EP4259239A1 - Système d'administration de principe actif - Google Patents

Système d'administration de principe actif

Info

Publication number
EP4259239A1
EP4259239A1 EP21835203.7A EP21835203A EP4259239A1 EP 4259239 A1 EP4259239 A1 EP 4259239A1 EP 21835203 A EP21835203 A EP 21835203A EP 4259239 A1 EP4259239 A1 EP 4259239A1
Authority
EP
European Patent Office
Prior art keywords
active substance
delivery system
reservoir
active
electronic device
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
EP21835203.7A
Other languages
German (de)
English (en)
Inventor
Michael Kulik
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.)
LTS Lohmann Therapie Systeme AG
Original Assignee
LTS Lohmann Therapie Systeme AG
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 LTS Lohmann Therapie Systeme AG filed Critical LTS Lohmann Therapie Systeme AG
Publication of EP4259239A1 publication Critical patent/EP4259239A1/fr
Pending legal-status Critical Current

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
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • 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
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0023—Drug applicators using microneedles
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure

Definitions

  • the invention relates to an active ingredient delivery system for delivering an active ingredient, in particular a pharmaceutical.
  • transdermal therapeutic systems are known for drug delivery. With the help of transdermal patches that are stuck to the patient's skin, it is possible to continuously absorb a stored active ingredient through the skin.
  • TTS transdermal therapeutic systems
  • Such systems have the advantage that, in contrast to injections, the drug delivery is painless for the patient.
  • microneedles drug delivery via microneedles.
  • the active ingredient is delivered to the dermis of the skin via a large number of needles, so that delivery to the outer layer of the skin takes place. Since there are no nerves in the outer layer of the skin, such a release of active substance is also painless for the patient.
  • the microneedles can be designed as hollow needles, in which the active substance is contained and is released through the needle openings via the needle tip.
  • microneedles are known, which consist of a material that dissolves in the skin, so that the active substance stored in the needles is released to the patient when the needles dissolve.
  • EP 0 840 634 An active ingredient delivery system with which an active ingredient delivery is also possible at time intervals is known from EP 0 840 634.
  • This drug delivery system includes a device with microneedles that are fluidically connected to a drug reservoir.
  • a pump that is integrated into the system and is connected to a control device can be used, for example, to deliver active substance at predetermined times or at predetermined intervals.
  • the system described in EP 0 840 634 is a very complex system.
  • the object of the invention is to create an active substance delivery system for the delivery of an active pharmaceutical ingredient in particular, with which an active ingredient delivery is possible in a simple and reliable manner, in particular over a longer period of time or at time intervals.
  • the active substance delivery system according to the invention is used in particular for the delivery of a pharmaceutical active substance.
  • the active ingredient delivery system it is possible in particular to deliver an active ingredient over a longer period of time. Time intervals, points in time, delivery quantities, etc. can be defined here.
  • the drug delivery system has a drug device and an electronic device that interacts with it.
  • the active ingredient device comprises an active ingredient reservoir in which the active pharmaceutical ingredient, in particular, is stored.
  • the drug reservoir is fluidic with a delivery device tied together.
  • the active substance is delivered to the patient with the aid of the delivery device. In particular, the active ingredient is released to the dermis of the patient's skin.
  • the electronic device has at least one control device and a pump device that is electrically connected to it.
  • the pump device can be controlled in such a way that active substance is delivered at predefined times over a predefined period.
  • the pump device is used to transport the active ingredient from the active ingredient reservoir to the dispensing device.
  • the pump device can act directly or indirectly on the active substance reservoir.
  • a pump chamber, on which the pump device acts, can also be arranged between the active substance reservoir and the delivery device.
  • the active substance device and the electronic device are separately designed components.
  • the active ingredient device is manufactured independently of the electronic device.
  • the active substance device can be sterilized in a simple manner without electronic components of the electronic device being able to be damaged by the sterilization. In this respect it is possible in particular to sterilize the active substance device by irradiation.
  • the separation of the two devices has the advantage that the active substance device can be produced as a film consisting in particular of several layers. In particular, production in a continuous process such as a rolling process is possible. This greatly simplifies the manufacture of the active substance device.
  • the separation of the active ingredient device from the electronic device into two separate components represents a significant advantage.
  • one is clear less complexity and thus also a more cost-effective production possible.
  • the separation of the two devices into different components has the advantage that, for example, different electronic devices can be connected to the same active substance device.
  • a modular system with different active substance devices and electronic devices can be provided, so that different active substance delivery systems, for example for different areas of application, can be implemented in a simple manner.
  • the drug device preferably has a skin contact surface for applying the drug delivery system to the skin of a patient.
  • the skin contact surface extends over the entire outside of the active substance device pointing in the direction of the patient and is particularly preferably flat and essentially planar, so that good skin contact is ensured.
  • an adhesive layer can be applied to the skin contact surface, so that the drug delivery system can be applied to the patient's skin in a simple manner.
  • the active substance device has a connecting surface opposite the skin contact surface.
  • the connecting surface is used to connect the active substance device to the electronic device.
  • the connecting surface is preferably also designed to be flat. If necessary, the connection surface does not extend over the entire surface, so that, for example, parts of the electronic device can protrude into recesses in the active substance device.
  • both the active substance device and the electronic device, apart from the electrode components etc., are made of a plastic material, in particular a plastic film is made.
  • the connection between the active ingredient device and the electronic device can thus be made, for example, by lamination.
  • the active substance device has a receiving area for receiving a particularly exchangeable active substance reservoir.
  • the active substance device can be produced independently of a reservoir containing the active substance. Active substance reservoirs, for example with different active substances, can then be inserted into the receiving area at a later point in time. An active substance reservoir can also be easily replaced in this way. This can also take place, for example, while the active substance delivery system is arranged on the patient's skin and an empty active substance reservoir is being replaced by a filled active substance reservoir.
  • the receiving area is preferably designed in such a way that it has an opening which is fluidically connected to the dispensing device.
  • a non-return valve can be arranged in this opening, so that when an active substance reservoir is exchanged, no active substance can get from the fluidic connection, i.e. a connection channel, into the receiving area.
  • a pump chamber is preferably provided between the active substance reservoir--regardless of whether the active substance reservoir is provided directly in the active substance device or a receiving area for an active substance reservoir is provided--and the dispensing device.
  • the pump chamber is thus fluidly connected to the active substance reservoir and the delivery device.
  • the pumping device acts on this pumping chamber in order to convey the active ingredient in the direction of the dispensing device.
  • a check valve can preferably be provided at the inlet and/or at the outlet of the pump chamber. The check valve provided at the inlet of the pumping chamber may be act the same check valve that is arranged in the opening of the receiving area.
  • the dispensing device has hollow needles.
  • the dispensing device preferably has a large number of microneedles which are designed as hollow needles.
  • a microneedle array is formed which has at least 4 needles/cm 2 , preferably at least 50 needles/cm 2 and particularly preferably at least 100 needles/cm 2 .
  • the penetration depth of the needles is preferably dimensioned in such a way that the needles penetrate into the dermis of the skin, but not deeper into the skin, so as not to penetrate layers of the skin in which nerves are present.
  • the pump device is preferably designed and arranged in such a way that it acts directly on the active substance reservoir and/or the pump chamber.
  • the pumping effect can be generated via a stroke-generating element.
  • the pumping device can have a piezo element, an eccentric or the like.
  • the electronic device has a sensor device for recording patient data.
  • the sensor device can include one or more sensors.
  • the patient data recorded by the sensor device can be transmitted directly to the control unit. It is preferable for the measured patient data to be taken into account directly when the pump device is activated.
  • the active substance device has a recess into which the sensor device protrudes. If necessary, several recesses can also be provided, in each of which one or more sensors are arranged.
  • the provision of at least one recess in the active substance device has the advantage that the sensors are close to the skin are arranged. If necessary, the active ingredient device can also have an opening in the recess, so that the sensor can have direct skin contact.
  • the electronic device can have a memory device for storing patient data, for calculating control signals and the like. Furthermore, a transmitting and/or receiving device can be provided for data transmission.
  • the electronic device has an energy store such as a battery or a capacitor. If necessary, it can be a rechargeable battery. A coupling of electrical and mechanical energy stores can also come into play.
  • FIG. 1 shows a schematic plan view of an active substance delivery system according to the invention
  • FIG. 2 shows a schematic sectional side view of the active ingredient delivery system according to the invention along the line II-II,
  • Fig. 3 is a schematic view of a pump chamber in different states
  • the active substance delivery system has an active substance device 10 and an electronic device 12 . This involves separately produced flat, in particular film-like, components.
  • the active ingredient device 10 has a receiving area 14 in which a reservoir 16 can be arranged in an exchangeable manner.
  • the reservoir 16 can be inserted into the receiving area 14 from the right in FIG. 1 .
  • an outlet 18 of the reservoir 16 protrudes into a channel 20.
  • the channel 20 is initially fluidly connected to a pump chamber 22, with a check valve 24, 26 being arranged at the inlet of the pump chamber 22 and at the outlet of the pump chamber 22.
  • the pump chamber 22 is then fluidically connected via channels 28 to a delivery device 30 for delivery of the active substance.
  • the delivery device 30 has a plurality of hollow needles 32 through which the active substance present in the reservoir 16 can be delivered into the patient's skin.
  • a pump device 34 which is arranged in the electronic device 12 , is provided for conveying the active ingredient from the reservoir 16 used in the receiving area 14 into the dispensing device 30 .
  • the pump device 34 is arranged above the pump chamber 22 and acts on the pump chamber 22 in such a way that the active substance is delivered from the reservoir 16 in the direction of the dispensing device 30.
  • the pumping device 34 is electrically connected to a control device 36 .
  • the control device 36 which may also have a storage element, is connected to a battery 38. Furthermore, the control device 36 is connected to a sensor device 40 .
  • These electronic components are arranged in the electronic device 12 (FIG. 2).
  • the sensor device 40 which may have several sensors, protrudes into a recess 42 that is provided in the active substance device 10.
  • An underside 44 of the sensor device 40 can thereby be brought into direct skin contact, wherein the recess 42 can optionally have an opening on its underside 46 for direct skin contact.
  • FIG. 2 shows the active substance device 10 and the electronic device 12 prior to assembly.
  • a cover film such as a blister 48 is also shown.
  • the blister 48 is arranged on an underside 50 of the active substance device 10 and is removed immediately before the active substance delivery system is placed on the patient's skin.
  • the underside 50 then forms a skin contact surface, which is in particular provided with an adhesive.
  • a connecting surface 52 is provided on the active substance device 10 opposite the skin contact surface 50 .
  • the active substance device 10 is connected via the connecting surface 52 to an underside 54 of the electronic device 12, which thus also serves as a connecting surface.
  • the connection can also be made by gluing, laminating or the like.
  • the pump chamber 22 can be designed as shown in FIG. 3 and can have the check valve 24 at the inlet and the check valve 26 at the outlet.
  • the valve 24 at the outlet opens so that active substance flows from the chamber in the direction of arrow 56 towards the dispenser 30.
  • valve 26 When the chamber 22 is being filled, the valve 26 is closed and the valve 24 is opened, so that fluid flows from the reservoir into the pumping chamber 22 in the direction of an arrow 58 .
  • the fluid can be conveyed with a pump device 34 shown schematically in FIG. 4 .
  • This has an electric motor 60 which is connected to an eccentric 64 via an axle 62 .
  • the eccentric 64 acts on the top of the pumping chamber 22 and, as described above with reference to FIG. 3, causes the active substance to be conveyed.

Landscapes

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

Abstract

L'invention concerne un système d'administration de principe actif permettant l'administration d'un principe actif en particulier pharmaceutique, lequel système comprend un dispositif à principe actif (10) et un dispositif électronique (12) coopérant avec ce dernier. Le dispositif à principe actif (10) comprend un réservoir de principe actif (16) qui est relié fluidiquement à un dispositif d'administration (30). Le dispositif électronique (12), réalisé en particulier sous la forme d'un élément séparé, comporte un dispositif de commande (36) et un dispositif de pompe (34) relié électriquement à ce dernier. À l'aide du dispositif de pompe (34), le principe actif est refoulé du réservoir de principe actif (16) au dispositif d'administration (30).
EP21835203.7A 2020-12-14 2021-12-06 Système d'administration de principe actif Pending EP4259239A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102020133395.1A DE102020133395A1 (de) 2020-12-14 2020-12-14 Wirkstoffabgabesystem
PCT/EP2021/084424 WO2022128576A1 (fr) 2020-12-14 2021-12-06 Système d'administration de principe actif

Publications (1)

Publication Number Publication Date
EP4259239A1 true EP4259239A1 (fr) 2023-10-18

Family

ID=79171195

Family Applications (1)

Application Number Title Priority Date Filing Date
EP21835203.7A Pending EP4259239A1 (fr) 2020-12-14 2021-12-06 Système d'administration de principe actif

Country Status (7)

Country Link
US (1) US20240050644A1 (fr)
EP (1) EP4259239A1 (fr)
JP (1) JP2023553092A (fr)
CN (1) CN116472084A (fr)
CA (1) CA3199522A1 (fr)
DE (1) DE102020133395A1 (fr)
WO (1) WO2022128576A1 (fr)

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19525607A1 (de) 1995-07-14 1997-01-16 Boehringer Ingelheim Kg Transcorneales Arzneimittelfreigabesystem
WO2008116105A1 (fr) * 2007-03-22 2008-09-25 Alza Corporation Dispositif d'administration de médicament par électrotransport à pièces multiples en contact pivotant
WO2010031059A2 (fr) * 2008-09-15 2010-03-18 Deka Products Limited Partnership Systèmes et procédés de distribution de fluides
EP3030286B1 (fr) * 2013-08-05 2019-10-09 Cam Med LLC Pompe patch moulante

Also Published As

Publication number Publication date
WO2022128576A1 (fr) 2022-06-23
US20240050644A1 (en) 2024-02-15
CA3199522A1 (fr) 2022-06-23
DE102020133395A1 (de) 2022-06-15
JP2023553092A (ja) 2023-12-20
CN116472084A (zh) 2023-07-21

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