Method and device for entering the subretinal region of the eye

Surgery – Instruments – Corneal cutter or guide for corneal cutter

Reexamination Certificate

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Reexamination Certificate

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06761724

ABSTRACT:

BACKGROUND OF THE INVENTION
The invention relates to a device for access to the subretinal region of the eye having an elongated flat body of a soft material, which is insertable to the subretinal region through an incision in the sclera of the eye.
A device of this type is disclosed in EP 0 460 320 A2, which is used for placement of a retina implant. It consists of an assembly including a flatly pressed plastic tube as well as a slider located in the plastic tube. To insert the implant, which is in the form of circular, flat microchip, the chip is placed in near the forward opening of the tube. The slider is placed in the tube behind the implant. This assembly is then inserted through an incision in the eye such that the free end of the tube is located at the desired implant location. The tube is then withdrawn with the slider being held fixed, whereby the implant is placed at the desired location.
Two different operation methods are suggested for implantation. In one method, an incision is made in the region of the pars plana and is passed through the vitreous humor of the eye. It is then passed into the subretinal region through an incision made on the vitreous humor side of the retina.
In the other method, an incision is made through the sclera directly behind the ora serrata. The incision is made through the chorioidea, the choriocapillaris, the Bruch membrane as well as the pigment epithelium of the retina, so that the implant can be placed between the inner and outer layers of the retina.
The known device however has the drawback that it is relatively thick and that a control of the positioning is hardly possible. The considerable thickness of the arrangement consisting of a flat tube and the slider is particularly disturbing in the case of entry into the subretinal region because both the retina and the chorioidea are very sensitive and in addition, the chorioidea tends to bleed strongly. The lack of position control is also very detrimental, because retina implants must be positioned precisely and because in other applications requiring access to the subretinal region, it is also important to know the exact position.
SUMMARY OF THE INVENTION
It is a first object of the present invention to provide an improved device which avoids the afore-mentioned disadvantages. It is a second object of the invention to provide a less harmful treatment in the region of the access path. It is a further object of the invention to allow for a precise control of the access positioning.
These and other objects are achieved with a body formed as a strip, whose one surface is configured as a guiding surface for a medical device. The object of the invention is completely achieved in this manner. The use of a strip has the advantage that a very flat construction is possible, while on the other hand, the guiding function is completely maintained. It has now been shown that the guidance over several guiding surfaces in the prior art is not only unnecessary in many applications, it also presents the danger of catching or clamping. This is overcome along with the already mentioned drawback relating to the large size, in particular the thickness of the known device.
In a preferred embodiment of the present invention, the strip is formed as a foil with a thickness of about 30 to 70 &mgr;m, preferably about 50 &mgr;m. This has the advantage of an extremely thin construction, where however the desired guidance function is completely guaranteed.
In a further preferred embodiment, the strip has a width of about 1 to 5 mm, preferably about 2 mm as well as a length of about 15 to 40 mm, preferably about 25 mm. In further preferred embodiments, the strip is made of plastic, preferably polyethylene or polypropylene,
In a further preferred embodiment of the present invention, at least the strip is provided with a scale. This provides the advantage of a precise control of positioning. The control can be provided in that the scale is read relative to the incision in the sclera. However, one can also read the scale relative to the position of the inserted medical device, in particular when it is also provided with a scale or corresponding markings.
Although the present invention is discussed in the following in conjunction with implantation in the subretinal region, it will be understood that the invention can also be applied in several other areas.
The invention is preferably employed with an operation kit for subretinal intervention in the eye, more particularly in that a retina implant is inserted into the subretinal region over the guiding surface of the strip by means of a slider.
In this operation kit, a microsurgical instrument can however also be inserted into the subretinal region over the guiding surface of the strip, where the microsurgical instrument is preferably a laser. In another application of the present invention, a micro-endoscope can be guided to the subretinal region by employing the device of the present invention. The same holds for the insertion of a carrier provided with a drug into the subretinal region of the eye.


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