Descemetorhexis creation device
Inventors
Mbagwu, Michael • Buickians, David • Myung, David
Assignees
US Department of Veterans Affairs • Leland Stanford Junior University
Publication Number
US-12029686-B2
Publication Date
2024-07-09
Expiration Date
2042-03-15
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Abstract
Precise concentric, symmetric, and repeatable circular scoring (cutting) of Descemet's membrane is made possible by a handheld surgical ophthalmic device. The precision of the cut is provided by a stabilizing point on a stabilizing arm as well the anchoring insertion point at the limbus. Stabilization through the insertion point and the stabilizing arm provides a two-point fixation thereby establishing a cutting plane. The cutting plane allows for precise depth of cut whereas the rotating blade's consistent radius allows for circularity of the cut. The stabilization arm fixates on tissue, and is then removed when the procedure is completed. Consistent torque and contact pressure of the cutting blade is provided through rotational control via the depression of a button on a handle thereby removing the need to “free-hand” the desemetorhexis.
Core Innovation
The invention is a handheld surgical ophthalmic device designed for the precise creation of a descemetorhexis. It includes a proximal drive shaft and a distal drive shaft coupled so that rotation of the proximal shaft rotates the distal shaft. At the distal end, a gearing mechanism converts this rotation into circular motion in a plane perpendicular to the rotational axis. Attached to the gearing mechanism are two arms: a first arm with a cutting protrusion that rotates to create the circular descemetorhexis, and a second, fixed arm with a stabilization protrusion. The stabilization arm provides a stationary contact point within the anterior chamber of an eye while the cutting arm makes the circular incision, allowing precision in the cut's depth and shape.
The problem addressed by this invention arises from current descemetorhexis procedures, which rely on a "freehand" technique prone to imprecision and complications such as decentration, irregular cuts, damage to adjacent tissue, and stromal scarring. These issues stem from dependence on surgeon skill and the lack of technology providing consistent, centered, and circular scoring of Descemet's membrane. Currently investigated alternatives like femtosecond laser-assisted descemetorhexis are cost-prohibitive and not widely accessible. The invention overcomes these limitations by providing mechanical stabilization via a two-point fixation system and a controlled rotational cutting mechanism, eliminating the need for freehand cutting and enhancing reproducibility.
Claims Coverage
The patent includes two independent claims covering a handheld surgical device and its method of use, featuring specific structural and functional aspects.
Two-point fixation with coupled rotating and fixed arms
The device incorporates a proximal and distal drive shaft coupled to rotate the distal shaft, with a gearing mechanism at the distal end translating rotation into circular motion. A first arm with a cutting protrusion rotates in a plane perpendicular to the rotational axis, while a second, fixed arm has a stabilization protrusion positioned superiorly relative to the first arm, providing simultaneous cutting and stabilization in the same direction.
Method of circular descemetorhexis creation using the device
The method involves inserting the first (cutting) and second (stabilization) arms into the anterior chamber via a corneal incision, docking their respective protrusions on the posterior cornea, and initiating the device to perform circular motion of the cutting arm, thereby creating a circular descemetorhexis.
These inventive features collectively enable precise, stable, and repeatable circular descemetorhexis creation using a handheld tool with mechanical guidance and stabilization.
Stated Advantages
Provides precise concentric, symmetric, and repeatable circular scoring of Descemet's membrane.
Ensures stabilization and centration via a two-point fixation system, enhancing cutting plane accuracy and reducing surgeon dependency on freehand technique.
Allows precise depth control of the cut to minimize damage to adjacent endothelium and stromal tissue.
Reduces irregular cut shapes, tags, and complications such as decentration and corneal perforation.
Facilitates consistent torque and contact pressure through mechanical rotation controlled by a button, improving the reproducibility of the descemetorhexis.
Documented Applications
Creation of a descemetorhexis during corneal transplant procedures such as DMEK, DSEK, and DWEK/DSO.
Use in surgeries treating Fuchs' endothelial dystrophy and Pseudophakic bullous keratopathy involving selective removal of diseased corneal layers.
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