WO2018219413A1

WO2018219413A1 - Device for preparing a human or animal tissue for corneal grafting

Info

Publication number: WO2018219413A1
Application number: PCT/DE2018/200046
Authority: WO
Inventors: Stefanie DEGENHARTT; Carlos Vargas; Juergen Eder
Original assignee: Geuder Ag
Priority date: 2017-05-31
Filing date: 2018-05-14
Publication date: 2018-12-06
Also published as: EP3496663A1; DE102017209202A1

Abstract

A device for preparing a human or animal tissue for introducing a transplant or implant, more particularly for corneal grafting, with an instrument (1) having a front end (2) for creating a tunnel in the tissue, is designed and developed for simple and fast preparation with structurally simple means such that the instrument (1) has a channel (3) extending through the instrument (1) at least in regions and substantially up to the front end (2) and having at least one opening (4) in the region of the front end (2), said channel being used to supply and inject a liquid or gaseous medium to and into the tissue. The invention also specifies a set with a device of this kind and with a device for storing and transporting a transplant or implant and/or a device for injecting a transplant or implant into a receiving eye and/or a device for preparing a transplant or implant from a donor eye.

Description

DEVICE FOR PREPARING A HUMAN OR

ANIMAL WOVEN FOR A KERATOPLASTIC

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.

Furthermore, 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 injecting a graft or implant into a recipient eye and / or

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 (epithelium, Bowman's membrane, stroma, Descemet's membrane and endothelial cell layer) as part of a perforating keratoplasty has 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.

A good half of all corneal transplants are performed for diseases of the corneal endothelium. In principle, a layer-specific replacement of the cornea would be suitable for these diseases. Suitable techniques for this are now available. By transplantation of Descemet's membrane with an attached stromal lamella (DSAEK), a much faster visual recovery and consequently better patient satisfaction can be achieved for several years in comparison with the perforating keratoplasty.

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 μηη.

Another development in DMEK history is the establishment of so-called no-touch techniques and equipment, which ensure a particularly gentle, non-contact treatment of the endothelium and thus the rapid recovery of the patient and low-complaint recovery of the patient.

The preparation of the donor lamella with the so-called liquid-bubble technique, first introduced by Ruzza, Acta Ophthalmol, 2015 Mar; 93 (2): e129-34, doi: 10. HH / aos.12520, Epub 2014 Aug 27, Bubble technique for Descemet membrane endothelial keratoplasty tissue preparation in an eye bank: air or liquid, Ruzza A1, Parekh M, Salvalaio G, Ferrari S, Camposampiero D, Amoureux MC, Busin M, Ponzin D, and described by Szurman, eg https://www.youtube.com/watch?v=kqOzlnB1 DbU, has been perfected, is one of the most significant advancements in the relatively recent history of DMEK.

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 Schwalbelinie 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.

During this preparation, the trabecular meshwork is opened and a small tunnel is prepared with a blunt spatula into the cornea. Following this, 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.

The provision of 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. 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.

In 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. For example. First, 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. As a result, 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.

According to the invention 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. In accordance with the invention, it has first been recognized that it is quite possible to combine the task and function of different instruments required for the preparation of a human or animal tissue for the introduction of a graft or implant in a device or in an instrument. It has been further recognized in accordance with the invention that the functions of dissecting a small tunnel into the cornea and injecting a liquid to separate the Descemet membrane from the stroma can be combined in one device. For this purpose, in concrete terms, 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. With such a device according to the invention or such an instrument, on the one hand, 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.

Consequently, a simple and rapid preparation of a human or animal tissue for introduction of a graft or implant with structurally simple means is made possible with the device according to the invention.

In view of a safe and gentle creation of the tunnel in the tissue, the front end may be formed dull or sharp and / or flattened and / or spade-shaped. With a sharp design of the front end, the instrument can advantageously replace a knife, for example, at the opening before the preparation of the tunnel. Alternatively or additionally, the front end may be formed thickened at least in relation to a portion of a remaining body of the instrument. As a result, a secure generation of the tunnel is made possible without undesirable injury to surrounding tissue.

With regard to a reliable supply of the medium to the tissue, the instrument may be at least partially cannula-shaped. In this case, the medium can be safely guided to the at least one opening in order to be able to be safely injected into the tissue.

Concretely, 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. However, 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.

In a particularly advantageous manner, 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. Especially with such a jet stream, the Descemet membrane can be safely separated from the stroma. For example. For example, 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. Alternatively or additionally, 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.

With regard to a particularly safe and convenient handling of the device, the instrument may have a curved shape.

Depending on the application situation, the instrument can be made of a resterilizable material, preferably of metal, in order to allow multiple use of the device. Alternatively, the instrument may be manufactured for single use, so that the preparation of a resterilisierbaren material is not required. In view of a particularly simple handling of the device or the instrument, the instrument at a rear end with a handle - preferably on and coupled - be connected. Thus, handles of different sizes and shapes can be used with the same type of instrument, depending on the user's preference. For example. The handle can be realized for multiple use be used, with only disposable instruments are used. In a further advantageous manner, 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.

In a particularly advantageous manner, 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.

There are now various possibilities for designing and developing the teaching of the present invention in an advantageous manner. For this purpose, on the one hand to refer to the subordinate claims and on the other hand to the following explanation of a preferred embodiment of the device according to the invention with reference to the drawing. In conjunction with the explanation of the preferred embodiment with reference to the drawing, generally preferred embodiments and developments of the teaching are explained. In the drawing show

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

implant in a bottom view and in a sectional view, respectively enlarged, the front end of the instrument of the device of Fig. 1 and Fig. 3 in a plan view and in a side view and in enlarged views of the front end, a further embodiment of a device according to the invention for preparation a human or animal tissue for insertion of a graft or implant.

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 spate-shaped.

In view of a simple and rapid preparation of a human or animal tissue for introduction of a graft or implant with structurally simple means, 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.

At the front end 2 opposite the rear end 5 of the instrument 1, 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.

2 shows an enlarged bottom view and in an enlarged sectional view of the front end 2 of the instrument 1. In the bottom view of the front end 2 shown on the left in FIG. 2, the lateral arrangement of the opening 4 is realized on the underside particularly recognizable. Furthermore, in this illustration, the flattened and slightly widened design of the front end 2 well recognizable.

2 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. In the upper area of FIG. 3, 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.

In this case, 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.

With regard to further advantageous embodiments of the device according to the invention, reference is made to avoid repetition to the general part of the specification and to the appended claims. Finally, it should be expressly understood that the embodiment described above is only for the purpose of discussion of the claimed teaching, but this does not limit this embodiment.

zugszeichenliste

1 instrument

2 front end

3 channel

4 opening

5 rear end

6 handle

7 central passage

Claims

1. A device for the preparation of a human or animal tissue for the introduction of a graft or implant, in particular for a

Keratoplasty, comprising an instrument (1) having a front end (2) for creating a tunnel in the tissue,

characterized in that the instrument (1) extends at least partially through the instrument (1) to substantially the front end (2) and in the region of the front end (2) at least one opening (4) having channel (3) Supplying and injecting a liquid or gaseous medium to and into the tissue.

2. Apparatus according to claim 1, characterized in that the front end (2) is formed dull or sharp and / or flattened and / or spade-shaped and / or at least opposite a portion of a remaining body of the instrument (1) thickened.

3. Apparatus according to claim 1 or 2, characterized in that the instrument (1) is at least partially formed like a cannula.

4. Device according to one of claims 1 to 3, characterized in that the channel (3) has a central passage (7) in the instrument (1) with a preferably centrally disposed rear opening at preferably a rear end (5) of the Instruments (1).

5. Device according to one of claims 1 to 4, characterized in that the at least one opening (4) on one side of the instrument (1) is formed.

6. Device according to one of claims 1 to 5, characterized in that the diameter of the channel (3) and / or the diameter of the at least one opening (4) and / or the diameter of the rear opening are realized or is such that with a flow of the medium in one to the front End towards the direction of supply or injection pressure builds up and / or a jet stream from the at least one opening (4) is formed.

7. Device according to one of claims 1 to 6, characterized in that the instrument (1) has a curved shape.

8. Device according to one of claims 1 to 7, characterized in that the instrument (1) from a resterilisierbaren material, preferably of metal, is formed.

9. Device according to one of claims 1 to 8, characterized in that the instrument (1) at a rear end (5) with a handle (6) is preferably connected to and decoupled, wherein the handle (6) preferably for feeding of the medium in the channel (3) is formed.

10. Set, in particular disposable set, comprising a device according to one of claims 1 to 9 and a device for storing and transporting a graft or implant, which preferably arrange a container with a medium, preferably nutrient medium, filled with a container in the container - Has a bare receiving device for the graft or implant, and / or a device for injecting a graft or implant into a receiver eye and / or

a device for the preparation of a graft or implant from a donor eye.