EP3749260A1 - Procédé de surveillance de la distribution d'une goutte et dispositif d'assistance - Google Patents

Procédé de surveillance de la distribution d'une goutte et dispositif d'assistance

Info

Publication number
EP3749260A1
EP3749260A1 EP19705130.3A EP19705130A EP3749260A1 EP 3749260 A1 EP3749260 A1 EP 3749260A1 EP 19705130 A EP19705130 A EP 19705130A EP 3749260 A1 EP3749260 A1 EP 3749260A1
Authority
EP
European Patent Office
Prior art keywords
liquid
drop
detection
distribution
dispensing
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP19705130.3A
Other languages
German (de)
English (en)
French (fr)
Inventor
Thierry Decock
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nemera la Verpilliere SAS
Original Assignee
Nemera la Verpilliere SAS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Nemera la Verpilliere SAS filed Critical Nemera la Verpilliere SAS
Publication of EP3749260A1 publication Critical patent/EP3749260A1/fr
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/0008Introducing ophthalmic products into the ocular cavity or retaining products therein
    • A61F9/0026Ophthalmic product dispenser attachments to facilitate positioning near the eye
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/0008Introducing ophthalmic products into the ocular cavity or retaining products therein
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16804Flow controllers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16831Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16886Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body for measuring fluid flow rate, i.e. flowmeters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16886Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body for measuring fluid flow rate, i.e. flowmeters
    • A61M5/1689Drip counters
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01FMEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
    • G01F22/00Methods or apparatus for measuring volume of fluids or fluent solid material, not otherwise provided for
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01LMEASURING FORCE, STRESS, TORQUE, WORK, MECHANICAL POWER, MECHANICAL EFFICIENCY, OR FLUID PRESSURE
    • G01L1/00Measuring force or stress, in general
    • G01L1/20Measuring force or stress, in general by measuring variations in ohmic resistance of solid materials or of electrically-conductive fluids; by making use of electrokinetic cells, i.e. liquid-containing cells wherein an electrical potential is produced or varied upon the application of stress
    • G01L1/22Measuring force or stress, in general by measuring variations in ohmic resistance of solid materials or of electrically-conductive fluids; by making use of electrokinetic cells, i.e. liquid-containing cells wherein an electrical potential is produced or varied upon the application of stress using resistance strain gauges
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01PMEASURING LINEAR OR ANGULAR SPEED, ACCELERATION, DECELERATION, OR SHOCK; INDICATING PRESENCE, ABSENCE, OR DIRECTION, OF MOVEMENT
    • G01P13/00Indicating or recording presence, absence, or direction, of movement
    • G01P13/0006Indicating or recording presence, absence, or direction, of movement of fluids or of granulous or powder-like substances
    • G01P13/0066Indicating or recording presence, absence, or direction, of movement of fluids or of granulous or powder-like substances by using differences of pressure in the fluid

Definitions

  • the invention relates to a method for monitoring the distribution of a drop by a device for dispensing a liquid product in the form of drops and a device for assisting the use of such a dispensing device.
  • US 2014/0257206 discloses a control device for the instillation of drops of ophthalmic liquid comprising a drop detector by optical principle capable of detecting the passage of a drop.
  • this method does not detect an effective distribution of gout in the subject's eye.
  • the invention is in particular to provide a method of monitoring the distribution of a drop and an assistance device to better know if a drop has actually been distributed.
  • the invention particularly relates to a method for monitoring the distribution of a drop by a device for dispensing a liquid product in the form of drops, using product detection means liquid disposed in the vicinity of a drop dispensing orifice, and a data processing system provided by the detection means, monitoring method in which the processing system receives information corresponding to the succession of the following steps:
  • a liquid presence detection step during which the detection means detect the presence of liquid in the vicinity of the dispensing orifice, the detection means being configured so that the detection of the presence of liquid is significant; a drop being formed, in contact with the dispensing orifice,
  • a step of detection of absence of liquid during which the means of detection detects the absence of liquid in said vicinity of the dispensing orifice, and the treatment system processes this successive detection information of presence and absence of liquid to provide information on the distribution of a drop.
  • the monitoring method thus provides information on the disappearance of a drop in the vicinity of the dispensing orifice, through the observation of a presence and then an absence of gout, in the same place and during two successive stages.
  • the sequence "presence, absence" of gout makes it possible to identify whether the drop formed has fallen well.
  • it allows to take into account the cases of misuse of the dispensing device, which could not necessarily be detected with the mere observation of the appearance of a drop, without then observing whether the drop is absent, particularly because that it has detached itself from the dispensing orifice.
  • the detected drop may not be dispensed and may remain in place as a residual drop.
  • the proposed monitoring method then makes it possible to detect this residual drop and to deduce a non-detachment from the drop, in order, for example, to signal it to the user and / or not to distort the count of drops dispensed or to be dispensed. .
  • the information provided by the processing system at the end of the monitoring process is for example information to assign a correct distribution of a drop, when the sequence "presence, absence" has been detected , or / and information to assign an incorrect distribution of a drop, when this sequence is not detected.
  • processing of information may take into account other information made available to the processing system to, for example, supplement or improve the information provided.
  • This information is for example the pressure exerted on the dispensing device, the duration of the presence of the detected drop in the vicinity of the dispensing orifice, etc.
  • the detection means are configured, not only so that the detection of the presence of liquid in the vicinity of the detection orifice is significant of a drop being formed, in contact with the orifice of distribution, but also so that the detection of absence of liquid in the same vicinity of the dispensing orifice is significant of a drop which has detached from the dispensing orifice, and which is therefore no longer contact with the dispensing orifice.
  • Drop forming a drop of liquid that has not detached from the dispensing orifice.
  • liquid in contact for a short time or a long time with the dispensing orifice, and which is not detached is considered a "drop forming".
  • the monitoring method may further comprise one or more of the following features, taken alone or in combination.
  • the monitoring method comprises, before the liquid presence detection step, said second detection step, a liquid absence detection step, said first detection step, during which the means detection detects the absence of liquid in said vicinity of the dispensing orifice.
  • This first detection step is particularly advantageous in that it makes it possible to identify, not only a drop which has detached from the dispensing orifice, but also the appearance of a drop in the vicinity of the orifice of distribution, thanks to the observation of an absence then of a presence of gout.
  • the link "absence, presence, absence" of gout makes it possible to identify whether the drop is newly formed and has fallen well.
  • the dispensing orifice does not include a residual drop, which may present a risk of contamination if it has been residual for some time, or which may involve an unsuitable drop size.
  • the assistance device signals a malfunction so that the user is encouraged to clean the dispensing orifice to eliminate the drop. residual.
  • the monitoring method comprises, before the liquid presence detection step, called the second detection step, a step of detecting an activation of a drop distribution, for example following a pressure exerted on a support zone or a certain inclination of the dispensing device.
  • This prior step of detecting an activation is advantageous because it makes it possible to ensure that the liquid detected during the second detection step results from a voluntary activation of a drop distribution. For example, in the case where a drop is distributed in a first eye and another in the second eye, it is possible that one can not detect an absence of liquid during a first detection step, because of residual liquid in the dispensing orifice between the distribution in the first eye and that in the second eye.
  • this residual liquid is not problematic because it is not exposed for a long time to the air, and therefore not likely to be contaminated.
  • the detection means emit a detection signal in the vicinity of the dispensing orifice, receive said emitted detection signal and detect the presence of liquid by receiving a disturbed detection signal with respect to a signal of detection received in the absence of liquid, the detection signal preferably being an optical signal, for example an infrared ray.
  • Optics means any electromagnetic wave, belonging to the visible spectrum or not.
  • the optical detection means used for this purpose are generally means capable of transmitting, receiving and / or reflecting such a wave.
  • the optical detection means comprise an emitter and a receiver, either distinct and preferably diametrically opposite with respect to the dispensing orifice, either merged or juxtaposed on the same component and receiving a detection signal by possible reflection on an opposite wall.
  • the monitoring method comprises a step during which the time elapsed between the beginning of the liquid presence detection step and the beginning of the liquid absence detection step and the system is measured.
  • processing method allocates an incorrect distribution of a drop when the elapsed time is less than a first threshold of predetermined duration and preferably makes accessible information corresponding to this distribution incorrect or correct to a user. It is found that the viscosity of the liquid product and the duration of formation of a drop have an influence on the volume of the drop. In particular, the volume of the drop away from an ideal or theoretical volume when the formation time is too short, for example due to a very strong pressure exerted on the tank.
  • the treatment system when the duration of formation of the drop is less than the first threshold of predetermined duration, for example 1 second, the treatment system considers that the amount of liquid product dispensed is quite different from the quantity of liquid product to be dispensed and that the distribution is incorrect.
  • the treatment system can choose to set the treatment system so that it assigns a correct distribution as long as there is distribution of liquid product, regardless of the volume of the drop distributed. In this case, the treatment system can assign a correct distribution while noting a non-optimal drop size.
  • the duration of formation of a drop is the time which elapses between the moment when no start of drop formation is initiated and the moment when the drop comes off.
  • the time elapsing between the moment when a start of drop formation is detected namely the beginning of the liquid presence detection step
  • the moment when the detachment of the drop is detected by its absence following its presence in the vicinity of the dispensing orifice namely the end of the liquid presence detection step coinciding with the beginning of the liquid absence detection step.
  • the duration of formation of a drop depending on the viscosity of the liquid product, the first threshold of predetermined duration is predefined as a function of the viscosity of the liquid product used.
  • the monitoring method comprises a step during which the time elapsed between the beginning of the liquid presence detection step and the beginning of the liquid absence detection step and the system is measured.
  • of treatment assigns an incorrect distribution of a drop when the elapsed time is greater than a second threshold of predetermined duration.
  • information corresponding to this incorrect distribution is made accessible to a user. It is advantageous that the treatment system considers that the distribution of a drop is correct when the formation time of the drop is less than the second threshold of predetermined duration.
  • the drop takes a long time to fall, that is to say that the formation of the drop is of a duration greater than the second threshold of predetermined duration, it can be assumed that the drop is not distributed in the receiving member and that it is a residual drop removed a posteriori, for example the fact that the assistance device is not maintained inclined long enough and / or that the pressure exerted on the dispensing device to distribute the drop is too weak. In this situation, the distribution of gout may be considered as not validated. By making this information accessible to the user, the user can then be encouraged to distribute another drop to make up for the lack.
  • the treatment system considers that the distribution of a drop is correct when the formation time of the drop is between the first and second thresholds of predetermined duration. If the duration of formation of the drop is greater than the first threshold of predetermined duration, the processing system may consider that the volume of the detected drop is optimal, substantially equal to an ideal or theoretical volume, as explained above. If in in addition to the duration of formation of the drop is less than the second threshold of predetermined duration, the treatment system may consider that the drop has been delivered into the eye.
  • the monitoring method not only makes it possible to detect that a drop has fallen well, with the sequence "presence, absence "But also to monitor that the drop has fallen with an optimal size and at the right time, so in the right place.
  • This embodiment in which one compares with the first threshold of predetermined duration and / or second threshold of predetermined duration is therefore particularly relevant.
  • the monitoring method comprises the following steps:
  • a theoretical volume of drop is determined, preferably depending on the geometric characteristics of the dispensing orifice and the viscosity of the liquid product, and preferably also from other characteristics of the dispensing device,
  • This elapsed time is used to weight the theoretical drop volume and estimate a volume of the drop distributed.
  • the theoretical volume is weighted if the measured duration is less than a first threshold of predetermined duration.
  • the elapsed time can be used to estimate the volume of drop dispensed, and thus the remaining dose. It is found in particular that for liquid products having a relatively low viscosity, for example less than 100Cp, the volume of the dispensed drop may be smaller when the formation time of the drop is shorter. Furthermore, for liquid products having a higher viscosity, for example greater than 100Cp, the volume of the dispensed drop may be greater when the formation time of the drop is shorter.
  • the theoretical drop volume can be weighted with the measured duration to obtain an estimated volume closer to the actual drop volume dispensed.
  • the monitoring method comprises a step during which the pressure exerted on a bearing zone for the activation of a drop distribution is monitored and the liquid product detection means is activated when the pressure exceeds a predetermined pressure threshold.
  • the predetermined pressure threshold corresponds, for example, to the minimum pressure to exert on the dispensing device to cause the formation of a drop.
  • the pressure is monitored, for example, by means of a pressure sensor which may for example be placed directly on a support zone of the assistance device or on a support zone of the dispensing device, or on a pressure sensor. zone intended to be secured to the reservoir of the dispensing device and receiving a certain pressure at the time of activation of a drop distribution, or in any other area requested when the user exerts pressure to activate a drop distribution.
  • the threshold is for example 5 N or 15 N.
  • "Support zone" means an area on which a user presses directly or via another element to exert an activation pressure on the reservoir to to activate the distribution of a drop of liquid.
  • the support zone may be arranged on the assistance device or on the dispensing device.
  • the monitoring method comprises a step during which the pressure exerted on a bearing zone for the activation of a drop distribution is monitored and the treatment system assigns an incorrect distribution of a drop when the pressure is below a predetermined pressure threshold, preferably when the lower pressure is exerted over a duration greater than a predetermined time.
  • the treatment system assigns an incorrect drop distribution when the pressure is below the predetermined pressure threshold at the beginning of the third detection step.
  • the sequence "absence, presence, absence” detected may correspond with a certain probability to an incorrect distribution, corresponding for example to a partially formed drop which detaches from the orifice because of parasitic agitation for a dispensing device without reapplication of drop, or a partially formed drop which is sucked back into the dispensing orifice for a dispensing device with re-aspiration.
  • the drop formed will not be distributed in the receiving member, hence the fact that the processing system considers that the distribution is incorrect, and it is interesting to be able to launch an action such as to prevent the user of an incorrect distribution.
  • the pressure exerted on a bearing zone required to assign a correct drop distribution can be exerted in several steps, for example, a first pressure below the pressure threshold. predetermined, then a second pressure lower than the predetermined pressure threshold, but the sum of these two pressures being greater than the predetermined pressure threshold if each of the first and second pressures below the predetermined pressure threshold are nevertheless greater than a predetermined minimum pressure threshold .
  • the processing system can assign a correct drop distribution, preferably if both the first and second pressures below the predetermined pressure threshold are spaced in time by a time shorter than a predetermined time.
  • the monitoring method comprises a step during which the displacement of a bearing zone is monitored, preferably the duration of this displacement, for example by means of a first accelerometer mounted integral with the d-zone. support and a second accelerometer mounted integral with the reservoir of the dispensing device containing the liquid product, and the treatment system assigns an incorrect drop distribution when the displacement is less than a predetermined displacement threshold during the second step of detection or that the duration of the movement is less than a threshold of predetermined duration.
  • the displacement of the support zone reflects the pressure exerted, so by measuring it, the pressure exerted on the bearing zone is measured indirectly, taking into account the mechanical strength of the latter.
  • the treatment system can determine whether a drop has been formed and dispensed.
  • the displacement of the bearing zone can also be carried out in several steps.
  • the processing system considers the sum of these displacements, and preferably the sum of the duration of these displacements, and preferably if these displacements are spaced apart by a shorter duration. at a predetermined time.
  • the absence of liquid is detected at a first distance from the dispensing orifice and during a simultaneous liquid presence detection step. or following the step of detecting the absence of liquid, the presence of liquid is detected at a second distance from the dispensing orifice, the second distance being greater than the first distance.
  • Said liquid presence detection step is called the fourth detection step. The distance is defined in the direction from the dispensing orifice to the target organ of a user. An absence of liquid is therefore detected at a distance closer to the dispensing orifice than a presence of liquid.
  • the detection of an absence of liquid makes it possible to know that the drop has left the dispensing orifice and the detection of a presence of liquid a little further from the dispensing orifice makes it possible to know that the drop has well distributed out of the hole.
  • the treatment system detects the distribution of a drop out of the dispensing device and discards for example the cases where the drop is re-sucked inside the dispensing orifice.
  • the liquid presence detection step, or fourth detection step is simultaneous with the liquid absence detection step when the distance between the first and second distances is less than the drop size.
  • the liquid presence detection step, or fourth detection step is successive to the liquid absence detection step when the distance separating the first and second distances is greater than the drop size.
  • the monitoring method comprises a step during which the inclination of the dispensing device is measured, and the treatment system assigns an incorrect drop distribution when the variation of the inclination exceeds a predetermined value in the course of time. the second detection step.
  • the treatment system assigns an incorrect drop distribution when the variation of the inclination exceeds a predetermined value in the course of time. the second detection step.
  • the monitoring method comprises a step during which the inclination of the dispensing device is measured and the processing system derives an estimate of the volume of the detected drop.
  • the inclination of the dispensing device influences the volume of the drop. More specifically, it is found that the volume of the dispensed drop increases with the angle of inclination of the dispensing device measured relative to the horizontal.
  • the treatment system can weight a theoretical volume of drop to estimate the volume of the drop actually distributed.
  • the treatment system may possibly calculate a new value of residual volume of liquid product in the dispensing device.
  • the monitoring method comprises:
  • a step of determining the volume of theoretical drop preferably according to the geometrical characteristics of the dispensing orifice and the viscosity of the liquid product, and preferably also from other characteristics of the dispensing device,
  • a step of estimating the volume of the dispensed droplet comprising a step of weighting the theoretical volume drop, during which at least one of the following parameters is taken into account for this weighting:
  • the theoretical volume preferably corresponds to a volume calculated from fixed data on the liquid product or the dispensing device, not varying according to the conditions of use of the latter.
  • the fixed data can be determined by the information processing system, for example by reading the information carried by the dispensing device or by manual setting.
  • the calculated theoretical volume is adapted to the conditions of use of the dispensing device, which allows to obtain a more realistic estimate and therefore a more accurate and reliable determination of the amount of liquid product dispensed.
  • the monitoring method comprises a step during which a contact between a support surface of a device for assisting the use of the dispensing device and the skin of the subject is detected and during which the The processing system treats this information to assign a correct drop distribution, preferably when the contact detection is simultaneous at the beginning of the liquid absence detection step.
  • the detection of the contact reflects a good position of the receiving member in front of the dispensing orifice. This ensures the distribution of a drop at the desired location. With this, it is conceivable to prevent any droplet distribution as long as there is no detected contact, or to send information to the user, or that the treatment system attributes a drop distribution. incorrect.
  • the monitoring method comprises a step during which the user is informed when the processing system does not receive the information corresponding to the succession of the two stages of detection of the presence of liquid and the absence of liquid, even when the treatment system does not receive the information corresponding to the succession of the three stages of detection of absence of liquid, presence of liquid and absence of liquid, or when the treatment system assigns an incorrect drop distribution for example by a visual signal, sound or tactile.
  • a visual signal By informing the user of an incorrect drop distribution, the latter may, for example, dispense another drop to correct the previous incorrect distribution.
  • the visual signal can be emitted by an LED or alphanumeric display.
  • the touch signal can be in the form of vibrations.
  • the user can be informed when the processing system receives the information corresponding to the succession of two or even three detection steps, or when the processing system assigns a correct drop distribution.
  • the method comprises a step during which the weight of the dispensing device is measured to deduce the quantity of liquid product remaining in the dispensing device. Knowing the value of the residual volume by weight measurement, it is possible to deduce the amount of liquid product dispensed. Thus, the measurement of the weight also makes it possible to validate the estimated volume of the detected drop or to translate the quantity of remaining liquid into the number of remaining theoretical drops.
  • the step of measuring the weight can be triggered conditionally according to the inclination detected, in particular according to the maintenance of a certain inclination of the dispensing device for a predetermined time.
  • the invention also relates to a device for assisting the use of a liquid product dispensing device in the form of drops for the implementation of the above monitoring method, comprising the means of liquid product detection, the treatment system and at least one of the group members comprising:
  • Each of these means makes it possible to provide additional information to the processing system to obtain information on the drop distribution, such as the attribution of a correct or incorrect distribution or the quantification of the quantity of liquid product dispensed or remaining.
  • the invention also relates to a device for assisting the use of a liquid product dispensing device in the form of drops, comprising
  • liquid product detection means disposed in the vicinity of a drop dispensing orifice
  • the processing system being configured to provide information on the distribution of a drop
  • the liquid product detecting means comprising first detecting means configured to detect liquid at a first distance from the dispensing orifice, and second detecting means configured to detect liquid product at a second distance from the dispensing orifice. distribution, the second distance being greater than the first distance.
  • the first and second distances are defined in the direction from the dispensing orifice to the user receiving member.
  • the detection means can detect the presence or absence of liquid, so a drop at two different distances from the dispensing orifice.
  • the processing system can deduce if a drop of liquid product is only formed, distributed, become residual or sucked back inside the orifice.
  • the treatment system can deduce that a drop of liquid product has detached from the dispensing orifice.
  • the assistance device may further comprise means for blowing residual drop, for example by means of an air nozzle.
  • means for blowing residual drop for example by means of an air nozzle.
  • FIGS. 1A and 1B are perspective views of an assistance device according to one embodiment, FIG. 1A representing the assistance device alone and FIG. 1B representing the upper part of the assembly. the assistance device and a dispensing device secured to the assistance device, the assistance device being in the open position and the dispensing device being provided with a protection cap of the dispensing orifice,
  • FIGS. 2A and 2B are diagrammatic views in longitudinal section of different parts of the assembly of FIG. 1B,
  • FIG. 3 is a set of three longitudinal sectional views of the upper part of the dispensing device of FIG. 1B,
  • FIG. 4 is a graph showing information processed by the assistance device of FIG. 1A
  • FIG. 5 is a graph showing the steps of a monitoring method according to one embodiment.
  • FIG. 1A illustrates an assistance device 10 for the use of a dispensing device 12 for a liquid product in the form of drops, the liquid product being contained in a reservoir of the dispensing device 12 (visible in Figure 1B).
  • FIG. 1B illustrates a dispensing kit comprising the assistance device 10 and the dispensing device 12 disposed inside the assistance device 10.
  • the assistance device 10 comprises means of attachment to the dispensing device 12 so that the whole is solidary.
  • the securing means may comprise, for example, a latching of the dispensing device 12 in the assistance device 10.
  • the assistance device 10 comprises a main body 14 in which the dispensing device 12 is placed, and a support structure 16 against the skin of the user during the distribution of drops in a target organ of a user (or subject), for example an eye.
  • the support structure 16 is for example removably mounted on the main body 14 between an open position of insertion of the dispensing device 12, visible in Figure 1 B, and a closed position of use, for example by means of a hinge 18.
  • the support structure 16 can be designed in a flexible manner to ensure the comfort of the support against the skin of the user and adapt to the reliefs in the vicinity of the target organ, and / or enough rigid to ensure the supporting support function and impose a predetermined distance between the target member and a dispensing orifice 20 (visible in Figures 2A and 2B) disposed in this example on the dispensing device 12 but can be arranged according to a variant on the assistance device 10).
  • the support structure 16 includes an axial orifice 22 for allowing the passage of drops of liquid product from the dispensing orifice 20 to the body of the user.
  • the support structure 16 optionally includes recesses 24 on two opposite sides and at its end, in particular to prevent the user's eye from being in the dark when the assistance device 10 is applied against the skin of the user around his eye.
  • the support structure 16 may have a closed contour or not, for example a contour C.
  • the outline C allows for example the user to pass his finger through the opening of the C to pull the lower eyelid, to further open his eye and ensure that the drop reaches the eye.
  • the assistance device 10 also comprises a bearing zone 26, intended here both for gripping and to allow the support of the user to distribute the liquid product.
  • the bearing zone 26 is disposed on two opposite sides of the main body 14. An activation pressure exerted on the bearing zone 26 is transmitted to the reservoir of the dispensing device 12, in particular at a contact zone. between the reservoir and the assistance device 10.
  • the bearing zone 26 may be made of a different material, in particular more flexible, than that of the rest of the main body 14. It can also include reliefs that facilitate the grip by the user.
  • the assistance device 10 increases the gripping area of the user and the activation pressure on the reservoir relative to that of the dispensing device 12 alone, which is particularly advantageous for users with neuromuscular diseases.
  • the assistance device 10 comprises detection means 28, 30, 36, 38 of liquid product disposed in the vicinity of the dispensing orifice 20. It can be seen in Figures 2A and 2B that these detection means comprise first detection means 28, 30 configured so that the presence detection of liquid is significant of a drop being formed, in contact with the dispensing orifice 20, and comprising optical means in the form of a transmitter 28 and a receiver 30 of an optical detection signal 32 (visible in FIG. 3 and hereinafter referred to as optical signal 32) configured to detect the presence of liquid disturbing the optical signal 32 and to measure the duration of this signal. presence.
  • the transmitter 28 comprises, for example, infrared emitting diodes and the receiver 30 comprises, for example, photo-transistors capable of detecting infrared rays.
  • the transmitter 28 and the receiver 30 thus detect the presence of a drop passing through the optical signal 32 when the optical optical signal 32 is disturbed, for example by a variation of the intensity of this optical signal 32.
  • the first detection means 28, 30 are preferably located at a distance of between 1 and 3 mm, preferably 2 mm, from the dispensing orifice 20, detecting the presence of liquid in the detection zone situated between the emitter 28 and the receiver 30.
  • the assistance device 10 advantageously comprises second detecting means 36, 38, comprising another pair of emitter 36 and receiver 38 located at a distance from the upper dispensing orifice 20. to that of the first transmitter pair 28 and receiver 30. The operation of this second pair 36, 38 is similar to that of the first.
  • the second detection means 36, 38 are located at a distance of between 5 and 10 mm, for example close to 7 mm from the dispensing orifice 20.
  • the receiver 30, 38 may have an axially and / or circumferentially extending optical signal receiving zone 32, the transmitter 28, 36 being configured to transmit said optical signal 32 in the reception area, in order to ensure the detection the passage of a drop even when the assitance device 10 is inclined.
  • the assistance device 10 comprises a data processing system 40, in particular detection information provided by the detection means 28, 30, 36, 38.
  • the processing system 40 is configured to provide information on the distribution of a drop.
  • the information processing system 40 is a system comprising a set of components (mechanical, electronic, chemical, photonic and / or biological) capable of automatically processing information. It includes, for example, a printed circuit board (PCB), a set of transistors and / or a computer.
  • the assistance device 10 comprises measuring means 42 of the duration of presence of a drop in the vicinity of the orifice, for example by measuring the signal perturbation time of the detection means.
  • the measuring means 42 comprise for example an electronic time counter activated at the same time as the detection means.
  • the assistance device 10 further comprises tilt measuring means 44 configured to provide information on the inclination of the dispensing device 12 secured to the assistance device 10.
  • the means of Tilt measurement 44 includes an inclinometer such as an electronic gyroscope or an accelerometer.
  • the means for measuring the inclination 44 are preferably placed in the main body 14 or in the support structure 16, for example in a zone intended to be placed in the vicinity of the dispensing orifice 20.
  • the assistance device 10 further comprises means for measuring the activation pressure 46 exerted on a bearing zone for the activation of a drop distribution, such as the bearing zone 26, for triggering the detection means 28, 30, 36, 38 and / or providing information to the treatment system 40.
  • the means for measuring the activation pressure 46 can provide information on the intensity of the activation pressure applied to the zone of support and the duration of application of this activation pressure.
  • the detection of this activation pressure can be direct, by measuring the pressure applied by the user on the bearing zone 26 to activate the dispensing device 12, or indirectly, for example by measuring the pressure exerted on a zone of the assistance device 10 or the dispensing device 12 secured to the reservoir of the dispensing device 12 during the activation pressure by the user on the reservoir or on another support zone.
  • the means for measuring the activation pressure 46 comprise, for example, a pressure sensor of the FSR type intended to be placed in contact with the reservoir of the dispensing device 12, being carried for example by the inner face of the assistance device.
  • the assistance device 10 comprises contact detection means 48 with the skin of a user, located on the support structure 16.
  • the contact detection means 48 can provide information to the treatment system 40 on the correct placement of the target organ facing the dispensing orifice 20 to ensure the distribution of drop at the desired location.
  • the contact detection means 48 can operate by optical principle (light sensor which detects the presence or absence of light on the surface of the support structure 16), by electrical principle (closing of an electrical circuit by the presence of the skin), by mechanical principle or by any other principle.
  • the assistance device 10 comprises means for measuring the weight 50 of the dispensing device 12 secured to the assistance device 10, configured to provide information on the amount of liquid product remaining in the reservoir of the dispensing device 12
  • the means for measuring the weight 50 comprise a weight sensor, for example of the "Force Sensing Resistor" (FSR) type, disposed below or above the reservoir of the dispensing device 12 making it possible to measure the weight of the dispensing device 12, from which the weight of liquid product in the reservoir, and therefore the volume, of the quantity of liquid product remaining is deducted.
  • FSR Force Sensing Resistor
  • the assistance device 10 has several weight sensors around the reservoir in order to be able to measure the weight of the dispensing device 12 secured to the assistance device 10 regardless of its inclination.
  • the assistance device 10 comprises means 52 for indicating information provided by the processing system 40, for example visual means 52, sound means and / or tactile means. They include for example an information display screen in alphanumeric form. In a variant, they furthermore or alternatively comprise light-emitting diodes around the dispensing orifice 20 making it possible to provide a light signal to indicate, for example, a correct or incorrect distribution of a drop of liquid product.
  • the assistance device 10 may further comprise residual drop blowing means, such as an air nozzle directed towards the dispensing orifice 20.
  • residual drop blowing means such as an air nozzle directed towards the dispensing orifice 20.
  • the detection means 28, 30 arranged in the vicinity of the dispensing orifice 20 detect in a liquid absence detection step D1, hereinafter referred to as the first detection step D1 (represented in FIG. drop formation, an absence of detection signal disturbance (by detecting for example a high intensity infrared signal), meaning an absence of liquid and therefore of drop in the detection zone, and in a liquid presence detection step D2 , hereinafter referred to as the second detection step D2 (shown in FIG.
  • a disturbance of the detection signal signifying the presence of liq thus using a drop (by detecting a decrease in intensity of the infrared signal).
  • the droplet is detached from the dispensing orifice 20 and the detection signal disturbance disappears during a liquid absence detection step D3, called the third detection step D3. represented in FIG. 3C (the detection means 28, 30 again detect a high intensity infrared signal).
  • the detection means 28, 30 send this succession of information "absence, presence, absence” to the processing system 40, which processes it to deduce the appearance and the correct distribution of a drop. If this succession "absence, presence, absence” is not detected, the processing system 40 deduces that there is no correct distribution of gout, because there has been no training drop and / or that the drop has not become detached from the dispensing orifice 20.
  • the assistance device 10 comprises second detection means 36, 38, during the third detection step D3, an absence of liquid is detected at the first distance from the dispensing orifice 20, thanks to the first detection means 28, 30 and simultaneously or successively, during a liquid presence detection step called in the fourth fourth detection step, a presence of liquid at the second distance from the dispensing orifice 20, thanks to the second detecting means 36, 38. Since the absence of liquid is detected at a distance of the dispensing orifice 20 lower than the distance at which a presence of liquid is detected, the processing system 40 deduces that the drop has detached from the dispensing orifice 20 and has been correctly distributed.
  • the curve C1 represents the disturbance of the detection signal as a function of time and the curve C2 represents the pressure (ie the intensity of the force) exerted on the dispensing device 12. function of time.
  • the duration of the presence or absence of signal perturbation, representing the corresponding duration is also measured. at each detection step.
  • the elapsed time T is measured between the beginning of the second detection step D2 and the beginning of the third detection step D3.
  • the processing system 40 assigns an incorrect distribution of a drop when the elapsed time is less than a first threshold of predetermined duration T1, because the volume of the dispensed drop is considered to be different from a theoretical volume.
  • the treatment system 40 assigns an incorrect distribution because it considers that the drop is probably not distributed in the target organ, the drop may have become detached while the user no longer had the dispensing device 12 facing the eye.
  • the processing system 40 allocates a correct distribution. In each of these three cases, the user can be notified by making available to him corresponding information via the means of indication 52.
  • T which corresponds to the formation time of the drop of liquid product to estimate the volume of this drop.
  • a theoretical drop volume is first determined, here according to the geometric characteristics of the dispensing orifice 20 and the viscosity of the liquid product, and preferably furthermore from other characteristics of the dispensing device. 12, then the elapsed time T between the beginning of the second detection step D2 and the beginning of the third detection step D3 is measured, and then this time is used to weight the theoretical drop volume and to estimate a volume of the drop. distributed.
  • the first detection step D1 can be replaced by a step detection of an activation of a drop distribution, for example following a pressure exerted on a bearing zone 26 or a certain inclination of the dispensing device 12. In this case, the drop may be before the activation of the detection means 28, 30 and the first detection step D1 does not take place.
  • the processing system 40 assigns an incorrect drop distribution.
  • the monitoring method further comprises, or alternatively, a weighing step of the dispensing device 12 to deduce the amount of liquid product remaining in the tank.
  • a weighing step of the dispensing device 12 By comparing the weight obtained with the weight of the dispensing device 12 before droplet dispensing, the treatment system 40 can detect or validate the distribution of a droplet if there is a change in weight.
  • the treatment system 40 can assign a correct or incorrect distribution of a drop, or even allow the distribution of liquid product only if a contact is detected.
  • a theoretical volume is first determined, for example as a function of geometric characteristics of the dispensing orifice 12 and the viscosity of the liquid product, and preferably from other characteristics of the dispensing device 12. Then, the estimation of the volume of the detected drop is obtained by weighting this theoretical volume. taking into account at least one of the previously mentioned parameters, namely:
  • the information system calculates one or more coefficients from one or the combination of the above parameters and applies it by multiplication to the calculated theoretical volume.
  • the monitoring method starts with a first step E1 of detecting an activation pressure exerted by the user on the support zone. 26.
  • a predetermined threshold for example 15 N
  • the detection means 28, 30 are then activated for the detection of a drop in a step E2.
  • Other means of the assistance device 10 can also be activated at this time.
  • the detection means 28, 30 monitor the zone of formation of the drop in the vicinity of the dispensing orifice 20 until they detect the presence of liquid in step E3, corresponding to the second detection step D2.
  • a timer is started at step E4 when the liquid is detected.
  • a step E5 the detection means 28, 30, 36, 38 detect the absence of liquid during the third detection step D3, and a pressure test is performed. If during this test, the pressure exerted on the bearing zone 26 does not reach a predetermined pressure threshold, for example 15 N, then it is considered that the drop has not been detached thanks to an optimal pressure exerted , and the processing system 40 assigns an incorrect distribution.
  • a predetermined pressure threshold for example 15 N
  • the processing system 40 assigns a correct distribution (at step E6 'unless the processing system 40 has received information to the contrary from other means of measurement or detection related using the dispensing device 12).
  • the processing system 40 may furthermore process information on the inclination of the dispensing device 12 secured to the assistance device 10 and / or information provided by the detection means 28, 30. For example, if it is not possible there is more disturbance of the optical signal but that the processing system 40 receives information indicating a significant change of inclination, it means that the drop of liquid product has been distributed in the wrong place, for example fallen next to the orifice 20.
  • step E5 is started and if the measured pressure is below the threshold of predetermined pressure, then it means that there is a residual drop at the dispensing orifice 20 and this is confirmed by the fact that we are still in the second step of e detection D2.
  • the pressure test is performed during the second detection step. If during this test, the pressure exerted on the bearing zone 26 does not exceed the predetermined pressure threshold for a predetermined duration, then it is considered that the drop has not become detached thanks to an optimal pressure exerted, and the processing system 40 assigns an incorrect distribution.

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  • Health & Medical Sciences (AREA)
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  • Anesthesiology (AREA)
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  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Ophthalmology & Optometry (AREA)
  • Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
EP19705130.3A 2018-02-06 2019-02-05 Procédé de surveillance de la distribution d'une goutte et dispositif d'assistance Pending EP3749260A1 (fr)

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FR1850986A FR3077485A1 (fr) 2018-02-06 2018-02-06 Procede de surveillance de la distribution d’une goutte et dispositif d’assistance
PCT/EP2019/052767 WO2019154803A1 (fr) 2018-02-06 2019-02-05 Procédé de surveillance de la distribution d'une goutte et dispositif d'assistance

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JP (1) JP2021511914A (ja)
CN (1) CN111954508B (ja)
BR (1) BR112020016006A2 (ja)
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US20240041648A1 (en) * 2022-08-02 2024-02-08 Twenty Twenty Therapeutics Llc Eye drop monitoring device and method

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WO2019154803A8 (fr) 2020-10-29
BR112020016006A2 (pt) 2020-12-15
MX2020008227A (es) 2020-11-11
JP2021511914A (ja) 2021-05-13
CA3089785C (fr) 2024-01-02
US20210113371A1 (en) 2021-04-22
CN111954508A (zh) 2020-11-17
CA3089785A1 (fr) 2019-08-15
CN111954508B (zh) 2023-04-07
FR3077485A1 (fr) 2019-08-09

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