WO2023062596A1 - Dispositif d'administration sous-cutanée - Google Patents

Dispositif d'administration sous-cutanée Download PDF

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Publication number
WO2023062596A1
WO2023062596A1 PCT/IB2022/059865 IB2022059865W WO2023062596A1 WO 2023062596 A1 WO2023062596 A1 WO 2023062596A1 IB 2022059865 W IB2022059865 W IB 2022059865W WO 2023062596 A1 WO2023062596 A1 WO 2023062596A1
Authority
WO
WIPO (PCT)
Prior art keywords
injection
detecting
main body
patient
insulin
Prior art date
Application number
PCT/IB2022/059865
Other languages
English (en)
Inventor
Ermanno CORDELLI
Luisa FRANCINI
Silvia MANFRINI
Vincenzo PIEMONTE
Rosa SICILIA
Paolo Soda
Original Assignee
Universita' Campus Bio-Medico Di Roma
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 Universita' Campus Bio-Medico Di Roma filed Critical Universita' Campus Bio-Medico Di Roma
Publication of WO2023062596A1 publication Critical patent/WO2023062596A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/3159—Dose expelling manners
    • A61M5/31593—Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2422—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31566—Means improving security or handling thereof
    • A61M5/31568—Means keeping track of the total dose administered, e.g. since the cartridge was inserted
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3306—Optical measuring means
    • A61M2205/3313—Optical measuring means used specific wavelengths
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3507—Communication with implanted devices, e.g. external control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3546—Range
    • A61M2205/3569—Range sublocal, e.g. between console and disposable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3592—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/62—Posture
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/63—Motion, e.g. physical activity

Definitions

  • the present invention relates to a device usable for the subcutaneous administration of a drug.
  • the device is particularly suitable in case of administration of insulin in diabetic subjects.
  • the diabetic patients using a so-called “insulin pen” for subcutaneous injection can incur in a series of problems, often linked to the mode with which the above-mentioned pen is manoeuvred. Some of such critical issues are listed as follows.
  • the known art provides limited means and methods to obviate said problems.
  • the patient may use the camera of her/his own smart phone and take a picture of the area selected for the injection; by means of an application associated to a database containing the historical data of the previous injections, from the picture it can be recognized if the selected point is or is not close to a previous injection site.
  • This technique is clearly quite complex, time consuming, and its reliability is linked to the patient’s ability in taking a picture of the injection site in a clear and repeatable way.
  • Other systems are configured to send a warning signal to the patient related to the time of the administration to be performed.
  • US2018/211562A1 describes a device for measuring the dose of a substance administered by injection and the injection position.
  • the device comprises sensors positioned distally with respect to the injection site.
  • US2020/023139A1 describes a system for monitoring an injection process, including an electronic unit incorporated in the injection device.
  • W02020/072299A1 describes a system for detecting an operating status inserted in an injection set.
  • the known devices in any case are not capable of assisting the patient in a sufficiently reliable and repeatable way for the purpose of correctly administering the prescribed insulin dose.
  • the technical problem placed and solved by the present invention is then to provide a device for subcutaneous administration allowing to obviate one or more of the drawbacks mentioned above with reference to the known art.
  • the device of the invention is generally defined as for subcutaneous administration and it can be provided in association with a dispenser, and then it can incorporate a function of real administration, or as independent accessory, which if required can be connected to the dispenser itself.
  • the device of the invention is specifically effective for administering insulin, in particular in association with an insulin pen even of already known type.
  • the device of the invention integrates “smart’ functions allowing an accurate control of the modes for the subcutaneous administration of a medicinal substance, in particular, as said, insulin.
  • the device is then configured to allow an injection in a suitable body site, even avoiding the onset of lipodystrophies, and in the right dose.
  • the device is structurally in accessory form, in particular of sensorized case, suitable to receive - or be mounted on or connected to - an insulin pen or other subcutaneous dispenser.
  • the device comprises detection means including one or more among:
  • ⁇ means for detecting the injection angle
  • ⁇ means for recognizing the anatomical site in which the patient is going to perform the administration and a specific region thereof;
  • ⁇ means for identifying local lipodystrophy
  • ⁇ means for detecting the quantity of injected substance.
  • the device can further include, or be associated to, means for storing the administration features in terms of date, time, site and dose, arranged locally or in remote communication therewith.
  • the device can include local and/or remote processing and control means.
  • the device can further include means for communicating with a storage and/or control remote unit, for example a server, a smartphone and/or other.
  • a storage and/or control remote unit for example a server, a smartphone and/or other.
  • the device can be completed with a front-end and back-end application to offer the patient or the clinician, who is in charge of her/him, to consult the acquired data, preferably through graphic interfaces and/or synthesis and/or detailed representations of the information on display.
  • the above-mentioned means for recognizing the anatomical site comprises sensors of IMU (Inertial Measurement Unit) type associated to an algorithm of Artificial Intelligence, identifying the motions performed by the patient to bring the dispenser towards one of the injection sites.
  • IMU Inertial Measurement Unit
  • Such means is configured to go back in real time to the region selected to perform the puncture and to activate possible signalling elements in case the site is not considered suitable or optimum, even depending upon stored information about the previous administrations and/or simultaneous detections of other sensors.
  • FIG. 1 shows a side view of a device for subcutaneous administration according to a preferred embodiment of the present invention, represented with an insulin pen received inside thereof;
  • Figure 1 A shows an anterior, or front, view of the device of Figure 1 , in particular at a proximal portion with respect to the anatomical administration site;
  • Figures 2A and 2B relate respectively to means for detecting the quantity of injected substance and a relative housing of the device of Figure 1 , by showing schematic side views thereof;
  • Figures 3A and 3B show, each one, a side view of the device of Figure 1 associated to an insulin pen received inside thereof, in a respective position of a piston of the insulin pen itself;
  • Figures 4A and 4B relate to means for detecting an injection angle of the device of Figure 1 , by showing respectively a schematic side view of a portion of the device itself and a schematic front view analogous to that of Figure 1 A;
  • Figures 5A and 5B show a housing for means for detecting the injection anatomical site of the device of Figure 1 , by showing, each one, a respectively front and side schematic view thereof;
  • Figure 6 shows a block diagram exemplifying actions which the patient can perform with the device of Figure 1 ;
  • FIG. 7 shows a flow chart exemplifying functions of the device of Figure 1 ;
  • FIG. 8 shows a flow chart exemplifying operating modes of means for detecting the injection angle of the device of Figure 1 ;
  • FIG. 9 shows a flow chart exemplifying operating modes of means for recognizing the injection site of the device of Figure 1 ;
  • FIG. 10 shows a flow chart exemplifying operating modes of means for identifying a local lipodystrophy of the device of Figure 1 ;
  • FIG. 11 shows a flow chart exemplifying operating modes of means for detecting the quantity of injected insulin of the device of Figure 1 .
  • a device for intracutaneous administration is designated as a whole with 1 .
  • the device 1 comprises a main body 10 in form of casing, implemented in one or more portions, suitable to house, or however to be mounted on or connected to, a dispenser of substance.
  • the casing 10 is configured to be arranged circumscribed to an insulin pen 100 and however removably connected thereto for the administration of a dose of said hormone. Therefore, the device 1 is an accessory component for the insulin pen and reusable on several pens in subsequent dispensing procedures.
  • the insulin pen 100 is of type known on itself and equipped with a needle 101 in communication with a reservoir 102 in which a piston 103 moves.
  • Variants can provide that the device of the invention is integral with, or however connected in a fixed way to, the dispenser of substance at least at portions or components thereof.
  • the main body 10, in the present example, has an implementation in two portions with elongated, in particular substantially cylindrical, geometry and a substantially tubular structure, in order to be arranged circumscribed to the insulin pen 100 and to receive it inside thereof at its own longitudinal lumen.
  • a longitudinal axis of the system is designated with L in Figure 1.
  • the main body 10 comprises a plurality of housings, advantageously in form of slots, which receive means for detecting parameters related to an incipient, or just performed, administration.
  • such detection means can be associated to the main body 10 by means of a shape and/or interlocking mechanical coupling.
  • the device 1 comprises in particular:
  • ⁇ means 2 for detecting the quantity of injected substance
  • ⁇ means 3 for detecting and injection angle
  • ⁇ means 4 for recognizing the anatomical site in which the patient is going to perform the administration
  • ⁇ means 5 for identifying local lipodystrophy.
  • the means 2 for detecting the quantity of injected substance comprises one or more optical sensors mounted by an interlocking 21 on the main body 10.
  • the latter provides a housing 22 equipped with a transparent window 23 allowing to the sensor(s) to detect the motion of the piston 103.
  • the sensor is positioned so as to cover longitudinally the whole insulin cartridge, that is the reservoir 102, and to generate a different output based upon the position of the piston 103 during the injection.
  • the change in position of the piston 103 is exemplified in Figures 3A and 3B, which show respectively a more or less advanced arrangement of the needle 101 thereof, in particular the position before and after injection.
  • Figures 3A and 3B show respectively a more or less advanced arrangement of the needle 101 thereof, in particular the position before and after injection.
  • the device 1 can then include, or be associated to, a local or remote processing or calculation unit, to determine the quantity of substance dispensed based upon the detection of the above-mentioned sensors and in case to actuate a signaller or interface communicating with the patient.
  • a local or remote processing or calculation unit to determine the quantity of substance dispensed based upon the detection of the above-mentioned sensors and in case to actuate a signaller or interface communicating with the patient.
  • the above-mentioned processing or calculation unit can be incorporated in the same means 2.
  • the described functionality allows to obviate the problem of a failed or partial taking of the insulin dose.
  • the selected sensors are of optical type even because the drug liquid is transparent and then allows the passage of light.
  • the light radiation is detected by sensor(s) which return a signal proportional to the shifting of the piston 103.
  • the means 3 for detecting an injection angle comprises three, in particular optical, proximity sensors respectively designated with 31 , 32 and 33 and equipped with IR (infrared) ray emitter.
  • Such sensors are arranged peripherally equidistant at a front region of the main body 10 configured to be positioned, in use, proximally to the anatomical injection site.
  • the sensors are arranged at the vertices of an equilateral triangle (designated as A, B and C).
  • the sensors 31-33 use the LIDAR (Laser Imaging Detection and Ranging) technology, which allows to measure the absolute distance of the sensor from the object (in the specific case from the skin surface) independently from the reflectance of the latter. In fact, in order to obtain the angle, one does not observe the quantity of light reflected by the skin, but one measures the time which has elapsed between the emission of the laser beam and the reception of the reflected light, invisible to the naked eye, that is the flight time. Once known the position of the sensors and their distance from the skin, it is possible to know the tilting angle of the main body 10 and then the incidence angle of the needle 101 coaxial thereto.
  • LIDAR Laser Imaging Detection and Ranging
  • the means 4 for recognizing the anatomical administration site is received, preferably by interlocking, in a housing 41 of the main body 10.
  • the lumen, or seat, 40 of the main body 10 receiving the insulin pen 100 is visible.
  • the portion of main body 10 receiving the means 4, designated with 11 which can even be a sub-component not united with the remaining portion of the main body 10 itself and coupled on the dispenser 100, for example distally with respect to the injection site.
  • the means 4 comprises detection means of inertial type (IMU - Inertial Measurement Unit) detecting the motion performed by the patient to approach to the selected injection site and processing means, preferably based upon an Artificial Intelligence algorithm, to associate the detected motion to the target anatomical site.
  • IMU - Inertial Measurement Unit IMU - Inertial Measurement Unit
  • the means 5 for identifying local lipodystrophy allows to recognize automatically if the tissue is healthy or if it has lipodystrophy due to an excessive number of injections.
  • the means 5 includes an optical sensor. When the patient approaches the pen 100 to the skin, through the sensor it is determined if the area is lipodystrophic through the emission of infrareds and the detection of a difference in absorbing light by the skin, with respect to a healthy area, caused by an alteration in the cutaneous tissue due to the local lipodystrophy.
  • the device 1 can include elements to return to the user a, for example acoustic or visual, feedback for correction while performing the injection.
  • Such elements can be directly actuated by one or more of the above-mentioned detection means and/or by processing means associated thereto or incorporated in one or more local or remote control units.
  • the device can advantageously include a wireless communication module, for example of BLE (Bluetooth Low Energy) and/or wifi type guaranteeing even the communication of the detected data to other compatible devices, such as smart phone, cloud infrastructures or voice assistants.
  • a wireless communication module for example of BLE (Bluetooth Low Energy) and/or wifi type guaranteeing even the communication of the detected data to other compatible devices, such as smart phone, cloud infrastructures or voice assistants.
  • All pieces of detected information can be accessed through a web interface or through smart phone.
  • Figure 7 exemplifies the different functionalities of the device 1 and of the possible local or remote interfaces associated thereto.
  • a unique control unit CPU
  • the described device is compatible for a use on diabetic pens on the market, even of disposable type.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un dispositif (1) pour aider les patients diabétiques lors de la prise d'insuline par l'intermédiaire d'un stylo d'insuline classique (100), le dispositif comprenant une enveloppe munie de capteurs (10), avec lequel il est possible de mesurer l'angle d'injection, de reconnaître le site anatomique (et le point à l'intérieur de celui-ci) sur lequel le patient choisit d'effectuer l'injection, d'identifier la présence d'une lipodystrophie et de détecter la dose d'insuline injectée.
PCT/IB2022/059865 2021-10-14 2022-10-14 Dispositif d'administration sous-cutanée WO2023062596A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT102021000026348A IT202100026348A1 (it) 2021-10-14 2021-10-14 Dispositivo per somministrazione sottocutanea
IT102021000026348 2021-10-14

Publications (1)

Publication Number Publication Date
WO2023062596A1 true WO2023062596A1 (fr) 2023-04-20

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IT (1) IT202100026348A1 (fr)
WO (1) WO2023062596A1 (fr)

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999007425A1 (fr) * 1997-08-06 1999-02-18 Pharmacia & Upjohn Ab Dispositif d'apport automatique et procede de fonctionnement associe
US20150085286A1 (en) * 2012-05-21 2015-03-26 Common Sensing Inc. Dose measurement system and method
US20150206456A1 (en) * 2014-01-17 2015-07-23 Truinject Medical Corp. Injection site training system
US20170232204A1 (en) * 2014-10-20 2017-08-17 Becton, Dickinson And Company Improved systems and methods for medicine delivery
US20180211562A1 (en) * 2017-01-23 2018-07-26 Truinject Corp. Syringe dose and position measuring apparatus
US20200023139A1 (en) * 2017-03-30 2020-01-23 Tecpharma Licensing Ag Monitoring an injection process
WO2020072299A1 (fr) * 2018-10-03 2020-04-09 Eli Lilly And Company Systèmes de détection d'états dans un ensemble de dispositif d'injection
WO2021059211A1 (fr) * 2019-09-25 2021-04-01 Janssen Pharmaceuticals, Inc. Réglage d'administration de médicament
US20210177306A1 (en) * 2019-12-13 2021-06-17 Medtronic Minimed, Inc. Multi-sensor gesture-based operation of a medication delivery system

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999007425A1 (fr) * 1997-08-06 1999-02-18 Pharmacia & Upjohn Ab Dispositif d'apport automatique et procede de fonctionnement associe
US20150085286A1 (en) * 2012-05-21 2015-03-26 Common Sensing Inc. Dose measurement system and method
US20150206456A1 (en) * 2014-01-17 2015-07-23 Truinject Medical Corp. Injection site training system
US20170232204A1 (en) * 2014-10-20 2017-08-17 Becton, Dickinson And Company Improved systems and methods for medicine delivery
US20180211562A1 (en) * 2017-01-23 2018-07-26 Truinject Corp. Syringe dose and position measuring apparatus
US20200023139A1 (en) * 2017-03-30 2020-01-23 Tecpharma Licensing Ag Monitoring an injection process
WO2020072299A1 (fr) * 2018-10-03 2020-04-09 Eli Lilly And Company Systèmes de détection d'états dans un ensemble de dispositif d'injection
WO2021059211A1 (fr) * 2019-09-25 2021-04-01 Janssen Pharmaceuticals, Inc. Réglage d'administration de médicament
US20210177306A1 (en) * 2019-12-13 2021-06-17 Medtronic Minimed, Inc. Multi-sensor gesture-based operation of a medication delivery system

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