[go: up one dir, main page]

WO2018100176A1 - Cartridge for biochemical sensor - Google Patents

Cartridge for biochemical sensor Download PDF

Info

Publication number
WO2018100176A1
WO2018100176A1 PCT/EP2017/081221 EP2017081221W WO2018100176A1 WO 2018100176 A1 WO2018100176 A1 WO 2018100176A1 EP 2017081221 W EP2017081221 W EP 2017081221W WO 2018100176 A1 WO2018100176 A1 WO 2018100176A1
Authority
WO
WIPO (PCT)
Prior art keywords
disposable
removable cartridge
support device
sensing area
anyone
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.)
Ceased
Application number
PCT/EP2017/081221
Other languages
French (fr)
Inventor
Julien FILS
Haytem JARRAR
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.)
Metemis Development
Original Assignee
Metemis Development
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 Metemis Development filed Critical Metemis Development
Publication of WO2018100176A1 publication Critical patent/WO2018100176A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14507Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
    • A61B5/1451Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid
    • A61B5/14514Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14503Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/150022Source of blood for capillary blood or interstitial fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150977Arrays of piercing elements for simultaneous piercing
    • A61B5/150984Microneedles or microblades
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15142Devices intended for single use, i.e. disposable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802Sensor mounted on worn items
    • A61B5/681Wristwatch-type devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04Constructional details of apparatus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0295Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14532Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14546Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1455Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/1459Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters invasive, e.g. introduced into the body by a catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1468Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1473Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150229Pumps for assisting the blood sampling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15146Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • A61B5/15148Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
    • A61B5/15149Arrangement of piercing elements relative to each other
    • A61B5/15153Multiple piercing elements stocked in a single compartment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813Specially adapted to be attached to a specific body part
    • A61B5/6824Arm or wrist
    • 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
    • A61M2230/00Measuring parameters of the user
    • A61M2230/20Blood composition characteristics
    • A61M2230/201Glucose concentration

Definitions

  • the present invention relates to systems, devices and the use of such systems and devices for monitoring blood or interstitial fluid component or properties.
  • the invention relates to systems or devices continuously monitoring the level of blood or interstitial fluid components or blood properties.
  • BACKGROUND OF INVENTION Monitoring of physiologic parameters is a high demand for patient in the medical field for athletes or patients who want to follow continuously or substantially continuously their health status.
  • the more standard method consists in taking a blood sample from a patient and sending this sample to a laboratory in order to perform tests.
  • Continuous monitoring sensors are generally implanted subcutaneously and measure glucose levels in the interstitial fluid at various periods throughout the day, providing data that show trends in glucose measurements over a short period of time. These sensors are painful during insertion and usually require the assistance of a health care professional. Further, these sensors are intended for use during only a short duration (e.g., monitoring for a matter of days to determine a blood sugar pattern).
  • the document WO 02/091922 teaches a portable interstitial fluid monitoring device.
  • This device comprises microneedles, a diaphragm pump to extract interstitial fluid from the skin, and a sensor that detects the concentration of the fluid.
  • Said device comprises a color interrogation window and an optical sensor.
  • This device comprises many drawbacks. Indeed it requires assistance or handling after each use to change the microneedles or the color interrogation window. Furthermore, such device is able to measure the level of glucose in the blood but is not able to measure a plurality of different biological parameters.
  • the document WO 2008/077147 discloses an apparatus for continuous glucose monitoring of a patient including a plurality of cylindrical tissue piercing elements allowing the diffusion of glucose from the interstitial fluid into a sensing area.
  • this device does not permit to remove the sensors without throwing out the entire device.
  • this device is able to monitor the glucose level in blood but does not enable an athlete to monitor a plurality of biological parameters.
  • the purpose of the present invention is to provide a system which enables the monitoring of one or several biochemical parameters within the blood or within the interstitial fluid of a mobile person without pain by means of removable and replaceable sensors.
  • the present invention relates to a disposable and removable cartridge configured to cooperate with a wearable support device, said wearable support device comprising securing means configured to secure the wearable support device to the skin of a subject, at least one connection track and at least one first positioning means;
  • said disposable and removable cartridge comprising:
  • microfluidic circuit in fluid communication with said at least one microneedle and with said sensing area
  • At least one sensor adapted to monitor at least one parameter of a fluid within the sensing area
  • the disposable and removable cartridge further comprises a pumping means fluidly connected to the sensing area and ensuring the flow of the fluid in at least said microfluidic circuit and said sensing area.
  • the disposable and removable cartridge further comprises a waste receiver in fluid communication with said sensing area.
  • said pumping means is fluidly connected between the sensing area and the waste receiver or said waste receiver is fluidly connected between the sensing area and the pumping means.
  • said waste receiver comprises on at least a part of its surface, an opening comprising a material, wherein said material is hermetic to the liquid and permeable to the steam.
  • said material is a Gortex®.
  • the waste receiver further comprises solid foam.
  • said pumping means is a piezoelectric pump, a peristaltic pump or a diaphragm pump.
  • the fluid is blood or interstitial fluid.
  • the disposable and removable cartridge further comprises at least one microfluidic chamber, at least one additional microneedle and an additional microfluidic circuit fluidly connected to said at least one additional microneedle and said microfluidic chamber.
  • the additional microfluidic circuit and the microfluidic circuit are fluidly connected. In one embodiment, the additional microfluidic circuit and the microfluidic circuit are not fluidly connected.
  • said microfluidic chamber comprises substances to be injected on the skin of a subject.
  • the disposable and removable cartridge further comprises an additional pumping means fluidly connected to the microfluidic chamber.
  • said at least one sensor is an optical sensor or an electrochemical sensor.
  • the disposable and removable cartridge further comprises a printed circuit board, wherein said at least one sensor and said second connection track are electrically connected to said printed circuit board.
  • said at least one sensor is adapted to monitor the concentration of a component in the fluid within the sensing area.
  • said at least one sensor is adapted to monitor the concentration of glucose or lactate ions in the fluid within the sensing area. In one embodiment, said at least one sensor is adapted to monitor the concentration of hormones such as estrogen or estradiol within the sensing area.
  • said at least one sensor is adapted to monitor the conductivity, the density, or the temperature of the fluid within the sensing area.
  • the disposable and removable cartridge further comprises a liquid detector fluidly connected to the microfluidic circuit.
  • the disposable and removable cartridge further comprising a fluid receiver fluidly connected to the sensing area and further comprising a membrane fluidly connected between said sensing area and said fluid receiver.
  • the pores of said membrane have a length or a diameter ranging from lnm to K ⁇ m.
  • the porosity is a barrier for elements which have a molecular weight higher than a value ranging from 1 to 1500 Da.
  • the present invention also relates to a wearable support device, configured to cooperate with the disposable and removable cartridge according to the present invention; said wearable support device comprising:
  • - securing means configured to secure the wearable support device to the skin of a subject
  • At least one first positioning means configured to interact with the at least one second positioning means of said disposable and removable cartridge in such a way the at least one first connection track of the support device is connected at said at least one second connection track of the disposable and removable cartridge, and in such a way the cartridge is releasably secured to the wearable support device.
  • said securing means comprises a strip, an armband, a wristwatch, an elastic band, or an adhesive.
  • the wearable support device further comprises a microcontroller configured to calculate the concentration of the component measured by the at least one sensor of the disposable and removable cartridge.
  • the wearable support device further comprises a display connected to the microcontroller.
  • the present invention also relates to a system comprising the disposable and removable cartridge according to the present invention, and the wearable support device according to the present invention.
  • said disposable and removable cartridge is inserted in said wearable support device by rotation or by pressure.
  • the first positioning means is a clip, a screw, a hook, a loop or an adhesive.
  • the second positioning means is a clip, a screw, a hook, a loop or an adhesive.
  • first positioning means are male means and the second positioning means are female means or conversely.
  • system further comprises an elastic element between the disposable and removable cartridge and the wearable support device.
  • said elastic element is a spring.
  • Microcroneedle refers to a substantially cylindrical or pyramidal tissue piercing element having a distal opening, a proximal opening, and an interior lumen extending from the distal opening to the proximal opening.
  • Disposable refers to a device designed to be thrown away after being used, or after a short-time utilization.
  • Removable refers to a device designed to be moved, dislodged and replaced in its position.
  • the present invention relates to a disposable and removable cartridge 1 configured to cooperate with a wearable support device 2, said wearable support device 2 comprising securing means 21 configured to secure the wearable support device 2 to the skin of a subject, at least one connection track and at least one first positioning means.
  • the disposable and removable cartridge 1 according to the present invention, configured to cooperate with a wearable support device 2, said wearable support device 2 comprising securing means 21 configured to secure the wearable support device 2 to the skin of a subject, at least one connection track and at least one first positioning means.
  • said cartridge 1 comprises:
  • microfluidic circuit in fluid communication with said at least one microneedle 11 and with said sensing area 12;
  • At least one sensor 121 adapted to monitor at least one parameter of a fluid within the sensing area 12;
  • connection track 123 electrically connected to the at least one sensor 121
  • At least one second positioning means configured to cooperate with the at least one first positioning means of the wearable support device 2 in such a way that when cooperates, the at least one first connection track of the wearable support device 2 is connected to said at least one second connection track 123 of the disposable and removable cartridge 1, and the cartridge is releasably secured to the wearable support device 2.
  • Said disposable and removable cartridge 1 is configured to be secured to a wearable support device 2 and said wearable support device 2 comprising securing means configured to secure the wearable support device 2 to the skin of a subject in such a way that the at least one microneedle is in contact, in front of the skin of said subject, or in such a way that the at least one microneedle penetrates the skin of said subject.
  • said disposable and removable cartridge 1 comprises a matrix of microneedles.
  • the at least one microneedle is on a substrate and the at least one microneedle forms with said substrate an angle ranging from 35 to 90° such that said at least one microneedle penetrates the skin at a 35° to 90° angle.
  • the disposable and removable cartridge 1 comprises a pumping means 13 fluidly connected to the sensing area 12 and ensuring the flow of the fluid in at least said microfluidic circuit and said sensing area 12.
  • This pumping means 13 pumps the fluid from the microfluidic circuit to the sensing area 12 to be analyzed.
  • the microfluidic circuit does not comprise pumping means and the fluid fills the microfluidic circuit by capillarity.
  • the microfluidic circuit comprise a foam, narrow surface, capillary tubes or a to ensure the motion of the fluid along the microfluidic circuit via capillarity.
  • the pumping means 13 is configured to be used in both ways: aspiring the fluid from the microfluidic circuit to the sensing area 12 and pushing the fluid through the sensing area 12, the microfluidic circuit and the at least one microneedle 11. This embodiment permits to wash the microfluidic circuit, the at least one microneedle 11 and the sensing area 12 after use.
  • the pumping means 13 is also fluidly connected to a chamber containing a washing liquid.
  • the washing liquid is a sterilization liquid.
  • the washing liquid is peracetic acid or ethanol.
  • the pumping means 13 is able to be inverted in such a way that the pumping means 13 can empty the waste receiver 14, the sensing area and/or the microfluidic circuit.
  • the microfluidic circuit is connected to a waste receiver after arranged to receive the washing liquid after the washing.
  • the microfluidic circuit comprises at least one sterilization element.
  • the sterilization element irradiates the microfluidic circuit with UV light to sterilize said microfluidic circuit.
  • the sterilization element is an Ultraviolet Light Emitting Diode (also called UV LED).
  • the microfluidic circuit comprise an array of UV LED along the length of the microfluidic circuit.
  • the present cartridge 1 is removable, which permits the user to use different cartridges, each comprising different sensors 121 for monitoring different components or fluid parameters, keeping the same wearable support device 2.
  • the disposable and removable cartridge 1 comprises a waste receiver 14 in fluid communication with said sensing area 12. Said waste receiver 14 receives the fluid after being passed within the sensing area 12. According to one embodiment, the waste receiver 14 stocks the fluid components and the water or the volatile parts of the fluid that can evaporate.
  • the pumping means 13 is fluidly connected between the sensing area 12 and the waste receiver 14 (figures 2 and 4) or said waste receiver 14 is fluidly connected between the sensing area 12 and the pumping means 13 (figure 3).
  • the waste receiver 14 comprises on at least a part of its surface, an opening 141 comprising a material.
  • said material is hermetic to the liquid and permeable to the steam.
  • said material is a Gortex® . This embodiment allows the water or the volatile component of the fluid to evaporate and the waste receiver 14 is still hermetic to the liquid and dust.
  • the waste receiver 14 also comprises solid foam.
  • the solid foam is located inside the waste receiver 14 to be in contact with the fluid. This solid foam increases the surface between the fluid and the air, increasing the speed of evaporation of water or volatile components within the fluid.
  • said pumping means 13 is a piezoelectric pump, a peristaltic pump or a diaphragm pump.
  • the fluid is blood or interstitial blood.
  • the components of the blood or the interstitial fluid to be monitored do not move to the sensing chamber 12 by diffusion.
  • the sensors can be dried before two measurements. Such feature increases the lifetime of said sensors.
  • the fluid is sampled from the skin of a subject by the at least one microneedle.
  • the disposable and removable cartridge 1 further comprises at least one microfluidic chamber 15, at least one additional microneedle 16 and an additional microfluidic circuit fluidly connecting said at least one additional microneedle 16 to said microfluidic chamber 15.
  • said microfluidic chamber 15 comprises substances to be injected on the skin of a subject.
  • the disposable and removable cartridge 1 further comprises an additional pumping means 17 fluidly connected to the microfluidic chamber 15.
  • This microfluidic chamber 15 and additional elements permit the injection of a substance to the subject.
  • this substance could be insulin. Therefore, the cartridge 1 is able, for example, to inject insulin in function of the glucose concentration in the blood or in the interstitial fluid of said subject monitored by the at least one sensors of the sensing area.
  • the additional microfluidic circuit and the microfluidic circuit are fluidly connected. According to one embodiment, the additional microfluidic circuit and the microfluidic circuit are not fluidly connected.
  • said at least one sensor 121 is connected to a printed circuit board.
  • said printed circuit board is also connected to the second connection track 123 of the cartridge 1 configured to be connected to the first track of the wearable support device 2.
  • the at least one sensor 121 is connected to the second connection track 123.
  • the connection track s located on the exterior surface of the cartridge 1.
  • the pumping means is located on the wearable support device.
  • said at least one sensor 121 is adapted to monitor the concentration of a component in the fluid within said sensing area 12.
  • said at least one sensor 121 is adapted to monitor the concentration of glucose or lactate ions in the fluid within the sensing area 12.
  • said at least one sensor 121 is adapted to monitor the concentration of hormones such as estrogen or estradiol.
  • said at least one sensor 121 is adapted to monitor the conductivity, the density, or the temperature of the fluid within said sensing area 12.
  • said at least one sensor 121 is an optical sensor or an electrochemical sensor.
  • the disposable and removable cartridge 1 further comprises a liquid detector fluidly connected to the microfluidic circuit. This liquid detector can advise the subject that the disposable and removable cartridge 1 is working.
  • the liquid detector detects the presence of the fluid in the circuit.
  • the liquid detector is in the sensing chamber.
  • the liquid detector is an electrochemical sensor and said electrochemical sensor detects the fluid when a tension can be measured between its electrodes.
  • the liquid detector is an optical sensor which detects the presence of the liquid when the signal received by said optical sensor is different from the baseline signal.
  • the at least one sensor within the sensing chamber is the liquid detector.
  • the at least one sensor and the liquid detector are two different elements.
  • the at least one sensor and the liquid detector comprise two or three electrodes.
  • the liquid detector is the reference electrode and the at least one sensor comprises at least two working electrodes.
  • the working electrodes are located in the microfluidic circuit between the microneedles 11 and the reference electrode. In said embodiment, the device ensure that the microfluidic circuits filled and the sensors 121 are fluidly covered when the measure occurs.
  • the disposable and removable cartridge 1 comprises a fluidic receiver 182 fluidly connected to the sensing area 12 and further comprises a membrane 18 fluidly connected to the microfluidic circuit between the sensing area 12 and said fluid receiver 182.
  • the membrane 18 filters the fluid.
  • the water and the ions in the fluid pass through the membrane 18 while the solid components, or cells are stopped by the membrane 18.
  • the membrane 18 comprises pores having a very small porosity.
  • the porosity is a barrier for elements which have a molecular weight higher than a value ranging from 1 to 1500 Da.
  • the pores of the membrane 8 have a length or a diameter ranging from 1 nm to 10 ⁇ m, from lnm to 1 ⁇ m or from lnm to 100nm.
  • the disposable and removable cartridge 1 further comprises a valve 181 and/or a second pumping means 13, ensuring the guidance of the fluid to the fluid receiver.
  • the liquid within the fluid receiver 182 can be reused to clean the sensing area 12 and the microfluidic circuit, for example using pumping means 13 and valves 181, 183.
  • the invention further relates to a wearable support device 2, configured to cooperate with the disposable and removable cartridge 1 according to the present invention.
  • the wearable support device 2 configured to cooperate with the disposable and removable cartridge 1 according to the present invention, comprises:
  • - securing means 21 configured to secure the wearable support device 2 to the skin of a subject
  • At least one first positioning means configured to cooperate with the at least one second positioning means of said disposable and removable cartridge 1 in such a way that when cooperates, the at least one first connection track of the support device is connected at said at least one second connection track 123 of the disposable and removable cartridge 1 , and that the cartridge is releasably secured to the wearable support device 2.
  • This wearable support 2 can be a watch.
  • said securing means 21 comprises a strip, an armband, a wristwatch, an elastic band, or an adhesive.
  • the securing means 21 are arranged to maintain the contact between the cartridge 1 and the skin of the subject.
  • the wearable support device 2 further comprises a microcontroller configured to calculate the concentration of the component measured by the at least one sensor of the disposable and removable cartridge 1.
  • the wearable support device 2 further comprises a display 22 connected to the microcontroller. The display 22 can show to the subject the parameters of the fluid monitored by the at least one sensor 121 in the cartridge 1.
  • the wearable support device 2 comprises other means of information to inform or alert the subject of its health status (for example, vibrations).
  • the present invention also relates to a system 3 comprising the disposable and removable cartridge 1 and the wearable support device 2 according to the present invention.
  • said disposable and removable cartridge 1 is inserted in said wearable support device 2 by rotation or by pressure.
  • the first or the second positioning means is a clip, a screw, a hook, a loop or an adhesive.
  • the first positioning means are male means and the second positioning means are female means or conversely.
  • the wearable support device 2 further comprises a battery and the system 3 is autonomous and mobile.
  • the system 3 further comprises an elastic element between the disposable and removable cartridge 1 and the wearable support device 2 such as a spring.
  • This elastic element permits the subject, applying a pressure on the system 3, to displace the disposable and removable cartridge 1 relative to the wearable support device 2 and to allow the at least one microneedle 11 to penetrate in the skin of the subject which wears the system 3.
  • Figure 1 is a schematic drawing of the disposable and removable cartridge according to one embodiment.
  • Figure 2 is a schematic drawing of the disposable and removable cartridge comprising a waste receiver according to one embodiment.
  • Figure 3 is a schematic drawing of the disposable and removable cartridge comprising a waste receiver located between the sensing area and the pumping means.
  • Figure 4 is a schematic drawing of the disposable and removable cartridge having a cylindrical geometry.
  • Figure 5 is a drawing of the system according to one embodiment, wherein the wearable support device 2 is a watch.
  • Figure 6 is a schematic drawing of the disposable and removable cartridge comprising a microfluidic chamber containing a substance.
  • Figure 7 is a schematic drawing of the waste receiver, wherein the fluidic connections are not represented.
  • FIG 8 is a schematic drawing of the disposable and removable cartridge according to one embodiment wherein said cartridge comprises a membrane and a fluid receiver with a second pumping element.
  • FIG. 9 is a schematic drawing of the disposable and removable cartridge according to one embodiment wherein said cartridge comprises a membrane and a fluid receiver with at least one valve.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Hematology (AREA)
  • Optics & Photonics (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

The present invention relates to a disposable and removable cartridge (1) configured to cooperate with a wearable support device, said wearable support device comprising means to be secured to the skin of a subject, at least one connection track and at least one first positioning means; said disposable and removable cartridge (1) comprising: at least one microneedle (11); a sensing area (12); a microfluidic circuit in fluid communication with said at least one microneedle (11) and with said sensing area (12); at least one sensor (121) adapted to monitor at least one parameter of a fluid providing from the patient, in the sensing area (12); a second connection track (123) electrically connected to the at least one sensor (121); at least one second positioning means configured to cooperate with the at least one first positioning means of the support device in such a way that the at least one first connection track of the support device is connected at said at least one second connection track (123) of the disposable and removable cartridge (1), and in such a way the cartridge is releasably secured to the wearable support device. The present invention also relates to a wearable support device corresponding and a system comprising such disposable and removable cartridge (1) and such wearable support device

Description

CARTRIDGE FOR BIOCHEMICAL SENSOR
FIELD OF INVENTION
The present invention relates to systems, devices and the use of such systems and devices for monitoring blood or interstitial fluid component or properties. In particular, the invention relates to systems or devices continuously monitoring the level of blood or interstitial fluid components or blood properties.
BACKGROUND OF INVENTION Monitoring of physiologic parameters is a high demand for patient in the medical field for athletes or patients who want to follow continuously or substantially continuously their health status. The more standard method consists in taking a blood sample from a patient and sending this sample to a laboratory in order to perform tests.
Persons suffering from diabetes have limited option for treatment, including taking insulin orally or by injection. In some instances, controlling weight and diet can impact the amount of insulin required. Monitoring blood glucose levels is an important process that is used to help diabetics maintaining blood glucose levels as near as normal as possible throughout the day. In the same way, athletes have to follow their level of lactate in the blood or their hydration during effort. For these persons, the standard method (i.e. laboratory tests) explained above is not appropriate for their need.
Today, some other methods enable to make such analysis or to monitor biochemical parameters, said methods require for example to prick the extremity of the finger or are very indirect such as the monitoring of 02 in the muscle to monitor the lactate ratio.
Continuous monitoring sensors are generally implanted subcutaneously and measure glucose levels in the interstitial fluid at various periods throughout the day, providing data that show trends in glucose measurements over a short period of time. These sensors are painful during insertion and usually require the assistance of a health care professional. Further, these sensors are intended for use during only a short duration (e.g., monitoring for a matter of days to determine a blood sugar pattern).
Subcutaneously implanted sensors also frequently lead to infection and immune response complications. Another major drawback of currently available continuous monitoring devices is that they require frequent, often daily, calibration using blood glucose results that must be obtained from painful finger-sticks. This calibration, and re-calibration, is required to maintain sensor accuracy and sensitivity, but it can be cumbersome as well as painful.
The document WO 02/091922 teaches a portable interstitial fluid monitoring device. This device comprises microneedles, a diaphragm pump to extract interstitial fluid from the skin, and a sensor that detects the concentration of the fluid. Said device comprises a color interrogation window and an optical sensor. This device comprises many drawbacks. Indeed it requires assistance or handling after each use to change the microneedles or the color interrogation window. Furthermore, such device is able to measure the level of glucose in the blood but is not able to measure a plurality of different biological parameters.
The document WO 2008/077147 discloses an apparatus for continuous glucose monitoring of a patient including a plurality of cylindrical tissue piercing elements allowing the diffusion of glucose from the interstitial fluid into a sensing area. However, this device does not permit to remove the sensors without throwing out the entire device. Furthermore, this device is able to monitor the glucose level in blood but does not enable an athlete to monitor a plurality of biological parameters.
Consequently, the purpose of the present invention is to provide a system which enables the monitoring of one or several biochemical parameters within the blood or within the interstitial fluid of a mobile person without pain by means of removable and replaceable sensors. SUMMARY
The present invention relates to a disposable and removable cartridge configured to cooperate with a wearable support device, said wearable support device comprising securing means configured to secure the wearable support device to the skin of a subject, at least one connection track and at least one first positioning means;
said disposable and removable cartridge comprising:
- at least one microneedle;
- a sensing area;
- a microfluidic circuit in fluid communication with said at least one microneedle and with said sensing area;
- at least one sensor adapted to monitor at least one parameter of a fluid within the sensing area;
- a second connection track electrically connected to the at least one sensor;
- at least one second positioning means configured to cooperate with the at least one first positioning means of the support device in such a way that when cooperates, the at least one first connection track of the support device is connected at said at least one second connection track of the disposable and removable cartridge, and the cartridge is releasably secured to the wearable support device. In one embodiment, the disposable and removable cartridge further comprises a pumping means fluidly connected to the sensing area and ensuring the flow of the fluid in at least said microfluidic circuit and said sensing area.
In one embodiment, the disposable and removable cartridge further comprises a waste receiver in fluid communication with said sensing area.
In one embodiment, said pumping means is fluidly connected between the sensing area and the waste receiver or said waste receiver is fluidly connected between the sensing area and the pumping means. In one embodiment, said waste receiver comprises on at least a part of its surface, an opening comprising a material, wherein said material is hermetic to the liquid and permeable to the steam.
In one embodiment, said material is a Gortex®. In one embodiment, the waste receiver further comprises solid foam.
In one embodiment, said pumping means is a piezoelectric pump, a peristaltic pump or a diaphragm pump.
In one embodiment, the fluid is blood or interstitial fluid.
In one embodiment, the disposable and removable cartridge further comprises at least one microfluidic chamber, at least one additional microneedle and an additional microfluidic circuit fluidly connected to said at least one additional microneedle and said microfluidic chamber.
In one embodiment, the additional microfluidic circuit and the microfluidic circuit are fluidly connected. In one embodiment, the additional microfluidic circuit and the microfluidic circuit are not fluidly connected.
In one embodiment, said microfluidic chamber comprises substances to be injected on the skin of a subject.
In one embodiment, the disposable and removable cartridge further comprises an additional pumping means fluidly connected to the microfluidic chamber.
In one embodiment, said at least one sensor is an optical sensor or an electrochemical sensor.
In one embodiment, the disposable and removable cartridge further comprises a printed circuit board, wherein said at least one sensor and said second connection track are electrically connected to said printed circuit board. In one embodiment, said at least one sensor is adapted to monitor the concentration of a component in the fluid within the sensing area.
In one embodiment, said at least one sensor is adapted to monitor the concentration of glucose or lactate ions in the fluid within the sensing area. In one embodiment, said at least one sensor is adapted to monitor the concentration of hormones such as estrogen or estradiol within the sensing area.
In one embodiment, said at least one sensor is adapted to monitor the conductivity, the density, or the temperature of the fluid within the sensing area.
In one embodiment, the disposable and removable cartridge further comprises a liquid detector fluidly connected to the microfluidic circuit.
In one embodiment, the disposable and removable cartridge further comprising a fluid receiver fluidly connected to the sensing area and further comprising a membrane fluidly connected between said sensing area and said fluid receiver.
In one embodiment, the pores of said membrane have a length or a diameter ranging from lnm to K^m.
In one embodiment, the porosity is a barrier for elements which have a molecular weight higher than a value ranging from 1 to 1500 Da.
The present invention also relates to a wearable support device, configured to cooperate with the disposable and removable cartridge according to the present invention; said wearable support device comprising:
- securing means configured to secure the wearable support device to the skin of a subject;
- at least one connection track;
- at least one first positioning means configured to interact with the at least one second positioning means of said disposable and removable cartridge in such a way the at least one first connection track of the support device is connected at said at least one second connection track of the disposable and removable cartridge, and in such a way the cartridge is releasably secured to the wearable support device.
In one embodiment, said securing means comprises a strip, an armband, a wristwatch, an elastic band, or an adhesive. In one embodiment, the wearable support device further comprises a microcontroller configured to calculate the concentration of the component measured by the at least one sensor of the disposable and removable cartridge.
In one embodiment, the wearable support device further comprises a display connected to the microcontroller. The present invention also relates to a system comprising the disposable and removable cartridge according to the present invention, and the wearable support device according to the present invention.
In one embodiment, said disposable and removable cartridge is inserted in said wearable support device by rotation or by pressure. In one embodiment, the first positioning means is a clip, a screw, a hook, a loop or an adhesive.
In one embodiment, the second positioning means is a clip, a screw, a hook, a loop or an adhesive.
In one embodiment, the first positioning means are male means and the second positioning means are female means or conversely.
In one embodiment, the system further comprises an elastic element between the disposable and removable cartridge and the wearable support device.
In one embodiment, said elastic element is a spring. DEFINITIONS
In the present invention, the following terms have the following meanings:
- "Microneedle" refers to a substantially cylindrical or pyramidal tissue piercing element having a distal opening, a proximal opening, and an interior lumen extending from the distal opening to the proximal opening.
- "Disposable" refers to a device designed to be thrown away after being used, or after a short-time utilization.
- "Removable" refers to a device designed to be moved, dislodged and replaced in its position.
DETAILED DESCRIPTION
The following detailed description will be better understood when read in conjunction with the drawings. For the purpose of illustrating, the system, the device and the cartridge are shown in the preferred embodiments. It should be understood, however that the application is not limited to the precise arrangements, structures, features, embodiments, and aspects shown. The drawings are not drawn to scale and are not intended to limit the scope of the claims to the embodiments depicted. Accordingly it should be understood that where features mentioned in the appended claims are followed by reference signs, such signs are included solely for the purpose of enhancing the intelligibility of the claims and are in no way limiting on the scope of the claims.
The present invention relates to a disposable and removable cartridge 1 configured to cooperate with a wearable support device 2, said wearable support device 2 comprising securing means 21 configured to secure the wearable support device 2 to the skin of a subject, at least one connection track and at least one first positioning means. The disposable and removable cartridge 1 according to the present invention, configured to cooperate with a wearable support device 2, said wearable support device 2 comprising securing means 21 configured to secure the wearable support device 2 to the skin of a subject, at least one connection track and at least one first positioning means. In one embodiment, said cartridge 1 comprises:
- at least one microneedle 11 ;
- a sensing area 12;
- a microfluidic circuit in fluid communication with said at least one microneedle 11 and with said sensing area 12;
- at least one sensor 121 adapted to monitor at least one parameter of a fluid within the sensing area 12;
- a second connection track 123 electrically connected to the at least one sensor 121;
- at least one second positioning means configured to cooperate with the at least one first positioning means of the wearable support device 2 in such a way that when cooperates, the at least one first connection track of the wearable support device 2 is connected to said at least one second connection track 123 of the disposable and removable cartridge 1, and the cartridge is releasably secured to the wearable support device 2.
Said disposable and removable cartridge 1 is configured to be secured to a wearable support device 2 and said wearable support device 2 comprising securing means configured to secure the wearable support device 2 to the skin of a subject in such a way that the at least one microneedle is in contact, in front of the skin of said subject, or in such a way that the at least one microneedle penetrates the skin of said subject.
According to one embodiment, said disposable and removable cartridge 1 comprises a matrix of microneedles. According to one embodiment the at least one microneedle is on a substrate and the at least one microneedle forms with said substrate an angle ranging from 35 to 90° such that said at least one microneedle penetrates the skin at a 35° to 90° angle.
According to one embodiment, illustrated on figure 1, the disposable and removable cartridge 1 comprises a pumping means 13 fluidly connected to the sensing area 12 and ensuring the flow of the fluid in at least said microfluidic circuit and said sensing area 12. This pumping means 13 pumps the fluid from the microfluidic circuit to the sensing area 12 to be analyzed. In one embodiment non-illustrated, the microfluidic circuit does not comprise pumping means and the fluid fills the microfluidic circuit by capillarity.
In one embodiment, the microfluidic circuit comprise a foam, narrow surface, capillary tubes or a to ensure the motion of the fluid along the microfluidic circuit via capillarity. According to one embodiment, the pumping means 13 is configured to be used in both ways: aspiring the fluid from the microfluidic circuit to the sensing area 12 and pushing the fluid through the sensing area 12, the microfluidic circuit and the at least one microneedle 11. This embodiment permits to wash the microfluidic circuit, the at least one microneedle 11 and the sensing area 12 after use. According to one embodiment, the pumping means 13 is also fluidly connected to a chamber containing a washing liquid. In one embodiment, the washing liquid is a sterilization liquid. In one embodiment, the washing liquid is peracetic acid or ethanol.
According to another embodiment, the pumping means 13 is able to be inverted in such a way that the pumping means 13 can empty the waste receiver 14, the sensing area and/or the microfluidic circuit. According to an alternative embodiment, the microfluidic circuit is connected to a waste receiver after arranged to receive the washing liquid after the washing.
In one embodiment, the microfluidic circuit comprises at least one sterilization element. In one embodiment, the sterilization element irradiates the microfluidic circuit with UV light to sterilize said microfluidic circuit. In one embodiment, the sterilization element is an Ultraviolet Light Emitting Diode (also called UV LED). In one element, the microfluidic circuit comprise an array of UV LED along the length of the microfluidic circuit.
The present cartridge 1 is removable, which permits the user to use different cartridges, each comprising different sensors 121 for monitoring different components or fluid parameters, keeping the same wearable support device 2.
According to one embodiment, illustrated on figure 2, the disposable and removable cartridge 1 comprises a waste receiver 14 in fluid communication with said sensing area 12. Said waste receiver 14 receives the fluid after being passed within the sensing area 12. According to one embodiment, the waste receiver 14 stocks the fluid components and the water or the volatile parts of the fluid that can evaporate.
According to one embodiment, the pumping means 13 is fluidly connected between the sensing area 12 and the waste receiver 14 (figures 2 and 4) or said waste receiver 14 is fluidly connected between the sensing area 12 and the pumping means 13 (figure 3).
According to one embodiment, illustrated on figure 7, the waste receiver 14 comprises on at least a part of its surface, an opening 141 comprising a material. In one embodiment, said material is hermetic to the liquid and permeable to the steam. According to one embodiment, said material is a Gortex® . This embodiment allows the water or the volatile component of the fluid to evaporate and the waste receiver 14 is still hermetic to the liquid and dust.
According to one embodiment, the waste receiver 14 also comprises solid foam. The solid foam is located inside the waste receiver 14 to be in contact with the fluid. This solid foam increases the surface between the fluid and the air, increasing the speed of evaporation of water or volatile components within the fluid.
According to one embodiment, said pumping means 13 is a piezoelectric pump, a peristaltic pump or a diaphragm pump.
According to one embodiment, the fluid is blood or interstitial blood. According to one embodiment, there is a net fluid transfer between the at least one microneedle 11 and the sensing area 12. According to one embodiment, the components of the blood or the interstitial fluid to be monitored do not move to the sensing chamber 12 by diffusion. In said embodiment, there is no need to fill the microfluidic circuit or the sensing area before use. The sensors can be dried before two measurements. Such feature increases the lifetime of said sensors.
According to one embodiment, the fluid is sampled from the skin of a subject by the at least one microneedle. According to one embodiment, illustrated on figure 6, the disposable and removable cartridge 1 further comprises at least one microfluidic chamber 15, at least one additional microneedle 16 and an additional microfluidic circuit fluidly connecting said at least one additional microneedle 16 to said microfluidic chamber 15. According to one embodiment, said microfluidic chamber 15 comprises substances to be injected on the skin of a subject. According to one embodiment, the disposable and removable cartridge 1 further comprises an additional pumping means 17 fluidly connected to the microfluidic chamber 15. This microfluidic chamber 15 and additional elements permit the injection of a substance to the subject. For example, this substance could be insulin. Therefore, the cartridge 1 is able, for example, to inject insulin in function of the glucose concentration in the blood or in the interstitial fluid of said subject monitored by the at least one sensors of the sensing area.
According to one embodiment, the additional microfluidic circuit and the microfluidic circuit are fluidly connected. According to one embodiment, the additional microfluidic circuit and the microfluidic circuit are not fluidly connected.
According to one embodiment, said at least one sensor 121 is connected to a printed circuit board. According to one embodiment, said printed circuit board is also connected to the second connection track 123 of the cartridge 1 configured to be connected to the first track of the wearable support device 2.
According to one embodiment illustrated on figure 4, the at least one sensor 121 is connected to the second connection track 123. In one embodiment, the connection track s located on the exterior surface of the cartridge 1. In one embodiment, the pumping means is located on the wearable support device. According to one embodiment, said at least one sensor 121 is adapted to monitor the concentration of a component in the fluid within said sensing area 12. According to one embodiment, said at least one sensor 121 is adapted to monitor the concentration of glucose or lactate ions in the fluid within the sensing area 12. According to one embodiment, said at least one sensor 121 is adapted to monitor the concentration of hormones such as estrogen or estradiol. According to one embodiment, said at least one sensor 121 is adapted to monitor the conductivity, the density, or the temperature of the fluid within said sensing area 12.
According to one embodiment, said at least one sensor 121 is an optical sensor or an electrochemical sensor.
According to one embodiment, the disposable and removable cartridge 1 further comprises a liquid detector fluidly connected to the microfluidic circuit. This liquid detector can advise the subject that the disposable and removable cartridge 1 is working. The liquid detector detects the presence of the fluid in the circuit. According to one embodiment, the liquid detector is in the sensing chamber. According to one embodiment, the liquid detector is an electrochemical sensor and said electrochemical sensor detects the fluid when a tension can be measured between its electrodes. According to one embodiment, the liquid detector is an optical sensor which detects the presence of the liquid when the signal received by said optical sensor is different from the baseline signal. According to one embodiment, the at least one sensor within the sensing chamber is the liquid detector. According to another embodiment, the at least one sensor and the liquid detector are two different elements.
In one embodiment, the at least one sensor and the liquid detector comprise two or three electrodes. In one embodiment, the liquid detector is the reference electrode and the at least one sensor comprises at least two working electrodes. In one embodiment, the working electrodes are located in the microfluidic circuit between the microneedles 11 and the reference electrode. In said embodiment, the device ensure that the microfluidic circuits filled and the sensors 121 are fluidly covered when the measure occurs.
According to one embodiment, illustrated on figure 8 and figure 9, the disposable and removable cartridge 1 comprises a fluidic receiver 182 fluidly connected to the sensing area 12 and further comprises a membrane 18 fluidly connected to the microfluidic circuit between the sensing area 12 and said fluid receiver 182. In said embodiment, the membrane 18 filters the fluid. The water and the ions in the fluid pass through the membrane 18 while the solid components, or cells are stopped by the membrane 18. According to one embodiment, the membrane 18 comprises pores having a very small porosity. According to one embodiment, the porosity is a barrier for elements which have a molecular weight higher than a value ranging from 1 to 1500 Da.
It is commonly used by the membrane manufacturer to describe such membrane in Dalton and the skilled person will immediately identified the membrane to be used to reproduce this embodiment.
According to one embodiment, the pores of the membrane 8 have a length or a diameter ranging from 1 nm to 10μm, from lnm to 1μm or from lnm to 100nm.
According to one embodiment illustrated on figure 8, the disposable and removable cartridge 1 further comprises a valve 181 and/or a second pumping means 13, ensuring the guidance of the fluid to the fluid receiver.
According to one embodiment illustrated on figure 8 and figure 9, the liquid within the fluid receiver 182 can be reused to clean the sensing area 12 and the microfluidic circuit, for example using pumping means 13 and valves 181, 183. The invention further relates to a wearable support device 2, configured to cooperate with the disposable and removable cartridge 1 according to the present invention.
The wearable support device 2, configured to cooperate with the disposable and removable cartridge 1 according to the present invention, comprises:
- securing means 21 configured to secure the wearable support device 2 to the skin of a subject;
- at least one connection track;
- at least one first positioning means configured to cooperate with the at least one second positioning means of said disposable and removable cartridge 1 in such a way that when cooperates, the at least one first connection track of the support device is connected at said at least one second connection track 123 of the disposable and removable cartridge 1 , and that the cartridge is releasably secured to the wearable support device 2.
This wearable support 2 can be a watch. According to one embodiment, said securing means 21 comprises a strip, an armband, a wristwatch, an elastic band, or an adhesive. According to one embodiment, the securing means 21 are arranged to maintain the contact between the cartridge 1 and the skin of the subject. According to one embodiment, the wearable support device 2 further comprises a microcontroller configured to calculate the concentration of the component measured by the at least one sensor of the disposable and removable cartridge 1. According to one embodiment, the wearable support device 2 further comprises a display 22 connected to the microcontroller. The display 22 can show to the subject the parameters of the fluid monitored by the at least one sensor 121 in the cartridge 1. According to one embodiment, the wearable support device 2 comprises other means of information to inform or alert the subject of its health status (for example, vibrations).
The present invention also relates to a system 3 comprising the disposable and removable cartridge 1 and the wearable support device 2 according to the present invention. According to one embodiment illustrated on figure 5, said disposable and removable cartridge 1 is inserted in said wearable support device 2 by rotation or by pressure.
According to one embodiment, the first or the second positioning means is a clip, a screw, a hook, a loop or an adhesive.
According to one embodiment, the first positioning means are male means and the second positioning means are female means or conversely.
According to one embodiment, the wearable support device 2 further comprises a battery and the system 3 is autonomous and mobile.
According to one embodiment, the system 3 further comprises an elastic element between the disposable and removable cartridge 1 and the wearable support device 2 such as a spring. This elastic element, permits the subject, applying a pressure on the system 3, to displace the disposable and removable cartridge 1 relative to the wearable support device 2 and to allow the at least one microneedle 11 to penetrate in the skin of the subject which wears the system 3. While various embodiments have been described and illustrated, the detailed description is not to be construed as being limited hereto. Various modifications can be made to the embodiments by those skilled in the art without departing from the true spirit and scope of the disclosure as defined by the claims.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a schematic drawing of the disposable and removable cartridge according to one embodiment.
Figure 2 is a schematic drawing of the disposable and removable cartridge comprising a waste receiver according to one embodiment.
Figure 3 is a schematic drawing of the disposable and removable cartridge comprising a waste receiver located between the sensing area and the pumping means.
Figure 4 is a schematic drawing of the disposable and removable cartridge having a cylindrical geometry. Figure 5 is a drawing of the system according to one embodiment, wherein the wearable support device 2 is a watch.
Figure 6 is a schematic drawing of the disposable and removable cartridge comprising a microfluidic chamber containing a substance.
Figure 7 is a schematic drawing of the waste receiver, wherein the fluidic connections are not represented.
Figure 8 is a schematic drawing of the disposable and removable cartridge according to one embodiment wherein said cartridge comprises a membrane and a fluid receiver with a second pumping element.
Figure 9 is a schematic drawing of the disposable and removable cartridge according to one embodiment wherein said cartridge comprises a membrane and a fluid receiver with at least one valve. REFERENCES
1 - Disposable and removable cartridge;
11 - Microneedle;
12 - Sensing area;
121 - Sensors;
123 - Second connection track;
13 - Pumping means;
14 - Waste receiver;
141 - Opening;
15 - Microfluidic chamber;
16 - Additional microneedle;
17 - Additional pumping means;
18 - Membrane;
181 -Valve;
182 - Fluid receiver;
183 -Valve;
2 - Wearable support device;
21 - Securing means;
22 - Display;
3 - System.

Claims

CLAIMS 1. A disposable and removable cartridge (1) configured to cooperate with a wearable support device (2), said wearable support device (2) comprising securing means configured to secure the wearable support device (2) to the skin of a subject, at least one connection track and at least one first positioning means;
said disposable and removable cartridge 1 comprising:
- at least one microneedle (11);
- a sensing area (12);
- a microfluidic circuit in fluid communication with said at least one microneedle (11) and with said sensing area (12);
- at least one sensor (121) adapted to monitor at least one parameter of a fluid within the sensing area (12);
- a second connection track 123 electrically connected to the at least one sensor (121);
- at least one second positioning means configured to cooperate with the at least one first positioning means of the support device in such a way that when cooperates, the at least one first connection track of the support device is connected to said at least one second connection track (123) of the disposable and removable cartridge (1), and the cartridge is releasably secured to the wearable support device 2. 2. The disposable and removable cartridge (1) according to claim 1, further comprising a pumping means (13) fluidly connected to the sensing area (12) and ensuring the flow of the fluid in at least said microfluidic circuit and said sensing area (12). 3. The disposable and removable cartridge (1) according to claim 1 or claim 2, further comprising a waste receiver (14) in fluid communication with said sensing area (12). 4. The disposable and removable cartridge (1) according to claim 3, wherein said pumping means (13) is fluidly connected between the sensing area (12) and the waste receiver (14) or said waste receiver (14) is fluidly connected between the sensing area (12) and the pumping means (13).
5. The disposable and removable cartridge ( 1 ) according to claim 3 or claim 4, wherein said waste receiver (14) comprises on at least a part of its surface, an opening (141) comprising a material, wherein said material is hermetic to the liquid and permeable to the steam.
6. The disposable and removable cartridge (1) according to claim 5, wherein said material is a Gortex®.
7. The disposable and removable cartridge (1) according to anyone of claims 3 to 6, wherein the waste receiver (14) further comprises solid foam.
8. The disposable and removable cartridge (1) according to anyone of claims 2 to 7, wherein said pumping means (13) is a piezoelectric pump, a peristaltic pump or a diaphragm pump.
9. The disposable and removable cartridge (1) according to anyone of claims 1 to 8, wherein the fluid is blood or interstitial fluid.
10. The disposable and removable cartridge (1) according to anyone of claims 1 to 9, further comprising at least one microfluidic chamber (15), at least one additional microneedle (16) and an additional microfluidic circuit fluidly connected to said at least one additional microneedle (16) and said microfluidic chamber (15). 11. The disposable and removable cartridge 1 according to claim 10, wherein the additional microfluidic circuit and the microfluidic circuit are fluidly connected.
The disposable and removable cartridge 1 according to claim 11, wherein the additional microfluidic circuit and the microfluidic circuit are not fluidly connected.
13. The disposable and removable cartridge 1 according to anyone of claims 10 to 12, wherein said microfluidic chamber (15) comprises substances to be injected on the skin of a subject.
14. The disposable and removable cartridge (1) according to anyone of claims 10 to 13, further comprises an additional pumping means (17) fluidly connected to the microfluidic chamber (15).
15. The disposable and removable cartridge (1) according to anyone of claims 1 to 14, wherein said at least one sensor (121) is an optical sensor or an electrochemical sensor.
16. The disposable and removable cartridge (1) according.to anyone of claims 1 to 15, further comprising a printed circuit board, wherein said at least one sensor (121) and said second connection track (123) are electrically connected to said printed circuit board.
17. The disposable and removable cartridge (1) according to anyone of claims 1 to 16, wherein said at least one sensor (121) is adapted to monitor the concentration of a component in the fluid within the sensing area (12).
18. The disposable and removable cartridge (1) according to anyone of claims 1 to 17, wherein said at least one sensor (121) is adapted to monitor the concentration of glucose or lactate ions in the fluid within the sensing area (12).
19. The disposable and removable cartridge (1) according to anyone of claims 1 to 17, wherein said at least one sensor (121) is adapted to monitor the concentration of hormones such as estrogen or estradiol within the sensing area (12).
20. The disposable and removable cartridge (1) according to anyone of claims 1 to 15, wherein said at least one sensor (121) is adapted to monitor the conductivity, the density, or the temperature of the fluid within the sensing area (12).
21. The disposable and removable cartridge (1) according to anyone of claims 1 to 20 further comprises a liquid detector fluidly connected to the microfluidic circuit.
22. The disposable and removable cartridge (1) according to anyone of claims 2 to 21, further comprising a fluid receiver (182) fluidly connected to the sensing area (12) and further comprising a membrane (18) fluidly connected between said sensing area (12) and said fluid receiver (182).
23. The disposable and removable cartridge (1) according to claim 22, wherein the pores of said membrane (18) have a length or a diameter ranging from lnm to 10μm.
24. The disposable and removable cartridge (1) according to claim 22, wherein the porosity is a barrier for elements which have a molecular weight higher than a value ranging from 1 to 1500 Da.
25. A wearable support device (2), configured to cooperate with the disposable and removable cartridge (1) according to anyone of preceding claims; said wearable support device (2) comprising:
- securing means (21) configured to secure the wearable support device (2) to the skin of a subject;
- at least one connection track;
- at least one first positioning means configured to interact with the at least one second positioning means of said disposable and removable cartridge (1) in such a way the at least one first connection track of the support device is connected at said at least one second connection track (123) of the disposable and removable cartridge (1), and in such a way the cartridge is releasably secured to the wearable support device (2).
26. The wearable support device (2) according to claim 25, wherein said securing means (21) comprises a strip, an armband, a wristwatch, an elastic band, or an adhesive.
27. The wearable support device (2) according to claim 25 or claim 26, further comprising a microcontroller configured to calculate the concentration of the component measured by the at least one sensor (121) of the disposable and removable cartridge (1). 28. The wearable support device (2) according to claim 27, further comprising a display (22) connected to the microcontroller.
29. A system (3) comprising the disposable and removable cartridge (1) according to anyone of claims 1 to 24, and the wearable support device (2) according to anyone of claims 25 to 28.
30. A system (3) according to claim 29, wherein said disposable and removable cartridge (1) is inserted in said wearable support device (2) by rotation or by pressure.
31. A system (3) according to claim 29 or claim 30, wherein the first positioning means is a clip, a screw, a hook, a loop or an adhesive.
32. A system (3) according to claim 29 or claim 30, wherein the second positioning means is a clip, a screw, a hook, a loop or an adhesive.
33. A system (3) according to claim 29 or claim 30, wherein the first positioning means are male means and the second positioning means are female means or conversely.
34. A system (3) according anyone of claims 29 to 33, further comprising an elastic element between the disposable and removable cartridge (1) and the wearable support device (2).
35. A system (3) according to claim 34, wherein said elastic element is a spring.
PCT/EP2017/081221 2016-12-02 2017-12-01 Cartridge for biochemical sensor Ceased WO2018100176A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662429210P 2016-12-02 2016-12-02
US62/429,210 2016-12-02

Publications (1)

Publication Number Publication Date
WO2018100176A1 true WO2018100176A1 (en) 2018-06-07

Family

ID=60702665

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2017/081221 Ceased WO2018100176A1 (en) 2016-12-02 2017-12-01 Cartridge for biochemical sensor

Country Status (1)

Country Link
WO (1) WO2018100176A1 (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111948930A (en) * 2020-09-02 2020-11-17 中国科学院深圳先进技术研究院 Rotating sensor chip array disk and smart wearable watch using the same
FR3106050A1 (en) * 2020-01-14 2021-07-16 Pkvitality BRACELET FOR BODY SURVEILLANCE DEVICE

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002091922A1 (en) 2001-05-11 2002-11-21 The Procter & Gamble Company Portable interstitial fluid monitoring system
EP1260815A2 (en) * 2001-05-25 2002-11-27 Lifescan, Inc. Methods for automatically monitoring analyte concentration using minimally invasive devices
EP1661516A1 (en) * 2003-09-02 2006-05-31 Koji Sode Glucose sensor and glucose level measuring apparatus
WO2006115663A2 (en) * 2005-04-25 2006-11-02 Honeywell International Inc. A flow control system of a cartridge
WO2008077147A2 (en) 2006-12-20 2008-06-26 Arkal Medical, Inc. Devices, systems, methods and tools for continuous glucose monitoring
US20130274568A1 (en) * 2005-09-30 2013-10-17 Intuity Medical, Inc. Fully integrated wearable or handheld monitor

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002091922A1 (en) 2001-05-11 2002-11-21 The Procter & Gamble Company Portable interstitial fluid monitoring system
EP1260815A2 (en) * 2001-05-25 2002-11-27 Lifescan, Inc. Methods for automatically monitoring analyte concentration using minimally invasive devices
EP1661516A1 (en) * 2003-09-02 2006-05-31 Koji Sode Glucose sensor and glucose level measuring apparatus
WO2006115663A2 (en) * 2005-04-25 2006-11-02 Honeywell International Inc. A flow control system of a cartridge
US20130274568A1 (en) * 2005-09-30 2013-10-17 Intuity Medical, Inc. Fully integrated wearable or handheld monitor
WO2008077147A2 (en) 2006-12-20 2008-06-26 Arkal Medical, Inc. Devices, systems, methods and tools for continuous glucose monitoring

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR3106050A1 (en) * 2020-01-14 2021-07-16 Pkvitality BRACELET FOR BODY SURVEILLANCE DEVICE
CN111948930A (en) * 2020-09-02 2020-11-17 中国科学院深圳先进技术研究院 Rotating sensor chip array disk and smart wearable watch using the same

Similar Documents

Publication Publication Date Title
CN100553560C (en) Be used for monitoring the system of body fluid analyte concentration
ES2470979T3 (en) Device for sampling body fluids
US7258673B2 (en) Devices, systems and methods for extracting bodily fluid and monitoring an analyte therein
US9028409B2 (en) Fluid delivery with in vivo electrochemical analyte sensing
CA2449925C (en) Control solution packets and methods for calibrating bodily fluid sampling devices
US20090312622A1 (en) Device And Method For Determining A Value Of A Physiological Parameter Of A Body Fluid
EP1792565B1 (en) Selectively exposable miniature probes with integrated sensor arrays for continuous in vivo diagnostics
JP2003033336A (en) Device and method for sampling and measuring biofluid component
JP2006527020A (en) A system for extracting body fluid and monitoring analytes in the body fluid
HK1049951A1 (en) Biological fluid sampling and analyte measurement device
EP2467707A2 (en) Apparatus and method for measuring biochemical parameters
EP2611362A2 (en) Device for continuous measuring of an analyte
WO2018100176A1 (en) Cartridge for biochemical sensor
KR101760899B1 (en) Blood Glucose Sensing Module and Continuous Blood Glucose Monitoring Device with Auto-Calibration
US20160113561A1 (en) Apparatus and method for detecting and/or monitoring one or more compounds in blood
WO2017100480A1 (en) Apparatus and method for detecting and/or monitoring one or more compounds in blood
EP2440114B1 (en) Device for the transcutaneous, in vivo measurement of the concentration of at least one analyte in a living organism
KR102302991B1 (en) Injection module and inject medicine device comprising the same
WO2014108087A1 (en) Portable monitoring system for dynamically and continuously measuring analyte in body liquid
Diamond On-body chem/bio-sensing-opportunities and challenges
HK1063595B (en) System and method for monitoring the concentration of analytes in body fluids
HK1116648A (en) System, for monitoring the concentration of analytes in body fluids
HK1070549A (en) Devices, systems and methods for extracting bodily fluid and monitoring an analyte therein

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 17816596

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 2017816596

Country of ref document: EP

Effective date: 20190702

122 Ep: pct application non-entry in european phase

Ref document number: 17816596

Country of ref document: EP

Kind code of ref document: A1