Abstract:
An ultrasonic surgical instrument that is configured to permit selective positioning of the relative distance between an end effector for cutting and coagulating tissue and a power actuation switch that is carried by the instrument for selectively energizing the end effector. In one instance, the end effector is able to change position relative to the actuation switch, alternatively, the actuation switch moves relative to the end effector, and still further, both the end effector and the actuation switch are capable of moving relative to each other.

Description:
REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation of U.S. patent application, Ser. No. 14/246,808, filed on Apr. 7, 2014, which is a continuation of U.S. patent application, Ser. No. 12/014,378, filed on Jan. 15, 2008, which claims the priority benefit of U.S. Provisional patent applications, Ser. No. 60/968,357, filed on Aug. 28, 2007 and Ser. No. 60/885,086, filed on Jan. 16, 2007, both of which are incorporated by reference herein. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention generally relates to ultrasonic surgical systems and, more particularly, to an ultrasonic device that allows surgeons to perform cutting, coagulation, and fine dissection required in fine and delicate surgical procedures such as plastic surgery. 
       BACKGROUND OF THE INVENTION 
       [0003]    Ultrasonic surgical instruments are finding increasingly widespread applications in surgical procedures by virtue of the unique performance characteristics of such instruments. Depending upon specific instrument configurations and operational parameters, ultrasonic surgical instruments can provide substantially simultaneous cutting of tissue and homeostasis by coagulation, desirably minimizing patient trauma. The cutting action is typically realized by an end-effector, or blade tip, at the distal end of the instrument, which transmits ultrasonic energy to tissue brought into contact with the end-effector. Ultrasonic instruments of this nature can be configured for open surgical use, laparoscopic or endoscopic surgical procedures including robotic-assisted procedures. 
         [0004]    Performing an average plastic surgery procedure (e.g. abdominoplasty, breast reconstruction/reduction, and face lift) involves significant recovery time for the patient and risk of post-operative complications such as seroma and hematoma. The recovery time includes additional office visits post-operatively, affecting patient satisfaction and decreasing the amount of time a surgeon is available for surgery. Advanced energy instruments (in lieu of traditional monopolar electrosurgery—“bovie”) can provide a less complicated recovery experience and potentially shorten the post-operative recovery time. However, the advanced energy instruments currently available are not designed specifically for plastic surgery procedures. They lack the comfort and versatility required for such procedures. 
         [0005]    For example, present energy instruments are available only in fixed lengths. This is a problem for many plastic surgery procedures because the surgeon prefers to have a short blade at the beginning of a procedure for superficial work and a longer blade later during the procedure to obtain deeper access to tissue. With current instruments, the surgeon is required to switch instruments during the procedure, which is both time and cost prohibitive. 
         [0006]    Some surgical instruments utilize ultrasonic energy for both precise cutting and controlled coagulation. Ultrasonic energy cuts and coagulates by using lower temperatures than those used by electrosurgery. Vibrating at high frequencies (e.g. 55,500 times per second), the ultrasonic blade denatures protein in the tissue to form a sticky coagulum. Pressure exerted on tissue with the blade surface collapses blood vessels and allows the coagulum to form a hemostatic seal. The precision of cutting and coagulation is controlled by the surgeon&#39;s technique and adjusting the power level, blade edge, tissue traction and blade pressure. 
         [0007]    Some current designs of ultrasonic surgical devices utilize a foot pedal to energize the surgical instrument. The surgeon operates the foot pedal to activate a generator that provides energy that is transmitted to the cutting blade for cutting and coagulating tissue while simultaneously applying pressure to the handle to press tissue against the blade. Key drawbacks with this type of instrument activation include the loss of focus on the surgical field while the surgeon searches for the foot pedal, the foot pedal getting in the way of the surgeon&#39;s movement during a procedure and surgeon leg fatigue during long cases. 
         [0008]    It would be desirable to provide an ultrasonic surgical instrument that overcomes some of the deficiencies of current instruments. The ultrasonic surgical instrument described herein overcomes those deficiencies. 
       SUMMARY OF THE INVENTION 
       [0009]    An ultrasonic surgical instrument assembly embodying the principles of the present invention is configured to permit selective dissection, cutting, coagulation and clamping of tissue during surgical procedures. 
         [0010]    A first expression of a first embodiment of an ultrasonic surgical instrument is a housing configured to accept a transducer and further defining a longitudinal axis; a first switch positioned on the housing for actuation by one or more fingers of a user and further electrically connected to a generator for providing an electrical signal to the generator for controlling a first level of ultrasonic energy delivered by the transducer. 
         [0011]    A second expression of the first embodiment of an ultrasonic surgical instrument is for a second switch positioned on the housing for actuation by one or more fingers of a user and further electrically connected to a generator for providing an electrical signal to the generator for controlling a second level of ultrasonic energy delivered by the transducer. 
         [0012]    A first expression of a second embodiment of an ultrasonic surgical instrument is a blade extending along a longitudinal axis of the housing and configured to translate or telescope along the longitudinal axis. Such a feature allows the user to have one instrument with multiple blade lengths. The distance of the activation buttons adjusts with respect to the distal end of the blade and thereby provides precise control in the short blade position and deep access in the longer positions. This also allows for fewer instrument exchanges to reduce procedure time. 
         [0013]    A second expression of the second embodiment is a sheath enclosing the blade and the sheath configured to translate along a longitudinal axis. 
         [0014]    A third expression of the second embodiment is a sheath enclosing the blade and the blade configured to rotate with respect to the housing. 
         [0015]    A first expression of a third embodiment of an ultrasonic surgical instrument is a locking mechanism for preventing the blade and/or sheath from translating along the longitudinal axis. 
         [0016]    A second expression of the third embodiment is a locking mechanism for preventing the blade from rotating with respect to the housing. 
     
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         [0017]    The novel features of the invention are set forth with particularity in the appended claims. The invention itself, however, both as to organization and methods of operation, may best be understood by reference to the following description, taken in conjunction with the accompanying drawings in which: 
           [0018]      FIG. 1A  is a perspective exploded assembly view illustrating an embodiment of an ultrasonic surgical instrument in accordance with the present invention; 
           [0019]      FIG. 1B-C  are alternate perspective views of the assembled instrument of  FIG. 1A ; 
           [0020]      FIG. 2A  is a partial cutaway perspective view of one embodiment of the invention having multiple switches to support blade translation with the end effector in a most distal position; 
           [0021]      FIG. 2B  is a partial cutaway perspective view of one embodiment of the invention using multiple switches to support blade translation with the end effector in a most proximal location; 
           [0022]      FIG. 2C  is an exploded cutaway perspective view illustrating one embodiment of the rotation mechanism using detent features; 
           [0023]      FIG. 2D  is an electrical schematic of an alternate embodiment of the hand switch circuit having multiple switches; 
           [0024]      FIG. 2E  is a cutaway view of one embodiment of the translation mechanism using a spiral flex circuit with the end effector in a distal location; 
           [0025]      FIG. 2F  is a cutaway view of one embodiment of the translation mechanism using a spiral flex circuit with the end effector in a proximal location; 
           [0026]      FIG. 2G  is an enlarged elevation view of the one embodiment of the electrical connection with a spiral flex circuit; 
           [0027]      FIG. 2H  is an enlarged elevation view of one embodiment of the invention illustrating one embodiment of the rotation mechanism using detent features; 
           [0028]      FIG. 2I  is a cutaway perspective view of one embodiment of the translation mechanism using an electrical rail connector with the end effector in a proximal location; 
           [0029]      FIG. 2J  is an enlarged view of an alternate embodiment of the electrical connection utilizing an electrical rail; 
           [0030]      FIG. 2K  is a cutaway perspective view of one embodiment of the translation mechanism using an electrical rail connector with the end effector in a distal location; 
           [0031]      FIG. 2L  is an enlarged cutaway perspective view of one embodiment of rotational mechanism utilizing circular detent features; 
           [0032]      FIG. 2M  is an enlarged cutaway perspective view of one embodiment of the electrical connection using concentric cylinders with bushings; 
           [0033]      FIG. 2N  is an exploded assembly view illustrating one embodiment of the electrical connection showing the concentric cylinders with bushings; 
           [0034]      FIG. 3A  is an exploded perspective view of an alternate embodiment of the translation and rotation mechanism utilizing a helix on the blade sheath; 
           [0035]      FIG. 3B  is a cutaway perspective view of one embodiment of the translation and rotation mechanism utilizing a friction lock; 
           [0036]      FIGS. 3C-D  are an elevation and side view, respectively, view of one embodiment of the friction lock knob; 
           [0037]      FIG. 3D  is a side view of one embodiment of the friction lock knob; 
           [0038]      FIG. 3E  is a side and cross sectional view of an alternate embodiment of the friction lock knob; 
           [0039]      FIG. 3F  is an exploded view of an alternate embodiment of the translation and rotation mechanism utilizing a friction lock; 
           [0040]      FIG. 4A  is an elevation view of an alternate embodiment of the invention illustrating a finger pad for coagulating; 
           [0041]      FIG. 4B  is a side view of an alternate embodiment of the invention illustrating a finger pad for coagulating; 
           [0042]      FIG. 4C  is a perspective view of an alternate embodiment of the invention illustrating a pad on a stick for coagulating; 
           [0043]      FIG. 5A  is a cutaway elevation view of one embodiment of the blade and pin assembly; 
           [0044]      FIG. 5B  is an exploded assembly view of one embodiment of the blade and pin assembly; 
           [0045]      FIG. 6  is a perspective view of an alternate embodiment of the invention utilizing a lighting system; 
           [0046]      FIG. 7A  is a perspective view of one embodiment of the invention containing a haptic ring activation assembly; 
           [0047]      FIG. 7B  is an exploded perspective view of the haptic ring activation assembly; 
           [0048]      FIG. 8A  is an elevation view of one embodiment of a counterbalance mechanism; 
           [0049]      FIG. 8B  is an elevation view of one embodiment of a counterbalance mechanism; 
           [0050]      FIG. 8C  is an elevation view an alternate embodiment of the counterbalance mechanism with movable weights; 
           [0051]      FIG. 8D  is an elevation view of an alternate embodiment of the counterbalance mechanism containing movable weights and a gear system; 
           [0052]      FIG. 9A  is a perspective view of an alternate embodiment of the invention having slidable activation buttons attached through a magnetic connection; 
           [0053]      FIG. 9B  is a cutaway elevation view of one embodiment of the invention showing the magnetic rail connections; 
           [0054]      FIG. 9C  is an enlarged perspective view of one embodiment of the activation button assembly that is attached through a magnetic connection; 
           [0055]      FIG. 10  is an electrical schematic of a hand switch circuit; 
           [0056]      FIG. 11A  is a perspective view of a hand wrench in accordance with the present invention; 
           [0057]      FIG. 11B  is an elevation view of the hand wrench of  FIG. 11A ; 
           [0058]      FIG. 11C  is a cross sectional end view of the distal end of a hand wrench depicting cantilever arm and teeth geometry; and 
           [0059]      FIG. 11D  is a cross sectional view of an adaptor depicting spline gear geometry. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0060]    Before explaining the present invention in detail, it should be noted that the invention is not limited in its application or use to the details of construction and arrangement of parts illustrated in the accompanying drawings and description. The illustrative embodiments of the invention may be implemented or incorporated in other embodiments, variations and modifications, and may be practiced or carried out in various ways. Further, unless otherwise indicated, the terms and expressions employed herein have been chosen for the purpose of describing the illustrative embodiments of the present invention for the convenience of the reader and are not for the purpose of limiting the invention. 
         [0061]    Further, it is understood that any one or more of the following-described embodiments, expressions of embodiments, examples, etc. can be combined with any one or more of the other following-described embodiments, expressions of embodiments, examples, etc. 
         [0062]    The present invention is particularly directed to an improved ultrasonic surgical instrument, which is configured for effecting tissue dissecting, cutting and/or coagulation during surgical procedures, including delicate surgical procedures, such as plastic surgery. The present apparatus is configured for use in open surgical procedures, but has applications in other types of surgery, such as laparoscopic. Versatile use is facilitated by selective use of ultrasonic energy. When ultrasonic components of the apparatus are inactive, tissue can be manipulated, as desired, without tissue cutting or damage. When the ultrasonic components are activated the ultrasonic energy provides for both tissue cutting and coagulation. 
         [0063]    Further, the present invention is disclosed in terms of a blade-only instrument. This feature is not intended to be limiting, as the embodiments disclosed herein have equal application in clamp coagulator instruments as are exemplary disclosed in U.S. Pat. Nos. 5,873,873 and 6,773,444. 
         [0064]    As will become apparent from the following description, the present surgical apparatus is particularly configured for disposable use by virtue of its straightforward construction. As such, it is contemplated that the apparatus be used in association with an ultrasonic generator unit of a surgical system, whereby ultrasonic energy from the generator unit provides the desired ultrasonic actuation for the present surgical instrument. It will be appreciated that surgical instrument embodying the principles of the present invention can be configured for non-disposable or multiple use, and non-detachably integrated with an associated ultrasonic generator unit. However, detachable connection of the present surgical instrument with an associated ultrasonic generator unit is presently preferred for single-patient use of the apparatus. 
         [0065]    With specific reference now to  FIGS. 1A-C , an embodiment of a surgical system  19 , including an ultrasonic surgical instrument  100  in accordance with the present invention is illustrated. The surgical system  19  includes an ultrasonic generator  300  connected to an ultrasonic transducer  50  via cable  22 , and an ultrasonic surgical instrument  100 . It will be noted that, in many applications, the ultrasonic transducer  50  is also referred to as a “hand piece assembly” or “handpiece” because the surgical instrument of the surgical system  19  is configured such that a surgeon may grasp and manipulate the ultrasonic transducer  50  during various procedures and operations. A suitable generator is the GEN04 (also referred to as Generator 300) sold by Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio. A suitable transducer is disclosed in co-pending U.S. patent application filed on Oct. 10, 2006, Ser. No. 11/545,784, entitled MEDICAL ULTRASOUND SYSTEM AND HANDPIECE AND METHODS FOR MAKING AND TUNING. 
         [0066]    Ultrasonic transducer  50  and an ultrasonic waveguide  80  together provide an acoustic assembly of the present surgical system  19 , with the acoustic assembly providing ultrasonic energy for surgical procedures when powered by generator  300 . The acoustic assembly of surgical instrument  100  generally includes a first acoustic portion and a second acoustic portion. In the present embodiment, the first acoustic portion comprises the ultrasonically active portions of ultrasonic transducer  50 , and the second acoustic portion comprises the ultrasonically active portions of transmission assembly  71 . Further, in the present embodiment, the distal end of the first acoustic portion is operatively coupled to the proximal end of the second acoustic portion by, for example, a threaded connection. 
         [0067]    The ultrasonic surgical instrument  100  includes a multi-piece handle assembly  68  adapted to isolate the operator from the vibrations of the acoustic assembly contained within transducer  50 . The handle assembly  68  can be shaped to be held by a user in a conventional manner, but it is contemplated that the present ultrasonic surgical instrument  100  principally be grasped and manipulated in a pencil-like arrangement provided by a handle assembly of the instrument, as will be described. While a multi-piece handle assembly  68  is illustrated, the handle assembly  68  may comprise a single or unitary component. The proximal end of the ultrasonic surgical instrument  100  receives and is fitted to the distal end of the ultrasonic transducer  50  by insertion of the transducer into the handle assembly  68 . The ultrasonic surgical instrument  100  may be attached to and removed from the ultrasonic transducer  50  as a unit. The ultrasonic surgical instrument  100  may include a handle assembly  68 , comprising mating housing portions  69  and  70  and an ultrasonic transmission assembly  71 . The elongated transmission assembly  71  of the ultrasonic surgical instrument  100  extends orthogonally from the instrument handle assembly  68 . 
         [0068]    The handle assembly  68  may be constructed from a durable plastic, such as polycarbonate or a liquid crystal polymer. It is also contemplated that the handle assembly  68  may alternatively be made from a variety of materials including other plastics, ceramics or metals. 
         [0069]    The transmission assembly  71  includes a waveguide  80  and a blade  79 . It will be noted that, in some applications, the transmission assembly is sometimes referred to as a “blade assembly”. The waveguide  80 , which is adapted to transmit ultrasonic energy from transducer  50  to the tip of blade  79  may be flexible, semi-flexible or rigid. The waveguide  80  may also be configured to amplify the mechanical vibrations transmitted through the waveguide  80  to the blade  79  as is well known in the art. The waveguide  80  may further have features to control the gain of the longitudinal vibration along the waveguide  80  and features to tune the waveguide  80  to the resonant frequency of the system. In particular, waveguide  80  may have any suitable cross-sectional dimension. For example, the waveguide  80  may have a substantially uniform cross-section or the waveguide  80  may be tapered at various sections or may be tapered along its entire length. Ultrasonic waveguide  80  may, for example, have a length substantially equal to an integral number of one-half system wavelengths (nλ/2). The ultrasonic waveguide  80  and blade  79  may be preferably fabricated from a solid core shaft constructed out of material, which propagates ultrasonic energy efficiently, such as titanium alloy (i.e., Ti-6Al-4V), aluminum alloys, sapphire, stainless steel or any other acoustically compatible material. 
         [0070]    Ultrasonic waveguide  80  may further include at least one radial hole or aperture  66  extending therethrough, substantially perpendicular to the longitudinal axis of the waveguide  80 . The aperture  66 , which may be positioned at a node, is configured to receive a connector pin  27 , discussed below, which connects the waveguide  80 , to the outer sheath  72 . Proximal o-ring  67   a  and distal o-ring  67   b  are assembled onto transmission assembly  71  near the nodes. 
         [0071]    Blade  79  may be integral with the waveguide  80  and formed as a single unit. In an alternate expression of the current embodiment, blade  79  may be connected by a threaded connection, a welded joint, or other coupling mechanisms. The distal end of blade  79 , or blade tip  79   a,  is disposed near an anti-node in order to tune the acoustic assembly to a preferred resonant frequency f 0  when the acoustic assembly is not loaded by tissue. When ultrasonic transducer  50  is energized the blade tip  79   a  is configured to move substantially longitudinally (along the x axis) in the range of, for example, approximately 10 to 500 microns peak-to-peak, and preferably in the range of about 20 to about 200 microns at a predetermined vibrational frequency f 0  of, for example, 55,500 Hz. Blade tip  79   a  also preferably vibrates in the y-axis at about 1 to about 10 percent of the motion in the x-axis. 
         [0072]    One embodiment of waveguide  80  and blade  79  is product code HF105 sold by Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio and further disclosed in U.S. Pat. No. 6,423,082, entitled ULTRASONIC SURGICAL BLADE WITH IMPROVED CUTTING AND COAGULATION FEATURES. Other blade designs are also contemplated for use with the current invention, including product code DH105 sold by Ethicon Endo-Surgery, Inc. and further disclosed in U.S. Pat. No. 5,324,299, entitled ULTRASONIC SCALPEL BLADE AND METHODS OF APPLICATION. Other ultrasonic blade designs are also useful as is well known to those skilled in the art. 
         [0073]    Waveguide  80  is positioned within outer sheath  72  and held in place via pin  27 . Preferably pin  27  is made of any compatible metal, such as stainless steel or titanium or a durable plastic, such as polycarbonate or a liquid crystal polymer. In a first expression of one embodiment, pin  27  is partially coated with an elasto-meric material, such as silicon for that portion  29  of pin  27  that extends through waveguide  80 . The silicone provides insulation from the vibrating blade throughout the length of hole  66 . This enables high efficiency operation whereby minimal overheating is generated and maximum ultrasonic output power is available at the blade tip for cutting and coagulation. 
         [0074]    Outer sheath  72  passes through an aperture  210  of release button  200 . Positioned below release button and within housing portion  69  is a spring  220  that asserts an upward force on release button  200 . The upward force causes aperture  210  to firmly assert pressure against outer sheath  72  and thereby prevents outer sheath  72  and waveguide  80  and blade  79  from either rotating within handle  68  or axially translating with respect to handle  68 . When the user exerts a downward force on release button  200 , the spring is compressed and it no longer asserts a holding force on outer sheath  72 . The user may then axially translate outer sheath  72  and waveguide  80  and blade  72  relative to handle  68  and/or rotate the outer sheath and waveguide  80  and blade  72  relative to handle  68 . 
         [0075]    Housing  68  includes a proximal end, a distal end, and a cavity  59  extending longitudinally therein. Cavity  59  is configured to accept a switch assembly  300  and the transducer assembly  50 . In one expression of the current embodiment, the distal end of transducer  50  threadedly attaches to the proximal end of transmission rod  80 . The distal end of transducer  50  also interfaces with switch assembly  300  to provide the surgeon with finger-activated controls on surgical instrument  19 . 
         [0076]    Transducer  50  includes a first conductive ring  400  and a second conductive ring  410  which are securely disposed within the transducer body  50  as is described in co-pending application Ser. No. 11/545,784. Switch assembly  300  comprises a pushbutton assembly  310 , a circuit assembly  330 , a switch housing  350 , a first pin conductor  360  and a second pin conductor  370  (see  FIG. 10 ). Switch housing  350  is annular-shaped and is supported within handle assembly  68  by way of corresponding supporting mounts on switch housing  350  and housing portions  69  and  70 . 
         [0077]    With reference also to  FIG. 10 , pins  360  and  370  are electrically connected to dome switches  332  and  334  via conductors  337  and  335 , respectively, at one end and to the distal end of transducer  50  at a second end. Pins  360  and  370  each have spring-loaded tips that interface with transducer  50 . Each end spring-loaded tip has a 0.050-inch working travel to allow for manufacturing tolerances associated with the stack up of the assembled parts. 
         [0078]    A circuit  330  provides for the electro-mechanical interface between pushbuttons  321  and  322  and the generator  30  via transducer  50 . Circuit  330  comprises two dome switches  332  and  334  that are mechanically actuated by depressing pushbuttons  321  or  322 , respectively. Dome switches  332  and  334  are electrical contact switches, that when depressed provide an electrical signal to generator  30  as shown by the electrical wiring schematic of  FIG. 10 . Circuit  330  also comprises two diodes within a diode package  336  and conductors,  335  and  337  as is known to those in the art, that connect to pins  360  and  370 , respectively, which in turn provide electrical contact to ring conductors  400  and  410  (not shown), which in turn are connected to conductors in cable  22  that connect to generator  30 . 
         [0079]    As is readily apparent, by depressing pushbuttons  321  and  322  the corresponding contact surfaces depress against corresponding dome switches  332  and  334  to activate the circuit illustrated in  FIG. 10 . When the surgeon depresses  321  pushbutton, the generator will respond with a certain energy level, such as a maximum (“max”) power setting; when the surgeon depresses pushbutton  322 , the generator will respond with a certain energy level, such as a minimum (“min”) power setting, which conforms to accepted industry practice for pushbutton location and the corresponding power setting. 
         [0080]    Referring also now to  FIGS. 11A-D , a two-piece torque wrench  450  is shown. The torque wrench includes a hand wrench  500  and an adaptor  550 . In one embodiment, hand wrench  500  is provided with cantilever arms  501  disposed in an annular fashion about the centerline of hand wrench  500 . Cantilever arms  501  include teeth  501   a  disposed, in one embodiment, in an inward perpendicular fashion in relation to cantilever arms  501 . Teeth  501   a,  in one embodiment of the current invention, are disposed with a cam ramp  501   b  at a 25° angle with respect to the perpendicular angle between arm  501  and teeth  501   a.  Lumen  502  extends the entire length of hand wrench  500  for accepting adaptor  550 . 
         [0081]    Adaptor  550  has a longitudinal shaft  552  with cantilevered tabs  554  at its distal end. At the proximal end of shaft  552  are spline gears  556  projecting in a perpendicular fashion along the outer circumference of shaft  552 . Spline gears  556  include cam ramps  556   a  disposed at an angle from about 23° to about 28° with respect to the perpendicular angle between the outer circumference of shaft  552  and spline gears  556 . Adaptor further includes an interface  560  rigidly connected to shaft  552  and defining an opening for rigidly engaging the distal end of outer sheath  72 . 
         [0082]    In assembly, torque wrench opening  502  is aligned with shaft  552  and guided along substantially the entire length of shaft  552  until the tabs  554  flex inward and capture shoulder  505  at the distal end of hand wrench  500 . Cam ramp  501   b  slidably engages retainer cam ramps  556   a.  The torque wrench assembly  450  slidably engages the distal end of outer sheath  72  and is held rigidly in place. Flat surfaces of interface  560  mate with flat surfaces (not shown) at the distal end of outer sheath  72 . 
         [0083]    Clockwise annular motion or torque is imparted to hand wrench  500  through paddles  504 . The torque is transmitted through arms  501  and teeth  501   a  to gears  556 , which in turn transmit the torque to the waveguide  80  via outer shroud  72  via insulated pin  27 . When a user imparts 5-12 lbs. of torque, the ramps  501   b  and  556  cause the arms  501  to move or flex away from the centerline of wrench  500  ensuring that the user does not over-tighten the waveguide  80  onto transducer  50 . When a counter-clockwise torque is applied to wrench  500  via paddles  504 , the perpendicular flat sides of teeth  501   a  and  556  abut allowing a user to impart a torque to the interface between the waveguide  80  and transducer  50  in proportion to the force applied to the paddles facilitating removal of the instrument  100  from the transducer  50 . The torque wrench  450  may be constructed from a durable plastic, such as polycarbonate or a liquid crystal polymer. It is also contemplated that the wrench  450  may alternatively be made from a variety of materials including other plastics, ceramics or metals. 
         [0084]    In another embodiment (not shown), the paddles and cantilever arm assembly may be separate components attached by mechanical means or chemical means such as adhesives or glue. 
         [0085]    Preferably, the ultrasonic apparatus  100  described above will be processed before surgery. First, a new or used ultrasonic apparatus  100  is obtained and if necessary cleaned. The ultrasonic apparatus can then be sterilized. In one sterilization technique the ultrasonic apparatus is placed in a closed and sealed container, such as a plastic or TYVEK bag. Optionally, the ultrasonic apparatus can be combined in the container as a kit with other components, including a torque wrench  450 . The container and ultrasonic apparatus, as well as any other components, are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation kills bacteria on the ultrasonic apparatus and in the container. The sterilized ultrasonic apparatus can then be stored in the sterile container. The sealed container keeps the ultrasonic apparatus sterile until it is opened in the medical facility. 
         [0086]    Pushbutton Activation 
         [0087]      FIGS. 2A-B  illustrate an alternate expression for the electrical connection between the activation buttons and the handpiece. Activation button  422  is stationary on housing  169   a.  Blade and sheath assembly  400  contains  2  separate dome switch locations, which each contain two dome switches,  432   a,    432   b,  and  434   a,    434   b.  Blade assembly  400  translates to allow for rocker button  422  to activate the device through proximal dome switches  432  or distal dome switches  432 . When dome switches  432  are in use, end effector  79   b  is extended relative to housing  169   a.  When dome switches  434  are used, end effector  79   b  is retracted relative to device housing  169   a.  The electrical schematic of  FIG. 2D  illustrates both sets of switches in parallel electrical connection. 
         [0088]    Referring to  FIGS. 2E-G , an alternate expression of the electrical connection between the handpiece  50  and activation switches utilizes a spiral flex circuit  640 . Spiral flex circuit  640  carries the connection wires between the switches and handpiece  50  of  FIG. 2D . Dome switches  622  are connected to hand piece connector  642  through spiral flex circuit  640 . Spiral flex circuit  640  allows sheath  180  to translate with respect to housing  169   b  while dome switches and button  622  remain stationary on housing  169   b.  Dome switches  622  maintain a connection with transducer  50  at all times via spiral flex circuit  640 . 
         [0089]    Another expression for the electrical connection is found in rail design  644  of  FIGS. 2I-K . Brushes  680  are used to maintain an electrical connection between activation button  625  and hand piece connector  646  through electric rail  644 . Rail  644  maintains the connection as sheath  180  is translated between distal position  650   b  and proximal position  650   a.    
         [0090]    Axial Translation 
         [0091]    Referring now to  FIGS. 2E-F , a means for translation exists on sheath  180 . Detent features  650   a  and  650   b  are spaced apart on blade sheath  180  and create two positions for end effector  79   b  relative to the housing  169   b.  Blade sheath  180  may also contain additional detent features, which would create additional positions for end effector  79   b.  Detent clip  635  locks shaft  180  into proximal detent position  650   a  or distal detent position  650   b.  User force disengages detent clip  635  and allows shaft  180  to translate from locking position  650   a  to  650   b  or  650   b  to  650   a.  These detent features are utilized for translation of end effector  79   b  with respect to housing  169   b.    
         [0092]    Rotation 
         [0093]    Referring to  FIG. 2C , to allow for rotation of the end effector relative to housing  169   a,  blade sheath  172  contains  4  equally spaced detent features  630  that capture fingers  610 . Fingers  610  move in and out of detent features  630 . This allows for end effector  79   b  to rotate and lock in  4  different positions, 90 degrees apart. An alternate expression for rotation is shown at  FIG. 2H . Pin  665  attached to sheath  180  allows for rotation in detent feature  660   a.  Detent feature  660   a  is composed of  5  features spaced equally apart in connector  655 . Slots  660   b  and  660   c  on either side of  660   a  allow for compliance to provide the desired detent torque to rotate end effector  79   b  with respect to housing  169   b.    
         [0094]    Shown at  FIG. 2L , detent wheel assembly  670  is used to allow 360-degree rotation of end effector  79   b  and using the rail feature of  FIGS. 2I-K . A non-slidable connector  672  is rotatably fixed relative to rails  644 . Positioned on connector  672  are tabs  673  spaced 180 degrees apart and contact detent wheel  676  positioned over sheath  185 . Detent teeth  678  are equally spaced around detent wheel  676 . As end effector  79   b  is rotated with respect to housing  169   c,  tabs  673  move in and out of teeth  678  locking end effector  79   b  in place. This allows the user to change the angle with which the end effector is used with respect to housing  169   c.  Positioned within openings of connector  672  (not shown) are two electrical bushings  682   a  and  682   b,  which contact stationary rail  644  and concentric cylinder assembly  690 . Cylinder assembly  690  comprises a proximal cylindrical connection  691   a  on sheath  185 . An electrical cylindrical element  691   b  concentrically fits around connection  691   a,  and a cylindrical insulator  691   c  concentrically fits around electrical element  691   b,  and electrical cylindrical element  691  d fits around insulator  691   c.  Electrical bushings  682   a  and  682   b  contact cylindrical elements  691   b  and  691   d,  respectively on one connection point and rail  644  at an opposite connection point. Electrical bushings  682   a  and  682   b  provide electrical connection to handpiece  50 , thus providing a continuous electrical connection between pushbuttons  625  and handpiece  50 . 
         [0095]    Referring now to  FIGS. 3A-F  and  FIG. 1 , alternate embodiments for telescoping and rotating end effector  79   b  are shown. Blade sheath  772  contains grooves  702  in the form of a helix. Grooves  702  interact with end cap  700  in the same fashion as a nut and bolt. Sheath  772 , grooves  702  and end cap  700  are all contained within housing halves  269   a  and  269   b.  As sheath  772  is rotated, end effector  79   b  will advance and retract with respect to housing  269 . Rotation and translation happen simultaneously and are not independent of each other. An alternate expression of the current embodiment is found in sheath  775 . Sheath  775  contains grooves  705 , which has a change in pitch near proximal and distal ends  706   a  and  706   b  respectively. This change in pitch allows for further precision near maximum and minimum extension of end effector  79   b  relative to housing  269 . While rotation and translation are still dependent on each other, grooves  705  gives the user more positions for end effector  79   b  relative to housing  269 . 
         [0096]    Reference is now made to  FIGS. 3B-F  illustrating additional embodiment for a friction lock mechanism. Knob  720  contains teeth  705 , which are equally spaced 180 degrees apart. Knob  720  fits into the distal end of housing  270 . Slanted surface  710  within housing  270  acts as a ramp and interferes with flexing teeth  705  inward when knob  720  is rotated. This interference creates compressive forces and locks the blade sheath in place with respect to housing  270 . When the interference is relieved, the blade sheath is free to translate and rotate using any of the previous discussed translation and rotation embodiments. An alternate expression of knob  720  is knob  721 . Knob  721  contains teeth  706  which are cut out and hinged on knob  721 . As knob  721  is rotated in housing  270 , teeth  706  flex inward and create compressive forces to lock the blade sheath with respect to the sheath  270 . 
         [0097]    An alternate expression to the friction lock is knob  730 . When knob  730  is rotated it creates interference between housing  271   a  and  271   b.  This interference causes knob  730  to deflect, and applies compressive forces and friction to sheath  776  locking it in place. When knob  730  is not creating interference, end effector  79   b  is able to translate and rotate with respect to housing  271 . 
         [0098]      FIG. 7A and 7B  illustrate an alternative embodiment for activation buttons. Ultrasonic instrument  100   b  contains ring activation button assembly  810 . Ring activation button assembly  810  contains eight segments  810   b.  A minimum of two button segments  810   b  must be contacted to activate harmonic energy in ultrasonic instrument  100   b.  Ultrasonic instrument  100   b  can be configured to accommodate different user grips. Instrument  100   b  can activate upon user contact with a second ring segment  810   b,  or after contact with a third ring segment  810   b  depending on how many of the user&#39;s fingers are used to hold the device. Ring activation button assembly  810  would allow ultrasonic instrument  100   b  to be easily rotated in a surgeon&#39;s hand while maintaining harmonic energy to the targeted area. 
         [0099]    Referring now to  FIG. 9A-C , in an alternate embodiment, a removable activation button assembly  835  translates longitudinally along metal rails  842  carried by ultrasonic surgical instrument  100   c.  Magnetic rails are electrically connected to the handpiece or transducer  50  as would be readily apparent to a skilled artesian. Activation button assembly  835  contains one or more magnets  840  to anchor onto and form an electrical connection with metal rails  842 . Magnet  840  is covered in an electrically conductive material and wired to dome switches  838 . Dome switches are activated by, for example, a rocker switch  837 ; however any type of switch is available as is known to the skilled artesian. Activation button assembly  835  can be rotated on ultrasonic surgical instrument  100   c  to switch the location of max and min rocker button  837 . Activation button assembly  835  can also move in a sliding fashion to any place on ultrasonic surgical instrument  100   c  where magnet  840  holds assembly  835  in place on metal rails  842 . This allows for a variable distance between end effector  79   c  and activation assembly  835 . In one expression of this embodiment, end effector  79   c  and shaft  180   b  are fixed relative to housing  68   a,  as shown in  FIG. 9A ; alternatively, end effector  79   c  and shaft  180   b  are able to move relative to housing  68   a,  shown in  FIG. 9B  (end effector in proximal position). 
         [0100]    An alternate expression for alignment pin  27  is found in  FIGS. 5A and 5B . Hole  66   b  and rear bumper  62  are relocated to the place of minimum displacement on blade  81   b.  Rear bumper  62  is over molded onto blade  81   b  with an elasto-meric material such as silicon. The inside walls of through hole  66   b  are also insert molded with an elasto-meric material such as silicone. Alignment pin  129  is no longer coated with a material, and is pressed through blade sheath  73 , rear bumper  62 , and blade  81   b.  This process would be a cost savings on the alignment pin related to the elimination of the secondary insert-molding step of the alignment pin. There would also be an acoustical improvement and a slight heat reduction as over molded rear bumper  62  and pin  129  could both be placed at the location of minimum displacement. 
         [0101]    Referring now to  FIG. 8A-D , an additional embodiment for the ultrasonic instrument  100  is counterbalance feature  820 . In a first embodiment counterbalance feature  820  remains in a fixed position inside housing  815  and provides a statically balances instrument  100  with respect to the multiple positions of handpiece  50   b  relative to housing  815 . An alternate expression utilizes counterbalance  820   b  in the form of an annulus or asymmetric shape. 
         [0102]    A further expression for counterbalance system is one that dynamically balances instrument  100  with respect to he multiple positions of handpiece  50   b  with respect to housing  815 . Counterbalance  820   c  is moved inside housing  815  by band  823  and post  824 . Band  823  is grounded to handpiece  50   b.  As handpiece  50   b  retracts proximally, counterbalance  820   c  is moves distally through the pulling of handpiece  50   b  on band  823  around post  824 . Once adjusted, counterbalance  820   c  is located further from handpiece  50   b  to better balance ultrasonic instrument  100   c.  As handpiece  50   b  is extends distally, counterbalance  820   c  moves proximally toward the center of mass of the system. 
         [0103]    Counterbalance  820   d  of  FIG. 8D  is an alternate expression for the movable counterbalance mechanism. As hand piece  50   b  retracts proximally and distally, counterbalance  820   d  is shifted via pinion gears  828 , and rack gear  829 . Pinion gears  828  are grounded to handpiece  50   b.  Pinion gears  828  could also be grounded to other ultrasonic surgical instrument  100   c  components. This movement of counterbalance  820   d  will counteract the weight of handpiece  50   b.  The counterbalance system would give optimal balance of the device for all positions of the end effector relative to the activation buttons. This would give the user better precision when operating the device. 
         [0104]    Referring now to  FIG. 6  and  FIG. 1A , an alternate embodiment for ultrasonic surgical instrument  100   a  includes LED ring  60 . LED ring  60  is composed of one or more LED or other low power light sources spaced evenly apart on the distal end of housing  70 . One skilled in the art may determine an alternate light source or configuration to achieve the objective of pointing light in the direction of harmonic blade end effector  79   a.  LED ring  60  may be powered by an external power source or battery pack. LED ring  60  may be activated with buttons  332  and  334  that also activate generator  300 . LED ring  60  may also be continuously on or activated through a separate switch. 
         [0105]    Part of a kit to go along with the device could include a means to better coagulate vessels. Referring now to  FIG. 4A-C , hand held tissue pad  800  consists of Teflon or another compatible material chosen by one skilled in the art to interact with the harmonic blade. Pad  800  is attached to finger hole  805  and resides on the surgeon&#39;s non-dominant hand. Pad  800  is used to apply pressure to blood vessels against blade end effector  79   a  which closes the vessels. An alternate expression consists of pad  802  on stick  807 . Stick  807  is held in the surgeon&#39;s non-dominant hand and is used to apply pressure to blood vessels against blade end effector  79   a  which closes the vessels. This allows for improved hemostasis and blade multifunctionality. 
         [0106]    While the present invention has been illustrated by description of several embodiments, it is not the intention of the applicant to restrict or limit the spirit and scope of the appended claims to such detail. Numerous variations, changes, and substitutions will occur to those skilled in the art without departing from the scope of the invention. Moreover, the structure of each element associated with the present invention can be alternatively described as a means for providing the function performed by the element. Accordingly, it is intended that the invention be limited only by the spirit and scope of the appended claims.