Abstract:
A method of conducting traditional two-handed phacoemulsification through two relatively small incisions by using a phacoemulsification tip/sleeve along with a second irrigation tip, with or without an attached manipulation tool.

Description:
This application is a continuation-in-part of U.S. patent application Ser. No. 11/011,417, filed Dec. 14, 2004, currently co-pending, which is a continuation-in-part of U.S. patent application Ser. No. 10/937,065, filed Sep. 9, 2004, also currently co-pending. 
    
    
     BACKGROUND OF THE INVENTION 
     This invention relates generally to the field of cataract surgery and more particularly to a method and apparatus for bi-manual phacoemulsification surgery. 
     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 or disease causes the lens to become less transparent, vision deteriorates because of the diminished light that can be transmitted to the retina. This deficiency in the lens of the eye is medically known as a cataract. An accepted treatment for this condition is surgical removal of the lens and replacement of the lens function by an artificial intraocular lens (IOL). 
     In the United States, the majority of cataractous lenses are removed by a surgical technique called phacoemulsification. A typical surgical handpiece suitable for phacoemulsification procedures consists of an ultrasonically driven handpiece, an attached cutting tip, and irrigating sleeve and an electronic control console. The handpiece assembly is attached to the control console by an electric cable and flexible tubings. Through the electric cable, the console varies the power level transmitted by the handpiece to the attached cutting tip and the flexible tubings supply irrigation fluid to and draw aspiration fluid from the eye through the handpiece assembly. 
     The operative part of the handpiece is a centrally located, hollow resonating bar or horn directly attached to a set of piezoelectric crystals. The crystals supply the required ultrasonic vibration needed to drive both the horn and the attached cutting tip during phacoemulsification and are controlled by the console. The crystal/horn assembly is suspended within the hollow body or shell of the handpiece by flexible mountings. The handpiece body terminates in a reduced diameter portion or nosecone at the body&#39;s distal end. The nosecone is externally threaded to accept the irrigation sleeve. Likewise, the horn bore is internally threaded at its distal end to receive the external threads of the cutting tip. The irrigation sleeve also has an internally threaded bore that is screwed onto the external threads of the nosecone. The cutting tip is adjusted so that the tip projects only a predetermined amount past the open end of the irrigating sleeve. 
     A modified phacoemulsification technique called “bimanual” phacoemulsification has been adopted by many surgeons. With the bimanual technique, the irrigation sleeve is removed from around the ultrasonically drive tip. This allows for the small tip to be inserted into the eye through a smaller incision. Irrigation fluid is supplied by a second irrigating tip. Additional information concerning traditional phacoemulsification and bimanual phacoemulsification is included in U.S. Patent Publication No. US 2003/0004455 A1. And in particular, Paragraphs [0001] through [0008], which are incorporated herein by reference. As described in this reference, traditional phacoemulsification tips/irrigation sleeves have a larger overall diameter, requiring a larger incision. Traditional phacoemulsification tips/irrigation sleeves are also described as causing “roiling” in the area immediately in front of the phaco tip, and visibility-reducing “clouding” of debris. According to this reference, a bi-manual technique solves these and other problems. In the bimanual technique, the incision may be smaller because the irrigation sleeve on the ultrasonic tip is not used, but without the sleeve, there is direct contact between the vibrating tip and the tissue at the wound. This can result in extra stress on the wound tissue, delaying healing and possibly requiring the use of a suture to seal the wound at the completion of surgery. The soft irrigation sleeve also acts to seal the wound from leakage during surgery. Without the use of the irrigation sleeve, excessive wound leakage can cause shallowing of the anterior chamber, excessive turbulence and premature removal of the protective viscoelastic material. Excessive wound leakage can also cause over-hydration of the wound tissue, possibly resulting in edema. 
     Therefore, a need continues to exist for a method and device for conducting phacoemulsification through a small incision. 
     BRIEF SUMMARY OF THE INVENTION 
     The inventors of the present invention have discovered that traditional one-handed phacoemulsification can be conducted through a relatively small incision by reducing the diameter of the phacoemulsification tip/sleeve. A second irrigation tip, with or without an attached manipulation tool, may also be used to provide addition irrigation. Such an arrangement minimizes wound leakage, thereby helping to avoid over-hydration of the wound, low intraocular pressure, excessive turbulence and premature removal of the viscoelastic material. 
     Accordingly, one objective of the present invention is to provide a method for two-handed phacoemulsification with irrigation directed through both incisions. 
     Another objective of the present invention is to provide a small incision phacoemulsification method and apparatus having reduced wound leakage. 
     Another objective of the present invention is to provide a small incision phacoemulsification method and apparatus having reduced turbulence. 
     Another objective of the present invention is to provide a small incision phacoemulsification method and apparatus that minimized premature removal of the viscoelastic material. 
     Another objective of the present invention is to provide a small incision phacoemulsification method and apparatus that minimizes wound hydration. 
     These and other advantages and objectives of the present invention will become apparent from the detailed description and claims that follow. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a partial cross-section of the phacoemulsification and irrigation/aspiration tips that may be used with the present invention. 
         FIG. 2  is a schematic illustration of a phacoemulsification handpiece and irrigation/aspiration handpiece being used for a traditional bi-manual phacoemulsification surgical procedure. 
         FIG. 3  is a schematic illustration of a phacoemulsification handpiece and irrigation handpiece being used for the bi-manual phacoemulsification surgical procedure of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     As seen in  FIGS. 1 and 3 , the method of the present invention is generally practiced using irrigation tip  10  and phacoemulsification tip  12  simultaneously in what is called a “Bi-Manual” surgical technique. Irrigation tip  10  may be any conventional irrigation tip and may include irrigation port  17  and flexible outer silicone sleeve  14  and inner tube  16 . Inner tube  16  may also be formed with hook  15  or some other manipulation device. Space  18  between sleeve  14  and tube  16  defines a pathway for irrigating solution to flow out port  20  and into the surgical site. Port  17  can be used as an additional irrigation port, and irrigating solution may be expressed out of ports  17  and  20 . Phacoemulsification tip  12  is of similar construction and generally contains flexible outer silicone sleeve  22  and inner tube  24  defining a first irrigating fluid path  26  that allows irrigating fluid to flow out of port  30 . Inner tube  24  contains open distal end  28  allowing material to be aspirated through inner tube  24 . Preferably, phacoemulsification tip  12  has a reduced overall diameter, on the order of 0.8 mm to 1.0 mm. Such a small diameter permits an incision size of preferably less than around 2.4 mm in width, even more preferably less than around 2.2 mm in width, and even more preferably less than around 2.0 mm in width, and even more preferably less than around 1.8 mm in width and most preferably less than around 1.6 mm in width. Alternatively, tip may be a liquefracturing tip similar to the AQUALASE® tip sold by Alcon Laboratories, Inc., Fort Worth, Tex. and described more fully in U.S. Pat. No. 6,579,270 B2 (Sussman, et al.) at FIGS. 23 and 24 and column 7, lines 32–45, the contents of which being incorporated herein by reference. 
     As best seen in  FIG. 2 , in a traditional bimanual phacoemulsification technique, irrigation/aspiration handpiece  100  is connected to pressurized or elevated source of irrigation fluid  102  through tubing  103 . Ultrasound handpiece  104  is connected to aspiration pump  106  through tubing  105  and to ultrasound driver  107  through cable  109 . Ultrasound handpiece  104  is not connected to source  102  and does not have any irrigation capabilities. 
     As seen in  FIGS. 1 and 3 , in use, irrigation handpiece  200 , having tip  10 , is connected to pressurized or elevated source of irrigation fluid  202  through tubing  207 , fitting  208  and tubing  203 . Ultrasound handpiece  204 , having tip  12 , is connected to aspiration pump  206  through tubing  205 , to source  202  through tubing  207  and fitting  208  and to ultrasound driver  207  through cable  209 . Preferably, fitting  208  is located at handpiece  204 . Accordingly, both handpiece  200  and handpiece  204  have a common irrigation source and both provide an irrigation function. Irrigation tip  10  is held in one hand by the surgeon and used in a conventional manner to provide an irrigating fluid, such as a saline solution, into eye  32  to help maintain the integrity of the eye and prevent anterior chamber collapse. Phacoemulsification tip  12  is held in the other hand by the surgeon and is connected to a suitable ultrasound handpiece. One suitable handpiece is the INFINITI® system handpiece available commercially from by Alcon Laboratories, Inc., Worth, Tex. Phacoemulsification tip  12  is used to conduct a traditional phacoemulsification technique during which an irrigating fluid, such as a saline solution, is introduced into eye  32  through fluid path  26  and port  30  and debris is aspirated from eye  32  through distal end  28  and inner tube  24 . Such an arrangement prevents direct contact between vibrating inner tube  24 . 
     This description is given for purposes of illustration and explanation. It will be apparent to those skilled in the relevant art that changes and modifications may be made to the invention described above without departing from its scope or spirit.