Multi-functional second instrument for cataract removal

Apparatus for the removal of lens tissue includes a first instrument for inserting into a lens capsule and removing a cataract therein, the first instrument including a lumen for aspiration of cataract tissue and irrigation fluid from the lens capsule and manipulate the cataract until cataract is removed. The second instrument includes an irrigation port for introducing the irrigation fluid into the lens capsule.

The present invention generally relates to surgical instruments, and more particularly, relates to apparatus which provides for improved irrigation and reduced risk of corneal or sclera tissue damage during cataract removal.

Cataracts cause the lens of an eye to become clouded, and a common practice to alleviate this condition is by surgically removing the cataractic lens and replacing it with an artificial intraocular lens.

Early lens removal was effected through manual extraction which required a wound of about 12 mm in length. This large opening can result in corneal or sclera tissue damage.

Phacoemulsification, on the other hand, enables the removal of a cataractic lens through a much smaller incision, for example, between about 2.5 to about 4 mm. In this procedure, a needle is inserted through the incision into a lens capsule and the needle is vibrated to mechanically emulsify the lens. It is often desirable to utilize a second tool in order to manipulate the lens toward and around the phacoemulsification needle in order to more effectively emulsify the lens. Once fragmented or emulsified, the lens material is aspirated through a lumen through the phacoemulsification needle.

Heretofore, while emulsifying the lens and aspirating lens fragments, a simultaneous flow of irrigation fluid into the lens capsule has been provided around the needle through an annulus established by a sleeve concentrically disposed over the needle. This flow of liquid into the eye is necessary to prevent collapse of the interior chamber of the eye during aspiration. In addition, the irrigation fluid cools the needle in order to prevent any thermal damage of the corneal or sclera tissue. While the sleeve surrounding a phacoemulsification needle provides the important function of establishing an annulus for introducing irrigation fluid into the lens capsule it also enlarges the overall diameter of the sleeve needle for which an incision must be made.

In addition, when irrigation fluid is introduced proximate the emulsifying needle tip, the immediate area in front of the needle is roiled. This occurs because of the counter-current flow of fluid being aspirated by the needle itself and the irrigation fluid being introduced over the surface of the needle. Needle vibration causes a cloud of debris which is roiled by the incoming infusion fluid which lessens the physicians visual acuity of the end of the needle which can slow the procedure. This roiling also pushes nuclear fragments away from the needle rendering the procedure less efficient.

The present invention overcomes the drawbacks of a sleeved phacoemulsification needle.

SUMMARY OF THE INVENTION

Apparatus in accordance with the present invention includes a first instrument for inserting into a lens capsule and removing a cataract therein, the needle including a lumen therethrough for aspiration of lens tissue and irrigation fluid from said lens capsule through a primary aspiration port defined by an end of said lumen and a second instrument for inserting into the lens capsule and manipulating the cataract as the cataract is being removed, said second instrument having an irrigation port for introducing the irrigation fluid into said lens capsule.

More specifically, the second instrument may include a tip, such as a hook or blade, attached to a shaft for manipulating the cataract and the shaft includes a shaft lumen for delivery the irrigation fluid to the irrigation port. Alternatively, the second instrument may include a conduit attached to the shaft, for delivering the irrigation fluid to the irrigation port. Further, a plurality of irrigation ports may be provided, each in fluid communication with the shaft lumen or conduit.

More specifically, the first instrument may include a sonic or ultrasonic device needle for emulsifying the lens tissue. In this instance, the needle includes a lumen for aspiration of emulsifying lens tissue and aspiration flow from the lens capsule.

DETAILED DESCRIPTION

With reference toFIG. 1, there is shown apparatus10for the removal of lens tissue12which includes a first needle14for introducing an irrigation fluid indicated by the arrow18into a lens capsule20.

Manipulation of the needle14within the lens capsule20is effected through a handpiece24which communicates to a control console26through an irrigation line28. The control console26may be of any suitable type as for example, one manufactured by Allergan, Inc., under the trade name Sovereign.

Also shown inFIG. 1, as well as inFIG. 2, is a second needle32which is ultrasonically vibrated by a handpiece34. Any suitable handpiece may be utilized such as for example, one sold by Allergan, Inc., under the trade name Sovereign. The handpiece34is interconnected to the console26and control thereby through an aspiration line38and a power line40for controlling ultrasonic power delivered to the needle32by the handpiece34.

The second needle32fragments or emulsifies the cataractic lens12which is then aspirated along with irrigation fluid through a lumen42in the needle32as indicated by the arrow44. Manipulation of the irrigating needle14is effective in enabling more efficient removal of the cataractic lens12as the fluid is now a manipulation tool, moving fragments of lens12to the needle32.

Because the needle32does not include a conventional sleeve (not shown inFIGS. 1 and 2) a smaller incision or wound50is required. The wound size may be as small as 0.8 mm which is to be compared with conventional sleeved needles (not shown) which would require a slit or wound opening, of about 2.5 to 3 mm (or larger).

As more clearly shown inFIG. 2, the needle32includes a primary aspiration port52defined by the lumen42and one or more secondary aspiration ports54,56disposed along a length60of the needle32between the primary aspiration port52and a hub62for attachment of the needle32to the handpiece34.

The secondary aspiration ports54,56may be spaced apart axially from the primary aspiration port and one another as shown inFIG. 2or, alternatively, as shown inFIG. 1, aspiration ports64,66may be disposed along the needle32in a spaced apart radial relationship with one another resulting in aspiration of fluid from the lens capsule20in opposing direction as indicated by the arrows70,72.

The secondary aspiration ports54,56,64,66also provide an important function in maintaining the fluid flow through the needle should the primary aspiration port52become occluded. This insures cooling of the needle32to prevent overheating thereof. Preferably, the secondary aspiration ports54,56,64,66are disposed within 6 mm of the primary aspiration port to insure that their aspirating functionality is performed within the lens capsule20. In order to insure that the majority of aspiration occurs through the primary aspiration port, it is preferred that the total cross-sectional area of the secondary aspiration ports54,56,64,66be no more than 10% of the cross-sectional area of the primary aspiration port52.

The advantages of the unsleeved needle32are more clearly understood with reference toFIGS. 3 and 4.FIG. 3illustrates smooth laminar flow of aspiration fluid as shown by the arrows78into the primary aspiration port52and secondary aspiration ports64,66.

This is to be contrasted with a conventional phacoemulsification needle tip80which is surrounded by a sleeve82for the introduction of irrigation fluid proximate to an aspiration port84as indicated by the arrows86. The sleeve82also has side holes88for irrigation outflow.

As illustrated, aspiration of fluid as indicated by the arrows90,92may be partially diverted from the port84before entering which causes a roiling of the fluid indicated by the arrows96,98. This roiling of fluid causes a “milky cloud” to appear proximate the needle tip80and pushes lens fragments away which interferes with the physician acuity of the needle tip80which interferes with efficient phacoemulsification of lens tissue, not shown inFIG. 4.

With reference toFIG. 5, there is shown in an alternative embodiment100in accordance with the present invention, in reference, characters refer to a similar or substantially identical elements hereinabove discussed in connection with the embodiment10shown inFIG. 1.

Embodiment100includes a second instrument102which includes a vibrated needle104for inserting into a lens capsule106for removing a cataract108therein. The needle104includes a lumen112therethrough for aspiration of cataract tissue from the lens through a primary aspiration port114defined by an end116of the needle104, this aspiration is indicated by the arrow118. Preferably, second aspiration ports120,122are provided in the needle112for aspirating cataractic tissue, as well as irrigation fluid, from the lens capsule106as indicated by the arrows126,128.

A first instrument130, which includes a shaft132and tool tip134, is inserted into the lens capsule106for manipulating the cataract108as the cataract108is being emulsified by the needle104.

The first instrument130includes one or more irrigation ports136,138,140for introducing irrigation fluid into the eye capsule106as indicated by the arrows140.

An enlarged view of the tool tip34and shaft132are shown inFIG. 6. Irrigation fluid is provided to the ports138,140shown inFIG. 6through a lumen146within the shaft132. Alternatively, as shown inFIG. 7, the tool tip34may be supported by a solid shaft148and a separate conduit150may be utilized to provide irrigation fluid to irrigation ports152,154.

The tool tip134may be of any suitable type, such as for example, a hook or a blade, for manipulation of the cataractic tissue108and may be fixed to a shaft148as shown inFIG. 7or removably coupled to a shaft132by a conventional coupling mechanism160. When a coupler160is utilized, alternative tool tips162, as shown inFIG. 8, may be attached to the shaft132by the user.

The irrigation ports138,140,152,154are preferably spaced apart axially on the shaft132,148respectively or, as illustrated inFIG. 5, there may be also space radially about the shaft. The size of the ports138,140,152,154may be 0.6 to 1.5 mm in order to introduce irrigation fluid164at the rate of 20-60 cc/min. The irrigation port138,140,152,154size and location is dependant upon surgeon technique and incision location.

Although there has been hereinabove described apparatus for the removal of lens tissue in accordance with the present invention for the purposes of illustrating in which the manner in which the invention may be used to an advantage, it will be appreciated that the invention is not limited thereto. Accordingly, any and all modifications, variations, or equivalent arrangements which may occur to those skilled in the art should be considered to be within the scope of the invention as defined in the appended claims.