Patent Document

CROSS-REFERENCE TO COPENDING PATENT APPLICATIONS 
       [0001]    The present application is a continuation-in-part utility patent application from U.S. utility patent application Ser. No. 12/794,715 filed Jun. 4, 2010, now U.S. Pat. No. 8,398,578 issued Mar. 19, 2013, which in turn claims the benefit of priority from U.S. provisional patent application Ser. No. 61/184,399 filed Jun. 5, 2009. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    One aspect of the invention relates to surgical tools in the form of an elongated shaft and tip suited for use in phacoemulsification surgical instruments and irrigation-aspiration instruments. 
         [0004]    2. Discussion of Related Art 
         [0005]    Conventional phacoemulsification tips are sharp and have an overly large port that admits the eye capsule in a blink-of-an-eye. The eye capsule, when sucked into the overly large port, puckers and rips to produce rapidly widening tear lines through which vitreous prolapses, which often leads to vitreous loss. Therefore, the use of such conventional phacoemulsification tips that are sharp with the overly large port run the risk of causing capsule ruptures, which is a very serious intraoperaive, i.e., surgical, complication. As an alternative, femto lasers are used (sometimes referred to as femtosecond lasers) to assist cataract surgery procedures. 
         [0006]    In an article entitled “Femtosecond Laser Cataract Surgery: Advantages Await Clinical Trial Results” by James Brice and published Nov. 26, 2012, Femtosecond laser cataract surgery are discussed. Excerpts from the article are in the following seven paragraphs. 
         [0007]    Femtosecond lasers promise to literally to cut a new edge in terms of the precision and accuracy of incisions made during cataract surgery, according to Calvin Roberts, MD, chief medical officer of Bausch+Lomb. Bausch+Lomb is 1 of 5 companies that produce US Food and Drug Administration-cleared femtosecond laser surgical systems. 
         [0008]    Surgery using handheld instruments is the current standard for treating cataracts, which are responsible for nearly 50% of blindness worldwide. The success of this approach depends to a great extent on the surgeon&#39;s skill and experience. About 10 million cataract surgeries are performed annually worldwide, according to the World Health Organization. Many of those patients could benefit from a conversion to femtosecond lasers guided by ultra-high-resolution 3-dimensional optical coherence tomography (OCT). 
         [0009]    Femtosecond lasers are well suited for cataract surgery because of their ability to tightly focus energy to produce precise surgical incisions, Dr. Roberts said. Cuts of a uniform depth into the lens are possible. The disruptive heat associated with current laser technology is reduced as the laser pulses once every one-trillionth of a second. The ability to focus such energy allows the surgeon to cut deeply on a single plane without collateral damage, he said. 
         [0010]    Results of preliminary research are promising. Femtosecond lasers produce continuous anterior incisions for capsulorrhexis that are twice as strong and more than 5 times as precise in size and shape as manual incisions, according a 2010 study by Palanker and colleagues at Stanford University School of Medicine, Stanford, Calif. 
         [0011]    Palanker and colleagues&#39; research revealed that segmenting and softening the lens with a femtosecond laser simplifies its emulsification and removal. Three-dimensional cutting of the cornea takes advantage of internal pressure in the eye to create self-sealing incisions, and it allows exact placement of the limbal-relaxing incisions, often performed in the same procedure, that are used to treat astigmatism. 
         [0012]    Friedman and colleagues, also at Stanford University School of Medicine, measured the accuracy of an OCT-guided femtosecond laser for cutting specified circles and curved incisions and compared it with manually created capsulorhexis in a small human study. Deviation from the intended diameter of the resected capsule disk was 29 (±26 μm) for the laser technique and 337 μm (±258 μm) for manual incisions. Mean deviations from circularity were 6% for the laser and 20% for manual incisions. 
         [0013]    The advantage conferred by this precision can be applied to corneal incisions, anterior capsulotomy, and lens softening and fragmentation before aspiration, noted Roger F. Steinert, MD, chair of ophthalmology at the University of California, Irvine, School of Medicine. “You can&#39;t do these things repeatedly or dependably when you are operating manually with a blade,” he said. 
         [0014]    Indeed, the safety benefits of femtosecond laser-assisted cataract surgery are mentioned in a further article entitled “Technique yields safety benefits Femtosecond laser-assisted cataract study procedure minimizes corneal trauma” by Cheryl Guttman Krader, reviewed by Zoltan Z Nagy, MD, PhD, and published in Opthalmology Times on Dec. 1, 2012. The article mentions that the increased safety of the femto[second] laser procedure in this study might be attributed to the user of less ultrasound energy during phacoemulsification and was associated with less early corneal edema and better corneal endothelial cell function compared with standard cataract surgery. Average phaco power was reduced by as much as 51% compared to standard cataract surgery and the effective phaco time was reduced by as much as 43% compared to standard cataract surgery. 
         [0015]    An intraocular lens, or IOL, is an artificial lens made of plastic, silicone or acrylic that performs the function of the eye&#39;s natural lens. Most of today&#39;s IOLs are less than a quarter of an inch in diameter and soft enough to be folded so they can be placed into the eye through a very small incision. 
         [0016]    There is a need to reduce a risk of causing capsule ruptures, i.e., by avoiding the use of conventional phacoemulsification tips that are sharp and that have an overly large port. That is, there is a need for phacoemulsification tips that are safe in the sense that they are not as likely to cause capsule ruptures. That is, the surgical tool should be “capsule friendly” to lessen the likelihood of creating capsule ruptures during their use in phacoemulsification surgical procedures or in irrigation-aspiration applications of the eye. 
         [0017]    There is also a need to score and break-up glossy, coagulated walls, whose glossy, coagulated state resulted from impingement by a laser energy beam during the course of Femtosecond laser-assisted cataract surgery. 
       SUMMARY OF THE INVENTION 
       [0018]    One aspect of the invention resides in “capsule friendly” tips suited for use with phacoemulsification type machines and with aspiration-irrigation instruments. Such “capsule friendly” tips achieve safe removal of cataract fractions without sucking in iris tissue or pulling in and thus rupturing the capsule. The “capsule friendly” tips are constructed so only the aspiration of soft cortex occurs while irrigating the area. 
         [0019]    One embodiment resides in a mulberry tip that has protrusions configured to collectively and cooperatively engage with epinucleus cortical material so as, under manual pressure and guidance, to divide cortical fibers of the epinucleus cortical material. The mulberry tip being secured to a hollow shaft of an aspiration-irrigation tool in an airtight manner that is sufficiently tight for a suction force imparted into the hollow of the hollow shaft to suck the divided cortical fibers into the port and then flow through the hollow of the base to reach the hollow of the hollow shaft. Neighboring ones of the protrusions are separated from each other by gaps or recesses. Each of the protrusions have curved external surfaces entirely free of sharp edges. Both the hollow shaft and the hollow base are constructed of materials sufficient to avoid their collapse upon being subjected to the suction force that is of a magnitude necessary for the divided cortical fibers to suck into the port. 
         [0020]    Still another embodiment resides in a hollow tip having a base that extends between proximal and distal ends, with the distal end terminating into a port crossed by micro wires in a shape of a Maltese cross. The proximal end is configured to fit to a hollow shaft in an airtight manner. The airtight manner is sufficiently tight for a suction force imparted into the hollow of the hollow shaft to suck divided cortical fibers of an epinucleus cortical material into the open port about the micro wires and then flow through the hollow of the base to reach the hollow of the hollow shaft. Both the hollow shaft and the hollow base are constructed of materials sufficient to avoid their collapse upon being subjected to the suction force that is of a magnitude necessary for the divided cortical fibers to suck into the open port around the micro wires. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWING 
         [0021]    For a better understanding of the present invention, reference is made to the following description and accompanying drawings, while the scope of the invention is set forth in the appended claims. 
           [0022]      FIG. 1  is an isometric view of a funnel style kugeln tip embodiment in accordance with the invention in which an irrigation/aspiration shaft or needle curves to terminate into a funnel shape with pores directed backward to constitute a distal tip of an irrigation/aspiration surgical hand piece. 
           [0023]      FIG. 2  is an isometric view of a horseshoe style kugeln tip embodiment in accordance with the invention in which an irrigation/aspiration shaft or needle curves to terminate into a horseshoe shape with pores directed backward to constitute a distal tip of an irrigation/aspiration surgical hand piece. 
           [0024]      FIG. 3  is an isometric view of an oblong “Retro” style kugeln tip embodiment in accordance with the invention with longer backward reach in which an irrigation/aspiration shaft or needle curves to terminate into a oblong shape with pores directed backward to constitute a distal tip of an irrigation/aspiration surgical hand piece. 
           [0025]      FIG. 4  is an isometric end view of a cross-bun or Maltese cross tip embodiment in accordance with the invention. 
           [0026]      FIG. 5  is an isometric side view of a cross-bun or Maltese cross tip embodiment in accordance with  FIG. 4 . 
           [0027]      FIG. 6  is an isometric view of a mulberry tip in accordance with a straight shaft embodiment of the present invention. 
           [0028]      FIG. 7  is an isometric view of a mulberry tip in accordance with an indented shaft embodiment of the present invention. 
           [0029]      FIG. 8  is an isometric view of a conventional regular, rounded phacoemulsification tip. 
           [0030]      FIG. 9  is an isometric view of a cataract with the nucleus of the lens being broken up by energy delivered by a laser beam in accordance with conventional techniques. 
           [0031]      FIG. 10  is an isometric view of a conventional smooth, rounded tip having difficulty getting across a tissue peripheral wall (peripheral wall arising from the peripheral effect of an laser energy beam on tissue) in an effort to enter soft cortex for the purpose of aspirating. 
           [0032]      FIG. 11  is an isometric view of a Mulberry tip in accordance with the invention breaking up a tissue peripheral wall (the tissue peripheral wall arising from the peripheral effect an laser energy beam on tissue) that can be pushed more easily than the smooth, rounded tip of  FIG. 10  into the soft tissue of the cortex to start aspirating. 
           [0033]      FIGS. 12-13  are isometric views of side-by-side comparison of the Mulberry tip aspiration/irrigation tool of  FIG. 11  and the conventional smooth, rounded tip aspiration/irrigation tool of  FIG. 10 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0034]    The tips of each of the embodiments include surgical hand piece tips that are suited for ultrasonic phacoemulsification (U-Phaco) type applications, irrigation/aspiration (I/A) type applications or both types of applications. 
         [0035]    Kugeln Tip  60 ,  62 ,  64   
         [0000]    Turning to  FIGS. 1-3 , kugeln tips in accordance with different embodiments of the invention are shown each with a face with pores directed backward toward the surgeon to facilitate the removal of hard-to-get cortex under the port of entry, which is usually the 12 o&#39;clock cortex. 
         [0036]    In the case of  FIG. 1 , a funnel type kugeln tip is shown having a circular disc shaped globe  60  and an irrigation/aspiration shaft or needle  66  that extends within an infusion sleeve  16 . The shaft or needle  66  terminates into a funnel shape that diverges at a transition into a face of the circular disc shaped globe  60 . The pores  68  are directed backward and arranged in the face of the circular disc shaped globe  60  on the same side of the circular disc shaped globe  60  where the shaft or needle  66  funnels into the circular disc shaped globe  60 . There are no pores on the opposite side of the circular disc shape globe  60 . 
         [0037]    In the case of  FIG. 2 , a horseshoe style kugeln tip is shown with a horseshoe shaped globe  62  and an irrigation/aspiration shaft or needle  66  that extends within an infusion sleeve  16 . The shaft or needle  66  terminates into the horseshoe shaped globe  62 . The pores  68  are directed backward in the horseshoe shaped globe  62  on the same side of the horseshoe shaped globe  62  from which approaches the shaft or needle  66  to reach the horseshoe shaped globe  62 . There are no pores on the opposite side of the horseshoe shaped globe  62 . 
         [0038]    In the case of  FIG. 3 , an oblong “Retro” style kugeln is shown having an oblong globe  64  with a longer backward reach that in the case of the embodiments of  FIGS. 1 and 2 . The irrigation/aspiration shaft or needle  66  of  FIG. 3  extends within an infusion sleeve  16  and terminates into the oblong globe  64 . The oblong globe  64  has pores  68  that are directed backward on the same side of the oblong globe  64  that the shaft or needle  66  reaches the oblong globe  64 . There are no pores on the opposite side of the oblong globe  64 . 
         [0039]    Turning to  FIGS. 4-5 , the cross-bun or Maltese cross guard tips  80  resemble conventional U-Phaco and I/A tips the most out of all the embodiments and thus are likely the easiest to retool an existing tip manufacturing facility and thus the easiest for a conventional tip manufacturer to produce. Both U-Phaco and I/A type cross-bun or Maltese cross guard tips  80  look somewhat alike in that the aspiration port of each is located dead front and each has a built-in guard that is all one-piece with the tip. 
         [0040]    The globe of the tip of the cross-bun or Maltese cross type is constituted by a hollow base  86  the extends between proximal and distal ends with two wire arms  82  made of fine smooth micro wires that straddle crosswise the port  84  at the distal end of the hollow base  86 . They minimally bulge to appear slightly rounded and not sharp and connect to the edges of the port widened a bit, as if in shape of a Maltese cross. The two wire arms  82  cross at 90 degrees across the port  84 , thereby dividing the port  84  into four smaller entrances that are each too small for the capsule to enter. The emulsified matter, however, flow faster around the wires, but then quickly join together to flow the full sized channel downstream of the wire part of he port to continue to be aspirated in accordance with the flow dynamics of conventional tips. This cross-bun or Maltese cross type of tip may be considered that of a shaft tip with the aspiration prevented by wire guards from sucking in the capsule and iris. 
         [0041]    The proximal end of the cross-bun or Maltese cross type tip is configured to fit to a hollow shaft in an airtight manner. The airtight manner is sufficiently tight for a suction force imparted into the hollow of the hollow shaft to suck divided cortical fibers of an epinucleus cortical material into the open distal end around the micro wires and then flow through the hollow of the base to reach the hollow of the hollow shaft. Both the hollow shaft and the hollow base are constructed of materials sufficient to avoid their collapse upon being subjected to the suction force that is of a magnitude necessary for the divided cortical fibers to suck into the open distal end around the micro wires. 
         [0042]    Turning to  FIGS. 6 and 7 , two types of mulberry tips  90 ,  92  are shown, i.e.,  FIG. 7  is for a straight phaceoemuslfication shaft and  FIG. 8  is for an indented phacoemulsification shaft. The size of the shaft for each type of mulberry tip  90 ,  92  is the same as that of a shaft of a conventional phacoemulsification rounded tip  100  of  FIG. 9 . The conventional phacoemulsification rounded tip  100  in this example has an end that is to smooth and thus just compresses the cortex material to shrivel it up so it could be aspirated better. 
         [0043]    Each mulberry tip  90 ,  92  has a respective rounded surfacew protrustions  94 ,  96  separated from each other by gaps or recesses  95 . The rounded surface protrusions  94 ,  96  are configured to engage epinucleus cortical material to work as a “battering ram” to divide cortical fibers so they can become dislodged and be aspirated with more ease than for conventional aspiration/irrigation tips  100  of  FIG. 9 . For instance, the rounded surface protrusions  94 ,  96  may take the form of a plurality of rounded protrusions that extend in a direction of elongation of the shaft (from which the mulberry tip extends). The rounded protrusions may be arranged concentric with a center axis of the tip and may be arranged in a symmetrical manner. 
         [0044]    Further, there is a suction port  98  (hole, port or opening) for aspiration that should be sized to prevent sucking in the capsule during aspiration. The smooth, rounded surfaces of the tips form no regions of sharpness that might otherwise cut into the capsule during aspiration. For instance, there are intersecting planar surfaces in such smooth, rounded surfaces of the tips. 
         [0045]    The mulberry tip  90 ,  92  of the present invention is fitted onto a hollow aspiration tube  112  of a conventional aspiration-irrigation instrument or handpiece for removal of the cortex through aspiration, which removal may or may not be in conjunction with Femto[second] laser-assisted cataract surgery. 
         [0046]    The Femto laser is operated to chop or cut the cortex as shown in  FIG. 9  and subsequently aspiration is carried out via a suction port  98  to remove the cortex. The mulberry tip  90 ,  92  used in the manner of  FIG. 11  disrupts soft cortical material better than can be done for smoothly, rounded conventional aspiration/irrigation tips  100  used in the manner of  FIG. 10 . A side-by-side comparison of the surgical tools of  FIGS. 10 and 11  are set forth in  FIGS. 12 and 13 . 
         [0047]    Initially, a Femto laser beam creates a circular opening in the anterior capsule of the cataract. This circular opening is defined by an edge  104  of the capsule following previous capsularhesis (see  FIG. 9 ). 
         [0048]    The Femto laser beam  102  is then directed to scan a grid pattern as it passes through the circular opening defined by the edge  104  to core out the cataract contents  106  contained within the capsular bag and chops the cataract contents  106  (that constitutes the nucleus of the cataract) into chunky pieces  110  of fragmented, deconstructed nucleus) but leaves a smooth, peripheral wall  108  that is more viscous than the softer, adjacent cortical tissue. The smooth, peripheral wall  108  borders around the outer periphery of the energy beam from the laser and lies adjacent to softer, cortical tissue that beyond the smooth, peripheral wall. Indeed, the smooth, peripheral wall is in a somewhat glossy, coagulated state and may be considered an interface constituted by a cylindrical zone of coagulative remnants of cortical material. One might analogize the effect of the laser beam going through the cataract tissue with that of a pineapple core: the laser beam cubes the nucleus into small pieces but leaves the smooth, peripheral wall somewhat coagulated. 
         [0049]    Turning to  FIG. 10 , a conventional aspiration-irrigation tool is shown having a conventional, smooth rounded tip  100  whose proximal end is secured to a distal end of an aspiration tube  112  in any conventional manner (such as with engaging screw threads or friction fit). One can appreciate that the rounded distal end of the conventional smooth, rounded tip  100  renders it difficult for it to grasp the cortex when brought into contact with the wall of the smooth cylinder. 
         [0050]    In a conventional manner, suction is imparted to the hollow tube  112  to suck in cut tissue through the suction port  98 . In a conventional manner, the proximal end of the smooth rounded tip  100  is secured to a distal end of a hollow aspiration tube  112 , such as with engaging screw threads or is friction fit as the case may be. There is also a surrounding concentric sleeve  16  for irrigating the region in the eye while aspiration is being carried out by directing irrigation fluid to flow in the space between the inner surface of the surrounding concentric sleeve  16  the outer surface of the hollow aspiration shaft  112 . 
         [0051]    Turning to  FIG. 11 , the mulberry tip  90 ,  92  of the present invention has no sharp edges—just rounded, surface protrusions  94 ,  96  separated from each other by gaps or recesses. In a conventional manner, the proximal end of the mulberry tip  90 ,  92  is secured to a distal end of a hollow aspiration tube  112 , such as with engaging screw threads or friction fit as the case may be. There is also a surrounding concentric sleeve  16  for irrigating the region in the eye while aspiration is being carried out by directing irrigation fluid to flow in the space between the inner surface of the surrounding concentric sleeve  16  the outer surface of the hollow aspiration shaft  112 . 
         [0052]    Under manual force of sufficient magnitude being imparted to the mulberry tip  90 ,  92 , the mulberry tip  90 ,  92  is urged against a smooth, peripheral wall  108  to wedge cortical tissue of the smooth, peripheral wall  108  into the gaps or recesses that are between neighboring ones of the rounded, surface protrusions  94 ,  96 . The mulberry tip  90 ,  92  readily and easily scores and breaks up the smooth, peripheral wall  108  into crumbled, cortical pieces  114  by virtue of the collective action of the rounded surface protrusions  94 ,  96  that are separated from each other by the gaps or recesses (in effect defining indentations between neighboring ones of the rounded, surface protrusions  94 ,  96 ). 
         [0053]    The rounded, surface protrusions  94 ,  96  resemble a cobblestone layout when viewed from the front end so they can wedge in and loosen cortex tissue that is of a consistency of cream cheese (or in any event more viscous than the adjacent, softer cortex tissue). The loosened cortex tissue is then aspirated into the suction port  98  to enter and pass through the base tube and to reach the hollow aspiration tube  112 . The base tube lies between the surface port  98  and the hollow aspiration tube  112  and is in the vicinity of where the reference line for  90 ,  92  touches in  FIG. 11 . 
         [0054]    The soft, fluffy cortex can then right away be sucked into the suction port  98  and thus be removed—in effect speeding up the cortical removal time over that where the conventional smoothly, rounded tip design is used. Indeed, the protrusions are configured, by virtue of their rounded surfaces separated from each other by gaps or recesses  95 , to collectively and cooperatively engage with epinucleus cortical material under manual pressure and guidance to divide cortical fibers of the epinucleus cortical material. 
         [0055]    The mulberry tip  90 ,  92  has a base tube and is elongated between proximal and distal ends and has the suction port  98  spaced from the proximal and distal ends. However, the base tube is hollow from the port to the proximal end, but need not be hollow all the way to the distal end. Indeed, the protrusions are arranged at the distal end. 
         [0056]    The proximal end connects to the hollow shaft  112  in an airtight manner sufficient to enable a suction force, which is imparted within the hollow shaft  112 , to suck divided cortical fibers of epinucleus cortical material into the port and thereafter flow through the hollow of the mulberry tip  90 ,  92  to enter the hollow of the hollow shaft. 
         [0057]    Both the hollow shaft  112  and the hollow base (between the suction port  98  and the proximal end) are constructed of materials sufficient to avoid collapsing (that would impede or block suction) upon being subjected to the suction force that is of a magnitude necessary for the divided cortical fibers to suck into the port and thereafter flow through the hollow of the mulberry tip  90 ,  92  to enter the hollow of the hollow shaft. 
         [0058]    Any of the “capsule friendly” tips as depicted in all the embodiments of the present invention may be used as the irrigation-aspiration tips for all models and makes of conventional irrigation-aspiration handpieces utilizing in phacoemulsification consoles by conventional manufacturers. The choice of material for the “capsule friendly” tips of any of the embodiments of the present invention may include that of metal or hardened silicone. 
         [0059]    While the foregoing description and drawings represent the preferred embodiments of the present invention, it will be understood that various changes and modifications may be made without departing from the scope of the present invention.

Technology Category: 1