WO2020007436A1 - Récipient d'accueil et procédé de disposition d'une préparation de cornée - Google Patents

Récipient d'accueil et procédé de disposition d'une préparation de cornée Download PDF

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Publication number
WO2020007436A1
WO2020007436A1 PCT/EP2018/000345 EP2018000345W WO2020007436A1 WO 2020007436 A1 WO2020007436 A1 WO 2020007436A1 EP 2018000345 W EP2018000345 W EP 2018000345W WO 2020007436 A1 WO2020007436 A1 WO 2020007436A1
Authority
WO
WIPO (PCT)
Prior art keywords
container
preparation
front chamber
reservoir
environment
Prior art date
Application number
PCT/EP2018/000345
Other languages
German (de)
English (en)
Inventor
Norbert Schrage
Claudia PANFIL
Original Assignee
Acto Service Gmbh
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 Acto Service Gmbh filed Critical Acto Service Gmbh
Priority to DE112018007802.7T priority Critical patent/DE112018007802A5/de
Priority to PCT/EP2018/000345 priority patent/WO2020007436A1/fr
Publication of WO2020007436A1 publication Critical patent/WO2020007436A1/fr

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M23/00—Constructional details, e.g. recesses, hinges
    • C12M23/02—Form or structure of the vessel
    • C12M23/08—Flask, bottle or test tube
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00—Preservation of bodies of humans or animals, or parts thereof
    • A01N1/02—Preservation of living parts
    • A01N1/0236—Mechanical aspects
    • A01N1/0263—Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving, e.g. cool boxes, blood bags or "straws" for cryopreservation
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M23/00—Constructional details, e.g. recesses, hinges
    • C12M23/22—Transparent or translucent parts
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M23/00—Constructional details, e.g. recesses, hinges
    • C12M23/34—Internal compartments or partitions
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M23/00—Constructional details, e.g. recesses, hinges
    • C12M23/38—Caps; Covers; Plugs; Pouring means
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M23/00—Constructional details, e.g. recesses, hinges
    • C12M23/40—Manifolds; Distribution pieces
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M35/00—Means for application of stress for stimulating the growth of microorganisms or the generation of fermentation or metabolic products; Means for electroporation or cell fusion
    • C12M35/08—Chemical, biochemical or biological means, e.g. plasma jet, co-culture
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M41/00—Means for regulation, monitoring, measurement or control, e.g. flow regulation
    • C12M41/46—Means for regulation, monitoring, measurement or control, e.g. flow regulation of cellular or enzymatic activity or functionality, e.g. cell viability

Definitions

  • Container for receiving and method for storing a corneal preparation
  • the invention first relates to a container for receiving a
  • Corneal preparation wherein the container has a closed front chamber for an aqueous nutrient solution, which adjoins the corneal preparation on the endothelial side, and a work space which borders the corneal preparation on the epithelial side and is at least fluid-tightly separated from the anterior chamber by the corneal preparation, the corneal preparation being separated from the work space the environment is visible and accessible.
  • the invention further relates to a method for storing a corneal preparation in a container, one endothelium attached to the
  • the front chamber of the container bordering the corneal preparation is filled with a nutrient solution and the front chamber is closed in a fluid-tight manner against an environment of the container.
  • Containers and methods of the aforementioned type are used in order to provide a corneal preparation, in particular for physical and / or chemical tests of medicaments or chemicals in a defined environment, and to maintain the quality of the preparation during transport to the location of the test and during the test.
  • a substance to be tested is applied to the epithelium of the corneal preparation.
  • WO 2014/140434 A1 proposes a flat front chamber for a disk-shaped container for receiving a corneal preparation, which essentially has the diameter of the container.
  • a flat front chamber for a disk-shaped container for receiving a corneal preparation which essentially has the diameter of the container.
  • the small volume of the anterior chamber ensures that the corneal preparation is supplied with nutrients only for a short period of time.
  • the use of the corneal preparation is therefore limited in time.
  • the invention is based, the nutrient supply of the task
  • the container has a reservoir connected to the front chamber via a channel.
  • the reservoir increases that for the nutrient solution
  • the reservoir can be inside or outside.
  • a container according to the invention preferably has an inlet and an outlet, the front chamber being flushable with the nutrient solution from the surroundings via the inlet and via the outlet into the surroundings.
  • the corneal preparation can thus be subjected to a defined volume flow of the nutrient solution during the test.
  • the inlet or the outlet connects the surroundings with the reservoir.
  • the container according to the invention thus avoids a non-rinsed dead volume in the reservoir.
  • the inlet connects the surroundings with the reservoir and the outlet connects the surroundings with a second reservoir.
  • a container according to the invention preferably has a translucent, polished lens which closes the front chamber from the surroundings.
  • An artificial anterior chamber forms under the corneal preparation due to the hydrostatic internal pressure of the nutrient solution.
  • the container according to the invention thus permits direct microscopic examination of the endothelial side of the corneal preparation.
  • Glass, polypropylene (PP), polyethylene (PE), polymethyl methacrylate (PMMA) or a combination of these materials are used in particular as the material of the lens.
  • a container according to the invention preferably has a carrier which carries the corneal preparation and has the anterior chamber, the reservoir and the channel, and a holding element which rests on the endothelial side on a scleral margin of the corneal preparation.
  • the corneal preparation can first be placed in the holding element and then the carrier can be placed on the Scleral margin of the corneal preparation are placed in order to fix it to the holding element. Since the corneal preparation closes the front chamber in a fluid-tight and pressure-stable manner, the front chamber between the carrier and the corneal preparation can then be filled with the nutrient solution and positioned upwards.
  • the material of the carrier and the holding element are mechanically stable
  • Plastics such as PMMA or metallic materials such as aluminum are used, when using the container according to the invention for testing aggressive materials, in particular chemically resistant high-performance plastics (e.g.
  • Connecting element that connects the carrier to the holding element The carrier with the holding element can thus be in the container according to the invention
  • the container according to the invention thus avoids a burden on the
  • a container according to the invention is preferably closed by pivoting the connecting element against the carrier and the holding element about an axis of the container, the connecting element with the carrier and / or the holding element in the manner of a bayonet catch in this way
  • the connecting element has a pin arranged radially to the axis and the carrier and / or the holding element has a slot, or the carrier and / or the holding element has the pin and the connecting element has the slot , with the pin being inserted into the slot and causing the fixed connection when pivoting about the axis.
  • Anterior chamber continuously absorbs nutrients from the corneal preparation and their concentration in the nutrient solution drops, they diffuse
  • the front chamber and the reservoir with the nutrient solution are preferably closed in a fluid-tight manner from the environment by means of a common cover. Closing the front chamber and reservoir with a common cover simplifies the execution of the method according to the invention.
  • the nutrient solution is preferably pumped from the reservoir into the anterior chamber.
  • the flow of the nutrient solution can thus be ensured regardless of the position of the container and can also be controlled as required.
  • FIG. 1 shows a section through a container according to the invention
  • FIG. 3a-c side views of the connecting element, the carrier and that
  • the container 1 according to the invention shown in FIG. 1 has a carrier 2 made of PMMA, a holding element 3 made of PMMA for holding a corneal preparation (not shown) on the carrier 2 and a connecting element 4 made of aluminum for connecting the carrier 2 to the holding element 3.
  • Holding element 3 and the connecting element 4 are each constructed in a rotationally symmetrical manner with respect to a vertical axis 5 of the container 1
  • the carrier 2 has an essentially circular-cylindrical base body 6 with a height 7 of 13 mm and a diameter 8 of 50 mm and one to the Axis 5 concentric, dome-shaped polished lens 10 made of PMMA with a diameter 11 of 20 mm protruding downwards by a height 9 of 6 mm from the base body 6. Run parallel to axis 5 in
  • Base body 6 two tubular channels 12 with a diameter 13 of 3 mm, which end in the lens 10 and are connected at the top via a branch channel 14, each with one of two kidney-shaped reservoirs 15 with a width 16 of 10 mm and a height 17 of 8 mm are.
  • the carrier 2 has two mounting bores 18 running parallel to the axis 5 through the carrier 2 and on the outside of the base body 6 two grooves 19 running parallel to the axis 5.
  • Luer adapters closed bore 20 with a diameter 21 of 10 mm radially to the axis 5 from the base body 6 to the outside.
  • the carrier 2 is closed at the top with a disc-shaped transparent cover 22 made of PMMA with a diameter of 45 mm, which also covers the branch channels 14 and the reservoirs 15.
  • the cover 22 is glued to the carrier 2 after the reservoirs 15 have been milled.
  • the cup-shaped holding element 3 has an outer diameter 24 of again 50 mm and a working space 25 which is open at the bottom.
  • the floor 26, which closes the working space 25 upward, has an axial one
  • Breakthrough 27 for the lens 10 with the corneal preparation The holding element 3 has two helically rising slots 29 on its outer side.
  • the tubular connecting element 4 has an inner diameter 30 of 50 mm and two radially inwardly projecting pins 31, as well as an inwardly projecting collar 32.
  • Holding element 3 is placed with the mounting holes 18 on two mounting pins of a mounting device, not shown, and the corneal preparation according to its predetermined shape (endothelium points upwards) into the opening 27 inserted. Subsequently, the carrier 2 with the lens 10 pointing downward is placed on the corneal preparation via the guide of the mounting pins such that the lens 10 with the corneal preparation lies in the opening 27 and the bottom 26 of the holding element 3 presses a scleral edge of the corneal preparation onto the carrier 2 , A front chamber 33 is formed between the corneal preparation and the carrier 2, which surrounds the lens 10 in a ring shape.
  • the holding element 3 has only a small contact to the scleral edge of the
  • Corneal preparation which is pressed on from the inside (endothelium side) in a fluid-tight manner by a silicone ring (not shown) which is placed over the lens 10.
  • the carrier 2 and the holding element 3 are closed in a fluid-tight manner by means of the connecting element 4. Then the connecting element 4 is slipped over the carrier 2 and the holding element 3 in the direction of the axis 5 in such a way that the pins 31 pass through the grooves 19 into the slots 29
  • the Luer adapters are irreversibly glued into the bores 20, three-way valves are screwed on, then the reservoirs 15 and the front chamber 33 are filled with nutrient solution and finally the three-way valves are closed. In this position, the reservoirs 15 and the anterior chamber 33 are filled with a nutrient solution for the corneal preparation.
  • container 1 with the corneal preparation can be stored and transported for several days. In order to avoid drying out of the corneal preparation in the working space 25, this should be done regularly if necessary
  • a substance - for example a drug or one
  • the container 1 is open with the top Working room 25 used. Visible changes on the endothelial side of the corneal preparation can be examined in particular through the lens 10. For a targeted further supply of the corneal preparation with
  • the nutrient solution can be continuously exchanged via the luer adapter in the bores 20.
  • the lens can have a diameter between 3 and 20 mm.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Genetics & Genomics (AREA)
  • Biotechnology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Sustainable Development (AREA)
  • General Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Biomedical Technology (AREA)
  • Clinical Laboratory Science (AREA)
  • Cell Biology (AREA)
  • Analytical Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Physiology (AREA)
  • Hematology (AREA)
  • Mechanical Engineering (AREA)
  • Dentistry (AREA)
  • Environmental Sciences (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne d'abord un récipient (1) d'accueil d'une préparation de cornée, le récipient (1) comportant une chambre avant (33) fermée pour une solution nutritive aqueuse qui est adjacente à la préparation de cornée du côté de l'endothélium, et un espace de travail (25) qui est adjacent à la préparation de cornée du côté de l'épithélium et qui est séparé fluidiquement de la chambre avant (33) au moins par la préparation de cornée, la préparation de cornée étant visible et accessible à travers l'espace de travail (25) hors de l'environnement. L'invention concerne en outre un procédé destiné à disposer une préparation de cornée dans un récipient (1), une chambre avant (33) du récipient (1) adjacente à la préparation de cornée du côté de l'endothélium étant remplie d'une solution nutritive et la chambre avant (33) étant fermée fluidiquement par rapport à l'environnement du récipient (1). Afin d'améliorer l'approvisionnement en substance nutritive de la préparation de cornée, selon l'invention, le récipient (1) comporte un réservoir (15) relié à la chambre avant (33) par le biais d'un canal (12).
PCT/EP2018/000345 2018-07-05 2018-07-05 Récipient d'accueil et procédé de disposition d'une préparation de cornée WO2020007436A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
DE112018007802.7T DE112018007802A5 (de) 2018-07-05 2018-07-05 Behälter zur Aufnahme und Verfahren zum Lagern eines Korneapräparats
PCT/EP2018/000345 WO2020007436A1 (fr) 2018-07-05 2018-07-05 Récipient d'accueil et procédé de disposition d'une préparation de cornée

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2018/000345 WO2020007436A1 (fr) 2018-07-05 2018-07-05 Récipient d'accueil et procédé de disposition d'une préparation de cornée

Publications (1)

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WO2020007436A1 true WO2020007436A1 (fr) 2020-01-09

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PCT/EP2018/000345 WO2020007436A1 (fr) 2018-07-05 2018-07-05 Récipient d'accueil et procédé de disposition d'une préparation de cornée

Country Status (2)

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DE (1) DE112018007802A5 (fr)
WO (1) WO2020007436A1 (fr)

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0262766A1 (fr) * 1986-08-06 1988-04-06 Minnesota Mining And Manufacturing Company Dispositif pour la cornée
DE9422008U1 (de) * 1993-06-07 1997-08-28 Mayer Berndt Priv Doz Dr Med Vorrichtung zur Konservierung von Organen, Extremitäten und Gewebelappen
US5789240A (en) * 1995-09-21 1998-08-04 Abdulrazik; Mohammad Diffusion cell for ex-vivo pressure-controlled transcorneal drug penetration studies
EP1148120A1 (fr) * 2000-04-22 2001-10-24 Forschungszentrum Jülich Gmbh Appareil et procédé pour le traitement et l'examen d'organismes et de tissus vivants à température et contrôlée
DE69615683T2 (de) * 1995-06-05 2003-01-30 Neurotech Sa Gerät und verfahren zum aufbewahren und transport von bioartifiziellen organen
US20110014690A1 (en) * 2009-06-17 2011-01-20 Wilson Wolf Manufacturing Cornea storage container to maximize cornea health
WO2014140434A1 (fr) 2013-03-14 2014-09-18 Universite Jean Monnet Dispositif medical destine a la conservation longue duree d'une cornee, ou a l'experimentation ex vivo sur cornee humaine ou animale
EP3018195A1 (fr) * 2014-11-05 2016-05-11 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Système de bioréacteur et procédé de stabilisation à long terme de tissu cornéen

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0262766A1 (fr) * 1986-08-06 1988-04-06 Minnesota Mining And Manufacturing Company Dispositif pour la cornée
DE9422008U1 (de) * 1993-06-07 1997-08-28 Mayer Berndt Priv Doz Dr Med Vorrichtung zur Konservierung von Organen, Extremitäten und Gewebelappen
DE69615683T2 (de) * 1995-06-05 2003-01-30 Neurotech Sa Gerät und verfahren zum aufbewahren und transport von bioartifiziellen organen
US5789240A (en) * 1995-09-21 1998-08-04 Abdulrazik; Mohammad Diffusion cell for ex-vivo pressure-controlled transcorneal drug penetration studies
EP1148120A1 (fr) * 2000-04-22 2001-10-24 Forschungszentrum Jülich Gmbh Appareil et procédé pour le traitement et l'examen d'organismes et de tissus vivants à température et contrôlée
US20110014690A1 (en) * 2009-06-17 2011-01-20 Wilson Wolf Manufacturing Cornea storage container to maximize cornea health
WO2014140434A1 (fr) 2013-03-14 2014-09-18 Universite Jean Monnet Dispositif medical destine a la conservation longue duree d'une cornee, ou a l'experimentation ex vivo sur cornee humaine ou animale
US20160029618A1 (en) * 2013-03-14 2016-02-04 Universite Jean Monnet Medical device intended for the long-term storage of a cornea, or for ex vivo experimentation on a human or animal cornea
EP3018195A1 (fr) * 2014-11-05 2016-05-11 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Système de bioréacteur et procédé de stabilisation à long terme de tissu cornéen

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
M. A. THIEL ET AL: "A simple corneal perfusion chamber for drug penetration and toxicity studies", BRITISH JOURNAL OF OPHTHALMOLOGY, vol. 85, 31 January 2001 (2001-01-31), pages 450 - 453, XP055033125, DOI: 10.1136/bjo.85.4.450 *

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