 126; and optionally, a fluid valve, wherein the second check valve 125B is located upstream of the fluid chamber 110 and is in fluid communication with the fluid chamber 110.

[0043] The aforementioned infusion device 10 operates in three steps: 1. pump priming, 2. pumping, and 3. gravity-driven fluid flow.

[0044] Pump priming generally requires crushing the pump 126 by physical force, which is applied manually by a medical professional, for example by crushing a flexible pressure sphere, resulting in air being expelled from the downstream check valve, i.e., the second check valve 125B.

[0045] After priming the pump, pumping is first performed by removing the force from the pump 126, which expands the pump 126 and draws the fluid 11 into the pump 126 from the upstream check valve, i.e., the first check valve 125A. Then the pump 126 is physically compressed, which causes the fluid 11 to be discharged from the fluid and / or the downstream check valve 125B, and this operation is repeated as many times as necessary until the desired flow rate of the infusion is obtained (the flow rate is calculated by the processor 145 of the infusion device 10).

[0046] After pumping stops, gravity continues to cause flow downstream through the first check valve 125A and the second check valve 125B. Here, the first check valve 125A and the second check valve 125B can be adjusted to change the flow rate.

[0047] Therefore, it should be noted that the first check valve 125A and the second check valve 125B of the infusion device 10 are adjustable to increase or decrease the fluid flow from the fluid container 100 to the fluid chamber 110.

[0048] In some embodiments of the present invention, the fluid chamber 110 (i.e., the drip chamber) is configured as a rigid chamber having flat sides to optimize the clarity of optical imaging in images and / or video 146 captured by the camera 140. The fluid chamber 110 is preferably configured to be transparent and has at least one planar (flat) wall portion 117, which is positioned so that the camera 140 can capture images 146 of the fluid 11 inside and / or fluid droplets 150 entering the fluid chamber 110 through the planar wall portion 117. The fluid chamber 110 includes a proximal end 111 and a distal end 119, with a fluid inlet 122 located in the proximal end (upstream end) 111 and a fluid outlet 113 located in the distal end (downstream end) 119. The fluid chamber 110 has a body 161 that defines an internal cavity 160 in which the fluid 11 is stored. The body 161 of the fluid chamber 110 is preferably made transparent, has an optically clear structure, and has flat, rigid (i.e., non-flexible) wall portions 117.

[0049] The present invention may include a method ("V1") for measuring the amount of fluid 11 flowing into the fluid chamber 110 of the infusion device 10. Generally, in a typical embodiment, this method is achieved using an image 146 of the drop 150, which is captured by a camera 40 as the drop 150 falls through the air and transmitted to a processor 145. The volume of the drop 150 is calculated based on the equation of an ellipsoid, using the aspect ratio of the drop image 146 and the height and width derived from the area of ​​the drop image 146. If the supply pressure is constant, the amount of fluid 11 flowing into the fluid chamber 110 is equal to the amount of fluid 11 flowing out of the fluid chamber 110, enabling accurate flow measurement.

[0050] Generally, method (V1) involves the following:

[0051] After the fluid droplet 150 has separated from the droplet-forming section 123 located within the cavity 160 of the fluid chamber 110, the camera 140 captures one or more images 146 of the fluid droplet 150 and transmits these images 146 from the camera 140 to the processor 145. The processor 145, which implements software 148 and 149, measures the height (H) and width (W) of the fluid droplet 150 in each image 146, and the software enables the measurement of the area (A) of the fluid droplet 150 in each image 146. Software 148 and 149 use the following equation to calculate the volume (V) of the fluid droplet 150.

[0052] JPEG2026509532000002.jpg1897

[0053] The following method may be used in combination with the infusion device 10, assuming that the infusion device 10 described in the attached claims and above includes a droplet forming unit 123 in the fluid chamber 110, and comprises: (1) capturing at least one image 146 of the fluid droplet 150 away from the droplet forming unit 123 via the camera 140; (2) transmitting at least one image 146 of the fluid droplet 150 from the camera 140 to the processor 145; (3) having the processor 145 measure the height (H) and width (W) of at least one image 146; (4) having the processor 145 calculate the area (A) from the height (H) and width (W) of at least one image 146; and (5) having the processor 145 calculate the volume (V) of the fluid droplet 150 using the following formula. JPEG2026509532000003.jpg1797(6) The processor 145 calculates the volume of subsequent images 146 in which additional fluid droplets 150 are captured, thereby determining the total amount of fluid supplied to the fluid chamber 110.

[0054] The present invention may also include a method that combines the aforementioned method (V1) with a method (V2) for determining the amount of fluid in the fluid chamber 110, and generally method (V2) includes (1) capturing an image 146 of the fluid 11 in the fluid chamber 110 with a camera 140, (2) transmitting the image 146 from the camera 140 to the processor 145, and (3) calculating the amount of fluid 11 from the image 146 by (4) measuring the height of the fluid 11 and (5) multiplying the cross-sectional area of ​​the fluid chamber 110 by the said height. It should be understood that the fluid chamber 110 has a cross-sectional area known as a programmable dimension for the processor 145 of the infusion device 10.

[0055] The present invention may include a method (V3) for determining the amount of fluid 11 flowing out of a fluid chamber 110, and method (V3) also employs the steps of the two methods (V1 and V2) described above. Generally, method (V3) further includes a method (V2) for determining the amount of fluid in a fluid chamber 110, which includes capturing an image 146 of the fluid 11 in the fluid chamber 110 with a camera 140, transmitting the image 146 from the camera 140 to a processor 145, and calculating the amount of fluid 11 from the image 146 by measuring the height of the fluid 11 and multiplying the cross-sectional area of ​​the fluid chamber 110 by that height, and a method (V3) for determining the amount of fluid 11 flowing out of a fluid chamber 110, (1) The processor 145 subtracts the increase in the amount of fluid in the fluid chamber 110 (V2) from the amount of fluid 11 flowing into the fluid chamber 110 (V1), (2) The processor 145 adds the decrease in the amount of fluid in the fluid chamber 110 (V2) from the amount of fluid 11 flowing into the fluid chamber 110 (V1).

[0056] In other words, the software 148 and 149 of the processor 145 determines the amount of fluid 11 (i.e., V2) in the fluid chamber 110 by multiplying the fluid height in the fluid chamber 110 by the cross-sectional area of ​​the fluid chamber 110.

[0057] In other words, the software 148 and 149 of the processor 145 calculates the amount of fluid flowing out of the fluid chamber 110 (i.e., V3) by subtracting any increase in the amount of fluid in the fluid chamber 110 from the amount of fluid flowing into the fluid chamber 110 during a given period, and / or adding any decrease in the amount of fluid in the fluid chamber 110 to the amount of fluid flowing into the fluid chamber 110 during a given period.

[0058] The present invention requires that, in order to perform the operations described herein, the camera 140 has characteristics suitable for recording images of fluid droplets with appropriate resolution and clarity. Figure 5 shows a typical camera 140 system and indicates that multiple cameras 140 may be present.

[0059] Figure 6 shows a typical method for determining the flow rate of fluid through an infusion device 10, including step 600, which enables fluid to flow from a fluid container 100 to a fluid chamber 110. The method includes step 605, which controls the fluid flow by opening, partially opening, partially closing, and closing at least one of the fluid inlet 122 and a first check valve 125A; opening, partially opening, partially closing, and closing at least one of the air outlet 137 via an air control valve 135; and opening, partially opening, partially closing, and closing at least one of the fluid outlet 113 via a fluid control valve 500. The method includes step 610, which images the fluid chamber 110 and the fluid droplets 150 within it using a camera 140 operably connected to at least one processor 145. The method may also include step 615, which calculates the volume of one or more imaged fluid droplets 150. The method may include a step 620 for estimating the dimensions of one or more imaged fluid droplets 150. The method may also include a step 625 for determining the total fluid volume from the sum of the volumes of the one or more imaged fluid droplets 150. The method may also include a step 630 for at least partially pumping the fluid through the fluid chamber 110 using the pump 126. The method may also include a step 635 for drawing the fluid from the first check valve 125A into the pump, then crushing the pump 126 to discharge the fluid, and repeating this as necessary until a desired fluid flow rate is obtained.

[0060] It will be understood that various aspects, other features and functions of the present invention, or variations thereof, may be incorporated in a desirable manner into many other different systems and applications. Various alternatives, modifications, variations, or improvements that are not currently foreseeable or anticipated may subsequently be made by those skilled in the art, each of which is also intended to be covered within the following claims. [Components] 10 Infusion device 11 Fluid 12 pumps 25. Outer container portion of the infusion device 100 Fluid containers 101 Proximal end of fluid container 102 Pipe section 109 Distal end of fluid container 110 Fluid Chamber 111 Proximal end of the fluid chamber 113 Fluid outlet 114 Fluid outlet line 117 Planar (flat) wall section 119 Distal end of the fluid chamber 120 Infusion supply equipment 122 Fluid inlet 123 Droplet formation part 125 Check valve 125A First check valve 125B Second check valve 128 Pump bulb 129 Diaphragm 130 Pneumatic release device 135 Air control valve 137 Air outlet 140 Cameras 145 processors 145A Primary Processor 145B Secondary Processor 146 images 147 Vein puncture site 148 Computing Software 149 Programmable Software 150 fluid drop 160 internal cavities 161 Main unit 166 Droplet Chamber Cap 500 Fluid control valve 600-635 Typical methods

Claims

1. Infusion device, A fluid container having a proximal end and a distal end, A fluid pump is located downstream of the fluid container and is in fluid communication with the fluid container, A fluid chamber having a proximal end and a distal end, wherein the fluid chamber is located downstream of the fluid pump and is in fluid communication with the fluid pump. A fluid inlet located at the proximal end and in fluid communication with the fluid pump, the fluid inlet having a first check valve located on the upstream side, An air outlet located at the proximal end of the fluid chamber and in fluid communication with the distal end of the fluid container, the air outlet having an air control valve located downstream of the fluid container and further upstream of the fluid chamber, A fluid chamber comprising: a fluid outlet located at the distal end of the fluid chamber and further equipped with a fluid control valve, the fluid outlet communicating with a fluid outlet line located downstream of the fluid control valve; An infusion device comprising at least one processor and a camera electrically connected to it, which has a view of the fluid chamber.

2. A fluid chamber according to claim 1, wherein the fluid chamber is transparent and comprises at least one planar wall.

3. A fluid chamber according to claim 2, wherein the fluid chamber has a rigid structure.

4. Infusion apparatus according to claim 1, wherein the first check valve is disposed between the fluid chamber and the pump, and the second check valve is disposed between the pump and the fluid container, the first check valve restricts the flow of fluid upstream and allows the flow of fluid downstream, and the second check valve restricts the flow of fluid upstream and allows the flow of fluid downstream.

5. An infusion apparatus according to claim 1, wherein the pump is a manual pump that enables fluid flow downstream, and the pump is further provided with an air control valve.

6. Infusion apparatus according to claim 5, wherein the first check valve is disposed between the fluid chamber and the pump, and the second check valve is disposed between the pump and the fluid container, the first check valve restricts the flow of fluid upstream and allows the flow of fluid downstream, and the second check valve restricts the flow of fluid upstream and allows the flow of fluid downstream.

7. An infusion device according to claim 1, wherein the fluid chamber further comprises a droplet-forming section inside, the droplet-forming section is in fluid communication with the fluid inlet and is located downstream of the fluid inlet.

8. Infusion device according to claim 1, wherein the camera is adapted to image fluid droplets falling into the fluid chamber.

9. Infusion device according to claim 8, wherein the at least one processor and software implemented therein are adapted to calculate the volume of one or more imaged fluid droplets.

10. The amount of fluid (V) flowing into the fluid chamber according to claim 8 １ A method for measuring ) To capture at least one image of a fluid droplet separated from the droplet-forming section via the camera, Transmitting at least one image of the fluid droplet from the camera to the processor, The processor measures the height (H) and width (W) of at least one image, The processor calculates the area (A) from the height (H) and width (W) of at least one image, The processor calculates the volume (V) of the fluid droplet using the following formula, A method comprising determining the total amount of fluid supplied to the fluid chamber by summing the calculated volumes of subsequent images in which additional fluid droplets are captured by the processor.

11. The amount of fluid in the fluid chamber (V) according to claim 1 ２ A method for determining ) The camera captures an image of the fluid inside the fluid chamber, The image is transmitted from the camera to the processor, From the aforementioned image, The height of the aforementioned fluid is measured, A method comprising calculating the amount of fluid by multiplying the cross-sectional area of ​​the fluid chamber by the height.

12. The amount of fluid (V) that flows out of the fluid chamber according to claim 10 ３ A method for determining ) and further, The amount of fluid (V) in the fluid chamber ２ A method for determining ) The camera captures an image of the fluid inside the fluid chamber, The image is transmitted from the camera to the processor, From the aforementioned image, The height of the aforementioned fluid is measured, A method comprising: calculating the amount of fluid by multiplying the cross-sectional area of ​​the fluid chamber by the height, The amount of fluid (V) that flows out of the fluid chamber. ３ The method for determining this is: The processor determines the amount of fluid (V) flowing into the fluid chamber. １ ) from the amount of fluid (V) in the fluid chamber ２ Subtracting the increase in ) and The processor adds at least one of the following operations: adding the decrease in the amount of fluid (V １ ) in the fluid chamber to the amount of fluid (V ２ ) flowing into the fluid chamber.

13. An infusion device according to claim 5, wherein the manual pump includes a ball.

14. An infusion device according to claim 5, wherein the manual pump includes a diaphragm.

15. An infusion device according to claim 5, wherein the manual pump has a circuit configured inside.

16. Infusion device, It comprises a fluid container that is in fluid communication with a fluid chamber and positioned above the fluid chamber, The fluid chamber is A fluid inlet, and a first check valve adapted to control the fluid flowing through the fluid inlet, An air outlet, and an air control valve adapted to control the airflow through the air outlet, A fluid outlet, and a fluid control valve adapted to control the fluid flowing through the fluid outlet, Equipped with, The aforementioned infusion device is An infusion device further comprising a camera operably connected to at least one processor and adapted to image the fluid chamber and fluid droplets within the fluid chamber.

17. An infusion apparatus according to claim 16, wherein the infusion apparatus includes a pump as part of the fluid chamber.

18. An infusion device according to claim 17, wherein the pump is adapted to be operated manually.

19. An infusion apparatus according to claim 17, wherein a second check valve is disposed between the pump and the fluid container.

20. Infusion device according to claim 16, wherein the camera is adapted to image droplets falling within the fluid chamber.

21. Infusion device according to claim 16, wherein the at least one processor and software implemented therein are adapted to calculate the volume of one or more imaged fluid droplets.

22. The infusion device according to claim 16, having a rigid fluid chamber.

23. An infusion device according to claim 16, further comprising at least one valve adapted to release air.

24. An infusion device according to claim 16, wherein the fluid chamber further includes a droplet-forming section below the fluid inlet.

25. A method for determining the amount of fluid flowing through an infusion device, To enable fluid to flow from the fluid container to the fluid chamber, The flow of a fluid, Opening, partially opening, partially closing, or closing the fluid inlet and the first check valve, at least one of these, Opening, partially opening, partially closing, or closing the air outlet via the air control valve, and Controlling the fluid outlet via a fluid control valve by opening, partially opening, partially closing, or closing at least one of the following: A method comprising imaging the fluid chamber and fluid droplets within the fluid chamber using a camera operably connected to at least one processor.

26. A method for determining the amount of fluid flowing through an infusion device according to claim 25, further comprising calculating the volume of one or more imaged fluid droplets.

27. A method for determining the amount of fluid flowing through an infusion device according to claim 26, further comprising estimating the dimensions of one or more imaged fluid droplets.

28. A method for determining the amount of fluid flowing through an infusion device according to claim 26, further comprising calculating the total amount of fluid from the sum of the volumes of one or more imaged fluid droplets.

29. A method for determining the amount of fluid flowing through an infusion device according to claim 26, further comprising pumping at least a portion of the fluid passing through the fluid chamber using a pump.

30. A method for determining the amount of fluid flowing through an infusion device according to claim 29, further comprising drawing fluid from the first check valve to the pump, then crushing the pump to discharge the fluid, and repeating this as necessary until a desired flow rate is obtained.

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