Abstract:
Embodiments described herein provide ophthalmic surgical instruments. One embodiment provides an instrument including an infusion sleeve, aspiration tube, and infusion/aspiration tip. The sleeve can include a body defining an infusion channel. The tube can be in the infusion channel and define an aspiration channel. The tip can conform to the distal end of the tube. The tip can seal a gap between the sleeve and tube and can include a flange with a profile (e.g., a tapered portion) corresponding to the profile of the sleeve. The sleeve and tip can be keyed such that the sleeve directs fluid in one direction and the tip draws fluid perpendicularly from that direction. The tip&#39;s aspiration channel can extend distally beyond its aspiration port. The tip can extend to a point adjacent to an infusion port of the sleeve. A disposable component (including an aspiration tube and infusion/aspiration tip) for use with instruments is provided.

Description:
BACKGROUND OF THE INVENTION 
     Embodiments relate generally to the field of ophthalmic surgery and more particularly to instruments and methods for removing cataracts. 
     The human eye in its simplest terms functions to provide vision by transmitting light through a clear outer portion called the cornea, and focusing the image by way of the lens onto the retina. The quality of the focused image depends on many factors including the size and shape of the eye, and the transparency of the cornea and lens. 
     When age, disease, trauma, etc. causes the lens to become less transparent, vision deteriorates because of the diminished light which can be transmitted to the retina. This deficiency in the lens of the eye is medically known as a cataract. A generally accepted treatment for this condition is surgical removal and replacement of the lens with an artificial intraocular lens (IOL). 
     SUMMARY OF THE INVENTION 
     Embodiments described herein provide instruments for infusion and aspiration during eye surgery. 
     One embodiment provides an instrument including an infusion sleeve, an aspiration tube, and an infusion/aspiration tip. The infusion sleeve can include a body which defines an infusion channel. The aspiration tube can be positioned in the infusion channel and can define an aspiration channel. The infusion/aspiration tip can couple to and conform to the distal end of the aspiration tube. The infusion/aspiration tip can seal a gap between the infusion sleeve and the aspiration tube. Furthermore, in some embodiments, the infusion/aspiration tip can include a flange with a profile (e.g., a tapered portion) corresponding to a profile of the infusion sleeve. In some embodiments, the infusion sleeve and the infusion/aspiration tip can be keyed such that the infusion sleeve directs fluid in one direction and the infusion/aspiration tip aspirates material from another direction. The infusion and aspiration directions can be perpendicular to each other. The aspiration channel of the infusion/aspiration tip can extend distally beyond the aspiration port. In some embodiments, the infusion/aspiration tip can extend proximally to a point adjacent to an infusion port of the sleeve. 
     One embodiment provides a single use, disposable component for use with an ophthalmic surgical instrument. The instrument can include an infusion sleeve comprising an elongated body defining an infusion channel and having a proximal end, a distal end, and a longitudinal axis along the length of the elongated body whereas the component can include an aspiration tube and an infusion/aspiration tip. The aspiration tube can define an aspiration channel and can have a proximal end and a distal end. When the disposable component is in the instrument, the aspiration tube can be positioned in the infusion channel. The infusion/aspiration tip can couple to and conform to the distal end of the aspiration tube. 
     In some embodiments, when the disposable component is coupled to the instrument, a gap can exist between the distal end of the infusion sleeve and the distal end of the aspiration tube. The infusion/aspiration tip can seal the gap when the disposable component is coupled to the instrument. The infusion/aspiration tip can define an aspiration port oriented to draw material from the environment from a direction which is perpendicular to the longitudinal axis of the disposable component and perpendicular to the direction in which an infusion port of the infusion sleeve directs infusion fluid when the disposable component is coupled to the instrument. In some embodiments, when the disposable component is coupled to the instrument, the infusion/aspiration tip can extend in a direction along the longitudinal axis to a point adjacent to the infusion port. 
     Embodiments provide instruments which reduce patient trauma during cataract extraction and other ophthalmic procedures. More particularly, embodiments provide instruments which reduce, if not eliminate, the possibility of tears in capsular bags due to micro burrs on various instruments. Embodiments provide inexpensive and disposable aspiration tubes for ophthalmic instruments. In some embodiments, leakage of infusion fluid between the infusion sleeve and the infusion/aspiration tip can be eliminated or greatly reduced. Embodiments eliminate the need to clean aspiration tubes and infusion/aspiration tips of various ophthalmic surgical instruments following surgery. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
       A more complete understanding of the present invention and the advantages thereof may be acquired by referring to the following description, taken in conjunction with the accompanying drawings in which like reference numbers indicate like features. 
         FIG. 1  is a cross sectional view of an eye undergoing ophthalmic surgery. 
         FIG. 2  is a perspective view of one embodiment of an ophthalmic surgical instrument. 
         FIG. 3  is a cross sectional view of one embodiment of an ophthalmic surgical instrument. 
         FIG. 4  is a diagrammatic representation of an embodiment of a curved ophthalmic instrument. 
         FIG. 5  is a diagrammatic representation of an embodiment of a bent ophthalmic instrument. 
     
    
    
     DETAILED DESCRIPTION 
     Preferred embodiments are illustrated in the FIGURES, like numerals generally being used to refer to like and corresponding parts of the various drawings. 
     As used herein, the terms “comprises,” “comprising,” “includes,” “including,” “has,” “having” or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a process, process, article, or apparatus that comprises a list of elements is not necessarily limited only those elements but may include other elements not expressly listed or inherent to such process, process, article, or apparatus. Further, unless expressly stated to the contrary, “or” refers to an inclusive or and not to an exclusive or. For example, a condition A or B is satisfied by any one of the following: A is true (or present) and B is false (or not present). A is false (or not present) and B is true (or present), and both A and B are true (or present). 
     Additionally, any examples or illustrations given herein are not to be regarded in any way as restrictions on, limits to, or express definitions of, any term or terms with which they are utilized. Instead these examples or illustrations are to be regarded as being described with respect to one particular embodiment and as illustrative only. Those of ordinary skill in the art will appreciate that any term or terms with which these examples or illustrations are utilized will encompass other embodiments which may or may not be given therewith or elsewhere in the specification and all such embodiments are intended to be included within the scope of that term or terms. Language designating such nonlimiting examples and illustrations includes, but is not limited to: “for example”, “for instance”, “e.g.”, “in one embodiment”. 
     Previously, to remove a lens from an eye, surgical personnel sometimes used an ophthalmic instrument with an infusion sleeve and an aspiration tube therein. Surgical personnel also used a sleeve made of silicon and having a hole therein for aspirating fluid. Surgical personnel slipped the sleeve over the aspiration tube and then used the instrument for ophthalmic surgery. The sleeves, though, were often difficult to use. For instance, the sleeves could tear thereby making it necessary to remove and replace the damaged sleeve. In addition, once on the aspiration tube, these sleeves could slip off of the aspiration tube making its replacement on the aspiration tube necessary. Moreover, because these sleeves only partially filled the space between the aspiration tube and the infusion tube, some infusion fluid could leak out of the distal end of the instrument and move in a forward direction and into the eye. This condition can be undesirable because surgical personnel typically prefer that the instrument direct the infusion fluid perpendicularly from the instrument while aspirating material longitudinally from the distal end of the instrument. 
     With reference now to  FIG. 1 , a cross sectional view of eye  10  undergoing ophthalmic surgery is illustrated. The procedure illustrated could be a cataract extraction. Eye  10  includes sclera  12 , optic nerve  14 , retina  16 , lens  18 , capsular bag  19 , iris  20 , cornea  22 , and pupil  24 . Normally, lens  18  focuses light passing through cornea  22  and pupil  24  on to retina  16 . Retina  16  converts light to nerve impulses which retina  16  sends along optic nerve  14  to the brain. Iris  20  regulates the amount of light passing through pupil  24  and lens  18  thereby allowing eye  10  to adapt to varying levels of light. Capsular bag  19  holds lens  18  in place and is transparent so that light may pass through it. Thus, the nerve impulses traveling along optic nerve  14  correspond to scenes visible to eye  10 . 
     However, various diseases, conditions, injuries, etc. can cause lens  18  to become clouded, translucent, etc. to the point that it might be desirable to extract lens  18  from eye  10 . In such situations, the affected patient can be said to have a “cataract.” Often, when lens  18  is removed from eye  10  (i.e., the cataract is extracted), surgical personnel replace lens  18  with an artificial lens, thereby restoring sight to the affected patient. Alcon Laboratories, Inc. (of Fort Worth, Tex.) provides exemplary artificial lenses such as the AcrySof® intraocular lenses. To remove lens  18 , surgical personnel sometimes use instrument  100 . As illustrated by  FIG. 1 , instrument  100  can include elongated infusion sleeve  102 , infusion/aspiration tip  104 , and handpiece  113 . Ophthalmic tubing  115  can be connected to instrument  100  at handpiece  113  and can supply infusion fluid from an infusion/aspiration machine to instrument  100  and return material aspirated from eye  10  to the infusion/aspiration machine. Handpiece  113  can provide communication channels between ophthalmic tubing  115  and infusion sleeve  102  and infusion/aspiration tip  104 . Additionally, handpiece  113  can couple with infusion sleeve  102  and indirectly with infusion/aspiration tip  104  (via one or more internal components) thereby holding these components  102  and  104  in fixed operational relationship to each other. 
     To extract the cataract, surgical personnel can make an incision in cornea  22  and capsular bag  19 . Through the incision, surgical personnel can insert infusion/aspiration tip  104  of instrument  100  into lens  18 . Using instrument  100 , surgical personnel can direct infusion fluid from infusion/aspiration tip  104  into lens  18  thereby causing lens  18  to disintegrate. Infusion/aspiration tip  104  can draw the infusion fluid, cortical material, and portions of disintegrated lens  18  from capsular bag  19 . At some time, surgical personnel can withdraw instrument  100  from eye  10 , insert an artificial lens into capsular bag  19  of eye  10 , and close the incision. 
     Previously, during such procedures, micro burrs on surfaces of previously available instruments would catch on, and tear, capsular bag  19 . Furthermore, forward leakage of infusion fluid from previously available instruments could interfere with aspiration of material from capsular bag  19 . Forward leakage can reduce the efficiency of various surgical techniques and increase the time necessary for performing such techniques. Embodiments of instrument  100 , though, can have a smooth, relatively micro burr-free, surfaces. Thus, embodiments of instrument  100  can reduce, if not eliminate, capsular bag  19  tears caused by micro burrs while increasing the speed and efficiency of various ophthalmic techniques. 
       FIG. 2  further illustrates instrument  100  including infusion sleeve  102 , infusion/aspiration tip  104 , infusion port  106 , aspiration tube  108 , aspiration port  110 , distal end  112  of infusion sleeve  102 , flange  114  of infusion/aspiration tip  104 , proximal end  116  of infusion/aspiration tip  104 , tapered portion  118  of infusion/aspiration tip  104 , distal end  120  of infusion/aspiration tip  104 , and longitudinal axis  122  of instrument  100 . Aspiration tube  108  can fit coaxially within infusion sleeve  102  and both can couple to handpiece  113  (see  FIG. 1 ) at their respective proximal ends. Handpiece  113  can provide communication paths from ophthalmic tubing  115  (see  FIG. 1 ) to and from, respectively, infusion sleeve  102  and aspiration tube  108 . Thus, infusion fluid can be directed distally through infusion sleeve  102  and out through infusion port  106  in a direction perpendicular to longitudinal axis  122 . Aspiration port  110  of infusion/aspiration tip  104  can draw material from its environment (for instance, lens  18  of  FIG. 1 ) for return to, for example, an infusion/aspiration machine via aspiration tube  108 . The direction from which aspiration port  110  can draw material can be perpendicular to the direction in which infusion port  106  directs fluid. 
       FIG. 3  illustrates a cross sectional view of one embodiment of instrument  100 . Furthermore,  FIG. 3  illustrates infusion sleeve  102 ; infusion channel  103 ; irrigation/aspiration tip  104 ; aspiration channel  105 ; infusion port  106 ; aspiration tube  108 ; aspiration channel  109 ; aspiration aperture  110 ; distal end  112  of infusion sleeve  102 ; flange  114 ; proximal end  116  of infusion/aspiration tip  104 ; tapered portion  118 ; distal end  120  of infusion/aspiration tip  104 ; longitudinal axis  122 ; and distal end  124  of aspiration tube  108 . More particularly,  FIG. 3  illustrates infusion/aspiration tip  104  being coupled to and conforming to distal end  124  of aspiration tube  108 . In some embodiments, infusion/aspiration tip  104  can be overmolded onto aspiration tube  108 . Aspiration channel  105  of infusion/aspiration tip  104  can align with and correspond to aspiration channel  109  of aspiration tube  108 . In some embodiments, aspiration channel  105  of infusion/aspiration tip  104  can extend distally beyond aspiration port  110 . Aspiration channel  105  of infusion/aspiration tip  104  can communicate with aspiration port  110  thereby allowing instrument  100  to aspirate material generally adjacent to infusion/aspiration tip  104  through aspiration port  110 , aspiration channel  105  of infusion/aspiration tip  104 , and aspiration channel  109  of aspiration tube  108  (and then through ophthalmic tubing  115  for disposal). From aspiration channel  109  of aspiration tube  108 , aspirated material can be returned to an infusion/aspiration machine (or other system for disposal) via ophthalmic tubing  115  (see  FIG. 1 ). 
     Flange  114  of infusion/aspiration tip  104  can abut distal end  112  of infusion sleeve  102  and can seal infusion channel  103  against leakage from distal end  112  of infusion sleeve  102 . Infusion/aspiration tip  104  can extend into infusion channel  103  some distance thereby also sealing against the internal walls of infusion sleeve  102 . Furthermore, infusion/aspiration tip  104  can extend into infusion sleeve  102  to a point adjacent to a portion of infusion port  106  thereby blocking flow through infusion channel  103  and directing infusion fluid out through infusion port  106 . In some embodiments, the interior surface of infusion sleeve  102  can taper away from infusion/aspiration tip  104  in the vicinity of infusion port  106 , thereby allowing flow through infusion port  106  passed infusion/aspiration tip  104 . In some embodiments, infusion/aspiration tip  104  can be retained in infusion sleeve  102  by friction between infusion/aspiration tip  104  and the internal walls of infusion sleeve  102  despite pressure within infusion channel  103 . For instance, infusion/aspiration tip  104  and infusion sleeve  102  can be shaped and dimensioned to create an interference fit when infusion/aspiration tip  104  is inserted into infusion sleeve  102 . Alternatively, some clearance can exist between infusion/aspiration tip  104  and infusion sleeve  102 . In some embodiments, infusion/aspiration tip  104  can be indirectly coupled to handpiece  113  (see  FIG. 1 ) by aspiration tube  108 , thereby allowing it to remain in infusion sleeve  102  despite pressure therein. The indirect coupling of infusion/aspiration tip  104  and handpiece  113  can hold infusion/aspiration tip  104  against distal end  112  of infusion sleeve  102  thereby creating a seal between these two components  104  and  102 . Thus, infusion/aspiration tip  104  can prevent leakage of infusion fluid from infusion sleeve  102  in a direction along longitudinal axis  122 . 
       FIG. 3  also illustrates infusion/aspiration tip  104  including tapered portion  118 . Tapered portion  118  can have a diameter at proximal end  116  of infusion/aspiration tip  104  which is about the same as the diameter of distal end  112  of infusion sleeve  102 . Thus, the profile of infusion/aspiration tip  104  can correspond to the profile of infusion sleeve  102 . Tapered portion  118  can taper to another, smaller diameter some distance from proximal end  116  of infusion/aspiration tip  104 . Thus, the interface between infusion/aspiration tip  104  and infusion sleeve  102 , can be smooth and offer little or no resistance to inserting instrument  100  into eye  10  (see  FIG. 1 ). From the distal end of tapered portion  118 , the surface of infusion/aspiration tip  104  can be parallel to longitudinal axis  122  from approximately tapered portion  118  to approximately the distal edge of aspiration port  110 . 
     Infusion/aspiration tip  104  can be formed from various plastics, elastomers, etc. while infusion sleeve  102  and aspiration tube  108  can be formed from stainless steel, titanium, or any other biocompatible material. In some embodiments, infusion/aspiration tip  104  is made from a plastic material such as Makrolon® 2558 (which is available from Bayer MaterialScience L.L.C. of Pittsburgh, Pa.). Thus, infusion/aspiration tip  104  can have a smooth surface free of sharp edges, micro burrs, etc. Accordingly, infusion/aspiration tips  104  of various embodiments can avoid tearing capsular bag  19 , thereby speeding patient recovery and reducing patient discomfort associated with certain ophthalmic surgical procedures. 
     Moreover, instrument  100  can be quickly assembled by surgical personnel. Instrument  100  can be assembled by sliding aspiration tube  108  (with infusion/aspiration tip  104  overmolded thereon) into infusion sleeve  102 . As infusion/aspiration tip  104  approaches distal end  112  of infusion sleeve  102 , surgical personnel can align infusion/aspiration tip  104  and distal end  112  of infusion sleeve  102 . Surgical personnel can push infusion/aspiration tip  104  into infusion channel  103  thereby sealing distal end  112  of infusion sleeve  102 . Surgical personnel can, when desired, connect infusion sleeve  102  and aspiration tube  108  to handpiece  113 , ophthalmic tubing  115 , etc. (see  FIG. 1 ). 
     Surgical personnel can navigate instrument  100  to the vicinity of eye  10  and begin to insert distal end  120  of infusion/aspiration tip  104  into an incision therein. As infusion/aspiration tip  104  enters eye  10 , smooth surfaces of infusion/aspiration tip  104  can distract tissues it encounters without tearing capsular bag  19  or otherwise traumatizing eye  10 . As surgical personnel advance instrument  100  into eye  10 , tapered portion  118  can also distract tissues without tearing capsular bag  19  or otherwise traumatizing eye  10 . Surgical personnel can therefore manipulate instrument  100  to extract cataracts and other tissues as may be desired. When desired, surgical personnel can withdraw instrument  100  from eye  10 . 
     Surgical personnel can disassemble instrument  100  and dispose of infusion/aspiration tip  104  and aspiration tube  108 . Infusion/aspiration tip  104  and aspiration tube  108  can be relatively inexpensive to manufacture thereby allowing such single uses of infusion/aspiration tip  104  and aspiration tube  108 . Thus, embodiments can alleviate surgical personnel from the need to clean and sterilize infusion/aspiration tip  104  and aspiration tube  108  following various surgical procedures. Moreover, because infusion/aspiration tip  104  and aspiration tube  108  can be pre-sterilized, the need for surgical personnel to clean and sterilize infusion/aspiration tip  104  and aspiration tube  108  (including any crevice that might exist between infusion sleeve  102  and infusion/aspiration tip  104 ) prior to certain ophthalmic surgical procedures can be alleviated by various embodiments. 
     In the previous embodiments, the surgical instrument has a generally straight profile. In  FIG. 4 , one the other hand, surgical instrument  300  can have a curved profile. In  FIG. 4 , instrument  300  can include aspiration sleeve  302 , infusion/aspiration tip  304 , and an attachment portion  306  for attachment to a hand piece. The radius of curvature of aspiration tube  302  can be selected to be extend the entire length of aspiration tube  302  or a portion of the length. One or more sections of aspiration tube  302  can remain straight when the tube is curved. As shown in  FIG. 5 , the curved section may be relatively small and have a small radius, while the remainder of aspiration tube  302  remains straight to give the instrument a bent appearance. For example a straight portion can run from attachment portion  306  to the curved section and another straight portion can run from the curved section to infusion/aspiration tip  304 . In other embodiments, a bent profile can be achieved using a non-curved interface between straight sections. 
     While the disclosure has been described with reference to particular embodiments, it should be understood that the embodiments are illustrative and that the scope of the invention is not limited to these embodiments. Many variations, modifications, additions and improvements to the embodiments described above are possible. It is contemplated that these variations, modifications, additions and improvements fall within the scope of the invention as detailed in the following claims.