Surgery – Instruments – Means for removing – inserting or aiding in the removal or...
Reexamination Certificate
2001-08-03
2003-08-19
Robert, Eduardo C. (Department: 3732)
Surgery
Instruments
Means for removing, inserting or aiding in the removal or...
Reexamination Certificate
active
06607537
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates to an injector for implanting a (temporarily) folded intraocular lens, with which the folded lens can be inserted in the capsula of the lens of the eye through an opening incision of approx. 3 mm in the eye.
In eye surgery it is very important that the surgical incision through which a cataract is removed and then the required artificial lens is implanted is as small as possible (approx. 3 mm) so that optimum healing is guaranteed and no suture is required. To be able to implant artificial lenses with the required diameter of approx. 5-6 mm, these must be foldable so that they pass through the small incision of 3 mm.
A wide variety of devices are known for folding the lenses and inserting the folded lens with the aid of forceps and also injectors for direct insertion of the lenses in the eye. In the case of the latter, generally the lens which is inserted essentially unfolded is progressively folded axially as it is slid forwards in the injector, or an already folded lens is inserted and only slid out.
Thus, EP 0 503 136 A1, EP 0 497 505 A1, EP 0 402 138 A1, WO 98/25548, WO 94/10912 and DE 40 39 119 C1 for example disclose devices for folding an intraocular lens in a wide variety of embodiments through which the lenses are in each case accordingly folded or prefolded and then inserted in the eye by means of forceps or an injector. This procedure is relatively complex and in addition uncertain due to the handling with the forceps as the folded lens can easily slip out of the forceps.
DE 41 10 278 A1, DE 36 10 925 C2, WO 96/15743, EP 0 270 257 A1, EP 0 477 466 A1, WO 97/113476 and WO 97/15253 disclose lens injectors in which partly prefolded lenses are inserted in the receiving chamber of an inserting cartridge which can be fastened to the front end of the injector. Usually, this cartridge also serves as receiving chamber for safely storing and transporting the lens. After the cartridge is fitted to the handle part of the injector body, the lens is slid through the tapering channel to the outlet end by axial displacement by means of a plunger, through which the lens is folded or folded again. These known injectors are of relatively complex design comprising a large number of individual parts, and the user must assemble at least two separate parts before the lens can be slid out.
WO 97/13476 discloses an injector in which the lens is first folded in a folding instrument and then placed together with the latter radially in the injector. Then, with the aid of a plunger, the folded lens is slid out of the folding device through the tapering delivery cover, through which the lens undergoes further folding. Thus, two instruments are needed here, one for the preliminary folding and one for injecting the folded lens.
WO 98/05281 discloses an injector the lens-holding cartridge of which exhibits at its rearward end a radially swivelling flap with a central holding rib by means of which the unfolded lens is pressed radially into the transporting channel and held there. However, genuine folding of the lens only takes place through the forward sliding movement of the lens through the tapering transporting channel. Thus, this is a relatively complex design with correspondingly complex handling.
In addition, WO 95/07059 and WO 95/13022 describe an injector with a cylindrical transporting channel into which an unfolded lens is slid tangentially with the aid of an independent slider rib not connected to the injector body so that the lens is rolled in the transporting channel. The rolled lens is then slid out by means of an additionally separate cylindrical slider filling the transporting channel completely. Thus, two separate parts have to be introduced into the injector and the lens delivered in a rolled state.
In addition, U.S. Pat. No. 3,123,905 A describes an injector with a cylindrical body and a cylindrical transporting channel which is provided coaxially therein and debouches into a delivery tip which tapers conically. The cylindrical injector body incorporates a relatively narrow radial insertion slot through which the lens placed on the surface of the body over the insertion slot is pressed in with the aid of an independent insertion rib. Apart from the fact that this known injector cannot be used at the same time for transporting and safely storing an unfolded lens, the insertion of the lenses through the very narrow insertion slot is difficult or even impossible since lenses are known to be practically incompressible. In addition, the independent rigid slider also fills the entire cross-section of the transporting channel so that the insertion rib must be removed after insertion of the lens. In addition, the transporting channel tapers conically to a point so that the inserted lens, in cylindrical form in the channel, is rolled up even further when it is slid out, giving major delivery problems.
Lastly, DE 43 03 051 A1 and U.S. Pat. No. 5,190,552 A show an injector in which an unfolded lens is inserted through a radial insertion opening into the transporting channel which is open upwards radially in this section, on to a lens-holding slide. The lens is held securely to prevent it dropping out by means of a lens locking rod which is slid axially over the inserted lens. When slid out, the holding rod and the slide are together slid through an at least initially tapering transporting channel of the injection tube, through which the lens, still held centrally by the holding rod, is folded around this rod. This is also a relatively complex design with relatively complex handling. In addition, the lens must be held securely pressed down in its position in the slide by the locking rod as it is slid forwards so as not to be slid off the slide by the rod.
SUMMARY OF THE INVENTION
The object of the invention is to provide an injector of the kind named above which exhibits the simplest possible construction and allows reliable sterile handling during safe storage, transport, folding and implanting of the lenses.
According to the invention, the transporting channel of the one-piece injector body is an axially continuous opening with a constant cross-section. Thus, the transporting channel has a cross-section which is always the same throughout the entire injector, namely from the slider inlet end to the lens delivery end, which represents a simplification in terms of manufacturing. In addition, the supporting surface for the unfolded lens is arranged radially offset upwards in the direction of insertion relative to the transporting channel. As a result of this, the lens is inserted lying above the transporting channel or at least essentially a distance from the bottom of the transporting channel, but at the same time below the upper surface of the body. Lastly, the holding rib or rod holding the unfolded lens on the supporting surface is a radially extending plate-shaped folding rib which is arranged like the die of a stamping tool and can be pressed radially well into the transporting channel or transversely to the transporting direction through the slot-shaped insertion opening. Thus, the folding rib and the body act like a correspondingly embodied mold and die on the lens lying between them and bend this in the middle, at the same time sliding it into the transporting channel in its final folded state. Then, it is only necessary for the lens to be slid forwards in this final folded state in the transporting channel by the slider, which here obviously is also a rod with a constant cross-section.
In a further embodiment of the invention, the one-piece injector body can exhibit a rectangular cross-section overall, i.e. both the thicker insertion and folding part and the thinner injecting part and the transporting channel each exhibit a rectangular cross-section. All these parts, namely the body sections and the transporting channel, can also exhibit a round or oval cross-section or the holding part can be rectangular while the injection tube and the transporting channel exhibit a round cross-section.
Obviously, in its cross-section the transport
Ostrolenk, Faber, Gerb & Siffen, LLP
Robert Eduardo C.
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