Abstract:
A phacoemulsification apparatus configured for reciprocating a rotary cutting bit, preferably at high frequency. Most preferably, the phacoemulsification apparatus is configured for vibrating and reciprocating the rotary cutting bit in various modes.

Description:
FIELD OF THE INVENTION  
         [0001]    An ultrasonic phacoemulsification apparatus for removing the natural crystalline lens of the eye. The ultrasonic phacoemulsification apparatus according to the present invention is configured for rotary and/or reciprocating motion. In a preferred embodiment, a rotary cutting bit is driven by an ultrasonic hand piece.  
         BACKGROUND OF THE INVENTION  
         [0002]    The conventional phacoemulsification apparatus includes an ultrasonic hand piece and an electrical driver/controller for electronically driving and controlling the ultrasonic hand piece.  
           [0003]    The conventional hand piece includes an ultrasonic transducer configured for vibrating an ultrasonic horn. The ultrasonic horn is provided with a mechanical coupler for releasably connecting a phacoemulsification needle thereto. Thus, when assembled the ultrasonic hand piece drives the phacoemulsification needle at a preselected ultrasonic frequency. The ultrasonic needle is rigidly connected to the hand piece, and is configured not to rotate in any manner and vibrate along with the ultrasonic horn of the hand piece. A resilient sleeve (e.g. made of silicone) is removably connected to the hand piece and surrounds the ultrasonic needle except as the tip thereof.  
           [0004]    The conventional hand piece is connected to a supply of irrigation fluid with an irrigation line made of tubing, and connected to a pump (e.g. peristaltic, venturi, etc.) by an aspiration line made of tubing. During operation, irrigation fluid flows into the conventional hand piece, and is circulated between a passageway defined between the phacoemulsification needle and sleeve and then out of a tip of the sleeve. The fluid enters the eye and is circulated within the eye, and then aspirated through a fluid passageway provided in the phacoemulsification needle.  
         SUMMARY OF THE INVENTION  
         [0005]    An object of the present invention is to provide an improved phacoemulsification apparatus.  
           [0006]    A second object of the present invention is to provide a phacoemulsification apparatus according to the present invention including a rotary reciprocating hand piece, a rotary cutting bit connected to said hand piece, and a device for driving and controlling the hand piece, the device configured for driving and rotating the hand piece and the rotary cutting bit in a reciprocating motion, preferably in a high frequency reciprocating motion.  
           [0007]    A third object of the present invention is to provide a phacoemulsification apparatus according to the present invention wherein the hand piece is an ultrasonic hand piece.  
           [0008]    A fourth object of the present invention is to provide a phacoemulsification apparatus according to the present invention wherein the ultrasonic hand piece includes an ultrasonic transducer.  
           [0009]    A fifth object of the present invention is to provide a phacoemulsification apparatus according to the present invention wherein said ultrasonic transducer is configured for ultrasonically driving the rotary cutting bit in a high frequency rotary reciprocating motion.  
           [0010]    A sixth object of the present invention is to provide a phacoemulsification apparatus according to the present invention wherein the ultrasonic transducer is configured for ultrasonically driving the rotary cutting bit in a high frequency translating motion.  
           [0011]    A seventh object of the present invention is to provide a phacoemulsification apparatus according to the present invention wherein the ultrasonic transducer is configured for ultrasonically driving the rotary cutting bit in a high frequency translating motion.  
           [0012]    An eighth object of the present invention is to provide a phacoemulsification apparatus according to the present invention including a sleeve surrounding at least a portion of the rotary cutting bit.  
           [0013]    A ninth object of the present invention is to provide a phacoemulsification apparatus according to the present invention wherein the sleeve surrounds the rotary cutting bit except for a tip thereof.  
           [0014]    A tenth object of the present invention is to provide a phacoemulsification apparatus according to the present invention wherein the rotary cutting bit is provided with a fluid passageway therethrough.  
           [0015]    An eleventh object of the present invention is to provide a phacoemulsification apparatus according to the present invention including a sleeve surrounding at least a portion of the rotary cutting bit, a device for providing irrigation fluid into the hand piece, and a device for providing aspiration fluid out of the hand piece.  
           [0016]    A twelfth object of the present invention is to provide a phacoemulsification apparatus according to the present invention wherein irrigation fluid is circulated within the hand piece through a first passageway defined by the fluid passageway provided in the rotary cutting bit and out of a tip of the sleeve, and aspiration fluid is then circulated into the tip of the sleeve and through a second passageway defined between the rotary cutting bit and the sleeve.  
           [0017]    A thirteenth object of the present invention is to provide a phacoemulsification apparatus according to the present invention wherein irrigation fluid is circulated within the hand piece through a first passageway defined between the rotary cutting bit and the sleeve, and aspiration fluid is then circulated into the tip of the sleeve and through a second passageway defined by the fluid passageway provided in the rotary cutting bit.  
           [0018]    A fourteenth object of the present invention is to provide a phacoemulsification apparatus according to the present invention wherein the rotary cutting bit is provided with cutting teeth provided on an end face thereof A fifteenth object of the present invention is to provide a phacoemulsification apparatus according to the present invention wherein the teeth are radially aligned extending from a center portion to an outer portion of the end face of the rotary cutting bit.  
           [0019]    The present invention is directed to an improved phacoemulsification apparatus including a rotary cutting bit. The phacoemulsification apparatus according to the present invention is configured to drive the rotary cutting bit in one direction (i.e. clockwise or counter-clockwise) or is two (2) directions (i.e. clockwise and counter-clockwise). Preferably the phacoemulsification apparatus is configured to drive the rotary cutting bit in a reciprocating motion, and more preferably, a high frequency reciprocating motion. Most preferably, the phacoemulsification apparatus is configured to drive the rotary cutting bit with an ultrasonic frequency reciprocating motion.  
           [0020]    The reciprocating motion can be translational and/or rotational. Specifically, the rotary cutting bit can be driven to mechanically reciprocate back-and-forth along an axis of its shaft, and/or can be driven to mechanically reciprocate by rotating back-and-forth. The reciprocating motion can be a fixed frequency, randomly changing frequency, and/or non-randomly changing frequency (e.g. cyclic change of frequency). Further, the reciprocating motion can be single frequency or multiple frequency (e.g. 60 Hz with 0.5 mm amplitude vibration provided by mechanical oscillator (i.e. translational) or stepping motor (i.e. rotational) in combination with ultrasonic frequency vibration provided by one or more ultrasonic transducers). 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0021]    [0021]FIG. 1 is perspective view of a hand piece for the phacoemulsification apparatus according to the present invention.  
         [0022]    [0022]FIG. 2 is a side elevational view of the hand piece shown in FIG. 1.  
         [0023]    [0023]FIG. 3 is a detailed longitudinal cross-sectional view of the rotary cutting bit for the phacoemulsification apparatus according to the present invention.  
         [0024]    [0024]FIG. 4 is an end elevational view of the rotary cutting bit for the phacoemulsification apparatus according to the present invention.  
         [0025]    [0025]FIG. 5 is a detailed longitudinal cross-sectional view of an alternative embodiment of a rotary cutting bit for the phacoemulsification apparatus according to the present invention.  
         [0026]    [0026]FIG. 6 is an end elevational view of the rotary cutting bit shown in FIG. 5.  
         [0027]    [0027]FIG. 7 is a diagrammatical view showing an electrical stepping motor for driving the rotary cutting bit for the phacoemulsification apparatus according to the present invention.  
         [0028]    [0028]FIG. 8 is a diagrammatical view of an electrical stepping motor in combination with an ultrasonic transducer configured for both rotating and vibrating in a translational motion the rotary cutting tip for the phacoemulsification apparatus according to the present invention.  
         [0029]    [0029]FIG. 9 is a diagrammatical view of an electrical stepping motor, first ultrasonic transducer, and a second ultrasonic transducer configured for rotating, vibrating in a translational motion, and vibrating in a rotary motion the rotary cutting bit for the phacoemulsification apparatus according to the present invention.  
         [0030]    [0030]FIG. 10 is a diagrammatical view showing a possible configuration for the second transducer of FIG. 9, for providing a vibrating rotary motion for the rotary cutting bit for the phacoemulsification apparatus according to the present invention.  
         [0031]    [0031]FIG. 11 is a diagrammatical view of the phacoemulsification apparatus according to the present invention. 
     
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS  
       [0032]    A phacoemulsification apparatus  10  according to the present invention is shown in FIG. 1. The phacoemulsification apparatus  10  is provided with an irrigation supply  16  (e.g. bottle or bag) and a replaceable tubing set including irrigation tubing  18  and aspiration tubing  20 . Further, the phacoemulsification apparatus  10  includes the main components of a hand piece  12 , control console  14 , personal computer  15 , foot pedal  70  and movable stand  71 .  
         [0033]    The control console  14  is provided with a display  14   a , and touch control buttons  14   b  and  14   c . The back panel of the control console  14  is provided with a conventional AC power jack. The control console  14  contains a variety of electrical components, including a circuit board and microprocessor controller (not shown).  
         [0034]    The personal computer  15  is provided with an integral screen  15   a  and connected to a remote keyboard  15   b . The personal computer  15  is supported above the console  14 . The personal computer  15  is programmed to communicate with the control console  14 .  
         [0035]    A foot pedal  70  is electrically connected to the console  14 . The foot pedal  70  is a multi-position type foot pedal configured to control operation of the phacoemulsification apparatus  10 .  
         [0036]    The hand piece  12  for the phacoemulsification apparatus  10  according to the present invention is shown in detail in FIGS. 2 and 3. The hand piece includes a body  30  containing the components for driving a rotary cutting bit  32 . A soft resilient sleeve (e.g. made of silicone material) surrounds the rotary cutting bit  32  except for a tip  32   a  thereof. The sleeve  34  is configured (i.e. sized and shaped) to be inserted and fit within a small incision made in the eye during phacoemulsification surgery.  
         [0037]    The hand piece  12  is provided with an irrigation fluid port  36  provided with a tubing connector  36   a , and an aspiration fluid port  38  including a tubing connector  38   a . An electrical cable  22  connects to hand piece  12  to the console  14  of the phacoemulsification  10 , shown in FIG. 1.  
         [0038]    The rotary cutting bit  32  is shown in detail in FIGS. 4 and 5. The rotary cutting bit  32  includes a shaft  40  connecting to a drive mechanism enclosed in the body  30  of the hand piece  12 . The shaft  40  is provided with an annular recess  42  to provide a fluid bearing between the inner surface of the sleeve  34  and the outer surface of the rotary cutting bit  32  along shaft  36  to prevent wear or damage to the inner surface of the sleeve  34  by the rotating movement of the rotary cutting bit  32 . The rotating cutting bit  32  is provided with a fluid passageway  44 . In operation, irrigation fluid is provided along irrigation tubing  18  to irrigation fluid port  36  of the hand piece  12 , and flows through the hand piece  12  and then through an annular fluid passageway  46  defined between the shaft  40  of the rotary cutting bit  32  and the sleeve  34 . The irrigation fluid then flows into the eye and is circulated, and then drawn in by suction into the fluid passageway  44  of the rotating cutting bit  32 .  
         [0039]    The rotary cutting bit  32  is provided with a plurality of radially extending teeth  32   a , shown in FIG. 5. The individual teeth  32   a  are radially oriented and extend from a center of the rotary cutting bit  32  to an outer peripheral edge of the rotary cutting bit  32 . The fluid passageway  44  includes a wider inwardly tapering fluid passageway  44   a . The tapering fluid passageway  44   a  provides somewhat of a venturi effect to help facilitate the circulation and aspiration of fluid and lens particles resulting from the phacoemulsification of the natural crystalline lens.  
         [0040]    In an alternative embodiment shown in FIGS. 6 and 7, a rotary cutting bit  32 ′ not provided with a fluid passageway, is used with the phacoemulsification apparatus  10  according to the present invention. In this embodiment, a side port incision is provided in the eye and irrigation fluid is provided through a separate needle or cannula into the side port in the eye. The aspiration of fluid and particles from the natural crystalline lens are aspirated through the annular fluid passageway  46 . Thus, in this embodiment, a fluid passageway  44  of the embodiment shown in FIGS. 4 and 5 is not required.  
         [0041]    The hand piece  12  of the phacoemulsification apparatus  10  according to the present invention can be configured in various manners. Specifically, the hand piece  12  can be configured to provide the following modes of operation:  
         [0042]    1) one direction (e.g. clockwise or counterclockwise) rotary motion of the rotary cutting bit  32 ;  
         [0043]    2) two (2) direction (i.e. clockwise and counterclockwise) rotary motion of the rotary cutting bit  32 ;  
         [0044]    3) ultrasonic translational vibration (i.e. ultrasonic vibration along the longitudinal axis) of the rotary cutting bit  32 ;  
         [0045]    4) ultrasonic rotary vibration (i.e. rotational movement) of the rotary cutting bit  32 ; and  
         [0046]    5) any combination of the above motions.  
         [0047]    These various modes of operation of the rotary cutting bit  32  can be provided by various electrical components or assemblies within the body  30  of the hand piece  12 .  
         [0048]    In the embodiments shown in FIG. 8, an electrical rotary stepping motor  50  is connected to the shaft  40  of the rotary cutting bit  32  by mechanical coupling  52  (e.g. internal threaded shaft  54  of rotary stepping motor  50  and external threaded shaft of the shaft  40 ). The rotary stepping motor  50  is configured to incrementally rotate the rotary cutting bit in one (1) direction (i.e. clockwise or counterclockwise) or two (2) directions (clockwise and counterclockwise). The electronic controller in the console  14  can be programmed so that the magnitude of rotation (i.e. number of degrees and minutes of rotation) can be fixed or varied. The programming can be such that the magnitude can be changed randomly or non-randomly (e.g. cyclically). For example, the magnitude can increase a fixed amount or variable amount each cycle until a preset limit and then return to its initially set lower limit. As shown in FIG. 5, the angle A has a small magnitude (i.e. approximately 10 degrees) versus the larger magnitude shown in FIG. 7 (i.e. approximately 180 degrees). In these embodiments, the rotary cutting bit  32  is rotated back and forth through the angles shown.  
         [0049]    In the embodiment shown in FIG. 9, the rotary stepping motor  50  is mechanically coupled through shaft  56  to ultrasonic transducer  58  configured to ultrasonically vibrate the rotary cutting bit  32  in a translational motion (i.e. vibrating back and forth along the longitudinal axis of the shaft  40  of the rotary cutting bit  32 ).  
         [0050]    In the embodiment shown in FIG. 10, the rotary stepping motor  50  is mechanically coupled via shaft  56  to ultrasonic transducer  58 , which in turn is mechanically coupled via shaft  60  to ultrasonic transducer  62 . The ultrasonic transducer  62  is configured to provide ultrasonic vibrating rotary movement to the shaft  40  of the rotary cutting tip  32 . For example, the ultrasonic transducer  62  can be configured as shown in FIG. 11. Specifically, in this embodiment the shaft  60  is supported by a bearing  64  with an arm  66  connecting the shaft  62  and ultrasonic vibrator  68 . When the ultrasonic vibrator  64  is activated, an ultrasonic vibrating rotary moment is provided along arm  66  to shaft  60 . Thus, an ultrasonic vibrating torsional force is applied along the shaft  60  in a back and forth motion. The frequency and magnitude of the ultrasonic vibrator  68  can be controlled via a program to adjust and change the magnitude and direction of the ultrasonic vibration motion of the shaft  60  mechanically coupled to shaft  40  of the rotating cutting bit  32 .