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WO2025202047A1 - Injecteur pouvant être porté et dispositif d'injection le mettant en œuvre - Google Patents

Injecteur pouvant être porté et dispositif d'injection le mettant en œuvre

Info

Publication number
WO2025202047A1
WO2025202047A1 PCT/EP2025/057759 EP2025057759W WO2025202047A1 WO 2025202047 A1 WO2025202047 A1 WO 2025202047A1 EP 2025057759 W EP2025057759 W EP 2025057759W WO 2025202047 A1 WO2025202047 A1 WO 2025202047A1
Authority
WO
WIPO (PCT)
Prior art keywords
housing
reservoir
connector
injector
injection
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/EP2025/057759
Other languages
English (en)
Inventor
Vincent DELOBELLE
Nicolas BESSON
Gilles BERNÈDE
Salim Bouyahiaoui
Aurélien GAUTIER
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.)
Becton Dickinson France SA
Original Assignee
Becton Dickinson France SA
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 Becton Dickinson France SA filed Critical Becton Dickinson France SA
Publication of WO2025202047A1 publication Critical patent/WO2025202047A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/1413—Modular systems comprising interconnecting elements
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14212—Pumping with an aspiration and an expulsion action
    • 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
    • A61M5/36—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 with means for eliminating or preventing injection or infusion of air into body
    • A61M5/365—Air detectors
    • 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
    • A61M5/36—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 with means for eliminating or preventing injection or infusion of air into body
    • A61M5/38—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 with means for eliminating or preventing injection or infusion of air into body using hydrophilic or hydrophobic filters
    • A61M5/385—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 with means for eliminating or preventing injection or infusion of air into body using hydrophilic or hydrophobic filters using hydrophobic filters
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M2005/1401—Functional features
    • A61M2005/1402—Priming
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A61M2005/14252—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion means
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M2005/14268—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body with a reusable and a disposable component
    • 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
    • A61M2205/10—General characteristics of the apparatus with powered movement mechanisms
    • 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
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6063—Optical identification systems
    • 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
    • A61M2209/00—Ancillary equipment
    • A61M2209/08—Supports for equipment
    • A61M2209/088—Supports for equipment on the body

Definitions

  • Wearable injector and injection device including this wearable injector
  • the present invention relates to a wearable injector and to an injection device including this wearable injector.
  • Wearable injectors are injectors configured to be worn by a patient, and more specifically attached to the patient’s skin, during a predetermined time period, usually ranging from several minutes or hours to several days.
  • the wearable injectors are configured to deliver a predetermined volume of medical product at a predetermined flow rate and at a predetermined time after activation.
  • Wearable injectors typically include a reservoir, such as a cartridge, a syringe or a bag, for containing the medical product and an injection mechanism for expelling the medical product contained within the reservoir into an injection site at the predetermined time, volume and flow rate.
  • a reservoir such as a cartridge, a syringe or a bag
  • the reservoir rarely is a vial requiring a control of its orientation to avoid air injection.
  • the catheter insertion mechanism is configured for inserting a catheter into the patient’s skin at an injection site.
  • the connector is arranged outside the housing.
  • the connector includes a flexible tube defining a fluidic channel for guiding the medical product from the external reservoir to the housing.
  • the connector includes an adapter comprising any of: a luer, a septum, a spike interface or a vial adapter.
  • the adapter may be configured to connect the inlet port to the external reservoir.
  • the adapter may be directly arranged at the inlet port, or may be indirectly connected to the inlet port via the flexible tube when the adapter is arranged at proximal end of the flexible tube.
  • the inlet port is arranged through a lateral face of the housing.
  • the connector includes a valve configured to allow priming of the injector before injection.
  • the valve is a one-way valve.
  • the valve includes a liquid barrier preventing the medical product to get out the connector.
  • the connector includes an air detection unit arranged at or downstream the valve in order to detect passage of air in the connector.
  • the connector includes an inlet opening configured to allow air to get in the connector to push the medical product towards the inlet port.
  • the connector includes one or more detection units configured to detect one or more of: a connection between the connector and the reservoir, temperature of the medical product, presence of air within the connector, a flow parameter of the medical product circulating inside the connector.
  • the detection units may include any one of: a switch, an air detector, a temperature probe, a doppler probe, or any tubular thin probe.
  • a wearable injection device including a wearable injector as above-described, and an external reservoir located outside the housing of the wearable injector, the external reservoir being configured to be fluidly connected to the inlet port of the wearable injector via the connector.
  • the external reservoir is independent from the housing of the wearable injector, i.e. is not fixed to the housing.
  • the only connection between the reservoir and the housing is the connector, and possibly the attachment member when the reservoir and the housing share the same attachment member.
  • the reservoir is located outside the housing. That is, the housing cannot accommodate the reservoir.
  • the reservoir is thus detached, separate from the housing. This offers remote, detached, movable, away from, independent.
  • the housing is thus less cumbersome, and the reservoir can be placed at a location where the reservoir does not annoy the patient.
  • the injection device includes a same attachment member for attaching the housing and the reservoir to the patient.
  • the injection device includes a single attachment member shared by the housing and the external reservoir.
  • the attachment member is flexible.
  • the reservoir and the housing are thus free to move relative to each other while being worn by the patient.
  • the injection device includes an attachment member for attaching the reservoir to the patient, the attachment member of the reservoir being distinct from the attachment member of the housing.
  • the wearable injection device includes a remotely readable data unit, such as a RFID tag or a QR code, arranged on the reservoir, and a reader unit configured to read data contained in the data unit.
  • a remotely readable data unit such as a RFID tag or a QR code
  • the terminal may be a smartphone or may be included in the wearable injector, for instance contained within the housing.
  • the injection device includes a second external reservoir located outside the housing of the wearable injector and configured to be fluidly connected to the inlet port of the wearable injector via the connector.
  • Figure 1A is schematic view of a wearable injector according to an embodiment of the invention
  • Figure 1 B is a perspective view of a wearable injector according to an embodiment of the invention.
  • FIGS 2-11 are perspective views of wearable injectors according to embodiments of the invention.
  • Figure 12C is a schematic view of a tube of a wearable injector according to the embodiment of Figure 12A, during injection,
  • Figures 13A-13C are schematic views of a tube of a wearable injector according to an embodiment of the invention.
  • Figure 14A is a schematic view of a tube of a wearable injector according to an embodiment of the invention.
  • Figure 14B is a cross section view of the tube of Figure 14A
  • Figure 15A is a schematic view of a tube of a wearable injector according to an embodiment of the invention.
  • Figures 15B and 15C are cross section views of the tube of Figure 15A
  • Figure 16 is a schematic view of a wearable injector and system according to an embodiment of the invention
  • Figure 17 is a schematic view of a wearable injector and system according to an embodiment of the invention
  • Figure 18 is a schematic view of a wearable injector according to an embodiment of the invention.
  • connection Unless limited otherwise, the terms “connected,” “coupled,” and “mounted,” and variations thereof herein are used broadly and encompass direct and indirect connections, couplings, and mountings. In addition, the terms “connected” and “coupled” and variations thereof are not limited to physical or mechanical connections or couplings. In contrast, when an element is referred to as being “directly connected” or “directly coupled” to another element, there are no intervening elements present. Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs.
  • the wearable injector 1 is configured to be attached to a patient, for instance to the patient’s skin, in order to inject, at a predetermined time, a predetermined volume at a predetermined flow rate of a medical product contained within a reservoir 2.
  • the wearable injector 1 of the invention includes a housing 10, and an attachment member 30 for attaching the housing 10 to a supporting site, such as the patient’s skin or clothes, and a connector 40 for fluidly connecting the wearable injector 1 to a reservoir 2 containing a medical product.
  • the wearable injector 1 may further include an injection mechanism 20 and a catheter insertion mechanism 214 contained within the housing 10 for inserting a flexible catheter into an injection site in order to deliver the medical product. More details about the injection and the catheter insertion mechanisms may be found for instance in the patent document US10737038B2.
  • the housing 10 may be in the form of a parallelepipedic box configured to contain the injection mechanism and the catheter insertion mechanism 214. Instead being parallelepipedic, the housing 10 may otherwise be cylindrical, hemispherical or of any other suitable shape
  • the housing 10 is fixed with respect to the attachment member.
  • the housing 10 may be made of two parts (not shown): a base secured to the attachment member 30 and a shell attached to the base.
  • the housing 10 may include a proximal face 110, a distal face (not shown) attached to the attachment member 30, and lateral faces 111.
  • the proximal face 110 may include an opening 112 allowing extension of an activation button 213 therethrough.
  • the housing 10 further includes an inlet port 113, which may be arranged through one of the lateral faces 111 , for establishing a fluid connection between the reservoir 2 and the injection mechanism 20, such that the medical product can flow from the reservoir 2, which is outside the housing 10, to the injection mechanism 20, which is inside the housing 10.
  • This inlet port 113 is therefore configured to receive the connector 40 of the wearable injector 1.
  • the inlet port 113 may be arranged through any other lateral face or through the proximal face 110.
  • the connector has two ends 412, 413: one first end 413 configured to be connected to the inlet port 113, and an opposite second end 412 configured to be connected to the reservoir 2.
  • This second end 412 may include an adapter 410 such as a luer.
  • the attachment member 30 may be a patch configured to be attached to the patient’s skin.
  • the patch may include an adhesive layer (not shown) allowing attachment of the injector 1 to the injection site, and a liner (not shown) configured to protect the adhesive layer before use of the injector 1.
  • the adhesive layer may be fixedly attached, for example glued or hot sealed, to the housing 10 of the injector 1 .
  • the liner may be configured to be peeled off before attachment of the injector 1 to the patient’s skin.
  • the patch may be flexible.
  • the connector 40 is configured to fluidly connect the housing 10 to the reservoir 2, whatever the location of the reservoir 2 with respect to the housing 10, and wahtever movements that the patient may accomplish while wearing the wearable injector 1. More specifically, the connector 40 may include an adapter 410 configured for establishing a secure tight connection with the reservoir 2, and may further include a tube 411 for conducting the medical product from the location of the reservoir 2 to the inlet port 113 of the housing 10. The connector 40, or its tube 411 , may be directly connected to an adapter 410 of the reservoir 2.
  • the tube 41 1 extends between the housing 10 and the reservoir 2.
  • the tube 411 is attached to the housing 10, and thus is part of the housing 10.
  • the tube 411 may be attached to the reservoir 2 and thus be part of the reservoir 2.
  • the tube 411 is flexible so that the tube 411 can bend depending on the locations of the housing 10 and of the reservoir 2, and depending on the gestures of the patient when the patient is wearing the injector 1.
  • the tube 411 may be made of a transparent or translucent material.
  • the tube 411 can be placed between the housing 10 and an adapter 410 of the reservoir 2 or between two adapters 410, one fixed to the housing 10 and one fixed to the reservoir 2.
  • the tube 411 includes a proximal end 412 provided with an adapter 410, a distal end 413, and defines at least one fluidic channel 414, Figure 14A, for circulation of the medical product from the proximal end 412 to the distal end 413, and thus from the reservoir 2 to the fluid path of the housing 10.
  • the adapter 410 When the reservoir 2 is a syringe with a needle, the adapter 410 may be a septum. When the reservoir 2 is a cartridge, the adapter 410 may be a spike interface. When the reservoir 2 is a vial, the adapter 410 may be a vial adapter 410.
  • the invention also relates to a system including the above-described wearable injector 1 , a reservoir 2, an attachment member 3 for attaching the reservoir 2 to the supporting site, and a fastener 4 for fastening the reservoir 2 to the attachment member 3.
  • the housing 10 and the reservoir 2 may share the same attachment member 3, Figures 2-3 and 5-6, or may each have their respective attachment member 3, 30, Figures 9-11 .
  • the reservoir 2 is configured for containing a volume of a medical product, and specifically high volumes of the the medical product, such as volumes greater than or equal to 10 mL, preferably between 10 mL and 50 mL, or even volumes greater than or equal to 50 mL.
  • the reservoir 2 is independent from the housing 10. That is, the reservoir 2 is not contained within the housing 10, but is rather located outside the housing 10. This permits some sort of freedom of movement between the reservoir 2 and the housing 10, so that the reservoir 2 and the housing 10 are not so uncomfortable to wear for the patient. This also permits to have a reduced size housing 10 and to limit the cumbersomeness of the system.
  • the reservoir 2 may connected by the connector 40 only. Sometimes, they may also be mechanically connected by a common attachment member 3, 30, as illustrated in Figures 2-6, but the attachment member 3, 30 is made of a flexible material so that the reservoir 2 and the housing 10 can still move with respect to one another.
  • the attachment member 3 may be a patch configured to be attached to the patient’s skin.
  • the patch may include an adhesive layer (not shown) allowing attachment of the reservoir 2 to the patient’s skin.
  • the patch may be flexible.
  • the attachment member 3 may otherwise be configured for attachment to the patient’s clothes, for instance the attachment member 3 may be a clipping member configured to be attached to the patient’s belt as illustrated in Figure 8, or to the patient’s trousers or a pocket.
  • the attachment member 3 may be a necklace configured to maintain the vial in a predetermined vertical position, hung around the patient’s neck.
  • the necklace may include a gyroscope system so that the reservoir 2 (vial) is maintained head down; therefore, the bubble in the vial can always be on the top so that the full dose of the medical product can exit the vial. This may be interesting when the injection is short and is not to be done in a long time so that the patient can mainly stay in a seated position when wearing the injector 1 .
  • the housing 10 and the reservoir 2 share the same attachment member 3, 30.
  • the attachment member 30 of the housing 10 and the attachment member 3 of the reservoir 2 are distinct from each other. That is, the attachment members 3, 30 are separate from each other and do not form a single common attachment member.
  • the Figures 12A to 15C illustrate variants of the connector 40.
  • the connector 40 may include some or all of a valve 415 and a hydrophobic filter 416.
  • the volume of the fluidic channel 414 may form a dead volume at the end of injection. Medical products may be costly and waste of medical products trapped in the so-called dead volume is undesirable.
  • the connector 40 may further include an inlet opening 419 in fluid communication with the fluidic channel 414 of the the tube 411.
  • the inlet opening 419 is configured for limiting the dead volume, that is to say to limit the volume of medical product that stays trapped in the fluidic channel 414 at the end of injection.
  • the inlet opening 419 is configured to let air get in the fluidic channel 414 at the end of injection, i.e. when the remaining volume of medical product passes through the fluidic channel 414.
  • the connector 40 may further include a sensor, or air detection unit 425, configured to detect air/liquid transition in the fluidic channel 414 during injection, so that injection can be stopped once air is detected.
  • the sensor may also be used to confirm priming of the fluidic channel 414 of the tube 411 during filling.
  • the sensor is arranged downstream the inlet opening 419, and may be arranged at the valve 415, or preferably downstream the valve 415, i.e. between valve 415 and pump 413, to limit the dead volume even more.
  • the tube 411 may include one or more inner channels or cavities 422, in addition to the above-described fluidic channels 414. These inner channels are configured to accommodate additional functions, such as detection of connection between the adapter 410 of the injector 1 and the adapter 410 of the reservoir 2, or detection of air within the fluidic channel 414 as above-explained. That is, the connector 40 may be configured to include one or more detection units 421 .
  • the tube 411 includes an inner channel accomodating an electrical wire 423 and a switch 421 for detecting proper connection between the reservoir 2 and the connector 40. The switch is in communication with a controller located in the housing 10 of the injector 1.
  • the injector 1 may be conditioned to a proper connection between the connector 40 and the reservoir 2. It is contemplated that the switch or sensor may equip the connector 40 even if there is no tube 411.
  • the tube 411 may include another inner channel 422 accommodating a temperature probe 424 for measuring the temperature of the medical product. It should be noted that other functions may be added to the injector 1 , such as but not limited to: detection of the presence or not of the reservoir 2, detection of air bubbles in the medical product through detection of air in the fluidic channel 414, flowmeter through an integrated doppler probe.
  • the reservoir 2 (here a vial) may include a RFID tag and the wearable injector 1 may include a RFID reader so that the drug can be directly recognized by the system and its injection parameters set in the system.
  • the reservoir 2 may include a RFID tag 210 or QR code 211 that can be read by a smartphone 5; depending on retrieved information, parameters of the injection may be sent by the smartphone 5 and implemented into the wearable injector 1 via wireless connection, such as Bluetooth® or the like, or via direct wire connection before starting the injection process. This may allow dosage of the medical product to be injected, for regular treatment or for treatment follow-up, the full dose of treatment being contained in the reservoir 2.
  • the reservoir 2 may be registered through an application which controls the dosage, i.e. set the appropriate volume to inject at the predetermined flow rate.
  • the system of the invention may include more than one reservoirs 2, such as for instance two reservoirs 2 that are connected to the connector 40, each reservoir 2 containing a different medical product.
  • the medical products may transit by the same fluidic channel 414 of the connector 40, or by two different fluidic channels 414 of the connector 40.
  • Having more than one reservoir 2 connected to the housing 10 may be useful for multi-drug treatments, or for drug reconstitution when the medical products contained in each of the reservoir 2 mix in the connector 40 before injection. It is readily understandable from the above description that the wearable injector 1 and system of the invention allow for wearing the housing 10 (which includes the electronic circuitry and the injection mechanism 20) separately from the reservoir 2.
  • the housing 10 is devoid of any reservoir for storing the medical product inside the housing 10, i.e. devoid of any internal reservoir, since the medical product is all stored by the external reservoir 2.
  • the external reservoir 2 and the housing 10 are not fixedly connected to each other; they are moveable relative to each other.
  • the external reservoir 2 is configured to be attached to the patient’s skin.
  • the connector 40 extends outside the housing 10.

Landscapes

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

Abstract

L'injecteur pouvant être porté (1) comprend : un logement (10), un mécanisme d'injection (20) disposé à l'intérieur du logement (10) qui commande l'injection et fait circuler un produit médical depuis un réservoir externe (2) à un site d'injection, le mécanisme d'injection (20) comprenant un mécanisme d'insertion de cathéter (214). Un élément de fixation (30) est agencé de façon à relier le logement (10) au site d'injection. Un orifice d'entrée (113) traverse le logement (10) en communication fluidique avec le mécanisme d'insertion de cathéter (214). Un connecteur (40) est conçu pour relier de manière fluidique l'orifice d'entrée (113) du logement (10) au réservoir externe (2).
PCT/EP2025/057759 2024-03-28 2025-03-21 Injecteur pouvant être porté et dispositif d'injection le mettant en œuvre Pending WO2025202047A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP24305479 2024-03-28
EP24305479.8 2024-03-28

Publications (1)

Publication Number Publication Date
WO2025202047A1 true WO2025202047A1 (fr) 2025-10-02

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PCT/EP2025/057759 Pending WO2025202047A1 (fr) 2024-03-28 2025-03-21 Injecteur pouvant être porté et dispositif d'injection le mettant en œuvre

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WO (1) WO2025202047A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012072555A1 (fr) 2010-11-29 2012-06-07 Sanofi-Aventis Deutschland Gmbh Patch de pompe à réservoirs multiples
US20190224407A1 (en) 2016-07-18 2019-07-25 Bayer Healthcare Llc Fluid injector and patient set therefor
US10737038B2 (en) 2014-04-24 2020-08-11 Becton, Dickinson And Company Catheter insertion device and method of inserting a catheter
US20220211935A1 (en) * 2021-01-05 2022-07-07 Becton, Dickinson And Company Needle Hub and Applicator for Drug Delivery Device
WO2022261095A1 (fr) 2021-06-11 2022-12-15 Becton, Dickinson And Company Appareil de remplissage d'un dispositif d'administration de fluide
US20240017001A1 (en) 2022-03-15 2024-01-18 Chaoyoung Lee Systems, devices, and methods for fluid pumping

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012072555A1 (fr) 2010-11-29 2012-06-07 Sanofi-Aventis Deutschland Gmbh Patch de pompe à réservoirs multiples
US10737038B2 (en) 2014-04-24 2020-08-11 Becton, Dickinson And Company Catheter insertion device and method of inserting a catheter
US20190224407A1 (en) 2016-07-18 2019-07-25 Bayer Healthcare Llc Fluid injector and patient set therefor
US20220211935A1 (en) * 2021-01-05 2022-07-07 Becton, Dickinson And Company Needle Hub and Applicator for Drug Delivery Device
WO2022261095A1 (fr) 2021-06-11 2022-12-15 Becton, Dickinson And Company Appareil de remplissage d'un dispositif d'administration de fluide
US20240017001A1 (en) 2022-03-15 2024-01-18 Chaoyoung Lee Systems, devices, and methods for fluid pumping

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