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WO2015155229A1 - Cartouche pour dispositif d'injection médical - Google Patents

Cartouche pour dispositif d'injection médical Download PDF

Info

Publication number
WO2015155229A1
WO2015155229A1 PCT/EP2015/057602 EP2015057602W WO2015155229A1 WO 2015155229 A1 WO2015155229 A1 WO 2015155229A1 EP 2015057602 W EP2015057602 W EP 2015057602W WO 2015155229 A1 WO2015155229 A1 WO 2015155229A1
Authority
WO
WIPO (PCT)
Prior art keywords
cartridge
septum
reservoir
way valve
needle cannula
Prior art date
Application number
PCT/EP2015/057602
Other languages
English (en)
Inventor
Henrik Bengtsson
Christian Højris NIELSEN
Mie HARALDSTED
Lars Eilertsen
Original Assignee
Novo Nordisk A/S
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 Novo Nordisk A/S filed Critical Novo Nordisk A/S
Publication of WO2015155229A1 publication Critical patent/WO2015155229A1/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
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2448—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic comprising means for injection of two or more media, e.g. by mixing
    • 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
    • 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
    • A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A61M5/2459—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst
    • 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
    • A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A61M5/2459—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst
    • A61M2005/2462—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst by displacing occluding plugs

Definitions

  • the invention relates to a cartridge for a medical injection device.
  • the invention especially refers to such cartridge having a one-way valve and especially a cartridge wherein the oneway valve is part of the cartridge unit.
  • a standard cartridge for a medical injection device is known from ISO standard No. 1 1608-3.
  • Such cartridge comprises a hollow body which at the proximal end is closed by a membrane through which an injection needle can penetrate. The opposite end is sealed by a movable plunger which can be moved forward by the medical injection device.
  • the variable volume reservoir between the outlet and the movable plunger contains the liquid drug which is pressed out through the lumen of the injection needle when a pressure is applied to the liquid drug.
  • a general problem with cartridges is that back-flow of bodily liquids are possible.
  • the injection needle establishes a liquid communication between the body of the user and the interior of the cartridge.
  • the injection needle is usually maintained inserted into the tissue of the user during the delivery of the required dose.
  • the pressure inside the cartridge has decreased and in some cases the pressure in the tissue of the user is higher and bodily liquids flow through the lumen of the injection needle and into the interior of the cartridge. This leads to contamination of the entire content of liquid drug in the variable volume reservoir which is undesired.
  • one-way valves for medical injection devices are given in e.g. US 7,981 ,081 and EP 555,900. These known one-way valves are adapted to prevent back-flow into the drug chamber. However, they are constructed as external components that need to be attached to the injection device.
  • a cartridge assembly for a needle free jet injector having a one-way valve is further known from US 6,883,222.
  • This cartridge assembly is however a complex construction and not suit- able for a medical injection device using an injection needle. DESCRIPTION OF THE INVENTION:
  • the cartridge needs to be similar to standard cartridges as in ISO standard No.
  • the cartridge including the one-way valve must be able to be handled as one unitary unit both in production, in storage and during sale.
  • the present invention relates to a cartridge and a needle cannula in combination.
  • the needle cannula can either be remova- ble attached to the injection device holding the cartridge or it can be permanent coupled to the injection device.
  • the cartridge can either be permanently secured in the injection device or it can be exchangeable.
  • the combined cartridge and needle cannula comprises:
  • a cartridge with a first variable volume reservoir containing the liquid drug to be expelled This first variable volume reservoir is distally sealed by a septum unit and proximally sealed by a movable plunger.
  • a pressure "P" is generated inside the first variable reservoir by moving the movable plunger distally inside the cartridge.
  • a septum unit, or septum assembly with a first septum having a distal surface and a second septum having a proximal surface, provided such that a second reservoir is formed in the space between the first septum and the second septum.
  • This second reservoir is preferably formed inside the boundaries of the cartridge and holds a small quantum of the liquid drug to be expelled.
  • a needle cannula having a proximal end which is penetrated through the first septum and at least partly into the second reservoir such that liquid communication can be established between the second reservoir and a patient.
  • a one-way valve provided between the first variable volume reservoir and the second reservoir. This one-way valve opens when the pressure ("P") inside the first variable volume reservoir reaches a pre-determined threshold value i.e. the one-way valve is a pressure actuated one-way valve.
  • the one-way valve is according to the invention located inside the boundaries of the cartridge and the one-way valve is located between the distal surface and the proximal surface of the septum unit.
  • the general idea thus being that the one-way valve is provided within the boundaries of the cartridge such that the cartridge can be handled as one unitary component in all matters and further that the one-way valve isolates a second reservoir i.e. the second reservoir is separated from the first variable volume reservoir by the one-way valve.
  • One single unitary cartridge in which backflow is prevented is thus realized.
  • the first variable volume reservoir usually has an initiate capacity of 1 ,5 to 5 ml of liquid drug whereas the second reservoir has a significant smaller volume.
  • the volume of the second reservoir can in one example be as small as 1/50 part of the first variable volume reservoirs initial volume.
  • the one-way valve is designed such that it opens when the pressure "P" in the liquid drug in the first variable volume reservoir reaches a predetermined threshold value referred to as the opening pressure.
  • the one-way valve further shuts when the pressure decreases below a certain value referred to as the closing pressure.
  • the medical injection device applies a pressure to the liquid drug which is larger than the opening pressure such that the liquid drug flow through the one-way valve into the second reservoir and further through the lumen of the injection needle and into the tissue of the user.
  • the pressure inside the first variable volume reservoir falls below the closing pressure and the one-way valve shuts off the flow into the second reservoir thereby preventing backflow into the first variable volume reservoir.
  • the opening pressure and the closing pressure does not necessarily have the same value, however, the closing pressure is usually set higher than the pressure normally occurring in human tissue such that the one-way valve shuts off before bodily liquids starts to flow into the first variable volume reservoir.
  • the part of the cartridge forming the first variable reservoir is usually formed as a glass ampoule having a distal neck part. However, it could alternatively be manufactured from a suita- ble polymer.
  • the first septum and the second septum abut each other at the periphery such that the second reservoir is formed around a centre axis of the cartridge.
  • Both septums are preferably attached to the cartridge by a metal cap beaded under the neck part.
  • the volume of the first variable volume reservoir is variable and decreases as the plunger is moved distally inside the first variable volume reservoir, however the volume of the second reservoir is fixed.
  • the one-way valve can be any kind of one-way valve which prevents backflow when the oneway valve is shut.
  • the one-way valve is preferably a pressure valve which opens and closes in response to a pressure. The presence of such one-way valve would also prevent any other than the original producer from filling a liquid drug into the cartridge, at least via the distal opening.
  • the one-way valve can be a separate part or it can be part of the cartridge itself.
  • the one-way valve is an integrated part of the septum unit closing the distal end of the cartridge.
  • the septum unit is formed as one single septum assembly, such that the septum assembly comprises both the first septum and the second septum and the one-way valve.
  • the cartridge including the septum unit housing the second reservoir and the one-way valve thus makes up one single unitary unit which can be sold separately and used in a large varie- ty of known medical injection devices.
  • the cartridge could in one example be filled with insulin and accommodated in a pen system such as e.g. the FlexPen® currently sold by Novo Nordisk A/S.
  • the one-way valve comprises a dish which is pressed against a seat by a resilient member.
  • the resilient member thus defines the opening and the closing pressure.
  • the seat is preferably formed as an integral part of the second septum.
  • the resilient member is preferably provided to urge the dish into contact with the seat. Distally the resilient member abuts a part of the second septum, which can be either a recess moulded in the second sep- turn or a separate part embedded in the second septum.
  • the one-way valve is an integral part of the second septum.
  • the one-way valve is preferably moulded as a plurality of lips having an inherent resiliency pressing the lips together to close the flow. Once the pressure reaches the opening pressure, the lips are forced apart to allow flow. When the pressure in the first variable volume reservoir falls below the pressure applied inherently by the lips, the lips will close and shut off the flow.
  • an "injection pen” is typically an injection apparatus having an oblong or elongated shape somewhat like a fountain pen for writing. Although such pens usually have a tubular cross- section, they could easily have a different cross-section such as triangular, rectangular or square or any variation around these geometries.
  • the term "drug” is meant to encompass any drug-containing flowable medicine capable of being passed through a delivery means such as a hollow needle in a controlled manner, such as a liquid, solution, gel or fine suspension.
  • Representative drugs includes pharmaceuticals such as peptides, proteins (e.g. insulin, insulin analogues and C- peptide), and hormones, biologically derived or active agents, hormonal and gene based agents, nutritional formulas and other substances in both solid (dispensed) or liquid form.
  • Cartridge is the term used to describe the container containing the drug. Cartridges are usually made from glass but could also be moulded from any suitable polymer.
  • a cartridge or ampoule is preferably sealed at one end by a pierceable membrane referred to as the "septum" which can be pierced e.g. by the back-end of a needle cannula.
  • the opposite end is typically closed by a plunger or piston made from rubber or a suitable polymer.
  • the plunger or piston can be slidable moved inside the cartridge. The space between the pierceable membrane and the movable plunger holds the drug which is pressed out as the plunger de- creased the volume of the space holding the drug.
  • injection needle defines a piercing member adapted to penetrate the skin of a subject for the purpose of delivering or removing a liquid.
  • the needle cannula of the injection needle comprises a front part for penetrating the skin of the user and a back part for penetrating the septum of the cartridge thus creating a liquid flow between the interior of the cartridge and the subcutaneous layer of the user.
  • Figure 1 show a cross sectional view of the distal end of the cartridge with the one- way valve in a closed condition.
  • Figure 2 show a cross sectional view of the distal end of the cartridge with the one- way valve in an open condition.
  • Figure 3 show a cross sectional view of a different embodiment with the one-way valve in a closed condition.
  • Figure 1 discloses the distal end of the cartridge 1 .
  • the car- tridge 1 is made from a cylindrical glass ampoule 2 forming the first variable volume reservoir 3.
  • the glass ampoule 2 is proximally provided with a movable plunger 4 and distally with a septum unit 10.
  • the plunger 4 is moved distally the volume of the first variable volume 3 reservoir decreases.
  • the ampoule 2 has a neck portion 5 around which a metal cap 6 is beaded. The metal cap 6 secures the septum unit 10 to the ampoule 2.
  • the septum unit 10 comprises a distal septum 1 1 and a proximal septum 15 which there between define a second reservoir 12.
  • the first septum 1 1 can be constructed of several layers. In the depicted embodiment, there are two layers of individual rubber sheets which are sandwiched together. However, any known kind of pierceable septum in any construction can be used.
  • the septum unit 10 is preferably manufactured as one unitary assembly housing the first septum 1 1 and the second septum 15 with the second reservoir 12 there between and thus also the one-way valve 20. This septum unit or assembly 10 can then be attached to the car- tridge 1 with a metal cap 6 beaded to the neck portion 5 of the glass ampoule 2..
  • the distal septum 1 1 has a distal surface 13 which is in contact with the surroundings and the proximal septum 15 has a proximal surface 16 which is in contact with the liquid drug internally in the cartridge 1 , preferably with the liquid drug in the first variable volume reservoir 3.
  • first septum 1 1 and the second septum 15 are sandwiched together at the periphery whereby the second reservoir 12 is formed between the two sep- tums 1 1 , 15 around the centre line X.
  • this second reservoir 12 is sealed by a valve 20.
  • This valve 20 basicly comprises;
  • the seat 21 is formed in the second septum 15 and the disc 23 rests against the seat 21 when no pressure is present in the first variable volume reservoir 3.
  • the dish 23 is actively pressed against the seat 21 by the resilient member 22 which is encompassed between the dish 23 and a ring-shaped member 24.
  • This ring-shaped member 24 has a centre opening through which the liquid drug in the first variable volume reservoir 3 can flow and a peripheral solid part supporting the resilient member 22.
  • the periphery of the ring-shaped member 24 is further secured to the second septum 15.
  • the ring-shaped member 24 can either be a separate part or it can be formed as an integral part of the distal septum 15.
  • a needle cannula 30 is also provided. This needle cannula 30 is preferably secured in a non- shown hub such that the needle assembly can be mounted on the injection device holding the cartridge 1 . In an alternative, the needle cannula 30 can be a non-removable and integral part of the injection device.
  • the needle cannula 30 has a proximal part 31 which penetrates the first septum 1 1 such that the proximal part 31 (or at least part of it) is located inside the second reservoir 12. Any liquid drug contained in the second reservoir 12 can thus escape through the lumen 32 of the needle cannula 30.
  • the pressure "P" inside the first variable volume reservoir 3 falls. Once this decreasing pressure falls below a certain closing pressure, the valve 20 closes and shut off further flow.
  • the closing force of the one-way valve 20 is preferably set such that the one-way valves 20 closes before the pressure in the tissue of the user forces bodily fluids through the lumen 32 and into the first variable volume reservoir 3.
  • the one-way valve 20 is formed integral with the second septum 15.
  • the second septum 15 is proximal provided with a plurality of lips 17 which are pressed together by the inherent resiliency.
  • the second septum 15 and thus the lips 17 are preferably moulded from a rubber composition.

Landscapes

  • 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)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne une cartouche (1) pour un dispositif d'injection médical ayant une aiguille d'injection (30) montée sur celui-ci. La cartouche possède un premier réservoir à volume variable (3) contenant un médicament liquide à injecter. La cartouche comporte en outre, de façon proximale, un piston mobile (4) et, de façon distale, une unité de cloison (10). L'unité de cloison comporte une première cloison (11), pouvant être pénétrée par une canule d'aiguille, et une seconde cloison (15). En outre, un clapet de non-retour (20) est fourni sous la forme d'une partie de l'unité de cloison. Le clapet de non-retour régule l'écoulement du premier réservoir à volume variable dans un second réservoir qui est formé entre la première cloison et la seconde cloison. La canule d'aiguille pénètre dans le second réservoir et le clapet de non-retour permet à un médicament liquide de s'écouler du premier réservoir à volume variable au second réservoir uniquement lorsqu'une pression prédéterminée est appliquée au médicament dans le premier réservoir à volume variable.
PCT/EP2015/057602 2014-04-10 2015-04-08 Cartouche pour dispositif d'injection médical WO2015155229A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP14164159 2014-04-10
EP14164159.7 2014-04-10

Publications (1)

Publication Number Publication Date
WO2015155229A1 true WO2015155229A1 (fr) 2015-10-15

Family

ID=50473123

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2015/057602 WO2015155229A1 (fr) 2014-04-10 2015-04-08 Cartouche pour dispositif d'injection médical

Country Status (1)

Country Link
WO (1) WO2015155229A1 (fr)

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019197061A1 (fr) * 2018-04-13 2019-10-17 Novo Nordisk A/S Unité de communication fluidique à configuration raccordée et non raccordée
US10857287B2 (en) 2017-01-06 2020-12-08 Trustees Of Boston University Infusion system and components thereof
US10881789B2 (en) 2013-10-24 2021-01-05 Trustees Of Boston University Infusion system for preventing mischanneling of multiple medicaments
US11278661B2 (en) 2020-03-10 2022-03-22 Beta Bionics, Inc. Infusion system and components thereof
US11331463B2 (en) 2015-07-08 2022-05-17 Trustees Of Boston University Infusion system and components thereof
US11439756B2 (en) 2017-08-30 2022-09-13 Novo Nordisk A/S Flow communication unit with preservative
US11571507B2 (en) 2019-07-16 2023-02-07 Beta Bionics, Inc. Ambulatory device and components thereof
US11944791B2 (en) 2017-08-30 2024-04-02 Novo Nordisk A/S Multi-use drug delivery device for drugs with less preservatives
USD1031975S1 (en) 2020-03-10 2024-06-18 Beta Bionics, Inc. Medicament infusion pump device
US12144968B2 (en) 2018-04-13 2024-11-19 Novo Nordisk A/S Flow communication unit with unconnected and connected configuration

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2828742A (en) * 1957-05-02 1958-04-01 American Home Prod Cartridge-needle unit
US3091240A (en) * 1958-12-29 1963-05-28 Robert K Mcconnaughey Hypodermic syringe and ventable closure means
US20060229562A1 (en) * 2005-04-11 2006-10-12 Marsh Ronald W Injection device with secondary reservoir
US20130085470A1 (en) * 2011-09-29 2013-04-04 Animas Corporation Method for pressure-independent, refillable drug infusion device

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2828742A (en) * 1957-05-02 1958-04-01 American Home Prod Cartridge-needle unit
US3091240A (en) * 1958-12-29 1963-05-28 Robert K Mcconnaughey Hypodermic syringe and ventable closure means
US20060229562A1 (en) * 2005-04-11 2006-10-12 Marsh Ronald W Injection device with secondary reservoir
US20130085470A1 (en) * 2011-09-29 2013-04-04 Animas Corporation Method for pressure-independent, refillable drug infusion device

Cited By (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10881789B2 (en) 2013-10-24 2021-01-05 Trustees Of Boston University Infusion system for preventing mischanneling of multiple medicaments
US11357911B2 (en) 2013-10-24 2022-06-14 Trustees Of Boston University Infusion pump and system for preventing mischanneling of multiple medicaments
US11331463B2 (en) 2015-07-08 2022-05-17 Trustees Of Boston University Infusion system and components thereof
US11771821B2 (en) 2017-01-06 2023-10-03 Trustees Of Boston University Infusion system and components thereof
US10857287B2 (en) 2017-01-06 2020-12-08 Trustees Of Boston University Infusion system and components thereof
US11439756B2 (en) 2017-08-30 2022-09-13 Novo Nordisk A/S Flow communication unit with preservative
US11944791B2 (en) 2017-08-30 2024-04-02 Novo Nordisk A/S Multi-use drug delivery device for drugs with less preservatives
JP2021520878A (ja) * 2018-04-13 2021-08-26 ノボ・ノルデイスク・エー／エス 非接続構成および接続構成を有する流れ連通ユニット
US12144968B2 (en) 2018-04-13 2024-11-19 Novo Nordisk A/S Flow communication unit with unconnected and connected configuration
WO2019197061A1 (fr) * 2018-04-13 2019-10-17 Novo Nordisk A/S Unité de communication fluidique à configuration raccordée et non raccordée
JP7301874B2 (ja) 2018-04-13 2023-07-03 ノボ・ノルデイスク・エー／エス 非接続構成および接続構成を有する流れ連通ユニット
US11571507B2 (en) 2019-07-16 2023-02-07 Beta Bionics, Inc. Ambulatory device and components thereof
US11633535B2 (en) 2019-07-16 2023-04-25 Beta Bionics, Inc. Ambulatory device and components thereof
USD1022185S1 (en) 2020-03-10 2024-04-09 Beta Bionics, Inc. Medicament infusion pump device
USD1031975S1 (en) 2020-03-10 2024-06-18 Beta Bionics, Inc. Medicament infusion pump device
US12115338B2 (en) 2020-03-10 2024-10-15 Beta Bionics, Inc. Infusion system and components thereof
US11278661B2 (en) 2020-03-10 2022-03-22 Beta Bionics, Inc. Infusion system and components thereof

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