WO2022195236A1 - Capteur pour dispositif de surveillance corporelle limitant les irritations - Google Patents
Capteur pour dispositif de surveillance corporelle limitant les irritations Download PDFInfo
- Publication number
- WO2022195236A1 WO2022195236A1 PCT/FR2022/050501 FR2022050501W WO2022195236A1 WO 2022195236 A1 WO2022195236 A1 WO 2022195236A1 FR 2022050501 W FR2022050501 W FR 2022050501W WO 2022195236 A1 WO2022195236 A1 WO 2022195236A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- sensor
- sensor according
- microneedle
- wafer
- microneedles
- 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
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6801—Arrangements 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
- A61B5/683—Means for maintaining contact with the body
- A61B5/6832—Means for maintaining contact with the body using adhesives
- A61B5/6833—Adhesive patches
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6801—Arrangements 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
- A61B5/6802—Sensor mounted on worn items
- A61B5/681—Wristwatch-type devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
- A61B5/685—Microneedles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring 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
- A61B5/14507—Measuring 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
- A61B5/1451—Measuring 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
- A61B5/14514—Measuring 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring 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
- A61B5/14532—Measuring 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150015—Source of blood
- A61B5/150022—Source of blood for capillary blood or interstitial fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150969—Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150977—Arrays of piercing elements for simultaneous piercing
- A61B5/150984—Microneedles or microblades
Definitions
- the invention relates to a body monitoring device and in particular a body monitoring device by an analysis of body fluid, typically interstitial by means of microneedle(s).
- Certain pathologies such as diabetes require daily monitoring of biochemical parameters of the human body, in particular the concentrations of certain compounds (glycaemia in the example of glucose).
- GlucoWatch uses a phenomenon called iontophoresis (or iontophoresis) in which an electric field is used to "pull" interstitial fluid through the skin to a sensor on the wall of the device.
- iontophoresis or iontophoresis
- transcutaneous probes have been proposed in the form of a self-adhesive patch placing a “microneedle-sensor” just under the skin, so as to place the sensor in permanent fluid communication with the interstitial liquid, for continuous monitoring.
- patch-type transcutaneous probes include wireless communication means making it possible to send the measurements on the interstitial fluid to a mobile terminal, for storage and/or processing of the measurements (verification of thresholds and variations, production of statistics , triggering alerts if necessary, etc.). Mention may be made, for example, of the sugarBEAT TM or FreeStyle Libre systems.
- the invention makes it possible to overcome at least one of these drawbacks.
- the invention proposes a sensor for a body monitoring device comprising: an internal face intended to come into contact with the skin of an individual; at least one microneedle disposed on said internal face; at least one wafer placed on the internal face of the substrate near a microneedle and configured to absorb/adsorb humidity when the sensor is on the skin.
- the wafer is placed between 0.1 and 10 mm from the microneedle;
- each microneedle is at a distance of between 0.1 mm and 10 mm from a pad;
- the pad consists of at least one absorbent material preferably chosen from the following group: fiber, foam, textile or artificial fiber, hydrogel, silica gel, magnesium sulphate, calcium chloride, calcium sulphate, lithium chloride, zeolites; or a nonwoven compress preferably consisting of a mixture of viscose and polyester or a woven compress consisting of woven hydrophilic gauze;
- the wafer has a surface of between 1 and 500 mm 2 , preferably 15 mm 2 and/or a thickness of between 0.1 and 2 mm, preferably 0.5 mm;
- the insert comprises one of the shapes chosen from the following group: polygonal, rounded, parallelepiped, triangle, round;
- the invention also relates to a body monitoring device comprising a sensor according to the invention.
- At least one absorbent pad helps reduce irritation and therefore limits the appearance of bacteria. In addition, it makes it possible to prolong the wearing of the same sensor by increasing its duration of use. The user therefore changes the sensor less often.
- FIG. 1 illustrates an overall view of a body monitoring device according to one embodiment of the invention
- FIGS. 2 and 3 illustrate, in bottom view, configurations of sensors of a monitoring device according to the invention.
- FIG. 4 illustrates a microneedle surrounded by a channel implemented in a device according to the invention
- FIG. 5 illustrates a plate comprising four microneedles implemented in a device according to the invention.
- similar elements bear identical references.
- a body monitoring device 1 comprises a housing 2, a sensor 3, an adhesive patch 4. Such a monitoring device is advantageously used to implement a body monitoring method.
- body monitoring we mean the verification of biochemical constants of a person wearing the device, typically the concentration of a protein, a hormone, a marker, oxygen, nutrients, etc. in a body fluid of the person.
- biochemical constants of a person wearing the device typically the concentration of a protein, a hormone, a marker, oxygen, nutrients, etc. in a body fluid of the person.
- An example is blood sugar.
- the person skilled in the art can also monitor, if necessary, other bodily physical quantities such as temperature, hydration, etc.
- the biochemical constant to be monitored is the concentration of glucose (or glycaemia) within the interstitial liquid of the skin.
- Interstitial fluid glycaemia is considered representative of blood plasma glycaemia.
- body fluid is interstitial fluid but we can also consider other body fluids such as blood.
- the sensor 3 is a needle sensor provided to provide a measurement of electric current within the interstitial liquid of the wearer of the device 1 .
- the needles are advantageously arranged on an internal face 31 of the sensor 3. This internal face 31 is intended to be placed on the wearer's skin.
- the needles 32 are advantageously micro-needles.
- the sensor 3 preferably comprises between four and fifty micro-needles or even 400 micro-needles. Of course, a different number can be considered without this limiting the description of the invention given here.
- micro-needle is meant a needle having a low height, preferably between 10 ⁇ m and 1000 ⁇ m, preferably between 0.3 mm and 0.8 mm. Furthermore, the micro-needles are substantially pyramidal. The height of the micro-needles is low enough to avoid contact with a nerve of the wearer when the device is worn. The micro-needles 31 make it possible to measure or sample the body fluid.
- the 32 microneedles are hollow when it comes to taking liquid or full to directly analyze the liquid.
- the microneedles allow the extraction of interstitial liquid from the dermis in a painless manner without beading of blood and sends it towards a sensor housed in the box 2.
- the microneedles do not take up liquid and integrate the sensor on their surface in the form of a coating such as a biochemical material capable of reacting with the analysis to be carried out on the liquid.
- the senor 3 comprises several microneedles which consist of a network of microneedles in that they are electrically connected to each other.
- the microneedles pierce the skin to come into contact with the interstitial fluid when the sensor is in contact with the skin.
- the senor 3 is assembled to the adhesive patch 4 and can together constitute a capsule.
- the sensor 3 can also be removable with respect to the patch 4.
- Such a capsule is advantageously removably mounted with the box 2.
- the capsule therefore the sensor 3 preferably engages in a cavity 21 of the box 2 located on its face. intended to be in contact with the skin.
- the sensor 3 further comprises an outer face 34 opposite the inner face 31 .
- the sensor 3 shown here is circular in shape with a central orifice 33 but it can take other shapes: rectangular, oblong, ellipsoidal with or without a central orifice.
- the central hole 33 allows the sensor 3 to be correctly positioned in the cavity 21 of the box which includes a central stud 22
- the sensor 3 therefore comprises elements which make it possible to sample the liquid or to bring the signals detected by each microneedle to the box 2 for processing (not described here).
- the adhesive patch 4 is adapted to be stuck to the skin and supports the sensor 3 and makes it possible to detach the case 2 without removing the sensor 3 while keeping it stuck to the body. Such a configuration makes it possible to avoid removing the sensor for certain operations which only involve the box: recharging the battery, repair, replacement, extraction of data to a computer.
- the case 2 is advantageously in the form of a watch case and comprises a bracelet 23 adapted to surround a person's wrist.
- the box 2 houses several elements making it possible to analyze or extract interstitial liquid.
- the senor is intended to be placed against the skin and this for several days and in particular beyond three days.
- the sensor 3 comprises at least one absorbent plate 34 placed on the internal face 31 of the sensor 3.
- a plate 34 is configured to absorb humidity when the sensor 3 is on the skin.
- the wafer 34 is preferably made of a moisture-absorbing material, this material being biocompatible.
- the wafer 34 is made of a material chosen from the following group: foam, textile or artificial fiber, hydrogel, silica gel, magnesium sulphate, calcium chloride, calcium sulphate, lithium chloride, zeolites; or a non-woven compress preferably consisting of a mixture of viscose and polyester or a woven compress consisting of woven hydrophilic gauze.
- biocompatible material or combination of biocompatible materials can be used for the wafer as long as it absorbs/adsorbs moisture.
- the wafer 34 is polygonal, in particular of parallelepipedic, triangular, round, rounded shape, etc. the shape depends on the way in which the plate 34 is arranged as well as the place where it is arranged.
- the wafer has a surface of between 1 mm 2 and 500 mm 2 , preferably 15 mm 2 and/or a thickness of between 0.1 and 2 mm, preferably 0.5 mm.
- a plate 34 is placed at a distance of between 0.1 and 10 mm from the microneedle.
- each microneedle 32 is at a distance from the plate of between 1 and 10 mm.
- This proximity makes it possible to ensure good absorption of humidity by the plate 34 during the period during which the sensor 3 is positioned on the skin. This advantageously makes it possible over a given period to limit irritation but also to increase the duration during which the same sensor 3 is worn by the user without him feeling the need to change sensor 3.
- the microneedles 32 are distributed over a determined zone 35 of the internal face 31 .
- absorbent pads 34 are arranged on either side of zone 35.
- microneedles 32 are for example described in document WO 2020/025820 A1 in the name of the Applicant.
- the microneedles are distributed over a sector of the internal face, the pads 34 being on either side of the sector (see for example FIG. 2).
- the senor 3 comprises one or more passages 36 formed in its thickness, these passages 36 are in communication with the outside and are configured to bring air towards the face 31 in contact with the skin while being permeable. at the water. In this way, the air around the microneedles 32 and the pads 34 is renewed, which contributes to drying out the area in contact with the sensor 3.
- the passage 36 is preferably formed over the entire thickness of the sensor 3 from its outer face to the inner face.
- the passage can extend from a zone where the microneedles are towards an edge of the sensor 3 so that the passage is in contact with the outside.
- the passage is not formed over the entire thickness of the sensor but only over a part.
- the passage 36 may comprise a section adapted to prevent the entry of water by capillary repulsion or else may further comprise a barrier placed in each passage 36, said barrier being made of permeable material. in water but not in air.
- a channel 37 surrounds the microneedles and may be in communication with a passage. Such a channel is for example described in document WO 2021/023884 A1 in the name of the Applicant.
- FIG. 4 illustrates a preferred embodiment in which the sensor 3 has the shape of a ring (but can also be oblong) and comprises on its internal face housings 38 making it possible to accommodate plates 39 which each support at least one microneedle 32 As illustrated in Figure 5, each platen 39 preferably supports four microneedles 32.
- the plates 39 are rectangular and the microneedles 32 are arranged at the four corners of one face of the platen 39.
- the sensor 3 comprises a central orifice 33 around which is delimited a sector in which the housings 38 and therefore the plates are distributed. At the ends of this sector are arranged pads 34.
- passages 36 are distributed over this sector to allow air to be brought to the microneedles 32.
- the adhesive patch 4 surrounds the sensor 3 in order to allow it to be held on the individual's skin.
- a sealing ring 331 surrounds the central orifice 33.
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- Life Sciences & Earth Sciences (AREA)
- Health & Medical 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)
- Optics & Photonics (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
Abstract
Description
Claims
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP22715123.0A EP4307998A1 (fr) | 2021-03-19 | 2022-03-18 | Capteur pour dispositif de surveillance corporelle limitant les irritations |
| US18/282,681 US20240164667A1 (en) | 2021-03-19 | 2022-03-18 | Irritation-limiting sensor for body monitoring device |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FRFR2102766 | 2021-03-19 | ||
| FR2102766A FR3120779B1 (fr) | 2021-03-19 | 2021-03-19 | Capteur pour dispositif de surveillance corporelle limitant les irritations |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2022195236A1 true WO2022195236A1 (fr) | 2022-09-22 |
Family
ID=76283876
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/FR2022/050501 Ceased WO2022195236A1 (fr) | 2021-03-19 | 2022-03-18 | Capteur pour dispositif de surveillance corporelle limitant les irritations |
Country Status (4)
| Country | Link |
|---|---|
| US (1) | US20240164667A1 (fr) |
| EP (1) | EP4307998A1 (fr) |
| FR (1) | FR3120779B1 (fr) |
| WO (1) | WO2022195236A1 (fr) |
Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20020169394A1 (en) * | 1993-11-15 | 2002-11-14 | Eppstein Jonathan A. | Integrated tissue poration, fluid harvesting and analysis device, and method therefor |
| EP1266607A2 (fr) * | 2001-06-12 | 2002-12-18 | Lifescan, Inc. | Dispositif de mesure et méthode d'échantillonnage percutane des constituants de fluide biologique |
| US20150335288A1 (en) * | 2013-06-06 | 2015-11-26 | Tricord Holdings, Llc | Modular physiologic monitoring systems, kits, and methods |
| US20160058380A1 (en) * | 2014-08-26 | 2016-03-03 | Dexcom, Inc. | Systems and methods for securing a continuous analyte sensor to a host |
| WO2017218878A1 (fr) * | 2016-06-17 | 2017-12-21 | The Board Of Trustees Of The University Of Illinois | Systèmes microfluidiques souples et portables capables de capturer, stocker et détecter des fluides biologiques |
| WO2019121324A1 (fr) * | 2017-12-22 | 2019-06-27 | Brighter Ab (Publ) | Timbre dermique pour le diagnostic |
| WO2019141743A1 (fr) | 2018-01-16 | 2019-07-25 | Pkvitality | Système de surveillance corporelle avec adhésif |
| WO2020025820A1 (fr) | 2018-08-03 | 2020-02-06 | Pkvitality | Capsule multi-position |
| WO2021023884A1 (fr) | 2019-08-08 | 2021-02-11 | Pkvitality | Systeme de surveillance corporelle comprenant une microaiguille |
-
2021
- 2021-03-19 FR FR2102766A patent/FR3120779B1/fr active Active
-
2022
- 2022-03-18 WO PCT/FR2022/050501 patent/WO2022195236A1/fr not_active Ceased
- 2022-03-18 EP EP22715123.0A patent/EP4307998A1/fr active Pending
- 2022-03-18 US US18/282,681 patent/US20240164667A1/en active Pending
Patent Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20020169394A1 (en) * | 1993-11-15 | 2002-11-14 | Eppstein Jonathan A. | Integrated tissue poration, fluid harvesting and analysis device, and method therefor |
| EP1266607A2 (fr) * | 2001-06-12 | 2002-12-18 | Lifescan, Inc. | Dispositif de mesure et méthode d'échantillonnage percutane des constituants de fluide biologique |
| US20150335288A1 (en) * | 2013-06-06 | 2015-11-26 | Tricord Holdings, Llc | Modular physiologic monitoring systems, kits, and methods |
| US20160058380A1 (en) * | 2014-08-26 | 2016-03-03 | Dexcom, Inc. | Systems and methods for securing a continuous analyte sensor to a host |
| WO2017218878A1 (fr) * | 2016-06-17 | 2017-12-21 | The Board Of Trustees Of The University Of Illinois | Systèmes microfluidiques souples et portables capables de capturer, stocker et détecter des fluides biologiques |
| WO2019121324A1 (fr) * | 2017-12-22 | 2019-06-27 | Brighter Ab (Publ) | Timbre dermique pour le diagnostic |
| WO2019141743A1 (fr) | 2018-01-16 | 2019-07-25 | Pkvitality | Système de surveillance corporelle avec adhésif |
| WO2020025820A1 (fr) | 2018-08-03 | 2020-02-06 | Pkvitality | Capsule multi-position |
| WO2021023884A1 (fr) | 2019-08-08 | 2021-02-11 | Pkvitality | Systeme de surveillance corporelle comprenant une microaiguille |
Also Published As
| Publication number | Publication date |
|---|---|
| FR3120779A1 (fr) | 2022-09-23 |
| FR3120779B1 (fr) | 2024-02-09 |
| US20240164667A1 (en) | 2024-05-23 |
| EP4307998A1 (fr) | 2024-01-24 |
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