Patent Document

[0001]    This application is a continuation of U.S. application Ser. No. 09/675,683, filed Sep. 29, 2000, now U.S. Pat. No. ______. 
     
    
     
       FIELD OF THE INVENTION  
         [0002]    The present invention generally pertains to ophthalmic surgical procedures. More particularly, but not by way of limitation, the present invention pertains to combined anterior segment and posterior segment ophthalmic surgical procedures, as well as consumables utilized in such procedures.  
         DESCRIPTION OF THE RELATED ART  
         [0003]    Ophthalmic surgical procedures are commonly classified as anterior segment surgical procedures, such as cataract surgery, and posterior segment procedures, such as vitreoretinal surgery. Traditionally, surgeons who performed anterior segment procedures did not typically perform posterior segment procedures, and vice versa. Therefore, two different sets of instrumentation and associated consumables were created for anterior segment surgery and posterior segment surgery. The Series 20000® Legacy® cataract surgical system, the Phaco-Emulsifier® aspirating unit, and their associated surgical cassettes, drainage bags, and tubing sets available from Alcon Laboratories, Inc. of Fort Worth, Tex. are examples of such anterior segment instrumentation and consumables. The Accurus® 400VS surgical system and its associated surgical cassettes, drainage bags, and tubing sets, are examples of such posterior segment instrumentation and consumables.  
           [0004]    In posterior segment procedures involving phakic eyes, the crystalline lens may be surgically extracted. Such extraction is typically performed using posterior segment instrumentation (e.g. a vitrectomy probe) and consumables via a lensectomy. Due to the anatomical relationship of the lens to the scleratomies, a lensectomy requires the removal of the posterior lens capsule. The removal of the posterior lens capsule precludes the implantation of an intraocular lens (IOL) into the posterior chamber, the anatomically preferred location for IOL implantation. In addition, it is believed that the removal of the posterior lens capsule contributes to secondary complications such as cystoid macular edema.  
           [0005]    Recently, a new procedure typically referred to as a combined anterior segment and posterior segment procedure, or “combined procedure”, has been developed. A posterior segment surgeon typically performs the combined procedure. In an uncomplicated combined procedure, the posterior segment surgeon first performs an anterior segment procedure, such as a cataract removal via phacoemulsification with posterior chamber IOL implantation, using an anterior segment surgical system and its associated consumables. The surgeon then immediately performs a posterior segment procedure using a separate posterior segment surgical system and its associated consumables. In more complicated combined procedures, the posterior chamber IOL implantation is often deferred until completion of the posterior segment procedure.  
           [0006]    Even more recently, surgical systems have been developed that support both an anterior segment procedure and a posterior segment procedure via a single surgical console. An example of such a system is the Accurus® 600DS surgical system available from Alcon Laboratories, Inc. Two groups of consumables (surgical cassette, drainage bag, tubing sets) are currently available for use with this surgical system.  
           [0007]    The first group of consumbables is the Accurus® Anterior Pak available from Alcon Laboratories, Inc., which is for use only in anterior segment procedures. A schematic representation of the consumables in the Accurus® Anterior Pak, in their assembled form, is shown in FIG. 1. The Accurus® Anterior Pak includes a surgical cassette  10  having a vacuum chamber  12 , an irrigation inlet  14 , an irrigation outlet  16 , and an aspiration port  18 . As shown schematically in FIG. 1, a series of manifolds  22  fluidly couple vacuum chamber  12 , irrigation inlet  14 , irrigation outlet  16 , and an aspiration port  18 . Cassette  10  is disposed in a cassette receiving mechanism (not shown) in the Accurus® surgical system. As shown schematically in FIG. 1, the cassette receiving mechanism includes a series of occluder valves  24  and microreflux valves  26  for opening and closing various portions of manifolds  22 . Cassette  10  further includes a pump manifold  20  that is used to drain aspirated fluid from vacuum chamber  12  into a drain bag (not shown) connected to cassette  10 . A bottle  28  containing a conventional ophthalmic infusion fluid  30 , such as saline solution or BSS PLUS® intraocular irrigating solution available from Alcon Laboratories, Inc., is disposed above cassette  10 . Bottle  28  is not part of the Accurus® Anterior Pak. Bottle  28  is fluidly coupled to irrigation inlet  14  via tubing  32 . A conventional drip chamber  34  may be fluidly coupled between bottle  28  and tubing  32 . Tubing  36  is fluidly coupled to irrigation outlet  16 . The distal end  38  of tubing  36  is for fluidly coupling to a conventional irrigation handpiece, the irrigation inlet of a conventional irrigation/aspiration handpiece, or the irrigation inlet of a conventional ultrasonic handpiece. Tubing  40  is fluidly coupled to aspiration port  18 . The distal end  42  of tubing  40  is for fluidly coupling to the aspiration port of a conventional ultrasonic handpiece, or to the aspiration port of a conventional irrigation/aspiration handpiece. Tubing  32 ,  36 , and  40  are preferably conventional medical grade flexible tubing.  
           [0008]    The second group of consumbables is the Total Plus™ Pak available from Alcon Laboratories, Inc., which is for use only in posterior segment procedures. A schematic representation of the consumables in the Total Plus™ Pak, in their assembled form, is shown in FIG. 2. The Total Plus™ Pak includes a surgical cassette  50  having a vacuum chamber  52 , a first aspiration port  54 , and a second aspiration port  56 . As shown schematically in FIG. 2, a first manifold  58  fluidly couples vacuum chamber  52  and port  54 , and a second manifold  60  fluidly couples vacuum chamber  52  and port  56 . Cassette  50  is disposed in a cassette receiving mechanism (not shown) in the Accurus® surgical system. As shown schematically in FIG. 2, the cassette receiving mechanism includes a series of occluder valves  62  and microreflux valves  64  for opening and closing various portions of manifolds  58  and  60 . Cassette  50  further includes a pump manifold  66  that is used to drain aspirated fluid from vacuum chamber  52  into a drain bag (not shown) connected to cassette  50 . Tubing  68  is fluidly coupled to aspiration port  54 . The distal end  70  of tubing  68  is for fluidly coupling to a conventional extrusion handpiece or a conventional ultrasonic handpiece used for pars plana lensectomy. Tubing  72  is fluidly coupled to aspiration port  56 . The distal end  74  of tubing  72  is for fluidly coupling to the aspiration port of a conventional vitrectomy probe. A bottle  28  containing a conventional ophthalmic infusion fluid  30 , such as saline solution or BSS PLUS® intraocular irrigating solution, is disposed above cassette  10 . Bottle  28  is not part of the Total Plus™ Pak. Bottle  28  is fluidly coupled to tubing  76 . A conventional drip chamber  78  may be fluidly coupled between bottle  30  and tubing  76 . A stopcock  80  is fluidly coupled to tubing  76 , and a stopcock  82  is fluidly coupled to stopcock  80 . Stopcocks  80  and  82  are preferably conventional three-way stopcocks. An outlet  84  of stopcock  82  is for fluidly coupling to a conventional infusion cannula. An inlet  86  of stopcock  80  is for fluidly coupling to a source of pressurized air that can be used to perform a fluid/air exchange during a posterior segment procedure. An inlet  88  of stopcock  82  is for fluidly coupling to a source of pressurized gas, such a perfluorocarbon gas, that can be used to perform a fluid/gas exchange, or an air/gas exchange, during a posterior segment procedure. Tubing  68 ,  72 , and  76  are preferably conventional medical grade flexible tubing.  
           [0009]    Therefore, the Accurus® 600DS surgical system, and its associated consumbables, greatly simplify the combined anterior segment and posterior segment ophthalmic surgical procedure. However, even with the Accurus® 600DS surgical system, a combined procedure requires the use of two separate sets of consumables. When changing from an anterior segment procedure to a posterior segment procedure, the surgeon and his or her staff must remove the anterior segment consumbables and set up the surgical system with the posterior segment consumbables. Therefore, a need continues to exist in the ophthalmic surgical field for ways to further simplify the combined anterior segment and posterior segment procedure for the surgeon.  
         SUMMARY OF THE INVENTION  
         [0010]    The present invention is directed to a surgical cassette for use in a combined ophthalmic surgical procedure. The surgical cassette includes an irrigation inlet for receiving irrigation fluid from a source, a first irrigation outlet for providing irrigation fluid to a first ophthalmic microsurgical instrument, a first manifold fluidly coupling the irrigation inlet with the first irrigation outlet, a second irrigation outlet for providing irrigation fluid to a second ophthalmic microsurgical instrument, and a second manifold fluidly coupling the irrigation inlet with the second irrigation outlet. The surgical cassette greatly simplifies the combined procedure by eliminating the need for separate anterior segment and posterior segment cassettes for the combined procedure. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0011]    For a more complete understanding of the present invention, and for further objects and advantages thereof, reference is made to the following description taken in conjunction with the accompanying drawings in which:  
         [0012]    [0012]FIG. 1 is a schematic view of a conventional set of anterior segment consumables in their assembled form;  
         [0013]    [0013]FIG. 2 is a schematic view of a conventional set of posterior segment consumbables in their assembled form;  
         [0014]    [0014]FIG. 3 is a front, perspective view of a surgical cassette for a combined ophthalmic surgical procedure according to a preferred embodiment of the present invention;  
         [0015]    [0015]FIG. 4 is a rear, perspective view of the surgical cassette of FIG. 3;  
         [0016]    [0016]FIG. 5 is a front, perspective view of the body of the cassette of FIG. 3;  
         [0017]    [0017]FIG. 6 is a rear, perspective view of the body of the cassette of FIG. 3;  
         [0018]    [0018]FIG. 7 is a front, perspective view of the cover of the cassette of FIG. 3;  
         [0019]    [0019]FIG. 8 is a front schematic view of the fluidics of the cassette of FIG. 3;  
         [0020]    [0020]FIG. 9 is a front schematic view of the cassette of FIG. 3 being used in a combined ophthalmic surgical procedure according to a preferred method of the present invention; and  
         [0021]    [0021]FIG. 10 is a perspective, partially sectional view of a package for the cassette of the present invention and its associated consumables.  
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0022]    The preferred embodiment of the present invention and its advantages are best understood by referring to FIGS. 3 through 10 of the drawings, like numerals being used for like and corresponding parts of the various drawings.  
         [0023]    [0023]FIGS. 3 through 8 illustrate a surgical cassette  100  according to a preferred embodiment of the present invention. Surgical cassette  100  is especially designed for use in a combined anterior segment and posterior segment ophthalmic surgical procedure, or “combined procedure”. Cassette  100  is preferably formed from a body  102  and a mating cover  104  made of conventional plastics. Cover  104  preferably has a handle  106  for grasping cassette  100 , and a header  107 . Cassette  100  also generally includes a vacuum chamber  108 , and irrigation inlet  110 , an anterior irrigation outlet  112 , a posterior irrigation outlet  114 , a general aspiration port  116 , a posterior aspiration port  118 , a first vacuum chamber port  120 , a second vacuum chamber port  122 , a third vacuum chamber port  124 , and a drainage bag port  126 . The locations of anterior irrigation outlet  112  and posterior irrigation outlet  114  may be reversed, if desired. As shown best in FIG. 6, vacuum chamber port  120  preferably has an oval-shaped geometry that is capable of receiving two manifolds made from conventional medical grade flexible tubing.  
         [0024]    Irrigation inlet  110  is for fluidly coupling to a source of a conventional ophthalmic infusion fluid (not shown), such as saline solution or BSS PLUS® intraocular irrigating solution, via conventional medical grade flexible tubing. By way of example, the source of infusion fluid is preferably a bottle disposed above cassette  100  via a conventional IV pole.  
         [0025]    Referring specifically to FIG. 8, the preferred routings of the various manifolds that define the fluidics of cassette  100  are schematically illustrated. Portions of a manifold on the front side of cassette  100  are designated with solid lines, and portions of a manifold on the rear side of cassette  100  are designated with dashed lines. All of the manifolds of cassette  100  are preferably made from medical grade silicone or other conventional, flexible plastic. More specifically, a manifold  130  fluidly couples irrigation inlet  110  and anterior irrigation outlet  112 . A manifold  132  fluidly couples irrigation inlet  110  and posterior irrigation outlet  114 . Manifolds  130  and  132  are preferably formed as an integral component. A manifold  134  fluidly couples general aspiration port  116  and first vacuum chamber port  120 . A manifold  136  fluidly couples posterior aspiration port  118  and first vacuum chamber port  120 . Manifolds  134  and  136  are preferably formed as an integral component. A conventional vacuum source is preferably fluidly coupled to second vacuum chamber port  122  via a console connection (not shown). This console connection is described in greater detail in U.S. Pat. No. 5,676,530, which is incorporated herein in its entirety by this reference. The conventional vacuum source is preferably part of a conventional ophthalmic surgical system capable of performing a combined procedure, such as the Accurus® 800 CS surgical system. A manifold  138  fluidly couples third vacuum chamber port  124  with drainage bag port  126 . Drainage bag port  126  is for fluidly coupling with a conventional drain bag (not shown) supported by flanges  140 .  
         [0026]    Cassette  100  is for removably disposing in a conventional cassette receiving mechanism of a conventional ophthalmic surgical system such as the Accurus® 800 CS surgical system. The cassette receiving mechanism of the Accurus® surgical system is described in more detail in U.S. Pat. Nos. 5,676,530 and 5,588,815, which are incorporated herein in their entirety by this reference. When cassette  100  is disposed in the cassette receiving mechanism, second vacuum chamber port  122  is preferably fluidly coupled with a conventional source of vacuum within the surgical system. In addition, various portions of the manifolds located on the rear side of cassette  100  are positioned for operative engagement with various occluder valves and microreflux valves located in the surgical system. Each of these valves is preferably a conventional plunger valve that can be actuated to “pinch off” and close the manifolds in response to an electrical signal generated by the surgical system. The microreflux valves preferably have a slightly larger footprint than the occluder valves. More specifically, as shown in FIG. 8, manifold  130  is positioned for operative engagement with an occluder valve  142 . Manifold  132  is positioned for operative engagement with an occluder valve  144 . Manifold  134  is positioned for operative engagement with occluder valves  146  and  148 , and microreflux valves  150  and  152 . Manifold  136  is positioned for operative engagement with occluder valves  146 ,and  154 , and microreflux valve  150 . Furthermore, manifold  138  is positioned for operative engagement with a conventional peristaltic pump (not shown) disposed in the surgical system. Peristaltic pump opens and closes manifold  138  in order to pump aspirated ophthalmic tissue and fluid from vacuum chamber  108 , through third vacuum chamber port  124 , into manifold  138 , through drainage bag port  126 , and into the drain bag.  
         [0027]    Having described the structure of the preferred embodiment of cassette  100 , the preferred method of using cassette  100  in a combined anterior segment and posterior segment ophthalmic surgical procedure in conjunction with a conventional ophthalmic surgical system will now be described in greater detail with reference to FIGS. 3 through 9. Cassette  100  is disposed in the cassette receiving mechanism of the conventional surgical system. A conventional source  160  of ophthalmic infusion fluid  30  is fluidly coupled to irrigation inlet  110  via tubing  162 . The source of ophthalmic fluid may be, by way of example, bottle  28  described hereinabove in connection with FIGS. 1 and 2. In addition, although not shown in FIG. 9, a tube providing pressurized air may be fluidly coupled to tubing  162  so as to provide different infusion pressures for fluid  30  without the necessity of moving source  160  to different heights above cassette  100 . One method of providing such different infusion pressures is to use a vented gas forced irrigation/infusion tubing set available from Alcon Laboratories, Inc. as tubing  162 . A conventional drain bag is attached to cassette  100  via flanges  140 . The bag is fluidly coupled to drainage bag port  126  in the conventional manner. A conventional ultrasonic handpiece  164  is fluidly coupled to cassette  100 . Ultrasonic handpiece  164  is preferably a phacoemulsification handpiece. More specifically, anterior irrigation outlet  112  of cassette  100  is fluidly coupled to irrigation inlet  166  of handpiece  164  via tubing  168 . In addition, aspiration port  170  of handpiece  164  is fluidly coupled to general aspiration port  116  of cassette  100  via tubing  172 . A conventional vitrectomy probe  174  is fluidly coupled to cassette  100 . Probe  174  may be pneumatically or electrically driven, and probe  174  may be a “guillotine style” or a “rotational style” vitrectomy probe. More specifically, aspiration port  176  of probe  174  is fluidly coupled to posterior aspiration port  118  of cassette  100  via tubing  178 . A conventional infusion cannula  180  is fluidly coupled to cassette  100 . More specifically, port  182  of cannula  180  is fluidly coupled to posterior irrigation outlet  114  of cassette  100  via tubing  184 . Tubing  168 ,  172 ,  178 , and  184  are preferably conventional medical grade flexible tubing. Although not shown in FIG. 9, ultrasonic handpiece  164  may be replaced with a conventional irrigation handpiece or a conventional irrigation/aspiration handpiece for certain anterior segment procedures.  
         [0028]    The surgeon typically then performs the anterior segment portion of the combined procedure using ultrasonic handpiece  164 . More specifically, the surgeon selects an anterior segment mode on the conventional surgical system. The anterior segment mode is utilized to control ultrasonic handpiece  164 . In the anterior segment mode, the surgical system actuates occluder valve  142  to open manifold  130 , allowing infusion fluid to flow from irrigation inlet  110  to anterior irrigation outlet  112 . During the procedure, occluder valve  142  may be actuated via the surgical system to start or stop this flow of irrigation fluid as desired. The surgical system also actuates occluder valve  144  to close manifold  132 , preventing the flow of infusion fluid from irrigation inlet  110  to posterior irrigation outlet  114 . The surgical system also actuates occluder valves  146  and  148  to open manifold  134 , providing vacuum to general aspiration port  116 . The surgical system further actuates occluder valve  154  to close manifold  136 , stopping vacuum to posterior aspiration port  118 . Ultrasonic handpiece  164  may then be utilized to perform the anterior segment portion of the combined procedure. During the procedure, cassette  100  provides infusion fluid  30  to infusion inlet  166  of handpiece  164  via anterior irrigation outlet  112  and tubing  168  to cool the tip of handpiece  164  at the intraocular incision and to replace aspirated fluid and tissue. Cassette  100  also provides vacuum to aspiration port  170  of handpiece  164  via general aspiration port  116  and tubing  172 . Such vacuum removes ophthalmic tissue and fluid aspirated by handpiece  164  into vacuum chamber  108  via tubing  172  and manifold  134 .  
         [0029]    During the anterior segment portion of the combined procedure, a surgeon may need to perform a microreflux operation if, by way of example, portions of the posterior capsule or iris become too close to the cutting tip of ultrasonic handpiece  164 . The microreflux operation causes a small pressure wave or impulse to be sent from cassette  100  to aspiration port  170  of ultrasonic handpiece  164  by displacement of a small bolus of fluid within the manifolds of cassette  100 . This pressure wave exits the tip of ultrasonic handpiece  164  and moves the posterior capsule or iris away from the tip of handpiece  164 . More specifically, occluder valve  154  has already been actuated to close manifold  136 , and occluder valve  148  has already been actutated to open manifold  134 , at the beginning of the anterior segment mode. The surgical system actuates occluder valve  146  to close manifold  134 . The surgical system then actuates microreflux valve  150  to momentarily close manifold  134 , displacing fluid and creating a pressure wave that will exit through port  116 . Once the advancing pressure wave passes microreflux valve  152 , the surgical system preferably actuates microreflux valve  152  to close manifold  134 , augmenting the pressure wave. The pressure wave exits port  116  and travels through tubing  172  and aspiration port  170  of handpiece  164  and out through the tip of the handpiece. The surgical system then closes occluder valve  148  and opens occluder valve  146 , before opening microreflux valves  150  and  152 , to prevent microaspiration. If timed correctly, this closing of occluder valve  148  may also augment the microreflux pressure wave. The surgical system reopens occluder valve  148  to continue normal anterior segment aspiration.  
         [0030]    The surgeon then typically performs the posterior segment portion of the combined procedure using vitrectomy probe  174  and infusion cannula  180 . More specifically, the surgeon selects a posterior segment mode on the conventional surgical system. The posterior segment mode is used to control probe  174  and cannula  180 . In the posterior segment mode, the surgical system actuates occluder valve  144  to open manifold  132 , allowing infusion fluid to flow from irrigation inlet  110  to posterior irrigation outlet  114 . During the procedure, occluder valve  144  may be actuated via the surgical system to start or stop this flow of irrigation fluid as desired. The surgical system also actuates occluder valve  142  to close manifold  130 , preventing the flow of infusion fluid from irrigation inlet  110  to anterior irrigation outlet  112 . The surgical system also actuates occluder valves  146  and  154  to open manifold  136 , providing vacuum to posterior aspiration port  118 . The surgical system further actuates occluder valve  152  to close manifold  134 , stopping vacuum to general aspiration port  116 . Vitrectomy probe  174  and infusion cannula  180  may then be utilized to perform the posterior segment portion of the combined procedure. During the procedure, cassette  100  provides infusion fluid  30  to port  182  of cannula  180  via posterior irrigation outlet  114  and tubing  184  to maintain appropriate intraocular pressure of the eye. Cassette  100  also provides vacuum to aspiration port  176  of probe  174  via posterior aspiration port  118  and tubing  178 . Such vacuum removes ophthalmic tissue and fluid aspirated by probe  174  into vacuum chamber  108  via tubing  178  and manifold  136 .  
         [0031]    During the posterior segment portion of the combined procedure, a surgeon may need to perform a microreflux operation if, by way of example, portions of the retina become too close to the cutting port vitrectomy probe  174 . The microreflux operation causes a small pressure wave or impulse to be sent from cassette  100  to aspiration port  176  of vitrectomy probe  174 , by displacement of a small bolus of fluid within the manifolds of cassette  100 . This pressure wave exits the cutting port of probe  174 , and moves the retina away from the cutting port of probe  174 . More specifically, occluder valve  148  has already been actuated to close manifold  134 , and occluder valve  154  has already been actuated to open manifold  136 , and the beginning of posterior segment mode. The surgical system actuates occluder valve  146  to close manifold  136 . The surgical system then actuates microreflux valve  150  to momentarily close manifold  136 , displacing fluid and creating a pressure wave that exits through port  118 . This pressure wave travels through tubing  178  and aspiration port  176  of probe  170  and out through the cutting port of the probe. The surgical system then closes occluder valve  154  and opens occluder valve  146 , before opening microreflux valve  150 , to prevent microaspiration. If timed correctly, this closing of occluder valve  154  may augment the microreflux pressure wave. The surgical system reopens occluder valve  154  to continue normal posterior segment aspiration.  
         [0032]    In both the anterior segment portion and the posterior segment portion of the combined procedure, aspirated ophthalmic tissue and fluid is removed from vacuum chamber  108  into a drain bag via third vacuum chamber port  124 , manifold  138 , and drainage bag port  126 . This aspirated fluid is removed via the operative engagement of a peristaltic pump with manifold  138  as described hereinabove.  
         [0033]    [0033]FIG. 10 illustrates an exemplary package  300  for housing cassette  100  and its associated consumables for distribution purposes. Package  300  generally includes a body  302  and a cover  304 . Body  302  has an interior  306  and an opening  308 . Body  302  is preferably formed from conventional plastics in a shape to conveniently store cassette  100  and its associated consumables. Cover  304  is removably coupled to body  302  and is disposed over opening  308 . Cover  304  is preferably formed from a breathable, porous material, such as, by way of example, high density polyethylene. A preferred material for cover  304  is Tyvek® available from E. I. duPont de Nemours and Company of Wilmington, Del. Cover  304  is preferably removably coupled to body  302  via an adhesive. Package  300  is preferably suitable for sterilization via conventional gamma radiation or ethylene oxide processes.  
         [0034]    It will be apparent to those skilled in the art that the surgical system may actuate the occluder valves of cassette  100  to provide irrigation from anterior irrigation outlet  112  and posterior irrigation outlet  114  simultaneously, or to prevent irrigation from both irrigation outlet  112  and posterior irrigation outlet  114 , if desired. Similarly, the surgical system may actuate the occluder valves of cassette  100  to provide for vacuum from general aspiration port  116  and posterior aspiration port  118  simultaneously, or to prevent vacuum to both general aspiration port  116  and posterior aspiration port  118 , if desired.  
         [0035]    From the above, it may be appreciated that the present invention provides a surgeon with a simplified method of performing a combined anterior segment and posterior segment ophthalmic surgical procedure. Significantly, using the present invention, the surgeon no longer must changeover the surgical system from anterior segment consumables to posterior segment consumables in order to complete the combined procedure.  
         [0036]    It is believed that the operation and construction of the present invention will be apparent from the foregoing description. While the apparatus and methods shown or described above have been characterized as being preferred, various changes and modifications may be made therein without departing from the spirit and scope of the invention as defined in the following claims.

Technology Category: 1