Abstract:
A method of operating an ultrasonic handpiece by pulsing the power supplied to the handpiece and varying the type of vibration during the power pulse.

Description:
[0001]    This application is a continuation of U.S. patent application Ser. No. 11/207,642, now U.S. Pat. No. ______ which is a continuation-in-part of U.S. patent application Ser. No. 11/183,591, filed Jul. 18, 2005, currently co-pending, which is a continuation-in-part application of U.S. patent application Ser. No. 10/916,675, filed Aug. 12, 2004, currently co-pending. This application is also is a continuation-in-part of co-pending U.S. patent application Ser. No. 10/818,314, filed Apr. 5, 2004, priority to which is claimed under 35 U.S.C. §120, which claims priority to U.S. Provisional Application Serial No. 60/555,240, filed Mar. 22, 2004, under 35 U.S.C. §119. This application also claims priority under 35 U.S.C. §119 to U.S. Provisional Application Serial No. 60/587,693, filed Jul. 14, 2004. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    This invention relates to ultrasonic devices and more particularly to devices for tuning and controlling an ophthalmic phacoemulsification handpiece. 
         [0003]    A typical ultrasonic surgical device suitable for ophthalmic procedures consists of an ultrasonically driven handpiece, an attached hollow cutting tip, an irrigating sleeve and an electronic control console. The handpiece assembly is attached to the control console by an electric cable and flexible tubings. Through the electric cable, the console varies the power level transmitted by the handpiece to the attached cutting tip and the flexible tubings supply irrigation fluid to and draw aspiration fluid from the eye through the handpiece assembly. 
         [0004]    The operative part of the handpiece is a centrally located, hollow resonating bar or horn directly attached to a set of piezoelectric crystals. The crystals supply the required ultrasonic vibration needed to drive both the horn and the attached cutting tip during phacoemulsification and are controlled by the console. The crystal/horn assembly is suspended within the hollow body or shell of the handpiece at its nodal points by relatively inflexible mountings. The handpiece body terminates in a reduced diameter portion or nosecone at the body&#39;s distal end. The nosecone is externally threaded to accept the irrigation sleeve. Likewise, the horn bore is internally threaded at its distal end to receive the external threads of the cutting tip. The irrigation sleeve also has an internally threaded bore that is screwed onto the external threads of the nosecone. The cutting tip is adjusted so that the tip projects only a predetermined amount past the open end of the irrigating sleeve. Ultrasonic handpieces and cutting tips are more fully described in U.S. Pat. Nos. 3,589,363; 4,223,676; 4,246,902; 4,493,694; 4,515,583; 4,589,415; 4,609,368; 4,869,715; and 4,922,902, the entire contents of which are incorporated herein by reference. 
         [0005]    When used to perform phacoemulsification, the ends of the cutting tip and irrigating sleeve are inserted into a small incision of predetermined width in the cornea, sclera, or other location in the eye tissue in order to gain access to the anterior chamber of the eye. The cutting tip is ultrasonically vibrated along its longitudinal axis within the irrigating sleeve by the crystal-driven ultrasonic horn, thereby emulsifying upon contact the selected tissue in situ. The hollow bore of the cutting tip communicates with the bore in the horn that in turn communicates with the aspiration line from the handpiece to the console. A reduced pressure or vacuum source in the console draws or aspirates the emulsified tissue from the eye through the open end of the cutting tip, the bore of the cutting tip, the horn bore, and the aspiration line and into a collection device. The aspiration of emulsified tissue is aided by a saline flushing solution or irrigant that is injected into the surgical site through the small annular gap between the inside surface of the irrigating sleeve and the outside surface of the cutting tip. 
         [0006]    There have been prior attempts to combine ultrasonic longitudinal motion of the cutting tip with rotational motion of the tip, see U.S. Pat. Nos. 5,222,959 (Anis), No. 5,722,945 (Anis, et al.) and No. 4,504,264 (Kelman), the entire contents of which are incorporated herein by reference. These prior attempts have used electric motors to provide the rotation of the tip which require O-ring or other seals that can fail in addition to the added complexity and possible failure of the motors. 
         [0007]    There have also been prior attempts to generate both longitudinal and torsional motion without the use of electric motors. For example, in U.S. Pat. Nos. 6,028,387, 6,077,285 and 6,402,769 (Boukhny), one of the inventors of the current invention, describes a handpiece having two pairs of piezoelectric crystals are used. One pair is polarized to product longitudinal motion. The other pair is polarized to produce torsional motion. Two separate drive signals are used to drive the two pairs of crystals. In actual practice, making a handpiece using two pairs of crystals resonate in both longitudinal and torsional directions is difficult to achieve. One possible solution, also described by one of the current inventors, is described in U.S. Patent Publication No. US 2001/0011176 A1 (Boukhny). This reference discloses a handpiece have a single set of piezoelectric crystals that produces longitudinal motion, and a series of diagonal slits on the handpiece horn or tip that produce torsional motion when the horn or tip is driven at the resonate frequency of the piezoelectric crystals. Again, in practice, the resonate frequency of the piezoelectric crystals and the tip or horn did not coincide, so simultaneous longitudinal and torsional motion was difficult to achieve. 
         [0008]    When the tip becomes occluded or clogged with emulsified tissue, the aspiration flow can be reduced or eliminated, allowing the tip to heat up, thereby reducing cooling and resulting in temperature increase, which may burn the tissue at the incision. In addition, during occlusion, a larger vacuum can build up in the aspiration tubing so that when the occlusion eventually breaks, a larger amount of fluid can be quickly suctioned from the eye, possibly resulting in the globe collapsing or other damage to the eye. 
         [0009]    Known devices have used sensors that detect large rises in aspiration vacuum, and detect occlusions based a particular pre-determined vacuum level. Based on this sensed occlusion, power to the handpiece may be reduced and/or irrigation and aspiration flows can be increased. See U.S. Pat. Nos. 5,591,127, 5,700,240 and 5,766,146 (Barwick, Jr., et al.), the entire contents of which are incorporated herein by reference. These devices, however, use a fixed aspiration vacuum level to trigger a response from the system. This fixed level is a threshold value based upon a fixed percentage of the selected upper vacuum limit. The use and effectiveness of such systems, however, are limited since they do not respond until that preset vacuum level is reached. In addition, some surgical techniques require the plugging or occlusion of the tip, and the occurrence of an occlusion does not necessarily indicate that the tip and/or wound is getting heated sufficiently to create a concern or a thermal injury or bum at the wound site. 
         [0010]    U.S. Pat. No. 4,827,911 (Broadwin, et al.) and No. 6,780,165 B2 (Kadziauskas, et al.) suggests that the risk of a thermal injury can be reduced by delivering the ultrasound energy in pulses of very short duration follow by a period wherein no energy is delivered to the tip. Such short pulses can help reduce the amount of energy entering the eye, but as the pulses get shorter, there is less time for the feedback loop to establish the optimum frequency. Current ultrasound handpiece tuning systems use a feedback loop to monitor the operation of the handpiece and continually tune the handpiece to ensure that the stock of the tip remains constant under all loading conditions. See U.S. Pat. No. 5,431,664 (Ureche, et al.). Such feedback loops typically take on the order of 3-5 milliseconds to cycle and automatically adjust the operating parameters of the handpiece. As a result, with current systems, ultrasonic power pulses of less than  5  milliseconds have limited ability to establish the optimum frequency, but in general, improvements to the tuning algorithm can be achieved for pulse durations of less than 20 milliseconds. 
         [0011]    Accordingly, a need continues to exist for a reliable ultrasonic handpiece that is capable of delivering ultrasound pulses of less than 5 milliseconds while remaining in tune. 
       BRIEF SUMMARY OF THE INVENTION 
       [0012]    The present invention improves upon prior art methods of operating an ultrasonic handpiece by pulsing the power supplied to the handpiece and varying the amplitude of the power during the power pulse. 
         [0013]    It is accordingly an object of the present invention to provide a method for operating a pulsed ultrasound handpiece. 
         [0014]    It is a further object of the present invention to provide a method of operating an ultrasound handpiece that delivers ultrasound pulses of less than 5 milliseconds while remaining in tune. 
         [0015]    Other objects, features and advantages of the present invention will become apparent with reference to the drawings, and the following description of the drawings and claims. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0016]      FIG. 1  is a perspective view of the handpiece of the present invention with the outer case removed. 
           [0017]      FIG. 2  is a perspective view of the ultrasonic horn that may be used with the handpiece of the present invention. 
           [0018]      FIG. 3  a block diagram of a driving circuit that may be used with the present invention. 
           [0019]      FIGS. 4 and 5  are graphs illustrating ultrasound power versus time. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0020]    As best seen in  FIG. 1  handpiece  10  that may be used with the method of the present invention generally comprises ultrasonic horn  12 , typically made from a titanium alloy. Horn  12  has a plurality of helical slits, which will be discussed below. A plurality (typically 1 or 2 pairs) of ring-shaped piezoelectric elements  14  are held by compression nut  15  against horn  12 . Aspiration shaft  16  extends down the length of handpiece  10  through horn  12 , piezoelectric elements  14 , nut  15  and through plug  18  at the distal end of handpiece  10 . Aspiration tube  16  allows material to be aspirated through hollow tip  20 , which is attached to horn  12 , and through and out handpiece  10 . Plug  18  seals outer shell  11  of handpiece  10  fluid tight, allowing handpiece  10  to be autoclaved without adversely affecting piezoelectric elements  14 . Addition grooves  22  for sealing O-ring gaskets (not shown) are provided on horn  12 . 
         [0021]    As best seen in  FIG. 2 , horn  12  contains a plurality of spiral slits  24 . Preferably, the width of slits  24  is between 2% and 65% of the outside diameter of horn  12 . This, of course, will affect how many slits  24  can be made on horn  12  (e.g., if slits  24  are 65% of the diameter of horn  12 , then only one slit  24  may be cut into horn  12 ). The width of slits  24  selected will depend upon the desired amount of torsional movement. The depth of slits  24  in horn  12  preferably is between 4% and 45% of the outside diameter of horn  12 . Slits  24  may have a flat or square cut bottom, but preferably have a rounded or radiused bottom, which are easier to manufacture. The length of slits  24  preferably is between 8% and 75% of the length of the larger diameter of horn  12 . The pitch of slits  24  preferably is between 125% and 500% of the larger diameter of horn  12 . By way of example, the inventors have found that one suitable configuration of slits  24  on horn  12  with an outside diameter of 0.475 inches is a total of eight slits  24 , having a width of 0.04 inches, a depth of 0.140 (with a full radius bottom), a length of 0.7 inches and a pitch of 1.35 inches gives suitable torsional movement of horn  12  without compromising the longitudinal movement of horn  12 . 
         [0022]    As best seen in  FIG. 1 , the location of longitudinal and torsional nodal points (the points with zero velocity of the respective mode) is important for proper functioning of handpiece  10 . The torsional node  26  preferably is located at the proximal longitudinal node  28 , so that the torsional node  26  and the longitudinal node  28  are coincident, e.g., both of which are located on plug  18 . Handpiece  10  also contains a distal longitudinal node  30  located at reduced diameter portion  32  of horn  12 . 
         [0023]    As best seen in  FIG. 3 , drive circuit  34  that may be used with handpiece  10  of the present invention preferably is similar to that described in U.S. Pat. No. 5,431,664, the entire contents of which being incorporated herein by reference, in that drive circuit  34  provides a drive signal to handpiece  10  and tracks the admittance of handpiece  10  and controls the frequency of handpiece  10  to maintain a constant admittance. However, drive circuit  34  monitors both the torsional mode and the longitudinal mode and controls these modes in handpiece  10  using two different drive frequencies. Preferably, the torsional drive signal is approximately 32 kHz and the longitudinal drive signal is 44 kHz, but these frequencies will change depending upon the piezoelectric elements  14  used and the size and shape of horn  12  and slits  24 . Although both the longitudinal or the torsional drive signal may be supplied in a continuous manner, preferably the longitudinal drive signal and the torsion drive signal are alternated, so that the drive signal is provided in a desired pulse at one frequency and then switched to the other frequency for a similar pulse, with no overlap between the two frequencies, but no gap or pause in the drive signal. Alternative, the drive signal can be operated in a similar manner as described, but short pauses or gaps in the drive signal can be introduced. In addition, the amplitude of the drive signal can be modulated and set independently for each frequency. 
         [0024]    The pause or gap between drive signals can serve various purposes. One purpose is to allow for the ultrasound movement of piezoelectric elements  14  and horn  12  to attenuate or stop so that lens fragments can once again be suctioned to tip  20  and an occlusion reestablished, thereby increasing the holding force on the lens fragment. Reestablishing the occlusion will increase cutting efficiency of the following pulse of ultrasound, whether longitudinal or torsional. Another purpose of the pause or gap between drive signals is to allow for the ultrasound movement of piezoelectric elements  14  and horn  12  to attenuate or stop prior to the other (either longitudinal or torsional) mode being excited. Such attenuation between drive signals will reduce amount of potential non-linear interactions in the system which can generate undesirable heat and lead to premature degradation of piezoelectric elements  14  or mechanical failure of the entire assembly. 
         [0025]    Alternatively, there can be a slight overlap in the longitudinal and torsional drive signals. The overlap may provide relatively short time intervals when the added action of both torsional and longitudinal displacements results in especially fast rate of lens emulsification, and yet the overlap is short enough to prevent piezoelectric elements  14  from premature degradation or failure of the entire mechanical assembly as a result of excessive stress. 
         [0026]    Yet another alternative if to have both longitudinal and torsional drive signals overlap completely thus resulting in applying high stress levels to the lens material when the two signals overlap, and yet leaving a pause in between for the occlusion to reestablish itself and allow for vacuum to build-up, thus improving efficiency of the following pulse application. 
         [0027]    Still another alternative is to apply a continuous longitudinal signal with a pulsed torsional signal, or vice versa, a continuous torsional signal with a pulsed longitudinal signal. Continuous application of torsional ultrasound does not cause repulsion because tip  20  movement is oriented perpendicular to the direction of the engagement of tip  20  with the lens, and the pulsed applications of longitudinal ultrasound are short enough to prevent overheating or mechanical damage to piezoelectric elements  14 . 
         [0028]    Finally, as discussed above, both the longitudinal and torsional drive signals can be applied continuously and simultaneously, with the amplitudes of the both signals being selected such that overheating and excessive mechanical stress on the system is reduced. If such a drive scheme is to be used, two sets of piezoelectric elements  14  are preferred with the torsional signal being applied to one set, while longitudinal signal applied to the other set. 
         [0029]    As best seen in  FIGS. 4 and 5 , typical duty cycle  200  includes power on portion  210  and power off portion  220 . By way of example,  FIG. 4  illustrates a 50% duty cycle  200 , meaning that on portion  210  equals off portion  220 . The inventor has discovered that the power level (which may be measured as a percent of the maximum possible stroke or rotation of the tip, or as a percentage of the maximum amplitude of the power signal delivered to piezoelectric elements  14 ), within on portion  210  may be further divided into high power portion  230  and low power portion  240 . By way of example, high power portion  230  may be at a 60% power level and low power portion  240  may be at a 10% power level. Such a division of on portion  210  allows high power portion  230  to be of extremely short duration, for example, between 1 millisecond and 5 milliseconds, and preferably less than 5 milliseconds, while the overall duration of on portion  210  may remain relatively long, for example, 20 milliseconds or greater. Maintaining a relatively long on portion  210  allows the feedback loop contained within drive circuit  34  sufficient time to cycle and automatically adjust the operating parameters of handpiece  10 . Further, because low power portion  240  encompasses a significant percentage of on power portion  210 , on the order of 75% to 95%, maintaining a relatively long on power portion  210  does not significantly increase the heat generated by tip  20 . As a result, ultrasonic power pulses of less than  5  milliseconds are possible while maintaining the optimum frequency for handpiece  10  while at the same time, the potential for thermal injury to the eye is reduced. 
         [0030]    One skilled in the art will recognize that both high power portion  230  and low power portion  240  may be include longitudinal or torsional vibration of tip  20  in any combination desired. In addition, while  FIGS. 4 and 5  demonstrate on power portion  210  as having one high power portion  230  and one low power portion  240 , on power portion  210  may be further sub-divided into multiple high power portions  230  and/or multiple low power portions  240 , serially, alternately or randomly. 
         [0031]    While certain embodiments of the present invention have been described above, these descriptions are given for purposes of illustration and explanation. Variations, changes, modifications and departures from the systems and methods disclosed above may be adopted without departure from the scope or spirit of the present invention.