Systems, methods and devices for monitoring, regulating or controlling fluid flow

Abstract

The present invention relates to systems, methods and devices for monitoring, regulating or controlling the flow of fluid. The device includes a flow sensor and a valve. The flow sensor uses an image to estimate the flow through an infusion chamber and then controls the valve based on the estimated flow. The valve includes a rigid housing that is arranged around a tube in which the flow of fluid is controlled. An increase in pressure in the housing controls the size of the lumen within the tube by deforming the tube, thereby controlling the flow through the tube.

Description

[0001] This application is a divisional application of the patent application with application number 202010020852.2 filed on January 9, 2020, and the invention name is “System, method and device for monitoring, regulating or controlling fluid flow”. The divisional application with application number 202010020852.2 is a divisional application of the patent application with application number 201480023329.8 (PCT / US2014 / 029020) filed on October 23, 2015, with the international application date of March 14, 2014, and the invention name is “System, method and device for monitoring, regulating or controlling fluid flow”. Technical Field

[0002] The present disclosure relates to monitoring, regulating or controlling fluid flow. More specifically, the present disclosure relates to a system, method and apparatus for monitoring, regulating or controlling fluid flow, such as for use in medical applications, such as, for example, medical applications including, intravenous infusion therapy, dialysis, infusion therapy, peritoneal infusion therapy, bolus delivery, enteral nutrition therapy, parenteral nutrition therapy, hemoperfusion therapy, fluid resuscitation therapy, or insulin delivery. Background Art

[0003] In many medical settings, a common mode of medical treatment includes delivering fluids to a patient, such as a human, animal, or pet. The need may arise to deliver fluids to a patient quickly, to deliver fluids to a patient accurately, and / or to deliver fluids to a patient slowly. Saline and lactated Ringer's are examples of commonly used fluids. These fluids can be used to maintain or increase blood pressure and promote adequate perfusion. In a shock-trauma setting or in septic shock, fluid resuscitation is often the treatment of choice to maintain or increase blood pressure.

[0004] The delivery of liquid to the patient can be facilitated by utilizing a gravity feed line (or tube) inserted into the patient. Typically, a reservoir (e.g., an IV bag) is suspended on a rod and communicated with a fluid tube. The fluid tube is sometimes coupled to a drip chamber for capturing air and estimating fluid flow. Below the fluid tube, there may be a manually actuated valve for regulating fluid flow. For example, by counting the droplets formed in the drip chamber over a certain amount of time, a caregiver can calculate the flow through the drip chamber and adjust the valve (if necessary) to obtain a desired flow.

[0005] Certain treatments require that the fluid delivery system strictly adhere to the flow rate set by the caregiver. Typically, these applications use infusion pumps, but these infusion pumps may not be used in all situations or environments. Summary of the invention

[0006] Briefly summarized, the present disclosure relates to systems, methods, and devices for monitoring, regulating, or controlling fluid flow, e.g., for use in medical applications such as, among others, intravenous therapy, dialysis, infusion therapy, peritoneal therapy, bolus delivery, enteral nutrition therapy, parenteral nutrition therapy, hemoperfusion therapy, fluid resuscitation therapy, or insulin delivery. More specifically, the present disclosure relates to a fluid flow meter for monitoring the flow of a fluid associated with a patient, a valve for regulating the flow of a fluid associated with a patient, and / or a fluid flow meter coupled to a valve (e.g., arranged in a closed loop, open loop, or feedback configuration) to monitor, regulate, and / or control the use of a fluid associated with a patient.

[0007] In some embodiments of the present disclosure, a fluid flow meter includes one or more optical sensors for monitoring fluid flow in a tube, for example, using an image sensor to monitor droplets in a drip chamber attached to the tube. The flow meter can be a stand-alone application device, can be combined with a pump or valve or both, and / or can be used to provide feedback to any electronic device. The flow meter can be remotely controlled, for example, by a monitoring client, a remote communication device, a smart phone, a computer, etc. The flow meter can measure average flow, instantaneous flow, droplet volume, droplet growth rate, or other parameters related to fluid flow.

[0008] The flow meter can use the flow rate or parameter related to fluid flow to perform: (1) display the flow rate or parameter on a screen, (2) provide feedback such as the flow rate or parameter related to fluid flow (wirelessly or via a wire) to an infusion pump such as a peristaltic pump, (3) provide feedback to a monitoring client or a remote monitoring client such as a smartphone, (4) issue an alarm when the flow rate or parameter related to fluid flow is outside a predetermined range, (5) issue an alarm when the flow rate or parameter related to fluid flow is above a predetermined threshold, (6) issue an alarm when free flow is detected, (7) communicate an alarm to a pump, a monitoring client or a remote monitoring client, (8) instruct a valve to stop fluid flow when free flow is detected, an alarm is issued, and / or the flow rate or parameter related to fluid flow is above a threshold or outside a predetermined range, and / or (9) broadcast the flow rate or parameter related to fluid flow.

[0009] In some embodiments described herein, a valve regulates the flow of fluid associated with a patient. The valves disclosed herein can be manually actuated or actuated with an actuator (or both). The valve can be used with or without a pump, can be used with or without a flow meter, and / or can be a stand-alone device. The valve can be remotely controlled, for example, by a monitoring client, a remote communication device, a smart phone, a computer, etc. The valve can compress the tube along a portion that is significantly larger than the diameter of the tube, for example, more than two times, more than five times, more than ten times, etc.

[0010] The valve may be made of two or more parts that compress the tube, or a single part that compresses the tube as the part moves or deforms. The two or more parts and / or the single part may be made using injection molding, ultrasonic welding, using multiple parts that are bonded or molded together, etc. Each of the two or more parts may be made of one or more sub-components that are either permanently or temporarily attached to each other. A single part may be made of one or more sub-components that are either permanently or temporarily coupled together, for example using ultrasonic welding, bonding, locking or other techniques. The parts may be plastic, metal, alloy, polymer or other materials.

[0011] In some embodiments of the present disclosure, a flow meter is coupled to a valve to regulate fluid flow, such as into a patient. A flow meter coupled to a valve can be used with a pump (e.g., a peristaltic infusion pump), or can be used without a pump (e.g., the flow meter can replace the function of a peristaltic pump). The combination of a flow meter and a valve can be remotely controlled, such as by a monitored client, a remote communication device, a smart phone, a computer, etc., or can be remotely monitored. A monitoring client can control a flow meter or a valve, can be a relay between a flow meter and a valve, can monitor the operation of a flow meter or a valve, can communicate information related to a flow meter or a valve to a server, and / or can be not used in the system.

[0012] The flow meter may directly or indirectly monitor fluid flow and make adjustments to a valve or pump (e.g., an infusion pump) directly or indirectly. The flow meter may alarm when it detects a free flow condition, determine whether the flow meter is greater than a predetermined threshold or outside a predetermined range, and / or detect any abnormal behavior. In response to an alarm or condition, the flow meter may cause the flow meter to stop fluid flow, instruct a valve to stop fluid flow, instruct a safety valve to stop fluid flow, notify a monitoring client or remote communication device, broadcast the detected condition, or execute a predefined routine or predefined algorithm.

[0013] In certain embodiments of the present disclosure, a device for regulating fluid flow includes a curved, elongated support member and an opposing support member. The curved, elongated support member is elastically deformable and has a first end and a second end. The opposing support member is configured to position a tube against the curved, elongated support member between the first end and the second end such that deformation of the curved, elongated support member by moving the first end and the second end toward each other reduces the internal volume of the tube. The opposing support member can be another curved, elongated support member.

[0014] The device may include an actuator coupled to the curved elongated support member to deform the curved elongated support member by being driven by the actuator to move the first end and the second end toward each other. In some such embodiments, the actuator may be a screw and a knob that may be coupled to the screw to drive the screw.

[0015] The actuator, the curved elongated support member, and the opposing support member can be configured to regulate fluid flow by actuation of the actuator according to a Gompertz curve. In some embodiments, the actuator can be further configured to actuate the first end and the second end toward each other along a predetermined portion of the Gompertz curve. For example, the actuator can actuate the actuator only along a portion of the actuatable range of the curved elongated support member and the opposing support member.

[0016] The actuator, the curved elongated support member and the opposing support member may be configured to regulate fluid flow by actuation of the actuator according to an S-shaped curve. The actuator may be further configured to actuate the first end and the second end toward each other along a predetermined portion of the S-shaped curve.

[0017] The curved elongated support member may be semi-rigid and / or may consist essentially of a stretchable material. The curved elongated support member may be an arcuate elongated support member, and / or may be a C-shaped support member.

[0018] The device may further include an elongated connecting member operatively coupled to the first and second ends of the curved elongated support member.

[0019] In certain embodiments of the present disclosure, a device may include an actuator coupled to the elongated connecting member and the curved elongated support member to apply an outward expansion force to thereby deform the first and second ends of the curved elongated support member toward each other.

[0020] In certain embodiments of the present disclosure, a curved elongated support member is arranged along a substantial portion thereof approximately parallel to another curved elongated support member. For example, the curved elongated support member defines a length, and the other curved elongated support member defines a length, and the length of the other curved elongated support member is arranged approximately parallel to the length of the curved elongated support member.

[0021] In certain embodiments of the present disclosure, the apparatus includes an actuator that is operatively coupled to the curved elongated support member at a first end and a second end, and to another curved elongated support member at a first end and a second end. Actuation of the actuator causes the first end and the second end of the curved elongated support member to approach each other, and also causes the first end and the second end of the other curved elongated support member to approach each other to thereby cause a reduction in the distance between the curved elongated support member and the other curved elongated support member to thereby compress the tube.

[0022] In certain embodiments of the present disclosure, the curved, elongated support member defines a length, and the opposing support members are disposed orthogonally from the length along a portion thereof.

[0023] In certain embodiments of the present disclosure, a curved, elongated support member includes a plurality of ridges disposed thereon to engage the tube.

[0024] In certain embodiments of the present disclosure, the opposing support members include a plurality of ridges disposed thereon to engage the tube.

[0025] In certain embodiments of the present disclosure, the curved elongated support member includes a flange extending from a section thereof configured to hold a tube. The opposing support member may include another flange extending from a section thereof configured to hold a tube such that the flange and the other flange are substantially parallel to each other and, when the tube is disposed therebetween, to a central axis defined by the tube.

[0026] In certain embodiments of the present disclosure, a device for regulating fluid flow includes a first elongated support member, a second elongated support member, and an actuator. The first elongated support member defines a section, and the second elongated support member also defines a free section thereof, so that a section of the second elongated support member is arranged in a spaced relationship with a section of the first elongated support member to cooperate with the first elongated support member to compress a tube. The actuator is mechanically engaged with at least one of the first elongated support member and the second elongated support member to push the first elongated support member and the second elongated support member toward each other to thereby compress the tube arranged therebetween to regulate the flow of fluid in the tube, so that the driving of the actuator causes the first elongated support member and the second elongated support member to actuate according to an approximate S-shaped curve to regulate the flow of fluid in the tube.

[0027] The length of the second elongated support member may be arranged substantially parallel to the length of the first elongated support member. The first elongated support member and the second elongated support member may be configured to cooperate with each other to compress the tube along a length of the tube that is at least significantly greater than the diameter of the tube. The actuator may be configured to drive the first elongated support member and the second elongated support member along a predetermined portion of the S-shaped curve to compress the tube to regulate fluid flow within the tube.

[0028] In certain embodiments of the present disclosure, a device for regulating fluid flow includes: a first elongated support member and a second elongated support member. The first elongated support member defines a length and the second elongated support member defines a length. A length of the second elongated support member is arranged in a spaced relationship with a length of the first elongated support member to cooperate with the first elongated support member to compress a tube. An actuator is mechanically engaged with at least one of the first elongated support member and the second elongated support member to push the first elongated support member and the second elongated support member toward each other to thereby compress the tube arranged therebetween to regulate the flow of fluid in the tube such that driving of the actuator causes the first elongated support member and the second elongated support member to actuate according to an approximate Gompertz curve to regulate the flow of fluid in the tube.

[0029] The length of the second elongated support member may be arranged generally parallel to the length of the first elongated support member.The first elongated support member and the second elongated support member may be configured to cooperate with each other to compress the tube along a length that is at least significantly greater than the diameter of the tube.

[0030] The actuator may be configured to drive the first elongated support member and the second elongated support member according to a predetermined portion of the Gompertz curve to compress the tube to regulate fluid flow within the tube.

[0031] In certain embodiments of the present disclosure, a device for regulating fluid flow includes a first elongated support member and a second elongated support member. The first elongated support member defines a length, and the second elongated support member defines a length such that the length of the second elongated support member is arranged in a spaced relationship with the length of the first elongated support member to cooperate with the first elongated support member to compress a tube. An actuator is mechanically engaged with at least one of the first elongated support member and the second elongated support member to drive the first elongated support member and the second elongated support member to press against each other to thereby compress the tube disposed therebetween to regulate the flow of fluid in the tube such that the driving of the actuator causes the first elongated support member and the second elongated support member to actuate according to an approximate generalized logistic function to regulate the flow of fluid in the tube.

[0032] A length of the second elongated support member may be arranged substantially parallel to a length of the first elongated support member. The first elongated support member and the second elongated support member may be configured to cooperate with each other to compress the tube along a length of the tube that is at least significantly greater than the diameter of the tube. The actuator may be further configured to drive the first elongated support member and the second elongated support member according to a predetermined portion of a generalized logistic function to compress the tube to adjust fluid flow within the tube.

[0033] In certain embodiments of the present disclosure, a device for regulating fluid flow includes a first support member, a second support member, and an actuator. The first support member forms at least one of an arc, multiple arcs, a bend, multiple bends, an arch, multiple arches, an S-shape, a C-shape, a convex shape, multiple convex shapes, a concave shape, and multiple concave shapes. The second support member is arranged in a spaced relationship with the first support member to cooperate with the first support member so as to compress the tube along a section of the tube that is at least significantly larger than the diameter of the tube. The actuator is coupled to at least one of the first support member and the second support member to drive the first support member and the second support member to press against each other to thereby compress the tube arranged therebetween to regulate the flow of fluid in the tube so that the driving of the actuator causes the first support member and the second support member to actuate according to an approximate nonlinear function to regulate the flow of fluid in the tube.

[0034] The approximated nonlinear function may be an approximated generalized logistic function, an approximated S-curve, and / or an approximated Gompertz curve.The actuator may be configured to actuate to thereby regulate the fluid flow within the tube according to a predetermined portion of the approximated nonlinear function.

[0035] In certain embodiments of the present disclosure, the first support member forms an arc, has a shape substantially consisting of an arc, forms multiple arcs, has a shape substantially consisting of multiple arcs, forms a curve, has a shape substantially consisting of a curve, forms multiple curves, has a shape substantially consisting of multiple curves, forms an arch, has a shape substantially consisting of an arch, forms multiple arches, has a shape substantially consisting of multiple arches, forms an S-shape, has a shape substantially consisting of an S-shape, forms a C-shape, has a shape substantially consisting of a C-shape, forms a convex shape, has a shape substantially consisting of a convex shape, forms multiple convex shapes, has a shape substantially consisting of multiple convex shapes, forms a concave shape, has a shape substantially consisting of a concave shape, forms multiple concave shapes, and / or has a shape substantially consisting of multiple concave shapes.

[0036] The length of the second support member may be arranged approximately parallel to the length of the first support member.The first support member and the second support member may be configured to cooperate with each other to compress the tube along a length of the tube that is at least substantially greater than a diameter of the tube.

[0037] In certain embodiments of the present disclosure, a device for regulating fluid flow includes a curved, elongated support member and an opposing support member. The curved, elongated support member is elastically deformable and has a first end and a second end. The opposing support member is configured to define a conduit with the curved, elongated support member, so that the conduit is defined between the curved, elongated support member and the opposing member. The deformation of the curved, elongated support member caused by the movement of the first end and the second end toward each other reduces the internal volume of the conduit. In some embodiments, the conduit can be configured to receive a tube. In other embodiments, the conduit is fluidically sealed, and the device further includes a first port and a second port in fluid communication with the conduit, so that each port is suitable for coupling to the tube.

[0038] In certain embodiments of the present disclosure, a system for regulating fluid flow includes a flexible tube and an inverted Bourdon tube valve. The flexible fluid tube has a fluid path and is configured to allow fluid to pass through it. The inverted Bourdon tube valve is coupled to the flexible fluid tube to regulate fluid flowing through the fluid path of the flexible fluid tube. An actuator can be coupled to the inverted Bourdon tube valve to actuate the inverted Bourdon tube valve to regulate fluid flowing through the fluid path of the flexible fluid tube. The inverted Bourdon tube valve works in a manner opposite to the Bourdon tube, where deformation of the fluid path causes a change in fluid flow and non-fluid flow causes deformation of the fluid path.

[0039] In certain embodiments of the present disclosure, a system for regulating fluid flow includes a fluid tube, a valve, and an actuator. The fluid tube defines a fluid path configured to allow fluid to pass through it. The valve is operatively coupled to the fluid tube and includes first and second flexible members. The second flexible member is operatively coupled to the first flexible member. The fluid tube is arranged between the first and second flexible members, and the first and second flexible members are configured to flex to thereby regulate the flow of fluid through the fluid tube. The actuator is coupled to at least a first end of the first flexible member and a second end of the first flexible member. The actuator can be a lead screw and there may be a motor coupled to the lead screw to rotate the lead screw.

[0040] In certain embodiments of the present disclosure, the system may include a knob coupled to the lead screw such that the knob is configured to rotate the lead screw. The knob may be engaged by an actuator driven by a motor.

[0041] In certain embodiments of the present disclosure, an actuator is coupled to a first end of a first flexible member and a second end of the first flexible member, and the actuator is configured to at least one of flex the first end and the second end toward each other and flex the first end and the second end away from each other. The actuator may flex the first end and the second end away from each other, and / or the actuator flexes the first and second flexible members so that the first end and the second end approach each other. The first and second flexible members may be generally rectangular. When the actuator stops applying force, the first member and / or the second member may be tensioned to at least substantially stop the fluid flow.

[0042] The system may include a flow meter coupled to the drip chamber coupled to the fluid tube such that the flow meter estimates fluid flow through the drip chamber and thus also estimates fluid flow through the fluid tube. The flow meter may be an image sensor based flow meter.

[0043] The flow meter may be operatively coupled to the motor to actuate the valve, and the system may include a control component to control the motor to actuate the valve to achieve a desired flow rate as estimated by the flow meter.

[0044] In certain embodiments of the present disclosure, a device for regulating fluid flow includes first and second C-shaped members. The first C-shaped member defines an inner surface and an outer surface, and the second C-shaped member defines an inner surface and an outer surface. At least one of the outer surface of the first C-shaped member and the inner surface of the second C-shaped member is configured to receive a tube. The inner surface of the second C-shaped member is arranged to be spaced apart from the outer surface of the first C-shaped member. In some specific embodiments, a large area of ​​the inner surface of the second C-shaped member can be close to the outer surface of the first C-shaped member.

[0045] In certain embodiments of the present disclosure, the second C-shaped member is flexible and the first C-shaped member is semi-rigid, rigid, and / or elastomeric.

[0046] The flexible member may be formed of a material selected from the group consisting of plastics, polymers, monomers, polypropylene, thermoplastic polymers, ceramics, polyvinyl chloride, and polyethylene.

[0047] In certain embodiments of the present disclosure, a device for regulating fluid flow includes first and second flexible sheets. The second flexible sheet is operatively coupled to the first flexible sheet. The first and second flexible sheets are configured to receive a fluid tube between them, and the first and second flexible sheets are also configured to flex to thereby regulate the flow of fluid through the fluid tube.

[0048] The device may include an actuator coupled to the first end of the first flexible sheet and the second end of the first flexible sheet. The actuator may be configured to at least one of flex the first end and the second end toward each other and flex the first end and the second end away from each other.

[0049] The device may include a lead screw and a knob, the lead screw coupled to the first end of the first flexible sheet and the second end of the first flexible sheet, the knob coupled to the lead screw so that rotation of the knob rotates the lead screw. The knob may be configured to engage with a motor-driven actuator so that the motor-driven actuator actuates the knob.

[0050] In certain embodiments of the present disclosure, a device for regulating fluid flow includes first and second curvilinear members. The first curvilinear member defines an inner surface and an outer surface, and the second curvilinear member also defines an inner surface and an outer surface. The inner surface of the second curvilinear member is arranged in a spaced relationship with the outer surface of the first curvilinear member.

[0051] At least one of the first and second curved members may be configured to position the fluid tube between them. The first curved member may be at least one of semi-rigid and rigid. The second curved member may be flexible. The second curved member may include an elastomer. The first and second curved members may be flexible.

[0052] The device may include a connecting member that operatively couples a first end of the first curvilinear member and at least one of a first end of the second curvilinear member, such that the connecting member is also operatively coupled to at least one of a second end of the first curvilinear member and a second end of the second curvilinear member. The connecting member may be flexible, may be rigid, and / or may be semi-rigid.

[0053] The device may include an actuator positioned between the connecting member and the second curvilinear member to apply a force between the connecting member and the second curvilinear member when actuated. The actuator may be a lead screw.

[0054] In certain embodiments of the present disclosure, a device for regulating fluid flow includes a first curvilinear member and a second curvilinear member. The first curvilinear member defines an inner surface and an outer surface. The first curvilinear member has a first receiving member and a second receiving member at both ends of the first curvilinear member. The second curvilinear member defines an inner surface and an outer surface. The second curvilinear member has a first fastener and a second fastener at both ends of the second curvilinear member. At least one of the first fastener and the second fastener can be a hook. The first receiving member of the first curvilinear member is configured to engage the first fastener of the second curvilinear member, and the second receiving member of the first curvilinear member is configured to engage the second fastener of the second curvilinear member.

[0055] At least one of the receiving members may be configured as a cylindrical member, such as a barrel nut, for coupling to the hook.

[0056] At least one of the receiving members may be operatively coupled to an actuator.One or more of the receiving members may be operatively coupled to a motor.

[0057] In certain embodiments of the present disclosure, the device 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 an outer surface thereof; (2) the second receiving member defines a threaded hole configured to receive the shaft; and (3) when the motor rotates the rotor to thereby rotate the shaft, the threaded hole and the shaft cooperate together to achieve at least one of increasing or decreasing the distance between the first receiving member and the second receiving member.

[0058] In certain embodiments of the present disclosure, an apparatus for regulating fluid flow includes a first curved elongated support member and a second curved elongated support member. The first curved elongated support member is elastically deformable and has a first end and a second end. The second curved elongated support member is elastically deformable and has a first end and a second end. The second curved elongated support member is configured to position a tube against the first curved elongated support member so that deformation of the first curved elongated support member and the second curved elongated support member caused by movement of the first end and the second end of the first curved elongated support member toward each other reduces the internal volume of the tube.

[0059] The first connector is coupled to the first end of the first curved elongated support member and is also coupled to the first end of the second curved elongated support member. The second connector is coupled to the second end of the first curved elongated support member and is also coupled to the second end of the second curved elongated support member. The second connector defines a hole. The connecting member has one end coupled to the first connector and the other end configured to be inserted into the hole of the second connector. The connecting member defines a threaded rod at least along a portion thereof. The knob has a ratchet configured to ratchet to the connector member when moving from the other end of the connecting member toward one end of the connector member. The knob is further configured to engage the threaded rod of the connecting member. The knob may include a plurality of fingers configured to engage the threaded rod of the connecting member. The knob defines an outer periphery and includes a hole defined at the center of the outer periphery of the knob. The hole is configured to receive the threaded rod. Each of the plurality of fingers is an arc to engage the threaded rod at a corresponding end of each of the plurality of fingers.

[0060] The first curved elongated support member defines a first aperture adjacent to a first end of the first curved elongated support member. The aperture is configured to hold a fluid tube.

[0061] The first curved elongated support member may define a first groove adjacent to the first end of the first curved elongated support member, such that the groove is configured to receive the fluid tube. The groove may include a neck configured to receive the fluid tube and a circular area configured to retain the fluid tube.

[0062] In certain embodiments of the present disclosure, a device for regulating fluid flow includes a base, a plurality of fingers, and a ring. The base defines a hole configured to receive a fluid tube. The plurality of fingers each have an end coupled to the base. The ring is configured to slide from the base and along the plurality of fingers. Movement of the ring away from the base and toward the fingers compresses the fingers against the tube. The ring is configured to frictionally lock against the plurality of fingers. Each finger includes an elongated end coupled to the base and a curved end coupled to an opposite end relative to the base.

[0063] In certain embodiments of the present disclosure, a device for regulating fluid flow includes a conical member, a supplementary member, and an actuator. The conical member has a surface for wrapping a tube around it. The supplementary member is configured to engage the conical member so as to compress the tube. The actuator is configured to compress the conical member against the supplementary member to thereby compress the tube.

[0064] In certain embodiments of the present disclosure, an intravenous administration device includes: a flexible tube for guiding a fluid flow therein; a first port at a first end of the flexible tube; a second port at a second end of the flexible tube; a curved, elongated support member that is elastically deformable and has a first end and a second end; and an opposing support member that is configured to position the flexible tube against the curved, elongated support member between the first end and the second end, such that deformation of the curved, elongated support member caused by movement of the first end and the second end toward each other reduces the internal volume of the tube.

[0065] The intravenous administration device may further include: a drip chamber coupled to the flexible tube; another port, which is configured to receive a syringe for injecting fluid into the fluid flow in the flexible tube, and / or a sliding occluder coupled to the flexible tube, which is configured to engage the flexible tube to block the fluid flow therein.

[0066] The first end of the curved, elongated support member may define a first aperture to receive the flexible tube, and the second end of the curved, elongated support member may define a second aperture to receive the flexible tube.

[0067] In certain embodiments of the present disclosure, a flow meter includes a coupler, a support member, a first image sensor and a second image sensor, and at least one processor. The coupler is adapted to be coupled to a drip chamber. The support member is operatively coupled to the coupler. 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 drip chamber within the first field of view. The second image sensor has a second field of view and is operatively coupled to the support member. The second image sensor is positioned to observe the drip chamber within the second field of view.

[0068] At least one processor is operatively coupled to the first image sensor and the second image sensor. The at least one processor receives first image data from the first image sensor and second image data from the second image sensor, and the at least one processor uses the first image data and the second image data to estimate at least one parameter of the liquid in the drip chamber.

[0069] The at least one parameter may be one of a type of formation of the liquid, a volume of the liquid, and a shape of the liquid.The at least one processor may use at least one of the first set of image data and the second set of image data to determine the presence of a free flow condition.

[0070] The flow meter may further include a background pattern positioned within the field of view of the first image sensor such that the drip chamber is between the first image sensor and the background pattern.

[0071] At least one processor of the flow meter may use the first set of image data to estimate at least one parameter by analyzing deformation of a background pattern caused by liquid 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 an opening of the drip chamber when viewed from the first image sensor in the first field of view using the first set of image data.

[0072] When in a free flow condition as viewed from the first image sensor within the first field of view, the at least one processor may determine that a free flow condition exists when the liquid causes the line array to change angles due to liquid-induced deformation.

[0073] At least one processor may compare at least one of the first image data and the second image data with a background image to estimate at least one parameter.

[0074] At least one processor may compare at least one of the first image data and the second image data with a background image by calculating at least one of: a difference between at least one of the first image data and the second image data and the background image, an absolute difference between at least one of the first image data and the second image data and the background image, and / or a squared absolute difference between at least one of the first image data and the second image data and the background image.

[0075] The flow meter may include a non-transitory processor-readable memory in operable communication with at least one processor, such that the memory stores an operational processor-executable instruction set configured for execution by the at least one processor. The operational processor-executable instruction set, when executed by the at least one processor, controls the operation of the at least one processor.

[0076] In certain embodiments of the present disclosure, the flow meter includes a coupler, a support member, a background pattern, and at least one processor. The coupler is adapted to be coupled to a drip chamber. The support member is operatively coupled to the coupler. The image sensor has a field of view and is operatively coupled to the support member. The image sensor is positioned to observe the drip chamber within the field of view. The background pattern is positioned within the field of view of the image sensor. The background pattern is positioned so that the drip chamber is between the background pattern and the image sensor. At least one processor is operatively coupled to the image sensor to receive image data therefrom. At least one processor is configured to estimate at least one parameter of the liquid within the drip chamber using a deformation of the background pattern caused by the liquid as indicated by the image data. The deformation is visible by the image sensor within the field of view of the image sensor. The at least one parameter is at least one of a type of formation of the liquid, a volume of the liquid, and a shape of the liquid. The background pattern may be a line array having at least one angle relative to an opening of the drip chamber when viewed from the image sensor using the image data.

[0077] The at least one processor may determine the presence of a free flow condition using deformation of a background pattern caused by the liquid as indicated by the image data. When in a free flow condition as observed within the field of view of the image sensor, the at least one processor may determine that a free flow condition exists when the liquid causes the line array to change angles due to the deformation caused by the liquid.

[0078] The flow meter may further include a non-transitory processor-readable memory in operable communication with the at least one processor. The non-transitory processor-readable memory may store an operable processor-executable instruction set configured for execution by the at least one processor such that the operable processor-executable instruction set, when executed by the at least one processor, controls the operation of the at least one processor.

[0079] In certain embodiments of the present disclosure, the flow meter includes a coupler, a support member, an image sensor, and at least one processor. The coupler is adapted to be coupled to a drip chamber. The support member is operatively coupled to the coupler. The image sensor has a field of view and is operatively coupled to the support member so that the image sensor is positioned to observe the drip chamber within the field of view. At least one processor is operatively coupled to the image sensor to receive image data therefrom so that the at least one processor compares an image of the image data with a reference image to estimate at least one parameter of the liquid in the drip chamber. 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 pixel of the image multiplied by a second constant.

[0080] The flow meter may include a non-transitory processor-readable memory in operable communication with at least one processor. The non-transitory processor-readable memory may include an operable processor-executable instruction set configured for execution by the at least one processor such that the operable processor-executable instruction set, when executed by the at least one processor, controls the operation of the at least one processor.

[0081] In certain embodiments of the present disclosure, a method for exposing an image sensor implemented by an operable processor-executable instruction set configured for execution by at least one processor includes: selecting a region of interest; determining whether a pixel is within the region of interest; if the pixel is within the region of interest, activating lights of a backlight source; and exposing the pixel. The activation action may activate a subgroup of lights, the subgroup including the lights of the backlight source. The lights of the backlight source may form a uniform backlight source. The image sensor may include a region of interest and a pixel.

[0082] A set of operable processor-executable instructions may be stored on a non-transitory processor-readable memory in operable communication with at least one processor, enabling the at least one processor to perform the method.

[0083] At least one processor may be coupled to the image sensor such that the at least one processor performs the method using the image sensor. The region of interest may be a region of the image sensor that images the drip chamber. The region of interest may correspond to the drip chamber.

[0084] The method may further include: receiving a vertical synchronization signal from the image sensor; and receiving a horizontal synchronization signal from the image sensor. The at least one processor may receive the vertical synchronization signal and the horizontal synchronization signal from the image sensor. The at least one processor may activate a lamp of the backlight source according to at least one of the vertical synchronization signal and the horizontal synchronization signal. The lamp may be a light emitting diode.

[0085] In certain embodiments of the present disclosure, the flow meter includes a coupler, a support member, an image sensor, a backlight, and at least one processor. The coupler is adapted to be coupled to a drip chamber. The support member is operatively coupled to the coupler. The image sensor has a field of view and is operatively coupled to the support member such that the image sensor is positioned to observe the drip chamber within the field of view. The backlight has at least one lamp. The backlight is coupled to the support member such that the backlight is adapted to illuminate the image sensor to expose the image sensor. The field of view of the image sensor at least partially images at least a portion of the drip chamber. At least one processor is operatively coupled to the image sensor to receive image data therefrom.

[0086] 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 within the region of interest; activate a light of a backlight source if the pixel of the image sensor is within the region of interest; and expose the pixel of the image sensor.

[0087] The flow meter may further include a non-transitory processor-readable memory readable by at least one processor. The non-transitory processor-readable memory includes an operable processor-executable instruction set stored thereon, the operable processor-executable instruction set being configured to cause the 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 within the region of interest; if the pixel of the image sensor is within the region of interest, activate a light of a backlight source; and expose the pixel of the image sensor. The at least one processor may be further configured to: receive a vertical synchronization signal from the image sensor; and receive a horizontal synchronization signal from the image sensor. The at least one processor may activate the light of the backlight source according to at least one of the vertical synchronization signal and the horizontal synchronization signal.

[0088] At least one processor can select a region of interest and determine whether a pixel of the image sensor is within the region of interest based on the image data. The region of interest is a region of the image sensor that images the drip chamber. The region of interest can correspond to the drip chamber.

[0089] At least one processor may activate a subgroup of lamps, the subgroup comprising the lamps of the backlight source. The lamps of the backlight source may form a uniform backlight source.

[0090] In certain embodiments of the present disclosure, a method includes: taking an image including an image of a drip chamber using an image sensor having a field of view including the drip chamber; subtracting the image from a background image to thereby generate a difference image; converting each pixel of the difference image to a true value if the absolute value of the corresponding pixel exceeds a predetermined threshold, or converting each pixel of the difference image to a false value if the absolute value of the corresponding pixel is less than the predetermined threshold; summing each row of the converted difference image to generate a plurality of sum values, wherein each sum value in the plurality of sum values ​​corresponds to the converted difference image of the corresponding row; and checking the plurality of sum values. The method may be implemented by an operable processor-executable instruction set stored in a non-transitory processor-readable memory in operable communication with at least one processor, so that the at least one processor performs the method.

[0091] The act of checking the plurality of sum values ​​may include determining whether a free flow condition exists within the drip chamber.

[0092] The act of determining whether a free flow condition exists may include determining whether the plurality of sum values ​​includes a plurality of consecutive sum values ​​above another predetermined threshold.

[0093] The act of checking the plurality of sum values ​​may include determining whether a drop has formed within the drip chamber.

[0094] The act of determining whether a drop has been formed in the drip chamber may include determining whether the plurality of sum values ​​includes a plurality of consecutive sum values ​​within a predetermined range that is greater than a minimum value and less than a maximum value.

[0095] The method may optionally include smoothing the plurality of sum values ​​prior to the checking act. The smoothing act may be based on at least one of a spline function, a cubic spline function, a B-spline function, a Bezier spline function, a polynomial interpolation, a moving average, a data smoothing function, and a cubic spline type function.

[0096] The at least one processor may optionally be coupled to the image sensor, and the at least one processor may perform the method using the image sensor.

[0097] The method may optionally include an act of converting each pixel of the difference image to an absolute value of each pixel after the subtracting act and before the converting act.

[0098] The method may optionally include an act of converting each pixel of the difference image into a squared value of each pixel after the subtracting act and before the converting act.

[0099] In certain embodiments of the present disclosure, the flow meter includes a coupler, a support member, a light, and at least one processor. The coupler is adapted to be coupled to a drip chamber. The support member is operatively coupled to the coupler. An 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 drip chamber within the field of view. The light is coupled to the support member and adapted to illuminate the image sensor to expose the image sensor such that the field of view of the image sensor at least partially images at least a portion of the drip chamber.

[0100] 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 drip chamber using the image sensor having a field of view including the drip chamber; subtract the image from a background image to thereby generate a difference image; convert each pixel of the difference image to a true value if an absolute value of the corresponding pixel exceeds a predetermined threshold, or convert each pixel of the difference image to a false value if the absolute value of the corresponding pixel is less than the predetermined threshold; sum each row of the converted difference image to generate a plurality of sum values, wherein each sum value in the plurality of sum values ​​corresponds to the converted difference image of the corresponding row; and check the plurality of sum values.

[0101] The flow meter may include: a non-transitory processor-readable memory readable by at least one processor, such that the non-transitory processor-readable memory includes an operable processor-executable instruction set stored thereon, the operable processor-executable instruction set being configured to cause the at least one processor, when executed, to: capture an image including an image of the drip chamber using an image sensor having a field of view including the drip chamber; subtract the image from a background image to thereby generate a difference image; convert each pixel of the difference image to a true value if the absolute value of the corresponding pixel is greater than a predetermined threshold, or convert each pixel of the difference image to a false value if the absolute value of the corresponding pixel is less than the predetermined threshold; sum each row of the converted difference image to generate a plurality of sum values, wherein each sum value in the plurality of sum values ​​corresponds to the converted difference image of the corresponding row; and check the plurality of sum values.

[0102] The at least one processor may be further configured to determine whether a free flow condition exists within the drip chamber when the processor examines the plurality of sum values.

[0103] The at least one processor may be further configured to determine whether the plurality of sum values ​​includes a plurality of consecutive sum values ​​above another predetermined threshold when the at least one processor determines whether a free flow condition exists.

[0104] The at least one processor may be further configured to determine whether a droplet has formed within the drip chamber when the at least one processor examines the plurality of sum values.

[0105] The at least one processor may be further configured to determine that a droplet has been formed if the plurality of sum values ​​include a plurality of consecutive sum values ​​within a predetermined range greater than a minimum value and less than a maximum value and positions of the consecutive sum values ​​correspond to positions within a predetermined range where a droplet can be formed.

[0106] The at least one processor may be further configured to smooth the plurality of sum values ​​before the at least one processor examines the plurality of sum values.

[0107] At least one processor may perform smoothing according to at least one of a spline function, a cubic spline function, a B-spline function, a Bezier spline function, a polynomial interpolation, a moving average, a data smoothing function, and / or a cubic spline type function.

[0108] The flow meter may further include a non-transitory processor readable memory having an operable processor executable instruction set stored thereon. The non-transitory processor readable memory is in operable communication with the at least one processor such that the operable processor executable instruction set controls the operation of the at least one processor.

[0109] The at least one processor may be further configured to, after the subtracting act and before the converting, convert each pixel of the difference image into an absolute value of each pixel.

[0110] The at least one processor may be further configured to, after the subtracting and before the converting, convert each pixel of the difference image into a square value of each pixel.

[0111] In certain embodiments of the present disclosure, a method includes: capturing an image of a drip chamber using an image sensor; identifying a plurality of pixels of interest within the image; determining a subgroup of pixels within the plurality of pixels of interest, wherein each pixel of the plurality of pixels is determined to be within the subgroup of pixels when there is a path to a baseline corresponding to the drip chamber; performing a rotation operation on the subgroup of pixels; and estimating a volume of a droplet within the drip chamber by counting the number of pixels within the rotated subgroup of pixels.

[0112] The baseline may be a predetermined set of pixels within the image sensor.A plurality of pixels of interest may be identified by comparing the image to a background image.

[0113] The method may optionally include one or more of the following: initializing a background image; updating the background image using an image captured by an image sensor; updating a variance array using an image captured by the image sensor; and / or updating an integer array based on an image captured by the image sensor.

[0114] The background image can be updated according to the following equation:

[0115] P background,i,j =P background,i,j (1-a background )+a background P input,i,j .

[0116] The variance array can be updated according to the following equation:

[0117]

[0118] Each integer in the integer array may correspond to a number of updates of a pixel of the background image. In some specific embodiments, comparing the image with the background image only compares a pixel in the image with a pixel in the background image if the corresponding integer in the integer array indicates that the corresponding pixel in the background image has been updated at least a predetermined number of times.

[0119] The method may optionally include one or more of the following: identifying a droplet and a predetermined band near the edge of the droplet in the image; and initializing a background image by setting each pixel of the background image to the image unless it is within an identified droplet or within a predetermined band near the edge of the droplet.

[0120] The method further includes setting a pixel of the background image to a predetermined value if the corresponding pixel of the image is within the identified droplet or within a predetermined band near an edge of the droplet. The corresponding pixel of the image has a position corresponding to the pixel of the background image.

[0121] The method may further include determining a baseline corresponding to the opening of the drip chamber.

[0122] The action of determining a pixel subgroup within a plurality of pixels of interest corresponding to a droplet may include determining that each of the plurality of pixels of interest is within the pixel subgroup if a corresponding pixel in the plurality of pixels has a continuous path back to a baseline of the droplet formed at an opening of the drip chamber.

[0123] The method may optionally include one or more of the following: capturing a first image using an image sensor; identifying a droplet within the first image and a predetermined band near the edge of the droplet; initializing a background image by setting each pixel to the first image unless it is within an identified droplet or within a predetermined band near the edge of the droplet; setting pixels within the area of ​​the droplet or within the predetermined band to predetermined values; initializing an integer array; and initializing a variance array.

[0124] The method may also include using the image to update one or more of a background image, an integer array, and / or a variance array.

[0125] In certain embodiments of the present disclosure, a flow meter includes a coupler, a support member, an image sensor, and at least one processor. The coupler is adapted to be coupled to a drip chamber. The support member is operatively coupled to the coupler. The image sensor has a field of view and is operatively coupled to the support member. The image sensor is positioned to view the drip chamber within the field of view.

[0126] 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 drip chamber using the image sensor; identify a plurality of pixels of interest within the image; determine a subset of pixels within the plurality of pixels of interest, wherein each pixel of the plurality of pixels is determined to be within the subset of pixels when there is a path to a baseline corresponding to the drip chamber; perform a rotation operation on the subset of pixels; and estimate a volume of a droplet within the drip chamber by counting the number of pixels within the rotated subset of pixels.

[0127] The flow meter may also include a non-transitory processor readable memory having an operable processor executable instruction set stored thereon. The non-transitory processor readable memory is in operable communication with the at least one processor such that the operable processor executable instruction set controls the operation of the at least one processor.

[0128] The flow meter may also include: a non-transitory processor-readable memory readable by at least one processor, such that the non-transitory processor-readable memory includes an operable processor-executable instruction set stored thereon, and the operable processor-executable instruction set is configured to cause the at least one processor when executed to: use an image sensor to capture an image of the drip chamber; identify a plurality of pixels of interest within the image; determine a subset of pixels within the plurality of pixels of interest, wherein each pixel of the plurality of pixels is determined to be within the subset of pixels when there is a path to a baseline corresponding to the drip chamber; perform a rotation operation on the subset of pixels; and estimate the volume of a droplet in the drip chamber by counting the number of pixels within the rotated subset of pixels.

[0129] The baseline may be a predetermined set of pixels within the image sensor. A plurality of pixels of interest may be identified by comparing the image to a background image. The at least one processor may be further configured to initialize the background image and / or to update the background image using an image captured by the image sensor.

[0130] The background image can be updated according to the following equation:

[0131] P background,i,j =P background,i,j (1-a background )+a background P input,i,j .

[0132] The at least one processor may be further configured to update the variance array using an image captured by the image sensor.

[0133] The variance array can be updated according to the following equation:

[0134]

[0135] The at least one processor may be further configured to update the integer array according to the image captured by the image sensor. Each integer in the integer array corresponds to the updated number of pixels of the background image.

[0136] Optionally, in some embodiments, comparing the image to the background image only compares a pixel within the image to a pixel within the background image if the corresponding integer in the integer array indicates that the corresponding pixel within the background image has been updated at least a predetermined number of times.

[0137] The at least one processor may be further configured to: identify a droplet and a predetermined band near an edge of the droplet in the image; and initialize the background image by setting each pixel of the background image to the image unless it is within an identified droplet or within a predetermined band near an edge of the droplet.

[0138] The at least one processor may be further configured to set a pixel of the background image to a predetermined value if a corresponding pixel of the image is within an identified droplet or within a predetermined band near an edge of a droplet.

[0139] In certain embodiments of the present disclosure, corresponding pixels of the image have positions corresponding to positions of pixels of the background image.

[0140] At least one processor can

[0141] Further configured to determine a baseline corresponding to an opening of the drip chamber.

[0142] At least one processor may be further configured to determine whether each of a plurality of pixels of interest is within a subset of pixels to determine whether the subset of pixels is within the plurality of pixels of interest corresponding to the drop if corresponding pixels of the plurality of pixels have a continuous path back to a baseline of a drop formed at an opening of the drip chamber.

[0143] The at least one processor can be further configured to: capture a first image using an image sensor; identify a droplet within the first image and a predetermined band near the edge of the droplet; initialize a background image by setting each pixel to the first image unless it is within an identified droplet or within a predetermined band near the edge of the droplet; set pixels within the area of ​​the droplet or within the predetermined band to a predetermined value; initialize an integer array; and initialize a variance array.

[0144] The at least one processor may be further configured to use the image to update a background image, an integer array, and / or a variance array.

[0145] In certain embodiments of the present disclosure, a flow meter includes an image sensor device and a flow estimator device. The image sensor device is used to capture multiple images of a drip chamber. The flow estimator device is used to estimate the flow of a fluid through the drip chamber using the multiple images.

[0146] The flow estimator means may comprise processor means for estimating the flow of the fluid through the drip chamber using the plurality of images.

[0147] The flow meter may further include a memory device in operable communication with the processor device to provide an operable processor-executable set of instructions to cause the processor device to estimate the flow of the fluid through the drip chamber using the plurality of images.

[0148] In certain embodiments of the present disclosure, a flow meter includes: a memory device having an operable processor-executable instruction set configured to be executed; and a processor device for executing the operable processor-executable instruction set to implement a flow estimator device that uses multiple images to estimate the flow of a fluid through an infusion chamber.

[0149] In certain embodiments of the present disclosure, a method includes: a step of taking a plurality of images of a drip chamber; and a step of using the plurality of images to estimate the flow of a fluid through the drip chamber. The method may be implemented by an operable processor-executable instruction set stored on a non-transitory memory and executed by at least one processor.

[0150] In certain embodiments of the present disclosure, a device includes: a coupler adapted to be coupled to a drip chamber; a support member operatively coupled to the coupler; an image sensor having a field of view and operatively coupled to the support member, wherein the image sensor is positioned to observe the drip chamber within the field of view; a valve configured to be coupled to a fluid tube in fluid communication with the drip chamber, wherein the valve is configured to regulate flow through the fluid tube to thereby regulate fluid flow through the drip chamber; and at least one processor operatively coupled to the image sensor to receive image data therefrom, wherein the at least one processor is configured to: use the image sensor to capture multiple images of the drip chamber; use the multiple images to estimate a volume growth rate of a droplet within the drip chamber; receive a set point corresponding to a fluid flow rate through the fluid tube; adjust a control system to achieve the set point based on the estimated volume growth rate of the droplet; and output a control signal from the control system to an actuator of the valve to control actuation of the valve based on the adjusted control system.

[0151] The apparatus may include a non-transitory processor-readable memory having an operable processor-executable instruction set stored thereon. The non-transitory processor-readable memory may be in operable communication with at least one processor such that the operable processor-executable instruction set controls the operation of the at least one processor.

[0152] The apparatus may include a non-transitory processor-readable memory readable by at least one processor. The non-transitory processor-readable memory may include an operable processor-executable instruction set stored thereon, the operable processor-executable instruction set being configured to cause the at least one processor, when executed, to: use the image sensor to capture a plurality of images of the drip chamber; use the plurality of images to estimate a volume growth rate of a droplet in the drip chamber; receive a set point corresponding to a fluid flow rate through the fluid tube; adjust a control system to achieve the set point based on the estimated volume growth rate of the droplet; and output a control signal from the control system to an actuator of the valve to control actuation of the valve based on the adjusted control system.

[0153] 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 a switch control system.

[0154] The control system may correlate the estimated volume growth rate of the droplets to the fluid flow through the fluid tube.

[0155] The valve may include: a curved elongated support member that is elastically deformable and has a first end and a second end; and an opposing support member configured to position the fluid tube against the curved elongated support member between the first end and the second end, wherein deformation of the curved elongated support member caused by movement of the first end and the second end toward each other reduces an internal volume of the fluid tube. The actuator may be configured to move the first end and the second end toward each other.

[0156] 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 arranged in a spaced relationship with the length of the first elongated support member to cooperate with the first elongated support member to compress the fluid tube. An actuator may be mechanically engaged with at least one of the first elongated support member and the second elongated support member to actuate the first elongated support member and the second elongated support member toward each other to thereby compress the fluid tube disposed between the first elongated support member and the second elongated support member to regulate the flow of fluid within the fluid tube, actuation of the actuator actuating the first elongated support member and the second elongated support member to regulate the flow of fluid within the tube according to an approximate S-shaped curve.

[0157] 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 arranged in a spaced relationship with the length of the first elongated support member to cooperate with the first elongated support member to compress the fluid tube. An actuator is mechanically engaged with at least one of the first elongated support member and the second elongated support member to actuate the first elongated support member and the second elongated support member toward each other to thereby compress the fluid tube disposed between the first elongated support member and the second elongated support member to regulate the flow of a fluid within the fluid tube, actuation of the actuator actuating the first elongated support member and the second elongated support member to regulate the flow of the fluid within the fluid tube according to an approximate Gompertz curve.

[0158] 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 arranged in a spaced relationship with the length of the first elongated support member to cooperate with the first elongated support member to compress the fluid tube. An actuator is mechanically engaged with at least one of the first elongated support member and the second elongated support member to actuate the first elongated support member and the second elongated support member toward each other to thereby compress the fluid tube disposed between the first elongated support member and the second elongated support member to regulate the flow of fluid within the fluid tube; actuation of the actuator actuates the first elongated support member and the second elongated support member to regulate the flow of fluid within the tube according to an approximate generalized logistic function.

[0159] The valve may include: a first support member forming at least one of an arc, multiple arcs, a curve, multiple curves, an arch, multiple arches, an S-shape, a C-shape, a convex shape, multiple convex shapes, a concave shape, and multiple concave shapes; and a second support member disposed in a spaced relationship with the first support member to cooperate with the first support member to compress the fluid tube along a length of the fluid tube that is at least substantially greater than a diameter of the fluid tube. An actuator is mechanically engaged with at least one of the first support member and the second support member to actuate the first support member and the second support member toward each other to thereby compress the fluid tube disposed between the first support member and the second support member to regulate the flow of a fluid within the fluid tube; actuation of the actuator actuates the first elongated support member and the second elongated support member to regulate the flow of fluid within the fluid tube according to an approximately nonlinear function.

[0160] The valve may include: a curved, elongated support member that is elastically deformable and has a first end and a second end; and an opposing support member that is configured to define a conduit with the curved, elongated support member. The conduit is defined between the curved, elongated support member and the opposing member. The fluid tube is disposed within the conduit, and deformation of the curved, elongated support member caused by movement of the first end and the second end toward each other reduces an internal volume of the fluid tube within the conduit.

[0161] The valve may be an inverted Bourdon tube valve coupled to the fluid tube to regulate fluid flow through a fluid path of the fluid tube.

[0162] The valve may include: a first flexible member; a second flexible member operatively coupled to the first flexible member. A fluid tube may be disposed between the first flexible member and the second flexible member. The first flexible member and the second flexible member are configured to flex to thereby regulate the flow of fluid through the fluid tube, and an actuator is coupled to at least a first end of the first flexible member and a second end of the first flexible member.

[0163] The valve may include: a first C-shaped member, the first C-shaped member defining an inner surface and an outer surface; and a second C-shaped member, the second C-shaped member defining an inner surface and an outer surface. At least one of the outer surface of the first C-shaped member and the inner surface of the second C-shaped member is configured to receive a fluid tube. The inner surface of the second C-shaped member is arranged in a spaced relationship with the outer surface of the first C-shaped member. An actuator is coupled to the first C-shaped member and the second C-shaped member to bend the first C-shaped member and the second C-shaped member to compress the fluid tube.

[0164] The valve may include: a first flexible sheet; and a second flexible sheet, the second flexible sheet being operatively coupled to the first flexible sheet. The first flexible sheet and the second flexible sheet are configured to receive a fluid tube between them. The first flexible sheet and the second flexible sheet are configured to flex to thereby regulate the flow of a fluid through the fluid tube. An actuator is coupled to the first flexible sheet and the second flexible sheet to regulate the flow of a fluid through the fluid tube.

[0165] The valve may include: a first curvilinear member defining an inner surface and an outer surface; and a second curvilinear member defining an inner surface and an outer surface. The inner surface of the second curvilinear member is arranged in a spaced relationship with the outer surface of the first curvilinear member, and the fluid tube is arranged between the first curvilinear member and the second curvilinear member, and an actuator is coupled to the first curvilinear member and the second curvilinear member to bend the first curvilinear member and the second curvilinear member to thereby regulate the flow of fluid in the fluid tube.

[0166] The valve may include: a first curvilinear member defining an inner surface and an outer surface, the first curvilinear member having a first receiving member and a second receiving member at opposite ends of the first curvilinear member; and a second curvilinear member defining an inner surface and an outer surface, the second curvilinear member having a first fastener and a second fastener at opposite ends of the second curvilinear member. The first receiving member of the first curvilinear member is configured to engage the first fastener of the second curvilinear member. The second receiving member of the first curvilinear member is configured to engage the second fastener of the second curvilinear member. An actuator is coupled to the first curvilinear member and the second curvilinear member to bend the first curvilinear member and the second curvilinear member to regulate the flow of a fluid in a fluid tube disposed therebetween.

[0167] The valve may include: a first curved, slender support member that is elastically deformable and has a first end and a second end; and a second curved, slender support member that is elastically deformable and has a first end and a second end, wherein the second curved, slender support member is configured to position the fluid tube against the first curved, slender support member, wherein deformation of the first curved, slender support member and the second curved, slender support member caused by movement of the first end and the second end of the first curved, slender support member toward each other reduces an internal volume of the fluid tube; and a first connector that is coupled to a first end of the first curved, slender support member. The invention can include a first end and coupled to the first end of the second curved elongated support member; a second connector coupled to the second end of the first curved elongated support member and coupled to the second end of the second curved elongated support member, wherein the second connector defines a hole; a connecting member having one end coupled to the first connector and another end configured for insertion into the hole of the second connector, wherein the connecting member defines a threaded rod along at least a portion thereof; and a knob having ratchet teeth configured to ratchet onto the connecting member when moved from the other end of the connecting member toward the one end of the connecting member, wherein the knob is further configured to engage the threaded rod of the connecting member. An actuator can be coupled to the knob to rotate the knob.

[0168] The valve may include: a base defining a hole configured to receive a fluid tube; a plurality of fingers, each of the plurality of fingers having one end coupled to the base; and a ring configured to slide from the base and along the plurality of fingers. The ring moves from the base to compress the fingers against the fluid tube. The ring is configured to frictionally lock against the plurality of fingers. An actuator is coupled to the ring to slide the ring.

[0169] The valve may include a conical member having a surface for wrapping a fluid tube around it and a complementary member configured to engage the conical member to compress the tube. The actuator is configured to compress the conical member against the complementary member to thereby compress the fluid tube.

[0170] The control system may be implemented in hardware, software, a combination of hardware and software, and / or by at least one operational amplifier.

[0171] The device may include a non-volatile processor readable memory, wherein: the control system is implemented by an operable processor-executable instruction set configured for execution by at least one processor, the operable processor-executable instruction set is stored on the non-volatile processor readable memory, and the non-volatile processor readable memory is in operable communication with at least one processor to convey the operable processor-executable instruction set operation to the at least one processor for execution by the at least one processor.

[0172] The set point can be compared to the volume growth rate of the droplets to adjust the control system. The set point can be compared to the volume growth rate of the droplets to determine an error signal. The error signal can be the difference between the set point and the volume growth rate of the droplets. The error signal can be passed through a signal processing device to generate an output signal. The signal processing device can implement a proportional integral derivative controller using at least one non-zero gain parameter.

[0173] In another embodiment of the present disclosure, a device for regulating fluid flow includes a curved, elongated support member and an opposing support member. The curved, elongated support member is elastically deformable and has a first end and a second end. The first end is configured to be pivotally coupled to a first dog-bone link and a second dog-bone link, and the second end is configured to be pivotally coupled to a third dog-bone link and a fourth dog-bone link. The opposing support member is configured to position a tube against the curved, elongated support member between the first end and the second end, so that deformation of the curved, elongated support member caused by movement of the first end and the second end toward each other reduces the inner cross-section of the tube along the length of the tube. The first end of the opposing support member is configured to be pivotally coupled to the first dog-bone link and the second dog-bone link, and the second end of the opposing support member is configured to be pivotally coupled to the third dog-bone link and the fourth dog-bone link.

[0174] The first end of the curved elongated support member may include an engagement finger configured to engage the rack. The second end of the curved elongated member may be configured to be pivotally coupled to the rack. The device may include a knob coupled to the first end of the curved elongated support member to move the rack.

[0175] In yet another embodiment of the present disclosure, a flow meter includes a coupler, a support member, an image sensor, a laser, and at least one processor. The coupler is adapted to be coupled to a drip chamber. The support member is operatively coupled to the coupler. The image sensor has a field of view and is operatively coupled to the support member, and the first image sensor is configured to observe the drip chamber within the field of view. The laser is configured to illuminate an optical light onto the binary optical assembly.

[0176] 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 having at least a portion of a background pattern displayed therein; and (2) the at least one processor uses the image data to estimate at least one parameter of the fluid within the drip chamber.

[0177] In another embodiment of the present disclosure, a flow meter includes a coupler, a support member, a first electrode, a second electrode, and at least one processor. The coupler is adapted to be coupled to a drip chamber. The support member is operatively coupled to the coupler. The first electrode is configured to be coupled to a fluid line in fluid communication with the drip chamber. The second electrode is configured to be coupled to a fluid line in fluid communication with the drip chamber.

[0178] At least one processor is operatively coupled to the first electrode and the second electrode to measure a capacitance therebetween, and the at least one processor is configured to monitor the capacitance. The at least one processor can be configured to use the monitored capacitance to determine whether a streaming condition exists within the drip chamber.

[0179] In another embodiment of the present disclosure, the safety valve includes a housing, a first blocking arm and a second blocking arm, a first shaft and a second shaft and a spring. The housing is configured to hold a tube. The first blocking arm and the second blocking arm are pivotally coupled together. The first shaft is pivotally coupled to the distal end of the first blocking arm. The second shaft is pivotally coupled to the distal end of the second blocking arm. The spring is arranged adjacent to the first blocking arm and the second blocking arm on opposite sides of the tube, and is configured to load the first blocking arm and the second blocking arm with a spring. The safety valve is configured to release the spring and block the tube when the first blocking arm and the second blocking arm pivot away from the spring by a predetermined amount along their common pivot. A solenoid can be used to engage the first blocking arm and the second blocking arm to release the spring.

[0180] In another embodiment of the present disclosure, an apparatus includes a coupler, a support member, and at least one processor. The coupler is adapted to be coupled to a drip chamber. The support member is operatively coupled to the coupler. An image sensor has a field of view and is operatively coupled to the support member. The image sensor is configured to observe the drip chamber within 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: (1) capture an image of the drip chamber; (2) position a template within the captured image to a first position; (3) average pixels within the template to determine a first average; (4) move the template to a second position; (5) average pixels within the template to determine a second average; (6) determine that the template is positioned at an edge of a droplet if the difference between the second average and the first average is greater than a predetermined threshold; (7) and, associate the second position with a volume of the droplet.

[0181] In another embodiment of the present disclosure, a method implemented by at least one processor executing an operational processor executable instruction set is disclosed, the operational processor executable instruction set being configured to be executed by the at least one processor to estimate flow rate. The method includes: (1) capturing an image of the drip chamber; (2) positioning a template within the captured image to a first position; (3) averaging pixels within the template to determine a first average; (4) moving the template to a second position; (5) averaging pixels within the template to determine a second average; (6) if the difference between the second average and the first average is greater than a predetermined threshold, determining that the template is positioned at the edge of a droplet; and (7), associating the second position with the volume of the droplet.

[0182] In another embodiment of the present disclosure, the flow meter includes a coupler, a support member, a modular backlight assembly, an image sensor, and at least one processor. The coupler is adapted to be coupled to the drip chamber. The support member is operatively coupled to the coupler. The modular 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 drip chamber and the modular backlight assembly within the field of view. At least one processor is operatively coupled to the image sensor and the modular backlight assembly such that at least one processor receives data from the image sensor, which displays at least a portion of the modular backlight assembly therein, and at least one processor is configured to modulate the backlight assembly to the first backlight and modulate the backlight assembly to the second backlight when estimating the droplet size. The first backlight can be a diffuser backlight without a pattern, and the second backlight can be a diffuser backlight with a striped pattern.

[0183] In yet another embodiment of the present disclosure, the tube restorer includes a first gear and a second gear. The second gear is arranged close to the first gear. The first gear and the second gear define a space along a radial portion of the first gear and the second gear to allow the tube to flex therebetween. The first and second gears are further configured to restore the tube when rotated so that the space is not positioned between the first gear and the second gear.

[0184] In yet another embodiment of the present disclosure, the valve includes first and second metal strips and first and second guide members. The first guide member is coupled to the distal ends of the first and second metal strips. The second guide member is coupled 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 actuated toward the proximal ends of the first and second metal strips. The valve may further include a rope (e.g., a metal rope or a rope made of any other material) that is threaded through the first and second metal strips to spirally surround the tube.

[0185] In yet another embodiment of the present disclosure, a valve includes a first clamshell and a second clamshell configured to provide a cavity between the first clamshell and the second clamshell. The first clamshell and the second clamshell are configured to receive a tube therebetween and within the cavity. The valve also includes a bladder disposed within the cavity and a pump configured to inflate or deflate the bladder to regulate the flow of fluid within the tube.

[0186] In yet another embodiment of the present disclosure, an apparatus includes a coupler, a support member, an image sensor, and at least one processor. The coupler is adapted to be coupled to a drip chamber. The support member is operatively coupled to the coupler. The image sensor has a field of view and is operatively coupled to the support member. The image sensor is configured to observe the drip chamber within the field of view.

[0187] 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 thresholded image from the first image by comparing each pixel of the first image to a threshold; (3) determine a pixel group within the first thresholded image that is connected to a predetermined pixel group within the first thresholded image; (4) filter all remaining pixels of the first thresholded image that are not within the pixel group, the filtering being performed pixel by pixel in the time domain to generate a first filtered image; (5) remove pixels determined to be not part of a droplet from the first thresholded image using the first filtered image to generate a second image; (6) determine a second pixel group within the second image that is connected to the predetermined pixel group within the second image to generate a third image, the third image identifying the second pixel group within the second image; and (7) filter the pixels of the first thresholded image by counting pixels that contain pairs of pixels. (10) summing the rows of the second thresholded image to create a plurality of row sums, each row sum corresponding to a row of the second thresholded image; (11) starting at a row position of the second thresholded image having a first sum of the plurality of sums corresponding to the first length; (12) incrementing the row position until the row position corresponds to a corresponding row sum of zero; (13) determining a second length equal to the current row position, the second length corresponding to a second estimated drop size; and (14) averaging the first length and the second length to determine an average length, the average length corresponding to a third estimated drop size.

[0188] In another embodiment of the present disclosure, a method implemented by at least one processor executing an operational processor executable instruction set, the operational processor executable instruction set being configured for execution by the at least one processor to estimate flow, the method comprising: (1) capturing a first image; (2) creating a first thresholded image from the first image by comparing each pixel of the first image with a threshold; (3) determining a pixel group within the first thresholded image that is connected to a predetermined pixel group within the first thresholded image; (4) filtering all remaining pixels of the first thresholded image that are not within the pixel group, the filtering being performed pixel by pixel in a time domain to generate a first filtered image; (5) removing pixels determined to be not part of a droplet from the first thresholded image using the first filtered image to generate a second image; and (6) determining a second pixel group within the second image that is connected to a predetermined pixel group within the second image to generate a third image, the third image (7) determining a first length of the droplet by counting the number of rows containing pixels corresponding to the second pixel group in the third image; (8) updating a background image using the first image; (9) creating a second thresholded image by comparing the first image to the background image; (10) summing the rows of the second thresholded image to create a plurality of row sums, each row sum corresponding to a row of the second thresholded image; (11) starting at a row position of the second thresholded image having a first sum of the plurality of sums corresponding to the first length; (12) incrementing the row position until the row position corresponds to a corresponding row sum of zero; (13) determining a second length equal to the current row position, the second length corresponding to a second estimated droplet size; and (14) averaging the first length and the second length to determine an average length, the average length corresponding to a third estimated droplet size.

[0189] In another embodiment of the present disclosure, the flow meter includes a coupler, a support member, a first loop antenna and a second loop antenna, and at least one processor. The coupler is suitable for coupling to the drip chamber. The support member is operatively coupled to the coupler. The first loop antenna is arranged adjacent to a fluid line in fluid communication with the drip chamber. The second loop antenna is arranged adjacent to the fluid line. At least one processor is operatively coupled to the first loop antenna and the second loop antenna to measure the magnetic coupling therebetween. At least one processor is configured to monitor the magnetic coupling between the first loop antenna and the second loop antenna to determine whether a flow condition exists within the drip chamber.

[0190] In another embodiment of the present disclosure, a method implemented by an operable processor executable instruction set includes: (1) determining multiple points of interest within an image; (2) randomly selecting N points of interest from the multiple points of interest; and / or (3) identifying a single unique geometric feature characterized by N parameters corresponding to the N points of interest.

[0191] In another embodiment of the present disclosure, a system includes a non-volatile memory and one or more processors. The non-volatile memory has a plurality of instructions stored thereon. The one or more processors are in operable communication with the non-volatile memory to execute the plurality of instructions. The plurality of instructions are configured to cause the processor to: (1) determine a plurality of points of interest within an image; (2) randomly select N points of interest from the plurality of points of interest; and / or (3) identify a single unique geometric feature characterized by N parameters corresponding to the N points of interest.

[0192] In certain embodiments of the present disclosure, fluid flow is controlled by a valve that deforms a tube using a plunger, a rigid housing, and a substantially incompressible filling portion. The tube is positioned within a channel defined in the filling portion. The rigid housing creates an enclosure surrounding the filling portion, and the housing has a hole that facilitates the plunger to enter the housing and engage the filling portion. An actuator is connected to the plunger and controls the movement of the plunger. The force from the plunger engaging the filling portion is transferred to the tube and causes the tube to deform by different amounts depending on how far into the housing the plunger is actuated.

[0193] The filling portion may have multiple layers of different hardness. The soft layer may be a material having a Shore OO hardness of from about 20 to about 25. The hard layer may be a material having a Shore OO hardness of about 15.

[0194] The actuator may be a linear actuator designed to actuate the plunger into the housing, out of the housing, or both.

[0195] In another embodiment of the present disclosure, the housing may include a first clamshell portion and a second clamshell portion that are pivotally connected to each other. The portions are connected to allow for clamshell-like opening and closing. A lock is connected to the housing to lock the clamshell portions in a fixed closed position. The first clamshell portion defines a hole sized to receive a plunger. A guide connected to the first clamshell portion and the actuator is configured to guide the actuated plunger through the hole of the first clamshell portion.

[0196] In another embodiment of the present disclosure, the first clamshell portion and the second clamshell portion each define a portion of a cavity when they are in a closed position. The filling portion positioned within the clamshell portion has at least two layers of different hardness, and a total of four layers. The first and second layers are within the cavity of the first portion, and the third and fourth layers are within the cavity of the second portion. The first and fourth layers are arranged on the inner surfaces of their respective clamshell portions. The second and third layers define a channel to guide the pipe to adjust the flow with a valve and are arranged on the first and fourth layers, respectively. The second layer material is harder than the first layer material, and the third layer material is harder than the fourth layer material.

[0197] In yet another embodiment of the present disclosure, a guide is connected to the first clamshell portion and the actuator to guide the plunger through the hole in the first clamshell portion. At least one spring is connected to the guide and the plunger, the spring applying a force that pulls the plunger toward the housing.

[0198] In yet another embodiment of the present disclosure, the actuator is configured to be controlled by a monitoring client.

[0199] Another embodiment of the present disclosure includes a system for controlling the flow of a fluid through a drip chamber. The system includes a drip chamber coupler, a support member, an image sensor, a valve, and at least one processor. The drip chamber coupler holds the drip chamber, positions it vertically, and is positioned in a position that can be viewed by the image sensor. The support member is connected to the drip chamber coupler and the image sensor is operatively attached to the support member. The image sensor is positioned to have the drip chamber within its field of view. The valve is fluidically coupled to the drip chamber and has the ability to control the flow of fluid through the drip chamber. The valve includes a housing, a filling portion, a plunger, and an actuator. The housing surrounds a tube in fluid communication with the drip chamber, and fixed within the housing is the filling portion. The housing may include a first clamshell portion and a second clamshell portion. The first clamshell portion defines a hole and is connected to a guide configured to guide the plunger through the hole. The filling portion has at least two layers of different hardness to facilitate uniform and consistent deformation of the tube. The plunger is configured to engage the filling portion through a hole in the housing and deform the tube within the filling portion during operation. The actuator is operatively connected to the plunger and configured to actuate the plunger. At least one processor is in communication with the image sensor and the actuator. The at least one processor is configured to receive image data from the image sensor, use the image data to at least estimate a parameter about the fluid in the chamber, and then actuate the plunger to achieve a target parameter. The parameter can be a formation of the liquid, a volume of the liquid, and a shape of the liquid. The target parameter can be a target flow rate or a target droplet growth rate. Using the image data, the processor can determine the presence of a streaming condition.

[0200] The drip chamber is positioned between the image sensor and the background pattern, and the background pattern can be positioned within the field of view of the image sensor.

[0201] The housing may include a first clamshell portion and a second clamshell portion, with the first portion being pivotally connected to the second portion. The portions are connected in a manner that allows an open position and a closed position to be defined for the cavity.

[0202] The first clamshell portion defines a first portion of the cavity and the second clamshell portion defines a second portion of the cavity.

[0203] The at least two different hardness layers of the filling portion may include: a first layer, a second layer, a third layer, and a fourth layer. The first layer and the second layer are positioned within the first portion of the cavity, and the third layer and the fourth layer are positioned within the second portion of the cavity. The first layer and the second layer are arranged on the inner surface of their respective clamshell portions, the second layer is arranged on top of the first layer, and the third layer is arranged on top of the fourth layer. The second layer and the third layer are harder than the first layer and the fourth layer. A channel is defined in the second layer and the third layer to guide the tube through the filling portion.

[0204] In certain embodiments of the present disclosure, a method includes: taking an image of a drip chamber using an image sensor, estimating a flow rate through the drip chamber from the image using a processor, receiving a desired flow rate from a user, comparing the estimated flow rate to the desired flow rate using a processor, determining a magnitude and direction of valve actuation to achieve the desired flow rate, and actuating the valve to achieve the desired flow rate according to the determined magnitude and direction. Actuating the valve may include adjusting the pressure around a flexible tube having a lumen in fluid communication with the drip chamber to deform the tube and change the shape of the lumen. Adjustment of the pressure can be made by arranging a rigid housing around a defined portion of the tube, enclosing a substantially incompressible filler within the housing, and engaging the filler with a plunger so that increasing the pressure in the housing causes deformation of the tube.

[0205] The method may further include communicating the estimated flow rate to a fluid monitoring client.

[0206] The method may further include monitoring for unexpected events and stopping the flow when an unexpected event occurs.

[0207] The method may also include deforming a flexible tube in fluid communication with the drip chamber to reduce its lumen size during the operation of installing or removing the tube from the device performing the method. Once the process of installing or removing the tube is completed, the compressive force is removed from the tube, allowing the lumen created by the tube to return to substantially its initial size.

[0208] In certain embodiments of the present disclosure, a system for controlling fluid passing through a drip chamber includes: a drip chamber frame, an imaging device, a flexible tube, and a valve. The drip chamber frame receives and fixes the drip chamber. The imaging device is configured to capture an image of the drip chamber and create image data from the captured image. The flexible tube is connected to the drip chamber and the lumen defined by the tube is in fluid communication with the drip chamber. The valve is axially arranged around the flexible tube portion and controls the fluid passing through the tube and ultimately through the drip chamber. The valve includes a first housing member and a second housing member, which are pivotally connected to each other and complementarily aligned to form an enclosure when in a closed position. The injection hole and the discharge hole are defined in the valve housing when the housing is closed and the plunger hole is defined in the first housing member. The male lock member is connected to the first housing member opposite the pivot connection, and the female lock member is coupled to the second housing member opposite the pivot connection. A substantially incompressible filling portion is enclosed in the housing. The filling portion defines a conduit connecting the injection hole and the discharge hole of the valve housing according to the size of the specific tube. There are multiple filling portions with varying hardness. The fill portion immediately adjacent to the tube may be harder than the surrounding fill portion. The plunger is longitudinally aligned with the plunger bore and attached to the actuator. The actuator is configured to actuate the plunger into and out of the plunger bore to engage the fill portion. The force on the portion of the tube within the housing is changed by the change in plunger displacement, causing the lumen to change size. The area of ​​the plunger head can be smaller than the longitudinal cross-section of the lumen disposed within the housing.

[0209] The system may also include a safety shutoff valve, which includes an occluding arm, at least one spring and a trigger mechanism. The occluding arm is configured to compress the tube into the check, which reduces the area of ​​the lumen defined by the tube. At least one spring maintains a constant pressure on the occluding arm, pushing it toward the check. The occluding arm is limited to return from the check by a trigger mechanism, which can release the occluding arm when triggered. The trigger mechanism can limit the occluding arm using a magnetic force generated from an adjacently positioned magnet or from a magnet in the coil. The first magnet and the second magnet can be configured to allow the opposite magnetic poles to align to induce an attractive magnetic force. A solenoid can be used to apply force to the trigger mechanism, causing it to release the occluding arm. Current-sensitive materials can be used to apply force to the solenoid. If the first magnet and the second magnet are used, they are reconfigured to align the same magnetic poles and apply a repelling magnetic force to the trigger mechanism. The safety sensor can be used to sense an unexpected event and transmit the data of the unexpected event to a processor that can engage the solenoid and release the occluding arm.

[0210] The system may also include at least one processor capable of receiving imaging data from the imaging device, estimating flow rate based on the imaging data, comparing the estimated flow rate to a desired flow rate, and adjusting the actuator to produce the desired flow rate.

[0211] The system may also include an enclosure housing including a body and a door pivotably connected to the body. When in a closed position, the door and the body create an enclosure that contains the valve. The arm can be pivotally connected to the door on a first side thereof and to a female lock member on a second side thereof. The arm is configured to unlock and open the two components of the valve housing when the door is opened, and to lock and close the two components of the valve housing when the door is closed.

[0212] The system may also include an arm with a first end pivotally attached to the door and a second end operatively configured to reset the safety shutoff valve to a free flow position when the door is opened.

[0213] The system may also include a valve having at least one cut-off spring, a threaded drive shaft, and a threaded engagement member. The at least one cut-off spring applies a force to the plunger in the direction of the valve housing. The threaded drive shaft has a first end attached to the actuator output shaft and an opposite second end connected to the plunger. The connection between the plunger and the drive shaft allows the plunger to rotate freely relative to the drive shaft. The threaded engagement member is operatively connected to the valve housing and is configured to engage the thread on the drive shaft. This allows the actuator to control the position of the plunger by rotating the threaded drive shaft. The engagement member has the ability to disengage from the thread on the drive shaft leaving only the cut-off spring to push the plunger toward the valve housing, thereby deforming the tube. The spring can be used to push the engagement member toward the drive shaft. The system may also include an arm with a first end pivotally attached to the door of the encapsulating housing and a second end configured to push the threaded engagement member away from the drive shaft when the door is opened.

[0214] In another embodiment of the present disclosure, the device includes a device housing, a drip chamber, an image sensor and a valve. The device housing includes a body and a door, which are pivotally connected to each other to form an enclosure when in a closed configuration. The drip chamber is connected to the outside of the housing body. The image sensor is also attached to the outside of the housing body and positioned so that the drip chamber is within its field of view. The valve is arranged in the device housing and includes a first valve housing member and a second valve housing member, a male lock member and a female lock member, a filling portion, a plunger and an actuator. The first valve housing member and the second valve housing member are pivotally connected to complementarily align and form an enclosure when in a closed position. When the housing is in a closed position, an injection hole and a discharge hole are defined. The first valve housing member has a plunger hole to allow the plunger to enter the housing. The male lock member is attached to the first valve housing member and the female lock member is attached to the second valve housing member, both of which are connected at a position opposite to the pivot on their respective housing members. The filling portion is made of a substantially incompressible material and is enclosed in the valve housing. A conduit sized for a particular tube is defined within the filling portion and connected to the injection and discharge holes of the valve housing. The filling portion is composed of multiple layers of varying hardness, and the layers of the filling portion immediately adjacent to the conduit can be harder than the surrounding layers. The plunger is connected to the actuator and longitudinally aligned with the plunger hole. The actuator is configured to force the plunger through the plunger hole. The plunger head can have an area smaller than the longitudinal cross-section of the lumen disposed within the housing.

[0215] The device may also include a user input device on the door of the device housing that allows a user to manually input information including a desired flow rate into the device. The device may also include a display on the door of the device housing that is configured to display infusion information. A touch screen display may be used in conjunction with or in place of buttons to allow a user to input information into the device.

[0216] The device may also include a processor in communication with the image sensor and the actuator. The processor receives data from the image sensor, estimates flow rate based on the imaging data, compares the estimated flow rate to a desired flow rate, and adjusts the actuator to achieve the desired flow rate.

[0217] The device may also include a safety shutoff valve comprising an occluding arm, a backstop, at least one spring and a trigger mechanism. The spring is operatively connected to the occluding arm, forcing it with sufficient force toward the backstop to compress the tube against the backstop and reduce the size of the lumen formed in the tube. When the mechanism is triggered, the trigger mechanism releases the occluding arm, allowing it to compress the tube. By applying force to the occluding arm, a solenoid can be used to trigger the safety shutoff valve. A safety sensor can be used in conjunction with a processor to sense an unexpected event and engage the solenoid to trigger the release of the occluding arm.

[0218] In certain embodiments of the present disclosure, the female lock member is a lever pivotally connected to the valve housing at a point offset from its end, which creates a lever with an input end and an opposite output end. The male lock member is a flange. When the valve housing is in a closed position, the lock member is positioned to allow the output end of the female member to engage with the opposite side of the flange. When rotating in the direction of pushing the output end of the lever into the flange, the lever compresses the first valve housing member and the second valve housing member together to apply force to the flange. The guide arm can be pivotally attached to the door of the device housing at its first end, and is attached to the input end of the female lock lever at its opposite second end. When the door is in a closed position, the guide arm engages the output end of the lever with the male lock flange and rotates the lever to compress the valve housing member together.

[0219] Certain embodiments of the present disclosure include a compression tab and a wedge. The compression tab is disposed within a hole in the body of the device housing. The tab has a compression force large enough to deform an IV tube positioned between the tab and the body of the device housing. The wedge protrudes outwardly from the door and is positioned to engage the tab when the door is closed, relieving the compression force of the tab against the body of the device housing or the tube therebetween.

[0220] In another embodiment of the present disclosure, the valve may include at least one cut-off spring, a threaded drive shaft, and a threaded engagement member. At least one cut-off spring applies force to pull the plunger and the actuator toward the valve housing. The threaded drive shaft has a first end attached to the actuator output shaft and an opposite second end connected to the plunger. The connection between the plunger and the drive shaft allows the plunger to rotate freely relative to the drive shaft. The threaded engagement member is operatively connected to the valve housing and is configured to engage the threads on the drive shaft. This allows the actuator to control the position of the plunger by rotating the threaded drive shaft. The engagement member has the ability to be removed from the threads on the drive shaft, allowing the cut-off spring to push the plunger toward the valve housing and thus deform the tube. The spring can be used to push the engagement member toward the drive shaft. The system may also include an arm with a first end pivotally attached to the door of the enclosing housing and a second end configured to push the threaded engagement member away from the drive shaft when the door is opened.

[0221] In another embodiment of the present disclosure, an apparatus includes a first metal structure and a second metal structure and an impedance matching structure coupled to the first metal structure and the second metal structure, wherein the impedance matching structure is configured to substantially match a desired interrogator frequency. The apparatus also includes a short circuit mechanism coupled to the first metal structure and the second metal structure.

[0222] The device may include a metal structure of a pre-existing component of the assembly. The device may also include an inductor, a capacitor, or a combination of an inductor and a capacitor as an impedance matching structure. The short-circuit mechanism may be a transistor or a switch and may be controlled by a microprocessor.

[0223] The apparatus may also include a low pass filter coupled to the first metal structure and the second metal structure and having a cutoff frequency sufficiently below a desired interrogator frequency.

[0224] In other embodiments of the present disclosure, the method includes coupling the first metal structure and the second metal structure to an impedance matching structure, and the impedance matching structure is configured to substantially match the desired interrogator frequency. The method may also include short-circuiting the coupled first metal structure and the second metal structure.

[0225] In other embodiments of the present disclosure, the method may further include coupling a low pass filter to the first metal structure and the second metal structure. The short circuit may be controlled by a microprocessor.

[0226] In another embodiment of the present disclosure: a system for regulating fluid flow, the system comprising: a fluid reservoir, the reservoir being used to input a fluid contained therein into a patient; a drip chamber, the drip chamber being fluidically connected to the reservoir, wherein the drip chamber is configured to allow fluid droplets to leave the reservoir and pass through the drip chamber; a backlight source, the backlight source being arranged proximate to the drip chamber so that the backlight source provides at least partial illumination to the drip chamber; a valve, the valve being configured to regulate the flow of fluid from the drip chamber to the patient; and a flow meter, the flow meter being used to monitor the flow rate of the fluid passing through the drip chamber, the flow meter comprising: an image sensor, the image sensor being configured to capture an image of the drip chamber; a processor, the processor being configured to determine whether the captured image of the drip chamber contains a match with a template; and an instruction set executable by the processor, the instruction set being configured to apply a blur function to an image captured by the image sensor of the drip chamber so that the processor can determine whether the captured image contains a match with the template.

[0227] The blur function may be a low pass filter configured to apply the low pass filter to the image captured by the image sensor in either the vertical direction or the horizontal direction. The low pass filter may include a one-dimensional Gaussian blur function.

[0228] The blur function may be a low pass filter, a processor executable instruction set configured to apply the low pass filter both vertically and horizontally to an image captured by the image sensor. The low pass filter includes a two-dimensional Gaussian blur function. The template includes an image of at least a portion of a droplet of fluid formed in the drip chamber. The captured image may include an image of the drip chamber at least partially illuminated by a backlight source.

[0229] The desired pattern may include at least a partial image of a droplet of fluid formed within the drip chamber, the droplet at least partially illuminated by a backlight source. The blur function filters the captured image so that the processor can determine whether the captured image contains a match to the template. The captured image is filtered to remove the effect of detail including an image of at least one of condensation or splashing within the drip chamber.

[0230] In another embodiment, a method for filtering a captured image of a drip chamber configured to allow a droplet to fall into the drip chamber includes: capturing an image of the drip chamber with an image sensor; determining whether the captured image contains a visual obstruction; applying a blur function to the captured image, the blur function being configured to eliminate detail effects in the captured image; and determining whether the captured image contains a match with a template.

[0231] The desired pattern may include at least a partial image of a droplet of fluid within the drip chamber. The blur function may be a low pass filter that is applied either vertically or horizontally. The low pass filter may include a one-dimensional Gaussian blur function. The blur function may be a low pass filter that is applied both horizontally and vertically. The low pass filter may include a two-dimensional Gaussian blur function. The removed detail effect may include an image of one of condensation or splash within the drip chamber.

[0232] In another embodiment, a method for capturing an image of a drip chamber includes: illuminating at least a portion of the drip chamber; capturing the image of the drip chamber with an image sensor; using a processor coupled to the image sensor in operation, determining whether there is a visual obstruction in the captured image; when it is determined that there is a visual obstruction in the captured image, using the processor to apply a blur function to the captured image to filter the captured image; and using the processor to determine whether there is a match with a template in the captured image.

[0233] The template may include at least a partial image of a fluid droplet in the drip chamber. The blur function may be a low pass filter, and the processor applies the low pass filter to the captured image in either the horizontal direction or the vertical direction. The low pass filter may include a one-dimensional Gaussian blur function. The blur function may be a low pass filter; the processor applies the low pass filter to the captured image in both the horizontal direction and the vertical direction. The low pass filter may include a two-dimensional Gaussian blur function. BRIEF DESCRIPTION OF THE DRAWINGS

[0234] These and other aspects will become more apparent from the following detailed description of various embodiments of the present disclosure with reference to the accompanying drawings, in which:

[0235] Figure 1A block diagram of a system for regulating fluid flow according to an embodiment of the present disclosure is shown;

[0236] Figure 2 A flowchart of a method for displaying an image sensor according to an embodiment of the present disclosure is shown;

[0237] Figure 3 The embodiment according to the present disclosure shows Figure 2 A timing diagram of an embodiment of the method;

[0238] Figure 4A-4B An example of image data (ie, image) captured by a flow meter of a drip chamber according to an embodiment of the present disclosure is shown. Figure 3 The timing diagram is shown for demonstrating Figure 2 Embodiments of the method of an image sensor;

[0239] Figure 5 A block diagram showing an integrated flow meter and valve for coupling with a drip chamber and an infusion bag according to an embodiment of the present disclosure is shown;

[0240] Figure 6 is a block diagram of an imaging system for depicting a flow meter of a drip chamber according to an embodiment of the present disclosure;

[0241] Figure 7 According to an embodiment of the present disclosure, Figure 6 An illustration of an image captured by an image sensor of a system;

[0242] Figure 8 is a block diagram of an imaging system for depicting a drip chamber using a background pattern according to an embodiment of the present disclosure;

[0243] Fig. 9 is an illustration of an image captured by an image sensor of a flow meter disclosed herein when a free flow condition exists according to an embodiment of the present disclosure;

[0244] Fig.10 is an illustration of an image captured by an image sensor of a flow meter and used as a background image according to an embodiment of the present disclosure;

[0245] Fig.11 is an illustration of an image captured by an image sensor when a droplet is formed in a drip chamber according to an embodiment of the present disclosure;

[0246] Fig.12 is an illustration of an image captured by an image sensor and used as a background image according to an embodiment of the present disclosure;

[0247] Fig.13 According to an embodiment of the present disclosure, there is an additional processing Fig.11 and Fig.12Legend of the differences between ;

[0248] Fig.14 According to an embodiment of the present disclosure, using Figure 11-13 Illustration of some of the imaging processes performed to determine if free flow conditions exist;

[0249] Fig.15 is an illustration of an image captured by an image sensor when free flow conditions exist according to an embodiment of the present disclosure;

[0250] Fig.16 is an illustration of an image captured by an image sensor and used as a background image according to an embodiment of the present disclosure;

[0251] Fig.17 is an embodiment of the present disclosure with some additional processing for detecting free flow conditions Fig.15 and Fig.16 An illustration of the difference between the images;

[0252] Fig.18 According to an embodiment of the present disclosure, using Figure 15-17 Illustration of some of the imaging processes performed to determine if free flow conditions exist;

[0253] Fig.19 A template for pattern matching to determine whether a free flow condition exists is shown according to an embodiment of the present disclosure;

[0254] Fig. 20 is a graphical representation of the difference between a reference image and an image containing flow processed with edge detection and line detection for detecting free flow conditions in accordance with an embodiment of the present disclosure;

[0255] Fig.21 is an illustration of an image of a drip chamber captured by an image sensor when free flow conditions exist according to an embodiment of the present disclosure;

[0256] 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 irradiating the stripes from a position adjacent to an image sensor according to an embodiment of the present disclosure;

[0257] Fig.23 is a block diagram of an imaging system for use with a flow meter having a background pattern of stripes and a light source shining onto the stripes from behind the background pattern opposite the opposite end of the image sensor according to an embodiment of the present disclosure;

[0258] Fig.24 According to an embodiment of the present disclosure, when the droplet Fig.23 The image from the image sensor is distorted when the background pattern is distorted;

[0259] Fig.25 is a block diagram of an imaging system for use with a flow meter having a background pattern in a checkerboard pattern and a light source shining onto the stripes from behind the background pattern opposite the opposite end of the image sensor according to an embodiment of the present disclosure;

[0260] Fig.26 FIG. 4 shows an embodiment of the present disclosure, when a droplet distorts a background pattern, Fig.25 an image of an image sensor;

[0261] Figure 27-Figure 28 An example flowchart of a method for estimating the volume of a droplet in a drip chamber according to an embodiment of the present disclosure is shown;

[0262] Figure 29-Figure 31 According to an embodiment of the present disclosure, the flow meter uses Figure 27-Figure 28 A method is shown to estimate the volume of a droplet in a drip chamber using or generating an image;

[0263] Fig.32 An embodiment according to the present disclosure is shown, for Figure 27-Figure 28 Pseudocode of a method to identify multiple pixels of interest;

[0264] Figure 33-Figure 36 According to an embodiment of the present disclosure, the flow meter uses Figure 27-Figure 28 A method is shown to estimate the volume of a droplet in a drip chamber using or generating an image;

[0265] Fig.37 shows pseudo code for determining a subset of pixels within a plurality of pixels of interest corresponding to a droplet according to an embodiment of the present disclosure;

[0266] Fig.38 shows a line graph showing blur circle diameters to illustrate various aspects of an image sensor of an imaging system disclosed herein, in accordance with an embodiment of the present disclosure;

[0267] Fig.39 is a diagram showing calculated blur circles for various lens-to-focal plane separations and lens-to-image separations for an image sensor of an imaging system disclosed herein, according to an embodiment of the present disclosure;

[0268] Fig.40 is a diagram showing a blur circle divided by pixel size when using a 20 mm lens focal length of an image sensor of an imaging system disclosed herein according to an embodiment of the present disclosure;

[0269] Fig.41is a diagram showing a blur circle divided by pixel size when using a 40 mm lens focal length of an image sensor of an imaging system disclosed herein according to an embodiment of the present disclosure;

[0270] Fig.42 shows a table showing corresponding fields of view about the optical axis for a full range of two configurations of imaging systems disclosed herein, according to an embodiment of the present disclosure;

[0271] Fig.43 shows a flow meter coupled to a drip chamber according to an embodiment of the present disclosure;

[0272] Fig.44 The method of opening the door according to an embodiment of the present disclosure is shown. Fig.43 The infusion chamber and flow meter;

[0273] Fig.45 shows a flow meter coupled to a drip chamber according to an embodiment of the present disclosure;

[0274] Fig.46 A pinch valve and a flow meter are shown coupled to a body of a flow meter to control the flow of fluid into a patient according to an embodiment of the present disclosure;

[0275] Fig.47 The embodiment according to the present disclosure is shown Fig.46 A close-up view of a pinch valve coupled to a flow meter body;

[0276] Fig.48 A flow meter and a pinch valve according to another embodiment of the present disclosure are shown, wherein the flow meter includes two image sensors;

[0277] Fig.49 A flow meter and valve including two curved elongated support members to control the flow of fluid into a patient according to an embodiment of the present disclosure is shown;

[0278] Figures 50A-50B The embodiment according to the present disclosure is shown Fig.49 A close-up view of the valve;

[0279] Figures 51A-51D Several views of a flow meter with a monitoring client, a valve, a drip chamber, an IV bag, and a fluid tube are shown, wherein the flow meter includes a receiving portion to receive the valve according to an embodiment of the present disclosure;

[0280] Figures 52A-52D Several views of another flow meter with a valve, a drip chamber, and a tube are shown, wherein the flow meter has a receiving portion to receive the valve according to an embodiment of the present disclosure;

[0281] Fig.53A The embodiment according to the present disclosure is shown Figures 51A-51D and Figures 52A-52D Another view of the valve;

[0282] Figures 53B-53C The embodiment according to the present disclosure is shown Fig.53A Two exploded views of the valve;

[0283] Fig.54 shows the valve of FIG. 53 in manual use according to an embodiment of the present disclosure;

[0284] Fig.55 A valve including two flexible members according to an embodiment of the present disclosure is shown;

[0285] Figure 56A-Figure 56C Several views of a valve having two curved elongated support members, one of the elongated support members having a plurality of ridges adapted to engage a tube, are shown in accordance with an embodiment of the present disclosure;

[0286] Figure 57A-Figure 57C Several views showing a valve having a ratchet engaged with a connecting member according to an embodiment of the present disclosure;

[0287] Figure 57D-Figure 57E The embodiment according to the present disclosure is shown Figure 57A-Figure 57C Two exploded views of the valve;

[0288] Figure 58A-Figure 58D Several views of a valve having two elongated support members, a connecting member, and a screw-type actuator are shown according to an embodiment of the present disclosure;

[0289] Figure 59A-Figure 59C Several views of a body of a valve according to an embodiment of the present disclosure are shown;

[0290] Figure 59D-Figure 59G The embodiment according to the present disclosure is shown in Figure 59A-Figure 59C Several views of the knobs used in the body;

[0291] Fig.59H The embodiment according to the present disclosure includes Figure 59D-Figure 59G The knob coupling is shown in Figure 59A-Figure 59C The valve body is assembled in the valve body;

[0292] Fig.60 A valve with a guided protrusion according to an embodiment of the present disclosure is shown;

[0293] Fig.61 A motor and a motor for use with an embodiment of the present disclosure are shown. Fig.60 a valve fixing structure coupled to the valve;

[0294] Fig.62 The embodiment of the present disclosure is shown in FIG. Fig.61 Motor and valve fixing structure Fig.60 valve;

[0295] Fig.63 The embodiment of the present disclosure is shown Fig.60 another motor coupled to the valve and a valve fixing structure;

[0296] Fig.64A A valve having a collar and several fingers for regulating fluid flow through a fluid line according to an embodiment of the present disclosure is shown;

[0297] Fig.64B The embodiment according to the present disclosure is shown Fig.64A A cross-sectional view of a valve;

[0298] Fig.65 A cross-sectional view of a valve having two curved surfaces for positioning a fluid tube therein to regulate fluid flow through the fluid tube is shown in accordance with an embodiment of the present disclosure.

[0299] Figure 66A-66G Several views of a valve having a knob to move a connecting member, which is locked in place after moving the knob, are shown in accordance with an embodiment of the present disclosure.

[0300] Fig.67 shows a diagram illustrating actuation versus flow for a valve according to an embodiment of the present disclosure;

[0301] Fig.68A A flow meter using binary optics according to an embodiment of the present disclosure is shown;

[0302] Fig.68B The embodiment according to the present disclosure is shown Fig.68A The circuit used;

[0303] Figure 69A-Figure 69I Several views showing a safety valve that may be used with a flow meter according to an embodiment of the present disclosure;

[0304] Fig.70 A flow chart illustrating a method of estimating droplet growth and / or flow within a drip chamber according to an embodiment of the present disclosure is shown;

[0305] Figure 71A-Figure 71E An image taken from a flow meter with a template overlaid therein to illustrate an embodiment of the present disclosure is shown. Fig.70 Methods;

[0306] Fig.72 An adjustable backlight assembly according to an embodiment of the present disclosure is shown;

[0307] Figure 73A-73CSeveral views of a tube recovery device according to an embodiment of the present disclosure are shown;

[0308] Fig.74 A system for regulating fluid flow using a valve having two flexible slats according to an embodiment of the present disclosure is shown;

[0309] Fig.75 The embodiment according to the present disclosure is shown Fig.74 valve;

[0310] Fig.76A A valve using a fluid-based bladder is shown according to an embodiment of the present disclosure;

[0311] Fig.76B An embodiment of the present disclosure is shown with two elastic filling parts. Fig.76A a cross-sectional view of the assembled valve;

[0312] Fig.77 A system for regulating fluid flow using a valve having two flexible strips actuable by a linear actuator is shown according to an embodiment of the present disclosure;

[0313] Fig.78 FIG. 1 shows a valve with an actuated valve according to an embodiment of the present disclosure. Fig.77 system;

[0314] Fig.79 The embodiment according to the present disclosure is shown Figure 77-Figure 78 A close-up view of the valve;

[0315] Fig.80 The embodiment according to the present disclosure is shown as follows Fig.78 A close-up view of the valve actuated in FIG.

[0316] Fig.81 FIG. 1 shows a method for estimating an image according to an embodiment of the present disclosure. Figure 82A-B Several images of methods of droplet augmentation and / or fluid flow in;

[0317] Figure 82A-B A flow chart illustrating a method of estimating droplet addition and / or fluid flow according to an embodiment of the present disclosure is shown;

[0318] Fig.83 A flow chart showing a method for reducing noise from condensation according to an embodiment of the present disclosure is shown;

[0319] Fig.84 Another valve for use with a flow meter according to an embodiment of the present disclosure is shown;

[0320] Fig.85A shows a perspective view of another valve in an open position according to an embodiment of the present disclosure;

[0321] Fig.85B The embodiment of the present disclosure is shown in the closed position. Fig.85A A perspective view of a valve;

[0322] Fig.85C A valve housing and a plunger guide are shown according to an embodiment of the present disclosure. Fig.85A A view of the valve;

[0323] Fig.86 The embodiment according to the present disclosure is shown when in the closed position Figure 85A-Figure 85C A cross-sectional view of a valve housing and a filling portion;

[0324] Fig.87A A front view of a device for closing a door according to an embodiment of the present disclosure is shown, the device being used to control the flow of fluid through a drip chamber connected to a tube;

[0325] Fig.87B The embodiment of the present disclosure is shown in which the door is opened and the valve is protruded. Fig.87A A perspective view of the device;

[0326] Fig.87C The embodiment of the present disclosure shows the door opening and the protruding safety cut-off mechanism. Fig.87A A perspective view of the device;

[0327] Fig.87D The embodiment according to the present disclosure is shown Fig.87A A bottom view of the device;

[0328] Fig.88A shows a perspective view of another device for controlling fluid flow through a drip chamber connected to a tube according to an embodiment of the present disclosure, wherein the device has an open door;

[0329] Fig.88B The embodiment according to the present disclosure is shown only from Fig.88A A perspective view of a valve;

[0330] Fig.88C According to an embodiment of the present disclosure, Fig.88B The internal operation of the valve;

[0331] Fig.88D shows a simplified diagram illustrating the operation of the valve shutoff mechanism in a door closed position according to an embodiment of the present disclosure;

[0332] Figure 88E shows a simplified diagram of a valve shutoff mechanism in a door open position according to an embodiment of the present disclosure;

[0333] Figure 89A-Figure 89BA flow chart of a method for controlling fluid flow through a liquid drip chamber according to an embodiment of the present disclosure is shown;

[0334] Fig.90 A block diagram of a system for controlling fluid flow through a drip chamber is shown; and

[0335] Fig.91 An apparatus configured to control fluid flow through a drip chamber connected to a tube and control communication with an RFID interrogator according to an embodiment of the present disclosure is shown;

[0336] Fig.92 A drip chamber is shown which may make it difficult to obtain an accurate image of the drip chamber with an image sensor;

[0337] Fig.93 A flow chart showing a method for obtaining an image of a drip chamber;

[0338] Fig.94 An image sensor is used to show the droplets, showing that each droplet grows in the drip chamber and then falls;

[0339] Fig.95 A diagram of a system for communicating device status is shown. DETAILED DESCRIPTION

[0340] Figure 1 A block diagram of a system 1 for regulating fluid flow according to an embodiment of the present disclosure is shown. For example, the system 1 can regulate, monitor and / or control the flow of fluid into a patient 3. The system 1 includes a fluid reservoir 2, which is used to input the fluid contained therein into the patient 3. The fluid reservoir 2 is gravity-fed into a drip chamber 4 via a fluid tube 5. The fluid reservoir 2, the drip chamber 4, and the patient 3 can be viewed as part of the system 1 or as separate or optional artifacts for the system 1 (e.g., any fluid reservoir 2 and drip chamber 4 can be used to treat any patient 3).

[0341] A flow meter 7 monitors the drip chamber 4 to estimate the flow rate of liquid through the drip chamber 4. Fluid from the drip chamber 4 is gravity fed to the valve 6. The valve 6 regulates (i.e., changes) the flow of fluid from the fluid reservoir 2 to the patient 3 by regulating the flow of fluid from the drip chamber 4 to the patient 3. The valve 6 can be any valve as described herein, including a valve having two curved members, a valve having two flexible sheets, a valve that squeezes (or uniformly compresses) the tube over a significant section of the tube, etc. The valve 6 can be an inverted Bourdon tube valve that works in the opposite manner of a Bourdon tube, in that deformation of the fluid channel causes changes in fluid flow rather than fluid flow causing deformation of the fluid channel.

[0342] In alternative embodiments, the 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-based pump, a diaphragm pump, other pumps, etc.) coupled to the fluid tube 5. The outlined box denoted as 414 represents an optional type of infusion pump 414, which may not be used in some embodiments. The infusion pump 414 can use the flow meter 7 as feedback to control the flow of fluid through the fluid tube 5. The infusion pump 414 can communicate wirelessly with the flow meter 414 to receive the flow rate therefrom. The infusion pump 414 can use a feedback control algorithm (e.g., Figure 1 A control member 14) is used to regulate the flow of fluid, such as a proportional-integral-differential ("PID"), on-off, neural network, and / or fuzzy logic control system. In this particular exemplary embodiment (i.e., an embodiment with an 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 based on measurements from the flow meter 7, such as flow rate, infusion volume, total infusion volume, etc. In addition or alternatively, when the flow meter 7 communicates to the infusion pump 414 that a free flow condition exists, the infusion pump 414 may stop the flow of fluid (e.g., by stopping the suction action). In yet another embodiment, the monitoring client 8 controls the operation of the infusion pump 414 (e.g., via a wireless connection) and receives feedback from the flow meter 7.

[0343] In some embodiments, for example, where the fluid reservoir 2 (e.g., an IV bag) is below the patient 3, the fluid reservoir 2 is pressurized to cause fluid to flow from the fluid reservoir 2 into the patient 3; the pressurization provides sufficient mechanical energy to cause the fluid to flow into the patient 3. Various pressure sources (e.g., physical pressure, mechanical pressure, and pneumatic pressure) can be applied to the interior or exterior of the fluid reservoir 2. In one such embodiment, pressurization can be provided by a rubber band wrapped around the IV bag.

[0344] The flow meter 7 and the valve 6 can form a closed loop system to regulate the flow of fluid to the patient 3. For example, the flow meter 7 can receive a target flow rate from the monitoring client 8 by communicating using the transceivers 9 and 10. That is, the transceivers 9 and 10 can be used to communicate between the flow meter 7 and the monitoring client 8. The transceivers 9 and 10 can communicate with each other using a modulated signal to encode various types of information such as a digital signal or an analog signal. Some modulation techniques used may include using a carrier frequency with FM modulation, using AM modulation, using digital modulation, using analog modulation, etc.

[0345] The flow meter 7 estimates the flow through the drip chamber 4 and adjusts the valve 6 to achieve the target flow received from the monitoring client 8. The valve 6 can be controlled by the flow meter 7 directly from a communication line coupled to the actuator of the valve 6 or via a wireless link from the flow meter 7 to the onboard circuit of the valve 6. The action of the valve 6 can be controlled using the onboard electronics of the valve 6 via the actuator coupled thereto. This closed loop embodiment of the flow meter 7 and valve 6 can use any control algorithm, including a PID control algorithm, a neural network control algorithm, a fuzzy logic control algorithm, etc., or some combination thereof.

[0346] The flow meter 7 is coupled to a support member 17, which is coupled to the drip chamber 4 via a coupler 16. The support member 17 also supports a backlight 18. The backlight 18 includes an array of LEDs 20 that provide illumination for the flow meter 7. In some specific embodiments, the backlight 18 includes a background pattern 19. In other embodiments, the backlight 18 does not include the background pattern 19. In some embodiments, the background pattern 19 is only present in the lower portion of the backlight 18 and there is no background pattern 19 at the top of the backlight 18 (e.g., away from the ground).

[0347] The flow meter 7 includes an image sensor 11, a free flow detector component 12, a flow estimator component 13, a control component 14, an exposure component 29, a processor 15, and a transceiver 9. The flow meter 7 may be battery powered, may be powered by an AC outlet, may include a supercapacitor, and may include an onboard power supply circuit (not explicitly shown).

[0348] The image sensor 11 may be a CCD sensor, a CMOS sensor or other image sensors. The image sensor 11 captures an image of the drip chamber 4 and transmits image data corresponding to the captured image to the processor 15 .

[0349] The processor 15 is also coupled to the free flow detector component 12, the flow estimator component 13, the control component 14, and the exposure component 29. The free flow detector component 12, the flow estimator 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 a memory (e.g., a non-transitory processor readable memory, ROM, RAM, EEPROM, hard disk, hard drive, flash drive, etc.).

[0350] The processor 15 can execute the instructions of the free flow detector component 12 by analyzing the image data from the image sensor 11 to determine whether a free flow condition exists in the infusion chamber 4. Various embodiments of the free flow detector component 12 for detecting a free flow condition are described below. In response to the detected free flow condition, the processor 15 can make a function call to control the component 14 to send a signal to the valve 6 to completely stop the flow of fluid to the patient 3. That is, if the free flow detector component 12 determines that a free flow condition exists, the flow meter 7 can instruct the valve 6 to stop the flow of fluid, can instruct the monitoring client 8 to stop the flow of fluid (which can be in communication with the valve 6 or the pump 414) and / or can instruct the pump 414 to stop suction or use an internal safety occluder to block the flow of fluid.

[0351] The flow estimator component 13 uses the image data from the image sensor 11 to estimate the flow rate of the fluid flowing through the drip chamber 4. The processor 15 communicates the estimated flow rate to the control component 14 (e.g., via a function call). Various embodiments of estimating the flow rate are shown below. If the flow estimator component 13 determines that the flow rate is greater than a predetermined threshold or outside a predetermined threshold, the flow meter 7 may instruct the valve 6 to stop the fluid flow (which may be communicated with the valve 6 or the pump 414), may instruct the monitoring client 8 to stop the fluid flow (which may communicate with the valve 6 or the pump 414), and / or may instruct the pump 414 to stop suction or use an internal safety occluder to block the fluid flow.

[0352] The processor 15 controls the array of LEDs 20 to provide sufficient illumination to the image sensor 11. For example, the exposure component 29 may be used by or in conjunction with the processor 15 to control the array of LEDs 20 so that the image sensor 11 captures sufficient image data for use by the free flow detector component 12 and the flow estimator component 13. When generating image data, the processor 15 may execute the exposure component 29 (see Figure 2 ) stored in the image sensor 11 to control the lighting conditions and / or the exposure of the image sensor 11. Additionally or alternatively, the exposure component 29 may be implemented as a circuit, an integrated circuit, a CPLD, a PAL, a PLD, a hardware description language-based implementation, and / or a software system.

[0353] The control means 14 calculates the adjustments to be made to the valve 6 based on the estimated flow from the flow estimator means 13. For example and as previously described, the control means 14 may execute a PID control algorithm to adjust the valve 6 to achieve a target flow.

[0354] In some embodiments, the monitoring client 8 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 communicate a signal to the valve 6 to interrupt the flow of fluid to the patient 3.

[0355] The flow meter 7 may additionally include various input / output devices to facilitate patient safety, such as various scanners, and may use the transceiver 9 to communicate with electronic medical records, medication error recovery systems, and / or facility services such as inventory control systems.

[0356] In certain embodiments, the flow meter 7 has a scanner, such as an RFID interrogator that reads and writes an RFID tag attached to the fluid reservoir 2 or a barcode scanner that scans a barcode on the fluid reservoir 2. The scanner can be used to determine whether the correct fluid is in the fluid reservoir 2, whether it is the correct fluid reservoir 2, whether the process programmed into the flow meter 7 corresponds to the fluid in the fluid reservoir 2, and / or whether the fluid reservoir 2 and flow meter 7 are correct for a particular patient (e.g., as determined from a patient's barcode, a patient's RFID tag, or other patient identification).

[0357] For example, the flow meter 7 may scan the RFID tag of the fluid reservoir 2 to determine if the serial number or fluid type encoded within the RFID tag is the same as indicated by the programmed process stored within the flow meter 7. Additionally or alternatively, the flow meter 7 may read and write the RFID tag of the fluid reservoir 2 for the serial number, and read and write the RFID tag of the patient 3 for the patient serial number, and also read and write the electronic medical record using the transceiver 9 to determine if the serial number of the fluid reservoir 2 within the RFID tag attached to the fluid reservoir 2 matches the serial number of the patient within the RFID tag attached to the patient 3 as shown in the electronic medical record.

[0358] Additionally or alternatively, the monitoring client 8 can scan the RFID tag of the fluid reservoir 2 and the RFID tag of the patient 3 to determine that the fluid in the fluid reservoir 2 is correct, the fluid reservoir 2 is correct, the process programmed into the flow meter 7 corresponds to the fluid in the fluid reservoir 2, and / or the fluid reservoir 2 is correct for the particular patient (e.g., as determined from the patient's barcode, RFID tag, electronic medical record, or other patient identification or information). Additionally or alternatively, the monitoring client 8 or the flow meter 7 can read and write to the electronic medical record database and / or the pharmacy to verify the prescription or download the prescription, for example using the serial number of the barcode on the fluid reservoir 2 or the RFID tag attached to the fluid reservoir 2.

[0359] Figure 2 An image sensor for exposure according to an embodiment of the present disclosure is shown. Figure 1 Flowchart of method 21 of image sensor 11. Method 21 includes actions 22, 23, 24 and 25. Method 21 may be Figure 1 The method may be executed by the processor 15 (eg, as the exposure component 29) and may be implemented as a processor-executed method, such as a set of instructions configured for execution by one or more processors in hardware, in software, etc., or some combination thereof.

[0360] Action 22 selects a region of interest. For example, see again Figure 1 , the image sensor 11 comprises a field of view, which field of view comprises the drip chamber 4. However, the drip chamber 4 may not occupy the entire field of view of the image sensor 11. Action 22 selects only pixels of the image sensor 11 showing, for example, the drip chamber 4.

[0361] Action 23 determines whether the pixel is within the region of interest 23. If the pixel of action 23 is, for example, a pixel that images the drip chamber 4, then action 23 determines that it is within the region of interest. Likewise, in this example, if the pixel of action 23 is a pixel that does not image the drip chamber 4, action 23 determines that the pixel is not within the region of interest.

[0362] If the pixel is within the region of interest, action 24 activates the backlight, e.g. Figure 1 The backlight 18 of the image sensor can be activated. The pixels of the image sensor can be exposed at different times. Therefore, the backlight 18 can be activated only when the pixels in the area of ​​interest are being exposed. For example, some image sensors include a vertical synchronization signal and a horizontal synchronization signal. The backlight can be synchronized with these signals to turn on when the pixels of interest are being exposed.

[0363] In some embodiments of the present disclosure, a subset of LEDs of a backlight (e.g., a subset of LED array 20, which may be a two-dimensional array) may be turned on. If the pixel is within the region of interest, the subset may be sufficient to adequately illuminate the pixel being exposed.

[0364] Act 25 exposes the pixel. If in act 23, it is determined that the pixel is within the region of interest, the pixel is exposed using at least a portion of the backlight source turned on in act 25. Additionally, if in act 23, it is determined that the pixel is not within the region of interest, the pixel is exposed without turning on at least a portion of the backlight source in act 25.

[0365] Figure 3 The embodiment according to the present disclosure is shown Figure 2 Timing of an embodiment of the method Fig.29 Timing Fig.29 Includes tracks 26, 27, and 28. Track 26 is the vertical sync signal from the image sensor and track 27 is the vertical sync signal from the image sensor (e.g., Figure 1 A circuit or software program (for example, in Figure 1 The exposure means 29 present in the flow meter 7 can use the synchronization tracks 26, 27 to generate a backlight enable signal 28 for activating the backlight or a subgroup thereof.

[0366] Figure 4A-4BAccording to the embodiment of the present disclosure, Figure 3 The timing diagram shows Figure 2 An example of image data of a flow meter 7 according to an embodiment of the method. Figure 4A Shown in no use Shown in Figure 2 and Figure 3 In the case of the exposure algorithm in , the image data obtained by the flow meter, such as Figure 1 Flow meter 7; Figure 4B Shown in use Figure 2 and Figure 3 The image data obtained by the flow meter under the exposure algorithm. Due to the less use of backlight, Figure 4A Less power is required to provide lighting for image capture than for Figure 4B Provides illumination during image capture.

[0367] Figure 5 A block diagram of a flow meter 67 and a valve 71 integrated together for coupling with a drip chamber 409 and an IV bag 69 according to an embodiment of the present disclosure is shown. The flow meter 67 includes an optical drop counter 68 that receives fluid from the IV bag 69. The optical drop counter 68 can be an image sensor, a pair of image sensors, a capacitive drop counter, etc. The flow meter 67 is coupled to a tube 70, which is coupled to a roller clamp 71 controlled by a motor 72. The motor 72 is coupled to a lead screw mechanism 73 to control the roller clamp 71 via cooperation with a mating member 74.

[0368] The motor 72 may be a servo motor and may be used to regulate the flow through the tube 70. That is, the flow meter 67 may also function as a flow meter and a regulator. For example, a processor 75 within the flow meter 67 may regulate the motor 72 so that a desired flow rate is obtained as measured by the optical drop counter 68. Using the optical drop counter 68 as feedback, the processor 75 may execute a control algorithm, such as a PID control loop, to supply output to the motor 72 and receive feedback from the optical drop counter 68.

[0369] In alternative configurations, the motor 72, the screw mechanism 73, and the rolling clamp 71 may be replaced and / or supplemented by an actuator that squeezes the tube 70 (e.g., using a cam mechanism or a linkage mechanism driven by a motor), or they may be replaced by any adequate motor-driven stick, screw, or slider. For example, in some embodiments of the present disclosure, the rolling clamp 71 may be replaced by any valve as described herein, including a valve having two C-shaped members, a valve having two curved support members, a valve having two flexible sheets, a valve that squeezes the tube on a significant section of the tube, and the like.

[0370] The flow meter 67 may also optionally include a display. The display may 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 rate.

[0371] Figure 6 is a block diagram of an imaging system 78 of a flow meter for imaging a drip chamber according to an embodiment of the present disclosure. Figure 6 The imaging system 78 shown in FIG. 1 may be used in the embodiments described herein including Figure 1 Flow meter 7 and / or Figure 5 Any flow meter within the flow meter 67.

[0372] Figure 6 The imaging system 78 includes an image sensor 63; a uniform backlight source 79 that partially transmits light through the drip chamber 59; and an infrared (“IR”) filter 80 that receives light from the uniform backlight source 79.

[0373] The system 78 also includes a processor 90 that is operatively coupled to the image sensor 63 and / or the uniform backlight 79. The processor 90 executes an algorithm to determine when a free flow condition exists and / or to estimate flow (e.g., using Figure 1 The processor 90 may be in operable communication with a processor readable memory 91 (e.g., a non-transitory processor readable memory) to receive one or more instructions to execute an algorithm to determine whether a free flow condition exists and / or estimate a flow velocity. One or more instructions from the processor readable memory 91 are configured to be executed by the processor 90.

[0374] The uniform backlight source 79 can be an array of light emitting diodes ("LEDs") of the same or different colors, light bulbs, windows receiving ambient light, incandescent lamps, etc. In some configurations, the uniform backlight source 79 can include one or more point source lamps.

[0375] The processor 90 may adjust the uniform backlight 79 based on the image sensor 63. For example, the processor 90 may activate the uniform backlight 79 for a predetermined amount of time and signal the image sensor 63 to capture at least one image, and thereafter signal the uniform backlight 79 to turn off. One or more images from the image sensor 63 may be processed by the processor 90 to estimate flow and / or detect free flow conditions. For example, in one embodiment of the present disclosure, the system 78 monitors the size of droplets being formed in the drip chamber 59 and counts the number of drops that flow through the drip chamber 59 within a predetermined amount of time; the processor 90 may average the periodic flow from each droplet over a period of time to estimate the flow rate. For example, if each X droplet having a flow rate Y flows through the drip chamber within a time Z, the flow rate may be calculated as (X*Y) / Z.

[0376] Additionally or alternatively, the system 78 can determine when IV fluid is flowing through the drip chamber 59 (i.e., during free flow conditions). The uniform backlight 79 transmits light through the drip chamber 59 to provide sufficient illumination for the image sensor 63 to image the drip chamber 59. The image sensor 63 is capable of capturing one or more images of the drip chamber 59.

[0377] Other orientations and configurations of the system 78 may be used to account for the orientation and output characteristics of the uniform backlight 79, the sensitivity and orientation of the image sensor 63, and ambient light conditions. In some embodiments of the present disclosure, the processor 90 executes an algorithm that utilizes the uniformity of the image collected by the image sensor 63. The uniformity may be facilitated by a uniform backlight 79. For example, when a uniform backlight 79 is used, the image sensor 63 may capture a consistently uniform image.

[0378] Ambient light can cause inconsistencies in the images received from the image sensor 63; for example, direct sunlight provides inconsistent illumination because the sun can be intermittently obscured by clouds and the brightness and angle of the sun depend on the time of day. Therefore, in some embodiments of the present disclosure, an IR filter 80 is optionally used to filter out some of the ambient light to mitigate variations in the images captured by the image sensor 63. The IR filter 80 can be a narrow-band infrared filter placed in front of the image sensor 63; and the uniform backlight source 79 can emit light of a wavelength approximately the same as the center frequency of the passband of the filter 80. The IR filter 80 and the uniform backlight source 79 can have a center frequency of approximately 850 nanometers. In some embodiments, the imaging system 78 can be surrounded by a visually translucent (but IR shielding) shell. In alternative embodiments, other optical frequencies, bandwidths, center frequencies, or filter types can be used in the system 79.

[0379] In some embodiments, the processor 90 may use the template to perform template matching of the pool of water within the drip chamber 59. Any pre-processing may be performed prior to the template matching operation. In addition, if the camera 63 is positioned higher than the preferred position, a prism may be used so that the field of view of the camera 63 is the preferred field of view of the drip chamber 59. The location of the peak template match may be related to the location of the pool and therefore the volume of the pool.

[0380] If the pool is too low, because water is leaving the pool and draining toward the patient at an unsafe rate, the device can trigger a safety valve (described below). The backlight 79 can be on or off depending on the embodiment. The oscillation of the top of the pool can be monitored to determine the resonant frequency of the water. The resonance of the top of the pool as droplets impact the pool can be related to the capacity of the pool. In other embodiments, sudden changes in the pool can be related to droplets impacting the pool so that the processor 90 can count the number of drops per unit time and estimate the fluid flow therein.

[0381] In some embodiments, autofocus may be used to find the waterline. That is, the focal line may be focused to ensure that the entire image is in focus.

[0382] In some embodiments, the processor 90 may be coupled to wires etched into a PCB board, making it a software radio. This allows the processor 90 to communicate information with another device capable of operating at a sufficient frequency.

[0383] Figure 7 According to the embodiment of the present disclosure Figure 6 83 is an illustration of an image 81 captured by the image sensor 63 of the system 78 of FIG. Image 81 is an image of the drip chamber 59 having condensation 82 and a flow 83 caused by free flow conditions therein. In some embodiments, edge detection may be used to determine the location of the flow 83 and / or condensation 82. Additionally or alternatively, a background image or pattern may be used.

[0384] Figure 8 is a block diagram of an imaging system 84 of a flow meter for imaging a drip chamber according to an embodiment of the present disclosure. The imaging system 84 can be used with any flow meter disclosed herein, including Figure 1 Flow meter 7 and Figure 5 Flow meter 67.

[0385] The system 84 includes an array of lines 85 that are opaque behind the drip chamber 59. The system 84 uses the array of lines 85 to detect free flow conditions. A free flow condition algorithm (e.g. Figure 1 The free flow detector component 12) can use the presence or absence of droplets to determine whether a flow condition (such as a free flow condition) exists.

[0386] In some specific embodiments, line 85 is present on only a portion of the image (e.g., the background pattern occupies only a portion of backlight 18 or binary optics only cause the pattern to appear in a portion of the image, such as the lower half or the upper half). For example, the lower portion of the image may include a banded background pattern.

[0387] See now Fig. 9 According to the embodiments of the present disclosure, Figure 8The image sensor 63 captures the image 86 when free flow conditions exist in the drip chamber 59. The image 86 shows a state where the drip chamber 59 is subjected to free flow conditions and shows the flow of the fluid 87 acting as a positive cylindrical lens. That is, Fig. 9 As shown in FIG. 1 , the array of lines 85 as captured in the image by the image sensor 63 is shown as an inverted line pattern 88 from the array of lines 85, compared to non-free flow conditions. As the light approaches the image sensor 63, the appearance of the inverted line pattern 88 results from the change in the light as it passes through the flow of the fluid 87.

[0388] In some embodiments of the present disclosure, the image 86 may be created using illumination with light having an optical wavelength of approximately 850 nanometers. Some materials may be opaque in the visible spectrum and transparent in the near IR spectrum of approximately 850 nanometers, and thus may be used to create an array of wires 85. The array of wires 85 may be created using a variety of rapid prototyping plastics. For example, the array of wires 85 may be created using a rapid prototyping structure printed with an infrared opaque ink or coated with metal to achieve the array of wires 85. Additionally or alternatively, in some embodiments of the present disclosure, another method of creating an array of wires 85 is to create a circuit board with the wires laid in copper. In another embodiment, the array of wires 85 is created by laying a ribbon cable over a uniform backlight source 79; the wires in the ribbon cable are opaque to the infrared spectrum, but the insulator is transparent so that the spacing of the wires can form wires for use during imaging by the image sensor 63 (see Figure 8 ). In yet another additional embodiment, a thin piece of electro-discharge machined (EDMed) metal may be utilized. Metal is opaque to light, and the spaces between the metal material deposits can be very finely controlled during manufacturing to allow IR light to pass through these spaces.

[0389] Processor 90 implements an algorithm to determine when a free flow condition exists (e.g., using Figure 1 The processor 90 may be in operable communication with a processor readable memory 91 (e.g., a non-transitory processor readable memory) to receive one or more instructions to implement an algorithm to determine whether a free flow condition exists. The one or more instructions from the processor readable memory 91 are configured for execution by the processor 90.

[0390] Refer again Figure 8 , the system 84 can use blood. For example, when utilizing an image sensor 63 configured, for example, for using visible light having a wavelength of 850 nanometers or 780 nanometers, an IR filter 80, and a uniform backlight source 79, for example, when using bovine blood, the system 84 can determine when a free flow condition of blood exists. Compared to an image taken using water, the blood may appear opaque.

[0391] The following algorithm implemented by processor 90 and received from processor readable memory 91 may be used to determine when a free flow condition exists: (1) Create a background image 89 (see Fig.10 ); and (2) subtracting the background image 89 from the current image. In addition, processing can be performed on the resulting image.

[0392] In some embodiments of the present disclosure, Fig.10 The background image 89 can be dynamically generated by the processor 90. The dynamic background image can be used to account for changing conditions, such as condensation or splash 82 on the surface of the drip chamber 59 (see Figure 7 ). For example, in one specific embodiment, for each new image captured by the image sensor (e.g., Figure 8 63), the background image has each pixel multiplied by 0.96, and the current image (e.g., the most recently captured image) has the corresponding pixel multiplied by 0.04, after which the two values ​​are added together to create a new value for the new background image of the corresponding pixel; this process can be repeated for all pixels. In yet another example, in a specific embodiment, if a pixel of the new image is at row x and column y, the new background image at row x and column y is the value of the previous background image at row x and column y multiplied by 0.96 plus the value of the pixel of the new image at row x and column y multiplied by 0.04.

[0393] When the system 84 has no water flowing through the drip chamber 59 (see Figure 8 ), the resulting difference image should be almost completely black, i.e., low pixel size, thus facilitating the algorithm to determine that the drip chamber 59 has no water flowing through it.

[0394] Fig.11 An image 92 from the image sensor 63 is shown when a droplet is present in the drip chamber 59 (see Figure 8 ). Fig.12 A background image 93 is shown for use by the system 84. When the system 83 has Fig.11 When the droplet shown in image 92 is Figure 8 The system 84 has several high contrast points where the image of the line array is distorted by the lensing action of the droplets, as shown by Fig.13 Image 94 illustrates the. Fig.13 The image 94 is obtained by taking each corresponding pixel from Fig.12 Image 93 minus Fig.11 The absolute value of the image 92 is generated by converting each corresponding pixel to a white pixel if the value is above a predetermined threshold or to a black pixel when the value is below a predetermined threshold. Fig.13Each white pixel within image 94 is the result of a difference in pixel position between image 92 and image 93 that is greater than a predetermined threshold.

[0395] For example, consider Fig.11 , Fig.12 ,and Fig.13 In order to determine the three corresponding pixels with row x and column y positions Fig.13 The pixels of row x and column y of the image 94 are obtained from Fig.12 The pixel at row x and column y of image 92 is subtracted from the pixel at row x and column y of image 92. Fig.11 92 of the image, then taking the absolute value of the subtracted result; and if the absolute value of the result is above a predetermined threshold (e.g., above a grayscale value of 128, for example), then Fig.13 The pixel at row x and column y of image 94 is white, otherwise Fig.13 The pixel at row x and column y of image 94 is black.

[0396] When determined in Fig.13 When there are a number of high-contrast spots in the image 94, the processor 90 of the system 84 (see Figure 8 ) determines that a droplet is formed in the drip chamber 59 and that a free flow condition does not exist. The image of the droplet can be used to determine the size of the droplet to estimate the flow rate as described herein.

[0397] Fig.14 According to the embodiments of the present disclosure, Figure 11-13 A graphical representation of some of the image processing performed to determine if free flow conditions exist. Fig.14 and Fig.13 , all white pixels in each row are added together, and Fig.14 Result 183 is shown in FIG. The y-axis represents the number of rows, and the x-axis represents the sum of the number of white pixels of each corresponding row.

[0398] Now only refer to Fig.14 As previously mentioned, the number of white pixels in each row is summed together and shown as result 183, which is used to determine whether or when a free flow condition exists. In some specific embodiments, when a predetermined number of consecutive values ​​of the summed rows of result 183 are above threshold 184, processor 90 (see Figure 8 ) determines that a free flow condition exists. For example, within result 183, a range of a plurality of consecutive rows, generally represented by 185, has a total value above threshold 184. When greater than a predetermined number of consecutive summed rows are determined to exist within result 183 above a predetermined threshold (e.g., threshold 184), Figure 8 The processor 90 determines that a free flow condition exists. For example, if Fig.14 As shown, the range of the plurality of consecutive summed rows 185 is below the predetermined number of consecutive summed rows (ie, the range 185 is not wide enough) and therefore a free flow condition is determined not to exist.

[0399] Fig.15 When free flow conditions exist, the flow is shown as Figure 8 The image 95 is captured by the image sensor 63 . Fig.16 A background image 96 is shown. Fig.17 It is shown that when the absolute value is converted to a white pixel (when the absolute value of the difference is above the threshold) or converted to a black pixel (when the absolute value of the difference is below the threshold), Fig.16 Images 96 and Fig.15 The absolute value of the difference between the images 95 forms the image 97. Fig.17 As shown, processor 90 may detect high contrast spots caused by reverse orientation of wires in a stream flowing from top to bottom. Figure 8 Processor 90 can use image 97 to determine whether a free flow condition exists using the algorithm described above.

[0400] That is, if Fig.18 As shown, the result 186 is shown as a continuous range 187 of results 186 having a threshold value 188. Because the summed row of the continuous range 187 is greater than a predetermined threshold number of consecutive values ​​above the threshold value 188, the processor 90 determines that a free flow condition exists (see Figure 8 That is, the continuous range of results 186 above threshold 188 is greater than the predetermined threshold range of continuous values; therefore, processor 90 uses Fig.18 A result of 186 determines that free flow conditions exist.

[0401] In other embodiments of the present disclosure, intensity, square of intensity, or other functions may be used to generate Fig.14 Results 183 and / or Fig.18 Result 186. In other embodiments, 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 B-spline function, a Bezier spline function, a polynomial interpolation, a moving average, or other data smoothing functions.

[0402] For example, a background image (e.g. Fig.16 Image 96) minus Figure 8 The image sensor 63 has an image (eg, Fig.15 The intensity value can be obtained from the image 95. Fig.16 The pixels of row x and column y of image 96 are subtracted Fig.15The pixel of row x and column y is used to create an intensity value at row x and column y; this process can be repeated for all pixel positions to obtain all intensity values. The intensity values ​​of each row can be added together to obtain the result 183 and / or 186 (see respectively Fig.14 and 18 ), such that when the intensity values ​​of the summed rows have a continuous range of summed rows above a threshold, the processor 90 can determine that a free flow condition exists. In some embodiments, the intensity values ​​are converted to absolute values ​​of intensity values, and the intensity values ​​of the absolute values ​​of the summed rows are used to determine whether the continuous range of summed rows of absolute values ​​is above a threshold range of continuous values. Additionally or alternatively, the intensities can be squared, and then the processor 90 can sum the squared intensity rows and determine whether there is a continuous range of summed rows of squared intensity values ​​that exceeds the threshold range of continuous values ​​to determine whether a free flow condition exists.

[0403] In some embodiments, the processor 90 may use a predetermined range of consecutive values ​​(e.g., a minimum and maximum range) above a threshold value for the summed rows of intensity values ​​or intensity square values ​​to determine whether a droplet is within the image. For example, each row of intensity values ​​(or intensity square values) may be summed, and the range of summed values ​​may be above a threshold number; if the range of consecutive values ​​is between the minimum range and the maximum range, the processor 90 may determine that the range of consecutive values ​​above the predetermined threshold is a droplet within the field of view of the image sensor 63 (see Figure 8 ). In some embodiments of the present disclosure, the summed rows of intensity values ​​or intensity square values ​​may be normalized, for example, normalized to have a value between 0 and 1.

[0404] A smoothing function similar to a cubic spline (i.e., a cubic spline type function) is described below, which may be used on a summed row, a summed row of intensity values, or a summed row of squared intensity values ​​prior to determining whether a free flow condition exists by the processor 90. In some specific embodiments, a cubic spline type function may be used to identify blocks, as described below, which may facilitate identification of a free flow condition by the processor 90.

[0405] A cubic spline type function is an analog of a cubic spline, but it smooths the data set rather than faithfully mimicking a given function. The data is sampled in an interval from [0,1] (e.g., along the normalized squared or row sum of intensities), and the processor 90 (see Figure 6 or Figure 8 ) can be in the interval [x0,x1],[x1,x2],2,[x N-1 ,x N ](x0=0, and x N =1) Find the best fitting set of cubic functions where the total function is continuous with continuous derivatives and continuous curvature.

[0406] The definition of the standard cubic spline is shown in equation (1):

[0407] χ(x)=A i (x)y i +B i (x)y i+1 +C i (x)y″ i +D i (x)y″ i+1 x i ≤x≤x i+1 (1)

[0408] And function A i ,B i ,C i ,D i It is defined as in equation (2):

[0409]

[0410] Equations (1) and (2) guarantee continuity and curvature continuity. The only values ​​that can be freely chosen are y i ,y″0 and y″ N . Please note that equation (3) is chosen as follows:

[0411] y″0=y″1=0 (3)

[0412] That is, the function is flat at 0 and 1. The remaining y″ i The following equations (4) must be satisfied:

[0413] The system of equations (4) can be rewritten as the following system of equations (5):

[0414] Sequentially, this becomes the matrix equation (6)

[0415]

[0416] The matrix equation (6) can be rewritten as the following equation system (7):

[0417] F dd =Gy

[0418] y dd =F -1 Gy=Hy (7)

[0419] Using the least squares criterion for the collected data, the selection of the values ​​in vector y is shown in equation (8) below:

[0420]

[0421] Equation (8) is the minimum deviation between the data and the spline, that is, equation (8) is the error function. The y value is selected to minimize the error defined in equation (8). The predicted value of the vector can be written as shown in the following equation (9):

[0422]

[0423] The elements of the matrix in the brackets of equation (9) depend on the x-values ​​corresponding to each data point (but this is a fixed matrix). Thus, the final equation can be determined using the pseudo-inverse. In turn, the pseudo-inverse depends only on the x-position of the data set and the position of the discontinuity set in the cubic spline. The significance of this is that once the geometry of the spline and the size of the image are chosen, given a set of measured values ​​ym, the best choice for y is shown in equation (10) below:

[0424] y=(A T A) -1 A.y m (10)

[0425] By accumulating the intensity-square function of the image, the cubic spline is then given by equation (11):

[0426] y cs =A·y (11)

[0427] Since the maximum of the cubic spline is of interest, the derivative of the cubic spline is determined and used to determine the maximum of the cubic spline. The derivative of the spline is given by the following equation (12):

[0428]

[0429] Equation (12) can be written as follows:

[0430] y′ cs =(A′ {k} +B′ {k} )y+(C′ {k} +D′ {k} )y dd

[0431] =[A′ {k} +B′ {k} +C′ {k} H+D′ {k} H]y

[0432] =A′y (13)

[0433] Once the current value of y is found, the three splines of y can be calculated cs and its derivative y' cs The cubic spline data may include a "block" of data that includes values ​​above a predetermined threshold. A pipe block is formed by liquid flowing from the pipe into the drip chamber 59, and a pool block is formed as liquid collects at the gravity end of the drip chamber 59 (see Figure 8 ).

[0434] The following algorithm can be applied to cubic spline data: (1) use derivative information to determine local maxima of the cubic spline data; (2) determine blocks around each local maximum by including all points where the cubic spline value is above a threshold; (3) merge all blocks that intersect; (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 of the initial sum of the intensity squared data in the block, the standard deviation of the initial sum of the intensity squared data in the block, and the average intensity of the high pass filtered image set in the block; and (5) interpret the collected data to obtain information about when droplets occur and when the system is flowing.

[0435] The average intensity of the high pass filtered image group in the block is used to determine whether the block generated by each continuous range of sampled data is the result of a high frequency artifact (e.g., a drop) or a low frequency artifact. This will act as a second background filter, which tends to eliminate artifacts such as condensation from the image. That is, all previous images in the image buffer memory (e.g., 30 previous frames, for example) are used to determine whether the data is the result of high frequency movement between frames. If the block is the result of a low frequency change, the block is removed, or if the block is the result of a high frequency change, the block is retained for further analysis. A finite impulse response filter or an infinite impulse response filter can be used.

[0436] Each block is drawn over its physical extent with a height equal to the mean of the data within the block. If a block has a mean of the high pass filtered image less than a threshold, it indicates that it has been surrounded for several images and can therefore be removed.

[0437] When a tube block extends close to a pool block, a tube block and a pool block are merged together, and / or the width range of the sum of the pool block and the tube block (or all blocks) is greater than a predetermined threshold, for example, the total range of the blocks exceeds 380 pixels in width, the processor 90 (see Figure 6 or Figure 8) uses these blocks to determine that a free flow condition exists. The processor 90 can detect a droplet when a transition from a larger width to a shorter width tube block occurs as a result of the droplet forming in the tube and as the droplet leaves the tube (i.e., tube) opening of the drip chamber 59. The processor 90 can detect a droplet by looking at the ratio of the current tube block width to the tube block width of the previous image, for example, an image where the ratio is less than 0.9 (also a local minimum) can be considered by the processor 90 as an image formed immediately after the droplet has formed.

[0438] Various filtering algorithms may be used to detect condensation or other low frequency artifacts, such as: if a block has a low average value in the high pass filtered image, it may be condensation. Such artifacts may be removed from consideration. Additionally or alternatively, long blocks with a low high pass average value (e.g., greater than a predetermined threshold) may be flow, since flow images tend to remain constant; processor 90 may determine that long blocks greater than a predetermined threshold correspond to a flow condition. Additionally or alternatively, an algorithm may be used on the current image to detect a free flow condition.

[0439] In some specific embodiments, processor 90 can use block data to count droplets to use system 84 as a drop counter. Processor 90 can also use the width change in the pool block to determine whether bubbles formed by droplets hit the pool when the droplets disturb the water. For example, processor 90 can determine that those blocks formed below the pool block are from bubbles formed when the droplets hit the water. When it is determined that the predetermined value of the total block range indicates that a free flow condition exists, processor 90 filters out the bubbles.

[0440] In some embodiments of the present disclosure, the depth of field of system 84 may have a narrow depth of field to make system 84 less sensitive to condensation and droplets on the chamber walls. In some embodiments, a close focus system may be used.

[0441] Now refer to Fig.19 In another embodiment of the present disclosure, template 189 is used to determine whether a free flow condition exists. When in an image (e.g., Fig.13 When the template matching algorithm is performed on the image 94), Figure 8 The processor 90 uses the template 189 to determine the pattern match score 190. For example, the module 189 can be compared to the image 94 to determine whether a portion or all of the image 94 closely matches the module 189. As previously mentioned, Fig.13 The image 94 is the background image with Figure 8The difference between the images captured by the image sensor 63 is calculated, and each pixel is converted to a black pixel if the difference value of the pixel is below a threshold, or converted to a white pixel if the difference value of the pixel is above a threshold. All pixels of the image 94 will be white pixels or black pixels. If the pattern matching score 190 is above a predetermined threshold, it is determined that a free flow condition exists. The template matching method can utilize a template matching algorithm such as found in the open source computer vision ("OpenCV") library. For example, using the CV_TM_CCOEFF method or the CV_TM_CCOEFF_NORMED method, the template 189 can be used with the matchTemplate() function call of the OpenCV library. The CV_TM_CCOEFF method uses the pattern matching algorithm described in equation (14) as follows:

[0442]

[0443] in:

[0444] T′(x′,y′)=T(x′,y′)-1 / (w·h)·∑ x″，y″ T(x″, y″)

[0445] I′(x+x′,y+y′)=I(x+x′,y+y′)-1 / (w·h)·∑x ″，y″ I(x+x″,y+y″)

[0446] I denotes image, T denotes template, and R denotes result. The summation is performed over the template and / or image patch such that: x'=0...w-1 and y'=0...h-1.

[0447] The result R can be used to determine how well the template T matches at a particular location within the image I as determined by the algorithm. The OpenCV template matching method of CV_TM_CCOEFF_NORMED uses the pattern matching algorithm described in equation (15) as follows:

[0448]

[0449] In another embodiment of the present disclosure, the template matching algorithm uses a fast Fourier transform ("FFT"). In some embodiments, any method of the matchTemplate() function of OpenCV can be used, for example, CV_TM_SQDIFF, CV_TM_SQDIFF_NORMED, CV_TM_CCORR, and / or CV_TM_CCORR_NORMED.

[0450] CV_TM_SQDIFF uses the pattern matching algorithm described in equation (17) as follows:

[0451]

[0452] CV_TM_SQDIFF_NORMED uses the pattern matching algorithm described in equation (18) as follows:

[0453]

[0454] CV TM CCORR uses the pattern matching algorithm described in equation (19) as follows:

[0455]

[0456] CV_TM_CCORR_NORMED uses the pattern matching algorithm described in equation (20) as follows:

[0457]

[0458] In yet another embodiment of the present disclosure, the template of the grayscale image of the free flow condition is compared with the template of the grayscale image of the free flow condition. Figure 8 The image sensor 63 is compared with the image acquired to determine whether a free flow condition exists. In some embodiments, the template matching function in the OpenCV library can be used.

[0459] Now refer to Fig. 20 and Fig.21 In another embodiment of the present disclosure, for example, as Figure 8 The algorithm executed by processor 90 to determine when a free flow condition exists may utilize an algorithm to utilize edge detection followed by line detection to determine whether the template pattern matches the pixel array. Fig. 20 As shown, by using detected edges followed by line detection, image 98 is represented by Fig.21 The processor 90 can use the resulting line to determine whether a free flow condition exists. Fig. 20 As shown, after processing by processor 90, the features shown are lines having a slope different from the expected 45° slope of the background reference image. Fig. 20 These lines that have an angle with the background image are filtered out. The lines can be detected as edges using the Canny algorithm as found in the OpenCV library. The slope of the line can be determined using the Hough algorithm also found in the OpenCV library.

[0460] One type of Hough transform uses the algorithm described in Progressive Probabilistic Hough Transform by J. Matas, C. Galambos, and J. Kittler, 1998 ("Algorithm 1"). However, the following "alternative Hough" transform may be utilized and is shown in pseudo code in Table 1 ("Algorithm 2"). Algorithm 2 randomly selects two pixels and computes the Hough transform of the line passing through these two points. Algorithm 2 is shown in Table 1 as follows:

[0461]

[0462] If the line includes a proportion p of the total points, then we will see that the result in the representative (r,θ) binary is p for Algorithm 1 and p for Algorithm 2 2 Generally, in some embodiments, the ratio test has at least 5 positive results and 5 negative results. Assuming that negative results are more likely to be seen than positive results, in some embodiments, Algorithms 1 and 2 continue searching the line until there are at least 5 positive results in a particular binary.

[0463] The probability of seeing a fifth positive result in Algorithm 1 after N ≥ 5 trials is shown in Equation (21) as follows:

[0464]

[0465] And the possibility in Algorithm 2 is shown in equation (22) as follows:

[0466]

[0467] Table 2 shown below shows that there is a 50% chance of seeing 5 successful results p 1,50 and p 2,50 The number of trials and a 90% chance of seeing 5 successful outcomes p 1,90 and p 2,90 The number of trials.

[0468]

[0469] Table 2 shows that the increase in the number of trials between Algorithm 1 and Algorithm 2 to see 5 positive results is approximately 1 / p. When the proportion is p, there will be 1 positive result in 1 / p trials.

[0470] In some embodiments, the computationally expensive operation of Algorithm 2 is the inverse tangent function, which may be about 40 floating point CPU operations. There are approximately 2N floating point operations in the equivalent steps of Algorithm 1'. The Hough transform of a 640x480 pixel image with full resolution has N equal to 2520, while the Hough transform of a 1080x1920 pixel image has N equal to 7020. This means that Algorithm 2 has a speed advantage over Algorithm 1 when p is greater than 0.008 for 640x480 images and when p is greater than 0.003 for 1080x1920 images.

[0471] In some embodiments, it is assumed that every binary in the Hough transform space is equally likely to be occupied in the presence of noise. This simplification speeds up the threshold decision, however, in some embodiments, this assumption does not hold. The initial effect of the simplification is to underestimate the probability of seeing a value greater than 1 in the Hough transform by erroneously declaring the corresponding probability of a line existing. For specific combinations of image size and Hough transform binary arrangement, the true probability can be pre-computed. This allows the false alarm rate to be minimized with no corresponding increase in the calculation. With additional restrictions on the type of imaging, an even more accurate estimate of the probability of seeing a value in the Hough transform binary is possible.

[0472] There are other forms of the Hough transform that parameterize different features. For example, there is a three-element parameterization of a circle (x, y, r), where x and y specify the center, and r is the radius. Algorithm 2 can also work with these parameterizations. For the circle example, Algorithm 2 will randomly select three pixels and calculate the circle that passes through them.

[0473] Algorithm 2 will have a similar speed advantage for features that include a significant portion of the total pixels considered. It will also have a significant advantage in required storage, since the Hough transform can be stored in a sparse matrix, whereas the analog of Algorithm 1 will require a full-size matrix.

[0474] Now refer to Figure 22-26 , Figure 22-26 The image sensor 103 may be used with various background patterns that may be used to detect free flow conditions or estimate the droplet size of a liquid. Figure 22-26 Use with background patterns and can be Figure 1 Image sensor 11, Figure 5 Image sensor 68, Figure 6 image sensor 63, or Figure 8 Each of the image sensors 63 may be coupled to a corresponding processor (such as Figure 1 Processor 15 or Figure 8 A processor 90) is provided to process images from the image sensor.

[0475] Fig. 22 is a device for use with a drip chamber 104 (e.g., Figure 1 1 is a block diagram of an imaging system 100 for use with a drip chamber 104 having a striped background pattern 101 and a light source 102 that illuminates the stripes from a position adjacent to an image sensor 103. Any droplets or free streams within the drip chamber 104 distort the image acquired by the image sensor 103. A processor (e.g., Figure 1 The processor 15) is able to use the deformation of the background pattern 101 as captured by the image sensor 103 to estimate the flow rate and / or detect free flow conditions.

[0476] Fig.23 is a block diagram of an imaging system 105 for use with a drip chamber 104 having a background pattern 101 with stripes and a light source 102 that illuminates the stripes from behind the background pattern 101 at an opposite end relative to an image sensor 103 in accordance with an embodiment of the present disclosure. Fig.24 The embodiment of the present disclosure shows that when the droplet uses Fig.23 The background pattern 101 is deformed when it comes from Fig.23 The image of the image sensor 103. Note that Fig.24 As shown, the stripes of background pattern 101 are deformed by the droplets in drip chamber 104 (or will be deformed by the free flow flow), as captured in an image by image sensor 103. This deformation can be used to estimate the droplet size, to calculate the flow rate through the drip chamber, or to determine whether a free flow condition exists within the drip chamber.

[0477] Fig.25 A block diagram of an imaging system for use with a flow meter having a background pattern with a checkerboard pattern and a light source that illuminates the stripes from behind the background pattern at the opposite end of the image sensor according to an embodiment of the present disclosure is shown. Fig.26 The embodiment of the present disclosure shows that when the droplet uses Figure 25-26 The background pattern 107 is deformed from Fig.25 In yet another embodiment of the present disclosure, the imaging system disclosed herein may utilize a background pattern having a plurality of random dots and / or circles.

[0478] Reference Figure 22-26, the "lensing effect" of the droplet (i.e., the deformation of the background pattern from the view of the image sensor) can be used to measure the radius of the droplet. The radius of the droplet corresponds to how much and what effect the droplet has on any light passing through it. By measuring the changes to a calibration grid (i.e., the background pattern) as seen 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 as seen through the droplet can be measured optically and the radius inferred from that measurement. In some embodiments of the present disclosure, the relationship between radius and droplet can be calculated and / or can be determined using a lookup table that has been empirically generated.

[0479] Figure 27-28 A flow chart showing a method for estimating the volume of a droplet in a drip chamber according to an embodiment of the present disclosure is shown. That is, Figure 27-28 Method 214 is described. Reference will also be made to Figure 29-37 Method 214 will be described. Figure 29-31 and Figure 33-36 An image is shown that is used or generated by a flow meter to estimate the volume of a droplet within a drip chamber in accordance with an embodiment of the present disclosure. Fig.32 and Fig.37 Show that it can be Figure 27-28 Pseudo code used by method 214.

[0480] Fig. 27 and Fig.28 The method 214 can be performed by Figure 1 Flow meter 7. Figure 5 Flow meter 67, Figure 6 Imaging system 78, Figure 8 The imaging system 84 of , or other flow meters of the imaging systems disclosed herein (each with or without background patterns and / or with or without active illumination).

[0481] Method 214 includes actions 200-213. Action 200 determines a baseline of a droplet formed at an opening of the drip chamber. Action 201 captures a first image. A uniform backlight source may be used to acquire the first image. In some embodiments, a background pattern and / or an exposure algorithm as described herein may be used to capture the first image. Actions 200 and 201 may be performed simultaneously. Fig.29 An image is shown with an overlaid baseline 215. The baseline 215 may be a predetermined set of pixels or may be formed using a pixel pattern arranged on the opening of the drip chamber and / or on a background pattern (in Fig.29 Method 214 uses the first image to initialize the background image μ i,j , variance array s i,j , and integer array I i,jThe background image may have i×j pixels, and the variance array and the integer array may be 2-D arrays also having a size of i×j.

[0482] Act 202 identifies a droplet within a first image and a predetermined band near the edge of the droplet (e.g., the band may be a predetermined number of pixels beyond the edge of the droplet). Act 203 initializes a background image by setting each pixel to the same value as the first image (for that corresponding position) unless it is within the identified droplet or the predetermined band near the edge of the droplet. Act 204 sets pixels within the region of the droplet or within the predetermined band to a predetermined value. Fig.30 An example background image is shown that is generated after initialization. Fig.30 In the exemplary image of FIG. 1 , the area of ​​the droplet and the band beyond the edge of the droplet, generally designated as 216 , is set to a predetermined value, for example, 140 .

[0483] For example, when the method generates a first background image, each pixel in the background image that is part of a droplet or a band outside the edge of a droplet is set to a default threshold, eg, 140, in the intensity range of 0-255.

[0484] Action 205 initializes the integers in the integer array to zero. Action 206 initializes the values ​​in the variance array to zero. The integer array is the same size as the image. The integer array counts how often each pixel of the background image is updated with new information and is initialized to zero. The variance array (e.g., an array of data type "double") is also the same size as the background image and contains an estimate of the intensity variance of each pixel in the background image.

[0485] Action 207 captures another image and action 208 identifies the droplet and another predetermined band near the edge of the droplet in the other image. Action 209 updates the background image, the integer array, and the variance array.

[0486] The background image can be updated as additional images are taken. For example, as the system collects images, the background algorithm evaluates each pixel. If a pixel is considered to be part of a droplet or its protection band, its value in the background image is not changed.

[0487] If the pixel is not considered to be part of the droplet or its guard band: (1) if the corresponding integer of the pixel in the integer array is zero, the value of the pixel in the background image is set equal to the value of the pixel in the input image; or (2) if the count of the pixel is greater than 0, a low-pass filter is used to update the background image value of the pixel. In some embodiments, any type of filter can be used, such as a high-pass filter, a band-pass filter, etc. One low-pass filter that can be used is shown in equation (23) as follows:

[0488] P background,i,j =P background,i,j (1-a background )+a background P input ,i,j (twenty three).

[0489] In addition, the variance array can be updated using equation (24) as follows:

[0490]

[0491] Note that the filters used for both operations are exponential filters; however in other embodiments, other suitable filters, such as other low-pass filters, may be used. Variance estimation may be performed in any known manner or using alternatives for estimation (eg, using standard errors).

[0492] A new estimate of the background intensity (mean) for each pixel, the number of images used to update the mean and variance for each pixel, and the variance for each pixel (e.g., a value that approximates the true variance and / or is proportional to the variance) are used to update the array. That is, each additional image taken can be used to update the background image, the integer array, and the variance array. After several images have been processed, the background image may appear as Fig.31 Note that the image still has regions where pixels have not changed from the initial threshold (a uniform mid-grey region, designated roughly 217). This region has been identified as part of a droplet or its guard band in each image.

[0493] Act 210 compares another image (eg, a current or most recent image) to a background image and identifies a plurality of pixels of interest. Act 211 determines a subset of pixels within the plurality of pixels of interest that correspond to a droplet.

[0494] The comparison of action 210 compares the other image with the background image pixel by pixel. From this comparison an array having the same size as the image is derived in which each pixel has a zero or non-zero value (255).

[0495] Action 210 can be performed by Fig.32. That is, the threshold is determined according to the following: if the input pixel is to the left or right of the baseline in the image, its output value is set to zero (line 1); if the background count array of the input pixel indicates that less than a predetermined number of images (e.g., 100) have been used to achieve the background value of the pixel (line 2), then: if the intensity of the input pixel is less than the threshold intensity (e.g., 140 in the range of 0-255), the output value of the pixel is set to non-zero (255) (line 2a); or if the intensity of the input pixel is greater than or equal to the threshold intensity, the output value of the pixel is set to zero (line 2b); and if the background count array of the input pixel is greater than a predetermined number of images (line 3), then: if the square of the difference between the input pixel intensity and the background pixel intensity is greater than an estimate of the background variance of the pixel multiplied by a constant γ 2 , then the output value of the pixel is set to non-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); or if the square of the difference between the input pixel intensity and the background pixel intensity is less than or equal to the estimate of the background variance of the pixel multiplied by a constant γ 2 , the output value of the pixel is set to zero (see line 3b). Line 3 captures the part of the image that is altered by the presence of the drop but results in a higher intensity.

[0496] When action 210 is implemented as an algorithm, the algorithm is initialized, and the input and output of the threshold algorithm will look like Fig.33 and Fig.34 Because the number of images used in estimating the background image is initially small, the only criteria applied are shown above lines (1) and (2) because for some corresponding pixels there are not enough images for the integer array to have a value above the threshold. This can result in many low intensity areas being identified as distinct, including edges that are not fully illuminated and condensation on the cavity wall.

[0497] After enough images have been collected so that most (or all) of the pixels of the background image have been generated with a sufficient number of pixels, Fig.32 Lines (3), (3a), and (3b) are used. After thresholding, the background is largely black and has temporary noisy pixels exceeding the variance threshold, such as Fig.35 and Fig.36 As shown in ( Fig.35 and Fig.36 The images captured by the camera and the results of the comparison algorithm described above are shown respectively).

[0498] As previously mentioned, after act 210, act 211 determines which of the subgroups of pixels within the plurality of pixels of interest corresponds to a droplet. Act 211 may be performed by Fig.37 That is, the threshold image is passed to find the representation as given by Fig.37 The pseudo code shows the algorithm for connecting components of a droplet.

[0499] In processing Fig.32 The pseudo code that follows evaluates the binary image to find the binary component that occupies the space given by the droplet. The algorithm passes the position of a pixel on the baseline that is white (or it passes the center pixel of the longest stretch of consecutive white pixels on the line).

[0500] Once the algorithm has an initial white pixel, it performs Fig.37 The algorithm shown in the pseudocode shown. The pseudocode determines the location of a white pixel that includes a path to the baseline (i.e., a white pixel path). Line 1 pushes the location of the first pixel onto the stack. While the stack is not empty, line 2 executes a while loop. The while loop includes lines (2a)-(2d). Line 2a pops the next position (i, j) from the stack. Line 2b makes the output pixel value at (i, j) white. Line 2c checks the 8 pixels adjacent to (i, j). Line (2ci) is an "if statement" and if the adjacent input pixel is white but outputs pixels If it is black, then row 2c will change the position Add to the stack. Line 2d returns to line 2 to continue the while loop (if the stack remains empty).

[0501] The algorithm sets to white all output pixel locations that can be connected to the location of an input pixel by a continuous path of white input pixels. The left boundary of the drop is found by stepping through each row of pixels from the left edge until the algorithm hits a white pixel. The right boundary is found by stepping from the right edge of the image until it hits a white pixel. The first row that can be stepped from the left edge to the right edge and does not hit a white pixel is considered the end of the drop.

[0502] Fig.37 The pseudo code shown is a one-pass version of a connected component labeling algorithm. However, other connected component labeling algorithms or other suitable algorithms may be used to determine which pixel corresponds to a droplet.

[0503] Fig.28 Act 212 performs a rotation operation on the pixel subset. Act 213 estimates the volume of the drop in the drip chamber by counting the number of pixels within the rotated pixel subset. The total number of pixels within the 3-D version of the drop is counted; and because each pixel corresponds to a distance, the number of pixels can be used to estimate the volume of the drop.

[0504] Imaging System Optics

[0505] Figure 38-42 The following description of optical elements for the imaging systems disclosed herein. For example, the image sensor disclosed herein may be an image sensor cube manufactured by OmniVision of 4275 Burton Drive, Santa Clara, California 95054; and, for example, the image sensor cube may be an image sensor cube manufactured for phone image sensor applications. In some embodiments of the present disclosure, the image sensor disclosed herein may use a fixed focal length and have a depth of field ("DOF") from 15 centimeters to infinity.

[0506] The image sensor may have a blur circle for points imaged within the range of the image sensor that is completely contained within the area of ​​a single pixel. The focal length of the image sensor lens may be 1.15 mm, the F# may be 3.0, and the aperture of the image sensor lens may be 0.3833 mm. A first order approximation of the optical system of one or more image sensors may be implemented using a matrix equation, where each ray r, is represented as a vector described in equation (25) as follows:

[0507]

[0508] In the above equation (25), h is the height of the light ray at the entrance of the image sensor, and θ is the angle of the light ray. Fig.38 , when the hypothetical point is at a distance d from one of the lenses of the image sensor (which has a focal length f) im The image is formed at the focal plane and the lens is at a distance d from the focal plane. fp When describing the corresponding matrix of the image sensor, M cam , described by the following equation (26):

[0509]

[0510] To find the location on the focal plane where the ray strikes, fp, a matrix multiplication as described by equation (27) can be used as follows:

[0511]

[0512] like Fig.38 As shown, the diameter of the blur circle, D blur , is shown as Fig.38 The approximate distance between the two points shown in . This distance is calculated by moving the lens d away from the optical axis. im It is found by tracing rays from the far point to the edge of the lens and then to the focal plane. These rays are given by the vectors shown in (28) as follows:

[0513]

[0514] like Fig.39 As shown, the blurred circle D blur is calculated and shown for various lens-to-focal-plane spacings and lens-to-image spacings. Fig.39 Contour lines are also shown Fig.77 The x-axis shows the distance in micrometers between the focal plane and a point located one focal length from the lens of the image sensor. The y-axis shows the distance in meters between the lens and the imaged point. Create contour lines Fig.77 The value of is the blur size divided by the pixel size; therefore, any value of about 1 or less is sufficient for imaging. Fig.39 As shown, the focal plane is located one focal length away from the lens plus 5 microns.

[0515] The image sensor can utilize a second lens. For example, the image sensor can utilize a second lens to create a relatively greater depth of field and a relatively greater field of view. Using the same analysis as above (but with the optical matrix modified to accommodate the second lens and the additional distance) the depth of field utilizing two lenses can be calculated and is shown in equation (29) as follows:

[0516]

[0517] Fig.40 and Fig.41 The field is shown to vary with changes in the separation between the lens and the image sensor and, accordingly, the focal length of the image sensor. Fig.40 and Fig.41 Shows the blur circle divided by the pixel size. Fig.40 The blur circle is shown divided by the pixel size when using a 20 mm focal length lens. Fig.41 Shown is the blur circle divided by the pixel size when using a 40 mm focal length lens. Fig.42 The expression in Fig.40 and Fig.41 The optical axes of the two configurations' corners correspond to the fields of view.

[0518] like Fig.42 As shown, in some embodiments, the image sensor can utilize a 40mm to 60mm focal length lens; this configuration can include placing the image sensor approximately 2 inches from the focal point. In other embodiments of the present disclosure, other configurations can be used, including those not in Fig.42 Those configurations shown in .

[0519] For example, the following analysis shows how the depth of field can be set for an image sensor: Using the focal length of the lens, f, the distance from the focal plane, z, and the distance from a point in space, d; the matrix of the system is shown in equation (30) below:

[0520]

[0521] Equation (30) is simplified to the following equation (31):

[0522]

[0523] Equation (31) is simplified to the following equation (32):

[0524]

[0525] Considering the on-axis point, all heights will be zero. The points on the focal plane that the different rays will hit are given by equation (33) as follows:

[0526]

[0527] As shown in (33) above, θ is the angle of the ray. The point in perfect focus is given by the lens maker's equation given in equation (34) as follows:

[0528]

[0529] Equation (34) can be rearranged to derive equation (35) as follows:

[0530]

[0531] Plugging d from equation (35) into equation (33) to show the point of impact in equation (36) results in:

[0532]

[0533] All light rays leaving this point hit the focal plane at the optical axis. As shown in equation (37), the situation when the image sensor is shifted a certain distance δ away from the focal point is described as follows:

[0534]

[0535] Equation (37) shows that by appropriately positioning the image sensor's lens relative to the focal plane, we can change the depth of field. In addition, the spot size depends on the size of the angle θ. This angle depends linearly on the aperture of the vision system produced by the image sensor.

[0536] In addition or alternatively, according to some embodiments of the present disclosure, an image sensor can be implemented by adjusting various parameters, including: the distance to the focus, because it affects the compactness, alignment, and sensitivity of the visual system to the environment; the field of view of the system; and the lens focal plane spacing, because it affects the alignment tolerance of the system and the sensitivity of the system to the environment.

[0537] Embodiments of flow meters with or without valves connected thereto

[0538] With reference to the accompanying drawings, Fig.43 and Fig.44 Flow meter 58 is shown coupled to drip chamber 59. As described below, flow meter 58 may optionally include free flow detector component 12 according to an embodiment of the present disclosure (see Figure 1 ). In addition, alternatively, or optionally, the flow meter 58 may include a flow estimator component 13 according to some embodiments of the present disclosure (see Figure 1 ). Fig.43 The flow meter 58 is shown with the door 62 closed, and Fig.44 The flow meter 58 is shown with the door 62 opened. The flow meter 58 may be Figure 1 Flow meter 7, with or without valve 6. Flow meter 58 includes a start knob 60 and a stop knob 61. Additionally or alternatively, flow meter 58 may include a backup valve to stop fluid flow therethrough, or may signal another valve to stop fluid flow in response to an error condition.

[0539] The flow meter 58 optionally includes image sensors 63 and 64 that are capable of estimating fluid flow and / or detecting free flow conditions. Although the flow meter 58 includes two image sensors (e.g., 63 and 64), only one of the image sensors 63 and 64 may be used in some embodiments. When a droplet is formed in the drip chamber 59, the image sensors 63 and 64 are capable of imaging the droplet and estimating its size. The size of the droplet can be used to estimate the fluid flow through the drip chamber 59. For example, in some embodiments of the present disclosure, the image sensors 63 and 64 use an edge detection algorithm to estimate the size of the droplet formed in the drip chamber 59; the processor (see Figure 1 Processor 15, Figure 5 processor 75, or Figure 6 The processor 90 of the processor 8 may assume that the profile is uniform from every angle of the droplet and can estimate the size of the droplet based on the profile. Fig.43 and Fig.44 In the exemplary embodiment shown, the two image sensors 63 and 64 can average the two profiles together to estimate the size of the drop. For example, the algorithm can average the measured profiles of the two image sensors 63 and 64 to determine the size of the drop. The image sensors 63 and 64 can use a reference background pattern to facilitate the identification of the size of the drop as described herein.

[0540] In another embodiment of the present disclosure, image sensors 63 and 64 image the fluid to determine if a free flow condition exists. Image sensors 63 and 64 can use background patterns to determine if the fluid is flowing freely (i.e., droplets are not forming and the fluid flows through the drip chamber 59). As previously mentioned, although the flow meter 58 includes two image sensors (e.g., 63 and 64), only one of the image sensors 63 and 64 can be used in some embodiments to determine if a free flow condition exists and / or to estimate the flow of fluid through the drip chamber.

[0541] Additionally or alternatively, in some embodiments of the present disclosure, another image sensor 65 monitors the fluid tube 66 to detect the presence of one or more bubbles within the fluid tube. In alternative embodiments, other bubble detectors may be used instead of the image sensor 65. In other embodiments, bubble detection is not used in the flow meter 58.

[0542] Referring now to the accompanying drawings, Fig.45 A flow meter 218 is shown coupled to a drip chamber 219 in accordance with an embodiment of the present disclosure. The drip chamber 219 is secured to the flow meter 218 via a coupler 410. A backlight 220 shines light through the drip chamber toward an image sensor 221 (shown in outline form).

[0543] The flow meter 218 can electronically transmit the flow rate to the monitoring client 8 (see Figure 1 ). In addition or alternatively, in some optional embodiments, the flow meter 218 may include a display (eg, a touch screen, a light emitting diode display, etc.) that displays the flow rate. The flow meter 218 may be coupled to the rod 223 via the clamp 222 .

[0544] In some embodiments, the flow meter 218 may be coupled to an actuator (which is coupled to a valve) (at Fig.45 ) to form a closed loop system (e.g., Figure 1 A control component 14, such as a PID, switch, neural network, or fuzzy logic control system) is used to regulate the flow of fluid through the drip chamber 219.

[0545] The flow meter 218 may use any of the flow algorithms described herein and may include any of the imaging systems described herein. Additionally or alternatively, the flow meter 218 may include a free flow detector component (e.g., Figure 1 Free flow detector component 12).

[0546] Fig.46 A flow meter 224 and a pinch valve 225 coupled to a body 226 of the flow meter 224 to control the flow of fluid into a patient are shown in accordance with an embodiment of the present disclosure. The flow meter 224 includes an image sensor 227 and a backlight 228.

[0547] The image sensor 227 images the drip chamber 229 and can receive illumination from a backlight source 228. The flow meter 224 includes a support member 230 coupled to a coupler 231 that couples the drip chamber 229 to the flow meter 224.

[0548] The flow meter 224 may implement any of the flow estimators described herein (e.g., Figure 1 Flow estimator component 13) and / or a free flow detector disclosed herein (e.g., Figure 1 The flow meter 224 may use a pinch valve 225 in a closed loop to control the flow of fluid to the patient (e.g., using a Figure 1 Control component 14 shown).

[0549] Pinch valve 225, as in Fig.47 , is coupled to shaft 233, which is coupled to actuator 234. Actuator 234 may be a solenoid or any actuator capable of moving pinch valve 225 toward tube 335.

[0550] Fig.48 A flow meter 336 and a pinch valve 225 are shown in accordance with an embodiment of the present disclosure. The flow meter includes two image sensors 337 and 338. The flow meter 336 can use the pinch valve 225 in a closed-loop feedback configuration. The flow meter 336 can use the image sensors 337 and 338 to implement the volume estimation algorithm described herein to estimate the flow of fluid through the drip chamber 229. For example, the flow meter 336 can average the two volumes together for use in the feedback loop.

[0551] Fig.49 Shown is a flow meter 339 and a valve 340 coupled to an actuator 341 to control the flow of fluid into a patient in accordance with an embodiment of the present disclosure. Fig.49 The flow meter 339 is similar to Fig.46 Flow meter 224; however, Fig.49 The flow meter 339 includes a valve 340 having curved elongated support members 342 and 343 (see Figures 50A-50B ).

[0552] The flow meter 339 includes an image sensor 227 and a backlight source 228. The image sensor 227 images the drip chamber 229 and can receive illumination from the backlight source 228. The flow meter 339 includes a support member 230 coupled to a coupler 231 that couples the drip chamber 229 to the flow meter 339.

[0553] The flow meter 339 can implement any of the flow estimators described herein (e.g., Figure 1Flow estimator component 13) and / or a free flow detector disclosed herein (e.g., Figure 1 The flow meter 339 may use a valve 340 in a closed loop to control the flow of fluid into the patient (e.g., using Figure 1 control component 14).

[0554] The flow meter 339 may actuate the actuator 341 to actuate the valve 340 , which in turn regulates the flow of fluid through the IV tube 335 in a feedback (ie, closed loop) configuration using any control algorithm.

[0555] Now refer to Figures 50A-50B , which shows an embodiment according to the present disclosure Fig.49 340. Valve 340 includes an inner curved elongated support member 343 and an outer curved elongated support member 342. Tube 335 is positioned between support members 342 and 343.

[0556] The inner support member 343 includes a cylindrical nut 344. The outer support member 342 is coupled to the cylindrical nut 344 via a hook 345. In some embodiments, the cylindrical nut 344 is not coupled to the valve 340, and the inner support member 342 includes a hole for sliding a threaded rod or screw 347 through. The outer support member 342 also has a hook 348 to secure it to a frame 349 of the actuator 341. The actuator 341 includes a shaft 346 coupled to the screw 347. As the actuator 341 rotates the shaft 346, the screw 347 can rotate to push the cylindrical nut 334 toward the actuator 341. That is, the hook 345 and the cylindrical nut 334 move toward the hook 348 and the frame 349 because the inner and outer support members 342 and 343 are flexible.

[0557] As support members 342 and 343 are compressed, tube 335 becomes compressed because it is positioned between support members 342 and 343. The compressed tube 335 restricts the flow of fluid through tube 335. Valve 340 compresses tube 335 by a length that is substantially greater than the diameter of tube 335.

[0558] Figures 51A-51D Several views of a flow meter 350 with a monitoring client 358, a valve 352, a drip chamber 357, an IV bag 411, and a fluid tube 412 are shown according to an embodiment of the present disclosure. The flow meter 350 includes a receiving portion 351 to receive the valve 352. The valve 352 includes two curved elongated support members 353 and 354.

[0559] The flow meter 350 includes an image sensor 355 and a backlight 356 capable of monitoring droplets formed within a drip chamber 357. The flow meter 350 can use the image sensor 355 to implement the flow estimator algorithm described herein (e.g., Figure 113) and / or implementing a free flow detector disclosed herein (e.g., Figure 1 Free flow detector component 12).

[0560] The flow meter 350 includes a base 359 that can form a dock to receive a monitoring client 358. The monitoring client 358 can be a smart phone or other electronic computing device (eg, an Android-based device, an Iphone, a tablet, a PDA, etc.).

[0561] Monitoring client 358 may include software therein to implement free flow detectors, flow estimators, control components, exposure components, etc. (e.g., Figure 1 The free flow detector component 12, the flow estimator component 13, the control component 14, the exposure component 29) and may include one or more transceivers (e.g., the transceiver 9). In addition or alternatively, the base 359 of the flow meter 350 can implement these items.

[0562] For example, the flow meter 350 may use internal software, hardware, electronics, etc. to implement a free flow detector, flow estimator, control component, exposure component, etc. The flow meter 350 may implement a closed-loop feedback system to regulate fluid flow to the patient by changing the fluid flowing through the valve 352.

[0563] As in Fig.51B As can be easily seen in FIG. 3 , valve 352 includes an inner support member 354 and an outer support member 353. Inner support member 354 is coupled to barrel nut 360 and to barrel 361. In some embodiments, barrel nut 360 is not coupled to inner support member 354, and inner support member 354 includes a hole for sliding threaded shaft 362 therethrough.

[0564] A threaded shaft 362 (e.g., a screw) rotates freely within a bearing located within barrel 361 and engages a threaded nut within barrel nut 360 by rotation of a knob 363 to push or pull barrel nut 360 relative to barrel 361 (e.g., the actuator is a lead screw with a knob to actuate the lead screw.). Knob 363 can be rotated manually.

[0565] Additionally or alternatively, the valve 352 may snap into a receiving portion 351 that includes a rotation member 364 that engages a knob 363 within the receiving portion 351 (see Fig.51C ). The rotating member 364 engages the rotating knob 363 to actuate the valve 352. The rotating member 364 may be coupled to a motor that rotates the rotating member 364. The motor (not explicitly shown) may be controlled by the flow meter 350 in a closed loop configuration to achieve a target flow rate of fluid flowing into the patient.

[0566] Figures 52A-52D Several views of another flow meter 365 having a valve 352 , a drip chamber 357 , and a fluid tube channel 413 having a receptacle 351 to receive the valve 352 are shown in accordance with an embodiment of the present disclosure. Figures 52A-52D The flow meter 365 is similar to Figures 51A-51D However, the base 359 holds the monitoring client 358 in a "vertical" position. In addition, the receiving portion 351 is on the side of the base 359 opposite the monitoring client 358 (see Fig.52B and 52C ).

[0567] Fig.52D A close up view of the valve 352 is shown engaging the receiving portion 351. The knob 363 engages a rotating member (in the interior of the base 359) Fig.52D ), the base 359 is coupled to the motor (in Fig.52D (also not shown).

[0568] Fig.53A Show Figures 51A-51D and Figures 52A-52D Another view of valve 352, and Figures 53B-53C The embodiment according to the present disclosure is shown Fig.53A Two exploded views of the valve.

[0569] like Figures 53A-53C As shown, valve 352 includes inner support member 354 and outer support member 353. A tube can be inserted into through holes 366 and 367 to position the tube between support members 354 and 353.

[0570] The knob 363 can be rotated to rotate the screw 362. The rotation of the screw 362 causes the barrel nut 360 to move toward the partial barrel 363 to compress the tube positioned between the support members 353 and 354. However, the partial barrel 363 includes two sides, and there is a space to securely hold the end 600 (e.g., a cap) of the screw 362 in the space (e.g., an auxiliary space). Fig.54 Valve 352 is shown for manual use and coupled to tube 368 .

[0571] Fig.55 A valve 369 is shown including two flexible members 370 and 371 according to an embodiment of the present disclosure. The flexible members 370 and 371 may be two flexible sheets. The flexible member 371 may include holes 373 and 374 for a tube 372 to be positioned between the flexible members 370 and 371.

[0572] The flexible members 370 and 371 are coupled together via two connector members 377 and 378. The connector members 377 and 378 are coupled to coupling members 376 and 375, respectively.

[0573] Actuation of the valve 369 can be by a linear actuator that pulls the coupling members 375, 376 toward or away from each other. The linear actuator (not explicitly shown) can be a screw-type actuator, a piston actuator, or other actuator. In some embodiments, one of the coupling members 375 and 376 can be coupled to a fixed support, and the actuator is coupled to the other of the coupling members 375 and 376 and the other fixed support to pull the coupling members 375 and 376 together or apart.

[0574] Figures 56A-56C Several views of a valve 380 having two curved elongated support members 381 and 382 are shown, with one of the elongated support members 381 having a plurality of ridges 387 suitable for engaging a tube positioned between the support members 381 and 382 in accordance with an embodiment of the present disclosure.

[0575] The valve 380 has two support members 381 and 382 coupled to the coupling member 383 at a first end and coupled to the second coupling member 384 at the other end. That is, the coupling member 384 around the screw 385 and the coupling member 383 includes an internal thread for pulling the coupling member 383 toward or away from the knob 386 when the screw 385 rotates with the rotation of the knob 386. Fig.56B Valve 380 is shown which, when actuated, serves to block fluid flow through the tube coupled between support members 381 and 382 . Fig.56C A support member 381 is shown having two holes 388 and 389 for receiving the tube. It is also noted that the support members 381 and 382 hold the tube eccentrically from the axis of the screw 385, which is Fig.56C Holding the tube eccentric from the axis of screw 385 facilitates free movement of the tube.

[0576] Figures 57A-57C Several views of a valve 390 having a ratchet 394 engaging a connecting member 393 of the valve 390 are shown according to an embodiment of the present disclosure, and Figures 57D-57E Show Figures 57A-57C Two exploded views of the valve 390. The ratchet 394 engages the connecting member 393 by interacting with the rack 397 disposed thereon. The finger 602 (see Fig.57D and 57E) interacts with the rack 397 to provide a ratcheting action. That is, the finger 602 can hold the rack 397 against the engaging finger on the side opposite to the holding finger 602. The valve 390 includes a support member 391 having one end coupled to the ratchet 394 and the other end pivotally coupled to the hinge 395. The valve 390 also includes a support member 392 having a hook 398 that can be coupled to the body of the ratchet 394.

[0577] like Fig.57C As shown, the tube 396 can be positioned between the support members 391 and 392, the hook 398 can be fastened to the body of the ratchet 394, and the connecting member 393 can be inserted into the ratchet 394 (as shown in FIG. Fig.57B As shown in Fig.57C As shown, tube 396 is positioned against support member 391 via openings 399 and 400 .

[0578] The ratchet 394 engages the rack 397 so that the ratchet 394 can be manually moved toward the hinge 395 for fluid flow adjustment. Thereafter, a knob (not shown) can be coupled to the ratchet 394 to make minor adjustments to the distance between the ratchet 394 and the hinge 395. Additionally or alternatively, the ratchet 394 can include a release knob (not shown) for releasing the ratchet from the connecting member 393.

[0579] Figures 58A-58D Several views of a valve 401 having two elongated support members 403 and 404, a connecting member 405, and a screw-type actuator 407 are shown in accordance with another embodiment of the present disclosure.

[0580] Support members 403 and 404 may be permanently molded at their ends with the ends of connecting member 405. Tube 402 may be positioned between support members 403 and 404.

[0581] As the knob 408 is rotated, the screw-type actuator 407 expands or contracts due to engagement with the threaded rod 406 . Fig.58A The valve is shown in the open position, while Fig.58B The valve is shown in the closed position. Note that the tube 402 is squeezed along the approximate length of the tube 402. Figures 58C-58D The valve 401 is shown from a perspective view in an open position and in a closed position, respectively.

[0582] Figures 59A-59C Several views of a body 501 of a valve 500 according to an embodiment of the present disclosure are shown (for assembly of the valve 500, see Fig.59H). The body 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 support members 502 and 503.

[0583] The body 501 further includes a first connector 506 coupled to one end of the support members 503 , 504 and a second connector 507 coupled to the other end of the support members 503 , 504 .

[0584] The first connector 506 is coupled to one end of the support members 503, 504 and is connected to the first end 508 of the connecting member 509. The second connector 507 includes a hole 510 for positioning the second end 511 of the connector member 509 therethrough (e.g., Fig.59B can be easily seen in the figure).

[0585] When the tube is disposed between support members 502, 503, movement of second connector 507 toward first connector 506 compresses the tube disposed between support members 502, 503. As second connector 507 moves toward the first connector, aperture 510 of second connector 507 allows second end 511 of connector member 509 to slide freely therein.

[0586] Figures 59D-59G The embodiment according to the present disclosure is shown Figures 59A-59C 501. The knob 512 includes ratchet teeth 513 defined by four fingers 514. Each of the fingers 514 includes a threaded surface 515 for engaging the threaded connection member 509. The fingers 514 are arched toward a hole 516 at the center of the knob 512. The knob 512 also includes a finger 517 that engages the second connector 507 (see Fig.59H In some embodiments, the body 501 includes a recess 510 to receive a finger 517 on the second connector 508 .

[0587] Fig.59H The assembly valve 500 according to an embodiment of the present disclosure is shown. The assembly valve 500 includes Figures 59A-59C The coupling shown is Figures 59D-59GThe knob 512 is provided with a body 501 of a knob 512. The knob 512 is slid onto the threads of the connecting member 509. The fingers 514 engage the threads of the connecting member 509 and ratchet to the connecting member 509. That is, the knob 512 can be freely moved along the threads of the connecting member 509 toward the first end 508 of the connecting member 509, but the knob 512 cannot be removed from the first end 508 of the connecting member 509 without rotating the knob 512. That is, the knob 512 can be placed on the connecting member 509 to provide a rough adjustment of the valve 500 by roughly moving the connectors 507, 508 toward each other to close the valve 500. Because the threaded surfaces 515 of the four fingers 514 engage the threads of the connecting member 509, the rotation of the knob 512 reduces or increases the fluid flow in the tube. Each of the fingers 514 includes a threaded surface 515 to engage threads of the connection member 509 such that rotation of the knob 512 moves the second connector 507 toward or away from the first connector 506 to thereby control the flow of fluid in the tube positioned between the support members 502 , 503 .

[0588] Fig.60 FIG. 5 shows a valve 520 having a guide protrusion 521 according to an embodiment of the present disclosure. The valve 520 is similar to Fig.59H The valve 500 of FIG. 5A , but includes a guide protrusion 521 and a knob 522 having first and second collars 523, 524. The knob 522 also includes internal threads (not shown) for engaging threads 525 of a connecting rod 526. In some embodiments, the internal threads may ratchet and in other embodiments, the internal threads may be fixed and not provide ratcheting action.

[0589] Fig.61 The embodiment of the present disclosure is shown for coupling to Fig.60 The valve 520 has a motor 536 and a valve fixing structure 537. The valve fixing structure 537 includes fixing finger-shaped members 528, 529, 530, 531, each of which has a bent portion 533 for being fixed on the collars 523, 524 of the knob 522 (see Fig.62 ) snaps into the corresponding collar guide portion 534.

[0590] Now refer to Fig.60 , 61 , and 62, once the collars 523, 524 are sufficiently secured, the knob 522 is free to rotate. That is, the collar 523 can be secured between the securing fingers 528 and 530 within their respective collar guides 534, allowing the knob 522 to rotate. Similarly, the collar 524 can be secured between the securing fingers 529 and 531 within their respective collar guides 534, allowing the knob 522 to rotate.

[0591] When the valve 520 is secured to the valve securing structure 537, rotation of the wheel 537 (caused by the motor 536) causes the knob 522 of the valve 520 to rotate. The protrusion 521 is free to move within or adjacent to the protrusion guide 535 as the valve 520 flexes. Fig.62 Show Fig.60 The valve is fastened to the motor 536 via the valve fixing structure 537.

[0592] Fig.63 The embodiment of the present disclosure is shown for coupling to Fig.60 Another motor 538 and a valve fixing structure 539 of the valve. The valve fixing structure 539 includes a protrusion guide 540 adjacent to the motor 538. The motor 538 is coupled to a wheel 541 to engage the knob 522 (see Fig.60 ).

[0593] Fig.64A A valve 542 is shown having a slidable collar 545 and several compression fingers 544 for regulating fluid flow through a fluid line 543 in accordance with an embodiment of the present disclosure. A base 546 is connected to all of the fingers 544. As the slidable collar 545 moves over the compression fingers 544, the compression fingers 544 compress the tube 543 to obstruct fluid flow therein. Fig.64B Show Fig.64A Cross-sectional view of the valve.

[0594] The finger 544 is coupled to the base 546 such that the base 546 and the finger 544 surround the tube 543. The collar 545 can slide away from the base 546 such that the finger 544 compresses the tube 543, which thereby reduces the internal volume of the tube 543 as the collar moves. The reduction in the internal volume of the tube 543 reduces the fluid flow through the tube. An actuator (not shown) can be coupled to the collar 545 to control the position of the collar 545 (e.g., a linear actuator can be coupled to the collar 545 and to the base 546). Fig.64B Show Fig.64A 542. Note that the finger 544 can be shaped to leave the opposite end of the tube near the base.

[0595] Fig.65 A valve 547 is shown having two curved surfaces 549 and 550 for positioning a fluid tube 548 between them to regulate fluid flow through the fluid tube 548, in accordance with an embodiment of the present disclosure. As the surfaces are compressed together, the tube 548 between them is compressed. The two curved surfaces 549 and 550 can be compressed together using an actuator. The tube 548 can be wrapped around the surface 549 several times.

[0596] Figures 66A-66GSeveral views of a valve 551 with a knob 552 are shown which, upon movement of the knob 552, moves a connecting member 553 which is locked in place, in accordance with an embodiment of the present disclosure.

[0597] The valve 551 includes an inner curved elongated support member 554 and an outer curved elongated support member 556. The knob 552 is pivotally coupled to the outer support member 556 via a pin 578. The connecting member 553 engages the teeth 576 of the knob 552.

[0598] The connecting member 553 can be inserted into the hole of the end 555 of the support member 556 so that the rotation of the knob 552 will engage the finger-shaped member 700 (see Fig.66D ) frictionally locks into the rack 558 of the connecting member 553. The engaging finger 700 can engage the teeth 576 to lock the knob 552 to thereby prevent the knob 552 from rotating unless sufficient torque overcomes the locking action of the engaging finger 700. The retaining finger 577 is positioned on the other side of the hole 571, pressing the connecting member 552 against the teeth 576 of the knob 552.

[0599] Inner support member 554 can be pivoted out from outer support member 556 so that the tube can be loaded via bosses 559 and 560 (see Fig.66C ). The inner support member 554 is pivoted out from the outer support member 556 via dog bone shapes 561, 562, 701, and 702, as shown in FIG. Fig.66C Thereafter, the inner support member 554 pivots back toward the support member 556, as shown. Fig.66D Then, the connecting member 553 is inserted into the end 555 of the outer support member 556 (at Fig.66E ), the outer support member 556 includes an engagement finger 700 that locks into the teeth 576 of the knob 552, which temporarily secures the connecting member 553 (see Figure 66G ). The other end 581 of the connecting member 553 is locked in the hole 582 of the end 557 of the support member 556. The connecting member 553 can be pivotally connected to the end 557. The knob 552 includes teeth 576 to enable the connecting member 553 to move into or out of the end 555. However, when the knob 552 is not moving, the engaging finger 700 locks the movement of the knob 552 unless a predetermined amount of torque taps the finger 700 to the next tooth of the teeth 576 in the interior of the knob 552.

[0600] As previously mentioned, support member 554 is capable of swinging away from outer support member 556, such as Fig.66CAs shown, dog bone links 561, 562, 701, and 702 facilitate this action. Dog bone link 561 includes pivot hole 572 coupled to pivot 563 and pivot hole 573 coupled to pivot 565. Dog bone link 562 includes pivot hole 575 coupled to pivot 566 and pivot hole 574 coupled to pivot 566. Dog bone link 701 is coupled to pivots 567 and 570, and dog bone link 702 is coupled to pivots 568 and 569, so that the end of support member 556 also swings away from inner support member 554.

[0601] Fig.67 A diagram 408 illustrating actuation relative to flow of a valve is shown according to an embodiment of the present disclosure. Diagram 408 illustrates the operation of a valve having an elongated support member, such as, for example, Fig.49 and Figures 50A-50B Valve 340, Figures 51A-54 Valve 352, Fig.55 Valve 369, Figures 56A-56C Valve 380, Figures 57A-57E Valve 380, Figures 58A-58D Valve 401, Fig.59H Valve 500, Figure 60-60 Valve 520, Figures 64A-64B Valve 542, Fig.65 valve 547, and / or Figures 66A-66G The valve 551 of the diagram 408. The x-axis of the diagram 408 shows the displacement between the two ends of the support member of the valve, and the y-axis shows the flow rate (e.g., caused by gravity and / or a pressure source). The response of the valve is a nonlinear function, such as an S-curve, an S-shaped curve, a Gompertz curve, or a generalized logistic function. These functions can be adjusted to match the valve and / or the valve can be adjusted to match one of the curves or functions.

[0602] Fig.68A A flow meter 703 using a binary optical element 705 is shown in accordance with an embodiment of the present disclosure. The flow meter 703 includes a camera 355 that captures one or more images to estimate the flow rate of a fluid through a drip chamber 357 using any sufficient method (e.g., the methods disclosed herein). The flow meter 703 includes a laser 704 that directs a laser beam onto the binary optical component 705. The binary optical component 705 then redirects and recombines the laser beam through the drip chamber 357 and onto the image sensor 355 so that the image sensor 355 sees a pattern, e.g., Figure 8 The line array 85 shown in FIG. 8 can be formed as shown in FIG. Fig.10 The stripes shown in the background pattern 89. The binary optical component 705 can form the stripes by using a plurality of ellipses.

[0603] Image sensor 355 may include a filter to filter out all frequencies except the frequency of laser 704. For example, image sensor 355 may include an optical bandpass filter having a center frequency equal to (or approximately equal to) the optical frequency of laser 704 (or the center frequency of the optical frequency).

[0604] The monitoring client 358 may be electrically coupled to the laser 801 to modulate the laser 801. For example, the monitoring client 358 may turn on the laser 801 only when predetermined pixels are exposed, and may turn off the laser 801 when other pixels except the predetermined pixels are exposed.

[0605] The flow meter 703 optionally includes a first electrode 800 and a second electrode 801. The monitoring client 358 can be electrically coupled to the first and second electrodes 800, 801 to measure the capacitance defined therebetween. Under flow conditions, the capacitance changes because the relative dielectric constant is different for air and water. By monitoring the capacitance between the first and second electrodes 800, 801, the monitoring client 358 can monitor changes due to flow conditions within the drip chamber 357, and associate increases and / or decreases in capacitance that exceed a threshold value as corresponding to flow conditions and / or non-flow conditions. For example, if the capacitance between the first and second electrodes 800, 801 is above a threshold value, the processor within the monitoring client 358 can determine that the drip chamber 357 is experiencing a flow condition.

[0606] In an optional embodiment, the first and second electrodes 800, 801 are loop antennas. The monitoring client 358 uses a transceiver to monitor the magnetic coupling between the loop antennas 800, 801. For example, the transceiver can transmit coded information from one of the loop antennas 800, 801 to another of the loop antennas 800, 801, and then determine whether the coded information was successfully received. If so, a received signal strength indication ("RSSI") measurement can be performed from the transceiver. RSSI can be used to monitor the magnetic coupling between the antennas 800, 801. If the magnetic coupling is above a threshold, the monitoring client 358 can determine that a flow condition exists in the infusion chamber 357. In some embodiments, a change in magnetic coupling or a change in capacitive coupling can be determined as an indication that a flow condition has occurred.

[0607] The flow meter 703 may also include a safety valve 706 . Figures 69A-69F Several views of a safety valve 706 that may be used with a flow meter, such as flow meter 703 of FIG. 68 , are shown in accordance with an embodiment of the present disclosure.

[0608] Figures 69A-69BAn exploded view of a safety valve 706 is shown. The safety valve may also be referred to as a safety shut-off valve in this application. The safety valve 706 may also include a solenoid 707, an interface structure 708, a tube housing 709, a spring 720, a panel 712, a first shaft 713, a second shaft 714, a first blocking arm 710, and a second blocking arm 711. The panel 712 includes a hole 715, and the tube housing 708 also includes a hole 819. The holes 715, 819 allow the shaft 713 to slide within the holes 715, 819.

[0609] See also Fig.69C , the tube can be placed in position 820 within the tube housing 709, which places the tube near the Fig.69D The first blocking arm 710 and the second blocking arm 711 are easily seen in the position 820. When in the retracted state (such as Fig.69D As shown), the spring 720 keeps the first sealing arm 710 and the second sealing arm 711 retracted, but stores energy so that a predetermined amount of movement of the first sealing arm 710 and the second sealing arm 711 toward the tube 810 causes the spring to release its stored mechanical energy to cause the first sealing arm 710 and the second sealing arm 711 to extend and seal the tube in position 820.

[0610] The spring can be connected to the first shaft 713 and the second shaft 714. The spring 720 can pull the first shaft 713 and the second shaft 714 toward each other. The first blocking arm 710 and the second blocking arm 711 are pivotally connected together. Because the first blocking arm 710 and the second blocking arm 711 are pivotally connected together at a pivot point away from the center of the shafts 713 and 714, the spring 720 pulls the shafts 713 and 714 toward each other, which will remain stable in the retracted state (such as Fig.69D ) until the solenoid 707 causes the arms 710, 711 to extend outwardly beyond a predetermined amount. Fig.69E As can be easily seen in FIG. 1 , the shaft 718 of the solenoid 707 can be actuated through the hole 719 to advance the arms 710, 711, which causes the spring 720 to release its energy and seal the tube at position 820 (see FIG. 1 ). Fig.69F , for when and where the first blocking arm 710 and the second blocking arm 711 are in the blocking position).

[0611] See also Figure 69GIn some embodiments, the current-sensitive material 717 can be coupled to the solenoid 707. The current-sensitive material 717 can be configured as a solenoid so that when the current-sensitive material 717 changes shape due to being affected by a change in current, the solenoid can engage the first blocking arm 710 and the second blocking arm 711. When the current-sensitive material 717 is affected by the change in current, the current-sensitive material 717 will apply a force to the solenoid 707. Thereafter, the solenoid 707 can apply a force to the trigger mechanism to release the blocking arm.

[0612] In another embodiment, Figure 69H As shown in , the first blocking arm and the second blocking arm can be held by magnetic force. In some embodiments, the first magnet 722 and the second magnet 723 can be oriented so that the magnetic poles of opposite sex are aligned (for example, a north magnetic pole and a south magnetic pole). Using this attractive magnetic force, the arms 710 and 711 can be maintained in a retracted state. One of the two magnets can be rotated so that the magnet is reoriented so that the first magnet and the second magnet are oriented so that the magnetic poles of the same sex are aligned (for example, a north magnetic pole and a north magnetic pole or a south magnetic pole and a south magnetic pole). The alignment of the magnetic poles of the same sex causes the magnets to repel each other. The repelling magnets can be used to cause the arms 710 and 711 to extend outward. In other embodiments, such as Fig.69I As shown, permanent magnet 724 may be placed within coil 725. In these embodiments, arms 710, 711 may be maintained in a retracted state using the magnetic force generated by magnet 724 and coil 725. By using a solenoid or some other element, the magnetic force may be overcome, causing arms 710, 711 to be engaged and extended outwardly beyond a predetermined amount. Fig.70 A flow chart illustrating a method 728 of estimating drop growth and / or flow within a drip chamber is shown in accordance with an embodiment of the present disclosure. The method 728 includes actions 729-735. Figure 71A-Figure 71E An image acquired by a flow meter with a template superimposed therein is shown to illustrate Fig.70 Note that template 727 is used to determine the location of the edge of the droplet in both the X and Y dimensions.

[0613] Action 729 captures an image of the drip chamber. Image capture can be Fig.71A Action 730 positions the template in the captured image to a first position. Fig.71A As shown, the template 727 can be positioned in a predetermined position. Action 731 averages all pixels in the template 727. Action 732 moves the template to a second position. For example, Fig.71A The template 727 in the embodiment can move the template in the Y direction (for example, Fig.71A (see below).

[0614] In act 733, pixels within the template are used to determine a second average. In act 734, if the difference between the second average and the first average is greater than a predetermined threshold, it is determined that the template is positioned at the edge of the droplet. Fig.71A , the template can be slowly lowered in the Y direction until the template 727 transitions from the edge of the droplet to a portion of the image that does not contain the droplet, in which case the average value of the pixels will suddenly transition from a dark average value to a lighter average value. When this transition occurs, the Y position of the template 727 is considered to be at the edge of the droplet (e.g., Fig.71A In action 735, the second position of the droplet is associated with the volume of the droplet. For example, the Y1 value may be associated with the volume of the droplet in a lookup table. In some embodiments of the present disclosure, multiple movements of the template 727 are required until the edge of the droplet is detected. For example, the template 727 may be moved one pixel at a time (or several pixels at a time) in the y direction, and several template 727 movements may be required to detect the edge of the droplet. By monitoring the edge of the droplet, the growth of the droplet can be controlled by a flow meter to achieve a target flow rate (for example, a PID control loop within the flow meter can control Fig.71A Y1 to Fig.71B The rate of transition between Y2). Fig.71B Show relative Fig.71A The position Y1 is changed to position Y2, which corresponds to the growth of the droplet. Figure 72-73C shows how the sequential growth of a droplet can be monitored.

[0615] Fig.72 A modular backlight assembly 740 is shown according to an embodiment of the present disclosure. Assembly 740 may be Figure 1 The backlight 18 of the embodiment of the present invention may be used as the backlight of any sufficient flow meter disclosed herein. The assembly 740 includes a first circuit board 738, a second circuit board 739, a first backlight diffuser 736, and a second backlight diffuser 737.

[0616] The first circuit board 738 includes an embedded light source 822 that extends along the interface between the first backlight diffuser 736 and the first circuit board 738. The embedded light source 822 shines light into the first backlight diffuser 736, which is directed outwardly, as indicated by 821. The light 821 can be directed toward the image sensor. When viewed through the image sensor, the first backlight diffuser 736 simply diffuses the light and no "pattern" is formed.

[0617] The second circuit board 739 includes an embedded light 823 that shines light into the second backlight diffuser 737. When viewed through the image sensor, the second backlight diffuser 737 produces a striped pattern shown as light 821. Thus, the monitoring client (e.g., Fig.51A Monitoring client 358) and / or flow meter (e.g., Figure 1 The flow meter 7) is able to select between a striped background pattern (by activating the embedded light 823) and a non-striped background pattern (by activating the embedded light 822).

[0618] For example, now refer to Figure 1 and Fig.72 In some specific embodiments, the flow meter 7 can use a backlight assembly 740; the flow meter 7 can use a non-striped backlight pattern (by activating embedded LED 822 and deactivating embedded LED 823) to monitor the growth of droplets and can switch to a striped background pattern (by activating embedded LED 823 and deactivating embedded LED 822) to detect flow conditions.

[0619] Figures 73A-73C Several views of a tube recovery device 741 according to an embodiment of the present disclosure are shown. The device 741 includes a drive gear 744 coupled to a first recovery gear 742. The first recovery gear 742 is mechanically coupled to a second recovery gear 743. A tube can be placed between the first and second recovery gears 742, 743. Portions of the first and second recovery gears 742, 743 define a space 745 in which the tube can be positioned. When the tube is positioned between the first and second recovery gears 742, 743, the rotation of the first and second recovery gears 742, 743 closes the distance between the space 745. FIG. 73B to FIG. 73C 1 shows the transition from the non-recovery position to the recovery position. For example, the tube can be positioned so that the blocking member presses against the tube from bottom to top (e.g. Fig.73B If the tube becomes distorted over time, a motor connected to drive gear 744 rotates gears 743 and 744 to press against the tube wall (as shown). Fig.73C ) to restore the tube to an approximate cross-section by compressing the wall portion of the tube that extends beyond the central axis of the tube, so that the tube is distorted into, for example, an elliptical shape.

[0620] Fig.74 A system for regulating fluid flow 746 using a valve 747 having two flexible strips 753 and 754 is shown (see Fig.75 );and Fig.75 The embodiment according to the present disclosure is shown Fig.74 of valve 746. Optionally, in one embodiment, a motor may be attached to valve 746 so as to be controlled by a flow meter.

[0621] like Fig.75 As shown, the valve 74 includes: two flexible strips 753 , 754 , between which a tube may be arranged; a guide shaft 752 for guiding members 749 , 750 ; a screw 751 ; and a knob 748 .

[0622] When the knob 748 is rotated, the screw 751 rotates. The rotation of the screw 751 pulls the distal guide member 750 toward the proximal guide member 749 (because the distal guide member 750 includes an internal thread and the screw 751 rotates freely within the proximal guide member 749). The guide 751 guides the movement of the distal guide member 750. The guide 751 is coupled to the proximal guide member 749.

[0623] Fig.76A A valve 755 utilizing a fluid-based bladder 758 is shown in accordance with an embodiment of the present disclosure. The valve 755 includes two clamshells 756, 757, a bladder 758, and a piston 759. The piston 759 can be any source of fluid. The bladder 758 can be placed within a cavity 764, and a tube can be placed across the bladder 758 and positioned within channels 760 and 761. Thereafter, the clamshell 757 can be placed over the bladder 758 such that the cavity 765 is placed over the bladder 758. The two clamshells 756, 757 can then be ultrasonically welded together, temporarily compressed together, and / or fully held together. Thereafter, an actuator (e.g., an actuator controlled by a flow meter disclosed herein) can be actuated to move fluid into and out of the bladder 758 via the piston 759.

[0624] Fig.76B The embodiment according to the present disclosure is shown Fig.76A 758 is a cross-sectional view of an assembled valve 755 having two elastomeric packings 1002, 1004. The elastomeric packings 1002, 1004 help hold the tube 1000 in place and help restore the tube 1000 when the bladder 758 is deflated.

[0625] Fig.77 A system 766 for regulating fluid flow using a valve 769 having two flexible strips 771 , 772 actuatable by a linear actuator 822 is shown in accordance with an embodiment of the present disclosure. Fig.78 A linear actuator 822 is shown actuating a valve 769 to obstruct fluid flow through a tube 775. The valve 769 is coupled to two couplers 767 and 768. The proximal coupler 768 moves with the linear actuator 822, while the distal coupler 767 is fixed relative to the non-moving end of the linear actuator 822.

[0626] Fig.79 Show Figures 77-78769. The valve 769 includes two strips 771, 772 (which may be metal strips) in which a tube 775 may be disposed. The two strips 771, 772 of the valve 769 may be coupled to a first end structure 773 and a second end structure 774. The first end structure 773 may be coupled to the distal coupler 767, and the second end structure 774 may be coupled to the proximal coupler 768 (see Figures 77-78 ). The rope 770 or membrane may be wrapped around the tube 775 so that, when the strips 771, 772 are aligned, the rope 770 presses against the side walls of the tube 775 to help round the tube 775. The membrane may be a flexible but non-stretchable material (or a minimally stretchable material). Fig.80 As shown in Fig.78 770 is threaded through holes 776 and 778. The rope 770 (which can be metal) is wrapped around the tube 775 in a spiral manner so that when the valve 769 is opened, the rope 770 recovers the tube 775.

[0627] Fig.81 The embodiment of the present disclosure is used to illustrate the estimation Figures 82A-82B Several images of the method of droplet growth and / or fluid flow are shown in FIG. Fig.81 Show the following mentioned Figures 82A-82B Related images 771-777.

[0628] Figures 82A-82B A flow chart illustrating a method 803 of estimating droplet growth and / or fluid flow is shown. The method 803 includes actions 804-818.

[0629] Action 804 captures a first image (eg, Fig.81 The first image may be a grayscale image of the droplet transducer. The droplet injection chamber may be uniformly illuminated by the stripe pattern on the bottom of the chamber (ie, there is no background pattern on the top of the droplet injection chamber).

[0630] Action 805 uses the first image to generate a first thresholded image. The first thresholded image may be Fig.81 The first thresholded image can be achieved by comparing each pixel of the first image to a threshold value (e.g., if the corresponding pixel of the first image is above the threshold value, the thresholded corresponding pixel is set to 0, or if the corresponding pixel of the first image is below the threshold value, the thresholded corresponding pixel is set to 1). This action highlights the area where water exists in front of the background.

[0631] In some specific embodiments, the threshold level is updated each time a new image is acquired to ensure that a predetermined ratio of 1 to 0 pixels is maintained to highlight the droplets. When used again, the ratio can be updated for use by act 805, or the update can adjust the threshold until a predetermined ratio of 1 to 0 pixels is produced, and then use the first thresholded image for the rest of method 803.

[0632] Act 806 determines a set of pixels connected to a predetermined set of pixels within the first thresholded image within the first thresholded image. The predetermined set of pixels can be determined by a reference point on a drip chamber or opening in which a droplet is formed. The predetermined set of pixels can be a set of predetermined x, y values ​​corresponding to pixels. Act 806 can use a connected component image analysis algorithm.

[0633] Action 807 filters all remaining pixels of the first thresholded image that do not have a pixel group. The filter operates pixel by pixel in the time domain to generate a first filtered image. The first filtered image is the first thresholded image ( Fig.81 The filter may be any filter, such as any filter described herein.

[0634] Action 808 uses the first filtered image to remove portions determined not to be droplets from the first thresholded image to generate a second image (eg, Fig.81 If the corresponding pixel in the first thresholded image is 1 and the corresponding pixel in the first filtered image is less than 0.5, the pixel in the second image will be set to 1, otherwise, the pixel will be set to 0.

[0635] Action 809 determines a second pixel group connected to a predetermined pixel group within the second image within the second image to generate a third image (eg, Fig.81 The third image identifies a second pixel group within the second image. Action 809 finds a group of "illuminated" pixels in the second image that are connected to a predetermined pixel group (eg, pixels representing an opening in which a droplet is formed).

[0636] Act 810 determines a first length of the drop by counting the number of rows containing pixels corresponding to the second pixel group within the third image. That is, the drop length is determined to be equal to the last "illuminated" row present in the pixel group in act 809. The first length corresponds to a first estimated drop size.

[0637] Action 811 updates the background image using the first image. A low pass filter may be used to update the value of each pixel in the background image. An infinite impulse response filter may be used to update the background image using the first image. Pixels in the background image are updated only for rows below the first length plus a predetermined safety zone. Pixels in the background image are updated by low pass filtering the values ​​of corresponding pixels in the first image.

[0638] Action 812 generates a second thresholded image by comparing the first image to a background image (eg, Fig.81 That is, the first image has the background image subtracted therefrom, and on a pixel-by-pixel basis, each pixel is set to 1 if its absolute value is above a second threshold value, and is set to 0 if its absolute value is below the second threshold value to generate a second thresholded image.

[0639] Action 813 sums the second thresholded rows to create a sum of multiple rows (see Fig.81 The sum of each row corresponds to a row of the second thresholded image.

[0640] Act 814 begins at a row position of the second thresholded image having a first sum corresponding to the plurality of sums of the first length. The row position is incremented in act 815. Act 816 determines whether the current row position corresponds to a corresponding row sum below a threshold value, such as zero. If not, act 815 is performed again until the current row position corresponds to a corresponding row sum that is zero, and then method 803 proceeds to act 817.

[0641] Action 817 determines that the second length is equal to the current row position. The second length corresponds to the second estimated drop size. Action 818 averages the first and second lengths to determine the average length. The average length corresponds to the third estimated drop size. By using the first and second lengths to determine the average length, the condensation effect on the inner wall of the drip chamber is mitigated. That is, the purpose of creating two estimates of the drop length is to compensate for the extent to which each length is affected by the presence of condensation. If the condensed drop intersects with the growing drop from the drip nozzle, the first length tends to underestimate the drop length. If the condensed drop intersects with the growing drop from the drip nozzle, the second length tends to overestimate the drop length. When condensation is present, their average provides a better estimate. In the absence of condensation, the estimates are almost equal. In other embodiments, only the first or second length is used to estimate the drop size.

[0642] Fig.83 A flow chart of a method 900 for reducing noise from condensation according to an embodiment of the present disclosure is shown. The method 900 includes actions 902-910.

[0643] Action 902 captures an image of the drip chamber. Action 904 performs a Canny edge detection operation on the image to generate a first processed image. Action 906 performs an AND operation of pixels on a first side of the axis of the first processed image and corresponding mirrored pixels on a second side of the axis of the first processed image. That is, action 902 defines an axis in the first process image, and performs an AND operation of each pixel on one side with the pixel on the other side using the pixel on the other side, so that the pixels on the other side are symmetrical with the pixels on the first side. For example, a 40 (x-axis) by 40 (y-axis) image may have an axis defined between pixel columns 19 and 20. The upper left pixel will be pixel (1, 1). The pixel at position (1,5) will be ANDed together with the pixel at (40,5). The resulting pixel will be used for two positions (1,5) and (40,5) to generate a second processed image.

[0644] After performing act 906, act 908 determines whether all pixels have been processed. Act 908 repeats act 906 until all pixels have been processed. Act 910 provides a second processed image as a result of all AND operations.

[0645] Fig.84 Another valve 2000 is shown for use with a flow meter according to an embodiment of the present disclosure. Valve 2000 is coupled to a portion of an injection fluid line 2001 and a portion of an exhaust fluid line 2002. A portion of a flexible tube 2003 is coupled between the portion of the injection fluid line 2001 and the portion of the exhaust fluid line 2002 within a rigid cylinder 2004. A fluid pump 2005 is coupled to the rigid cylinder 2004 to infuse and pump fluid into and out of the rigid cylinder 2004. The rigid cylinder 2004 may include a fluid, such as a liquid, disposed therein.

[0646] Actuator 2007 controls plunger 2008 of pump 2005 to compress flexible tube portion 2003 using fluid within rigid cylinder 2004 to control fluid flow between a portion of injection fluid line 2001 and a portion of exhaust fluid line 2002. Actuator 2007 may be controlled by a processor (e.g., Figure 1 By compressing the flexible tube portion 2003, the flow of the fluid flow within the flexible tube portion 2003 can be controlled by actuation of the actuator 2007.

[0647] Figure 85A-Figure 85C Another valve 8500 is shown for use with a flow meter according to an embodiment of the present disclosure. The embodiment uses a plunger 8512 and a substantially incompressible filler 8621 (the filler is omitted for clarity). Figure 85A-Figure 85C And shown in Fig.86The flexible tube may be an IV tube and may be arranged as a through hole 8518 (see FIG. 85) on the first clamshell portion 8504 and / or the second clamshell portion 8502. Fig.85B ). The substantially incompressible filler portion 8621 (see Fig.86 ) is contained within a rigid housing that includes a first clamshell portion 8504 and a second clamshell portion 8502. The first clamshell portion 8504 and the second clamshell portion 8502 are connected by a hinge 8505, which allows a user to open the housing to insert and remove a flexible tube in which fluid flow is controlled by the valve 8500. The plunger 8512 engages the substantially incompressible filler portion 8621 through the hole 8511 in the first clamshell portion 8504, ultimately deforming the tube.

[0648] Once the flexible tube is positioned in the housing, the first clamshell portion 8504 and the second clamshell portion 8502 are secured in a closed position by a lock (8503, 8506). The lock includes a male member 8503 on the second clamshell portion 8502 and a female member 8506 on the first clamshell portion 8504. The male member 8503 extends from the second clamshell portion 8502 as a plurality of fingers on opposite sides of the pivot. The female member 8506 is a lever with an input end 8506a and an output end 8506b. Fig.85B As shown, the lock secures the clamshells 8502, 8504 closed by positioning the output end 8506b of the female member 8506 on the male member 8503 and rotating the female member 8506 to the top of the second clamshell portion 8502. The connecting member 8501 connects the female portion 8506 to the first clamshell portion 8504 so that when the female member of the lock is rotated closed, the rounded edge of the output end 8506b of the female member 8506 (i.e., the output end 8506b is a rounded edge) is compressed against the male member 8503 of the lock 8503, 8506. This feature generates a force on the male member 8503 when the female portion 8506 is rotated, squeezing the first clamshell portion 8504 and the second clamshell portion 8502 together.

[0649] The plunger 8512 is guided into the first clamshell 8504 by a guide 8508 attached to the first clamshell 8504 and powered by a linear actuator 8510. The guide 8510 aligns the plunger 8512 with the hole 8511 in the first clamshell 8504. The actuator 8510 is attached to the guide 8508 at an end of the guide 8508 opposite to the end of the guide 8508 attached to the first clamshell 8504.

[0650] For clarity, Fig.85C A portion of valve 8500 is shown with components removed. Fig.85CAs shown, the plunger 8512 is connected to an output shaft 8520 on an actuator 8510 that drives the plunger 8512 into and out of the first clamshell portion 8504. A spring 8516 is placed between the plunger stabilizing arm 8514 and the actuator 8510 to push the plunger 8512 away from the actuator 8510. The spring 8516 helps balance the force applied to the plunger by the filling portion 8621 (see Fig.86 ), allowing actuator 8510 to apply less peak force.

[0651] In some embodiments of the present disclosure, the plunger head 8512a has a smaller area than the longitudinal cross-section of the tube within the valve housing 8502, 8504. The smaller head 8512a causes a smaller change in pressure when compared to a similar displacement with a larger head. In some embodiments, this can facilitate more precise changes in tube deformation brought about by the actuator 8510.

[0652] The first clamshell portion 8504 and the second clamshell portion 8502 are on the side adjacent to the hinge side.

[0653] A semicircular cutout is provided to create a hole 8518 (see Fig.85B ). When the housing is in the closed position, the cutouts are positioned to align, creating hole 8518. Hole 8518 allows for the housing to be positioned without deformation.

[0654] Flexible tubing (e.g., PVC IV tubing) passes through the closed rigid shells 8502, 8504.

[0655] Fig.86 A cross-sectional view of a valve housing is shown with a substantially incompressible filler 8621 enclosed therein. The substantially incompressible filler 862 encloses a first clamshell portion 8504 and a second clamshell portion 8502. A first layer 8628 and a second layer 8626 are laid within the first clamshell portion 8504, while a third layer 8624 and a fourth layer 8622 are laid within the second clamshell portion 8502. When the housing is closed and a conduit 8618 is formed in which a tube is placed, the second layer 8626 and the third layer 8624 are laid in between to aid in uniform deformation of the tube. The conduit 8618 connects the hole 8618 defined by the closed clamshell portions 8502, 8504.

[0656] The materials used to make some flexible tubes may be susceptible to creep, which affects the ability of the tube to rebound to its original shape after multiple deformations. When creep begins to affect the shape of the tube, in order to uniformly deform the tube, the second layer 8626 and the third layer 8624 are harder than the first layer 8628 and the fourth layer 8622. The harder second layer 8626 and the third layer 8624 are less affected by creep than the tube and return to their original shape after many deformations. Therefore, when the filler 8621 attempts to restore the original shape of the conduit 8618, it will restore the tube within the conduit.

[0657] Moreover, in some embodiments, the tube has a tendency to adhere to itself when deformed to the extent that the inner surfaces of the tube contact each other. This makes it difficult to control very low drip rates when the tube is almost completely closed. The hard layer surrounding the tubes 8624, 8626 exerts a force sufficient to overcome the adhesion force, thus causing the tubes to open evenly.

[0658] The first layer 8528 and the fourth layer 8522 fill the space between the second layer 8526 and the third layer 8524 and the clamshells 8502, 8504. In order to evenly distribute the force of the plunger 8512 throughout the entire portion of the tube within the clamshells 8502, 8504, the second layer 8526 and the third layer 8524 are softer. Instead of transferring the force directly to the area of ​​the tube directly above the plunger 8512, the plunger 8512 increases the pressure in the clamshells 8502, 8504. This causes a generally uniform deformation of the enclosed portion of the tube. Because the friction between the liquid and the tube contributes to the valve flow accuracy, uniform deformation is beneficial. The longer deformed portion transfers more friction on the flowing liquid, slowing its flow. Extending the portion of the tube whose flow is regulated by the valve creates conditions for low flow and a larger, more manageable lumen diameter.

[0659] The soft layers 8622, 8628 preferably have a Shore OO hardness of from about 20 to about 25. The hard layer preferably has a Shore A hardness of about 15. In some embodiments, preferred materials for the filler portion include silicone, polyurethane, fluororubber, or nitrile.

[0660] Figures 87A-87D Flow control device 8700 according to an embodiment of the present disclosure is shown. Flow control device 8700 includes a device housing 8702 surrounding a valve 8732 and a safety shut-off valve 8734 (see Fig.87B ). Fig.87B As can be easily seen in FIG. 87 , the housing 8702 includes a door 8702b and a body 8702a. A drip chamber rack 8714 having a top member 8714a and a bottom member 8714b is attached to the body 8702a and is configured to orient the drip chamber vertically. The laser 8708 and the diffraction device 8716 are attached to the body 8702a of the housing 8702 and are aligned so that the laser diffracts so that it creates a pattern on a drip chamber (the drip chamber is not shown in FIG. 87 ) loaded in the drip chamber rack 8714. An image sensor 8710 having a drip chamber and a diffraction pattern in its field of view can also be attached to the device housing 8702.

[0661] In some embodiments, the laser beam is first split into a first beam and a second beam by a beam splitter so that the first beam is directed toward the upper diffraction device 8716a and the second beam is directed toward the lower diffraction device 8716b. The beam splitter can be part of the laser beam exiting the lens.

[0662] The upper diffraction device 8716a directs its pattern in the upper part of the drip chamber and the lower diffraction device 8716b directs its pattern in the lower part of the drip chamber. In some embodiments, the diffraction devices 8716a, 8716b can use a binary optical film to redirect and restore the laser beam to a pattern. The upper film of the upper diffraction device 8716a converts the beam into an array of dots, or in some embodiments, into a single dot. This creates a contrast for the image sensor 8710 to track the growth of the droplet formed at the top of the drip chamber. The lower film of the lower diffraction device 8716b converts the beam into a horizontal stripe pattern. The stripes create a contrast for the image sensor 8710 to determine whether the fluid is flowing instead of dripping.

[0663] As in Fig.87B As can be easily seen in FIG. 8 , this embodiment has a valve closing arm 8720 connected to the door 8702b of the housing 8702 and connected to the input end 8722a of the female lock member 8722. When the door 8702b is opened, the closing arm 8720 pulls on the input end 8722a of the female lock member 8722, causing it to rotate upward and away from the valve 8732. This releases the pressure applied to the valve 8732 from the output end 8722b of the female lock member 8722. Once the female lock member 8722 is disengaged from the male lock member 8728, the closing arm 8720 pulls open the valve housing clamshells 8732a, 8732b by disengaging the female lock member 8722 from the valve 8732. When the door 8702b is fully opened, the clamshells 8732a, 8732b are open far enough for the operator to remove or insert the tube regulated by the valve into the valve 8732 (the open position is shown in FIG. 8 ). Fig.87B Once the tube is placed in the valve 8732, the operator closes the door 8792b. Closing the door 8702b causes the closing arm 8720 to engage the female lock member 8722 so that the output end 8722b of the female lock member 8722 engages the male lock member 8728, thereby further actuating the rotation of the female lock member 8722 into a fixed position (similar to the position shown in FIG. Fig.85B The closing arm 8720 increases the efficiency of the process of assembling the device 8700 and improves safety by ensuring that the valve 8732 is reliably closed when the door 8702b is closed.

[0664] When assembling the apparatus 8700, the operator lays the pipe through the safety shutoff valve 8734 (the physical mechanism of the safety shutoff valve is described with reference to FIG. 69 ) together with the valve 8732 (see FIG. Fig.87C). The safety shut-off valve 8734 uses a spring driven by the blocking arms 8739a, 8739b to compress the tube into the check valve 8741 when triggered. The solenoid applies force to trigger the mechanism and release the blocking arms 8739a, 8739b. Once the blocking arms 8739a, 8739b are released, they essentially cut off the flow through the tube and ultimately to the patient by compressing the tube against the check valve 8741. The safety shut-off valve 8734 is triggered by a processor that uses a safety sensor to sense unexpected events. Unexpected events may include loss of power, tipping of the device 8700, fluid flowing through the infusion chamber, or flow associated with incorrect position of the valve 8732. The latter of these examples can address the state of the tube being twisted at some location between the device and the patient.

[0665] The safety shutoff valve of the reset arm 8735 can be attached to the door 8702b and is configured to reset the safety shutoff valve 8734 to a free flow position by opening the door 8702b of the housing 8702. The safety shutoff valve 8734 used in this embodiment is similar to the valve described in FIG. 69. However, in FIG. 87, the blocking arm 711 in FIG. 69 extends past the screw 714 in FIG. 69, creating a tab protruding from the bottom. Fig.87C As shown, Fig.87B The safety shut-off valve 8734 includes this protrusion 8740.

[0666] See also Fig.87C , the reset arm 8735 includes three members 8736, 8738, 8742. The first member 8736 of the reset arm 8735 is attached to the door 8702b and to the second member 8738 of the reset arm 8735. The second member 8738 of the reset arm 8735 is attached to the third member 8742 of the reset arm 8735. Opening the door 8702b actuates the first member 8736, which sequentially actuates the second member 8738 and the third member 8742. The third member 8742 has a protrusion that is configured to engage the tab 8740 and force it back to a non-engaged parallel position (such as Fig.69D In other embodiments, the safety shut-off valve 8734 can be reset with fewer or more components as needed.

[0667] Fig.87DAn embodiment of the present disclosure is shown, which is designed to stop fluid flow through a valved tube when the door 8702b is in an open position. A compression tab 8744 can be used to substantially cut off flow through a valved tube when the device housing door 8702b is open. When the tube is installed, the operator inserts the tube into the gap 8745 between the compression tab 8744 and the housing body 8702a. When the door is open, the tension of the compression tab 8744 is applied to the tube, substantially cutting off flow by deforming the tube. When the door 8704b is closed, a wedge 8746 attached to the door 8702b is forced into the gap 8745 and splits the compression tab 8744. Splitting the tab 8744 allows fluid flow to allow the tube to be opened again. This feature is used as a safety mechanism to ensure that when the operator is installing the device, no liquid from the drip chamber is administered to the patient.

[0668] Actuating the valve 8732 causes a change in the prism pressure in the device housing 8702. An array of holes 8748 may be defined in the device housing body 8702a. These holes allow the pressure inside the housing to balance the pressure outside the housing 8702, which may improve accuracy in some embodiments.

[0669] See again Fig.87A In some embodiments of the present disclosure, a status light 8718 can be used to visually display the status of the flow control device 8700. The light 8718 is attached to the flow control device 8700 in a position where it can be easily seen by people nearby. In some embodiments, the status light 8718 will emit a first color when the fluid is flowing and a second color when the flow has stopped. In other embodiments, when the flow control device 8700 is operating normally,

[0670] The status light 8718 will emit a first color, a second color when the flow control device 8700 has detected a problem, and a third color when the flow control device 8700 is paused. The status light 8718 can also be configured to flash each time a drop of liquid falls into the drip chamber. This feature allows the operator to see the drip volume from a distance where the display 8704 should not be read.

[0671] Certain embodiments of the present disclosure can use batteries as a power supply. Other embodiments can use a combination of batteries and an AC wall adapter, or only an AC wall adapter.

[0672] In another embodiment of the present disclosure, the device 8700 includes an input button 8706 and a display 8704. The input button 8706 can be used to control the flow of liquid through the drip chamber. This allows the operator to initially set the flow rate and adjust the flow rate when needed. In other embodiments, the input button 8706 can be configured to adjust any adjustable parameters of the device 8700. The input button 8706 can light up different colors to help the user. For example, the green button of the input button 8706 can be used to increase or reduce the flow rate, the yellow button of the input button 8706 can be used to pause the flow, and the red button of the input button 8706 can be used to stop the flow of fluid. The display 8704 can display the infusion information including the current flow rate and the set flow rate to notify the operator. The display 8704 can also display information about the patient, the device, or the fluid delivered by the device. For example, the status of the battery, any alarm or the identification sequence of the patient.

[0673] The processor may also communicate with the status light 8718. The processor may tell the status light 8718 to emit a first color when the fluid is flowing, and to emit a second color when the flow has stopped. The status light 8718 may also emit a first color of light when the pump is operational, and a second color of light when a problem has been detected. The first color of light will likely be green and the second color of light will likely be red.

[0674] Certain embodiments may use an audio output device to communicate with the operator. For example, this device may transmit an error signal, update the operator about the status of the pump, or guide the operator through the settings of the flow control device 8700.

[0675] See now Figure 88A-Figure 88E : Fig.88A A perspective view showing a fluid flow device 8800 for controlling fluid flow through a drip chamber 8820 connected to a tube 8821, wherein the device 8800 is provided with a housing door 8809b open; Fig.88B Show according to Fig.88A A perspective view of only valve 8801; Fig.88C Show according to Fig.88B The internal workings of valve 8801; Fig.88D shows a simplified diagram illustrating the operation of the valve shutoff structure in the closed position of the door 8809b; and Figure 88E A simplified diagram showing the valve shutoff mechanism in an open position of door 8809b is shown according to an embodiment of the present disclosure.

[0676] When the housing door 8809b is open, the flow control device 8800 blocks the flow through the tube 8821 in the valve 8801. In this embodiment, the housing door 8809b is pivotally coupled to the housing body 8809a, and the stop spring 8806 (see FIG. 8806 ) is arranged in the filling portion of the valve 8801 housing. Fig.88B), actuator 8802 and attached plunger 8816 (see Fig.88C ) is connected to the valve 8801. The plunger 8816 is attached to the actuator 8802 by the threaded drive shaft 8812, and in some embodiments, the plunger can freely rotate on the drive shaft 8812. This allows the plunger 8816 to maintain a constant orientation while the drive shaft 8812 rotates. The half nut 8811 on the end of the engagement member 8810 is operatively connected to the fluid flow device 8800 so that the half nut 8811 has the ability to engage or disengage the threaded drive shaft 8812 with the threads of the threaded half nut 8811.

[0677] When the device housing door 8809b (see Fig.88A ) is closed, half nut 8811 (see Fig.88C ) engages with the drive shaft 8812 to allow the actuator 8802 to control the position of the plunger 8816 by rotating the threaded drive shaft 8812. Open the device housing door 8809b (see Fig.88A ) Make half nut 8811 (see Figure 88B-Figure 88C ) is disengaged from the drive shaft 8812 (by actuating the half nut away from the drive shaft), leaving only the cut-off spring 8806 to control the position of the plunger 8816. The cut-off spring 8806 drives the plunger 8816 into the filling section with sufficient force to substantially shut off flow through the drip chamber 8820 coupled to the drip chamber 8820 (see Fig.88A ) of the tube 9921. This mechanism can be used for the same purpose as the compression tab described in FIG. 87.

[0678] Figures 88D-88E The mechanism for engaging and disengaging the half nut 8811 is shown by means of a threaded drive shaft 8812. The engagement member 8810 has a half nut 8811 at one end and is pivotally connected to a pivot member 8803 at the other end. The pivot member 8803 is anchored by a hinge 8818 (coupled to the housing body 8809a) and positioned to be engaged by a pusher member 8805 connected to the housing door 8809b. The pusher member 8805 is coupled to the door 8809b (shown in FIG. Fig.88A ).

[0679] Fig.88D The position of the mechanism is shown when the housing door 8809b is closed. In this position, the push member 8805 is not engaged with the pivot member 8803, leaving only the force of the spring 8814 to affect the position of the pivot 8803 and connect to the engagement member 8810. Fig.88D From the perspective of FIG. 8 , spring 8814 biases pivot member 8803 to rotate in a counterclockwise direction. Because of hinge 8818, the rotational force is converted into a force that pushes the engagement member 8810 into the threaded drive shaft 8812.

[0680] Figure 88EThe position of the mechanism is shown when the housing door 8809b is open. Opening the door 8809b causes the propulsion member 8805 to rotate and engage the pivot member 8803. Figure 88E From this perspective, this balances the force of spring 8814 and rotates pivot member 8803 clockwise. Clockwise rotation of pivot member 8810 disengages engagement member 8803 from threaded drive shaft 8812.

[0681] Figure 89 shows a method for controlling the flow of fluid through a drip chamber according to an embodiment of the present disclosure. The method includes an installation action 8902. During the installation action 8902, a flexible tube in fluid communication with the drip chamber is substantially deformed while being installed in a fluid flow control device by an operator. In a reforming action 8904, once the installation process is complete, the tube is restored to substantially its original size. In an imaging action 8906, an image of the drip chamber in fluid communication with the tube is taken. In an estimating action 8908, the image from the previous action is used to estimate the flow through the drip chamber. In a communicating action 8910, the estimated flow is communicated to a fluid monitoring client. In a receiving action 8912, a desired flow is received from a user. The user can be an operator of a flow monitoring client or a device. In a comparing action 8914, the estimated flow is compared with the desired flow and a difference is generated. In a determining action 8916, the difference from the previous action is used to determine the size and direction of valve actuation to achieve the desired flow.

[0682] See now Fig.89B , in an actuation action 8918, the valve is actuated according to the determined magnitude and direction to achieve the desired flow rate. Valve actuation can be achieved by increasing the pressure around a defined portion of the tube that deforms the tube and changes the shape of the lumen within the tube. Pressure regulation can be achieved by arranging a rigid housing around a defined portion of the tube and engaging a plunger with a substantially incompressible material enclosed within the housing. The filler material converts the engaged plunger into pressure within the housing, thereby deforming the tube.

[0683] In lighting action 8920, light is emitted to indicate the status of the device performing this method. A first color of light may be emitted to indicate that fluid is flowing, and a second color of light may be emitted to indicate that flow has stopped. The first color of light may be used to indicate that the device is functioning normally and the second color of light may be used to indicate that a problem has been detected.

[0684] In monitoring action 8922, the method is used to monitor for an unexpected event. The unexpected event can be a loss of power or tipping over of the device performing the method. In shut-off action 8924, when an unexpected event is detected by the monitoring action, the flow of fluid through the drip chamber is stopped. In removal action 8926, while removing the tube from the device performing the method, the tube is deformed to substantially reduce the size of its lumen.

[0685] like Fig.90As shown, a system 9000 is shown. The system 9000 can be used with Figure 87A-Figure 87D Flow Control Device 8700 or Figures 88A-88D The system 9000 includes a processor 9002 that communicates with an image sensor 9006 and a valve actuator 9004. The processor 9002 receives image data from the image sensor 9006. Once the processor 9002 has received image data from the image sensor 9006, the processor uses the data to estimate the flow rate. The processor ...

Claims

1. A method for controlling the flow of a fluid through a drip chamber, the method comprising: photographing, using an image sensor to photograph a plurality of images of the infusion chamber; estimating, using a processor, a flow rate through the infusion chamber using a plurality of images; Receive, receive the desired traffic from the user; comparing, using the processor, the estimated flow rate to an expected flow rate; determining, using said processor, a magnitude and direction of valve actuation to achieve said desired flow rate; as well as actuating, actuating the valve according to the determined magnitude and direction to achieve the desired flow, Wherein, the photographing step comprises: capturing an image of the infusion chamber by means of the image sensor; Determine whether the captured image contains visual impairments; When it is determined that the captured image contains the visual impairment, applying a blur function to the captured image, the blur function being configured to eliminate the effect of details in the captured image; and A determination is made as to whether the captured image contains a match to a template.

2. The method of claim 1, further comprising an act of communicating the estimated flow rate to a fluid monitoring client.

3. The method of claim 1, further comprising the act of monitoring for unexpected events. The method of claim 3 , further comprising stopping flow when the unexpected event occurs.

5. The method according to claim 1, further comprising: When a flexible tube in fluid communication with the drip chamber is removed from or installed on a device performing the method, the tube is deformed to reduce the size of its lumen.

6. The method according to claim 5, further comprising: After the installation or removal process of the tube is complete, the force deforming the tube is removed, allowing the tube to return to approximately its original size.

7. The method according to claim 1, wherein: The valve actuation actions include: providing a flexible tube having a lumen in fluid communication with the drip chamber; and A valve is used to regulate pressure around a defined portion of the flexible tube containing the lumen to change the shape of the lumen.

8. The method according to claim 7, wherein: Pressure regulation actions include: disposing a rigid housing around a defined portion of the lumen; and A plunger is engaged with a substantially incompressible filler material enclosed within the housing, wherein the material transmits pressure generated by the engaged plunger to deform the lumen.

9. The method of claim 1, further comprising lighting a light to indicate a status of a device performing the method.

10. The method according to claim 9, wherein: When the pump is running, a first color light is emitted; when fluid flow is paused, a second color light is emitted; and when the pump is stopped, a third color light is emitted.

11. The method according to claim 9, wherein: Whenever a drop of liquid falls into a drip chamber in fluid communication with the valve, the light flashes.

12. The method of claim 1, further comprising displaying infusion information related to the method on a display.

13. The method of claim 1, further comprising outputting audio to notify an operator of a device performing the method.

14. A method of filtering a captured image of a drip chamber, the drip chamber being configured to allow a droplet of a fluid to fall into the drip chamber, the method comprising: capturing an image of the infusion chamber using an image sensor; Determine whether the captured image contains visual impairments; When it is determined that the captured image contains the visual impairment, applying a blur function to the captured image, the blur function being configured to eliminate the effect of details in the captured image; as well as A determination is made as to whether the captured image contains a match to a template.

15. The method according to claim 14, wherein: The desired pattern comprises at least a partial image of a droplet of fluid within the drip chamber.

16. The method according to claim 14, wherein: The blur function is a low pass filter, which is applied in one of a vertical direction and a horizontal direction.

17. The method according to claim 16, wherein: The low pass filter includes a one-dimensional Gaussian blur function.

18. The method according to claim 14, wherein: The blur function is a low pass filter which is applied both horizontally and vertically.

19. The method according to claim 18, wherein: The low pass filter includes a two-dimensional Gaussian blur function.

20. The method according to claim 14, wherein: The effect of the removed detail includes an image of one of condensation or splashing within the drip chamber.

21. A method for capturing an image of an infusion chamber, the method comprising: illuminating at least a portion of the drip chamber; capturing an image of the infusion chamber using an image sensor; determining, using a processor operatively coupled to the image sensor, whether there is a visual obstruction in the captured image; applying a blur function to the captured image to filter the captured image using the processor when it is determined that there is a visual impairment in the captured image; as well as The processor is used to determine whether there is a match to a template in the captured image.

22. The method according to claim 21, wherein: The template includes at least a partial image of a droplet of fluid within the drip chamber.

23. The method according to claim 21, wherein: The blur function is a low pass filter, and the processor applies the low pass filter to the captured image in one of a horizontal direction and a vertical direction.

24. The method according to claim 23, wherein: The low pass filter includes a one-dimensional Gaussian blur function.

25. The method according to claim 21, wherein: The blur function is a low pass filter, and the processor applies the low pass filter to the captured image in both the horizontal and vertical directions.

26. The method according to claim 25, wherein: The low pass filter includes a two-dimensional Gaussian blur function.

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