This invention relates generally to surgical forceps and, in particular, to microsurgical forceps and tissue grasping instruments with distal suctioning to enhance tissue adherence and/or prevent tissue loss.
There are extremely delicate microsurgical operations wherein minute pieces of tissue are grasped and removed to treat a particular condition. For example, one such procedure, macular peeling, refers to the surgical technique used to remove epiretinal fibrous tissue or the internal limiting membrane (ILM) in the macula of the eye. Macular or ILM peeling may be used to treat various vitreoretinal disorders, including macular holes, macular puckers, epiretinal membranes (ERMs), diabetic macular edema, retinal detachment, proliferative vitreoretinopathy, retinal vein occlusions, vitreomacular traction, optic pit maculopathy, and Terson syndrome.
In accordance with a typical macular peeling procedure, an initial flap is created in the epiretinal fibrous tissue and/or ILM with a sharp instrument such as pick forceps, bent MVR (micro-vitreoretinal) instrument, or vitreoretinal forceps. Once the flap is created, the desired area of ERM and/or ILM is removed with the vitreoretinal forceps using a variety of circular movements around the fovea similar to a capsulorhexis and in parallel to the retinal surface. The extent of surface membrane tissue to be peeled varies from limited regions centered at the fovea to areas extending from the superotemporal to the inferotemporal vascular arcades. Staining of the ILM with adjuvant dyes can make the procedure easier to perform and more effective, reducing also the operating time and the mechanical trauma to the retina. Such peeling procedures are carried out in conjunction with a vitrectomy.
ILM peeling has evolved in the last two decades, and the different instrumentations and approaches have progressively advanced such procedures into a safer, easier, and more useful option for the vitreoretinal surgeon. There are now many different types of membrane peeling forceps with varying sizes, shapes, and compositions. All have the ability to grasp a membrane only with the tip of forceps, and hence such instruments also called ‘end-gripping,’ ‘end-grabbing,’ or ‘epiretinal forceps’. Some tools are engineered for peeling and grasping, and some are diamond dusted to prevent membrane slippage from the forceps. Power-driven models are also available.
Despite advances, complications arise due to the delicate nature of the procedure. A membrane peel with forceps must be capable of holding a very thin ILM (approximately 2.5 microns thick) while being pulled away and removed from the macula, and then removed from the eye. This is tedious and time-consuming, and occasionally the membrane shreds. There is an outstanding need for improved instrumentation and procedures to assist with holding the membrane in place during peeling.
This invention resides in microsurgical suction forceps and methods of use. The invention is particularly suited to intraocular procedures of the type discussed in the Background of the Invention, including macular and ILM peeling procedures and all other surface epiretinal fibrous tissue. Forceps constructed in accordance with the invention comprise two elongated members with proximal and distal ends, including a first member terminating in a distal end with a first jaw surface, and a second member terminating in a distal end with a second jaw surface in opposing relation to the first jaw surface. The members are disposed in an outer sheath with the distal ends protruding from a distal opening in the sheath, such that when the two elongated members are drawn proximally into the sheath, the jaw surfaces are brought together to grasp tissue.
In accordance with the invention, at least the first member comprises a hollow tube, and wherein the first jaw surface includes one or more micromachined apertures in communication with the hollow tube of the first member. The proximal end of the first member is in communication with a source of suction having a suction pressure that is sufficient to enhance the adhesion of tissue against the first jaw surface, but likely be insufficient to intentionally draw the tissue into the apertures.
In preferred embodiments, the surfaces are configured and dimensioned for an intraocular peeling procedure such as a macular or epiretinal membrane peeling procedure wherein preretinal tissue, a portion of an internal limiting membrane (ILM) in the macula of an eye, or even retinal tissue itself is removed. The jaw surfaces may be elongated, having a length that exceeds their width, or the jaw surfaces may be disposed on the distal ends of members that are bent outwardly then toward one another such that the opposing jaw surfaces form a pincer configuration.
In some embodiments the apertures are laser-drilled apertures, and at least the distal ends of the members may be constructed in piecewise fashion and joined together. In some embodiments both members are hollow, and both jaw surfaces contain apertures that could be created by other drilling methods. In preferred embodiments the forceps are disposable and provided in sterile packaging ready for use. Methods of performing a microsurgical procedures using the inventive forceps are also disclosed herein.
This invention improves upon microsurgical forceps by providing aspiration through the small openings in one or both of the jaws of the instrument to achieve a more reliable hold on tissue during peeling and removal. The broad concept does not anticipate the use strong aspiration for direct auction of the tissue, but rather, to use delicate suction for the purpose of holding tissue to be removed in the jaws of the forceps. In simpler terms, the invention uses suction for additional mechanical leverage—to enhance holding power—as opposed to the use of suction through a conduit for regional evacuation.
The invention is not limited in terms of the particular grasping instrument or source of suction; however, the invention is ideally suited to vitreoretinal surgical procedures, with suction coming from an aspiration line connected to a vitrector machine, for example. Even within the realm of vitreoretinal surgery, the invention is applicable to multiple different types and styles of forceps, including yet-to-be developed designs, regardless of jaw geometry, with suction on one or both jaws of the instrument.
The inventive forceps described herein may be shaped in accordance with existing forceps, with the exception that one or more apertures are provided on one or both of the grasping surface. Such apertures are in communication with minute tubing or cannula to a source of gaseous or fluidic suction, with the number and size of the apertures being dictated by the type of forceps, which in turn dictates the size and shape of the grasping surface.
In preferred embodiments, the instruments are disposable, with the jaw surfaces of the forceps defining an area of less than 10 mm, and with the apertures being formed with a precise machining process capable of forming very small, precise holes. The areas or diameters of the apertures are typically less than 1 millimeter, more preferably down to 1 micron in some cases. In a conventional intraocular peeling procedure, the jaw surfaces might be less that 5 mm, and the apertures would be in the 1-100 micron range. In some embodiments, laser drilling is used to form the apertures though other techniques can be envisioned to create them as well. Note that while the drawings show certain jaw geometries with a certain number of apertures, more or fewer apertures may be provided in each instance.
This application claims priority to and the benefit of U.S. Provisional Patent Application Ser. No. 63/164,035, filed Mar. 22, 2021, the entire content of which is incorporated herein by reference.
Number | Date | Country | |
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63164035 | Mar 2021 | US |