Abstract:
A phacoemulsification system and method, and a surgical foot pedal device, system and method. The present invention may include a console comprising a plurality of modes for at least one physically associated surgical instrument, and a foot pedal communicatively associated with said console and suitable for varying ones of the plurality of modes. The foot pedal may include a housing comprising the communicative association, and comprising at least one potentiometer and at least two top switches for the varying of the ones of the plurality of modes, a treadle rotatably mounted within the housing and suitable for depressing the at least one potentiometer, and at least two side switches movably associated with the treadle for the varying of the ones of the plurality of modes.

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS 
       [0001]    This application claims priority to U.S. provisional application No. 61/814,097 filed on Apr. 19, 2013, the entire contents of which is incorporated herein by reference. 
     
    
     TECHNICAL FIELD OF THE INVENTION 
       [0002]    The present invention is generally related to methods, systems and apparatuses for controlling surgical aspects, particularly during treatment of an eye, and more particularly for controlling surgical aspects using a foot pedal. 
       BACKGROUND OF THE INVENTION 
       [0003]    Ophthalmic surgical apparatuses, such as phacoemulsification apparatuses, typically include operating controls for regulating parameters or functions of the apparatuses. A phacoemulsification apparatus is particularly directed to the surgical removal of the natural, crystalline lenses from cataractic eyes, such as to allow for and/or prior to the insertion of an artificial intraocular lens. 
         [0004]    Such an apparatus typically includes a console, power supply, one or more pumps as well as associated electronic hardware for operating a multifunction surgical implement to ultrasonically emulsify eye tissue, irrigate the eye with a saline solution and aspirate the emulsified lens from the eye. Typically, such surgical implements are handheld. 
         [0005]    In view of the handheld nature of the instrumentation necessary for a phacoemulsification procedure, it is generally desirable that the hands of a surgeon remain as free as possible during performance of a surgery. Accordingly, foot controls, such as in the form of a mechanical foot pedal, are frequently provided in order to facilitate use of the handpiece by delegating other control functions to the foot pedal device. 
         [0006]    Any number of foot pedal device systems have been utilized, and those utilized include a variety of pneumatic and electrical actuators to control an ophthalmic surgical apparatus. For instance, improved foot pedal control systems such as those described in U.S. Pat. No. 4,983,901 provide for a great number of control variations and modes for operating phacoemulsification apparatus. One popular type of foot control is termed a dual-control foot pedal because of the two directions of foot movement available to actuate the controls. For example, in a dual-control pedal, a treadle (the actual pedal) may be pivoted in a vertical plane (pitch), as in a standard car accelerator-type pedal, while also being rotated in a horizontal plane, or yaw, direction. In addition to the dual treadle control, one or more other foot-actuated switches placed close to the treadle are often provided for easy access. 
         [0007]    The foot pedal must be user friendly in order to provide a surgeon comfort and reliability in its use, so as not to initiate disruption of the surgeon&#39;s concentration when performing surgery. For example, during control of the foot pedal the surgeon&#39;s posture is influenced by efforts to prevent losing contact with the foot pedal, which is typically achieved by keeping one foot flexed above the pedal and loading the body weight on the other foot. This causes a non-ergonomic posture which can lead to physical discomfort, and sometimes mistakes in control of the foot pedal. 
         [0008]    Furthermore, as may be expected, different types of foot pedals are preferred by different surgeons, with some surgeons preferring an accelerator-type pedal in which the sole of the surgeon&#39;s foot is utilized for depression, while others desire a pedal engageable by the surgeon&#39;s toe in order to depress the pedal. This, of course, has led to the development of a multitude of foot pedal devices of diverse configuration in order to provide the comfort and reliability desired by individual surgeons. For instance, U.S. Pat. No. 6,360,630 to Holtorf discloses a dual position foot pedal rotatably mounted to a base in order to be operated by the toe or sole of a user&#39;s foot. However, even with such flexible designs, a change in foot pedals is often required when a phacoemulsification apparatus is utilized in sequence by different physicians, which is inconvenient and may require recalibration of the apparatus. In addition, such alternative foot pedals may not be available or even offered by a manufacturer. 
         [0009]    Despite the availability of a number of relatively effective foot pedal designs, there is a need for a more ergonomically flexible foot pedal that enhances surgeon comfort and concentration. 
       SUMMARY OF THE INVENTION 
       [0010]    The present invention provides at least phacoemulsification system and method, and a foot pedal device, system and method. The present invention may include a console comprising a plurality of modes for at least one physically associated surgical instrument, and a foot pedal communicatively associated with said console and suitable for varying ones of the plurality of modes. The foot pedal may include a housing comprising the communicative association, and comprising at least one potentiometer and at least two top switches for the varying of the ones of the plurality of modes, a treadle rotatably mounted within the housing and suitable for depressing the at least one potentiometer, and at least two side switches movably associated with the treadle for the varying of the ones of the plurality of modes. 
         [0011]    The invention may further include the foot pedal comprising a heel loop adjacent to a heel-receiving portion of the treadle. The treadle may further comprise a heel cup portion for receiving a user&#39;s heel. The heel cup portion may comprise an elastomer. 
         [0012]    Moreover, the side switches may be undercut with respect to a portion of the housing comprising the top switches. Further, the side switches may be curvilinear. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0013]    The present invention is best understood with reference to the following detailed description of the invention and the drawings, in which: 
           [0014]      FIG. 1  illustrates a prospective view of a foot pedal control for use in the system of  FIG. 6 ; 
           [0015]      FIG. 2  illustrates a cross sectional view of an exemplary a foot pedal control; 
           [0016]      FIG. 3A  illustrates a bottom view of an exemplary a foot pedal control; 
           [0017]      FIG. 3B  illustrates a prospective view of an exemplary a foot pedal control; 
           [0018]      FIG. 4A  illustrates a side view of an exemplary a foot pedal control; 
           [0019]      FIG. 4B  illustrates a cross sectional view of an exemplary a foot pedal control; 
           [0020]      FIG. 5A  is a top view of an exemplary foot pedal of the present invention; 
           [0021]      FIG. 5B  illustrates a cross sectional view of an exemplary a foot pedal control; and 
           [0022]      FIG. 6  is a schematic of an exemplary system in which a foot pedal control may operate. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0023]    Reference will now be made in detail to embodiments of the invention, examples of which are illustrated in the accompanying drawings. While the invention will be described in conjunction with the embodiments, it will be understood that they are not intended to limit the invention to those embodiments. On the contrary, the invention is intended to cover alternatives, modifications, and equivalents, which may be included within the spirit and scope of the invention as defined herein. 
         [0024]      FIG. 1  is a prospective view of an exemplary foot pedal control  100  for use in a surgical system, for instance during an ophthalmic surgery. The foot pedal control  100  comprises a base  130  on which is mounted body housing  120 , a treadle  150 , a heel cup assembly  110 , and an optional carrying handle  170 . The base  130  has an undercarriage  135  arranged to lie flat on a ground surface. More specifically, the undercarriage  135  includes either a flat bottom surface or a series of separate feet that may provide a stable base surface on the ground. The base may provide improved stability in undercarriage embodiments including a gripping surface, such as rubber, rubberized, plastic, or like traction strips or treads (not shown). 
         [0025]    For purposes of orientation, the foot pedal control  100  extends upward from the base  130 , a forward or anterior direction is to the left in  FIG. 1  and a rearward or posterior direction is to the right. Furthermore, in an embodiment the treadle  150  is symmetric about a vertical medial plane bisecting the treadle into two substantially symmetric lateral (left and right) halves. The various components of the foot pedal control  100  may be made from any suitable material, such as stainless steel, titanium, or plastic. In an exemplary embodiment, the treadle  150  and heel loop  116  may comprise at least one metal and the housing  120  may comprise carbon-plastic. 
         [0026]    Top switch assemblies  162  may be suitably and actuatably mounted on the body housing  120 . In embodiments, side switches  164  may be suitably and actuatably mounted to, and/or movably associated with, treadle  150 . 
         [0027]    The heel cup assembly  110  may include an upper portion comprising a heel loop  116  and a lower portion comprising an upper heel cup portion  112  and a lower heel cup portion  114 . The heel loop  116  may be substantially rigid and may or may not be static during use of foot pedal control  100 . Further, the heel loop may be adjustable, such as by allowing for an increase or decrease in the lateral distance from the rearmost point of the heel loop  116  and the frontmost portion of the pedal. 
         [0028]    The lower portion of heel cup assembly  110  may provide at least one angular portion to contact at least a portion of the side of a user&#39;s heel. For example, upper heel cup portion  112  may be angled and/or raised above lower heel cup portion  114  such that an object at rest of upper heel cup portion  112  may move towards lower heel cup portion  114  under the force of gravity. The heel cup portion may provide for ergonomic and comfortable receiving of the user&#39;s heel, and as such may be formed of an elastomeric material. 
         [0029]    As referenced, the heel loop  116  may be adjustable and may be moved along the anterior-posterior axis to allow for various foot/heel sizes. Similarly, both upper heel cup portion  112  and a lower heel cup portion  114  may be adjustable and may, for example, have their angle relative to each other changed by the user to conform more suitably with the user&#39;s heel. The heel cup assembly  110  may also be customizable and may be interchangeable. Further, in an embodiment of the present invention, both upper heel cup portion  112  and a lower heel cup portion  114  may be adjustable independently from heel loop  116 . The heel loop  116  may be affixed to or integrally formed with the base  130 , for example, to allow for more easy interchangeability of both upper heel cup portion  112  and a lower heel cup portion  114 . For example, a variety of heel cup assemblies may be provided to accommodate various foot sizes, shapes and/or desired support and may be inserted into foot pedal control  100  on a user-by-user basis. 
         [0030]    Heel loop  116  may also be used as a handle for moving foot pedal control  100  and as a resting place for the foot, providing a portion of the foot pedal control  100  on which a user&#39;s foot may rest away from active portions of the foot pedal control  100  such as, for example, one of the two switches  162 . More particularly, the heel loop may provide, for example, a carrying handle in embodiments in which the loop is not adjustable, in embodiments in which the adjustability of the heel loop may be locked, and in embodiments in which the handle  170  is removed and/or is not connected to the foot pedal control  100 . 
         [0031]    Yet further, the heel loop may accordingly allow for a user to make fine adjustments in the position of the foot pedal. For example, a user may raise her heel against a portion of the heel loop, thereby lifting the heel loop slightly, and, accordingly, thereby slightly raising the rearmost portion of the foot pedal to allow for positional adjustment of the pedal. Further detail on such embodiments is provided below. 
         [0032]      FIG. 2  illustrates a section view of the foot pedal control  100  and is shown orientated with the anterior on the right and the posterior of foot pedal control  100  on the left. The base  130  may have attached thereto a holder assembly  210  which may receive and provide support for a pin associated with treadle  150 . The pin may pass through the posterior end of the treadle  150  and may be perpendicular to the anterior-posterior axis of the foot pedal control  100 . The pin passing through the treadle  150  may engage at least one holder assembly  210  and may engage at least one potentiometer  200 , and may be statically engaged with treadle  150 . 
         [0033]    As pressure is exerted on treadle  150 , treadle  150  may rotate about the linear axis of the pin and may cause the potentiometer  200  to rotate and/or be depressed, thereby generating an electrical signal correspondent to the resistance change which is itself correspondent to the distance traveled by the treadle  150  at its anterior end. The signal generated by the potentiometer  200  may be received by the surgical console and may allow a program run on the console to determine the position of the treadle  150 . In this way, the user may control different modes and/or functionality provided through the surgical console. As explained in greater detail below, such modes and functionalities associated with various treadle positions may be customizable. The signal from the potentiometer  200  may be received by an encoder to provide a control signal to the surgical console. The encoder (not shown) may be included in the foot pedal control  100  and may communicate with the surgical console in various ways as described below. 
         [0034]    As illustrated in  FIG. 3 , the base  130  and, more specifically, the undercarriage  135  may include at least two portions  310  and  311 . Portion  310  may comprise a material having a lower friction coefficient than the material of portion  311  to allow for the foot pedal control  100  to be more easily moved when tipped forward in part by substantially limiting contact with the ground by portion  310 . For example, a user may raise the posterior end of the foot pedal control  100  using one&#39;s toes on the bottom portion of heel loop  116 , and may thereby maneuver the foot pedal control  100  by sliding substantially on portion  310 . Although any number of low friction materials may be used, portion  310  may preferably comprise Teflon® and/or Teflon® like materials to allow for portion  310  to readily slide, such as when only portion  310  is frictionally in contact with the floor. Of course, portion  310  may comprise any material suitable for the undercarriage of a surgical foot pedal, and may be partially a high friction surface and partially the aforementioned low friction surface. For example, portion  310  may include rubber and/or rubberized plastics. 
         [0035]    The foot pedal control  100  may be moved by hand or foot and may be preferably moved utilizing handle  170  and/or recess  330 . Although either may be grasped by the hand, recess  330  of heel loop  116  may be best utilized by the toe(s) of a user and may allow for positioning of the foot pedal control  100  by a user&#39;s foot. For example, a user my insert at least one toe into the recess  330  and raise the foot pedal control  100  off the ground at an angle sufficient to allow the foot pedal control  100  to slide along the floor substantially on portion  310 . As would be appreciated by those skilled in the art, the movement of the foot pedal control  100  may be forward and backwards and side to side as may be allowable by pivoting the foot pedal control  100  from recess  330 . 
         [0036]    Although handle  170  may be used by the foot of a user, it is preferably used by the hand of the user and may be removable so as to, for example, prevent interference with the use of foot pedal control  100 . As illustrated in  FIG. 3B , alternative embodiments of handle  170  may be employed. For example, the handle  170  may be attached to the posterior end of the housing  120  and may be located above the base  130 . As discussed above, in this embodiment handle  170  may similarly be removable and/or may be attached in various locations on the housing  120  and/or base  130 . 
         [0037]    At least one foot  320  may be included in the base  130  and/or the undercarriage  135 . Foot  320  may be composed of a high friction and/or non-slip material, such as a rubber, to prevent the foot pedal control  100  from inadvertently moving. Foot  320 , if located in portion  310 , may be composed of the same material as a foot  320  located in portion  311  or of a material having a smaller coefficient of friction than a foot  320  located in portion  311 . Although the foot  320  is illustrated as a round object in  FIG. 3 , for example, foot  320  may be of any shape and may for example, comprise a larger area of undercarriage  135 . 
         [0038]      FIG. 4A  is a side view of foot pedal control  100  showing the dissection used for the front dissection view illustrated in  FIG. 4B . As illustrated in  FIG. 4B , the top switch assemblies  162  may be affixed to housing  120  and may not engage treadle  150 . Top switch assembly  162  may be activated by any part of the user&#39;s foot and may be preferably activated by the underside of a user&#39;s foot by depressing the movable portion of the switch assembly  162  towards the base  130  of foot pedal control  100 . Side switch assemblies  164  may be affixed to the treadle  150  and/or otherwise movably associated with treadle  150 , may be activated by any part of the user&#39;s foot, and may be preferably activated by the side of a user&#39;s foot by depressing the movable portion of the switch assembly  164  towards the housing  120  of foot pedal control  100 . The side switch assemblies  164  may be connected with at least one PCB (Printed Circuit Board), which may interface to a main connect, such as may be communicatively connected to the console, at or near the front portion of the pedal, such as through cabling under treadle  150 . The cabling under the treadle  150  may comprise waterproof housing and may be sealed at points of intersection and connection with other aspects of foot pedal control  100  to maintain the overall waterproof nature of foot pedal control  100 . 
         [0039]    Side switch assemblies  164  may include at least one curved portion suitable for providing a receiving area for a portion of the user&#39;s foot. More particularly, the curvilinear portion may allow for the at least partial surrounding/receiving of at least a portion of the side of a user&#39;s foot. For example, a user may slide her right foot to the right side of the treadle  150  to engage the curved portion of the right side switch assembly  164 . The curved portion may allow the user to feel engagement with side switch assembly  164  without activating the function provided by the switch. Accordingly, the instant side switches may assist in avoiding accidental actuation of the side switches. 
         [0040]    When the treadle  150  is in the rest position, as illustrated in  FIG. 4B , the top of side switch assembly  164  may be recessed below the top of top switch assembly  162  and may preferably be level with the top planar surface of top switch assembly  162  accessible by the user. As illustrated in  FIG. 4B , top planar surface of top switch assembly  162  accessible to the user may be angled towards the treadle  150  to provide easier access by the user and to be more ergonomically situated. The undercut positioning of side switch assembly  164  as compared to top switch assembly  162  may prevent accidental and/or unwanted activation of a particular switch and may provide the user with increase tactile awareness of the position of the desired switch. 
         [0041]    Each of the top switch assemblies  162  and side switch assemblies  164  may be programmable to control different functions performed through, for example, the surgical console. Similarly, treadle  150  may be programmed to perform various functionalities, and/or provide various modes and/or sub-modes, based on the position of treadle  150  relative to a designated starting position, and additionally based on the actuation of the top and side switches. For example, the starting position of treadle  150  may be designated as the upper most position as illustrated in  FIG. 1  with at least two, three, or more additional positions delineated by, for example, preprogrammed correspondence or by the user. For example, the third position in a three position embodiment may be the lowest position of the treadle  150  with the reaming two positions located between the upper and lowest positions and roughly spaced between those positions. 
         [0042]    Each position may be reached through depression of the treadle  150  by, for example, a user&#39;s foot, and may be visually indicated on at least one graphical user interface (GUI) of the console associated with the foot pedal control  100 . Further, each position may have associated therewith a tactile, audio and/or motion alert to allow the user to accurately position treadle  150 . For example, such an alert may take the form a sound from the foot pedal control  100  and/or the console, or may be indicated by a vibration provided by the foot pedal control  100  or the potentiometer, which alert may be communicatively received by the user. 
         [0043]    The programmable positions of the treadle  150  may control different functions provided by the console and may be additive in nature. For example, a first position may be programmed to provide an irrigation function, a second position may add an aspiration and irrigation function, and a third position may add an ultrasound function to the aspiration and irrigation function. In addition, as discussed herein, the top switches  162  and side switches  164  may allow for control of the functions activated via the treadle  150 . For example, if an aspiration function is activated via the treadle  150 , at least one side switch  164  may be programmed to control the strength of the vacuum applied. Similarly, at least one top switch  162  may control which function is otherwise controlled by the treadle  150 . For example, a top switch  164  may be programmed to toggle the treadle  150  functionality between aspiration only and a mix of aspiration and irrigation as described above. In another example, a top switch  164  may be programmed to toggle through preprogrammed surgical modes or submodes. 
         [0044]      FIG. 5A  illustrates a top view of foot pedal control  100 .  FIG. 5B  is a cross sectional view of foot pedal control  100  divided as illustrated in  FIG. 5A  and looking towards the posterior end of foot pedal control  100 . In addition to the other features already described herein, a treadle stop  510  may be included. In an embodiment of the present invention, the treadle  150  may generally be of a rectangular shape and may extend to about the top switches  162 . In an alternative embodiment, the treadle  150  may be generally of a triangular shape with the base of the triangle deposed at the anterior end of the foot pedal control  100  to proximately locate side switches  164  to top switches  162 . 
         [0045]    The foot pedal control  100  may be powered by a battery source and may include a rechargeable battery. As may be appreciated by those skilled in the art, a charging station may be used to recharge a rechargeable battery and may be incorporated in the associated console, for example. Similarly, if the foot pedal control  100  is hard wired to the console, such a linkage may provide any necessary power. As with the foot pedal control  100  as a whole, any battery and/or battery compartment may be sufficiently sealed to provide a waterproof system. 
         [0046]    While the present foot pedal control may be used in various environments and applications, a particularly useful application is in an ocular surgical system such as a phacoemulsification/vitrectomy system. For instance,  FIG. 6  illustrates an exemplary phacoemulsification/vitrectomy system  600  in a functional block diagram to show the components and interfaces for a safety critical medical instrument system in which the foot pedal control disclosed herein may be utilized. 
         [0047]    A serial communication cable  602  may connect a GUI  604  and instrument host  606  for the purposes of controlling the surgical instrument host  606  by the GUI host  604 . The instrument host  606  may be considered a computational device in the arrangement shown, but other arrangements are possible. A switch module associated with an exemplary foot pedal  608 , such as described herein, transmits control signals relating internal physical and virtual switch position information as input to the instrument host  606  over a serial communications cable  610 , or wirelessly if desired. Instrument host  606  may provide a database file system for storing configuration parameter values, programs, and other data saved in a storage device (not shown). In addition, the database file system may be realized on the GUI host  604  or any other subsystem (not shown) that could accommodate such a file system. 
         [0048]    The system  600  has a handpiece  612  that typically includes a needle and electrical means, such as a piezoelectric crystal, for ultrasonically vibrating the needle. The instrument host  606  supplies power on line  614  to the operative tip  612 . An irrigation fluid source  616  can be fluidly coupled to operative tip  612  through line  618 . The irrigation fluid and ultrasonic power are applied by the operative tip  612  to an eye  620 , or other affected area or region. Alternatively, the irrigation source may be routed to the eye  620  through a separate pathway independent of the handpiece. Aspiration is provided from the eye  620  by one or more pumps (not shown), such as a peristaltic pump and/or venturi pump, via the instrument host  606 , through lines  622  and  624 . A surgeon/operator may select an amplitude of electrical pulses either using the handpiece, via the instrument host and GUI host, using the foot pedal, and/or voice command. 
         [0049]    An interface communications cable  626  connects to the instrument host  606  for distributing instrument sensor/parameter data  628 , and may include distribution of instrument settings and parameter information, to other systems, subsystems and modules within and external to instrument host  606 . Although shown connected to the instrument host  606 , interface communications cable  626  may be connected or realized on any other subsystem (not shown) that could accommodate such an interface device able to distribute the respective data. 
         [0050]    While the invention has been described in its preferred embodiments, it is to be understood that the words which have been used are words of description and not of limitation. Therefore, changes may be made within the appended claims without departing from the true scope of the invention. 
         [0051]    All references cited herein are hereby incorporated by reference in their entirety including any references cited therein. 
         [0052]    Although the present invention has been described in terms of specific embodiments, changes and modifications can be carried out without departing from the scope of the invention which is intended to be limited only by the scope of the claims.