WO2011007316A1 - Dispositif d'administration de fluide à microjet monté sur le poignet - Google Patents

Dispositif d'administration de fluide à microjet monté sur le poignet Download PDF

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Publication number
WO2011007316A1
WO2011007316A1 PCT/IB2010/053191 IB2010053191W WO2011007316A1 WO 2011007316 A1 WO2011007316 A1 WO 2011007316A1 IB 2010053191 W IB2010053191 W IB 2010053191W WO 2011007316 A1 WO2011007316 A1 WO 2011007316A1
Authority
WO
WIPO (PCT)
Prior art keywords
housing part
threaded
bayonet connector
delivery device
jet
Prior art date
Application number
PCT/IB2010/053191
Other languages
English (en)
Inventor
Markus Hijlkema
Original Assignee
Koninklijke Philips Electronics N.V.
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 Koninklijke Philips Electronics N.V. filed Critical Koninklijke Philips Electronics N.V.
Publication of WO2011007316A1 publication Critical patent/WO2011007316A1/fr

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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
    • A61M5/142—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
    • 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
    • A61M5/30—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
    • A61M2005/3022—Worn on the body, e.g. as patches
    • 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

Definitions

  • the present invention generally relates to the field of needle-less fluid delivery and an improved device for submitting fluids without a needle and methods of delivery.
  • the invention relates to a wearable drug-delivery device, e.g. a wrist-mounted transdermal drug delivery device and method of assembling the same.
  • Document WO 2008/142636 A2 discloses a wearable drug delivery device.
  • the device employs a high speed jet pump for transdermal, needle-less drug delivery. It is worn by a patient for long-term treatment.
  • a reservoir for storing the drug is comprised in the form of a cartridge.
  • the cartridge is replaceable while the pump remains fixed to a patient.
  • the pump and the cartridge are mounted together by a bayonet.
  • An advantage of the present invention is that it allows facilitated handling and provides improved characteristics with respect to hygienic and sterility issues at the device-skin interface.
  • micro-jet fluid delivery device comprising a first housing part and a second housing part, wherein the first housing part comprises:
  • driver electronics to control the jet pump
  • the second housing part (320) comprises:
  • first and the second threaded or bayonet connector are arranged to cooperate in a manner that the first and the second housing part are formed into a fixed assembly.
  • the pump may be a jet pump or any other pump able to delivery fluid at a pressure so that it may be micro-jetted transdermally.
  • the first and/or second fixing means may be threaded fixing means although other fixing methods are included within the scope of the invention such as a bayonet coupling. Both a threaded and a bayonet connection require rotational movement to make the connection.
  • the device of the present invention may be formed as a device that can be attached to the wrist of a person, like a watch.
  • the device preferably includes a housing and a strap for attachment around the wrist.
  • the device of the present invention may be formed as a wrist-mounted needless delivery device for transdermal delivery of a fluid such as a drug.
  • the device of the present invention may be used for the delivery of medicinal drugs or recreational drugs.
  • transdermal implies all layers comprised in a mammal's skin underneath the stratum corneum which performs as the interface with the outside world. In order of increasing depth with regard to the stratum corneum, these layers are the epidermis, the dermis and the hypodermis, wherein the latter layer is also referred to as the subcutis or subcutaneous fat.
  • the device of the present invention presents the significant additional advantage that it separates the reusable parts and the disposable parts of the device while at the same time providing a fixing structure to assemble the two parts, that is rigid enough to support the interaction of the actuator of the pump, e.g. jet pump and the micro-jet nozzle to allow for a controlled supply of the fluid.
  • a fixing structure to assemble the two parts, that is rigid enough to support the interaction of the actuator of the pump, e.g. jet pump and the micro-jet nozzle to allow for a controlled supply of the fluid.
  • the second housing part is arranged in such a manner that it is the only part of the assembly that contacts the skin of the user. This allows that only the disposable part needs to be sterilized; and at the same time the material of the first housing does not need to be selected to withstand aggressive sterilizing agents.
  • the first housing part comprises a static part and a movable part, whereas the movable part is coupled to the first fixing means, e.g. first threaded fixing means.
  • the first fixing means e.g. the first threaded fixing means
  • the operating means and the first fixing means e.g. the first threaded fixing means can be manufactured in one part and be kept by first guiding means that allow a rotating movement of the operating means and the first fixing means, e.g. the first threaded fixing means with respect to the first housing part. In this manner, if the device is
  • the tolerances of the first housing part and the integral operating and fixing means can be arranged and provided in such a manner, that the parts can be assembled by a snap-in connection.
  • a display is provided in the first housing part, which allows control of parameters of the micro-jet fluid delivery device; for instance if an injection is at present performed and the frequency of the injections can be displayed.
  • the display may be any suitable display, e.g. a digital display known from wristwatches such as an LCD display, an OLED display, etc.
  • an indication or an alarm can be given, e.g. once the container for the fluid for instance containing a dissolved drug is empty or has a low volume. This alarm can be an audio, an optical or a tactile alarm, for example.
  • a power source is provided inside the device, which is coupled to the driver electronics.
  • a controlled actuation of the pump, e.g. jet pump by the driver electronics is ensured and the fluid can be submitted in any amount and any frequency under the control of the driver electronics supplying power according to preset parameters to the electromechanical actuator.
  • the power source may be assisted by solar cells or power generation devices known from watches which make use of the mechanical movement of the wrist to generate electrical power.
  • the power source is coupled by contacts whereby the contacts are distributed over the first and second housing parts. This allows making the pump only operable once the device is assembled.
  • the power source is arranged in the second housing part.
  • the device is integrated in the first housing part and can be enclosed completely by plastic material, as no replaceable parts are in there and thus can be made water-resistant.
  • providing the battery in the disposal part allows it to always have defined operating conditions for the pump, e.g. jet pump and to secure that always enough power is left to submit the total amount of fluid included in the fluid container.
  • This embodiment is specifically beneficial in case non-rechargeable batteries are being employed. If a
  • rechargeable battery is installed, preferably it is mounted in the durable part of the device, i.e. the first housing.
  • cooperating second and third guiding means arranged in the first and second housing part are provided, which allows to keep the second housing part in a fixed position.
  • a rotational operation of the operating means is provided while assembling the first and the second housing part to build the micro-jet fluid delivery device (e.g. to form a threaded or bayonet connection).
  • a disposable cartridge may be used on the forearm of a user, the first housing part can be placed on top of it, the strap can be loosely fixed around the arm and while turning the operating part, the first and the second housing part can be screwed together, while the second and third guiding means engage each other in order to avoid a rotational movement of the cartridge.
  • This allows a facilitated handling of the fluid delivery device.
  • an embodiment of the device according to the present invention comprises a membrane in the second housing part. This allows it to always have defined pumping conditions for the electromechanical actuator and thus predefined and e.g. stored pumping parameters such as pumping frequency and an actuation voltage of the electromechanical actuator will lead to the same amount of fluid to be delivered subcutaneously.
  • the second housing part is arranged as a disposable cartridge.
  • a disposable cartridge This allows it to be a pre-fabricate cartridge containing a variety of drugs to be administered by the fluid delivery device and to maintain high hygienic sterility standards, while at the same time allowing a facilitated handling for the user.
  • a disposable cartridge may be manufactured by the manufacturer of the fluid delivery device and provided to a drug provider for filling and distribution.
  • the first housing part and the second housing part may be manufactured from different materials, wherein only the second housing part advantageously needs to be able to withstand sterilizing agents and/or temperatures. This allows for a cost-effective manufacturing and at the same time to protect the electronic components in the first housing part.
  • the operating means is arranged as a ring with indentations for easy gripping with the fingers of a hand, and knows that the ring may be turned to operate the device and at the same time it allows to securely exert force on the ring, e.g. when bringing the first housing part and the second housing part together, e.g. by screwing the first housing part and the second housing part together.
  • the device comprises coding means, in order to encode the drug contained in the fluid container and/or parameters to submit the drug via the jet pump.
  • coding means in order to encode the drug contained in the fluid container and/or parameters to submit the drug via the jet pump.
  • the coding means is associated to the contacts and/or the position of the contacts or another electrical parameter that is detectable by using the contacts and can be processed by the driver electronics in order to properly submit the drug contained in the fluid container.
  • the present invention also provides a method of attaching a disposable cartridge on the forearm of a user, the method comprising: placing a first housing part on top of the cartridge, loosely fixing the strap around the wrist of the user, turning the operating part, so that the first and the second housing part are joined together, while second and third guiding means engage each other in order to prevent a rotational movement of the cartridge.
  • Fig. 1 shows a micro-jet fluid delivery device according to an embodiment of the present invention
  • Fig. 2 shows a schematic cross-section of the embodiment shown in Fig. 1
  • Fig. 3 shows a more detailed cross-section of an interior part of an embodiment of the device according to the present invention
  • Fig. 4 shows two views from below and above respectively on the first housing part and the second housing part.
  • an element described herein of an apparatus embodiment is an example of a means for carrying out the function performed by the element for the purpose of carrying out the invention.
  • transdermal fluid delivery can be used, as the morphological and mechanical properties, such as thickness and tension of the tissue vary from subject to subject; and further also depend on the anatomical location as to where the fluid jet is applied.
  • a fluid delivery device for instance may be used to apply the drug insulin or to provide a vaccination.
  • the penetration depth of the fluid jet can be adjusted and a corresponding pain sensation of the user can be reduced, while a corresponding drug uptake can be optimized.
  • a second housing part may be sterilized underneath, as well as the stratum corneum may be sterilized and then the lower side of the second housing part and the stratum corneum, which both have been prepared and sterilized can be brought into contact, while the first housing part is then placed on top of the second housing part and screwed together, by using the operating means, e.g. a ring resembling the one of a diving watch, the two parts are rotated, e.g. screwed together to complete the fluid delivery device.
  • the operating means e.g. a ring resembling the one of a diving watch
  • Fig. 1 gives an example of an embodiment of a fluid delivery device of the present invention. It may for instance be used to administer drugs in liquid form to a wearer respectively user of the device.
  • the fluid delivery device 200 comprises a fixing means 220 or a strap, to fix the device on the wrist of a user like usually well-known from wearable wrist watches, as well as a first housing part 230, operating means 210 in form of a ring being rotatable and a display of the fluid delivery device, in this case the fluid delivery device shows the current time which is 12 hours and 36 minutes, and indicates that injections are currently administered at a frequency of 1 Hz.
  • the device may display an alarm, once the fluid container for instance containing a liquid drug is empty, and
  • the display may give an indication of a drug that is currently administered, in case a plurality of drugs needs to be administered by the same device.
  • the device of the present invention may be formed as a device that can be attached to the wrist of a person, like a watch.
  • the device includes a housing and a strap for attachment around the wrist.
  • the device of the present invention may be provided as a wrist -mounted needless delivery device for transdermal delivery of a fluid such as a drug.
  • the device of the present invention may be used for the delivery of medicinal drugs or recreational drugs. It has the specific advantage that infection by sharing hypodermic needles is reduced.
  • An arrow 223 indicates a direction of a turning the operating means or the operating ring, in order to join e.g. by screwing or bayoneting the first housing part and the second housing part together by means of turning the ring in the right direction.
  • the device will then disassemble itself, by pushing out the second housing part and allowing it to withdraw for instance a fluid container and dispose of it.
  • Fig. 2 shows a cross-section of the embodiment of Fig. 2.
  • the same parts of the fluid delivery device in this case are marked by the same reference signs and are not described again, for the sake of efficiency.
  • a second housing part 320 can be seen, which comprises a lower surface 365, which is in direct contact with the stratum corneum of a user, once the fluid delivery device will be worn.
  • an actuator 345 is indicated as well as first threaded fixing means 350 and second threaded fixing means 310.
  • a bayonet fixing means could be used.
  • Arrows 340 indicate a direction of assembly of the first housing part 320 and the second housing part 230.
  • the operating means 210 are coupled to the first threaded or bayonet fixing means 350.
  • the first threaded or bayonet fixing means 350 will start rotating, and in case of engaging the second threaded or bayonet fixing means 310 the first housing part 320 and the second housing part 230 will be joined, e.g. screwed together.
  • the operating means 210 is movable relative to the first housing part 230 and is guided by first guiding means 308.
  • the dimensions used in this drawing are not representative of the actual dimensions to be used in a manufactured product and serve only the purpose to demonstrate the configuration.
  • the first guiding means 308 may be attached to the operating means 210 and may be manufactured in one piece and in case of an assembly may be snapped into the first housing part 230 by a pushing operation, if proper tolerances are selected during manufacturing.
  • the first housing part may comprise a groove that engages a notch 360 which is provided on the second housing part 320. In this manner while rotating, e.g.
  • the fluid delivery device according to this embodiment may even be assembled, once the second housing part 320 is already placed on the wrist area of a user and the second housing part 230 is placed on top of it in order to assemble the fluid delivery device.
  • Fig. 3 shows a cross-section of another embodiment of a fluid delivery device of the present invention 400.
  • a first housing part 230 shown; and a second housing part 320 are assembled together by means of first threaded or bayonet fixing means 350 and second threaded or bayonet fixing means 310 each respectively attached to the first housing part 230 and the second housing part 320.
  • the first housing part is shown to have outer threads
  • the second housing part is shown to have complementary inner threads, it may however well be the other way round, because there is no constructive reason to have particular threaded fixing means at a respective housing part.
  • With 365 a surface of the second housing part is shown, that comes into contact with the epidermis stratum corneum.
  • fluid containers 455 and 460 are shown, which may be connected to each other or form a single unit.
  • a nozzle 435 for forming a micro -jet is shown as well as a membrane 430 of the micro-jet pump.
  • a fluid supply channel 437 supplying the drug fluid to an area below the membrane 430 is shown.
  • Fig. 3 depicts an electromechanical actuator 420, as well as driver electronics 415 and a power supply 410.
  • the power supply is connected by a first supply line 476 to a first contact 472 in the bottom surface 485 of the first housing part and driving electronics 415 is connected via a second supply line 474 to another second contact 470 on the bottom surface 485 of the first housing part.
  • the first housing part in its upper area may be similar to a wrist mounted device like a watch, e.g. including a watch display in order to indicate a present time and to display parameters of the fluid- respectively drug administration such as a frequency of the micro -jet pulses as well as if an injection is taking place at present or not. Furthermore a battery indicator and a fill indicator of the fluid container may be provided there.
  • first 472 and second 470 contacts may be different, and that they may cooperate with a different third contact 477 at a different location at the second housing part 320. It is also conceivable, that a plurality of contacts may cooperate in a different manner in order to provide a coding which is detectable by the driver electronics 415, in order to derive the type of a drug that is in the fluid container
  • Fig. 4 on the left-hand side shows a view from above 450 on the second housing part 230.
  • a membrane 430 is shown as well as a third contact 477.
  • second threaded fixing means 310 are depicted as well as the support structure of the second housing part 480.
  • the support structure 480 may also comprise a rectangular or a quadratic shape of any configuration. In this case, in order to avoid a rotating movement of the second housing part 230 a notch 360 may be provided on it to provide guidance during a fixing operation.
  • first housing part 230 On the right-hand side a view from below on the first housing part 230 is shown depicted by 440.
  • a plunger attached to the electromechanical actuator 420 is shown, as well as a Bottom surface 485 of the first housing part 230.
  • the first and second contacts that cooperate with the third contact 477 on the second housing part 320, are indicated by 470 and 472, respectively.
  • First threaded fixing means are shown and indicated by reference sign 320.
  • a groove 362 is incorporated in the first housing part 230.
  • the configuration shown in Fig. 4 allows provision of the first housing part and the second housing part in a sealed configuration.
  • the second housing part 320 is a disposable cartridge
  • the first housing part and the second housing part may be
  • the second housing part 320 has a larger diameter than the first housing part 230 and thus this part is the only part which contacts the epidermis of a user.

Landscapes

  • Health & Medical Sciences (AREA)
  • Dermatology (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)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L’invention concerne un dispositif d'administration de fluide (200) comprenant une partie jetable (320) et une partie durable ou pouvant être retenue (230) qui contient la source d’alimentation, l’électronique d’entraînement et l’actionneur pour une pompe à microjet. La partie jetable comprend un récipient contenant le fluide à administrer et la buse à microjet (460) éventuellement associée à la membrane de la pompe à microjet. Les deux parties de boîtier du dispositif peuvent être assemblées par une opération de torsion depuis l’extérieur de manière à fonctionner comme une montre de plongée par vissage des deux parties de boîtier équipées de moyens de fixation filetés (310) associés.
PCT/IB2010/053191 2009-07-17 2010-07-13 Dispositif d'administration de fluide à microjet monté sur le poignet WO2011007316A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP09165738 2009-07-17
EP09165738.7 2009-07-17

Publications (1)

Publication Number Publication Date
WO2011007316A1 true WO2011007316A1 (fr) 2011-01-20

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ID=42829308

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2010/053191 WO2011007316A1 (fr) 2009-07-17 2010-07-13 Dispositif d'administration de fluide à microjet monté sur le poignet

Country Status (1)

Country Link
WO (1) WO2011007316A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5860957A (en) * 1997-02-07 1999-01-19 Sarcos, Inc. Multipathway electronically-controlled drug delivery system
WO2004093818A2 (fr) * 2003-04-21 2004-11-04 Stratagent Life Sciences Appareil et methodes pour une distribution repetitive de medicaments par microjet
WO2008142636A2 (fr) * 2007-05-22 2008-11-27 Koninklijke Philips Electronics N.V. Dispositif portable d'administration de médicaments
WO2009027540A1 (fr) * 2007-08-30 2009-03-05 Novo Nordisk A/S Raccord à baïonnette pour dispositif d'injection médical et cartouche
WO2009136304A2 (fr) * 2008-05-05 2009-11-12 Koninklijke Philips Electronics N.V. Cartouche de médicament jetable

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5860957A (en) * 1997-02-07 1999-01-19 Sarcos, Inc. Multipathway electronically-controlled drug delivery system
WO2004093818A2 (fr) * 2003-04-21 2004-11-04 Stratagent Life Sciences Appareil et methodes pour une distribution repetitive de medicaments par microjet
US20040260234A1 (en) * 2003-04-21 2004-12-23 Ravi Srinivasan Apparatus and methods for repetitive microjet durg delivery priority statement
WO2008142636A2 (fr) * 2007-05-22 2008-11-27 Koninklijke Philips Electronics N.V. Dispositif portable d'administration de médicaments
WO2009027540A1 (fr) * 2007-08-30 2009-03-05 Novo Nordisk A/S Raccord à baïonnette pour dispositif d'injection médical et cartouche
WO2009136304A2 (fr) * 2008-05-05 2009-11-12 Koninklijke Philips Electronics N.V. Cartouche de médicament jetable

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