WO2018219413A1 - Dispositif pour la préparation d'un tissu humain ou animal pour une chirurgie kératoplastique - Google Patents

Dispositif pour la préparation d'un tissu humain ou animal pour une chirurgie kératoplastique Download PDF

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Publication number
WO2018219413A1
WO2018219413A1 PCT/DE2018/200046 DE2018200046W WO2018219413A1 WO 2018219413 A1 WO2018219413 A1 WO 2018219413A1 DE 2018200046 W DE2018200046 W DE 2018200046W WO 2018219413 A1 WO2018219413 A1 WO 2018219413A1
Authority
WO
WIPO (PCT)
Prior art keywords
instrument
implant
graft
channel
opening
Prior art date
Application number
PCT/DE2018/200046
Other languages
German (de)
English (en)
Inventor
Stefanie DEGENHARTT
Carlos Vargas
Juergen Eder
Original Assignee
Geuder 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 Geuder Ag filed Critical Geuder Ag
Priority to EP18735495.6A priority Critical patent/EP3496663A1/fr
Publication of WO2018219413A1 publication Critical patent/WO2018219413A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/148—Implantation instruments specially adapted therefor

Definitions

  • the present invention relates to a device for the preparation of a human or animal tissue for the introduction of a graft or implant, in particular for a keratoplasty, with an instrument having a front end for creating a tunnel in the tissue.
  • the present invention relates to a set, in particular disposable set, with a device as described above and a device for storing and transporting a graft or implant, which preferably one with a medium, preferably nutrient medium, can be filled with a container in the container having disposable receiving means for the graft or implant, and / or
  • a device for the preparation of a graft or implant from a donor eye a device for the preparation of a graft or implant from a donor eye.
  • Transplantation of the human cornea is one of the most common and successful transplant surgery procedures.
  • the transplantation of the cornea using all its layers epipithelium, Bowman's membrane, stroma, Descemet's membrane and endothelial cell layer
  • epithelium epidermal growth factor
  • stroma stroma
  • Descemet's membrane and endothelial cell layer have been known for over 100 years.
  • Good results are generally obtained with this method of operation, but convalescence is very lengthy and usually a visual recovery can only be achieved after removal of the second suture. This can be up to 18 months after the procedure.
  • the classic perforating keratoplasty is now regarded as overtreatment in endothelial corneal diseases, since the sole transplantation of vital endothelial cells is usually sufficient. Therefore, posterior lamellar techniques, especially the DMEK, Descemet Membrane Endothelial Keratoplasty, have become well established as a largely atraumatic alternative for the treatment of endothelial corneal disease.
  • the DMEK is limited to the transplantation of the isolated Descemet membrane with the endothelial cells located thereon.
  • the graft no longer contains any stromal components and is characterized by a thickness of only about 15 ⁇ .
  • a common procedure for preparing a graft or implant is described by Opitz et al., See http://www.egms.de/static/en/meetings/dgii2016/16dgii122. shtml. It is done after inserting the donor graft on a specially made Preparation bench with the endothelium upwards the identification of the iris base. The sharp probing of the trabecular meshwork takes place with a paraclytis lance. Subsequently, a blunt preparation under the Schwalbeline away up to 3 mm into the cornea. With a special cannula, stained medium, for example Medium Trypan Blue 1: 1, can be injected directly into the sub-desceme space. After high-level detachment and subsequent reinvestment of the Descemet membrane, the trepanation is carried out to approximately 7 to 9.5 mm diameter and the usual loading of the DMEK cartridge for implantation.
  • the trabecular meshwork is opened and a small tunnel is prepared with a blunt spatula into the cornea.
  • a cannula is introduced into this tunnel, with the aid of which a liquid, BSS or dye, is injected, thereby separating the Descemet membrane from the stroma.
  • a suitable graft or implant can be carried out, for example, by a device known from WO 2016/095884 A1 for the storage and transport of a graft or implant.
  • a device known from WO 2016/095884 A1 for the storage and transport of a graft or implant.
  • Such a device has a container that can be filled with a medium, preferably nutrient medium, and a receiving device for the graft or implant that can be arranged in the container.
  • the known technique for the preparation of a human or animal tissue for the introduction of a graft or implant is problematic that a variety of instruments must be kept and used to perform a safe preparation.
  • a sharp knife is used to access the trabecular meshwork and then a blunt spatula is used to prepare a small tunnel into the cornea, following which a cannula is inserted into the spatula prepared with the spatula to inject a fluid and to separate the Descemet membrane from the stroma.
  • the conventional preparation technique is therefore material-consuming and time-consuming due to the required change between several instruments, for example from the knife to the spatula and from the spatula to the cannula.
  • the present invention is therefore based on the object of specifying a device of the aforementioned type, according to which a simple and rapid preparation of a human or animal tissue for introduction of a graft or implant is made possible with structurally simple means.
  • the above object is achieved by a device having the features of claim 1 and by a set having the features of claim 10. Thereafter, the device according to the invention is configured and further developed such that the instrument is at least partially extending through the instrument to substantially the front end and in the front end at least one opening having channel for supplying and injecting a liquid or gaseous medium to the and in the tissue.
  • the instrument is at least partially extending through the instrument to substantially the front end and in the front end at least one opening having channel for supplying and injecting a liquid or gaseous medium to the and in the tissue.
  • the instrument with the front end formed to create a tunnel is additionally provided with a suitable channel for supplying and injecting a liquid or gaseous medium to and into the tissue.
  • the channel extends at least partially through the instrument to substantially the front end, wherein the channel has at least one opening for discharging the medium in the region of the front end.
  • a small tunnel can be prepared in the cornea on the one hand and, on the other hand, with the instrument located in the tissue, inject the required medium into the tissue.
  • the provision of two different instruments for these functions and a time-consuming change between different ones for the different functions suitable instruments is no longer required with the device according to the invention.
  • the small tunnel in the cornea required for the preparation is produced with the front end of the instrument according to the invention and the injection of a liquid medium, for example, can take place by means of the channel formed in the instrument.
  • the front end may be formed dull or sharp and / or flattened and / or spade-shaped.
  • the instrument can advantageously replace a knife, for example, at the opening before the preparation of the tunnel.
  • the front end may be formed thickened at least in relation to a portion of a remaining body of the instrument.
  • the instrument may be at least partially cannula-shaped.
  • the medium can be safely guided to the at least one opening in order to be able to be safely injected into the tissue.
  • the channel may have a central passage in the instrument with a rear opening preferably arranged centrally in the instrument.
  • the medium can thus be guided from the rear opening through the channel to the at least one opening.
  • the rear opening may preferably be formed at a rear end of the instrument.
  • the at least one opening may be formed in a manner particularly favorable for the separation of the Descemet membrane from the stroma on one side of the instrument.
  • This page may have a bottom or top of the be his.
  • the side can also be formed by a realized between the top and the bottom side of the range of the instrument. With regard to the specific positioning of the at least one opening, it is possible to focus on the respective application.
  • the diameter of the channel and / or the diameter of the at least one opening and / or the diameter of the rear opening can be realized in such a way that in a flow of the medium in a feed or directed towards the front end Injection creates a pressure and / or a jet stream is formed from the at least one opening.
  • the Descemet membrane can be safely separated from the stroma.
  • the diameter of the channel in the feed or injection direction in particular in a front region near the front end, may decrease continuously, in order to allow such pressure build-up and / or jet stream to occur during the flow of the medium.
  • the diameter of the at least one opening could be smaller than the diameter of the channel to allow this pressure build-up or this generation of a jet stream.
  • the instrument may have a curved shape.
  • the instrument can be made of a resterilizable material, preferably of metal, in order to allow multiple use of the device.
  • the instrument may be manufactured for single use, so that the preparation of a resterilisierbaren material is not required.
  • the instrument at a rear end with a handle - preferably on and coupled - be connected.
  • handles of different sizes and shapes can be used with the same type of instrument, depending on the user's preference.
  • the handle can be realized for multiple use be used, with only disposable instruments are used.
  • the handle for supplying the medium can be formed in the channel and for this purpose have suitable channels or lines which can be coupled to the channel of the instrument or a rear opening of the instrument.
  • the device according to the invention can be provided in the form of a set, in particular disposable sets, wherein such a set as described above apparatus for preparing a human or animal tissue for insertion of a graft or implant and a device for storage and for transporting a graft or implant and / or a device for injecting a graft or implant into a receiver eye and / or a device for preparing a graft or implant from a donor eye.
  • the device for storing and transporting a graft or implant can have a container that can be filled with a medium, preferably nutrient medium, with a receiving device for the graft or implant that can be arranged in the container.
  • FIG. 1 is a schematic side view of an embodiment of a device according to the invention for the preparation of a human or animal tissue for introduction of a graft or
  • FIG. 1 shows a side view of a device according to the invention for the preparation of a human or animal tissue for the introduction of a graft or implant.
  • This embodiment is particularly suitable for keratoplasty and has an instrument 1 with a front end 2 for creating a tunnel in the tissue.
  • the front end 2 is dull and flattened and thickened with respect to the rest of the body of the instrument 1.
  • One could also call the front end 2 involve-shaped.
  • the instrument 1 has a channel 3 for supplying and injecting a liquid or gaseous medium to and into the tissue.
  • the channel 3 extends along the entire instrument 1 substantially to the front end 2, wherein the channel 3 in the region of the front end 2 has an opening 4 for discharging the guided through the channel 3 medium.
  • the instrument 1 is substantially cannula-shaped with an elongated thin body.
  • the instrument 1 is connected to a handle 6 and decoupled connected.
  • the handle 6 is designed to supply the medium into the channel 3 and for this purpose has at least one suitable channel or a suitable line.
  • the channel 3 has in concrete a central passage 7 in the instrument 1 with a centrally arranged - not shown here - rear opening at the rear end 5 of the instrument 1.
  • the instrument 1 has a substantially curved shape, wherein a first portion of the instrument 1 on the handle 6 is initially rectilinear. The adjoining the first section curved portion of the instrument 1 is angled to the first section. This bend facilitates the handling of the instrument 1 in a preparation.
  • FIG. 2 shows an enlarged bottom view and in an enlarged sectional view of the front end 2 of the instrument 1.
  • the lateral arrangement of the opening 4 is realized on the underside particularly recognizable.
  • the flattened and slightly widened design of the front end 2 well recognizable.
  • the channel 3 shows the arrangement of the channel 3 with the opening 4 extending at a right angle to the channel 3.
  • the channel 3 is formed as a central passage 7 in the instrument 1.
  • Fig. 3 shows a second embodiment of a device according to the invention, wherein the embodiment in the lower part of Fig. 3 in a plan view - left - and on the other hand a side view - right - is shown.
  • the front area of the exemplary embodiment is shown - on the one hand in a sectional representation and on the other hand in a side view.
  • the second exemplary embodiment substantially corresponds to the first exemplary embodiment, with the exception that in the region of the front end 2 two laterally formed openings 4 are realized in side regions of the front end 2 of the instrument 1, wherein the openings 4 are formed starting from the channel 3 in opposite directions and aligned. Consequently, in order to avoid repetition, reference may be made to the description of the first exemplary embodiment, wherein the same reference numerals designate the same components. It should be expressly mentioned at this point that the number and positioning of the openings 4 can be adapted to the respective application, as long as the openings 4 are formed in the region of the front end 2. With the device according to the invention a simplification of the conventional preparation technique is achieved.
  • the device according to the invention may also be referred to as a "DMEK spatula cannula", since it fulfills both the function of a spatula and that of a cannula.
  • the design of the instrument 1 permits both the preparation of a tunnel and the high-speed spraying of the lamellae, ie the separation of Descemet membrane and stroma - with a suitable fluid following the tunnel preparation, eliminating the need to replace an instrument during the preparation procedure, resulting in a simplification of the preparation technique, in which the spatula and cannula are combined in one instrument 1.

Abstract

L'invention concerne un dispositif pour la préparation d'un tissu humain ou animal pour l'introduction d'un transplant ou d'un implant, en particulier pour une chirurgie kératoplastique, présentant un instrument (1) pourvu d'une extrémité avant (2) pour réaliser un tunnel dans le tissu, le dispositif étant équipé de moyens simples d'un point de vue construction et perfectionné, en vue d'une préparation simple et rapide, de manière telle que l'instrument (1) présente un canal (3) s'étendant au moins en partie à travers l'instrument (1) essentiellement jusqu'à l'extrémité avant (2) et présentant au moins une ouverture (4) au niveau de l'extrémité avant (2) pour le transport d'un milieu liquide ou gazeux vers le tissu et l'injection de celui-ci dans le tissu. L'invention concerne en outre un ensemble présentant un tel dispositif et un dispositif pour le stockage et le transport d'un transplant ou d'un implant et/ou un dispositif pour l'injection d'un transplant ou d'un implant dans l'œil d'un receveur et/ou un dispositif pour la préparation d'un transplant ou d'un implant à partir d'un œil d'un donneur.
PCT/DE2018/200046 2017-05-31 2018-05-14 Dispositif pour la préparation d'un tissu humain ou animal pour une chirurgie kératoplastique WO2018219413A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP18735495.6A EP3496663A1 (fr) 2017-05-31 2018-05-14 Dispositif pour la préparation d'un tissu humain ou animal pour une chirurgie kératoplastique

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102017209202.5 2017-05-31
DE102017209202.5A DE102017209202A1 (de) 2017-05-31 2017-05-31 Vorrichtung zur Präparation eines menschlichen oder tierischen Gewebes für ein Einbringen eines Transplantats oder Implantats

Publications (1)

Publication Number Publication Date
WO2018219413A1 true WO2018219413A1 (fr) 2018-12-06

Family

ID=62791469

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/DE2018/200046 WO2018219413A1 (fr) 2017-05-31 2018-05-14 Dispositif pour la préparation d'un tissu humain ou animal pour une chirurgie kératoplastique

Country Status (3)

Country Link
EP (1) EP3496663A1 (fr)
DE (1) DE102017209202A1 (fr)
WO (1) WO2018219413A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4759746A (en) * 1987-05-14 1988-07-26 Straus Jeffrey G Retro-bulbar needle
US6358262B1 (en) * 1999-11-05 2002-03-19 Alcon Universal Ltd. Lamellar dissecting instrument
US20050010244A1 (en) * 2003-04-29 2005-01-13 Medical Technology Transfer Holding B.V. Devices and methods for preparing and transplanting Descemet's membrane and lens capsule
US20080269771A1 (en) * 2007-04-26 2008-10-30 Fulcher Samuel F A Method and apparatus for ophthalmic surgery
WO2016095884A1 (fr) 2014-12-15 2016-06-23 Geuder Ag Dispositif de stockage et de transport d'un transplant ou d'un implant

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1522289A3 (fr) * 1999-10-21 2008-01-23 Alcon, Inc Administration sous-tendineuse de médicaments.
US6802829B2 (en) * 2001-11-16 2004-10-12 Infinite Vision, Llc Spray device
CN101495063B (zh) * 2006-01-26 2015-04-22 韦克福里斯特大学健康科学院 用于促进深板层内皮角膜移植术的医用工具和相关的方法
US20080281341A1 (en) * 2007-05-11 2008-11-13 Ension, Inc. Apparatus and method for endothelial keratoplasty donor tissue transport and delivery

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4759746A (en) * 1987-05-14 1988-07-26 Straus Jeffrey G Retro-bulbar needle
US6358262B1 (en) * 1999-11-05 2002-03-19 Alcon Universal Ltd. Lamellar dissecting instrument
US20050010244A1 (en) * 2003-04-29 2005-01-13 Medical Technology Transfer Holding B.V. Devices and methods for preparing and transplanting Descemet's membrane and lens capsule
US20080269771A1 (en) * 2007-04-26 2008-10-30 Fulcher Samuel F A Method and apparatus for ophthalmic surgery
WO2016095884A1 (fr) 2014-12-15 2016-06-23 Geuder Ag Dispositif de stockage et de transport d'un transplant ou d'un implant

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
RUZZA A1; PAREKH M; SALVALAIO G; FERRARI S; CAMPOSAMPIERO D; AMOUREUX MC; BUSIN M; PONZIN D, BUBBLE TECHNIQUE FOR DESCEMET MEMBRANE ENDOTHELIAL KERATOPLASTY TISSUE PREPARATION IN AN EYE BANK: AIR OR LIQUID?
RUZZA, ACTA OPHTHALMOL, vol. 93, no. 2, March 2015 (2015-03-01), pages e129 - 34

Also Published As

Publication number Publication date
DE102017209202A1 (de) 2018-12-06
EP3496663A1 (fr) 2019-06-19

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