EA043431B1 - DEVICE FOR CONTROLLING FLUID FLOW - Google Patents

Description

This patent application is a non-provisional, international application filed under the Patent Cooperation Treaty which claims priority to the following:

US Provisional Patent Application No. 61/578,649, filed December 21, 2011, entitled

System, Method, and Apparatus for Infusing Fluid (Patent Agent Register Number J02);

U.S. Provisional Patent Application No. 61/578,658, filed December 21, 2011, entitled System, Method, and Apparatus for Estimating Liquid Delivery (patent agent docket number J04);

U.S. Provisional Patent Application No. 61/578,674, filed December 21, 2011, entitled System, Method, and Apparatus for Dispensing Oral Medications (patent agent docket number J05);

U.S. Provisional Patent Application No. 61/651,322, filed May 24, 2012, entitled System, Method, and Apparatus for Electronic Patient Care (patent agent docket number J46); and U.S. Provisional Patent Application No. 61/679,117, filed Aug. 3, 2012, entitled System, Method, and Apparatus for Monitoring, Regulating, or Controlling Fluid Flow (patent attorney docket number J30), each of which therefore is incorporated herein by reference in its entirety.

This application claims priority and is also a continuation in part of the following:

US Patent Application No. 13/333,574, filed December 21, 2011, entitled System, Method, and Apparatus for Electronic Patient Care, now published US Application No. US-2012-0185267-A1, published July 19, 2012 ( patent agent file number 197), and PCT application No. PCT/US11/66588, filed December 21, 2011, entitled System, Method, and Apparatus for Electronic Patient Care (patent agent file number I97WO), which both, are therefore incorporated herein by reference in their entirety.

This application may also be related to one or more of the following patent applications filed on the same date, all of which are therefore incorporated herein by reference in their entirety:

non-provisional application for a system, method and device for limitation (patent agent register number J47);

non-provisional application for a system, method and device for dispensing oral medicinal products (patent agent register number J74);

PCT applications for a system, method and device for the dispensing of oral medicinal products (patent agent file number J74WO);

non-provisional application for a system, method and device for evaluating fluid delivery (patent attorney docket number J75);

non-provisional application for a system, method and device for fluid infusion (patent agent register number J76);

PCT applications for fluid infusion system, method and device (Patent Agent Docket number J76WO);

non-provisional application for a system, method and device for electronic patient care (patent agent register number J77);

non-provisional application for a system, method and device for electronic patient care (patent agent register number J78);

non-provisional application for a system, method and device for monitoring, regulating or controlling the flow of a fluid (patent agent register number J79);

non-provisional application for a system, method and device for evaluating fluid delivery (patent attorney docket number J81);

PCT Applications for a System, Method and Apparatus for Evaluating Liquid Delivery (Patent Attorney Docket No. J81WO); and a non-provisional application for an electronic patient care system, method and device (Patent Attorney Docket number J85).

BACKGROUND OF THE INVENTION

Field of technology

The present invention relates to monitoring, regulating or controlling the flow of a fluid. In particular, the present invention relates to a system, method and apparatus for monitoring, regulating or controlling the flow of a fluid, for example, for use in medical applications such as intravenous infusion therapy, dialysis, transfusion therapy, peritoneal infusion therapy, bolus delivery, enteral fluid therapy nutrition, parenteral nutrition therapy, hemoperfusion therapy, fluid resuscitation or insulin delivery, etc.

- 1 043431

State of the art

In many medical settings, one common medical treatment regimen involves administering fluids to a patient, such as a human, animal, or pet. It may be necessary to rapidly infuse a fluid into the patient's body, accurately infuse a fluid into the patient's body, and/or slowly infuse a fluid into the patient's body. Saline and lactated Ringer's are examples of commonly used fluids. Such fluids can be used to maintain or increase blood pressure and enhance adequate blood supply. In the setting of traumatic shock or septic shock, fluid resuscitation is often the emergency treatment to maintain or increase blood pressure.

Delivery of fluid into the patient's body can be facilitated by using a gravity line (or tube) inserted into the patient's body. Typically, a fluid reservoir (eg, an IV bag) is hung on a stand and connected to the fluid tubing. A fluid tube is sometimes attached to the dropper to capture air and estimate fluid flow. Below the fluid tube may be a manually actuated valve used to regulate the flow of fluid. For example, by counting the number of droplets produced in an IV over a period of time, the caregiver can calculate the flow rate of fluid that flows through the IV and adjust the valve (if necessary) to achieve the desired flow rate.

Certain treatments require that the fluid delivery system strictly follow the flow rate set by the caregiver. Typically such applications involve the use of an infusion pump, but such pumps may not be used in all situations or conditions.

The essence of the invention

Briefly and generally, the present invention relates to a system, method and apparatus for monitoring, regulating or controlling the flow of a fluid, for example, for use in medical applications such as intravenous infusion therapy, dialysis, transfusion therapy, peritoneal infusion therapy, delivery boluses, enteral nutrition therapy, parenteral nutrition therapy, hemoperfusion therapy, fluid resuscitation or insulin delivery, etc. In particular, the present invention relates to a fluid flow meter for monitoring the flow of fluids associated with a patient, a valve for regulating the flow of fluid patient-related fluid and/or a fluid flow meter connected to a valve (eg, in a closed-loop, open-loop, or feedback configuration) to monitor, regulate, and/or control the use of the patient-related fluid.

In some embodiments of the present invention, the flow meter includes one or more optical sensors for monitoring the flow of fluid in the tube, for example, using an image sensor to monitor droplets in a dropper attached to the tube. A flow meter can be a standalone device, can be used in conjunction with a pump or valve or both, and/or can be used to provide feedback to any electronic device. The flow meter allows remote control, for example, using a control client, remote communicator, smartphone, computer, etc. The flow meter may measure average flow rate, instantaneous flow rate, droplet volume, droplet growth rate, or other parameter associated with fluid flow.

The flow meter may use a flow rate or parameter associated with the fluid flow to: (1) display the flow rate or parameter on the screen, (2) provide feedback, for example, on the flow rate or parameter associated with the fluid flow (wireless or via wires, with an infusion pump, such as a peristaltic pump, (3) providing feedback to a monitoring client or a remote monitoring client, such as a smartphone, (4) issuing warning signals when the flow rate or parameter associated with the fluid flow is outside the limits in advance a certain range, (5) issuing an alarm signal when the flow rate or parameter associated with the fluid flow exceeds a predetermined threshold, (6) issuing an alarm signal when free flow is detected, (7) transmitting alarm signals to the pump, control client or client remote control, (8), instructing the valve to stop fluid flow when free flow is detected, a warning signal is issued, and/or when a flow rate or parameter associated with the fluid flow exceeds a threshold or is outside a predetermined range, and/or ( 9) broadcasting a flow rate or parameter associated with fluid flow.

In some embodiments described herein, the valve controls fluid flow associated with the patient. The valves disclosed herein may be operated manually or by an actuator (or both). The valve can be used with or without a pump, with or without a flow meter, and/or it can be a stand-alone device. The valve allows remote control, for example, using a control client, remote communicator, smartphone, computer, etc. The valve can compress the tube over an area that is significantly larger than the diameter

- 2 043431 tubes, for example, 2 times more, 5 times more, 10 times more, etc.

The valve may be made of two or more parts that compress the tube, or it may be made of one part that compresses the tube when the part moves or deforms. Two or more parts and/or one part can be produced using injection molding, ultrasonic welding, using multiple parts glued or molded together, and the like. Each of the two or more parts can be obtained from one or more parts that can be connected to each other either permanently or temporarily. One part can be made from one or more parts that are connected to each other either permanently or temporarily, for example, using ultrasonic welding, gluing, snapping, or other method. The parts may be made of plastic, metal, alloy, polymer, or other material.

In some embodiments of the present invention, a flow meter is connected to a valve to regulate the flow rate of a fluid, such as the flow rate of a fluid administered to a patient. A flow meter connected to the valve can be used in place of a pump, such as a peristaltic infusion pump, or can serve as a replacement for an infusion pump. The flow meter and valve combination allows remote control, for example by a control client, remote communicator, smartphone, computer, etc., or remote monitoring. The control client may control the flow meter or valve, may mediate between the flow meter and the valve, may monitor the operation of the flow meter or valve, may transmit information associated with the flow meter or valve to a server, and/or may not be used in the system.

A flow meter may monitor the flow of a fluid and regulate, directly or indirectly, the operation of a valve or pump (eg, an infusion pump). The flow meter may provide an alert when it detects free flow conditions, determines that the flow rate exceeds a predetermined threshold or is outside a predetermined range, and/or detects any anomalous behavior. The flow meter, in response to an alarm signal or condition, may cause the flow meter to stop fluid flow, cause a valve to stop fluid flow, cause a safety valve to stop fluid flow, notify a monitoring client or remote communicator, broadcast a detected condition, or implement a predetermined procedure or algorithm. .

In some embodiments of the present invention, the fluid flow control device includes a curved, elongated support member and an opposing support member. The curved, elongated support member is elastically deformable and has first and second ends. The opposite support piece is configured to place the tube opposite the curved, elongated support piece between the first and second ends, such that deformation of the curved, elongated support piece by moving the first and second ends towards each other reduces the internal volume of the tube. The opposite support member may be another curved, elongated support member.

The apparatus may include an actuator coupled to the curved, elongated support member for deforming the curved, elongated support member by moving the first and second ends toward each other by activating the actuator. In some such embodiments, the drive may be a lead screw, and a handwheel may be coupled to the lead screw to drive the lead screw.

The actuator, the curved, elongated support member, and the opposing support member may be configured to adjust the fluid flow rate by activating the actuator in accordance with a Gompertz curve. The drive may be further configured, in some embodiments, to drive the first and second ends toward each other along a predetermined portion of the Gompertz curve. For example, the actuator may activate the actuator only over a portion of the activated range of the curved, elongated support member and the opposing support member.

The actuator, the curved, elongated support member, and the opposing support member may be configured to adjust the fluid flow rate by activating the actuator in accordance with a sigmoidal curve. The drive may be further configured to drive the first and second ends toward each other along a predetermined portion of the sigmoidal curve.

The curved, elongated support member may be semi-rigid and/or may consist of substantially tensile material. The curved, elongated support member may be an arcuate, elongated support member, and/or may be C-shaped.

The device may further comprise an elongated connecting piece operatively coupled to the first and second ends of the curved, elongated support piece.

In some embodiments of the present invention, the device may include an actuator coupled to the elongate coupling member and the curved, elongated support member for applying an expansion force to thereby deform the first and second ends of the curved, elongated support members toward each other.

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In some embodiments of the present invention, a curved, elongated support member is positioned approximately parallel to another curved, elongated support member opposite a substantial portion thereof. For example, a curved, elongated support member defines a length, and another curved, elongated support member defines a length, and a length of another curved, elongated support member is approximately parallel to the length of the curved, elongated support member.

In some embodiments of the present invention, the device includes an actuator operatively coupled to a curved, elongated support member at the first and second ends and to another curved, elongated support member at the first and second ends. Activation of the actuator causes the first and second ends of the curved, elongated support piece to move closer to each other and also causes the first and second ends of the other curved, elongated support piece to move closer to each other, thereby resulting in a decrease in the distance between the curved, elongated support piece and the other curved support piece. , an elongated support piece to thereby compress the tube.

In some embodiments of the present invention, a curved, elongated support member defines a length, and an opposing support member is positioned orthogonal to the length along a portion thereof.

In some embodiments of the present invention, the curved, elongated support member includes a plurality of ribs disposed thereon for mating with the tube.

In some embodiments of the present invention, the counter support member includes a plurality of ribs arranged thereon to engage with the tube.

In some embodiments of the present invention, the curved, elongated support member includes a ridge extending from its length configured to support a tube. The opposing support member may include another ridge extending from its length configured to support a tube such that the ridge and the other ridge are approximately parallel to each other and approximately parallel to a central axis defined by the tube when the tube is positioned between them.

In some embodiments of the present invention, the fluid flow control device includes a first elongated support member, a second elongated support member, and an actuator. The first elongate support member defines a length, and the second elongate support member also defines its own length, such that the length of the second elongate support member is located at some distance from the length of the first elongated support member to, together with the first elongated support member, compress the tube. The actuator is mechanically coupled to at least one of the first and second elongate support members to drive the first and second elongate support members toward each other to thereby compress the tube disposed therebetween to adjust the flow rate of fluid in the tube thereby that activation of the actuator drives the first and second elongate support members to adjust the flow rate of fluid in the tube according to an approximate sigmoidal curve.

The length of the second elongate support member may be approximately parallel to the length of the first elongate support member. The first and second elongate support members may be configured to act in concert with each other to compress the tube over a length of the tube at least substantially greater than the diameter of the tube. The actuator may be configured to drive the first and second elongated support members to compress the tube to adjust the flow rate of fluid in the tube over a predetermined portion of the sigmoidal curve.

In some embodiments of the present invention, the fluid flow control device includes first and second elongate support members. The first elongate support member defines a length, and the second elongate support member defines a length. The length of the second elongated support member is located at some distance from the length of the first elongated support member so as, together with the first elongated support member, to compress the tube. The actuator is mechanically coupled to at least one of the first and second elongate support members to drive the first and second elongate support members toward each other to thereby compress the tube disposed therebetween to adjust the flow rate of fluid in the tube thereby that activation of the actuator drives the first and second elongated support members to adjust the flow rate of fluid in the tube according to an approximate Gompertz curve.

The length of the second elongate support member may be approximately parallel to the length of the first elongate support member. The first and second elongate support members may be configured to act in concert with each other to compress the tube over a length at least substantially greater than the diameter of the tube.

The actuator may be configured to drive the first and second elongate support members to compress the tube to adjust the flow rate of fluid in the tube according

- 4 043431 with a predetermined section of the Gompertz curve.

In some embodiments of the present invention, the fluid flow control device includes first and second elongate support members. The first elongate support member defines a length, and the second elongate support member defines a length such that the length of the second elongate support member is positioned at a distance from the length of the first elongate support member to, together with the first elongate support member, compress the tube. The actuator is mechanically coupled to at least one of the first and second elongate support members to drive the first and second elongate support members toward each other to thereby compress the tube disposed therebetween to adjust the flow rate of fluid in the tube thereby that activation of the actuator drives the first and second elongated support members to adjust the flow rate of fluid in the tube in accordance with an approximate generalized logistic function.

The length of the second elongate support member may be approximately parallel to the length of the first elongate support member. The first and second elongate support members may be configured to act in concert with each other to compress the tube over a length of the tube at least substantially greater than the diameter of the tube. The actuator may be further configured to drive the first and second elongated support members to compress the tube to adjust the flow rate of fluid in the tube in accordance with a predetermined portion of the generalized logistic function.

In some embodiments of the present invention, the fluid flow control device includes first and second support members and an actuator. The first support member defines at least one of an arc, a plurality of arcs, a curve, a plurality of curves, an arcuate shape, a plurality of arcuate shapes, an S-shape, a C-shape, a convex shape, a plurality of convex shapes, a concave shape, and a plurality of convex shapes. The second support member is positioned some distance from the first support member so as to, together with the first support member, compress the tube over a length of the tube at least substantially greater than the diameter of the tube. The actuator is mechanically coupled to at least one of the first and second support members to drive the first and second support members towards each other to thereby compress the tube disposed therebetween to adjust the flow rate of fluid in the tube such that activation of the actuator drives the first and second support members to adjust the flow rate of fluid in the tube according to an approximate nonlinear function.

The approximate nonlinear function may be an approximate generalized logistic function, an approximate sigmoid curve, and/or an approximate Gompertz curve. The actuator may be configured to be activated to thereby control the flow of fluid in the tube in accordance with a predetermined portion of the approximate nonlinear function.

In some embodiments of the present invention, the first support member forms an arc, has a shape consisting essentially of an arc, forms a plurality of arcs, has a shape consisting essentially of a plurality of arcs, forms a curve, has a shape consisting essentially , from a curve, forms a plurality of curves, has a shape consisting essentially of a plurality of curves, forms an arcuate shape, has a shape consisting essentially of an arcuate shape, forms a plurality of arcuate shapes, has a shape consisting essentially of a plurality of arcuate shapes, forms an S-shape, has a shape consisting essentially of an S-shape, forms a C-shape, has a shape consisting essentially of a C-shape, forms a convex shape, has the shape , consisting essentially of a convex shape, forms a plurality of convex shapes, has a shape consisting essentially of a plurality of convex shapes, forms a concave shape, has a shape consisting essentially of a concave shape, forms a plurality of concave shapes, and/ or has a shape consisting essentially of a plurality of concave shapes.

The length of the second support piece may be approximately parallel to the length of the first support piece. The first and second support members may be configured to act in concert with each other to compress the tube over a length of the tube at least substantially greater than the diameter of the tube.

In some embodiments of the present invention, the fluid flow control device includes a curved, elongated support member and an opposing support member. The curved, elongated support member is elastically deformable and has first and second ends. The opposite support member is configured to form a conduit with the curved, elongated support member such that the conduit is formed between the curved, elongated support member and the counter member; deformation of the curved, elongated support part due to the movement of the first and second ends towards each other reduces the internal volume of the pipeline. In some embodiments, the conduit may be configured to receive a tube. In other further embodiments, the conduit is hydraulically isolated, and the device further includes first and second ports fluidly coupled to the conduit such that each port is configured to

- 5 043431 connection to the tube.

In some embodiments of the present invention, the fluid flow control system includes a flexible tube and a Bourdon tube check valve. The flexible tube for fluid has a flow channel and is configured to pass fluid. A Bourdon tube check valve is connected to the flexible fluid conduit to regulate fluid flowing through the flow path of the flexible fluid conduit. An actuator may be coupled to the Bourdon tube check valve to operate the Bourdon tube check valve to regulate fluid flowing through the flow path of the flexible fluid tube. A Bourdon tube check valve operates opposite to a Bourdon tube in that deformation of the flow channel causes a change in fluid flow rather than fluid flow causing deformation of the flow channel.

In some embodiments of the present invention, a system for controlling fluid flow includes a fluid conduit, a valve, and an actuator. The fluid tube defines a flow channel configured to pass fluid. The valve is operatively coupled to the fluid conduit and includes first and second flexible members. The second flexible part is operatively connected to the first flexible part. The fluid conduit is disposed between the first and second flexible members, and the first and second flexible members are flexible to thereby control the flow rate of fluid passing through the fluid conduit. The drive is connected to at least the first end of the first flexible part and the second end of the first flexible part. The drive may be a lead screw, and a motor may be provided coupled to the lead screw to rotate the lead screw.

In some embodiments of the present invention, the system may include a handwheel coupled to the lead screw such that the handwheel is configured to rotate the lead screw. The handwheel can be driven by a motorized drive.

In some embodiments of the present invention, an actuator is coupled to a first end of the first flexible member and a second end of the first flexible member, and the actuator is configured to at least one of bending the first and second ends toward each other and bending the first and second ends away from each other. . The actuator may bend the first and second ends away from each other, and/or the actuator bends the first and second flexible members such that the first and second ends move closer to each other. The first and second flexible parts may be generally rectangular. The first piece and/or the second piece may be tensioned to at least substantially stop the flow of fluid when the actuator ceases applying force.

The system may include a flow meter coupled to a dripper that is coupled to the fluid conduit such that the flow meter estimates the flow rate of fluid through the dropper and thus also estimates the flow rate of fluid through the fluid conduit. The flow meter may be an image sensor based flow meter.

The flow meter may be operatively coupled to the motor to actuate the valve, and the system may include a control component for controlling the motor to actuate the valve to achieve a desired flow rate estimated by the flow meter.

In some embodiments of the present invention, the fluid flow control device includes first and second C-shaped pieces. The first C-shaped piece defines the inner and outer surfaces, and the second C-shaped piece defines the inner and outer surfaces. At least one of the outer surface of the first C-shaped piece and the inner surface of the second C-shaped piece is configured to receive a tube. The inner surface of the second C-shaped part is located at some distance from the outer surface of the first C-shaped part. A substantial area of the inner surface of the second C-shaped piece, in some particular embodiments, may be adjacent to the outer surface of the first C-shaped piece.

In some embodiments of the present invention, the second C-shaped piece is flexible and the first C-shaped piece is semi-rigid, rigid, and/or elastomeric.

The flexible member may be formed from a material selected from the group consisting of plastic, polymer, monomer, polypropylene, thermoplastic polymer, ceramic, polyvinyl chloride, and polyethylene.

In some embodiments of the present invention, the fluid flow control device includes first and second flexible plates. The second flexible plate is operatively coupled to the first flexible plate. The first and second flexible plates are configured to receive a fluid conduit therebetween, and the first and second flexible plates are also configured to bend, thereby adjusting the flow rate of fluid passing through the fluid conduit.

The device may include a drive coupled to a first end of the first flexible plate and a second end of the first flexible plate. The drive can be configured to

- 6 043431 at least one of bending the first and second ends towards each other and bending the first and second ends away from each other.

The apparatus may include a lead screw coupled to a first end of the first flexible plate and a second end of the first flexible plate, and a handwheel coupled to the lead screw such that rotation of the handwheel causes rotation of the lead screw. The handwheel may be configured to interface with a motorized drive, whereby the motorized drive drives the handwheel.

In some embodiments of the present invention, the fluid flow control device includes first and second curved parts. The first curved shaped piece defines the inner and outer surfaces, and the second curved shaped piece also defines the inner and outer surfaces. The inner surface of the second curved part is located at some distance from the outer surface of the first curved part.

At least one of the first and second curved shaped pieces may be configured to accommodate a fluid conduit therebetween. The first curved shaped piece may be at least one of semi-rigid and rigid. The second curved part may be flexible. The second curved part may contain an elastomer. The first and second curved shaped parts may be flexible.

The device may comprise a connecting piece operatively coupled to at least one of a first end of the first curved shaped piece and a first end of a second curved shaped piece such that the connecting piece is also operatively connected to at least one of a second end of the first curved shaped piece and a second the end of the second part of a curved shape. The connecting piece may be flexible, may be rigid and/or may be semi-rigid.

The device may include an actuator positioned between the coupling member and the second curved member to apply a force therebetween when activated. The drive can be a lead screw.

In some embodiments of the present invention, the fluid flow control device includes first and second curved parts. The first curved part forms the inner and outer surfaces. The first curved piece has first and second receiving pieces at opposite ends of the first curved piece. The second curved part forms the inner and outer surfaces. The second curved shaped piece has first and second attachments at opposite ends of the second curved shaped piece. At least one of the first and second fasteners may be a hook. The first receiving part of the first curved shaped part is configured to mate with the first fastening of the second curved shaped part, and the second receiving part of the first curved shaped part is configured to mate with the second fastening of the second curved shaped part.

At least one of the receiving parts may be a cylindrical shaped part, for example a cylindrical nut, configured to be attached to the hook.

At least one of the receiving parts may be operatively coupled to the drive. One or more of the receiving parts may be operatively coupled to the electric motor.

In some embodiments of the present invention, the apparatus further includes a motor coupled to the first receiving member such that: (1) the motor rotates a rotor coupled to a shaft having threads on its outer surface; (2) the second receiving member defines a threaded hole configured to receive the shaft; and (3) the threaded hole and the shaft act together to at least one of increase or decrease the distance between the first and second receiving members as the electric motor rotates the rotor to thereby rotate the shaft.

In some embodiments of the present invention, the fluid flow control device includes first and second curved, elongate support members. The first curved, elongated support member is elastically deformable and has first and second ends. The second curved, elongated support member is elastically deformable and has first and second ends. The second curved, elongated support piece is configured to place the tube opposite the first curved, elongated support piece such that deformation of the first and second curved, elongated support pieces due to movement of the first and second ends of the first curved, elongated support piece towards each other reduces the internal volume tubes.

The first connector is connected to the first end of the first curved, elongated support piece and is also connected to the first end of the second curved, elongated support piece. The second connector is connected to the second end of the first curved, elongated support piece and is also connected to the second end of the second curved, elongated support piece. Second connector

- 7 043431 forms a hole. The connecting piece has an end attached to the first connector and another end configured to be inserted into an opening of the second connector. The connecting piece forms a threaded rod at least along its portion. The handwheel has a ratchet configured to advance incrementally toward the connector piece as it moves from the other end of the connector piece to the end of the connector piece. The handwheel is additionally configured to mate with the threaded rod of the connecting part. The handwheel may include a plurality of fingers configured to mate with a threaded rod of the connecting member. The handwheel defines an outer periphery and includes an opening formed at the center of the outer periphery of the handwheel. The hole is configured to receive a threaded rod. Each of the plurality of fingers is curved to mate with a threaded rod at a corresponding end of each of the plurality of fingers.

The first curved, elongated support piece defines a first opening adjacent the first end of the first curved, elongated support piece. The hole is configured to hold a fluid tube.

The first curved, elongated support member may define a first recess adjacent a first end of the first curved, elongated support member such that the recess is configured to receive a fluid conduit. The recess may include a neck configured to receive a fluid conduit and a circular region configured to retain the fluid conduit.

In some embodiments of the present invention, the fluid flow control device includes a base, a plurality of fingers, and a ring. The base defines an opening configured to receive a fluid tube. Each of the many fingers has an end attached to a base. The ring is designed to slide from the base and along a plurality of fingers. Moving the ring from the base to the fingers presses the fingers against the tube. The ring is made with the possibility of frictional fixation on multiple fingers. Each finger includes an elongated end attached to the base and a curved end attached to an end opposite to the base.

In some embodiments of the present invention, the fluid flow control device includes a cone-shaped member, a mating member, and an actuator. The cone-shaped part has a surface for wrapping the tube around it. The mating part is configured to mate with a conical-shaped part to compress the tube, the drive is configured to press the conical-shaped part to the mating part to thereby compress the tube.

In some embodiments of the present invention, the intravenous administration kit includes a flexible tube for directing the flow of fluid therein; a first port at a first end of the flexible tube; a second port at the second end of the flexible tube; a curved, elongated support member that is elastically deformable and has first and second ends; and an opposing support piece configured to place the flexible tube opposite the curved, elongated support piece between the first and second ends such that deformation of the curved, elongated support piece by moving the first and second ends toward each other reduces the internal volume of the tube.

The intravenous administration set may further include an IV line connected to the flexible tubing, another port configured to receive a syringe for injecting fluid into a fluid stream in the flexible tubing, and/or a sliding barrier connected to the flexible tubing configured to interface with the flexible tube to obstruct the flow of fluid through it.

A first end of the curved, elongated support member may define a first opening for receiving flexible tubing, and a second end of the curved, elongated support member may define a second opening for receiving flexible tubing.

In some embodiments of the present invention, the flow meter includes a coupling device, a support member, first and second image sensors, and at least one processor. The connecting device is designed to be connected to a dropper. The support member is operatively connected to the connecting device. The first image sensor has a first field of view and is operatively coupled to the support member. The first image sensor is positioned to observe the IV in the first field of view. The second image sensor has a second field of view and is operatively coupled to the support member. A second image sensor is positioned to observe the IV in the second field of view.

At least one processor is operatively connected to the first and second image sensors. At least one processor receives first image data from a first image sensor and second image data from a second image sensor, and at least one processor estimates at least one parameter of the fluid in the dropper using the first and second image data.

The at least one parameter may be one of a liquid formation type, a liquid volume, and a liquid shape. The at least one processor may determine the presence of a free flow condition using at least one of the first and second sets of image data.

The flow meter may further include a background pattern located in the field of view of the first image sensor such that the dropper is located between the first image sensor and the background pattern.

The at least one flow meter processor may estimate at least one parameter using the first set of image data by analyzing the background distortion caused by the fluid in the first field of view as observed by the first image sensor. The background pattern may be an array of lines having at least one angle relative to the dropper opening as viewed from a first image sensor in a first field of view using the first set of image data.

The at least one processor may determine that a free flow condition exists when the fluid causes the line array to change angles due to distortion caused by the fluid for which the free flow condition is satisfied when viewed in a first field of view from the first image sensor.

The at least one processor may compare at least one of the first and second image data with the background image to estimate at least one parameter.

The at least one processor may compare at least one of the first and second image data to the background image, calculating at least one of a difference between at least one of the first and second image data to the background image, an absolute difference between at least one of the first and second background image data, and/or the square of the absolute difference between at least one of the first and second background image data.

The flow meter may include non-volatile processor-readable memory operatively coupled to the at least one processor such that the memory stores an operative set of processor-executable instructions configured for execution by the at least one processor. An online set of processor-executable instructions, when executed by at least one processor, controls the operation of the at least one processor.

In some embodiments of the present invention, the flow meter includes a connector, a support piece, a background pattern, and at least one processor. The connecting device is designed to be connected to a dropper. The support member is operatively connected to the connecting device. The image sensor has a field of view and is operatively coupled to the support member. An image sensor is positioned to observe the dropper in the field of view. The background image is located in the field of view of the image sensor. The background pattern is positioned such that the dropper is located between the background pattern and the image sensor. The at least one processor is operatively coupled to the image sensor to receive image data therefrom. The at least one processor is configured to estimate at least one parameter of the fluid in the dropper using the background distortion caused by the fluid, as indicated by the image data. Distortion may be observed in the field of view of the image sensor by the image sensor. The at least one parameter is at least one of a liquid formation type, a liquid volume, and a liquid shape. The background pattern may be an array of lines having at least one angle relative to the dropper opening as viewed from an image sensor using the image data.

The at least one processor may determine the presence of a free flow condition using background distortion caused by the fluid, as indicated by the image data. The at least one processor may determine that a free flow condition exists when the fluid causes the line array to change angles due to distortion caused by the fluid for which the free flow condition is satisfied when observed in the field of view of the image sensor.

The flow meter may further include non-volatile processor-readable memory operatively coupled to the at least one processor. Non-volatile processor-readable memory may store a run-time set of processor-executable instructions configured for execution by at least one processor such that the run-time set of processor-executable instructions, when executed by the at least one processor, controls the operation of the at least one processor.

In some embodiments of the present invention, the flow meter includes a connector, a support member, an image sensor, and at least one processor. The connecting device is designed to be connected to a dropper. The support member is operatively connected to the connecting device. The image sensor has a field of view and is operatively coupled to the support member such that the image sensor is positioned to view the dropper in the field of view. At least one processor is operatively coupled to the image sensor to receive image data from it such that the at least one processor compares the image of the image data with a reference image to estimate at least one parameter of the fluid in the dropper. The reference image may be a dynamic reference image. The at least one processor may update the reference image by multiplying each pixel of the reference image by a first constant and adding the corresponding image pixel multiplied by a second constant.

The flow meter may include non-volatile processor-readable memory operatively coupled to the at least one processor. The non-volatile processor-readable memory may include a real-time set of processor-executable instructions configured for execution by at least one processor such that the real-time set of processor-executable instructions, when executed by the at least one processor, controls the operation of the at least one processor.

In some embodiments of the present invention, a method of exposing an image sensor, implemented by a set of on-the-fly processor-executable instructions configured to be executed by at least one processor, includes the steps of: selecting a region of interest; determining whether the pixel is in a region of interest; activating the backlight light source if the pixel is in the area of interest; and exposing the pixel, the activation action may activate a subset of light sources including the backlight light source. The illumination light source can produce uniform illumination. The image sensor may include a region of interest and a pixel.

An operational set of processor-executable instructions may be stored in non-volatile processor-readable memory operatively coupled to the at least one processor such that the at least one processor may implement the method.

The at least one processor may be coupled to the image sensor such that the at least one processor implements the method using the image sensor. The region of interest may be the region of the image sensor that depicts the dropper. The area of interest may correspond to a dropper.

The method may further include the steps of: receiving a field timing signal from the image sensor; and receive a horizontal clock signal from the image sensor. The at least one processor may receive the field and horizontal clock signals from the image sensor. The at least one processor may activate the backlight light source in accordance with at least one of the field and horizontal clock signals. The light source may be an LED.

In some embodiments of the present invention, the flow meter includes a connector, a support member, an image sensor, a backlight, and at least one processor. The connecting device is designed to be connected to a dropper. The support member is operatively connected to the connecting device. The image sensor has a field of view and is operatively coupled to the support member such that the image sensor is positioned to view the dropper in the field of view. The backlight has at least one light source. The backlight is coupled to the support member such that the backlight is configured to illuminate the image sensor to expose the image sensor, wherein the field of view of the image sensor at least partially depicts at least a portion of the dropper. The at least one processor is operatively coupled to the image sensor to receive image data therefrom.

The at least one processor is configured to: select a region of interest of the image sensor; determine whether a pixel of the image sensor is located in a region of interest; activate the backlight light source if the image sensor pixel is in the area of interest; and expose the image sensor pixel.

The flow meter may further include non-volatile processor-readable memory readable by at least one processor. The non-volatile processor-readable memory includes an on-the-fly set of processor-executable instructions stored therein, configured to cause at least one processor, when executed: to select a region of interest of the image sensor; determine whether a pixel of the image sensor is located in a region of interest; activate the backlight light source if the image sensor pixel is in the area of interest; and expose the image sensor pixel. The at least one processor may be further configured to: receive a field clock signal from the image sensor; and receive a horizontal clock signal from the image sensor. The at least one processor may activate the backlight light source in accordance with at least one of the field and horizontal timing signals.

The at least one processor may select a region of interest and determine whether a pixel of the image sensor is located in the region of interest according to the image data. The region of interest is the area of the image sensor that depicts the dropper. The area of interest may correspond to a dropper.

The at least one processor may activate a subset of light sources including a backlight light source. The illumination light source can produce uniform illumination.

In some embodiments of the present invention, the method includes the steps of: capturing an image including an image of the dropper using an image sensor having a field of view including the dropper; subtracting the image from the background image to thereby generate a difference image; converting each pixel of the difference image to a value of true if the absolute value of the corresponding pixel is beyond a predetermined threshold or to a value of false if the absolute value of the corresponding pixel is less than a predetermined threshold; summing each row of the transformed difference image to generate a plurality of sum values, each sum value of the plurality of sum values corresponding to a corresponding row of the transformed difference image; and check a plurality of total values.

The method may be implemented by means of an on-the-fly set of processor-executable instructions stored in non-volatile processor-readable memory operatively coupled to at least one processor such that the at least one processor implements the method.

The act of checking a plurality of total values may include determining whether a free flow condition exists in the dripper.

The act of determining whether a free flow condition exists may include determining whether the plurality of total values includes a plurality of continuous total values exceeding another predetermined threshold.

The act of checking a plurality of total values may include determining whether a droplet has formed in the dropper.

The act of determining whether a droplet has formed in the dripper may include determining whether the plurality of total values includes a plurality of continuous total values in a predetermined range that is greater than a minimum value and less than a maximum value.

The method may optionally include smoothing the plurality of total values prior to the checking action. The smoothing action may be performed in accordance with at least one of a spline function, a cubic spline function, a B-spline function, a Bezier spline function, polynomial interpolation, a moving average, a data smoothing function, and a cubic spline type function.

The at least one processor may optionally be coupled to the image sensor, and the at least one processor may implement the method using the image sensor.

The method may optionally include the act of converting each pixel of the difference image to the absolute value of each pixel after the subtraction action and before the transform action.

The method may optionally include the act of converting each pixel of the difference image into the square of the value of each pixel after the subtraction action and before the transform action.

In some embodiments of the present invention, the flow meter includes a connector, a support member, a light source, and at least one processor. The connecting device is designed to be connected to a dropper. The support member is operatively connected to the connecting device. The image sensor has a field of view and is operatively coupled to the support member such that the image sensor is positioned to view the dropper in the field of view. The light source is coupled to the support member and is configured to illuminate the image sensor to expose the image sensor such that the field of view of the image sensor at least partially depicts at least the dropper portion.

At least one processor is operatively coupled to the image sensor to receive image data therefrom, and the at least one processor is configured to: capture an image including an image of the dropper using the image sensor having a field of view including the dropper; subtract the image from the background image to thereby generate a difference image; convert each pixel of the difference image to a value of true if the absolute value of the corresponding pixel is beyond a predetermined threshold or to a value of false if the absolute value of the corresponding pixel is less than a predetermined threshold; sum each row of the transformed difference image to generate a plurality of sum values, each sum value of the plurality of sum values corresponding to a corresponding row of the transformed difference image; and check multiple total values.

The flow meter may include a non-volatile processor-readable memory readable by at least one processor such that the non-volatile processor-readable memory includes an on-the-fly set of processor-executable instructions stored therein, configured to instruct the at least one processor when executed : capturing an image including an image of the dropper using an image sensor having a field of view including the dropper; subtract the image from the background image to thereby generate a difference image; convert each pixel of the difference image to a value of true if the absolute value of the corresponding pixel is beyond a predetermined threshold, or to a value of false if the absolute value of the corresponding pixel is less than a predetermined threshold; sum each row of the transformed difference image to generate a plurality of sum values, each sum value of the plurality of sum values corresponding to a corresponding row of the transformed difference image; and check multiple total values.

The at least one processor may be further configured to determine whether a free flow condition exists in the dripper when the processor checks the plurality of total values.

The at least one processor may be further configured to determine whether the plurality of total values includes a plurality of continuous total values greater than another predetermined threshold when the at least one processor determines whether a free flow condition exists.

The at least one processor may be further configured to determine whether a droplet has formed in the dropper when the at least one processor checks the plurality of total values.

The at least one processor may be further configured to determine that a droplet has formed if the plurality of total values includes a plurality of continuous total values in a predetermined range that is greater than a minimum value and less than a maximum value, and the position of the continuous total values corresponds to a predetermined range of positions in which a drop can form.

The at least one processor may be further configured to smooth the plurality of summary values before the at least one processor examines the plurality of summary values.

The at least one processor may perform smoothing in accordance with at least one of a spline function, a cubic spline function, a B-spline function, a Bezier spline function, polynomial interpolation, a moving average, a data smoothing function, and/or a cubic spline type function. .

The flow meter may further include a non-volatile processor-readable memory where an on-line set of processor-executable instructions is stored.

The non-volatile processor-readable memory is operatively coupled to the at least one processor such that an operative set of processor-executable instructions controls the operation of the at least one processor.

The at least one processor may be further configured to convert each pixel of the difference image to the absolute value of each pixel after the subtraction action and before the conversion.

The at least one processor may be further configured to transform each pixel of the difference image into the square of the value of each pixel after the subtraction action and before the conversion.

In some embodiments of the present invention, the method includes the steps of: capturing an image of the dropper using an image sensor; identifying a plurality of pixels of interest in the image; determining a subset of pixels within the plurality of pixels of interest, each pixel of the plurality of pixels being determined to be in the subset of pixels when a path to a baseline corresponding to the dropper exists; performing a rotation operation on a subset of pixels; and estimating the volume of the droplet in the dropper by counting the number of pixels in the rotated subset of pixels.

The baseline may be a predetermined set of pixels in the image sensor. Multiple pixels of interest can be identified by comparing the image to the background image.

The method may optionally include one or more steps of: initializing background images; updating the background image using the image captured by the image sensor; updating the array of variance values using the image captured by the image sensor; and/or updating the array of integers according to the image captured by the image sensor.

- 12 043431

The background image can be updated according to: р - Р fl - (Ύ + OL Р * background,i,j background,i,j ξ ^background / backgroundinput,i,j

An array of variance values can be updated in

Ισ ² = (Р . -Р . Ύ temp y background,г,J input,i,j J according to:

^background,i,j ^background,i,j ^background ) /^background^temp

Each integer in the array of integers can correspond to the number of updates to a pixel of the background image. In some specific embodiments, image-to-background-image comparison compares pixels in the image to pixels in the background image only if the corresponding integer of the array of integers indicates that the corresponding pixel in the background image has been updated at least a predetermined number of times.

The method may optionally include one or more steps of: identifying a droplet in the image and a predetermined stripe near the droplet boundary; and initializing the background image by setting each pixel of the background image to be equal to an image pixel if it is not in an identified blob or a predetermined stripe near a blob boundary.

The method may further include setting a background image pixel to a predetermined value if the corresponding image pixel is in an identified blob or a predetermined band near the blob boundary. The corresponding image pixel has a position corresponding to the background image pixel.

The method may further include determining a baseline corresponding to the dropper opening.

The act of determining a subset of pixels within the plurality of pixels of interest that corresponds to a blob may include determining that each of the plurality of pixels of interest is in the subset of pixels if the corresponding pixel of the plurality of pixels has a continuous path back to the blob formation baseline on the dropper hole.

The method may optionally include one or more steps of: capturing a first image using an image sensor; identifying a droplet in the first image and a predetermined stripe near the droplet boundary; initializing the background image by setting each pixel equal to a pixel in the first image if it is not in an identified blob or a predetermined stripe near the blob boundary; setting the pixels in the droplet region or in the predetermined stripe to a predetermined value; initialize an array of integers; and initialize an array of variance values.

The method may also include updating one or more of a background image, an array of integers, and/or an array of variance values using the image.

In some embodiments of the present invention, the flow meter includes a connector, a support member, an image sensor, and at least one processor. The connecting device is designed to be connected to a dropper. The support member is operatively connected to the connecting device. The image sensor has a field of view and is operatively coupled to the support member. An image sensor is positioned to observe the dropper in the field of view.

At least one processor is operatively coupled to the image sensor to receive image data therefrom, and the at least one processor is configured to: capture an image of the IV using the image sensor; identify a plurality of pixels of interest in the image; determining a subset of pixels within the plurality of pixels of interest, each pixel of the plurality of pixels being determined to be in the subset of pixels when a path to a baseline corresponding to the dropper exists; perform a rotation operation on a subset of pixels; and estimate the volume of the droplet in the dropper by counting the number of pixels in the rotated subset of pixels.

The flow meter may also include non-volatile processor-readable memory, where an operational set of processor-executable instructions is stored.

The non-volatile processor-readable memory is operatively coupled to the at least one processor such that an operative set of processor-executable instructions controls the operation of the at least one processor.

The flow meter may also include a non-volatile processor-readable memory readable by at least one processor such that the non-volatile processor-readable memory includes an on-the-fly processor-executable instruction set stored therein, configured to cause the at least one processor to, when executing: capture an image of the IV using an image sensor; identify a set of 13 043431 pixels of interest in the image; determining a subset of pixels within the plurality of pixels of interest, each pixel of the plurality of pixels being determined to be in the subset of pixels when a path to a baseline corresponding to the dropper exists; perform a rotation operation on a subset of pixels; and estimate the volume of the droplet in the dropper by counting the number of pixels in the rotated subset of pixels.

The baseline may be a predetermined set of pixels in the image sensor. Multiple pixels of interest can be identified by comparing the image to the background image. The at least one processor may be further configured to initialize the background image and/or update the background image using the image captured by the image sensor.

The background image can be updated according to:

Jp - P (L-a) + « p ^x background,i,j background,i, j \ ⁰⁰ background / ⁰⁰ backgroundinput,i,j *

The at least one processor may be further configured to update the array of dispersion values using the image captured by the image sensor.

An array of variance values can be updated in

According to:

^background,i,j ^background,i,j ^background ) + ^background^temp

The at least one processor may be further configured to update the array of integers in accordance with the image captured by the image sensor. Each integer in the integer array corresponds to the number of updates to a pixel of the background image.

Optionally, in some embodiments, image-to-background-image comparison compares pixels in the image to pixels in the background image only if the corresponding integer of the array of integers indicates that the corresponding pixel in the background image has been updated by at least a predetermined number once.

The at least one processor may be further configured to: identify a droplet in the image and a predetermined stripe near the border of the droplet; and initialize the background image by setting each pixel of the background image to be equal to an image pixel if it is not in an identified blob or a predefined stripe near the blob boundary.

The at least one processor may be further configured to set a background image pixel to a predetermined value if the corresponding image pixel is in an identified blob or a predetermined band near the blob boundary.

In some embodiments of the present invention, the corresponding image pixel has a position corresponding to the position of the background image pixel.

The at least one processor may be further configured to determine a baseline corresponding to the dropper opening.

The at least one processor may be further configured to determine whether each of the plurality of pixels of interest is in a subset of pixels if the corresponding pixel of the plurality of pixels has a continuous path back to the droplet formation baseline at the dropper orifice to determine whether it is contained whether a subset of pixels in the set of pixels of interest that corresponds to the blob.

The at least one processor may be further configured to: capture a first image using the image sensor; identify the droplet in the first image and a predetermined stripe near the droplet boundary; initialize the background image by setting each pixel equal to a pixel in the first image if it is not in an identified blob or a predefined stripe near the blob boundary; set the pixels in the droplet region or in a predetermined stripe to a predetermined value; initialize an array of integers; and initialize an array of variance values.

The at least one processor may be further configured to update the background image, the array of integers, and/or the array of variance values using the image.

In some embodiments of the present invention, the flow meter includes image sensor means and flow estimating means. The image sensor facility is designed to capture multiple images of the dropper. The flow estimator is designed to estimate the flow of fluid through a dropper using multiple images.

The flow estimator may include processor means for estimating the flow of fluid through the dropper using a plurality of images.

The flow meter may further include memory means operably coupled to the processor means to provide an operative set of processor-executable instructions for causing the processor means to estimate the flow of fluid through the drip chamber using a plurality of images.

In some embodiments of the present invention, the flow meter includes memory means having a run-time set of processor-executable instructions configured for execution; and processor means for executing an on-line set of processor-executable instructions for implementing a flow estimator for estimating the flow rate of fluid through the drip chamber using the plurality of images.

In some embodiments of the present invention, the method includes the step of capturing multiple images of the dropper; and the step of estimating fluid flow through the dropper using a plurality of images. The method can be implemented by means of an online set of processor-executable instructions stored in non-volatile memory and executed by at least one processor.

In some embodiments of the present invention, the device includes a connecting device configured to be connected to a dropper; a support member operatively connected to the connecting device; an image sensor having a field of view and operatively coupled to the support member, the image sensor being positioned to view the dropper in the field of view; a valve configured to be coupled to a fluid conduit fluidly coupled to the dripper, the valve configured to adjust the flow through the fluid conduit to thereby control the flow of fluid through the dripper; and at least one processor operatively coupled to the image sensor to receive image data therefrom, the at least one processor configured to: capture a plurality of images of the IV using the image sensor; estimating the rate of volumetric growth of a droplet in a dropper using multiple images; receiving a set value corresponding to the flow rate of fluid through the fluid tube; adjusting the control system in accordance with the estimated rate of volumetric growth of the drop to achieve a given value; and outputting a control signal from the control system to the valve actuator to control activation of the valve in accordance with the adjusted control system.

The device may include a non-volatile processor-readable memory that stores an on-line set of processor-executable instructions. The non-volatile processor-readable memory may be operatively coupled to the at least one processor such that an operative set of processor-executable instructions controls the operation of the at least one processor.

The device may include non-volatile processor-readable memory readable by at least one processor. The non-volatile processor-readable memory may include an on-the-fly set of processor-executable instructions stored therein, configured to cause at least one processor, when executing: to capture a plurality of IV images using an image sensor; estimate the rate of volumetric growth of a droplet in a dropper using multiple images; accept a predetermined value corresponding to the flow rate of the fluid through the fluid tube; adjust the control system in accordance with the estimated rate of volumetric growth of the drop to achieve a given value; and output a control signal from the control system to the valve actuator to control activation of the valve in accordance with the adjusted control system.

The control system may be at least one of a proportional-integral-derivative control system, a proportional-integral control system, a proportional-derivative control system, a proportional control system, an integral control system, a neural network control system, a fuzzy logic control system, and/ or two-position control system.

The control system may correlate the estimated rate of volumetric growth of the droplet with the flow of fluid through the fluid tube.

The valve may include: a curved, elongated support member that is resiliently deformable and has first and second ends; and an opposing support member configured to position the fluid conduit opposite the curved, elongated support member between the first and second ends, wherein deformation of the curved, elongated support member by moving the first and second ends toward each other reduces the internal volume of the fluid conduit . The drive may be configured to move the first and second ends toward each other.

The valve may include: a first elongated support member defining a length; and a second elongated support member defining a length, wherein the length of the second elongated support member is spaced some distance from the length of the first elongated support member to, in conjunction with the first elongated support member, compress the fluid tube. The drive can mechanically

- 15 043431 mate with at least one of the first and second elongated support parts to drive the first and second elongated support parts towards each other to compress, thereby, the fluid tube located between them, to regulate the flow of fluid in a fluid tube; activation of the actuator drives the first and second elongate support members to adjust the flow rate of fluid in the tube according to an approximate sigmoidal curve.

The valve may include: a first elongated support member defining a length; and a second elongated support member defining a length, wherein the length of the second elongated support member is spaced some distance from the length of the first elongated support member to, in conjunction with the first elongated support member, compress the fluid tube. The actuator is mechanically coupled to at least one of the first and second elongate support members for driving the first and second elongate support members towards each other to compress thereby compressing the fluid tube disposed therebetween to adjust the flow rate of the fluid in tube; activation of the actuator drives the first and second elongated support members to adjust the flow rate of fluid in the fluid tube according to an approximate Gompertz curve.

The valve may include: a first elongated support member defining a length; and a second elongated support member defining a length, wherein the length of the second elongated support member is spaced some distance from the length of the first elongated support member to, in conjunction with the first elongated support member, compress the fluid tube. The actuator is mechanically coupled to at least one of the first and second elongate support members for driving the first and second elongate support members towards each other to compress thereby compressing the fluid tube disposed therebetween to adjust the flow rate of the fluid in fluid tube; activation of the actuator drives the first and second elongated support members to adjust the flow rate of fluid in the tube in accordance with an approximate generalized logistic function.

The valve may include: a first support member that defines at least one of an arc, a plurality of arcs, a curve, a plurality of curves, an arcuate shape, a plurality of arcuate shapes, an S-shape, a C-shape, a convex shape, a plurality of convex shapes , concave shape and many convex shapes; and a second support member located some distance from the first support member to, in conjunction with the first support member, compress the fluid conduit over a length of the fluid conduit at least substantially greater than the diameter of the fluid conduit. The actuator is mechanically coupled to at least one of the first and second support members to drive the first and second support members towards each other to thereby compress the fluid tube disposed therebetween to adjust the flow rate of the fluid in the fluid tube. fluid; activation of the actuator drives the first and second support members to adjust the flow rate of fluid in the fluid tube in accordance with an approximate nonlinear function.

The valve may include: a curved, elongated support member that is resiliently deformable and has first and second ends; and an opposite support piece configured to form a pipeline with a curved, elongated support piece. A pipeline is formed between the curved, elongated support piece and the opposing piece. The fluid conduit is disposed in the conduit, and deformation of the curved, elongated support member by moving the first and second ends toward each other reduces the internal volume of the fluid conduit in the conduit.

The valve may be a Bourdon tube check valve coupled to the fluid conduit to regulate fluid flowing through the flow path of the fluid conduit.

The valve may include: a first flexible member; and a second flexible member operatively coupled to the first flexible member. The fluid tube may be located between the first and second flexible parts. The first and second flexible parts are flexible to thereby control the flow of fluid passing through the fluid tube, and an actuator is connected to at least the first end of the first flexible part and the second end of the first flexible part.

The valve may include a first C-shaped piece defining inner and outer surfaces; and a second C-shaped piece defining the inner and outer surfaces. At least one of the outer surface of the first C-shaped piece and the inner surface of the second C-shaped piece is configured to receive a fluid tube. The inner surface of the second C-shaped part is located at some distance from the outer surface of the first C-shaped part. An actuator is coupled to the first and second C-shaped pieces to bend the first and second C-shaped pieces to compress the fluid tube.

The valve may include: a first flexible plate; and a second flexible plate, promptly

- 16 043431 attached to the first flexible plate. The first and second flexible plates are configured to receive a fluid tube between them. The first and second flexible plates are flexible to thereby control the flow rate of fluid passing through the fluid tube. An actuator is coupled to the first and second flexible plates to control the flow rate of fluid passing through the fluid tube.

The valve may include: a first curved member defining an inner and outer surface; and a second curved piece defining the inner and outer surfaces. An internal surface of the second curved piece is spaced some distance from the outer surface of the first curved piece, a fluid conduit is disposed between the first and second curved pieces, and an actuator is coupled to the first and second curved pieces to bend the first and second curved pieces. to thereby control the flow of fluid in the fluid tube.

The valve may include: a first curved piece defining an inner and outer surface, the first curved piece having first and second receiving pieces at opposite ends of the first curved piece; and a second curved piece defining the inner and outer surfaces, the second curved piece having first and second attachments at opposite ends of the second curved piece. The first receiving part of the first curved part is configured to mate with the first fastening of the second curved part. The second receiving part of the first part of the curved shape is configured to mate with the second fastening of the second part of the curved shape. An actuator is coupled to the first and second curved pieces to bend the first and second curved pieces to adjust the flow of fluid in a fluid tube disposed therebetween.

The valve may include: a first curved, elongated support member that is resiliently deformable and has first and second ends; and a second curved, elongated support piece that is elastically deformable and has first and second ends, wherein the second curved, elongated support piece is configured to accommodate a fluid tube opposite the first curved, elongated support piece, wherein deformation of the first and second curved, elongated support pieces is by moving the first and second ends of the first curved, elongated support member towards each other, it reduces the internal volume of the fluid tube; a first connector coupled to a first end of the first curved elongated support member and coupled to the first end of the second curved elongated support member; a second connector coupled to a second end of the first curved, elongated support member and coupled to a second end of the second curved, elongated support member, the second connector defining an opening; a connecting piece having an end attached to the first connector and another end configured to be inserted into an opening of the second connector, the connecting piece defining a threaded rod at least over a portion thereof; and a handwheel having a ratchet configured to be incrementally advanced toward the connector piece as it moves from the other end of the connector piece to the end of the connector piece, the handwheel being further configured to mate with a threaded rod of the connector piece; wherein the drive may be connected to the handwheel to rotate the handwheel.

The valve may include a base defining an opening configured to receive a fluid conduit; a plurality of fingers, each of which has an end attached to a base; and a ring configured to slide from the base and along the plurality of fingers. Moving the ring away from the base presses the fingers against the fluid tube. The ring is made with the possibility of frictional fixation on multiple fingers. The drive is attached to the ring to slide the ring.

The valve may include: a cone-shaped member having a surface for wrapping a fluid conduit around it; and a mating part configured to mate with a conical-shaped part for compressing the tube. The actuator is configured to press the conical-shaped part against the mating part to thereby compress the fluid tube.

The control system may be implemented in hardware, software, a combination of hardware and software, and/or at least one operational amplifier.

The apparatus may include a non-volatile processor-readable memory, wherein: the control system is implemented by a RAM set of processor-executable instructions configured for execution by at least one processor, the RAM set of processor-executable instructions is stored in the non-volatile processor-readable memory, and the non-volatile the processor-readable memory is operatively coupled to the at least one processor for operatively transmitting a operative set of processor-executable instructions to the at least one processor for execution by the at least one processor.

The set value can be compared with the rate of volumetric growth of the drop to adjust the control system. The set value can be compared with the volumetric growth rate of the droplet to determine the error signal. The error signal may be the difference between the set value and the volumetric growth rate of the drop. The error signal can be passed through a signal processing device to generate an output signal. The signal processing apparatus may implement a proportional-integral-derivative controller with at least one non-zero gain parameter.

In another embodiment of the present invention, a fluid flow control device includes a curved, elongated support member and an opposing support member. The curved, elongated support member is elastically deformable and has first and second ends. The first end is rotatably coupled to the first and second figure-eight link members, and the second end is rotatably coupled to the third and fourth figure-eight link members. The opposite support piece is configured to place the tube opposite the curved, elongated support piece between the first and second ends, such that deformation of the curved, elongated support piece by moving the first and second ends towards each other reduces the internal cross-section along the length of the tube. The first end of the opposing support member is rotatably coupled to the first and second figure-eight coupling members, and the second end of the opposing support member is rotatably coupled to the third and fourth figure-eight coupling members.

The first end of the curved, elongated support piece may include a mating pin configured to mate with the rack. The second end of the curved, elongated support piece may be rotatably coupled to the rack. The apparatus may include a handwheel coupled to a first end of the curved, elongate support member for moving the rack.

In yet another embodiment of the present invention, the flow meter includes a connector, a support member, an image sensor, a laser, and at least one processor. The connecting device is designed to be connected to a dropper. The support member is operatively connected to the connecting device. The image sensor has a field of view and is operatively coupled to the support member, and the first image sensor is configured to view the dropper in the field of view. The laser is configured to emit light in the optical range onto the binary optics assembly.

The at least one processor is operatively coupled to the image sensor such that: (1) the at least one processor receives data from the image sensor where at least a portion of the background pattern is represented; and (2) at least one processor estimates at least one parameter of the fluid in the dropper using the image data.

In yet another embodiment of the present invention, the flow meter includes a coupling device, a support member, first and second electrodes, and at least one processor. The connecting device is designed to be connected to a dropper. The support member is operatively connected to the connecting device. The first electrode is configured to be connected to a pipeline hydraulically connected to the dropper. The second electrode is configured to be connected to a pipeline hydraulically connected to the dropper.

At least one processor is operatively coupled to the first and second electrodes to measure capacitance therebetween, and at least one processor is configured to monitor the capacitance. The at least one processor may be configured to determine whether a flow condition exists in the dripper using the monitored capacitance.

In yet another embodiment of the present invention, the safety valve includes a body, first and second shut-off arms, first and second spindles, and a spring. The housing is designed to hold the tube. The first and second overlapping arms are pivotally connected to each other. The first spindle is pivotally connected to the distal end of the first shut-off arm. The second spindle is pivotally connected to the distal end of the second shut-off arm. The spring is located next to the first and second shut-off arms on the opposite side of the tube, with the possibility of spring-loading the first and second shut-off arms. The safety valve is configured to relax the spring and close the tube when the first and second shut-off levers are turned away from the spring along their common pivot by a predetermined amount. The solenoid can be used to interface with the first and second overlap arms to relax the spring.

In yet another embodiment of the present invention, the device includes a coupling device, a support member, and at least one processor. The connecting device is designed to be connected to a dropper. The support member is operatively connected to the connecting device. The image sensor has a field of view and is operatively coupled to the support member. The image sensor is designed to monitor the dropper

- 18 043431 in sight. At least one processor is operatively coupled to the image sensor to receive image data therefrom, and the at least one processor is configured to: (1) capture an image of the IV; (2) placing the pattern in the captured image at the first position; (3) averaging the pixels in the template to determine the first average; (4) moving the template to the second position; (5) averaging the pixels in the template to determine the second average; (6) determining that the pattern is located at the droplet boundary if the difference between the second average and the first average is greater than a predetermined threshold value; (7) and correlation of the second position with the volume of the drop.

In yet another embodiment of the present invention, a method is disclosed, implemented by at least one processor executing an online set of processor-executable instructions configured to be executed by the at least one processor for estimating flow. The method includes the steps of: (1) capturing images of the dropper; (2) place the template in the captured image at the first position; (3) averaging the pixels in the template to determine the first average; (4) move the template to the second position; (5) averaging the pixels in the template to determine the second average; (6) determine that the pattern is located at the boundary of the droplet if the difference between the second average and the first average is greater than a predetermined threshold value; and (7) correlate the second position with droplet volume.

In yet another embodiment of the present invention, the flow meter includes a connector, a support member, a modulated backlight assembly, an image sensor, and at least one processor. The connecting device is designed to be connected to a dropper. The support member is operatively connected to the connecting device. The modulated backlight assembly is configured to provide a first backlight and a second backlight. The image sensor has a field of view and is operatively coupled to the support member. The image sensor is configured to observe the dropper in the field of view and modulate the backlight assembly. At least one processor is operatively coupled to the image sensor and the modulated backlight assembly such that the at least one processor receives data from the image sensor in which at least a portion of the modulated backlight assembly is represented, and the at least one processor is configured to with the ability to modulate the backlight assembly to the first backlight when estimating the droplet size and modulate the backlight assembly to the second backlight. The first backlight may be a backlight with a diffuser having no pattern, and the second backlight may be a backlight with a diffuser having a striped pattern.

In yet another embodiment of the present invention, the tube restorer includes first and second gears. The second gear is located directly opposite the first gear. The first and second gears define a gap along the radial portions of the first and second gears to allow the tube to bend between them. The first and second gears are further configured to recover the tube upon rotation, such that a gap is not located between the first and second gears.

In yet another embodiment of the present invention, the valve includes first and second metal strips and first and second guide members. The first guide piece is attached to the distal ends of the first and second metal strips. The second guide piece is attached to the proximal ends of the first and second metal strips. The first and second metal strips are configured to compress the tube when the distal ends of the first and second metal strips are driven toward the proximal ends of the first and second metal strips. The valve may further include a string (eg, a metal string or a string made of any other material) passed through the first and second metal strips to wrap around the tube.

In yet another embodiment of the present invention, the valve includes first and second flaps configured to provide a cavity between the first and second flaps. The first and second flaps are configured to receive the tube between themselves and in the cavity. The valve also includes a bubble located in the cavity and a pump configured to inflate and deflate the bubble to regulate the flow of fluid in the tube.

In yet another embodiment of the present invention, the device includes a coupling device, a support member, an image sensor, and at least one processor. The connecting device is designed to be connected to a dropper. The support member is operatively connected to the connecting device. The image sensor has a field of view and is operatively coupled to the support member. The image sensor is configured to observe the dropper in the field of view.

The at least one processor is operatively coupled to the image sensor to receive image data therefrom and is configured to: (1) capture a first image; (2) create a first constrained image from the first image by comparing each pixel of the first image with a threshold value; (3) determine a set of pixels in the first limited image associated with a predetermined set of pixels in the first limited image; (4) filter all other pixels of the first bounded image that are not associated with the pixel set

- 19 043431 lei, wherein the filter operates on a pixel-by-pixel basis in the time domain to generate the first filtered image; (5) removing pixels determined not to be part of the blob from the first constrained image using the first filtered image to generate a second image; (6) determining a second set of pixels in a second image associated with a predetermined set of pixels in the second image to generate a third image, the third image identifying a second set of pixels in the second image; (7) determine a first droplet length by counting the number of rows containing pixels corresponding to a second set of pixels in the third image, the first length corresponding to a first estimated droplet size; (8) update the background image using the first image; (9) create a second constrained image by comparing the first image with the background image; (10) sum the rows of the second limited image to create a plurality of row sums, each row sum corresponding to a row of the second limited image; (11) start at a row position of a second limited image having a first sum of a plurality of sums that corresponds to the first length; (12) increment the row position until the row position corresponds to the corresponding row sum equal to zero; (13) determine that the second length is equal to the current line position, the second length corresponding to the second estimated droplet size; and (14) averaging the first and second lengths to determine the average length, with the average length corresponding to the third estimated droplet size.

In yet another embodiment of the present invention, a method implemented by at least one processor executing an on-line set of processor-executable instructions configured to be executed by the at least one processor for estimating flow includes the steps of: (1) capturing a first image ; (2) creating a first constrained image from the first image by comparing each pixel of the first image with a threshold value; (3) determining a set of pixels in the first limited image associated with a predetermined set of pixels in the first limited image; (4) filtering all remaining pixels of the first limited image that are not associated with the set of pixels, the filter operating on a pixel-by-pixel basis in the time domain to generate the first filtered image; (5) removing pixels determined not to be part of the blob from the first constrained image using the first filtered image to generate a second image; (6) determining a second set of pixels in a second image associated with a predetermined set of pixels in the second image to generate a third image, the third image identifying a second set of pixels in the second image; (7) determining a first droplet length by counting the number of rows containing pixels corresponding to a second set of pixels in the third image, the first length corresponding to a first estimated droplet size; (8) updating the background image using the first image; (9) creating a second constrained image by comparing the first image with the background image; (10) summing the rows of the second limited image to create a plurality of row sums, each row sum corresponding to a row of the second limited image; (11) starting at a row position of a second limited image having a first sum of a plurality of sums that corresponds to the first length; (12) increase the row position until the row position corresponds to the corresponding row sum equal to zero; (13) determine that the second length is equal to the current line position, the second length corresponding to the second estimated droplet size; and (14) averaging the first and second lengths to determine an average length, the average length corresponding to a third estimated droplet size.

In yet another embodiment of the present invention, the flow meter includes a coupling device, a support member, first and second loop antennas, and at least one processor. The connecting device is designed to be connected to a dropper. The support member is operatively connected to the connecting device. The first loop antenna is located next to the pipeline, hydraulically connected to the dripper. The second loop antenna is located next to the pipeline. At least one processor is operatively connected to the first and second loop antennas to measure magnetic coupling between them. The at least one processor is configured to monitor magnetic coupling therebetween to determine whether a flow condition exists in the dripper.

In yet another embodiment of the present invention, a method implemented by an on-the-fly processor-executable instruction set includes the steps of: (1) determining a plurality of points of interest in an image; (2) randomly select N points of interest from the set of points of interest; and/or (3) identify a single, unique, geometric feature characterized by N parameters corresponding to N points of interest.

In yet another embodiment of the present invention, the system includes non-volatile memory and one or more processors. Non-volatile memory stores many instructions. One or more processors are operatively coupled to non-volatile memory for executing a variety of

- 20 043431 instructions. A plurality of instructions are configured to cause the processor to: (1) determine a plurality of points of interest in the image; (2) randomly select N points of interest from the set of points of interest; and/or (3) identify a single, unique, geometric feature characterized by N parameters corresponding to N points of interest.

Brief description of drawings

These and other aspects will be apparent from the following detailed description of various embodiments of the present invention with reference to the drawings, in which:

fig. 1 shows a block diagram of a system for controlling fluid flow in accordance with an embodiment of the present invention;

fig. 2 shows a flowchart of an image sensor exposure method according to an embodiment of the present invention;

fig. 3 shows a timing chart illustrating an embodiment of the method shown in FIG. 2 in accordance with an embodiment of the present invention;

fig. 4A-4B show illustrations of image data (ie, images) captured by the dropper flow meter to illustrate an embodiment of the image sensor exposure method shown in FIG. 2, in accordance with the timing diagram shown in FIG. 3, in accordance with an embodiment of the present invention;

fig. 5 shows a diagram of a flow meter and a valve that are combined with each other for connection to an IV and IV bag in accordance with an embodiment of the present invention;

fig. 6 is a block diagram of a flow meter imaging system for imaging a dropper in accordance with an embodiment of the present invention;

fig. 7 is a graphical illustration of an image captured by an image sensor of the system shown in FIG. 6, in accordance with an embodiment of the present invention;

fig. 8 is a block diagram of a flow meter imaging system for imaging a dropper using a background pattern in accordance with an embodiment of the present invention;

fig. 9 is a graphical illustration of an image captured by an image sensor of a flow meter disclosed herein when a free flow condition exists, in accordance with an embodiment of the present invention;

fig. 10 is a graphical illustration of an image captured by a flow meter image sensor for use as a background image in accordance with an embodiment of the present invention;

fig. 11 is a graphical illustration of an image captured by an image sensor when droplets are formed in a dropper according to an embodiment of the present invention;

fig. 12 is a graphical illustration of an image captured by an image sensor for use as a background image in accordance with an embodiment of the present invention;

fig. 13 is a graphical illustration of the difference between the images in FIG. 11 and 12 with additional processing in accordance with an embodiment of the present invention;

fig. 14 is a graphical representation of some image processing techniques implemented using FIG. 11-13, for determining whether a free flow condition exists, in accordance with an embodiment of the present invention;

fig. 15 is a graphical illustration of an image captured by the image sensor when a free flow condition exists, in accordance with an embodiment of the present invention;

fig. 16 is a graphical illustration of an image captured by an image sensor for use as a background image in accordance with an embodiment of the present invention;

fig. 17 is a graphical illustration of the difference between the images in FIG. 15 and 16 with some additional processing for use when detecting a free flow condition in accordance with an embodiment of the present invention;

fig. 18 is a graphical representation of some image processing techniques implemented using FIG. 15-17 for determining whether a free flow condition exists, in accordance with an embodiment of the present invention;

fig. 19 illustrates a pattern matching pattern for determining whether a free flow condition exists, in accordance with an embodiment of the present invention;

fig. 20 is a graphical illustration of the difference between a reference image and an image containing a stream processed with edge detection and line detection for use in detecting a free flow condition in accordance with an embodiment of the present invention;

- 21 043431 fig. 21 is a graphical illustration of an image of a dropper captured by an image sensor when a free flow condition exists, in accordance with an embodiment of the present invention;

fig. 22 is a block diagram of an imaging system for use with a flow meter having a background pattern of stripes and a light source illuminating the stripes from a position adjacent the image sensor, in accordance with an embodiment of the present invention;

fig. 23 is a block diagram of an imaging system for use with a flow meter having a stripe pattern and a light source illuminating the stripes behind the pattern relative to the opposite end of the image sensor, in accordance with an embodiment of the present invention;

fig. 24 shows an image from an image sensor when a droplet distorts the background pattern shown in FIG. 23, in accordance with an embodiment of the present invention;

fig. 25 is a block diagram of an imaging system for use with a flow meter having a checkerboard pattern and a light source illuminating stripes behind the pattern relative to the opposite end of the image sensor, in accordance with an embodiment of the present invention;

fig. 26 shows an image from the image sensor shown in FIG. 25 when the droplet distorts the background pattern, according to an embodiment of the present invention;

fig. 27-28 show a flowchart illustrating a method for estimating the volume of a droplet in a dropper according to an embodiment of the present invention;

fig. 29-31 show images used or generated by the flow meter to estimate the volume of a droplet in a dropper using the method presented in FIG. 27-28, in accordance with an embodiment of the present invention;

fig. 32 shows pseudo code for identifying a plurality of pixels of interest according to the method shown in FIG. 27-28, in accordance with an embodiment of the present invention;

fig. 33-36 show additional images used or generated by the flowmeter to estimate droplet volume in a dropper using the method presented in FIG. 27-28, in accordance with an embodiment of the present invention;

fig. 37 shows pseudo code for determining a subset of pixels in a plurality of pixels of interest that corresponds to a blob, in accordance with an embodiment of the present invention;

fig. 38 illustrates an optical diagram showing the diameter of a circle of confusion to illustrate image sensor aspects of an imaging system disclosed herein in accordance with an embodiment of the present invention;

fig. 39 is a graph illustrating the calculated circle of confusion for various lens-to-focal plane distances and lens-to-image distances for an image sensor of an imaging system disclosed herein in accordance with an embodiment of the present invention;

fig. 40 is a graph illustrating the circle of confusion divided by the pixel size when the 20 millimeter focal length lens of the image sensor of the imaging system disclosed herein is used in accordance with an embodiment of the present invention;

fig. 41 is a graph illustrating a circle of confusion divided by a pixel size when a 40 millimeter focal length lens of an image sensor of the imaging system disclosed herein is used in accordance with an embodiment of the present invention;

fig. 42 shows a table illustrating the corresponding fields of view about the optical axis for the angles of two configurations of an imaging system disclosed herein in accordance with an embodiment of the present invention;

fig. 43 shows a flow meter coupled to a dripper in accordance with an embodiment of the present invention;

fig. 44 shows the flow meter and dripper shown in FIG. 43, with the door open in accordance with an embodiment of the present invention;

fig. 45 shows a flow meter coupled to a dripper in accordance with an embodiment of the present invention;

fig. 46 shows a flow meter and a pinch valve coupled to the flow meter body for controlling the flow rate of fluid entering a patient's body, in accordance with an embodiment of the present invention;

fig. 47 shows an enlarged view of the pinch valve that is attached to the flow meter body shown in FIG. 46, in accordance with an embodiment of the present invention;

fig. 48 shows a flow meter and pinch valve, where the flow meter includes two image sensors, in accordance with another embodiment of the present invention;

fig. 49 shows a flow meter and valve including two curved, elongated

- 22 043431 support parts for controlling the flow of fluid entering the patient's body, in accordance with an embodiment of the present invention;

fig. 50A-50B show close-up views of the valve shown in FIG. 49, in accordance with an embodiment of the present invention;

fig. 51A-51D show several views of a flow meter with a control client, a valve, an IV, an IV bag, and a fluid tubing, where the flow meter includes a receiving portion for receiving a valve, in accordance with an embodiment of the present invention;

fig. 52A-52D show several views of another flow meter with a valve, dripper and tube, where the flow meter has a receiving portion for receiving the valve, in accordance with an embodiment of the present invention;

fig. 53A shows another view of the valve shown in FIG. 51A-51D and 52A-52D, in accordance with an embodiment of the present invention;

fig. 53B-53C show two detailed views of the valve shown in FIG. 53A, in accordance with an embodiment of the present invention;

fig. 54 shows the valve shown in FIG. 53, manually operated, in accordance with an embodiment of the present invention;

fig. 55 shows a valve that includes two flexible parts, in accordance with an embodiment of the present invention;

fig. 56A-56C show several views of a valve having two curved, elongated support members, one of the elongated support members having a plurality of ribs configured to mate with a tube, in accordance with an embodiment of the present invention;

fig. 57A-57C show several views of a valve having a ratchet that mates with a connecting piece, in accordance with an embodiment of the present invention;

fig. 57D-57E show two detailed views of the valve shown in FIG. 57A-57C, in accordance with an embodiment of the present invention;

fig. 58A-58D show several views of a valve having two elongated support members, a connecting member, and a screw-type actuator, in accordance with another embodiment of the present invention;

fig. 59A-59C show several views of a valve body in accordance with an embodiment of the present invention;

fig. 59D-59G show several types of handwheel for use with the housing shown in FIGS. 59A-59C, in accordance with an embodiment of the present invention;

fig. 59H shows a valve assembly that includes the body shown in FIG. 59A59C, attached to the handwheel shown in FIG. 59D-59G, in accordance with an embodiment of the present invention;

fig. 60 shows a valve having a guide in accordance with an embodiment of the present invention;

fig. 61 shows a motor and valve mounting structure for attachment to the valve shown in FIG. 60, in accordance with an embodiment of the present invention;

fig. 62 shows the valve shown in FIG. 60 attached to the motor and valve mounting structure shown in FIG. 61, in accordance with an embodiment of the present invention;

fig. 63 shows another motor and valve mounting structure for attachment to the valve shown in FIG. 60, in accordance with an embodiment of the present invention;

fig. 64A shows a valve having both a clamp and multiple pins for regulating the flow of fluid through a conduit in accordance with an embodiment of the present invention;

fig. 64B shows a sectional view of the valve shown in FIG. 64A, in accordance with an embodiment of the present invention;

fig. 65 shows a cross-sectional view of a valve having two curved surfaces for receiving a fluid conduit therebetween for adjusting the flow of fluid through the fluid conduit, in accordance with an embodiment of the present invention;

fig. 66A-66G show several views of a valve having a handwheel for moving a connecting piece that is locked in place after the handwheel is moved, in accordance with an embodiment of the present invention;

fig. 67 shows a graph that illustrates activation versus flow for a valve, in accordance with an embodiment of the present invention;

fig. 68A shows a flow meter that uses binary optics, in accordance with an embodiment of the present invention; fig. 68B shows an alternative embodiment in which the first and second electrodes are loop antennas.

fig. 69A-69F show several types of relief valve that can be used with a flow meter in accordance with an embodiment of the present invention;

fig. 70 is a flowchart illustrating a method for estimating droplet growth and/or flow rate in a dripper in accordance with an embodiment of the present invention;

fig. 71A-71E show images used by the flow meter with a template superimposed thereon to illustrate the method of FIG. 70, in accordance with an embodiment of the present invention;

fig. 72 shows a modulated backlight assembly in accordance with an embodiment of the present invention;

fig. 73A-73C show several views of a tube recovery device in accordance with an embodiment of the present invention;

fig. 74 shows a system for controlling fluid flow using a valve having two flexible strips in accordance with an embodiment of the present invention;

fig. 75 shows the valve shown in FIG. 74, in accordance with an embodiment of the present invention;

fig. 76A shows a valve that uses a fluid-based bubble, in accordance with an embodiment of the present invention;

fig. 76B shows a sectional view of the valve assembly shown in FIG. 76A, with two elastomeric fillers, in accordance with an embodiment of the present invention;

fig. 77 shows a system for controlling fluid flow using a valve having two flexible strips driven by a linear actuator, in accordance with an embodiment of the present invention;

fig. 78 shows the system shown in FIG. 77, where the valve is actuated in accordance with an embodiment of the present invention;

fig. 79 shows a close-up view of the valve shown in FIG. 77-78, in accordance with an embodiment of the present invention;

fig. 80 shows a close-up view of the valve being actuated as shown in FIG. 78, in accordance with an embodiment of the present invention;

fig. 81 shows several images for use in illustrating the method of estimating droplet growth and/or fluid flow shown in FIG. 82A-82B, in accordance with an embodiment of the present invention;

fig. 82A-82B show a flowchart illustrating a method for estimating droplet growth and/or fluid flow rate in accordance with an embodiment of the present invention; and figs. 83 shows a flowchart of a condensation noise reduction method according to an embodiment of the present invention.

Detailed description

Fig. 1 shows a block diagram of a system 1 for controlling fluid flow in accordance with an embodiment of the present invention. For example, system 1 may regulate, control and/or control the flow rate of a fluid entering the body of a patient 3. System 1 includes a fluid reservoir 2 for infusing a fluid contained therein into the body of a patient 3. From the reservoir 2 fluid The medium flows by gravity into the dropper 4 through the fluid tube 5. Fluid reservoir 2, IV, and patient 3 may be considered part of system 1 and may be considered separate or optional operating parts for system 1 (eg, any fluid reservoir 2 and IV may be used to treat any patient 3).

Flow meter 7 monitors dropper 4 to estimate the flow rate of fluid flowing through dropper 4. Fluid from dropper 4 flows by gravity into valve 6. Valve 6 regulates (i.e. changes) the flow of fluid from fluid reservoir 2 to patient 3 by adjusting the flow of fluid from the dropper 4 to the patient 3. The valve 6 can be any valve described herein, including a valve having two curved parts, a valve having two flexible plates, a valve that pinches (or evenly compresses) the tube on over a significant length of the tube, etc. Valve 6 may be a Bourdon tube check valve that operates opposite to the Bourdon tube in that deformation of the flow channel results in a change in fluid flow rather than fluid flow causing deformation of the flow channel.

In alternative embodiments, system 1 optionally includes an infusion pump 414 (e.g., a peristaltic pump, a finger pump, a linear peristaltic pump, a rotary peristaltic pump, a cassette pump, a diaphragm pump, another pump, etc.), connected to the fluid tube 5. The dotted box indicated as 414 represents the optional nature of the infusion pump 414, for example, the infusion pump may not be used in some embodiments. The infusion pump 414 may use the flow meter 7 as feedback to control the flow of fluid through the fluid tube 5. Infusion pump 414 can communicate wirelessly with flow meter 7

- 24 043431 to receive the flow rate from it. The infusion pump 414 may use a feedback control algorithm (e.g., control component 14 shown in FIG. 1) to adjust fluid flow, such as proportional-integral-derivative (PID), on-off, neural network, and/or fuzzy. -logical control system. In this particular illustrative embodiment (ie, the embodiment having the infusion pump 414), valve 6 is optional. However, in other embodiments, valve 6 may or may not be used and/or is optional. The infusion pump 414 may adjust the rotation of the cam and/or motor in accordance with measurements from the flow meter 7, such as flow rate, volume delivered, total volume delivered, etc. Additionally or alternatively, infusion pump 414 may stop fluid flow (eg, stopping the pumping action) when flow meter 7 communicates to infusion pump 414 that a free flow condition exists. In other additional embodiments, control client 8 controls the operation of infusion pump 414 (e.g., via a wireless connection) and receives feedback from flow meter 7.

In some embodiments, the fluid reservoir 2 is pressurized to facilitate the flow of fluid from the fluid reservoir 2 into the body of the patient 3, for example, in the case where the fluid reservoir 2 (for example, an IV bag) is located below patient 3; the increased pressure provides sufficient mechanical energy to cause the fluid to flow into the patient's body 3. Various sources of pressure, such as physical pressure, mechanical pressure and pneumatic pressure, can be applied inside or outside the fluid reservoir 2. In one such embodiment, the increased pressure may be provided by a rubber band wrapped around the IV bag.

Flow meter 7 and valve 6 may form a closed-loop system for adjusting fluid flow to patient 3. For example, flow meter 7 may receive a target flow rate from monitoring client 8 through communication using transceivers 9, 10. Thus, transceivers 9, 10 may be used to communication between the flow meter 7 and the control client 8. The transceivers 9, 10 can communicate with each other using a modulated signal to encode various types of information, for example, digital data or an analog signal. Some of the modulation methods used may include using a carrier frequency with FM modulation, using AM modulation, using digital modulation, using analog modulation, and the like.

The flow meter 7 estimates the flow through the dripper 4 and adjusts the valve 6 to achieve the target flow received from the control client 8. Valve 6 may be controlled by flow meter 7 directly from communication lines connected to the valve 6 actuator, or via a wireless communication link from flow meter 7 to valve 6's onboard circuitry. Valve 6's onboard electronics can be used to control activation of valve 6 through an actuator attached to it. This embodiment of the closed-loop flow meter 7 and valve 6 may use any control algorithm, including a PID control algorithm, a neural network control algorithm, a fuzzy logic control algorithm, etc., or some combination thereof.

The flow meter 7 is coupled to a support 17, which is coupled to the dripper 4 via a connector 16. The support 17 also supports a backlight 18. The backlight 18 includes an LED array 20 that provides illumination for the flow meter 7. In some specific embodiments, the backlight 18 includes includes a background pattern 19. In other embodiments, the backlight 18 does not include a background pattern 19. In some embodiments, the background pattern 19 is present only in the lower portion of the backlight 18, while in the upper portion of the backlight 18 (e.g., away from grounding) background image 19 is missing.

Flow meter 7 includes an image sensor 11, a free flow detector component 12, a flow estimating component 13, a control component 14, an exposure component 29, a processor 15, and a transceiver 9. The flow meter 7 may be powered by a battery, by AC power, or may include itself supercapacitors and may include an integrated power circuit (not explicitly shown).

The image sensor 11 may be a CCD sensor, a CMOS sensor, or another image sensor. The image sensor 11 captures images of the dropper 4 and transmits image data corresponding to the captured images to the processor 15.

The processor 15 is also connected to the free flow detector component 12, the flow estimation component 13, the control component 14 and the exposure component 29. The free flow detector component 12, the flow estimation component 13, the control component 14, and the exposure component 29 may be implemented as processor-executable instructions that may be executed by the processor 15 and may be stored in memory, such as non-volatile read-only memory, ROM, RAM, EEPROM, hard disk, flash disk, etc.

Processor 15 may execute instructions of free flow detector component 12 to determine whether a free flow condition exists in dropper 4 by analyzing image data from

- 25 043431 image sensor 11. Various embodiments of the free flow detector component 12 for detecting a free flow condition are described below. In response to a detected free flow condition, processor 15 may make a function call to control component 14 to send a signal to valve 6 to completely stop the flow of fluid to patient 3. Thus, if free flow detector component 12 determines that a free flow condition exists, flow meter 7 may direct valve 6 to stop fluid flow, may direct control client 8 (which may communicate with valve 6 or pump 414) to stop fluid flow, and/or may direct pump 414 to stop pumping or shut off fluid flow with using an internal protective barrier.

The flow estimating component 13 estimates the flow rate of the fluid flowing through the dripper 4 using image data from the image sensor 11 . Processor 15 transmits the estimated flow rate to control component 14 (eg, via a function call). Various embodiments of flow estimation are described below. If flow estimating component 13 determines that flow rate is greater than a predetermined threshold or is outside a predetermined range, flow meter 7 may instruct valve 6 (which may communicate with valve 6 or pump 414) to stop fluid flow, may instruct client 8 to control ( which may communicate with valve 6 or pump 414) to stop fluid flow, and/or may cause pump 414 to stop pumping or shut off fluid flow using an internal barrier.

The processor 15 controls the LED array 20 to ensure sufficient illumination of the image sensor 11. For example, exposure component 29 may be used by or in conjunction with processor 15 to control LED array 20 such that image sensor 11 captures sufficient image data for use by free flow detector component 12 and flow estimation component 13. Processor 15 may implement an exposure algorithm stored by exposure component 29 (see FIG. 2) to control lighting conditions and/or exposure of image sensor 11 when generating image data. Additionally or alternatively, display component 29 may be implemented as a circuit, integrated circuit, CPLD, PAL, PLD, hardware description language implementation, and/or software system.

The control component 14 calculates adjustments for the valve 6 in accordance with the estimated flow rate from the flow estimation component 13. For example, as mentioned above, control component 14 may implement a PID control algorithm to adjust valve 6 to achieve a target flow rate.

The monitoring client 8, in some embodiments, monitors the operation of the system 1. For example, when a free flow condition is detected by the free flow detector component 12, the monitoring client 8 may wirelessly transmit a signal to the valve 6 to interrupt the flow of fluid to the patient 3.

Flow meter 7 may further include various input/output devices to facilitate patient protection, such as various scanners, and may use transceiver 9 to communicate with electronic health records, anti-prescription systems, and/or support services, such as inventory management systems.

In a particular illustrative embodiment, the flow meter 7 has a scanner, such as an RFID reader that reads an RFID tag attached to the fluid reservoir 2, or a bar code scanner that scans a bar code of the fluid reservoir 2. The scanner can be used to determine whether the correct fluid is in the fluid reservoir 2, whether the correct fluid reservoir 2 is being used, whether the treatment programmed into the flow meter 7 matches the fluid in the fluid reservoir 2, and/or whether the reservoir is suitable 2 for a fluid and a patient-specific flow meter 7 (eg, based on a patient barcode, patient RFID tag, or other patient identification).

For example, flow meter 7 may scan an RFID tag of fluid reservoir 2 to determine whether the serial number or fluid type encoded in the RFID tag matches that specified in a treatment plan stored in flow meter 7. Additionally or alternatively, flow meter 7 may read the serial number from RFID tags of the fluid reservoir 2 and the patient serial number from the RFID tag of the patient 3, and also refer to the electronic medical record using the transceiver 9 to determine whether the serial number of the fluid reservoir 2 in the RFID tag attached to the fluid reservoir 2 matches with the patient's serial number in the RFID tag attached to patient 3, who is listed in the electronic medical record.

Additionally or alternatively, the monitoring client 8 may scan the RFID tag of the fluid reservoir 2 and the RFID tag of the patient 3 to determine whether the correct fluid is in the fluid reservoir 2, whether the correct fluid reservoir 2 is being used, or whether the treatment programmed into the flow meter is appropriate. 7, the fluid in the fluid reservoir 2, and/or whether the fluid reservoir 2 is suitable for a particular patient (for example, based on a patient barcode, RFID tag, electronic health record, or other patient identification or information) . Additionally or alternatively, control client 8 or flow meter 7 may access an electronic health record database and/or pharmacy to verify a prescription or to download a prescription, for example, using a serial number from a bar code on fluid reservoir 2 or an RFID tag attached to the fluid reservoir 2.

Fig. 2 shows a flowchart of an image sensor exposure method 21, such as the image sensor 11 shown in FIG. 1, in accordance with an embodiment of the present invention. Method 21 includes steps 22, 23, 24, and 25. Method 21 may be implemented by processor 15 shown in FIG. 1 (eg, as exposure component 29), and may be implemented in a processor-implemented manner, as a set of instructions configured for execution by one or more processors, hardware, software, etc., or some combination thereof.

Step 22 selects an area of interest. For example, returning to FIG. 1, the image sensor 11 includes a field of view that includes the dropper 4. However, the dropper 4 may not occupy the entire field of view of the image sensor 11. Action 22 selects only the pixels of the image sensor 11 that represent, for example, the dropper 4.

Action 23 determines whether the pixel is in the region 23 of interest. If action pixel 23 is a pixel that represents, for example, dropper 4, then action 23 determines that it is in the region of interest. Likewise, in this example, if action pixel 23 is a pixel that does not depict dropper 4, action 23 determines that the pixel is not in the region of interest.

Action 24 activates the backlight, such as backlight 18 shown in FIG. 1 if the pixel is in the region of interest. The pixels of the image sensor can be exposed for different periods of time. Thus, the backlight 18 can only be activated when the pixels in the area of interest are exposed. For example, some image sensors include field and horizontal sync signals. The backlight can synchronize with these signals to turn on when a pixel of interest is exposed.

In some embodiments of the present invention, a subset of the backlight LEDs (eg, a subset of the LED array 18, which may be a 2-dimensional array) may be turned on. The subset may be a sufficient subset to sufficiently illuminate the exposed pixel if the pixel is in the region of interest.

Action 25 exposes the pixel. If it is determined in step 23 that the pixel is in a region of interest, the pixel will be exposed by at least the highlight portion turned on in step 25. Additionally, if in act 23 it is determined that the pixel is not in a region of interest , the pixel will be exposed without the assistance of at least the highlight portion turned on in step 25.

Fig. 3 shows a timing diagram 29 illustrating an embodiment of the method shown in FIG. 2, in accordance with an embodiment of the present invention. Timing 29 includes traces 26, 27 and 28. Trace 26 represents a field clock signal from the image sensor, and trace 27 represents a horizontal clock signal from the image sensor (eg, image sensor 11 shown in FIG. 1). A circuit or software routine (eg, exposure component 29 included in flow meter 7 of FIG. 1) may use clock traces 26, 27 to generate a backlight-on signal 28 that is used to activate the backlight or a subset thereof.

Fig. 4A-4B show illustrations of image data of the flow meter 7 illustrating an embodiment of the method shown in FIG. 2, in accordance with the timing diagram shown in FIG. 3, in accordance with an embodiment of the present invention. Fig. 4A illustrates image data used by a flow meter, such as flow meter 7 shown in FIG. 1, without using the exposure algorithm presented in FIG. 2 and 3; fig. 4B illustrates image data used by the flow meter using the exposure algorithm shown in FIG. 2 and 3. When performing image capture shown in FIG. 4B, less power is required to provide illumination than to provide illumination for image capture shown in FIG. 4A, due to less use of backlight.

Fig. 5 shows a diagram of a flow meter 67 and a valve 71 that are integrated with each other for connection to an IV line 409 and an IV bag 69, in accordance with an embodiment of the present invention. Flow meter 67 includes an optical drop counter 68 that receives fluid from the IV bag 69. The optical drop counter 68 may be an image sensor, a pair of image sensors, a capacitive drop counter, etc. The flow meter 67 is connected to a tube 70 connected to a roller clamp 71, which is controlled by a motor 72. The motor 72 is connected to a lead screw mechanism 73 to control the roller clamp 71 through interaction with interacting parts 74.

The motor 72 may be a servo motor and may be used to adjust the flow through the tube 70. Thus, the flow meter 67 may also function as a flow meter and

- 27 043431 regulator. For example, processor 75 in flow meter 67 may adjust motor 72 to achieve a desired flow rate, which is measured by optical drop counter 68. The processor 75 may implement a control algorithm using the optical drop counter 68 as feedback, for example, a PID control loop where the output signal is provided to the motor 72 and the feedback is received from the optical drop counter 68.

In alternative embodiments, motor 72, lead screw mechanism 73, and roller clamp 71 may be replaced and/or supplemented with a drive that compresses tube 70 (e.g., using a cam mechanism or motor-driven linkage), or they may be replaced by any suitable roller, screw or slider driven by a motor. For example, in some embodiments of the present invention, the roller clamp 71 may be replaced by any valve described herein, including a valve having two C-shaped pieces, a valve having two curved support pieces, a valve having two flexible plates, a valve which pinches the tube over a significant length of the tube, etc.

Flow meter 67 may also optionally include a display. The display can be used to set a target flow rate, display the current flow rate, and/or provide a button, such as a touch screen button, to stop the flow.

In fig. 6 is a block diagram of a flow meter imaging system 78 for imaging a dropper in accordance with an embodiment of the present invention. The imaging system 78 shown in FIG. 6 can be used in any flow meter described herein, including flow meter 7 shown in FIG. 1 and/or flow meter 67 shown in FIG. 5.

The imaging system 78 shown in FIG. 6 includes an image sensor 63, a uniform illuminator 79 for emitting light at least partially through the dropper 59, and an infrared (IR) filter 80 that receives light from the uniform illumination 79.

System 78 also includes a processor 90 that may be operatively coupled to image sensor 63 and/or uniform illumination 79. Processor 90 implements an algorithm to determine whether a free flow condition exists and/or to estimate flow rate (e.g., using component 12 free flow detector or flow estimation component 13 shown in Fig. 1). Processor 90 may be operatively coupled to processor-readable memory 91 (eg, non-volatile processor-readable memory) to receive one or more instructions to implement an algorithm for determining whether a free flow condition exists and/or for estimating flow. One or more instructions from processor-readable memory 91 are configured for execution by processor 90.

The uniform backlight 79 may be an array of light emitting diodes (LEDs) having the same or different colors, a lamp, an ambient light receiving window, an incandescent light source, etc. In some embodiments, the uniform backlight 79 may include one or more point light sources.

The processor 90 may modulate the uniform backlight 79 in accordance with the image sensor 63 . For example, the processor 90 may activate the uniform backlight 79 for a predetermined period of time and signal the image sensor 63 to capture at least one image, and thereafter signal the uniform illumination 79 to turn off. One or more images from image sensor 63 may be processed by processor 90 to estimate flow and/or detect free flow conditions. For example, in one embodiment of the present invention, system 78 monitors the size of droplets produced in dripper 59 and counts the number of droplets flowing through dripper 59 over a predetermined amount of time; processor 90 may average the periodic flow of individual droplets over a period of time to estimate flow rate. For example, if X drops, each of volume Y, flow through the dripper in time Z, the flow rate can be calculated as (XxY)/Z.

Additionally or alternatively, system 78 may determine when IV fluid is flowing through IV drip 59 (ie, a free-flow condition is present). The uniform illumination 79 emits light through the dropper 59 to provide sufficient illumination so that the image sensor 63 can image the dropper 59. The image sensor 63 may capture one or more images of the dropper 59.

Other orientations and configurations of the system 78 may be used to account for the orientation and output characteristics of the uniform illumination 79, the sensitivity and orientation of the image sensor 63, and ambient light conditions. In some embodiments of the present invention, processor 90 implements an algorithm that takes advantage of the uniformity of images collected by image sensor 63. Uniformity can be enhanced by uniform illumination 79. For example, consistent uniform images can be captured by image sensor 63 when uniform illumination 79 is used.

Ambient lighting may cause inconsistencies in the images received from the image sensor 63; For example, direct sunlight provides inconsistent illumination because the sun may be obscured by clouds at times, and the brightness and angle of the sun varies depending on the time of day. Thus, in some embodiments of the present invention, an IR filter 80 is optionally used to filter out a portion of the ambient light to reduce changes in the images captured by the image sensor 63. The IR filter 80 may be a narrow band infrared filter located in front of the image sensor 63; and uniform illumination 79 may emit light at a wavelength approximately corresponding to the center frequency of bandpass filter 80. IR filter 80 and uniform illumination 79 may have a center frequency of about 850 nanometers. In some embodiments, the imaging system 78 may be surrounded by a shell that transmits visible light but blocks infrared radiation. In alternative embodiments, system 78 may use other optical frequencies, bands, center frequencies, or filter types.

In fig. 7 is a graphical illustration of an image 81 captured by the image sensor 63 of the system 78 shown in FIG. 6, in accordance with an embodiment of the present invention. Image 81 is an image of dripper 59 having condensation 82 and flow 83 resulting from the free flow condition therein. Edge detection can be used to determine the position of flow 83 and/or condensation 82, in some embodiments. Additionally or alternatively, an image or background design may be used.

In fig. 8 is a block diagram of a flow meter imaging system 84 for imaging a dropper in accordance with an embodiment of the present invention. Imaging system 84 can be used with any flow meter disclosed herein, including flow meter 7 shown in FIG. 1, and the flow meter 67 shown in FIG. 5.

System 84 includes an array of opaque lines 85 behind the dropper 59. System 84 uses an array of lines 85 to detect a free flow condition. A free-flow detection algorithm (eg, free-flow detector component 12 shown in FIG. 1) may use the presence or absence of droplets to determine whether a flow condition (eg, a free-flow condition) exists.

In some particular embodiments, the lines 85 are present in only a portion of the image (eg, the background pattern occupies only a portion of the backlight 18, or binary optics causes the pattern to appear only in a portion of the image, such as the bottom or top half). For example, the bottom portion of the image may include a background pattern in the form of stripes.

In fig. 9 is a graphical illustration of an image 86 captured by the image sensor 63 shown in FIG. 8 when a free flow condition exists in the dripper 59, in accordance with an embodiment of the present invention. Image 86 illustrates the state in which the dripper 59 is under a free flow condition and illustrates the effect that the fluid flow 87 acts as a positive cylindrical lens. Thus, as shown in FIG. 9, the line array 85 captured in the image by the image sensor 63 is a reversed line pattern 88 of the line array 85 compared to the non-free flow condition. The occurrence of the inverted line pattern 88 is caused by changes in light as light passes through the fluid stream 87 when the light reaches the image sensor 63 .

In some embodiments of the present invention, illumination with light having an optical wavelength of about 850 nanometers can be used to create an image 86. Some materials may be opaque in the visible spectrum and transparent in the near-infrared spectrum at a wavelength of about 850 nanometers, which can be used to creating 85 line arrays. 85 line arrays can be created using a variety of plastics for rapid prototyping. For example, the line array 85 may be created using a rapid prototyping structure printed with infrared opaque ink or coated with a metal to create the line array 85. Additionally or alternatively, in some embodiments of the present invention, another method for creating the line array 85 is provided to creating a circuit board with lines laid in copper. In another embodiment, an array of lines 85 is created by laying a piece of ribbon cable on a uniform backlight 79; the wires in the ribbon cable are opaque in the infrared spectrum, but the insulation is transparent so that the spaces between the wires can form lines for use in imaging by the image sensor 63 (see FIG. 8). In other additional embodiments, a piece of thin EDM-treated metal may be used. Metal is opaque to light, and the spacing between deposits of metal material can be very precisely adjusted during fabrication to allow IR light to pass through the gaps.

Processor 90 implements an algorithm to determine whether a free flow condition exists (eg, using the free flow detector component 12 shown in FIG. 1). Processor 90 may be operatively coupled to processor-readable memory 91 (eg, non-volatile processor-readable memory) to receive one or more instructions to implement an algorithm to determine whether a free-flow condition exists. One or more instructions from processor-readable memory 91 are configured for execution by processor 90.

- 29 043431

Returning to FIG. 8, the system 84 can use blood. For example, system 84 may determine whether a free flow of blood condition exists using image sensor 63, IR filter 80, and uniform illumination 79 configured, for example, for use with optical wavelength light having a wavelength of 850 nanometers or 780 nanometers. , for example, when using cow's blood. Blood may appear opaque compared to images obtained using water.

The following algorithm, implemented by the processor 90 and received from the processor-readable memory 91, can be used to determine whether a free-flow condition exists: (1) set the background image 89 (see FIG. 10); and (2) subtract the background image 89 from the current image. Additional processing can be performed on the resulting image.

In some embodiments of the present invention, the background image 89 shown in FIG. 10 may be dynamically generated by processor 90. A dynamic background image may be used to account for changing conditions, such as condensation or splashes 82 on the surface of the dropper 59 (see FIG. 7). For example, in one particular embodiment, for each new image captured by the image sensor (eg, 63 in FIG. 8), each pixel of the background image is multiplied by .96, and the corresponding pixel of the current image (eg, the most recently captured image) is multiplied by .04, after which, the two values are summed to create a new value for a new background image for that corresponding pixel; this process can be repeated for all pixels. In yet another example, in one particular embodiment, if a pixel of the new image is in row x and column y, the new background image in row x and column y is equal to the value of the previous background image in row x and column y multiplied by .96. which is added to the pixel value in row x and column y of the new image multiplied by .04.

When there is no water in system 84 flowing through dripper 59 (see FIG. 8) the result of the subtraction will be almost entirely backward, i.e. produce low pixel values, which helps the algorithm determine that the dripper 59 has no water flowing through it.

Fig. 11 shows an image 92 from image sensor 63 with a drop present in dropper 59 (see FIG. 8). Fig. 12 shows a background image 93 used by the system 84. When the system 83 has a droplet, as shown in image 92 in FIG. 11, system 84 shown in FIG. 8 has several high-contrast spots where the image of the line array is distorted due to the focusing effect of the drop, as demonstrated by image 94 in FIG. 13. Image 94 in FIG. 13 is generated by taking, for each corresponding pixel, the absolute value of the difference between image 92 in FIG. 11 and image 93 in FIG. 12 and converting each corresponding pixel to a white pixel if the value is above a predetermined threshold, or, otherwise, converting the pixel to a black pixel when the value is below a predetermined threshold. Each white pixel in image 94 in FIG. 13 occurs as a result of the difference for this pixel position between images 92 and 93 exceeding a predetermined threshold.

Consider, for example, the three corresponding pixels in FIG. 11, 12 and 13, located in row x and column y. To determine row x and column pixel y for image 94 in FIG. 13, a pixel in row x and column y of image 92 in FIG. 11 is subtracted from the pixel in row x and column y of image 92 in FIG. 12, after which the absolute value of the subtraction result is taken; and if the absolute value of the result exceeds a predetermined threshold (eg, above a grayscale value 128), the pixel at row x and column y position of image 94 in FIG. 13 is white, otherwise, the pixel at row x and column y position of image 94 in FIG. 13 is black.

When it is determined that in image 94 of FIG. 13 there are several high contrast spots, the processor 90 of the system 84 (see FIG. 8) determines that droplets are forming in the dripper 59 and a free flow condition does not exist. Droplet images can be used to determine droplet size for the flow estimation described here.

In fig. 14 is a graphical representation of some image processing techniques that can be performed using FIG. 11-13, to determine whether a free flow condition exists, in accordance with an embodiment of the present invention. According to FIG. 14 and 13, all white pixels for each row are summed and presented in FIG. 14 as results 183. The y-axis is the row number, and the x-axis is the total number of white pixels for each corresponding row.

Referring only to FIG. 14, as mentioned above, the number of white pixels for each row is summed and illustrated as the results 183, which are used to determine whether a free flow condition exists. In some specific embodiments, processor 90 of system 84 (see FIG. 8) determines that a free-flow condition exists when a predetermined number of contiguous values of the summed rows of results 183 exceeds threshold 184. For example, in results 183, a range of multiple adjacent rows, represented generally by position 185, has a total value greater than threshold 184. When it is determined that in results 183 exceeding a predetermined threshold (for example, threshold 184), there are more than a predetermined number of adjacent summed rows , the processor 90 shown in FIG. 8 determines that a free flow condition exists. For example, as shown in FIG. 14, the range of a plurality of adjacent summed rows 185 is below a predetermined number of neighboring summed rows (ie, the range 185 is not wide enough), and thus it is determined that the free flow condition does not exist.

Fig. 15 shows a flow image 95 captured by the image sensor 63 shown in FIG. 8 when free flow condition exists. Fig. 16 shows a background image 96. Fig. 17 shows an image 97 formed by the absolute value of the difference between the image 96 in FIG. 16 and image 95 in FIG. 15 when the absolute value is converted to either a white pixel (when the absolute value of the difference is above the threshold) or a black pixel (when the absolute value of the difference is below the threshold). As shown in FIG. 17, high-contrast spots caused by the reverse orientation of lines in the flow from top to bottom can be detected by the processor 90. The processor 90 shown in FIG. 8 may use image 97 to determine whether a free flow condition exists using the above algorithm.

Thus, as shown in FIG. 18, results 186 have a contiguous range 187 of results 186 that exceed threshold 188. Because the contiguous range 187 of the summed rows is greater than a predetermined threshold number of contiguous values exceeding threshold 188, processor 90 (see FIG. 8) determines that a free-flow condition exists. . Thus, the continuous range of results 186 exceeding the threshold 188 is greater than the predetermined threshold range of continuous values; thus, processor 90 determines that a free flow condition exists using results 186 in FIG. 18.

In yet another further embodiment of the present invention, intensity, intensity squared, or other function may be used to generate results 183 shown in FIG. 14 and/or results 186 shown in FIG. 18. In yet another further embodiment, one or more data smoothing functions may be used to smooth the results 183 and/or 186, such as a spline function, a cubic spline function, a Bspline function, a Bezier spline function, a polynomial interpolation, a moving average, or other data smoothing function.

For example, an image obtained by the image sensor 63 shown in FIG. 8, for example, image 95 in FIG. 15 can be subtracted from a background image, such as image 96 in FIG. 16 to obtain intensity values. Thus, the pixel located in row x and column y in FIG. 15 can be subtracted from a pixel located in row x and column y of image 96 in FIG. 16, to create an intensity value in row x and column y; this can be repeated for all pixel positions to obtain all intensity values. The intensity values of each row may be summed to produce results 183 and/or 186 (see FIGS. 14 and 18, respectively), which allows processor 90 to determine that a free flow condition exists when the summed rows of intensity values have a contiguous range of summed rows greater than threshold. In some embodiments, the intensity values are converted to absolute intensity value values, and the summed intensity absolute value rows are used to determine whether a continuous range of the summed absolute value rows exceeds a continuous value threshold range. Additionally or alternatively, the intensity may be squared, whereupon processor 90 may sum the rows of the squared intensity and determine whether a continuous range of the summed rows of intensity squared values is outside a threshold range of continuous values to determine whether a free flow condition exists.

In some embodiments, a predetermined range of continuous values greater than a threshold (eg, minimum and maximum ranges) of the summed rows of intensity values or squared intensity values may be used by processor 90 to determine whether a liquid droplet is present in the image. For example, each row of rows of intensity values (or intensity squared values) may be summed, and the range of summed values may exceed a threshold number; if the range of continuous values is between the minimum range and the maximum range, the processor 90 may determine that the range of continuous values exceeding a predetermined threshold is due to a drop in the field of view of the image sensor 63 (see FIG. 8). In some embodiments of the present invention, the summed rows of intensity values or squared intensity values may be normalized, for example, normalized to have a value between 0 and 1.

Described below is a smoothing function similar to a cubic spline (ie, a cubic spline type function) that can be used on summed rows, summed intensity value rows, or summed intensity squared rows before processor 90 determines whether a free flow condition exists. In some specific embodiments, a cubic spline type function may be used to identify blocks, described below, which may assist processor 90 in identifying free conditions.

- 31 043431 streams.

A cubic spline function is similar to a cubic spline, but it smoothes the data rather than faithfully simulating the function. Based on data sampled over the interval [0,1] (eg, by summing over a row of intensity squared or intensity that is normalized), processor 90 (see FIGS. 6 or 8) can find the best fitting set of cubic functions over the intervals [ _x0 ,x ₁ ], [xi,x ₂ ], ..., [x _N-1 ,x _N ], where x ₀ =0 and xN=1, and the complete function is continuous with continuous derivatives and continuous curvature.

The standard definition of a cubic spline is presented in equation (1) as follows: /(x) = D.(x)y _g .+D(x)^^ \<x<x _{m (1)} where the functions Ai, B _i , C _i , D _i are given by the system equation (2):

G M = THINK). d^b-^-b^))

Equations (1) and (2) guarantee continuity and continuity of curvature. Only the values yi, y ₀ and y _N can be freely selected. Note that the choice is expressed by the following equation (3):

those. the function is flat at 0 and 1. The remaining yi must obey the following system of equations (4):

У1~Уо । Uy^o Ug~U1 U1A Lv1

Δ _ο ⁺ 3 ^- 4 36

U2~U1 I Level1 I Level1 _ Uz~U2 _ Level2 _ Uz^2_ 6 3 ^— \ ₂ 36

Uz~U ₂ I U ₂ U I TzU _ Ud ~Uz _ UzU Urz

A ₂ 6 3 “Δ ₃ 36

Uy-2 Uy-Z I Uy-Z^u-E I Uy-2^y-3 _ Ulm Uy-g _ UU-2^U-2 _ y'N-l^N-2

Au-E 6 3 Du-2 36

Udm ~Um-2 । Uy-2^y-2 । Uu-0u-2 Uu ~Ulm Uu-Olm ^N-2 ^{6 3 A} LM ³ (4) .

System of equations (4) can be transformed into the following system of equations (5):

^_ ₂₊

In turn, it is transformed into matrix equation (6):

- 32 043431

Matrix equation (6) can be transformed into the following system of equations (7): Fy _dd =Gy

Y<y ⁼ FGy = Well ₍₇₎

The selection of vector y values using the least squares test on the collected data is shown in the following equation (8):

(8) .

Equation (8) expresses the minimum deviation between the data and the spline, i.e. equation (8) expresses the error function. The values of y are selected to minimize the error according to equation (8). The vector of predicted values can be expressed by the following equation (9):

The matrix elements in the parentheses of equation (9) depend on the x value corresponding to each data point (but it is a constant matrix). Thus, the final equation can be determined using the pseudo-inverse matrix. In turn, the pseudoinverse matrix depends only on the x-positions of the data array and the positions where discontinuities are specified in the cubic spline. It follows that after selecting the spline geometry and image size, the best choice for a given set of measured values ym is presented in the following equation (10):

In this case, the cubic spline can be expressed in terms of the sum of squared image intensity function according to the following equation (11):

Because the maximum values of the cubic spline are of interest, the derivative of the cubic spline is determined and used to determine the maximum values of the cubic spline. The derivative of a cubic spline is given by the following equation (12):

Equation (12) can be transformed into the following equation (13):

- 33 043431

Once you have found the current values of y, you can calculate the cubic spline, y _cs , and its derivative, y' _cs . Cubic spline data may include blocks of data that include values greater than a predetermined threshold. A tube block is formed by liquid flowing from the tube into the dripper 59, and a reservoir block is formed as liquid collects at the gravity end of the dripper 59 (see FIG. 8).

The following algorithm can be applied to cubic spline data: (1) determine local maxima of the cubic spline data using derivative information; (2) define a block surrounding each of the local maxima by including all points where the cubic spline value is greater than a threshold value; (3) merge all intersecting blocks; (4) calculate information about the data block, including the center of mass (intensity), the second moment of mass (intensity), the lower x value of the block, the upper x value of the block, the average value of the original sum of the intensity square data in the block, the standard deviation of the original sum of the squared intensity data in the block and the average intensity of the set of high-pass filtered images in the block; and (5) interpret the collected data to obtain information about when droplets occur and when the system is flowing.

The average intensity of a set of high-pass filtered images in a block is used to determine whether the block generated by each continuous range of spline data is the result of a high-frequency artifact (such as a blob) or a low-frequency artifact. This will act as a second background filter to remove artifacts such as condensation from the image. Thus, all previous images in the image memory buffer (eg, the previous 30 frames) are used to determine whether the data is the result of high-frequency movement between frames. If the block is the result of low-frequency changes, the block is removed, but if it is the result of high-frequency changes, the block is retained for further analysis. You can use a finite impulse response filter or an infinite impulse response filter.

Each block is plotted along its physical length, with a height equal to the average data value in the block. If the average value of a high-pass filtered image in a block is below the threshold, this indicates that it was present across multiple images and thus can be removed.

The processor 90 may determine that free flow conditions (see FIGS. 6 or 8) exist using the blocks when the pipe block passes adjacent the reservoir block, the pipe block and the reservoir block merge with each other, and/or the total width range of the reservoir blocks and the pipes (or all blocks) are larger than a predefined threshold, for example, the total length of the blocks is greater than 380 pixels wide. The processor 90 may detect a drop when a pipe block transition from a larger width to a smaller width occurs as a result of the formation of a drop in the tube and when the drop leaves the tube (i.e., tube) opening of the dripper 59. The processor 90 may detect this based on the current width ratio the pipe block to the width of the pipe block of the previous image, for example an image where the ratio is less than 0.9, since local minima may also be considered by the processor 90 to be an image formed immediately after the droplet is formed.

Various filtering algorithms can be used to detect condensation or other low-frequency artifacts, for example: if a block has a low average value in a high-pass filtered image, then it may be condensation. This artifact can be removed from consideration. Additionally or alternatively, long blocks (eg, above a predetermined threshold) with a low high-frequency average are possibly threads, since thread images tend to remain unchanged; processor 90 may determine that long blocks above a predetermined threshold meet a thread condition. Additionally or alternatively, the algorithm can be used on the current image to detect free flow conditions.

In some specific embodiments, processor 90 may use block data to count drops, allowing system 84 to be used as a drop counter. Processor 90 may also use changes in width in the reservoir block as the droplet disturbs the water to determine whether a bubble formed by the droplet hits the reservoir. For example, processor 90 may determine that the blocks that form underneath the reservoir block are from bubbles that form when a drop hits water. Processor 90 may filter the bubble when determining whether the predetermined value of the full block ranges indicates that a free flow condition exists.

In some embodiments of the present invention, the depth of field of the system 84 may be shallow so that the system 84 is less sensitive to condensation and droplets on the drip walls. In some embodiments, a near focus system may be used.

According to FIG. 19, in another embodiment of the present invention, template 189 is used to determine whether a free flow condition exists. Template 189 is used by processor 90 shown in FIG. 8, to determine the pattern matching rate 190 during implementation

- 34 043431 pattern matching algorithm on an image, for example, image 94 in FIG. 13. For example, template 189 may be compared to image 94 to determine how closely a portion or all of image 94 matches template 189. As mentioned above, image 94 in FIG. 13 is the difference between the background image and the image captured by the image sensor 63 shown in FIG. 8, each pixel of which is converted either to a black pixel if the difference value for that pixel is below a threshold value, or to a white pixel if the difference value for that pixel is above a threshold value. All pixels in image 94 will be either white pixels or black pixels. If the pattern match score 190 exceeds a predetermined threshold, it is determined that a free flow condition exists. The template matching method may use a template matching algorithm present in the Open Source Computer Vision (OpenCV) library. For example, template 189 can be used by calling the matchTemplate() function of the OpenCV library using the CV_TM_CCOEFF method or the CV_TM_CCOEFF_NORMED method. The CV_TM_CCOEFF method uses a pattern matching algorithm expressed in the following equation (14):

RiXy) = ^ЁГ(x\y ⁷ ) F(x + x\y +y'j) , (14)

HxW)

G(x + x ^L ,y + yO = I(x + <y + y0 - l/(w h) · 1(x + x ⁱ y + y) ₍₁₅₎ .

I denotes the image, T denotes the template, and R denotes the results. The summation is carried out over the template and/or image area, such that: x'=0...w-1 and y'=0...h-1.

The results of R can be used to determine how consistent the T pattern is at a particular location in image I, according to the algorithm. The pattern matching method with CV_TM_CCOEFF_NORMED from OpenCV uses the pattern matching algorithm expressed in equation (15) as follows:

.. E<'.„'(T'1x',y'rG(x + x',y + y'))

R(x,y I = , = yTvar Т'(К'.у')- Σ _ν .„. 1 ·(X + X', y + y 'j- _(16b

In another embodiment of the present invention, the template matching algorithm uses a fast Fourier transform (FFT). In some embodiments, you can use any of the matchTemplate() function methods from OpenCV, for example, CV_TM_SQDIFF, CV_TM_SQDIFF_NORMED, CV_TM_CCORR and/or CV_TM_CCORR_NORMED.

CV_TM_SQDIFF uses a pattern matching algorithm expressed in the following equation (17):

whether = Vm/. //) - /(.g -./. // - //) )(17)

CV_TM_SQDIFF_NORMED uses the pattern matching algorithm expressed in the following equation (18):

v, .(T(././/') /(.g-././/-//)) ²

L(.g.//) = —, ' ₍₁₈₎ .

CV_TM_CCORR uses a pattern matching algorithm expressed in the following equation (19):

Sh.g.c) = U) /(.g - I- c'p (19)

CV_TM_CCORR_NORMED uses the pattern matching algorithm expressed in the following equation (20):

E fir -././/-//)) , · = \/E>- l- ^T if // ) ² · E।- sch L u - // N

V -M ' -L ' ' (20)

In yet another embodiment of the present invention, a grayscale image pattern of the free flow condition is compared with the image obtained by the image sensor 63 shown in FIG. 8 to determine whether a free flow condition exists. In some embodiments, the template matching function in the OpenCV library may be used.

Let us now turn to FIG. 20 and 21; in yet another further embodiment of the present invention, an algorithm for determining whether a free flow condition exists, for example, performed by processor 90 shown in FIG. 8 can use an algorithm to determine whether a pattern pattern matches an array of pixels, using edge detection followed by line detection. As shown in FIG. 20, image 98 is formed from image 99 in FIG. 21 using the boundary detected after the lines are detected. The resulting lines may be used by processor 90 to determine that a free flow condition exists. As shown

- 35 043431 in Fig. 20, the feature that is detected after this processing by processor 90 is lines whose slope differs from the expected 45° slope of the background reference image. Lines having a background image angle may, in some embodiments, be filtered out from FIG. 20. Lines can be detected as edges using the Canny algorithm present in the OpenCV library. Hough's algorithm, also present in the OpenCV library, can be used to determine the slope of lines.

One type of Hough transform uses the algorithm described in the paper J. Matas, S. Galambos and J. Kittler Progressive Probabilistic Hough Transform published in 1998 (Algorithm 1). However, the following alternative Hough transform can be used and is shown as pseudocode in Table. 1 (algorithm 2). Algorithm 2 randomly selects two pixels and calculates the Hough transform of the line passing through these two points. Algorithm 2 is shown in Table. 1.

Table 1

Alternative Hough transform pseudocode

1. If the image is empty, then exit.

2. Randomly select two pixels and update the drive

A. Required Operations

i. Two random numbers

III. One inverse tangent

3. Check if the new position exceeds threshold 1, If not, go to 0

A. Operations

i. One logical operation

4. Search along the corridor defined by the peak in the accumulator and find the longest segment of pixels that is either continuous or exhibits a gap that does not exceed a given threshold.

5. Remove pixels in a segment from the input image.

6. Exclude from the storage all pixels from the line that was previously included.

7. If the line segment is longer than the minimum length, add it to the output list

8. Go to 1.

If a line contains a proportion p of all points, then the probability of seeing a result in a representative cell (r,θ) is p for Algorithm 1 and p ² for Algorithm 2. In general, in some embodiments, the proportion test produces at least 5 positive results and 5 negative results. Based on the premise that it is more likely to see negative results than positive results, in some embodiment, Algorithms 1 and 2 continue to search for lines until there are at least 5 positive results in a particular cell.

The probability of seeing a fifth positive result in Algorithm 1 after N>5 trials is expressed in the following equation (21):

A (5 on N) = p(4 in A -1) p = ^p ⁵ (1 - p) ^N5 (21) and the probability in Algorithm 2 is expressed in the following equation (22):

p ₂ (5 on A) = p (4 in A -1) p ² = , p ¹ ° (1 ~ p ² (22)

Table 2, shown below, shows the number of attempts made to obtain a 50% chance of seeing 5 successful results, P1, ₅₀ and P ₂ , ₅₀ , and the number of attempts made to obtain a 90% chance of seeing 5 successful results, P1 , ₉₀ and Р ₂ , ₉₀ .

table 2

R Р1.50 Р1.90 Р2.50 Rg, 90 ^g 50 ^g 90 0.5 9 14 20 31 2.22 2.21 0.25 19 thirty 76 127 4 4.23 0.125 39 62 299 511 7, 67 8.24 0.0625 76 127 1197 2046 15, 75 16, 11

Table Figure 2 demonstrates that the increase in the number of attempts between Algorithm 1 and Algorithm 2 to see 5 positive results is approximately ¹ / _p . There should be 1 positive result in 1/ _p attempts when the proportion is p.

- 36 043431

The computationally expensive operation of Algorithm 2 is, in some embodiments, the arctangent function, which can require about 40 CPU floating point operations. The equivalent step of Algorithm 1 performs approximately 2N floating point operations. The Hough transform of a 640x480 pixel full resolution image has an N of 2520, while the Hough transform of a 1080x1920 pixel image has an N of 7020. This means that Algorithm 2 has a speed advantage over Algorithm 1 when p is greater than 0.008 for a 640x480 image and when p is greater than 0.003 for a 1080x1920 image.

In some embodiments, each cell in the Hough transform space is assumed to be occupied with equal probability in the presence of noise. This simplification speeds up decision making on the threshold constraint; however, in some embodiments, this assumption is not true. The main result of the simplification is the underestimation of the probability of obtaining values greater than one in the Hough transform, with the corresponding probability of falsely declaring that the line exists. For a particular combination of image size and Hough transform cell configuration, truth probabilities can be calculated in advance. This allows the frequency of false alarms to be minimized without a corresponding increase in the computational load. Additional restrictions on the type of images provide an even more accurate estimate of the probability of seeing a value in a Hough transform cell.

There are additional forms of the Hough transform that parameterize different features. For example, there is a three-element parameterization of circles, (x,y,r), where x and y indicate the center, and r is the radius. Algorithm 2 can also work using these parameterizations. For the circle example, Algorithm 2 randomly selects three pixels and calculates the circle passing through it.

Algorithm 2 has a similar speed advantage for features containing a sufficiently large proportion of all pixels under consideration. It also has a significant advantage in the required storage, since the Hough transform can be stored in a sparse matrix, whereas the counterparts of Algorithm 1 require a full-size matrix.

Referring to FIG. 22-26, which illustrate various background patterns that can be used to detect a free flow condition or estimate the size of a liquid droplet. The image sensor 103 can be used with the wallpapers in FIG. 22-26, and may be the image sensor 11 shown in FIG. 1, the image sensor 68 shown in FIG. 5, the image sensor 63 shown in FIG. 6, or the image sensor 63 shown in FIG. 8, each of which may be connected to a corresponding processor for processing images from the image sensor, such as processor 15 shown in FIG. 1, or processor 90 shown in FIG. 8.

In fig. 22 is a block diagram of an imaging system 100 for use with a dripper 104 (e.g., dripper 4 shown in FIG. 1) having a background stripe pattern 101 and a light source 102 illuminating the stripes from a position adjacent to the image sensor 103 in accordance with, with an embodiment of the present invention. Any drops or free flows in the dropper 104 will distort the image captured by the image sensor 103. A processor coupled to image sensor 103 (eg, processor 15 shown in FIG. 1) may use distortions in background pattern 101 captured by image sensor 103 to estimate flow and/or detect free flow conditions.

In fig. 23 is a block diagram of an imaging system 105 for use with a dropper 104 having a stripe pattern 101 and a light source 102 illuminating the stripes from behind the pattern 101 relative to the opposite end toward the image sensor 103, in accordance with an embodiment of the present invention. Fig. 24 shows an image from the image sensor 103 shown in FIG. 23 when the droplet distorts the background pattern 101 in FIG. 23, in accordance with an embodiment of the present invention. Note that, as shown in FIG. 24, the stripes of the background pattern 101 are distorted by the drop (or will be distorted by the free flow) in the dropper 104, being captured in images by the image sensor 103. This distortion can be used to estimate droplet size, to calculate flow through an emitter, or to determine whether a free-flow condition exists in an emitter.

Fig. 25 shows a block diagram of an imaging system for use with a flow meter having a checkerboard pattern and a light source illuminating stripes from behind the background relative to the opposite end toward the image sensor, in accordance with an embodiment of the present invention. Fig. 26 shows an image from the image sensor shown in FIG. 25 when a droplet distorts the background pattern 107 in FIGS. 25-26, in accordance with an embodiment of the present invention. In yet another embodiment of the present invention, a background pattern having a plurality of random dots and/or circles may be used by the imaging system disclosed herein.

According to FIG. 22-26, the focusing effect of the drop (i.e., distortion of the background pattern in the field

- 37 043431 vision sensor) can be used to measure the radius of a drop. The radius of a droplet refers to how large and what effect the droplet has on any light passing through it. By measuring the change in the calibration grid (i.e., background pattern) observed through the droplet, the radius and therefore the volume of the droplet can be calculated. For example, the magnification of a test grid of known size observed through a droplet can be measured optically and the radius estimated from this measurement. In some embodiments of the present invention, the relationship between radius and droplet can be calculated and/or can be determined using a lookup table that has been empirically constructed.

Fig. 27-28 show a flowchart illustrating a method for estimating the volume of a drop in a dropper in accordance with an embodiment of the present invention. Thus, FIG. 27-28 illustrate method 214. Method 214 will also be described with reference to FIGS. 29-37. Fig. 2931 and 33-36 show images used or generated by a flow meter to estimate the volume of a droplet in a dropper in accordance with an embodiment of the present invention. Fig. 32 and 37 illustrate pseudo code that can be used by the method 214 shown in FIG. 27-28.

Method 214 shown in FIG. 27 and 28 can be implemented by the flow meter 7 shown in FIG. 1, flow meter 67 shown in FIG. 5, the imaging system 78 shown in FIG. 6, the imaging system 84 shown in FIG. 8, or another flow meter of the imaging system disclosed herein (with or without a background pattern and/or with or without active lighting).

Method 214 includes steps 200-213. Action 200 determines the baseline of droplet formation at the dropper orifice. Action 201 captures the first image. The first image can be captured using uniform illumination. In some embodiments, the first image may be captured using a background pattern and/or exposure algorithm described herein. Actions 200 and 201 may occur simultaneously. Fig. 29 shows an image with a baseline 215 overlaid. The baseline 215 may be a predetermined group of pixels or may be generated using fiducial marks located on the dropper opening and/or a background pattern (not shown in FIG. 29). The first image is used in method 214 to initialize a background image, _μi ,j, an array of variance values, si,j, and an array of integers, Ii,j. The background image could be i by j pixels, while the array of variance values and the array of integers could be 2-D arrays that are also i by j in size.

Action 202 identifies a blob in the first image and a predetermined band near the boundary of the blob (eg, the band may represent a predetermined number of pixels outside the boundary of the blob). Action 203 initializes the background image by setting each pixel to the same value as in the first image (for that corresponding position) when it is not in an identified blob or a predetermined band near the blob boundary. Action 204 sets the pixels in the droplet region or in a predetermined stripe to a predetermined value. Fig. 30 shows an example of a background image created after initialization. In the illustrative view of FIG. 30, the area of the droplet and stripe outside the droplet boundary, generally indicated by 216, is set to a predetermined value, for example, 140.

For example, when the method creates the first background image, each pixel in the background image that is part of a blob or stripe outside the blob boundary is set to a default threshold value, such as 140, from an intensity range of 0-255.

Action 205 initializes the integers of the integer array to zero. Action 206 initializes the values in the variance values array to zero. The array of integers is the same size as the image. An array of integers indicating how often each pixel in the background image is updated with new information and initialized to all zeros. The dispersion value array (eg, a double data array) is also the same size as the background image and contains an estimate of the intensity variance of each pixel in the background image.

Action 207 captures another image, and action 208 identifies a blob in the other image and another predetermined stripe near the blob's boundary. Action 209 updates the background image, the array of integers, and the array of variance values.

As additional images are captured, the background image can be updated. For example, when an image is collected by the system, a background algorithm evaluates each pixel. If the pixel is the part of the drop or its protective strip in question, then its value in the background image does not change.

If a pixel is not considered part of a blob or its guard band: (1) if the corresponding pixel integer in the integer array is zero, the pixel value in the background image is set equal to the pixel value in the input image; or (2) If the pixel count is greater than 0, then the background image value for that pixel is updated using a low-pass filter. In some embodiments, any type of filter may be used, such as a high pass filter, a band pass filter, etc. One low pass filter that can be used before

- 38 043431 is placed in the following equation (23):

ID -- 10 /d __ yy 1 I sy 10 ^g background,i,j ^background,i,j \ background / ^backgroundinput,i,j (23) .

Additionally, the array of variance values can be updated using the following equations (24):

^temp ^— (-^background,/,.; ^input,/,j ) ^background,i, j ^— ^background,i, j (^ /^background ) + /^background^temp ( 2 4 )

Note that the filter used for both operations is an exponential filter; however, in additional embodiments, other suitable filters, such as other low pass filters, can be used. Estimation of variance can be done by any known method or using a proxy estimate, for example, using standard deviation.

New estimates of each pixel's background intensity (average), the number of images used to update the expected value and variance of each pixel, and the variance of each pixel (e.g., an approximation of the true variance and/or a value proportional to the variance) are used to update the arrays. Thus, each additional image captured can be used to update the background image, an array of integers, and an array of variance values. After processing several images, the background image may look like FIG. 31. Note that this image still has an area (the area uniformly colored in medium gray, indicated generally at 217) where the pixels have never changed from the original threshold value. This region was the portion of the droplet or its guard band in question in each image.

Action 210 compares another image (eg, the current or most recent image) with the background image and identifies a plurality of pixels of interest. Action 211 determines a subset of pixels in the plurality of pixels of interest that corresponds to a blob.

Compare action 210 compares another image with a background image on a pixel-by-pixel basis. The result of this comparison is an array the same size as the image, where each pixel has a zero or non-zero (255) value.

Action 210 may be implemented through the pseudocode shown in FIG. 32. Thus, the determination of this threshold value is made according to the following: if the input pixel is located to the left or right of the baseline in the image, then its output value is set to zero (line 1); if an input pixel's background sample array indicates that fewer than a predetermined number of images were used to create that pixel's background value (e.g., 100), then (line 2): if the input pixel's intensity is less than a threshold intensity (e.g., 140 in the range 0-255) , then set the output pixel value to be different from zero (255) (line 2a); if the input pixel intensity is greater than the threshold intensity, then set the output pixel value to zero (line 2b); and if the array of background samples of the input pixel is greater than a predetermined number of images (line 3), then: if the square of the difference between the intensity of the input pixel and the intensity of the background pixel is greater than the pixel estimate for the background variance multiplied by the constant γ ² , then set the output pixel value to different from zero (255) (line 3a) (that is, if the difference between the current pixel value and the background image is greater than γ, then the pixel is different); if the squared difference between the input pixel intensity and the background pixel intensity is less than or equal to the pixel estimate for the background variance multiplied by the constant γ ² , then set the output pixel value to zero (see line 3b). Line 3 captures areas of the image that change in the presence of the drop, but whose intensity is increased.

When action 210 is implemented as an algorithm, the algorithm is initialized, the input and output of this thresholding algorithm will look like the images in FIG. 33 and 34, respectively. Since the number of images used in evaluating the background image is initially small, the only criterion applied is expressed in lines (1) and (2) above, since not enough images have been used so that for certain relevant pixels the array of integers has a value outside the threshold. This can cause many low intensity areas to be identified as separate, including poorly lit edges and condensation on the drip walls.

After collecting enough images such that most (or all) of the pixels are used, background images are generated with enough pixels, lines (3), (3a) and (3b) in FIG. 32. After thresholding, the background is mostly black with occasional noisy pixels above the dispersion threshold, as shown in FIG. 35 and 36 (which demonstrates the image captured by the camera and the results of the above algorithm

- 39 043431 comparisons, respectively).

As mentioned above, after action 210, action 211 determines which of a subset of pixels in the plurality of pixels of interest corresponds to a blob. Action 211 may be implemented through the pseudo code shown in FIG. 37. Thus, the thresholded image is passed to an algorithm that finds the connected component representing the droplet, as illustrated by the pseudocode shown in FIG. 37.

The binary image after processing according to the pseudocode shown in FIG. 32 is evaluated to find the binary component that occupies the space defined by the blob. The algorithm is given the position of the pixel on the baseline that is white (or it is given the center pixel of the longest stretch of consecutive white pixels on the line).

Having received the initial white pixel, the algorithm executes the algorithm illustrated by the pseudocode shown in FIG. 37. The pseudocode defines positions that include white pixels having a path to the baseline (ie, a white pixel path). Line 1 pushes the position of the first pixel onto the stack. Line 2 executes a loop with the condition of continuing until the stack is empty. The continuation loop includes lines (2a)-(2d). Line 2a pops the next position (i,j) from the stack. Line 2b sets the output pixel at position (i,j) to white. Line 2c checks the eight pixels next to (i,j). Line (2ci) is a conditional statement, and if the adjacent input pixel (ι,φ) is white but the output pixel (ι,φ) is black, line 2c adds the position (ι,φ) to the stack. Line 2d returns to line 2 to continue the loop with a continuation condition (if the stack remains empty).

This algorithm assigns the value white to all output pixel positions that can be connected to an input pixel position by a continuous path of white input pixels. The left edge of the droplet is found by moving step by step through each row of pixels from the left edge until the algorithm reaches a white pixel. The right border is found by moving step by step from the right border of the image until a white pixel is encountered. The first line, where it is possible to move step by step from the left border to the right border without encountering a white pixel, is considered the end of the drop.

The pseudocode shown in FIG. 37 is a one-pass version of the connected component marking algorithm. However, other connected component labeling algorithms or other suitable algorithms can be used to determine which pixels correspond to the blob.

Action 212 in FIG. 28 performs a rotation operation on a subset of pixels. Action 213 estimates the volume of the droplet in the dropper by counting the number of pixels in the rotated subset of pixels. The total number of pixels in the 3-D version of the drop is calculated; and since each pixel corresponds to a distance, the number of pixels can be used to estimate the volume of the droplet.

Imaging system optics

Fig. 38-42 illustrate the following description of the optics of the imaging system disclosed herein. For example, the image sensor disclosed herein may be an image sensor cube manufactured by OmniVision, located at 4275 Burton Drive, Santa Clara, California 95054; and, for example, the image sensor cube can be manufactured as a telephone image sensor. In some embodiments of the present invention, the image sensor disclosed herein may use a fixed focal length and have a depth of field (DOF) from 15 centimeters to infinity.

The image sensor may have a circle of confusion of a point imaged within a range of the image sensor entirely contained within a region of one pixel. The focal length of the image sensor lens may be 1.15 millimeters, the F# may be 3.0, and the aperture of the image sensor lens may be 0.3833 millimeters. A first-order approximation of the optical system of one or more of the image sensors can be obtained using matrix equations, where each ray, r, is represented by a vector described in the following equation (25):

⁽²⁵⁾

In the above equation (25), h is the height of the beam at the entrance to the image sensor, and 0 is the angle of the beam. According to FIG. 38, when an image is formed of a hypothetical point at a distance d _im from the lens of one of the image sensors (which has a focal length f), and the lens is at a distance dfp from the focal plane, the corresponding matrix, M _cam , describing the image sensor is represented by the following equation (26) :

m cam d _g fp 1

0'

To find the location on the focal plane where the beam hits, matrix multiplication can be used, described in the following equation (27):

F- 40 043431

According to FIG. 38, the diameter of the circle of blur, D _blur , is shown to be approximately equal to the distance between the two points shown in FIG. 38. This distance is found by tracing rays from the point dim from the lens on the optical axis to the edges of the lens and then to the focal plane. These rays are given by the vectors shown in (28) as follows:

As shown in FIG. 39, the circle of confusion, D _blur , is calculated and shown for various lens-to-focal plane distances and lens-to-image distances. In fig. 39 also shows a contour map 77. The x-axis represents the distance in microns between the focal plane and a point located at the focal length of the image sensor lens. The y-axis represents the distance in meters between the lens and the imaged point. The values creating the edge map 77 are the amount of unsharpness divided by the pixel size; thus, something around 1 or less is sufficient to form an image. As shown in FIG. 39, the focal plane is located at the focal length and another 5 microns from the lens.

The image sensor may use a second lens. For example, the image sensor may use a second lens to create a relatively greater depth of field and a relatively larger field of view. The depth of field using two lenses can be calculated using the same analysis as before, but the optical matrix must be modified to account for the second lens and the additional distances, which is expressed in the following equation (29):

Fig. 40 and 41 illustrate field changes depending on the distance between the lens and the image sensor and the corresponding change in the focus of the image sensor. Fig. 40 and 41 show the circle of confusion divided by the pixel size. Fig. 40 shows the circle of confusion divided by the pixel size when using a lens with a focal length of 20 millimeters. Fig. 41 shows the circle of confusion divided by the pixel size when using a lens with a focal length of 40 millimeters. The corresponding fields of view relative to the optical axis for the angles of the two configurations shown in FIG. 40 and 41 are presented in the table in Fig. 42.

As shown in FIG. 42, in some embodiments, the image sensor may use a lens with a focal length between 40 mm and 60 mm; this configuration may involve placing the image sensor about 2 inches from the focus. In other embodiments of the present invention, other configurations may be used, including those not shown in FIG. 42.

For example, the following analysis demonstrates how the depth of field for an image sensor can be set: using a lens with a focal length f, a distance z from the focal plane, and a distance d from a point in space; The matrix of the system is expressed in the following equation (30):

Equation (30) simplifies to the following equation (31):

Equation (31) simplifies to the following equation (32):

zero.

For points on the axis, all heights will be equal to different rays, given by the following equation (33):

I 7 dz\„ d + z--\θ

The point on the focal plane where (33) hits

As shown above in (33), θ denotes the beam angle. The point at ideal focus is given by the thin lens formula expressed by the following equation (34):

- 41 043431

1-1 1 ⁽³⁴⁾

Equation (34) can be rearranged to give the following equation (35):

X_1 zf ( ³⁵ ) / *

Substituting d from equation (35) into equation (33) to indicate the point of impact gives the following equation (36):

f- _+z :~f ^Z fz + fz^fz-fz ² f

(36)

All rays emanating from this point intersect the focal plane on the optical axis. As shown in Equation (37), the situation where the image sensor is offset by a distance δ from the focus is described as follows:

L _L C ^g „ A + fzS-f ² S ₊ fz ² -fz-fi ² -δζ ² + }δζ z~ff . .2 2 g β-f -z +fz δθ = (*-/) ²

-f) δθ = 1—^ ^δθ (37)

Equation (37) demonstrates that by properly positioning the image sensor lens relative to the focal plane, the depth of field can be varied. Additionally, the size of the spot depends on the magnitude of the angle θ. This angle is linearly dependent on the visual aperture created by the image sensor.

Additionally or alternatively, in accordance with some embodiments of the present invention, the image sensor can be implemented by adjusting various parameters, including: focus distance, as this affects the compactness, alignment and sensitivity of the visual system to environmental conditions; field of view of the system; and the distance between the lens and the focal plane, as it affects system alignment tolerances and the system's sensitivity to environmental conditions.

Embodiments of a flow meter with or without valves connected to them

Fig. 43 and 44 show flow meter 58 coupled to dripper 59. As described below, flow meter 58 may optionally include a free flow detector component 12 (see FIG. 1) in accordance with an embodiment of the present invention. Additionally, alternatively, or optionally, flow meter 58 may include a flow estimating component 13 (see FIG. 1) in accordance with some embodiments of the present invention. Fig. 43 shows flow meter 58 with hinged door 62, and FIG. 44 shows flow meter 58 with door 62 open. Flow meter 58 may be flow meter 7 shown in FIG. 1, with valve 6 or without valve. Flow meter 58 includes a start button 60 and a stop button 61. Additionally or optionally, flow meter 58 may include a redundant valve to stop fluid flow therethrough or may signal another valve to stop fluid flow in response to error conditions.

Flow meter 58 optionally includes image sensors 63 and 64 that can estimate fluid flow and/or detect free flow conditions. Although flowmeter 58 includes two image sensors (eg, 63 and 64), in some embodiments, only one of image sensors 63 and 64 may be used. Image sensors 63 and 64 may form an image of the droplet formed in the dropper 59 and estimate its size. Droplet size can be used to estimate fluid flow through the dropper 59. For example, in some embodiments of the present invention, image sensors 63 and 64 use an edge detection algorithm to estimate the droplet size contour formed in the dropper 59; an embedded processor (see processor 15 shown in FIG. 1, processor 75 shown in FIG. 5, or processor 90 shown in FIG. 6 or 8) may assume that the contour is uniform at each droplet angle and may estimate droplet size based on contour. In the exemplary embodiment shown in FIG. 43 and 44, two image sensors 63 and 64 may average two contours together to estimate droplet size. For example, the algorithm may average the contours measured by two image sensors 63 and 64 to determine the size of the droplet. 63 and 64 image sensors

- 42 043431 can use a reference background pattern to facilitate the drop size recognition described here.

In another embodiment of the present invention, image sensors 63 and 64 form an image of the fluid to determine whether a free flow condition exists. The image sensors 63 and 64 may use the background pattern to determine whether fluid is flowing freely (ie, droplets are not forming and fluid is flowing through the dropper 59). As mentioned above, although flow meter 58 includes two image sensors (e.g., 63 and 64), in some embodiments, only one of image sensors 63 and 64 may be used to determine whether a free flow condition exists and/or to estimate fluid flow rate. medium through a dropper.

Additionally or alternatively, in some embodiments of the present invention, another image sensor 65 monitors the fluid tube 66 to detect the presence of one or more bubbles in the fluid tube. In alternative embodiments, other bubble detectors may be used in place of the image sensor 65. In other additional embodiments, flow meter 58 does not use bubble detection.

In the drawings, FIG. 45 shows a flow meter 218 coupled to a dripper 219, in accordance with an embodiment of the present invention. Dropper 219 is attached to flow meter 218 via connectors 410. Illuminator 220 emits light through dropper to image sensor 221 (shown schematically).

Flow meter 218 may electronically transmit flow to monitoring client 8 (see FIG. 1). Additionally or alternatively, in some optional embodiments, flow meter 218 may include a display that displays flow (eg, touch screen, LED display, etc.). Flow meter 218 may be attached to stand 223 via clamps 222.

In some embodiments, flow meter 218 may be coupled to an actuator that is coupled to a valve (not shown in FIG. 45) to form a closed loop system (e.g., control component 14 shown in FIG. 1, e.g., PID, on/off, neural -network or fuzzy logic control system) to regulate the flow of fluid through the dropper 219.

Flow meter 218 may use any streaming algorithm described herein and may include any imaging system described herein. Additionally or alternatively, flow meter 218 may include a free flow detector component (eg, free flow detector component 12 shown in FIG. 1).

Fig. 46 shows a flow meter 224 and a pinch valve 225 coupled to a housing 226 of the flow meter 224 for controlling fluid flow to a patient, in accordance with an embodiment of the present invention. Flow meter 224 includes an image sensor 227 and a backlight 228.

The image sensor 227 forms an image of the dripper 229 and may receive illumination from the illumination 228. The flow meter 224 includes a support member 230 attached to a connecting device 231 that connects the dripper 229 to the flow meter 224.

Flow meter 224 may implement any flow estimator described herein (eg, flow estimator component 13 shown in FIG. 1) and/or free flow detector disclosed herein (eg, free flow detector component 12 shown in FIG. 1). Flow meter 224 may use pinch valve 225 in a closed loop mode to control the flow of fluid to the patient (eg, using control component 14 shown in FIG. 1).

Pinch valve 225, as more clearly shown in FIG. 47 is coupled to a shaft 233 that is coupled to an actuator 234. The actuator 234 may be a solenoid or any actuator that can move the pinch valve 225 to the tube 335.

Fig. 48 shows flow meter 336 and pinch valve 225 in accordance with an embodiment of the present invention. The flow meter includes two image sensors 337 and 338. Flow meter 336 may use pinch valve 225 in a closed loop feedback configuration. Flow meter 336 may implement the volume estimation algorithm described herein using both image sensors 337 and 338 to estimate fluid flow through dripper 229. For example, flow meter 336 may average two volumes together for use in a feedback loop.

Fig. 49 shows a flow meter 339 and a valve 340 coupled to an actuator 341 for controlling the flow of fluid entering a patient's body, in accordance with an embodiment of the present invention. Flow meter 339 shown in FIG. 49 is similar to flow meter 224 shown in FIG. 46; however, flow meter 339 shown in FIG. 49 includes a valve 340 having curved, elongated support members 342 and 343 (see FIGS. 50A-50B).

Flow meter 339 includes an image sensor 227 and a backlight 228. The image sensor 227 forms an image of the dropper 229 and may receive illumination from the backlight 228. The flow meter 339 includes a support member 230 coupled to a coupling device 231 that connects the dropper 229 to the flow meter 339.

- 43 043431

Flow meter 339 may implement any flow estimator described herein (eg, flow estimator component 13 shown in FIG. 1) and/or free flow detector disclosed herein (eg, free flow detector component 12 shown in FIG. 1). Flow meter 339 may use valve 340 in a closed loop mode to control the flow rate of fluid entering the patient's body (eg, using control component 14 shown in FIG. 1).

Flow meter 339 may activate actuator 341 to operate valve 340, which thereby controls the flow of fluid through IV tubing 335 in a feedback (ie, closed-loop) configuration using any control algorithm.

According to FIG. 50A-50B, which shows close-up views of valve 340 shown in FIG. 49, in accordance with an embodiment of the present invention. Valve 340 includes an inner curved, elongated support member 343 and an outer curved, elongated support member 342. Tube 335 is positioned between supports 342 and 343.

The inner support member 343 includes a cylinder nut 344. The outer support member 342 is attached to the cylinder nut 344 by hooks 345. In some embodiments, the cylinder nut 344 is not attached to the valve 340, and the inner support member 342 includes an opening through which a slide threaded rod or screw 347. The outer support piece 342 also has hooks 348 for attaching it to the frame 349 of the drive 341. The drive 341 includes a shaft 346 attached to the screw 347. When the drive 341 rotates the shaft 346, the screw 347 can rotate by pushing barrel nut 334 to actuator 341. Thus, hooks 345 and barrel nut 334 move toward hooks 348 and frame 349 because the inner and outer support members 342 and 343 are flexible.

When the support members 342 and 343 are compressed, the tube 335 is compressed as it is positioned between the support members 342 and 343. The compression of the tube 335 restricts the flow of fluid through the tube 335. The valve 340 compresses the tube 335 over a length that is substantially greater than the diameter of the tube 335.

Fig. 51A-51D show several views of a flow meter 350 with a control client 358, a valve 352, an IV line 357, and an IV bag 411 and fluid tubing 412 in accordance with an embodiment of the present invention. Flow meter 350 includes a receiving portion 351 for receiving valve 352. Valve 352 includes two curved, elongated support members 353 and 354.

Flow meter 350 includes an image sensor 355 and illumination 356 that can monitor droplets formed in the dropper 357. Flow meter 350 may use image sensor 355 to implement a flow estimation algorithm described herein (e.g., flow estimation component 13 shown in FIG. 1). and/or to implement a free flow detector disclosed herein (eg, free flow detector component 12 shown in FIG. 1).

Flow meter 350 includes a base 359 that may define a connector for receiving a monitoring client 358 . The monitoring client 358 may be a smartphone or other electronic computing device (for example, an Android device, iPhone, tablet, PDA, etc.).

The control client 358 may include software for implementing a free flow detector, a flow estimator, a control component, an exposure component, etc. (eg, free flow detector component 12, flow estimator component 13, control component 14, exposure component 29 shown in FIG. 1) and may include one or more transceivers (eg, transceiver 9). Additionally or alternatively, the base 359 of the flow meter 350 may implement these elements.

For example, flow meter 350 may implement a free flow detector, a flow estimator, a control component, an exposure component, etc. using internal software, hardware, electronics, etc. Flow meter 350 may implement a closed-loop feedback system to adjust fluid flowing to the patient by changing the flow of fluid through valve 352.

As can be seen from FIG. 51B, valve 352 includes an inner seat 354 and an outer seat 353. The inner seat 354 is coupled to a barrel nut 360 and a sleeve 361. In some embodiments, the barrel nut 360 is not attached to the inner seat 354, and the inner seat piece 354 includes a hole through which threaded shaft 362 is to slide.

A threaded shaft 362 (e.g., a screw) rotates freely in a bearing located in sleeve 361 and mates with a threaded nut in barrel nut 360 to push or pull barrel nut 360 relative to sleeve 361 by rotation of handwheel 363 (e.g., driven by a lead screw having a handwheel for driving the lead screw). Handwheel 363 can be rotated manually.

Additionally or alternatively, valve 352 may snap into a receiving portion 351 that includes a rotating member 364 that mates with a handwheel 363 in the receiving portion.

- 44 043431 plot 351 (see Fig. 51C). Rotating member 364 mates with rotating handwheel 363 to operate valve 352. Rotating member 364 may be coupled to an electric motor that rotates rotating member 364. The electric motor (not explicitly shown) may be controlled by flow meter 350 in a closed-loop configuration to achieve a target flow rate. fluid flowing towards the patient.

Fig. 52A-52D show several views of another flow meter 365 with valve 352, dripper 357, and fluid conduit groove 413 having a receiving portion 351 to receive valve 352 in accordance with an embodiment of the present invention. Flow meter 365 shown in FIG. 52A-52D is similar to the flow meter 350 shown in FIG. 51A-51D; however, the base 359 holds the control client 358 in a standing position. Additionally, the receiving portion 351 is located on the side of the base 359 opposite the monitoring client 358 (see FIGS. 52B and 52C).

Fig. 52D shows an enlarged view of valve 35 mating to receiving portion 351. Handwheel 363 mates with a rotating member that is internal to base 359 (not shown in FIG. 52D) that is coupled to a motor (also not shown in FIG. 52D). .

Fig. 53A shows another view of the valve 352 shown in FIG. 51A-51D and 52A-52D, and FIG. 53B-53C show two detailed views of the valve shown in FIG. 53A, in accordance with an embodiment of the present invention.

As shown in FIG. 53A-53C, valve 352 includes an inner support piece 354 and an outer support piece 353. A tube may be inserted through holes 366 and 367 to accommodate the tube between the support pieces 354 and 353.

The handwheel 363 may be rotated to rotate the screw 362. Rotation of the screw 362 causes the barrel nut 360 to move toward the split sleeve 363 to compress the tube located between the support members 353 and 354. The split sleeve 363 includes two sides, however, there is a gap to firmly hold the end 600 (eg, heads) of screw 362 in a space (eg, a correspondingly shaped space). Fig. 54 shows a manually operated valve 352 coupled to tubing 368.

Fig. 55 shows a valve 369 that includes two flexible parts 370 and 371 in accordance with an embodiment of the present invention. Flexible parts 370 and 371 may be two flexible plates. Flexible member 371 may include openings 373 and 374 for tube 372 to be positioned between flexible members 370 and 371.

The flexible parts 370 and 371 are connected to each other through two connector parts 377 and 378. Connector pieces 377 and 378 are attached to connecting pieces 376 and 375, respectively.

The valve 369 may be driven by a linear actuator that pulls the connecting parts 377, 378 toward or away from each other. The linear actuator (not explicitly shown) may be a screw-type actuator, a plunger-type actuator, or other actuator. In some embodiments, one of the connecting parts 375 and 376 may be coupled to a stationary support, while an actuator is coupled to another of the connecting parts 375 and 376 and the other stationary support to pull the connecting parts 375 and 376 toward or away from each other. .

Fig. 56A-56C show several views of a valve 380 having two curved, elongated support members 381 and 382, wherein one of the elongated support members 381 has a plurality of ribs 387 configured to mate with a tube located between the support members 381 and 382, in accordance with an embodiment implementation of the present invention.

Both support members 381 and 382 of valve 380 are connected to a link member 383 at the first end and a second link member 384 at the other end. Thus, the tie piece 384 surrounds the screw 385, and the tie piece 383 includes internal threads to pull the tie piece 383 toward or away from the handwheel 386 as the screw 385 rotates due to the rotation of the handwheel 386. FIG. 56B shows valve 380 actuated to shut off the flow of fluid through a tube connected between support members 381 and 382. FIG. 56C shows a support piece 381 having two holes 388 and 389 for receiving a tube. Also note that support members 381 and 382 hold the tube offset from the axis of screw 385, as illustrated in FIG. 56C. Holding the tube offset from the axis of screw 385 facilitates free movement of the tube.

Fig. 57A-57C show several views of a valve 390 having a ratchet 394 that mates with a connecting piece 393 of the valve 390, in accordance with an embodiment of the present invention, and FIGS. 57D-57E show two detail views of the valve 390 shown in FIG. 57A-57S. The ratchet 394 mates with the connecting piece 393 through interaction with the rack 397 located thereon. Pin 602 (see FIGS. 57D and 57E) interacts with rack 397 to provide a ratcheting action. Thus, the pin 602 can hold the rack 397 relative to the mating pin on the side opposite the retaining pin 602. The valve 390 includes a support member 391, one end of which is connected to the ratchet 394, and the other end of which is pivotally connected to the hinge 395. The valve 390 also includes a support piece 392 having hooks 398 that can be attached to the ratchet body 394.

- 45 043431

As shown in FIG. 57C, tube 396 may be positioned between support members 391 and 392, hooks 398 may then be attached to ratchet body 394, and connector 393 may be inserted into ratchet 394 (as shown in FIG. 57B). As shown in FIG. 57C, tube 396 is positioned against support 391 through openings 399 and 400.

Ratchet 394 mates with rack 397 such that ratchet 394 can be manually moved toward hinge 395 to make coarse adjustments to fluid flow. Thereafter, a handwheel (not shown) may be coupled to the ratchet 394 to make fine adjustments to the distance between the ratchet 394 and the hinge 395. Additionally or alternatively, the ratchet 394 may include a release button (not shown) to release the ratchet from the connecting piece 393.

Fig. 58A-58D show several views of a valve 401 having two elongated support members 403 and 404, a connecting member 405, and a screw-type actuator 407, in accordance with another embodiment of the present invention.

The support members 403 and 404 may be permanently molded together at their ends with the ends of the connecting member 405. The tube 402 may be located between the support members 403 and 404.

As handwheel 408 rotates, screw-type actuator 407 lengthens or contracts due to engagement with threaded rod 406. FIG. 58A shows the valve in the open position, and FIG. 58B shows the valve in the closed position. Note that tube 402 is compressed over a significant length of tube 402. FIG. 58C-58D show valve 401 in an open position and a closed position, respectively, in perspective view.

Fig. 59A-59C show several views of a body 501 of a valve 500 (see FIG. 59H for an assembled valve 500) in accordance with an embodiment of the present invention. Housing 501 includes a first curved, elongated support member 502 and a second curved, elongated support member 503. The first support member 502 includes raised holes 504, 505 for holding a tube between the supports 502 and 503.

Housing 501 also includes a first connector 506 that is coupled to the support members 503, 504 at an end, and a second connector 507 that is coupled to the other ends of the support members 503, 504.

The first connector 506 is attached to the end of the support pieces 503, 504 and to the first end 508 of the connecting piece 509. The second connector 507 includes an opening 510 for receiving the second end 511 of the connector piece 509 therein (as seen in FIG. 59B).

When the tube is positioned between the support pieces 502, 503, movement of the second connector 507 toward the first connector 506 compresses the tube located between the support pieces 502, 503. When the second connector 507 moves toward the first connector, the hole 510 of the second connector 507 allows the second end 511 of the connector piece 509 slide freely in it.

Fig. 59D-59G show several views of the handwheel 512 for use with the housing 501 shown in FIG. 59A-59C, in accordance with an embodiment of the present invention. The handwheel 512 includes a ratchet 513 formed by four fingers 514. Each of the fingers 514 includes a threaded surface 515 for mating with a threaded connection piece 509. The fingers 514 are curved toward a hole 516 in the center of the handwheel 512. The handwheel 512 also includes fingers 517, which mate with the second connector 507 (see Fig. 59H). In some embodiments, housing 501 includes a recess 510 for receiving fingers 517 on second connector 508.

Fig. 59H shows a valve assembly 500 that includes the body 501 shown in FIG. 59A-59C connected to the handwheel 512 shown in FIG. 59D-59G, in accordance with an embodiment of the present invention. The handwheel 512 slides along the threads of the connecting piece 509. The pins 514 mate with the threads of the connecting piece 509 and perform a ratcheting action on the connecting piece 509. Thus, the handwheel 512 can freely move towards the first end 508 of the connecting piece 509 along the threads of the connecting piece 509, but cannot move from the first end 508 of the connecting piece 509 without rotating the handwheel 512. Thus, the handwheel 512 can be placed on the connecting piece 509 to provide coarse adjustment of the valve 500 by roughly moving the connectors 507, 508 towards each other to close the valve 500. Because the threaded surfaces 515 four fingers 514 mate with the threads of the connecting piece 509, rotation of the handwheel 512 either reduces or increases the flow of fluid in the tube. Each of the fingers 514 includes a threaded surface 515 for mating with the threads of the connecting piece 509 such that rotation of the handwheel 512 causes the second connector 507 to move toward or away from the first connector 506, thereby controlling the flow of fluid in the tube, located between the supporting parts 502, 503.

Fig. 60 shows a valve 520 having a guide 521, in accordance with an embodiment of the present invention. Valve 520 is similar to valve 500 shown in FIG. 59H, but includes a guide 521 and a handwheel 522 having first and second clamps 523, 524. The handwheel 522 also includes internal threads (not shown) for mating with threads 525 of the connecting stud 526. In some embodiments, internal threads may have a ratcheting action, and in other embodiments, the internal threads may be fixed without providing a ratcheting action.

Fig. 61 shows motor 536 and valve mounting structure 537 for attachment to valve 520 shown in FIG. 60, in accordance with an embodiment of the present invention. The valve mounting structure 537 includes mounting pins 528, 529, 530, 531, each of which has a curved portion 533 for snap-fitting onto the clamps 523, 524 of the handwheel 522 (see FIG. 62) onto the corresponding clamp guide portions 534.

According to FIG. 60, 61 and 62, when the clamps 523, 524 are sufficiently secured, the handwheel 522 can rotate freely. Thus, the clamp 523 can be secured between the mounting pins 528 and 530 at their respective clamp guide portion 534, allowing the handwheel 522 to rotate. Likewise, the clamp 524 can be secured between the mounting pins 529 and 531 on their respective clamp guide portion 534, allowing the handwheel 522 to rotate.

When valve 520 is attached to valve mounting structure 537, rotation of wheel 537 (caused by motor 536) rotates handwheel 522 of valve 520. As valve 520 flexes, protrusion 521 moves freely in or adjacent to protrusion guide 535. Fig. 62 shows the valve shown in FIG. 60 attached to the engine 536 via a valve mounting structure 537.

Fig. 63 shows another motor 538 and valve mounting structure 539 for attachment to the valve shown in FIG. 60 in accordance with an embodiment of the present invention. The valve mounting structure 539 includes a protrusion guide 540 adjacent to the motor 538. The motor 538 is coupled to a wheel 541 for engagement with the handwheel 522 (see FIG. 60).

Fig. 64A shows a valve 542 having a sliding collar 545 and a plurality of compression pins 544 for controlling fluid flow through conduit 543 in accordance with an embodiment of the present invention. The base 546 is connected to all of the pins 544. As the sliding collar 545 moves over the compression pins 544, the compression pins 544 compress the tube 543 to prevent fluid from flowing through it. Fig. 64B shows a sectional view of the valve shown in FIG. 64A.

Fig. 64A shows a valve 542 having a sliding collar 545 and a plurality of pins 544 for controlling fluid flow through conduit 543 in accordance with an embodiment of the present invention. Pins 544 are attached to base 546 such that base 546 and pins 544 surround tube 543. Clamp 545 may slide away from base 546 such that pins 544 compress tube 543 and thereby reduce the internal volume of tube 543. Reducing the internal volume of tube 543 543 results in a decrease in fluid flow through the tube. An actuator (not shown) may be coupled to the yoke 545 to control the position of the yoke 545 (for example, a linear actuator may be coupled to the yoke 545 and to the base 546). Fig. 64B shows a cross-sectional view of the valve 542 shown in FIG. 64A. Note that fingers 544 may be curved away from the tube near the end opposite the base.

Fig. 65 shows a valve 547 having two curved surfaces 549 and 550 for receiving a fluid conduit 548 therebetween to regulate the flow of fluid through the fluid conduit 548 in accordance with an embodiment of the present invention. As the surfaces are pressed against each other, the tube 548 is compressed between them. The two curved surfaces 549 and 550 can be pressed against each other using a drive. Tube 548 may be wrapped several times around surface 549.

Fig. 66A-66G show several views of a valve 551 having a handwheel 552 for moving a connecting piece 553 that is locked in place after the handwheel 552 is moved in accordance with an embodiment of the present invention.

The valve 551 includes an inner curved, elongated support member 554 and an outer curved, elongated support member 556. The handwheel 552 is pivotally connected to the outer support member 556 by a pin 578. The coupling member 553 mates with teeth 576 of the handwheel 552.

The connecting piece 553 may fit into the hole of the end 555 of the support piece 556 such that rotation of the handwheel 552 frictionally locks the mating pin 700 (see FIG. 66D) on the rack 558 of the connecting piece 553. The mating pin 700 can mate with the teeth 576 to lock the handwheel. 552 to thereby prevent the handwheel 552 from rotating until sufficient torque overcomes the locking action of the mating pin 700. A retaining pin 577 is located on the other side of the hole 571, pressing the connecting piece 552 against the teeth 576 of the handwheel 552.

The inner support piece 554 can pivot away from the outer support piece 556 such that the tube can be loaded through the raised portions 559 and 560 (see FIG. 66C). The inner support member 554 is pivoted away from the outer support member 556 by means of figure-eight shaped link members 561, 562, 701 and 702, as shown in FIG. 66C. Thereafter, the inner support piece 554 rotates back toward the support piece 556, as shown in FIG. 66D. Then connecting

- 47 043431 a piece 553 is inserted into the end 555 of an outer support piece 556 (shown in close-up in FIG. 66E), which includes a mating pin 700 that locks onto the teeth 576 of the handwheel 552, temporarily preventing the movement of the connecting piece 553 (see FIG. .66G). The other end 581 of the connecting piece 553 is locked into an opening 582 of the end 557 of the support piece 556. The connecting piece 553 may be pivotally coupled to the end 557. The handwheel 552 includes teeth 576 for moving the connecting piece 553 toward or away from the end 555. However, when the handwheel 552 is not moving, the mating pin 700 blocks movement of the handwheel 552 until a predetermined amount of torque moves the pin 700 to the next tooth of the teeth 576 of the inner portion of the handwheel 552.

As mentioned above, the support member 554 can be folded away from the outer support member 556, as shown in FIG. 66C, which is facilitated by the figure-eight shaped connecting members 561, 562, 701 and 702. The figure-eight link member 561 includes a king pin hole 572 that is coupled to the king pin 563 and a king pin hole 573 that is coupled to the king pin 565. The figure eight link member 562 includes a king pin hole 575 that is coupled to the king pin. 566, and a kingpin hole 574 that is attached to the kingpin 566. A figure-eight link 701 is attached to the kingpins 567 and 570, and a figure-eight link 702 is attached to the kingpins 568 and 569 such that the end of the support member 556 is also hinged. from the internal support part 554.

Fig. 67 shows a graph 408 that illustrates activation versus flow for a valve, in accordance with an embodiment of the present invention. Plot 408 demonstrates the operation of a valve having elongated support members, such as valve 340 shown in FIG. 49 and 50A-50B, valve 352 shown in FIG. 51A-54, valve 369 shown in FIG. 55, valve 380 shown in FIG. 56A-56C, valve 380 shown in FIG. 57A-57E, valve 401 shown in FIG. 58A-58D, valve 500 shown in FIG. 59H, valve 520 shown in FIG. 60-60, valve 542 shown in FIG. 64A-64B, valve 547 shown in FIG. 65, and/or valve 551 shown in FIG. 66A-66G. The x-axis of graph 408 represents the displacement between the ends of the valve supports, and the y-axis represents flow (eg, due to gravity and/or a pressure source). The valve response is expressed by a nonlinear function, such as an S-curve, sigmoidal curve, Gompertz curve, or generalized logistic function. These functions can be adjusted to match the shape of the valve and/or the valve can be adjusted to match one of the curves or functions.

Fig. 68A shows a flow meter 703 that uses binary optics 705, in accordance with an embodiment of the present invention. Flow meter 703 includes a camera 355 that captures one or more images for estimating the flow of fluid through the dripper 357 using any suitable method, such as the methods disclosed herein. Flow meter 703 includes a laser 704 that directs a laser beam to a binary optics assembly 705. The binary optics assembly 705 then redirects and converts the laser beam through the dropper 357 and onto the image sensor 355 such that the image sensor 355 sees a pattern, such as the array of lines 85 shown in FIG. 8, which may form stripes as shown in background 89 in FIG. 10. The binary optics assembly 705 can form stripes using multiple ovals.

The image sensor 355 may include a filter for filtering out all frequencies except the frequency of the laser 704. For example, the image sensor 355 may include an optical bandpass filter whose center frequency is equal to (or approximately equal to) the optical frequency (or the center frequency of the optical frequency) of the laser 704.

Monitoring client 358 may be electrically coupled to laser 801 to modulate laser 801. For example, monitoring client 358 may turn on laser 801 only when predetermined pixels are exposed and may turn off laser 801 when pixels other than predetermined pixels are exposed.

Flow meter 703 optionally includes a first electrode 800 and a second electrode 801. Monitoring client 358 may be electrically connected to the first and second electrodes 800, 801 to measure the capacitance they produce. Under flow conditions, the capacitance changes due to differences in the relative dielectric constants of air and water. Monitoring client 358 may monitor changes due to a flow condition in the dripper 357 by monitoring the capacitance between the first and second electrodes 800, 801 and correlating increases and/or decreases in capacitance beyond a threshold as corresponding to a flow condition and/or a non-flow condition. . For example, if the capacitance between the first and second electrodes 800, 801 is above a threshold, the processor in the monitoring client 358 may determine that the dripper 357 satisfies a flow condition.

In an alternative embodiment, the first and second electrodes 800, 801 are loop antennas. Monitoring client 358 uses a transceiver to monitor magnetic coupling between loop antennas 800, 801. For example, the transceiver may transmit an encoded message from one loop antenna of antennas 800, 801 to another of loop antennas 800, 801 and then

- 48 043431 determine whether the encoded message has been successfully received. If so, a Received Signal Strength Indication (RSSI) measurement can be obtained from the transceiver. RSSI can be used to monitor magnetic coupling between antennas 800, 801. If magnetic coupling exceeds a threshold, then monitoring client 358 can determine that a flow condition exists at dripper 357. In some embodiments, a change in magnetic coupling or a change in capacitive coupling may be detected as evidence of a flux condition occurring.

Flow meter 703 may also include a relief valve 706. FIG. 69A-69F show several types of relief valve 706 that can be used with a flow meter, such as flow meter 703 shown in FIG. 68, in accordance with an embodiment of the present invention.

Fig. 69A-69B show detail views of the relief valve 706. The relief valve 706 includes a solenoid 707, a transmission structure 708, a tube body 709, a spring 720, a faceplate 712, a first spindle 713, a second spindle 714, a first shut-off lever 710, and a second shut-off lever. lever 711. The faceplate 712 includes an opening 715, and the tube housing 709 also includes an opening 819. The openings 715, 819 allow the spindle 713 to slide in the openings 715, 819.

As shown in FIG. 69C, tube 820 may be located in tube housing 709. The placement of the tube 820 places the tube 820 in proximity to the first and second shutoff arms 710, 711, which are shown in FIG. 69D. The spring 720 maintains the first and second closure arms 710, 711 retracted when in a compressed state (as shown in FIG. 69D) but stores energy, resulting in movement of a predetermined amount of the first and second closure arms 710, 711 toward the tube 810 causes the spring to release its stored mechanical energy, causing the first and second shut-off arms 710, 711 to extend outward and close the tube 820. The spring 720 may be a compression spring 720 may pull 713 and 714 toward each other. The first and second overlap arms 710, 711 are pivotally connected to each other. As can be seen from FIG. 69E, the shaft 718 of the solenoid 707 may act through the hole 719 in the tube to press against the spring 720, causing the spring 720 to release its energy and close the tube 820 (see FIG. 69F for the case where the first and second shut-off arms 710, 711 are in an overlapping position).

Fig. 70 shows a flowchart illustrating a method 728 for estimating droplet growth and/or flow rate in a dripper in accordance with an embodiment of the present invention. Method 728 includes steps 729-735. Fig. 71A-71E show images used by the flow meter with a template superimposed thereon to illustrate the method of FIG. 70.

Action 729 captures the image of the IV. The captured image may be image 721 in FIG. 71A. Action 730 places the pattern in the captured image at the first position. For example, as shown in FIG. 71A, the template 727 may be positioned at a predetermined position. Action 731 averages all pixels in pattern 727. Action 732 moves the pattern to a second position. For example, template 727 in FIG. 71A may move the template in the Y direction (eg, downward, as shown in FIG. 71A).

In action 733, the pixels in the pattern are used to determine the second average. In action 734, if the difference between the second average and the first average is greater than a predetermined threshold value, a determination is made that the pattern is located at the boundary of the droplet. For example, according to FIG. 71A, the pattern may slowly descend in the Y direction until the pattern 727 moves from the blob boundary to a portion of the image that does not contain the blob, in which case the average pixel value will abruptly transition from a dark average to a lighter average. When this transition occurs, the Y position of template 727 is considered to be at the boundary of the droplet (eg, Y1 in FIG. 71A). In action 735, the second drop position is correlated with the drop volume. For example, the value Y ₁ can be associated with the volume of the drop in the lookup table. In some embodiments of the present invention, multiple movements of the template 727 are required until the droplet boundary is detected. For example, pattern 727 may move in the y-direction one pixel at a time (or several pixels at a time), and multiple movements of pattern 727 may be required to detect a droplet boundary. By monitoring the droplet boundary, the flowmeter can control droplet growth to achieve a target flow rate (e.g. , the speed of transition from Y1 in Fig. 71A to Y ₂ in Fig. 71B can be controlled by a PID control loop in the flow meter). Fig. 71B-71E show the position Y ₂ which corresponds to growth in the droplet relative to the position Y1 in FIG. 71A.

Fig. 72 shows a modulated backlight assembly 740 in accordance with an embodiment of the present invention. Assembly 740 may be the backlight 18 shown in FIG. 1 or can be used as a backlight for any suitable flow meter disclosed herein. Assembly 740 includes a first circuit board 738, a second circuit board 739, a first backlight diffuser 736, and a second backlight diffuser 737.

The first circuit board 738 includes built-in light sources 822 that extend along the interface between the first backlight diffuser 736 and the first circuit board 738. The built-in light sources 822 emit light onto the first backlight diffuser 736, which is directed outward as indicated. position 821. Light 821 may be directed to the image sensor. The first backlight diffuser 736 diffuses only light, without a pattern formed when observed by the image sensor.

The second circuit board 739 includes built-in light sources 823 that illuminate the second backlight diffuser 737. The second backlight diffuser 737 creates a pattern of stripes that are detected in the light 821 when observed by the image sensor. Thus, the monitoring client (eg, monitoring client 358 shown in FIG. 51A) and/or the flow meter (eg, flow meter 7 shown in FIG. 1) can choose between a striped background pattern (activating the built-in light sources 823) and a stripless background pattern. pattern (activating the built-in 822 light sources).

For example, according to FIG. 1 and 72, flow meter 7 may use backlight assembly 740 in some specific embodiments; Flow meter 7 may use a stripeless backlight pattern (activating embedded LEDs 822 and not activating embedded LEDs 823) to monitor droplet growth and may switch to a striped background pattern (activating embedded LEDs 823 and not activating embedded LEDs 822) to detect flow conditions.

Fig. 73A-73C show several views of a tube recovery device 741 in accordance with an embodiment of the present invention. The device 741 includes a drive gear 744 that is coupled to a first recovery gear 742. A first recovery gear 742 is mechanically coupled to a second recovery gear 743. A tube may be disposed between the first and second recovery gears 742, 743. Portions of the first and second recovery gears 742, 743 form a gap 745 in which a tube can be located. Rotation of the first and second recovery gears 742, 743 reduces the gap 745 when the tube is positioned between the first and second recovery gears 742, 743. The transition from the non-recovery position to the recovery position is shown in FIG. 73B-73C. For example, the tube may be positioned such that the blockage pushes upward on the tube (as shown in FIG. 73B). If the tube becomes distorted over time, a motor attached to drive gear 744 rotates gears 743 and 744 to apply pressure to the tube walls (as shown in FIG. 73C) to restore the tube to an approximate cross-section by pressing against portions of the tube wall that expand beyond the central axis of the tube in such a way that the tube is distorted, acquiring, for example, an oval shape.

Fig. 74 shows a system for controlling the flow of fluid 746 using a valve 747 having two flexible strips 753 and 754 (see FIG. 75); and figs. 75 shows valve 746 shown in FIG. 74 in accordance with an embodiment of the present invention. Optionally, a motor may be coupled to valve 746 to control the flow meter in one embodiment.

As shown in FIG. 75, the valve 74 includes two flexible strips 753, 754, and between them may be a tube, a guide shaft 752, two guides 749, 750, a screw 751 and a handwheel 748.

When the handwheel 748 rotates, the screw 751 rotates. The rotating screw 751 pulls the distal guide piece 750 towards the proximal guide piece 749 (because the distal guide piece 750 includes internal threads and the screw 751 rotates freely in the proximal guide piece 749).

The guide 751 guides the movement of the distal guide piece 750. The guide 751 is attached to the proximal guide piece 749.

Fig. 76A shows a valve 755 that uses a fluid-based bladder 758 in accordance with an embodiment of the present invention. Valve 755 includes two flaps 756, 757, a bladder 758, and a plunger 759. The plunger 759 can be any fluid source. Bubble 758 may be positioned in cavity 764, and tubing may extend through bladder 758 and be positioned in channels 760 and 761. Thereafter, flap 757 may be positioned on top of bladder 758 such that cavity 765 is positioned on top of bladder 758. Then two flaps 756, 757 can be connected to each other by ultrasonic welding, temporarily pressed together and/or held together for a sufficiently long time. Thereafter, an actuator (e.g., an actuator controlled by the flow meter disclosed herein) can be actuated to move fluid into or out of the bubble 758 using the plunger 759.

Fig. 76B shows a cross-sectional view of the valve assembly 755 shown in FIG. 76A, with two elastomeric fillers 1002, 1004 in accordance with an embodiment of the present invention. The elastomeric fillers 1002, 1004 help hold the tube 1000 in place and help restore the tube 1000 when the bubble 758 is deflated.

Fig. 77 shows a system 766 for controlling fluid flow using a valve 769 having two flexible strips 771, 772 driven by a linear actuator 822 in accordance with an embodiment of the present invention. Fig. 78 shows linear actuator 822 operating valve 769 to prevent fluid from flowing through

- 50 043431 tube 775. Valve 769 is connected to two couplings 767 and 768. The proximal coupling 768 is moved by a linear actuator 822, while the distal coupling 767 is fixed relative to the stationary end of the linear actuator 822.

Fig. 79 shows a close-up view of valve 769 shown in FIG. 77-78. The valve 769 includes two strips 771, 772 (which may be metal strips) in which a tube 775 may be located. The two strips 771, 772 of the valve 769 may be attached to a first end structure 773 and a second end structure 774. The first end structure 773 may be attached to the distal connector 767, and the second end structure 774 can be attached to the proximal connector 768 (see FIGS. 77-78). The string 770 or membrane may be wrapped around the tube 775 such that, when the strips 771, 772 are straightened, the string 770 is pressed against the side walls of the tube 775, promoting the rounding of the tube 775. The membrane may be made of a flexible but non-extensible material (or minimally tensile material). Fig. 80 shows a close-up view of the valve being actuated as shown in FIG. 78. Note that string 770 is threaded through holes 776 and 778. String 770 (which may be metal) wraps around tube 775 such that when valve 769 is opened, string 770 restores tube 775.

Fig. 81 shows several images for use in illustrating the method of estimating droplet growth and/or fluid flow shown in FIG. 82A-82B, in accordance with an embodiment of the present invention. Fig. 81 shows images 771-777 mentioned below in connection with FIGS. 82A-82B.

Fig. 82A-82B show a flowchart illustrating a method 803 for estimating droplet growth and/or fluid flow rate. Method 803 includes steps 804-818.

Action 804 captures a first image (eg, image 771 in FIG. 81). The first image could be a grayscale image of a dropper. The dripper can be evenly illuminated with a striped pattern on the bottom of the dripper (i.e., there is no background pattern on the top of the dripper).

An action 805 creates a first constrained image using the first image. The first limited image may be image 774 in FIG. 81. The first constrained image can be obtained by comparing each pixel from the first image with a threshold value (for example, setting the corresponding pixel of the constrained image to 0 if the corresponding pixel of the first image is above the threshold, or setting the corresponding pixel of the constrained image to 1 if the corresponding pixel of the first image below the threshold). This action is designed to highlight areas where there is water in front of the background.

In some specific embodiments, the threshold level is updated for each new image to ensure that the predetermined ratio of 1 to 0 pixels for drop selection is maintained. The relation may be updated for use by action 805 upon reuse, or the update may adjust the threshold until a predetermined ratio of 1 to 0 pixels is reached and then use the first constrained image for the rest of the method 803.

Act 806 determines a set of pixels in the first constrained image associated with a predetermined set of pixels in the first constrained image. A predetermined set of pixels may be defined by fiducial points placed on the dropper or hole in which droplets are formed. The predetermined set of pixels may be a predetermined set of x, y values that correspond to the pixels. Act 806 may use a concatenated component image analysis algorithm.

Action 807 filters all remaining pixels of the first constrained image that are not associated with the set of pixels. The filter operates on a pixel-by-pixel basis in the time domain to generate the first filtered image. The first filtered image is an estimate of the inactive (eg, originating from features of no interest in the image) portion of the first limited image (image 774 in FIG. 81). The filter may be any filter, such as any filter described herein.

Act 808 removes pixels determined not to be part of a blob from the first constrained image using the first filtered image to generate a second image (eg, image 775 in FIG. 81). A pixel in the second image is set to 1 if the corresponding pixel in the first restricted image is 1, and the corresponding pixel in the first filtered image is less than 0.5, otherwise, the pixel is set to 0.

Act 809 determines a second set of pixels in a second image associated with a predetermined set of pixels in the second image to generate a third image (eg, image 776 in FIG. 81). The third image identifies a second set of pixels in the second image. Action 809 finds a set of luminous pixels in the second image associated with a predetermined set of pixels (for example, pixels representing a hole in which

- 51 043431 drops are formed).

Action 810 determines the first blob length by counting the number of rows containing pixels corresponding to a second set of pixels in the third image. Thus, the length of the blob is determined to be equal to the last glowing row in the set of pixels found in action 809. The first length corresponds to the first estimated size of the blob.

Action 811 updates the background image using the first image. A low pass filter can be used to update every pixel value in a background image. An infinite impulse response filter can be used to update the background image using the first image. The pixel in the background image is updated only for lines below the first length plus a predefined guard zone. A pixel in the background image is updated by low-pass filtering the value from the corresponding pixel in the first image.

Activity 812 creates a second constrained image (eg, image 772 in FIG. 81) by comparing the first image to the background image. Thus, to generate the second constrained image, a background image is subtracted from the first image, and, on a pixel-by-pixel basis, the absolute value of each pixel is set to 1 if it is above the second threshold and set to 0 if it is below the second threshold.

Activity 813 sums the rows of the second bounded image to create a plurality of row sums (see image 773 in FIG. 81). Each row sum corresponds to a row of the second bounded image.

Act 814 begins at a row position of a second limited image having a first sum of a plurality of sums that corresponds to the first length. The row position is incremented in action 815. Action 816 determines whether the current row position corresponds to a corresponding row amount that is below a threshold, such as zero. If not, then action 815 is performed again until the current line position corresponds to the corresponding line sum equal to zero, and then method 803 proceeds to action 817.

Action 817 specifies that the second length is equal to the current line position. The second length corresponds to the second estimated droplet size. Action 818 averages the first and second lengths to determine the average length. The average length corresponds to the third estimated droplet size. By using the first and second lengths to determine the average length, the effects of condensation on the internal walls of the drip tray are reduced. Thus, two droplet length estimates are created to compensate for the effect of the presence of condensation on each length. The first length is characterized by underestimation of the drop length if the condensation drop intersects with the growing drop from the faucet. The second length is characterized by overestimation of the drop length if the condensation drop intersects with the growing drop from the tap. Their average provides a more reliable estimate in the presence of condensation. In the absence of condensation, the scores are almost equal. In other embodiments, only one of the first and second lengths is used to estimate the droplet size.

Fig. 83 shows a flowchart of a condensation noise reduction method 900 in accordance with an embodiment of the present invention. Method 900 includes steps 902-910.

Action 902 captures an image of the IV. Act 904 performs a Canny edge detection operation on the image to generate a first processed image. Act 906 ANDs a pixel on a first axis side of the first processed image with a corresponding mirror-symmetric pixel on a second axis side of the first processed image. Thus, action 902 forms an axis in the first processed image, and ANDs each pixel on one side with the pixel on the other side, such that the pixel on the other side is symmetrical to the pixel on the first side. For example, an image 40 (x-axis) by 40 (y-axis) might have its axis defined between columns of pixels 19 and 20. The top left pixel would be pixel (1,1). The pixel at position (1, 5) is ANDed with the pixel at position (40, 5). The resulting pixel will be used for both positions (1, 5) and (40, 5) to generate the second processed image.

Thus, after action 906 occurs, action 908 determines whether all pixels have been processed. Action 908 repeats action 906 until all pixels have been processed. Action 910 provides a second processed image resulting from all AND operations.

Various alternatives and modifications may be suggested by those skilled in the art without departing from the scope of the disclosure. Accordingly, the present invention is intended to cover all such alternatives, modifications and variations.

Additionally, although certain embodiments of the present invention are shown in the drawings and/or discussed herein, it is not intended that the disclosure be limited thereto, as the disclosure is intended to cover the widest possible scope in the art, and the same applies to the description of the invention. Thus, the above description should not be considered by way of limitation, but only as a selection of specific embodiments. Those skilled in the art may suggest other modifications within the scope and spirit of the following.

Claims (30)

the following claims. Other elements, steps, methods and techniques that do not differ materially from those described above and/or in the following claims are also intended to be included within the scope of the disclosure. The embodiments shown in the drawings are presented only to show some examples of the disclosure. The drawings described are for illustration purposes only and not for limitation. In the drawings, for purposes of illustration, the size of some elements may be exaggerated and are not drawn to a specific scale. Additionally, elements shown in the drawings having the same reference numerals may be identical elements or may be similar elements, depending on the context. The term comprising, as used in the present specification and claims, does not exclude the presence of other elements or steps. The use of their names in the singular does not exclude the possibility of their presence in some quantity, unless the contrary is specifically stated. Accordingly, the term containing is not intended to be limited to the elements listed after it; it does not exclude the presence of other elements or steps, and therefore the scope of the expression device comprising elements A and B should not be limited to devices consisting only of components A and B. This expression indicates that, for the purposes of the present disclosure, the only relevant components of the device are A and B. In addition, the terms first, second, third, etc., when used in the specification or claims, are provided to indicate the difference between like elements and not necessarily to indicate sequence in space or time. It should be understood that the terms so used are interchangeable in appropriate circumstances (unless expressly stated to the contrary) and that the embodiments of the disclosure described herein are applicable to sequences and/or configurations other than those described or illustrated herein. CLAIM 1. A device for regulating fluid flow, containing a connecting device (16) configured to be connected to a dropper (4); a support piece (17) operatively connected to the connecting device; an image sensor (11) having a field of view and operatively connected to the support member, the image sensor being positioned to view the dropper in the field of view; a valve (6) configured to be connected to a fluid tube in fluid communication with the dropper, the valve being configured to adjust the flow through the fluid tube to adjust the flow of fluid through the dropper; at least one processor (75) operatively connected to the image sensor to receive image data from it, wherein the at least one processor is configured to: capturing multiple images of the dropper using an image sensor; estimating the rate of volumetric growth of a droplet in a dropper using multiple images; receiving a set value corresponding to the flow rate of fluid through the fluid tube; adjusting the control system in accordance with the estimated rate of volumetric growth of the drop to achieve a given value; and outputting a control signal from the control system to the valve actuator to control activation of the valve in accordance with the adjusted control system. 2. The device according to claim 1, further comprising a non-volatile processor-readable memory where a operative set of processor-executable instructions is stored, wherein the non-volatile processor-readable memory is operatively connected to at least one processor such that the operative set of processor-executable instructions controls operation of at least one processor. 3. The apparatus of claim 1, further comprising a non-volatile processor-readable memory readable by at least one processor, wherein the non-volatile processor-readable memory includes an on-the-fly processor-executable instruction set stored therein, configured to be directed to the at least one processor, at performing: capture multiple images of the dropper using an image sensor; estimate the rate of volumetric growth of a droplet in a dropper using multiple images; accept a predetermined value corresponding to the flow rate of the fluid through the fluid tube; adjust the control system in accordance with the estimated rate of volumetric growth of the drop to achieve a given value; and output a control signal from the control system to the valve actuator to control activation of the valve in accordance with the adjusted control system. 4. The device according to claim 1, in which the device additionally contains a control system, and when - 53 043431 this control system is at least one of a proportional-integral-derivative control system, a proportional-integral control system, a proportional-differential control system, a proportional control system, an integral control system, a neural network-based control system, a fuzzy-based control system logic and/or on/off control system. 5. The apparatus of claim 1, wherein the apparatus further comprises a control system, wherein the control system is configured to correlate the estimated rate of volumetric growth of the droplet with the flow of fluid through the fluid conduit. 6. The device of claim 1, wherein the valve includes an actuator, a curved, elongated support member that is elastically deformable and has first and second ends; and an opposing support member configured to position the fluid conduit opposite the curved, elongated support member between the first and second ends, wherein deformation of the curved, elongated support member by moving the first and second ends toward each other reduces the internal volume of the fluid conduit , and the drive is configured to move the first and second ends towards each other. 7. The device of claim 1, wherein the valve includes an actuator, a first elongated support member defining a length; and a second elongated support member defining a length, wherein the length of the second elongated support member is spaced some distance from the length of the first elongated support member to, in conjunction with the first elongated support member, compress the fluid tube, the actuator being mechanically coupled to at least one of first and second elongated support members for driving the first and second elongate support members towards each other to thereby compress the fluid tube disposed therebetween to adjust the flow rate of the fluid in the fluid tube; wherein activation of the actuator drives the first and second elongated support members to adjust the flow rate of fluid in the tube in accordance with an approximate sigmoidal curve, a Gompertz curve, a generalized logistic function. 8. The apparatus of claim 1, wherein the valve includes an actuator, a first support member that defines at least one of an arc, a plurality of arcs, a curve, a plurality of curves, an arcuate shape, a plurality of arcuate shapes, an S-shape, a C -shaped, convex, multiple convex, concave, and multiple convex; and a second support member disposed at some distance from the first support member to, in conjunction with the first support member, compress the fluid tube over a length of the fluid tube at least substantially greater than the diameter of the fluid tube, the drive being mechanically mated to at least one of the first and second support members to drive the first and second support members toward each other to thereby compress the fluid tube disposed therebetween to adjust the flow rate of the fluid in the fluid tube ; activation of the actuator drives the first and second support members to adjust the flow rate of fluid in the fluid tube in accordance with an approximate nonlinear function. 9. The device according to claim 1, in which the valve contains a curved, elongated support part, elastically deformable and having first and second ends; and an opposite support piece configured to form a pipeline with a curved, elongated support piece. A conduit is formed between the curved, elongated support member and the opposing member, wherein the fluid conduit is disposed in the conduit, and deformation of the curved, elongated support member by moving the first and second ends toward each other reduces the internal volume of the fluid conduit in the conduit. 10. The apparatus of claim 1, wherein the valve is a Bourdon tube check valve coupled to the fluid conduit to regulate fluid flowing through the flow path of the fluid conduit. 11. The device according to claim 1, in which the valve includes an actuator, a first flexible part; and a second flexible member operatively coupled to the first flexible member, wherein a fluid conduit may be disposed between the first and second flexible members, the first and second flexible members being flexible to thereby control the flow rate of fluid passing through the conduit for fluid, and the drive is connected to at least a first end of the first flexible part and a second end of the first flexible part. 12. The device according to claim 1, in which the valve contains an actuator, a first C-shaped part forming an internal and external surface; and a second C-shaped piece defining the inner and outer surfaces, wherein at least one of the outer surface of the first C-shaped piece and the inner surface of the second C-shaped piece is configured to receive a fluid tube, wherein the inner surface the second C-shaped piece is positioned some distance from the outer surface of the first C-shaped piece, and wherein an actuator is coupled to the first and second C-shaped pieces to bend the first and second C-shaped pieces to compress the fluid tube . - 54 043431 13. The device according to claim 1, wherein the valve includes an actuator, a first flexible plate (370); and a second flex plate (371) operatively coupled to the first flex plate. The first and second flexible plates are configured to receive a fluid tube between them. The first and second flexible plates are flexible to thereby adjust the flow rate of fluid passing through the fluid tube, wherein an actuator is connected to the first and second flexible plates to adjust the flow rate of fluid passing through the fluid tube. 14. The device according to claim 1, in which the valve contains an actuator, a first curved part forming an internal and external surface; and a second curved piece defining the inner and outer surfaces. An inner surface of the second curved piece is spaced some distance from the outer surface of the first curved piece, a fluid conduit is disposed between the first and second curved pieces, and an actuator is coupled to the first and second curved pieces to bend the first and second curved pieces. to thereby control the flow of fluid in the fluid tube. 15. The device of claim 1, wherein the valve comprises an actuator, a first curved piece defining an inner and outer surface, the first curved piece having first and second receiving pieces at opposite ends of the first curved piece; and a second curved piece defining the inner and outer surfaces, the second curved piece having first and second fasteners at opposite ends of the second curved piece, the first receiving piece of the first curved piece being configured to mate with the first fastener of the second curved piece, wherein a second receiving member of the first curved piece is configured to mate with a second mounting of the second curved piece, wherein an actuator is coupled to the first and second curved pieces for bending the first and second curved pieces to adjust the flow rate of a fluid in the fluid conduit, located between them. 16. The device of claim 1, wherein the valve comprises an actuator, a first curved, elongated support member (502) that is elastically deformable and has first and second ends; and a second curved, elongated support member (503) elastically deformable and having first and second ends, wherein the second curved, elongated support member is configured to accommodate a fluid tube opposite the first curved, elongated support, wherein deformation of the first and second curved, elongated supports the support members, by moving the first and second ends of the first curved, elongated support member towards each other, reduces the internal volume of the fluid tube; a first connector (506) connected to the first end of the first curved elongated support member and connected to the first end of the second curved elongated support member; a second connector (507) coupled to a second end of the first curved, elongated support member and coupled to a second end of the second curved, elongated support member, the second connector defining an opening (510); a connecting piece (509) having an end (508) attached to the first connector and another end (511) configured to be inserted into an opening of the second connector, the connecting piece defining a threaded rod at least over a portion thereof; and a handwheel (512) having a ratchet (513) configured to incrementally advance toward the connector piece as it moves from the other end of the connector piece to the end of the connector piece, the handwheel being further configured to mate with a threaded rod of the connector piece; wherein the drive is connected to the handwheel for rotating the handwheel. 17. The device according to claim 1, in which the valve includes an actuator, a base (546) defining an opening configured to receive a fluid tube; a plurality of fingers (544), each of which has an end attached to a base; and a ring (545) slidable from the base and along the plurality of fingers. Moving the ring away from the base presses the fingers against the fluid tube. The ring is made with the possibility of frictional fixation on multiple fingers. The drive is attached to the ring to slide the ring. 18. The device according to claim 1, in which the valve comprises an actuator, a conical-shaped part (549) having a surface for wrapping a fluid tube around it; and a mating piece (550) configured to mate with the conical shaped piece to compress the tube, the actuator being configured to press the conical shaped piece against the mating piece to thereby compress the fluid tube. 19. The device according to claim 1, wherein the device further comprises a control system, and wherein the control system is implemented in hardware. 20. The device of claim 1, wherein the device further comprises a control system, and wherein the control system is implemented by at least one operational amplifier. 21. The device according to claim 1, additionally containing an immutable processor-readable memory, in which: the control system is implemented by means of an operational set of processor- - 55 043431 executable instructions configured for execution by at least one processor, the operative set of processor-executable instructions is stored in non-volatile processor-readable memory, and the non-volatile processor-readable memory is operatively coupled to at least one processor for operative transfer of the operative set of processor-executable instructions to at least one processor for execution by at least one processor. 22. The apparatus of claim 1, wherein the set point is compared to the droplet volumetric growth rate to adjust the control system, wherein the setpoint may be compared to the droplet volumetric growth rate to determine an error signal, wherein the error signal may be a difference between the setpoint and the rate volumetric droplet growth, wherein the error signal may be passed through a signal processing device to generate an output signal, wherein the signal processing device may implement a proportional-integral-derivative controller with at least one non-zero gain parameter. 23. The apparatus of claim 1, wherein the at least one processor determines the presence of a free flow condition using the plurality of images. 24. The device according to claim 23, further comprising a background pattern (19) located in the field of view of the image sensor, the dropper being located between the image sensor and the background pattern. 25. The apparatus of claim 24, wherein the at least one processor estimates the at least one parameter using a set of image data from the image sensor by analyzing background distortion caused by liquid in the field of view as observed by the image sensor. 26. The apparatus of claim 25, wherein the background pattern is an array of lines (85) having at least one angle relative to the dropper opening when viewed from the image sensor in the field of view using the image data set. 27. The apparatus of claim 26, wherein the at least one processor determines that a free-flow condition exists when the fluid causes the line array to change angles due to distortion caused by the fluid for which the free-flow condition is satisfied when viewed in the first field of view. from the image sensor. 28. The device of claim 1, wherein the at least one processor is configured to: select an area of interest from the image sensor; determine whether a pixel of the image sensor is located in a region of interest; activate the backlight light source (18) if the image sensor pixel is in the area of interest, and expose the image sensor pixel. 29. The device of claim 1, further comprising a light source coupled to the support member and configured to illuminate the image sensor to expose the image sensor such that a field of view of the image sensor at least partially displays at least a portion of the dropper, wherein at least one processor is configured to: capturing an image including an image of the dropper using an image sensor comprising a field of view including a dropper camera; subtract the image from the background image to thereby generate a difference image; convert each pixel of the difference image to a value of true if the absolute value of the corresponding pixel is beyond a predetermined threshold, or to a value of false if the absolute value of the corresponding pixel is less than a predetermined threshold; sum each row of the transformed difference image to generate a plurality of sum values, each sum value of the plurality of sum values corresponding to a corresponding row of the transformed difference image; and check multiple total values. 30. The device of claim 1, wherein the at least one processor is configured to: capture an image of the dropper; placing the pattern in the captured image at a first position; averaging the pixels in the template to determine a first average; moving the template to the second position; averaging the pixels in the template to determine a second average; determining that the pattern is located at the boundary of the droplet if the difference between the second average and the first average is greater than a predetermined threshold value; and correlation of the second position with the volume of the drop. -