Abstract:
Phacoemulsification needle tips have indentations formed thereon to allow the needles to be used with torsional motion phaco handpieces and with phaco handpieces producing linear or longitudinal motion.

Description:
PRIORITY 
       [0001]    This application claims priority from U.S. provisional application Ser. No. 60/829,503, filed Oct. 13, 2006, which is incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This disclosure relates to surgical instruments and surgical techniques used in eye surgery and more particularly, to phacoemulsification apparatus and methods for their use. 
       BACKGROUND OF THE INVENTION 
       [0003]    A common ophthalmological surgical technique is the removal of a diseased or injured lens from the eye. Earlier techniques used for the removal of the lens typically required a substantial incision to be made in the capsular bag in which the lens is encased. Such incisions were often on the order of 12 mm in length. 
         [0004]    Later techniques focused on removing diseased lenses and inserting replacement artificial lenses through as small an incision as possible. For example, it is now a common technique to take an artificial intraocular lens (IOL), fold it and insert the folded lens through the incision, allowing the lens to unfold when it is properly positioned within the capsular bag. Similarly, efforts have been made to accomplish the removal of the diseased lens through an equally small incision. 
         [0005]    One such removal technique is known as phacoemulsification. A typical phacoemulsification tool includes a handpiece to which is attached a hollow needle. Electrical energy is applied to vibrate the needle at ultrasonic frequencies in order to fragment the diseased lens into small enough particles to be aspirated from the eye through the hollow needle. Commonly, an infusion sleeve is mounted around the needle to supply irrigating liquids to the eye in order to aid in flushing and aspirating the lens particles. 
         [0006]    It is extremely important to properly infuse liquid during such surgery. Maintaining a sufficient amount of liquid prevents collapse of certain tissues within the eye and attendant injury or damage to delicate eye structures. As an example, endothelial cells can easily be damaged during such collapse and this damage is permanent because these cells do not regenerate. One of the benefits of using as small in incision as possible during such surgery is the minimization of leakage of liquid during and after surgery and the prevention of such a collapse. 
         [0007]    Phacoemulsification needles and tips are well represented in the prior art. Needles and tips of varying configurations are well known. A particular shape for a tip or needle is often dictated by the type of handpiece with which the needle is to be used. 
         [0008]    United States Patent Application Publication 2006/0217672 (Chon) teaches and describes a phacoemulsification tip that is swaged or crimped at its distal end. The tip is intended for use with a handpiece producing torsional motion and the reference teaches that the crimping forms cutting edges at the distal end. 
         [0009]    U.S. Pat. No. 5,725,495 (Strukel et al) teaches and describes a phacoemulsification handpiece, sleeve and tip illustrating a wide variety of tip configurations and needle cross-sectional configurations. 
         [0010]    U.S. Pat. No. 6,007,555 (Devine) teaches and describes an ultrasonic needle for surgical emulsification. The needle and its tip are shown in both circular and oval configurations. 
         [0011]    U.S. Pat. No. 6,605,054 (Rockley) teaches and describes a multiple bypass port phaco tip having multiple aspiration ports and a single discharge port to infuse liquid into the eye. 
         [0012]    U.S. Pat. No. 5,879,356 (Geuder) teaches and describes a surgical instrument for crushing crystalline eye lenses by means of ultrasound and for removing lens debris by suction which demonstrates the use of a sleeve positioned concentric to the needle and having a pair of discharge ports formed thereon. 
         [0013]    U.S. Pat. No. 5,645,530 (Boukhny) teaches and describes a phacoemulsification sleeve, one variation of which has a bellows portion attached to a discharge port ring which directs an annular flow of liquid around the needle and into the eye. The use of the bellows is intended to allow the sleeve to absorb spikes in liquid pressure during the operation. 
         [0014]    Published U.S. Patent Application No. 2003/0004455 (Kadziauskas) teaches and describes a bi-manual phaco needle using separate emulsification and aspiration needles inserted into the eye simultaneously during surgery. 
         [0015]    U.S. Pat. No. 6,077,285 (Boukhny) teaches and describes a torsional ultrasound handpiece configured to impart both longitudinal and torsional motion to a phacoemulsification needle. 
         [0016]    U.S. Pat. No. 6,402,769 (Boukhny) is a continuation in part of the &#39;285 patent and further particularizes the frequencies at which the crystals providing both the torsional and longitudinal motion are activated. 
         [0017]    I have determined that improved results can be achieved using high-speed handpieces in both the longitudinal and torsional direction if the phacoemulsification tip is provided with a particular geometry. I have also determined that these improved results can be achieved using the straight phacoemulsification needle configuration, a configuration which is favored by a considerable number of doctors. 
         [0018]    In accordance with these criteria, I have designed a series of tips that are specifically configured to enhance the emulsifying defect created by the handpiece in the torsional direction. In addition, the improved results are anticipated with the use of handpieces providing longitudinal motion. 
         [0019]    In accordance with an example of the apparatus, a phacoemulsification needle is provided for use with a high-frequency torsional phacoemulsification handpiece as well as a longitudinal handpiece with the needle having a needle tip having a series of indentations formed on the tip proximate the tip opening. 
         [0020]    In a second example, the tip is formed with straight walls and a series of indentations impressed into the walls proximate the tip opening. 
         [0021]    In yet another example of the present invention, the tip is formed with a tapered wall portion and indentations are formed along the tapered portion of the wall proximate the tip opening. 
         [0022]    While the following describes an example or examples of the present invention, it is to be understood that such description is made by way of example only and is not intended to limit the scope of the present invention. It is expected that alterations and further modifications, as well as other and further applications of the principles of the present invention will occur to others skilled in the art to which the invention relates and, while differing from the foregoing, remain within the spirit and scope of the invention as herein described and claimed. Where means-plus-function clauses are used in the claims such language is intended to cover the structures described herein as performing the recited functions and not only structural equivalents but equivalent structures as well. For the purposes of the present disclosure, two structures that perform the same function within an environment described above may be equivalent structures 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0023]    These and further aspects of the present invention will be best understood by reference to the accompanying drawings wherein: 
           [0024]      FIG. 1  is a drawing showing prior art oval and square-shaped tips; 
           [0025]      FIG. 2  is a drawing showing several prior art needle cross-sectional configurations; 
           [0026]      FIG. 3  is a partial lateral sectional view of a phacoemulsification needle tip with the tip walls being unindented proximate the tip opening; 
           [0027]      FIG. 4  is a view along line  4 - 4  of  FIG. 3 ; 
           [0028]      FIG. 5  is a schematic view of the tip of  FIG. 3  showing the tip positioned between two forming die blocks; 
           [0029]      FIG. 6  is a view along  6 - 6  of  FIG. 5  also showing the bend parameters to be met by the forming die blocks; 
           [0030]      FIG. 7  is a partial schematic view showing the forming die blocks contacting the tip of  FIG. 3 ; 
           [0031]      FIG. 8  is a schematic view showing the operation of the forming die blocks as viewed along line  8 - 8  of  FIG. 7 ; 
           [0032]      FIG. 9  is a schematic view showing the tip of  FIG. 7  rotated  90  degrees and the forming die blocks positioned to perform a second operation; 
           [0033]      FIG. 10  is a view along line  10 - 10  of  FIG. 9 ; 
           [0034]      FIG. 11  is a schematic view showing the forming die blocks forming another set of indentations in the tip of  FIG. 3 ; 
           [0035]      FIG. 12  is a view along line  12 - 12  of  FIG. 11 ; 
           [0036]      FIG. 13  is a partial lateral sectional view showing the completed tip; 
           [0037]      FIG. 14  is a view along line  14 - 14  of  FIG. 13 ; 
           [0038]      FIG. 15  is a schematic view showing the tip of  FIG. 3  positioned between angled forming die blocks; 
           [0039]      FIG. 16  is a partial sectional view showing the tip of  FIG. 15  with opposed indentations formed proximate the tip opening; 
           [0040]      FIG. 17  is a top view showing the formation of four indentations 
           [0041]      FIG. 18  is a partial sectional view of the tip of  FIG. 17 ; 
           [0042]      FIG. 19  is a top schematic view of an unindented tip; 
           [0043]      FIG. 20  is a schematic sectional view of the tip of  FIG. 19  showing the placement of a forming block; 
           [0044]      FIG. 21  is a top schematic view of  FIG. 20  showing the positioning of four forming die blocks; 
           [0045]      FIG. 22  is a partial schematic cross-sectional view showing the positioning of two forming die blocks; 
           [0046]      FIG. 23  is a top schematic view showing the formation of indentations by four forming die blocks; 
           [0047]      FIG. 24  is a partial schematic cross-sectional view of  FIG. 23 ; 
           [0048]      FIG. 25  is a top schematic view of  FIG. 23  with the forming die blocks removed; and 
           [0049]      FIG. 26  is a partial schematic sectional view along  26 - 26  of  FIG. 25 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0050]    Referring now to  FIG. 1 , the numeral  10  indicates generally a prior art phacoemulsification needle tip as shown in U.S. Pat. No. 6,007,555. Needle  10  terminates in a mouth  12  defined by a lip  14  at the end of needle body  16 , with lip  14  and needle body  16  formed as having an oval cross-section configuration. 
         [0051]    Referring to  FIG. 1 , the numeral  18  indicates generally a prior art phacoemulsification needle tip from U.S. Pat. No. 6,007,555, having a mouth  20  defined by a lip  22  at the end of needle  24 . The cross-sectional configuration of needle  18  and mouth  20  is a rectangle. 
         [0052]    Referring now to  FIG. 2 , the numeral  26  identifies several prior art phacoemulsification needles as described in U.S. Pat. No. 5,725,495, with needle  28  having a circular cross-section as shown at  30 , needle  32  having a triangular cross-section as shown at  34  and needle  36  having an octagonal cross-section as shown at  38 . 
         [0053]    Referring now to  FIG. 3 , the numeral  40  indicates generally a phacoemulsification needle embodying certain aspects of the present invention. 
         [0054]    In  FIG. 3 , the numeral  40  identifies generally a partial sectional view of a phacoemulsification tip having a tip opening  42  defined by a lip  104  and having a side wall  44  along which a first portion  46  thereof is formed with straight wall, that is, with a cross-sectional configuration of portion  46  as a right circular section, and a second wall portion  48  tapered to form a throat  50 . Throat  50  is also depicted in  FIG. 4 . 
         [0055]    Referring now to  FIG. 5 , a pair of forming die blocks  52 ,  54  are placed with tip  40  positioned such that a portion of straight portion  46 , proximate to opening  42 , is positioned between die blocks  52 ,  54 . 
         [0056]    Referring to  FIG. 6 , a view along  6 - 6  of  FIG. 5  is shown wherein die blocks  52 ,  54  are positioned along an extended diameter  56  of tip  40 .  FIG. 6  also has a grid pattern  58  superimposed thereon showing the ultimate configuration of the bent portion  60  of tip  40 . Bent portion  60  is understood to be that portion of straight portion  46  that is contacted by die blocks  52 ,  54 . 
         [0057]    Referring now to  FIG. 7 , die blocks  52 ,  54  are shown as having been moved toward one another to contact tip  40  at portion  60  to form a first indentation  62  and a second indentation  64 . Referring to  FIG. 8 , the position of die blocks  52 ,  54  after the first forming step is depicted with indentations  62 ,  64  shown as generally V-shaped and having substantially planar sides  62   a,    62   b  and  64   a,    64   b  respectively. It is anticipated that the angle between sides  62   a  and  62   b  and between sides  64   a  and  64   b  would be approximately 90° although other angles can also be selected. 
         [0058]    Referring now to  FIG. 9 , tip  40  is shown as rotated  90  degrees between die blocks  52 ,  54  with first indentation  62  shown and with die blocks  52 ,  54  positioned to complete the formation of a second pair of indentations. 
         [0059]    Referring now to  FIG. 10 , die blocks  52 ,  54  are shown positioned along a second extended diameter  66  which, in this example, is at a 90° angle to first extended diameter  56 . Previously formed indentations  62 ,  64  are also shown. 
         [0060]    Referring now to  FIG. 11 , die blocks  52 ,  54  are shown positioned after the formation of a second set of indentations with the positioning of die blocks  52 ,  54  also shown in  FIG. 12 . 
         [0061]    Referring now to  FIG. 13 , a partial lateral sectional view of tip  40  is shown with the manufacturing or indentation process completed and with indentations  68  and  70  shown. 
         [0062]    In  FIG. 14 , a top view is shown with the upper wall portion  60  with finished indentations  62 ,  68 ,  64  and  70  shown. In this view it is seen that indentation  62  has sides  62   a  and  62   b  meeting at a crease  62   c,  indentation  64  has sides  64   a  and  64   b  meeting at a crease  64   c,  indentation  68  has sides  68   a  and  68   b  meeting at a crease  68   c,  and indentation  70  has sides  70   a  and  70   b  meeting at a crease  70   c.  Indentation  62  also has a land or “floor”  96  extending between sides  62   a  and  62   b,  indentation  64  has a land  100  extending between sides  64   a  and  64   c,  indentation  68  has a land  98  extending between sides  68   a  and  68   c,  and indentation  70  has a land  102  extending between sides  70   a  and  70   c.    
         [0063]    Consistent with the foregoing description, in this example, preferably the angle between sides  68   a  and  68   b  and  70   a  and  70   b  is approximately 90°. 
         [0064]    Referring now to  FIG. 15 , tip  40  is shown in the same configuration shown in  FIG. 3  with a pair of angled die blocks  72 ,  74  positioned proximate tip opening  42 . In  FIG. 16 , when die blocks  72 ,  74  are advanced to contact upper portion  76  of tip  40 , angled indentations  78 ,  80  are formed in side wall  82  at the upper periphery of tip  40  as defined by section  76 . 
         [0065]    Tip  40  is then rotated and positioned between die blocks  78 ,  80  which are oriented to create a second set of indentations  84 ,  86  (shown in  FIG. 17 ) in the same fashion as described in connection with  FIGS. 3-14 . 
         [0066]    Referring now to  FIG. 17 , a top view of the completed tip of  FIG. 15  is shown with indentations  78 ,  80 ,  84 , and  86 , it being understood that each indentation pair  78 ,  80  and  84 ,  86  are formed in the same manner as described hereinabove, are formed in pairs, and, in this example, are formed with an included angle of approximately 90°. As described above, indentation  78  has walls  78   a  and  78   b  meeting at crease  78   c,  indentation  80  has walls  80   a  and  80   b  meeting at crease  80   c,  indentation  84  has walls  84   a  and  84   b  meeting at crease  84   c,  and indentation  86  has walls  86   a  and  86   b  meeting at crease  86   c.  Preferably, creases  78   c,    80   c,    84   c  and  86   c  are formed inward at an angle less than 90° to wall section  76 . 
         [0067]    Referring now to  FIG. 18 , a partial lateral sectional view of tip  40  is shown with indentation  84  seen from the inside of tip  40  with the rear  84   d  of side  84   a  and the rear  84   e  of side  84   b.    
         [0068]    Referring to  FIGS. 13 and 18  the numerals  106 ,  108  identify, respectively, lip  104  after the associated manufacturing processes have been completed. Lips  106 ,  108  may if desired be polished smooth to reduce the possibility that contact between lip  106 ,  108  will cause damage to any eye tissue 
         [0069]    Referring now to  FIG. 14 , sides  62   a,    62   b,    64   a,    64   b,    68   a,    68   b,    70   a  and  70   b , together with creases  62   c,    64   c,    68   c  and  70   c  form cutting or emulsifying surfaces of tip  40  when tip  40  is used in a hand piece that moves tip  40  in a torsional direction. 
         [0070]    Referring now to  FIG. 14 , lip  106 , as it is included in indentations  62 ,  64 ,  68  and  70 , together with lands  96 ,  98 ,  100  and  102  form cutting or emulsifying surfaces when used in a handpiece imparting longitudinal motion to tip  40 . 
         [0071]    Referring now to  FIG. 17 , walls  78   a,    78   b,    80   a,    80   b,    84   a,    84   b,    86   a  and  86   b  form cutting or emulsifying surfaces when used in a handpiece imparting torsional motion to tip  40 . 
         [0072]    Referring now to  FIG. 17 , lip  108  as it is included in indentations  78 ,  80 ,  84  and  86  forms a cutting or emulsifying surface when tip  40  is used in a handpiece that imparts longitudinal motion to tip  40 . 
         [0073]    Referring now to  FIGS. 19 through 26  another example of a shaped phaco tip is described wherein the indentations are formed spaced downwardly from the lip. 
         [0074]    As seen in  FIGS. 19 and 20  a tip  110  has a mouth  114  with a lip  118 . A block  112  is inserted into mouth  114 . As seen in  FIG. 20  block  112  extends into mouth  114  a distance  116  past lip  118 . 
         [0075]    Referring now to  FIGS. 21 and 22 , forming die blocks  120 ,  122 ,  124  and  126  are positioned about the outer wall  128  of tip  110 . The example shown has four such die blocks spaced 90° apart to from four indentations but it should be understood that other numbers and configurations of indentations may be selected as well. In  FIG. 22  it can be seen that die blocks  122 ,  126  are positioned to contact wall  128  at points below the distance  116  to which block  112  is inserted into tip  110 . In this example, die blocks  120 ,  122 ,  124  and  126  are positioned to contact wall  128  at the same distance  116  down from lip  118 . 
         [0076]    Referring now to  FIGS. 23 and 24  the forming process is illustrated.  FIG. 23  is a view along  23 - 23  of  FIG. 24 . As die blocks  120 ,  122 ,  124  and  126  are moved axially inwardly they deform wall  128  to form, respectively, indentations  130 ,  132 ,  134  and  136 .  FIG. 24  illustrates the formation and configuration of indentations  130  and  134  by die blocks  122 ,  126 . 
         [0077]    Referring now to  FIGS. 25 and 26  the completed tip  110  is shown with block  114  removed.  FIG. 25  is a view along  25 - 25  of  FIG. 26 . In this example, indentations  130 ,  132 ,  134  and  136  are somewhat elliptical in shape and form a somewhat curvilinear surface. As an example, surface  130   a  of indentation  130  and  134   a  of indentation  134  form surfaces utilized in torsional motion to increase the efficiency of phacoemulsification, while lip  118  is usable with handpieces employing longitudinal motion.