OPHTHALMIC SURGICAL INSTRUMENTS

An ophthalmic surgical instrument for nucleus splitting includes an instrument handle having proximal and distal ends, wherein the distal end includes a pair of cooperating blade mounts which can be selectively moved relative to each other by manipulation of the handle. A pair of circular blade elements are respectively joined to the blade mounts at the distal end of the handle. Each of the blade elements have a lower cutting surface positioned generally beneath an axis defined by the respective blade mount. The lower cutting surfaces define a cutting edge for penetration of the nucleus of the eye when brought.

FIELD OF THE INVENTION

The present invention relates generally to surgical instruments, and more particularly to ophthalmic surgical instruments having a pair of cooperating blade elements, which together define a cutting edge when placed in an abutting relationship, with the instruments being particularly configured to facilitate incision and splitting of the nucleus of a lens such as during a cataract removal procedure.

BACKGROUND OF THE INVENTION

Phacoemulsification has come to be a technique of choice for the removal of damaged or diseased natural lenses from the eye. Commonly, such surgery is called for when a patient develops cataracts, a condition in which a portion of the eye lens becomes hard and opaque. Unless the damaged lens is removed and replaced with a properly selected artificial lens, blindness or severely impaired vision will result.

Phacoemulsification is the use of ultrasonic energy to emulsify the damaged lens and aspirate the resulting lens particles from the eye. One of the most significant advantages of the use of phacoemulsification is that the apparatus itself is small and can fit through a relatively small incision, resulting in less fluid leakage from the eye capsule and shorter patient recovery times.

It is desirable to limit the amount of ultrasonic energy used as much as possible in order to minimize the risk of damage to eye tissue. Often, the lens nucleus (the hardest portion of the lens) is chopped or split into smaller pieces prior to or during phacoemulsification. Smaller pieces require less energy to emulsify, and this shortens the time during which ultrasonic energy is actually being supplied to the phacoemulsification apparatus.

Known fractionating techniques include making incisions into the lens and, thereafter, prying the incisions open to split the lens into halves or quarters. U.S. Pat. No. 6,262,682, hereby incorporated by reference in its entirety, discloses a surgical instrument which facilitates the chopping and splitting of the lens nucleus.

The present invention is directed to an improved construction for an ophthalmic surgical instrument which facilitates chopping and splitting of the lens nucleus, and separation of the nucleus fragments.

SUMMARY OF THE INVENTION

In accordance with the present invention, an ophthalmic surgical instrument for nucleus splitting separation is disclosed which is particularly configured to facilitate chopping and splitting of a lens nucleus, and separation of the broken pieces of the nucleus. The instrument includes a handle having proximal and distal ends, wherein the distal end includes a pair of cooperating blade mounts which can be selectively moved relative to each other by manipulation of the handle.

The instrument includes a pair of blade elements respectively joined to the blade mounts at the distal end of the instrument handle. Each of the blade elements has at least a lower cutting surface positioned generally beneath an axis that is defined by the respective blade mount of each blade element.

In one form of the present invention, each of the blade elements has a generally circular shape and the lower cutting surfaces in a contacting relationship define a cutting edge for penetration of the nucleus of the eye.

In another form of the present invention, each of the blade elements includes an indicia therein in the form of either a recess or a through-hole. In one preferred form of the present invention, the indicia of each of the blade elements is circular in shape and is located substantially in the geometric center of the laterally-outwardly facing sides (exterior sides) of the blade elements

According to another aspect of the present invention, each of the blade elements has an upper cutting surface positioned generally above the axis of the respective blade mount such that the lower cutting surface and the upper cutting surface of each of the blade elements together extend substantially around a circumference of each of the blade elements.

According to yet another aspect of the present invention, each of the blade elements has a non-cutting, blunt surface positioned generally above the axis of the respective blade mount.

In another form of the present invention, each of the blade elements has a distal end free of any pointed cutting tip and each of the blade elements has a plurality of serrations formed on the lower cutting surface.

In another aspect of the present invention, the blade has a paddle shape wherein the lower cutting surfaces in a contacting relationship define a cutting edge for penetration of the nucleus. In one preferred form of the present invention, each of the blade elements includes a distal end in the form of a blunt edge connecting between the lower cutting surface and the non-cutting, blunt upper surface. In another preferred form of the present invention blunt edge at the distal end of each blade element is substantially flat. In yet another preferred form of the present invention, the blunt edge at the distal end of each blade element is semi-circular in shape. In another preferred form of the present invention, each blade element includes a sharpened, arcuate surface terminating at its distal end.

In accordance with another form of the present invention, an ophthalmic surgical instrument for nucleus splitting separation is disclosed which is particularly configured to facilitate chopping and splitting of a lens nucleus, and separation of the broken pieces of the nucleus. The instrument includes a handle having proximal and distal ends, wherein the distal end includes a pair of cooperating blade mounts which can be selectively moved relative to each other by manipulation of the handle.

The instrument includes a pair of blade elements respectively joined to the blade mounts at the distal end of the instrument handle. Each of the blade elements has at least a lower cutting surface positioned generally beneath an axis that is defined by the respective blade mount of each blade element and a non-cutting, blunt upper surface positioned generally above the axis. Each of the blade elements has a semi-circular shape, wherein the lower cutting surfaces terminate in a pointed distal end and in a contacting, relationship define a cutting edge for penetration of the nucleus. In one presently preferred form of the invention, one or both of the blade elements includes an indicia therein in the form of either a recess or a through-hole, the indicia having the form of a semi-circular shape with an arcuate side located adjacent the non-cutting, blunt upper surface and a flat side located adjacent the lower cutting surface.

In one presently preferred form of the invention, the handle of the present surgical instrument can be configured generally as forceps to activate and manipulate the cooperating blade elements of the instrument by either a regular action, or a reverse action. That is, a hand grip portion of the instrument handle can be configured such that it can be squeezed to move the blade elements toward each other (regular action) or can be configured such that the hand grip portion of can be squeezed to move the blade elements away from each other (reverse action.)

In one presently preferred form of the invention, the handle of the instrument includes a recessed, substantially flat portion aligned with a blunt edge of the blade elements.

Other features and advantages will become readily apparent from the accompanying drawings and the appended claims.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In accordance with the illustrated embodiments, the present ophthalmic surgical instrument10comprises an instrument handle12having proximal and distal ends, wherein the distal end includes a pair of cooperating blade mounts14which can be selectively moved relative to each other by manipulation of a hand grip portion of the handle12located intermediate of the proximal and distal ends.

As will be further described, the instrument further includes a pair of blade elements16, which are a mirror image of one another, and are respectively joined to the blade mounts14at the distal end of the instrument handle12. Each of the blade elements16includes a lower cutting surface18, positioned generally beneath an axis19defined by the respective blade mount14, and non-cutting, blunt surface20positioned generally above the axis19of the respective blade mount14. Each of the blade elements16, includes an exterior surface22and an interior surface24facing or opposing the adjacent blade element16. The exterior surfaces22of each blade element16may be substantially straight between the cutting surfaces18and the blunt surface20or may be convex or otherwise curved.

Notably, each of the cutting surfaces18, when brought into a contacting, adjacent relationship, defines at least one, non-pointed or pointed, cutting surface or edge for penetration of the nucleus.

The handle12of the present surgical instrument10can be configured generally as forceps to activate and manipulate the cooperating blade elements16of the instrument by either a regular action, or a reverse action. That is, the hand grip portion of the instrument handle12can be configured such that it can be squeezed to move the blade elements16toward each other (regular action) or can be configured such that the hand grip portion of can be squeezed to move the blade elements away from each other (reverse action.)

The handle12of the instrument10can be made of lightweight titanium or medical grade stainless steel. The blade elements16of the instrument can be made of stainless titanium or steel of various grades, including420SS,304SS, and 17-4 pH or other suitable materials.

A first illustrated embodiment of a surgical instrument10according to the present invention is shown inFIGS.1-8, wherein each of its blade elements16has a generally disc-like or circular shape that defines equal orthogonal axes21,23. Preferably, the axis21extends in a collinear or coextensive manner with the axis19of the blade mount14and handle12. However, it will be appreciated that the axis21may be angled or offset from the axis19of the blade mount14for some applications.

Referring toFIG.3, the lower cutting surface18has a medial point26, through which the axis23extends. Each lower cutting surface18extends from the blade mount14along one edge of the circular blade element16and terminates at a distal end30of the blade element16, proximate to the axis19. The blunt surface20extends along the opposite edge of the circular blade element16from the blade mount14to the distal end30. When the blade elements16are brought together during operation by a surgeon, then the lower cutting surface18becomes a cutting edge in the form of a semi-circular arc. Likewise, when the blade elements16are brought together during operation by a user, then the upper blunt surface20has the form of a semi-circular arc.

In the illustrated first embodiment of the instrument10, it is contemplated that each blade element16has a diameter (along the axes21and23) on the order of 2.0 mm. The blade elements of the illustrated shapes can also be designed on micro handles, for movement through a micro-incision (i.e., less than about 1.0 mm.).

With reference toFIGS.1and3, each blade element16includes an indicia28in the form of a generally circular through-hole located at the intersection of the axes21,23and extending between the exterior surface22and the interior surface24. The indicia28offers superior visualization within the surgical field for the surgeon to locate the lower cutting surface18and the upper blunt surface20during use of the instrument10. In some forms, the indicia28may have the form of a recess or indentation (i.e., not a through hole) in one or both of the blade elements16.

With reference toFIGS.1and2, the handle12includes a substantially flat portion40located at the same axial location on the handle12as the upper blunt surface20to further aid the user in locating both the lower cutting surface18and the upper blunt surface20during use of the instrument10. The flat portion40is preferably recessed relative to the remainder of the handle12to further aid the user of the instrument10in locating the flat portion40by feel alone, without requiring the user to look at the instrument10.

Each blade element16preferably has a greater thickness proximate the blunt surface20and a reduced thickness at the lower cutting surface18.

The inventor has found that the first illustrated embodiment of the instrument10, having circular blade elements16, is particularly advantageous and is most suitable for penetration into a hard grade nucleus with or without the support of a sustainer (not illustrated). The blunt surface20in the form of a semi-circular arc protects the posterior capsular bag from inadvertent rupture.

A second embodiment of a surgical instrument according to the present invention is shown inFIGS.9and10, designated by the numeral10A, and functions identically to the first illustrated embodiment of the instrument10as previously described. The numbered features of the second embodiment of the instrument10A illustrated inFIGS.9and10are designated generally with the suffix letter “A” and are analogous to features of the first embodiment of the instrument10that share the same number (without the suffix letter “A”). The second embodiment of the surgical instrument10A differs from the aforementioned first illustrated embodiment of the instrument10in that the second embodiment includes an indicia28A in the form of a non-through hole recess in each blade element16A and furthermore the upper surface20A of each blade element16A is sharpened such that the cutting edge of each blade element16A extends around the perimeter of each blade element16A. In other words, the lower cutting surface18A extends from the blade mount14A to the distal point30A and continues as an upper cutting surface20A instead of any blunt, non-cutting edge. The indicia28A may have the form of a notch, recess, through hole, etching, coloring, or protrusion (not illustrated) on the exterior surface22A of the blade element16A. The indicium or indicia28A may be omitted altogether. The second embodiment of the instrument10A offers a more versatile cutting means as compared to the first illustrated embodiment 10, however without the additional protection to the capsular bag offered by one or more blunt edges.

A third embodiment of a surgical instrument according to the present invention is shown inFIG.11, designated by the numeral10B, and functions nearly identically to the first illustrated embodiment of the instrument10as previously described. The numbered features of the third embodiment of the instrument10B illustrated inFIG.11are designated generally with the suffix letter “B” and are analogous to features of the first embodiment of the instrument10that share the same number (without the suffix letter “B”). The instrument10B has a pair of blade elements16B (only one of which is visible inFIG.11) which also have a generally circular shape. However, the lower cutting surface18B of each blade element16B differs from the prior-discussed embodiments in that it includes a plurality of teeth, serrations, or semi-sharp edges32B. The serrated edge32B extends between the blade mount14B to the distal point30B of each blade element16B. When the blade elements16B are brought together during operation by a user, then the lower cutting surface18B becomes a cutting edge in the form of a serrated arc or semicircle. When the blade elements16B are brought together during operation by the user, then the upper blunt surface20B has the form of an arc or semi-circle.

A fourth embodiment of a surgical instrument according to the present invention is shown inFIG.12, designated by the numeral10C, and functions similarly to the first illustrated embodiment of the instrument10as previously described. The numbered features of the fourth embodiment of the instrument10C illustrated inFIG.12are designated generally with the suffix letter “C” and are analogous to features of the first embodiment of the instrument10that share the same number (without the suffix letter

With reference toFIG.12, each blade element16C (only one of which is visible inFIG.12) of the fourth illustrated embodiment of the instrument10C is substantially paddle-shaped or rectangular and includes a lower, sharpened cutting surface18C having a linear configuration, positioned beneath the axis19C of the respective blade mount14C, and an upper, blunt surface20C having a linear configuration, positioned above the axis19C. The lower cutting surface18C of each blade element16C terminates in a distal end30C in the form of a flat, blunt edge31C. In this embodiment of the instrument10C, the operative, distal end of each blade element16C is blunt, including radiused corners where the blunt edge31C merges with the upper, blunt surface20C and the lower, cutting surface18C to provide additional protection against inadvertent posterior capsule rupture. The indicia28C has the form of an enlarged through hole in each of the blade elements16C.

A fifth embodiment of a surgical instrument according to the present invention is shown inFIG.13, designated by the numeral10D, and functions similarly to the fourth illustrated embodiment of the instrument10C as previously described. The numbered features of the fifth embodiment of the instrument10D illustrated inFIG.13are designated generally with the suffix letter “D” and are analogous to features of the fourth embodiment of the instrument10C that share the same number (without the suffix letter “C”).

Referring now toFIG.13, each blade element16D includes a lower, sharpened cutting surface18D having a linear configuration, positioned generally beneath the axis19D of the respective blade mount14D. Each blade16D includes a generally linear blunt surface20D positioned above axis19D of the respective blade mount14D. The lower cutting surface18D and blunt, upper surface20D merge at a distal end30D positioned on an arcuate, blunt surface31D.

A sixth embodiment of a surgical instrument according to the present invention is shown inFIG.14, designated by the numeral10E, and functions similarly to the fifth illustrated embodiment of the instrument10D as previously described. The numbered features of the sixth embodiment of the instrument10E illustrated inFIG.14are designated generally with the suffix letter “E” and are analogous to features of the fifth embodiment of the instrument10D that share the same number (without the suffix letter “E”).

Referring now toFIG.14, each blade element16E includes a lower, sharpened cutting surface18E having a linear configuration, positioned generally beneath the axis19E of the respective blade mount14E. Each blade16E includes a generally linear blunt surface20E positioned above axis19D of the respective blade mount14E. The lower cutting surface18E merges to the distal end30E in a sharpened, arcuate surface31E. The indicia28E has the form of an elongate aperture or oval through hole in each of the blade elements16E.

A seventh embodiment of a surgical instrument according to the present invention is shown inFIG.15, designated by the numeral10F, and functions similarly to the first illustrated embodiment of the instrument10as previously described. The numbered features of the seventh embodiment of the instrument10illustrated inFIG.15are designated generally with the suffix letter “F” and are analogous to features of the first embodiment of the instrument10that share the same number (without the suffix letter “F”).

Referring now toFIG.15, each blade element16F includes a lower, sharpened cutting surface18F having a linear configuration, positioned generally beneath the axis19F of the respective blade mount14F. Each blade16F includes a generally arcuate blunt surface20F positioned above axis19F of the respective blade mount14F. The lower cutting surface18F merges to its distal end30F in a sharpened, arcuate surface31F which functions as a secondary cutting surface. The indicia28F has the form of a semi-circular through hole or recess in one or both of the blade elements16F, which indicates to the user where the lower cutting surface18F and the upper, blunt surface20F are located on the instrument10F. The inventor has found that the instrument10F, having semi-circular shaped blade elements16F which terminate in a cutting tip40F at the distal ends30F thereof, is especially suitable for a Grade 2+/3−nucleus, which may present a particularly difficult problem for prior art pre-chopping instruments. Such a nucleus is typically too hard to pre-chop using some prior art instruments, and yet such a nucleus is not hard enough for other prior art pre-chopping instruments.

An eighth embodiment of a surgical instrument according to the present invention is shown inFIG.16, designated by the numeral10G, and functions similarly to the fifth illustrated embodiment of the instrument10D as previously described. The numbered features of the eighth embodiment of the instrument10G illustrated inFIG.16are designated generally with the suffix letter “G” and are analogous to features of the fifth embodiment of the instrument10D that share the same number (without the suffix letter “G”).

Referring now toFIG.16, each blade element16G of the instrument10G includes a lower, sharpened cutting surface18G having a linear configuration, positioned generally beneath the axis19G of the respective blade mount14G. Each blade16G includes a generally linear blunt surface20G positioned above axis19G of the respective blade mount14G. The lower cutting surface18G merges to the distal end30E in a blunt, arcuate surface31G. The indicia28G has the form of an enlarged, somewhat circular through hole in each of the blade elements16G.

A ninth embodiment of a surgical instrument according to the present invention is shown inFIG.17, designated by the numeral10H, and functions similarly to the eighth illustrated embodiment of the instrument10G as previously described. The numbered features of the ninth embodiment of the instrument10H illustrated inFIG.17are designated generally with the suffix letter “H” and are analogous to features of the eighth embodiment of the instrument10G that share the same number (without the suffix letter “H”).

Referring now toFIG.17, each blade element16H of the instrument10H includes a lower, sharpened cutting surface18H having a linear configuration, positioned generally beneath the axis19H of the respective blade mount14H. Each blade16H includes a generally linear blunt surface20H positioned above axis19H of the respective blade mount14H. The lower cutting surface18H merges to the distal end30H in a blunt, arcuate surface31H. The indicia28H has the form of an elongate aperture or oval through hole in each of the blade elements16H.

The surgical instruments10-10H are believed to possess an improved performance over one or more pre-choppers of the prior art in one or more of the following categories: insertion into the eye, separation of the nucleus, rotation and maneuverability of the instrument within the eye, and posterior capsule safety when separating the nucleus.

From the foregoing, it will be observed that numerous modifications and variations can be effected without departing from the true spirit and scope of the novel concept of the present invention. It is to be understood that no limitation with respect to the specific embodiments illustrated herein is intended or should be inferred. The disclosure is intended to cover, by the appended claims, all such modifications as fall within the scope of the claims.