This invention relates generally to surgical instruments designed for use in eye surgery and, more particularly, to a blunt internal limiting membrane (ILM) pick or spatula having a malleable tip.
Certain ophthalmological surgical procedures require the peeling or delamination of the retinal ILM. A description of the various surgical techniques requiring delamination may be found in the second edition of Vitrious Microsurgery by Steve Charles, Williams and Wilkins, 1987, particularly at pages 120-121, 222, 163 and 164. Charles describes the use of a scissors to effect cuts in the ILM, reducing it to small enough pieces to be removed from the eye.
It is believed that the use of this “sharp scissors” technique carries with it an increased risk of injury to delicate tissues in the eye, for example, the nerve fiber layer. To minimize such risks, surgeons now use blunt dissection techniques, employing instruments such as the VRTIS™ ILM spatula sold by ASICO, LLC, of Westmont Ill. as its Model Nos. AE-2917 and AE-2921. Such a spatula includes a handle to which a shaft is mounted with the shaft terminating in a shaped tip having no sharp edges. The tip is typically contoured and slightly curved to enable manipulation of the spatula along the rear portion of the eye to perform a delamination of the ILM. The spatula tips on such instruments are formed from rigid stainless steel, meaning that the blade, while conveniently shaped for delamination of some portions of the ILM must be manipulated in order to bring it into a preferred position for delaminating a different portion of the ILM. In some cases, this manipulation involves rotating the handle of the spatula to, in effect, reverse the curve of the blade. It would be convenient to allow at least a portion of the tip to be bent in one direction or another while the instrument remains in the operating field without requiring undue manipulation of the handle.
Surgical instruments having deformable, bendable or malleable features are represented in the prior art.
U.S. Pat. No. 7,112,208 (Morris et al) teaches and describes a compact suture punch with malleable needle consisting of a hand held instrument used to grip the tissue and a trocar for forcing a malleable or bendable needle through the tissue to be sutured. In other words, the needle is straight as it enters the instrument but curves as it is performing the suturing operation.
U.S. Pat. No. 7,147,651 (Morrison et al) teaches and describes a stiff tipped suture whereby an otherwise entirely flexible suture is provided with a stiff or non-bendable tip to make it easier to thread the suture through a surgical instrument and, thereafter, through tissue.
U.S. Pat. No. 5,818,571 (Johnson) teaches and describes an apparatus for bending a surgical instrument. This instrument is designed to allow the tip of a phacoemulsification needle to be bent to a convenient angle prior to insertion into the eye but is intended for use with otherwise non-bendable tips.
An ILM spatula has a handle, a shaft extending from the handle and a tip formed on the distal end of the shaft. A portion of the tip is formed as a blade with a first non-bendable portion integral with and extending from the shaft and a second, bendable portion extending from the terminus of the first blade portion to the tip of the blade. The blade is constructed in such a way as to allow the bending of the bendable portion by exerting very light pressure thereon making it possible for the surgeon to effect such bends during surgery without removing the instrument from the operating field. The blade in an exemplary embodiment is somewhat flattened in shape and is bendable both upwards and downwards across the flattened portion of the blade. A degree of bend may also be effected from side to side across the blade as well. The blade can be bent to allow the tip to be inserted under the periphery of the ILM to lift or delaminate the ILM sufficiently to allow the use of other instruments to dissect the ILM for removal.
While the following describes a preferred embodiment or embodiments of the present invention, it is to be understood that this description is made by way of example only and is not intended to limit the scope of the present invention. It is expected that alterations and further modifications, as well as other and further applications of the principles of the present invention will occur to others skilled in the art to which the invention relates and, while differing from the foregoing, remain within the spirit and scope of the invention as herein described and claimed. Where means-plus-function clauses are used in the claims such language is intended to cover the structures described herein as performing the recited functions and not only structural equivalents but equivalent structures as well. For the purposes of the present disclosure, two structures that perform the same function within an environment described above may be equivalent structures.
These and other aspects of the present invention will best be understood by reference to the accompanying drawings wherein:
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In use, the position at which blade 16 contacts the ILM is changed by turning or rotating the handle 12 to move blade 16 to positions intermediate those shown in
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Shaft 26 and blade 28 are typically formed from surgical stainless steel. It is a feature of the present invention that blade 30 is formed such that a first, stiff blade portion 42 extending from shoulder 38 toward tip end 40 is manufactured to be rigid and unbendable while a second, malleable blade portion 44 extending from stiff portion 42 to tip end 40 is manufactured to be malleable or bendable.
Typically, an instrument such as spatula 22 is manufactured from a single block of surgical stainless steel by use of a numerically computer-controlled (CNC) machining device. After machining, malleable portion 44 is treated, such as by annealing, to make it bendable.
The result of such a configuration is a spatula having a blade 30 that may, during surgery, be bent to a desired angle in order to more effectively use spatula 22 without removing it from the surgical operating field.
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The position of bend axis 46 may be selected during the manufacturing process and may be different from instrument to instrument to give each instrument its own particular feel.
It is feature of the present invention to allow blade 30 to be bent about bend axis 46 in both an upward and downward direction, and the bending of tip blade 30 in a downward direction is illustrated in
It is also intended that tip blade 30 have a degree of bend possible in a lateral direction with respect to shaft 26.
Referring now to
It is to be expected that the lateral bending of tip blade 30 may also be combined with the upward or downward bending in a relative twisting motion to produce a wide variety of selected positions for malleable blade portion 44 and tip end 40.