The invention relates to a device for fitting a cutting blade holder of a microsurgical cutting instrument, in particular a cutting instrument for use in refractive eye treatments, with a cutting blade unit.
For the treatment of refractive sight defects of the human eye, it is known to use a microsurgical cutting instrument called a microkeratome to cut a slice (flap) from the cornea surface in such a way that it is still connected to the cornea on one side (hinge). By lifting the flap and folding it away, the cornea interface (stroma) becomes accessible for reshaping of the cornea. The reshaping is carried out typically by means of an excimer laser (e.g. 193 nm) which suitably ablates the exposed cornea regions. After completion of the laser treatment, the flap is folded back.
The microkeratome normally has a suction ring unit which is to be placed on the eyeball and on which a cutting head (cutting blade holder) fitted with a cutting blade unit is held. By application of a vacuum, the suction ring unit is firmly sucked onto the eyeball (limbus) and thus fixes the latter. The cutting head is movably guided on the suction ring unit and can be moved over the cornea by means of an electric-motor drive unit. In the process, a cutting blade of the cutting blade unit cuts into the cornea and cuts the flap. During the forward stroke of the cutting head, the cutting blade unit is normally excited to oscillate laterally.
For reasons of hygiene, it is customary to replace the cutting blade unit after each operation. The insertion of a fresh cutting blade unit into the cutting head has hitherto been carried out mostly by introducing the cutting blade unit directly by hand or with the aid of tweezers into a receiving pocket, provided on the cutting head, for the cutting blade unit. After use, the cutting blade unit is withdrawn from the cutting head likewise with one's bare hand or with the aid of tweezers and then disposed of. It can readily be understood that there is a very high risk of injury in this process (the cutting blades are extremely sharp) and contamination of unprotected hands. The cutting blade for its part may be contaminated by hand injuries, which is naturally to be avoided in the case of a fresh cutting blade. There is also a risk of the cutting blade, in particular its cutting edge, being damaged by improper handling. Such damage of the cutting blade may be scarcely noticeable and yet greatly affect the cutting result. Since the cutting blade and the cutting head are high-precision components, a trained eye and great fine motor activity are required for the insertion and removal of the cutting blade unit, in order not to jeopardise the correct use of the microkeratome.
The object of the invention is to provide a device which permits simple, safe and damage-free insertion of a cutting blade unit into a cutting blade holder of a microsurgical cutting instrument, in particular for use in ophthalmic surgical treatments.
To achieve this object, such a device comprises, according to the invention, a blade cartridge which can be detachably coupled to the cutting blade holder and in which at least one cutting blade unit is received, and a slide which is or can be held slidably relative to the blade cartridge and by means of which the cutting blade unit can be pushed out of the blade cartridge into a blade receptacle of the cutting blade holder. The solution according to the invention makes it possible to insert a fresh cutting blade unit into the cutting blade holder without any contact with the body. To this end, it is merely necessary to actuate the slide, which pushes the cutting blade unit out of the cartridge and into the blade receptacle of the cutting blade holder. The sterility and intactness of the cutting blade unit can thereby be preserved. No hand injuries are to be feared either. In addition, the coupling of the cartridge to the cutting blade holder and the actuation of the slide are not complicated and laborious activities for the surgeon or his assistants, particularly since the cartridge and the slide, owing to their size, are very much easier to grip and handle than the cutting blade unit on its own.
In order not only to be able to insert the cutting blade unit into the cutting blade holder, but also withdraw it again, it is advisable for the cutting blade unit and the slide to be designed for thrust- and traction-transmitting coupling to one another. To this end, a distal coupling head of the slide (distal here means remote from an actuating section at which the user grasps and operates the slide) can be engageable with a suitable coupling formation on the cutting blade unit by the key-and-lock principle.
In order to prevent the cutting blade unit from inappropriately falling out of the blade cartridge, the cartridge is assigned securing means which secure the cutting blade unit in the cartridge. The securing means can comprise a detachable securing element which is intended and designed for engagement in a recess of the cutting blade unit, which recess serves for coupling the cutting blade unit to a blade oscillating drive. Alternatively or additionally, it is possible for the securing means to comprise securing formations which ensure frictional securing of the cutting blade unit in the blade cartridge.
In a preferred embodiment, the slide is part of an actuating unit which is produced separately from and can be detachably coupled to the cartridge. The actuating unit can, for example, be a multiple-use product which does not have to be replaced after each use. In contrast, the cartridge can, for example, be provided as a single-use product which has to be completely replaced along with the cutting blade unit after each use. It is understood that, in an alternative embodiment, the cartridge and the actuating unit can be fixedly connected to one another, so that the entire fitting instrument including cartridge and actuating unit then always has to be replaced. In the case of a two-part design, the actuating unit can, for example, have a gripping sleeve which longitudinally displaceably receives the slide and which is formed in the region of a distal sleeve end for coupling to the cartridge.
The cutting blade of the cutting blade unit normally forms a cutting edge at a front blade edge, it being possible for the opposite, rear blade edge to form at least one aligning edge which can serve for aligning the cutting blade unit in the blade receptacle of the cutting blade holder. In order to protect the cutting edge and, if necessary, also the aligning edge—the latter ensures the required precise positioning of the cutting blade unit in the cutting blade holder—from possible damage when a cartridge is fitted by the manufacturer with a fresh cutting blade unit and also when the cutting blade unit is pushed out of the cartridge, the cartridge is preferably configured in such a way that, when the cutting blade unit is correctly received therein, the cutting edge and desirably the aligning edge of the cutting blade have a clearance all the way round. It can thus be ensured that the cutting edge and optionally the aligning edge do not come into contact with the walls of the cartridge on introduction of the cutting blade into and withdrawal from the cartridge. This ensures the intactness of these edges.
According to one embodiment, the cartridge can be configured to receive a single cutting blade unit, while in a modified embodiment it is designed to receive two or more cutting blade units. In the latter case, each cutting blade unit can be accommodated in a respective dedicated cartridge chamber of the blade cartridge, in which case the fitting device according to the invention can then also have a respective slide assigned to each cartridge chamber. It is, of course, not precluded that a plurality of cutting blade units can be received in a common cartridge chamber.
Protection is sought, in the context of the invention, furthermore for a blade cartridge for use in a fitting device of the two-part type described above with an actuating unit structurally separate from the cartridge. The cartridge is in this case fitted with at least one cutting blade unit. Protection is also sought for a cutting blade unit which is designed with at least one coupling formation which is intended and designed for thrust- and traction-transmitting coupling of the cutting blade unit to a distal coupling head of a slide of a fitting device according to the invention.
The invention is explained in more detail below with reference to the appended drawings, in which:
The fitting device of
The cartridge 12 is designed, on its opposite second (distal) axial side, for detachable coupling to a cutting blade holder (cutting head) 26 of a microkeratome for ophthalmic surgical treatments. The cutting head 26 has a receiving pocket (not illustrated specifically in the drawings) for a cutting blade unit, by means of which a flap can be cut from the surface of the cornea. The blade receiving pocket of the cutting head 26 is open towards the side of the cartridge 12, so that a new, unused cutting blade unit can be pushed out of the cartridge 12 into the blade receiving pocket of the cutting head by means of the actuating unit 14 and, after use, withdrawn from the pocket again.
Reference is now made additionally to
Reference is now made additionally to
For further explanation of the cutting blade 36, reference is now made additionally to
Formed laterally in the top part 37 is a coupling formation 54 which can be brought into thrust- and traction-transmitting engagement with a distal coupling head 56 of the actuating rod 20. The engagement between the coupling formation 54 of the cutting blade unit 35 and the coupling head 56 is positive and/or non-positive. In the illustrated example of
On its axial side facing the cutting head 26, the cartridge 12 bears an arrangement of positioning formations, by means of which the cartridge 12 can be positioned on the cutting head 26 in a position permitting the correct introduction of the cutting blade unit 35 into the blade receiving pocket. In the illustrated example, the positioning formations of the cartridge 12 are formed by axially projecting positioning pins 60 which, on joining together the cartridge 12 and the cutting head 26, engage in assigned positioning holes (not illustrated specifically) of the cutting head 26. By a suitable arrangement pattern of the positioning pins 60 or/and by variation of the thickness or/and length of the positioning pins, it can be ensured that the cartridge 12 can be correctly attached to the cutting head 26 only in a single, uniquely defined relative positioning. The coupling between the cartridge 12 and the cutting head 26 can be a loose coupling, but it can also be fixed by the action of suitable holding means. For example, the thickness of the positioning pins 60 can be matched to the diameter of the positioning holes provided on the cutting head 26 in such a way that a certain frictional engagement of the positioning pins 60 in the positioning holes occurs, which ensures cohesion of the cartridge 12 and the cutting head 26. Alternative possibilities for ensuring retention of the cartridge 12 on the cutting head 26 comprise, for example, the provision of suitable latching means.
Reference is now made furthermore to
In
The cartridge 12 can be provided by a manufacturing company as a single-use product, in which case it can already be fitted by the manufacturer with a cutting blade unit 35, the latter being securable in the cartridge 12, for example, by means of the securing element 62 or in another way. The actuating unit 14 can be manufactured and supplied as a separate constructional unit, in which case it can be intended as a single-use product, but also as a multiple-use product.
To assemble the fitting device, the gripping sleeve 16 is locked by its coupling section 24 to the cartridge 12. If the actuating rod 20 is completely removable from the gripping sleeve 16, the locking of the gripping sleeve 16 to the cartridge 12 can, if desired, be performed with the actuating rod 20 removed. It is, of course, also possible for the actuating rod 20 to be secured against complete removal from the gripping sleeve 16 by suitable stop means.
Subsequently, the cartridge 12 can be attached to the cutting head 26, and the coupling head 56 of the actuating rod 20 can be brought into engagement with the coupling formation 54 of the cutting blade unit 35 situated in the cartridge 12. After removal of the securing element 62—where present—the cutting blade unit 35 can then be pushed out of the cartridge chamber 34 and into the blade receiving pocket of the cutting head 26 by exerting pressure on the gripping flange 22 of the actuating rod 20. The sections 40, 42, narrowed in the manner of a slot, of the cartridge chamber 34 form a sliding guide for the cutting blade 36 in this process. The cutting blade 36 can thus be moved into the cutting head 26 in a defined guided manner.
After the cutting blade unit 35 has been introduced into the cutting head 26, the actuating rod 20 is detached from the cutting blade unit 35 again, for example by rotation. After that, the cartridge 12 can be removed from the cutting head 26 together with the actuating unit 14.
After a treatment with the cutting blade unit previously inserted into the cutting head, the cartridge 12 can be attached to the cutting head 26 again, together with the actuating unit 14, and the actuating rod 20 can be coupled to the cutting blade unit 35 situated in the cutting head 26. By withdrawing the actuating rod 20, the cutting blade unit 35 can be transferred back into the cartridge 12. The used cutting blade unit 35 can be secured in the cartridge 12 again, for example by means of the securing element 62. The cartridge 12 can then be disposed of with the cutting blade unit 35 situated therein.
The various components of the fitting device 10 can be produced from materials such as plastic or metal. In the case of single-use products, plastic is recommended because it can be produced more easily. In general, care will have to be taken to use materials that are readily sterilisable.
In
In
The securing webs 72a can be formed, for example, integrally with the material of the cartridge housing 32a. The cartridge housing 32a for its part can be of one or more parts.
The securing webs 72a can extend, in the blade transverse direction, i.e. in the direction perpendicular to the plane of the drawing of
In
In the exemplary embodiment of
Number | Date | Country | Kind |
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05017649.4 | Aug 2005 | EP | regional |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/EP06/07699 | 8/3/2006 | WO | 00 | 4/30/2010 |