Abstract:
An ultrasonic surgical clamp coagulator apparatus is configured to effect cutting, coagulation, and clamping of tissue by cooperation of a clamping mechanism of the apparatus with an associated ultrasonic end-effector. The handle of the apparatus is configured to permit hand activation for cutting, coagulation, and clamping of tissue during surgical procedures. In order to promote convenient and efficient use of the apparatus, the fingertip controls are provided directly into the disposal shears handle in a position that allows surgeons to activate the device without repositioning their hand. The two buttons provide independent control of the two power levels available from the generator, matching the two foot pedal configuration of the prior art.

Description:
REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application is a continuation of U.S. patent application Ser. No. 10/869,351, filed Jun. 16, 2004, which claims the priority benefit of U.S. provisional patent application Ser. No. 60/478,984, filed on Jun. 17, 2003, which is incorporated herein by reference. 
         [0002]    This application contains subject matter related to co-owned patent application Ser. Nos. 09/879,319, granted Sep. 20, 2005, as U.S. Pat. Nos. 6,945,981, and 09/693,549, granted Sep. 23, 2003, as U.S. Pat. No. 6,623,500, both of which are hereby incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION 
       [0003]    The present invention relates generally to ultrasonic surgical devices, and more particularly to an ultrasonic surgical clamp coagulator apparatus for coagulating and/or cutting tissue, including a hand activated switch positioned on the handle for easy access by the surgeon. 
       BACKGROUND OF THE INVENTION 
       [0004]    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 hemostasis by coagulation, desirably minimizing patient trauma. The cutting action is typically effected by an end-effector at the distal end of the instrument, with the end-effector transmitting ultrasonic energy to tissue brought into contact therewith. Ultrasonic instruments of this nature can be configured for open surgical use, or laparoscopic or endoscopic surgical procedures. 
         [0005]    Ultrasonic surgical instruments have been developed that include a clamp mechanism to press tissue against the end-effector (i.e. the cutting blade) of the instrument in order to couple ultrasonic energy to the tissue of a patient. Such an arrangement (sometimes referred to as a clamp coagulator shears or an ultrasonic transactor) is disclosed in U.S. Pat. Nos. 5,322,055; 5,873,873 and 6,325,811, which are incorporated herein by reference. The surgeon activates the clamp pad to press against the end-effector by squeezing on the handgrip or handle. 
         [0006]    A foot pedal operated by the surgeon while simultaneously applying pressure to the handle to press tissue between the clamp pad and end-effector activates a generator that provides energy that is transmitted to the cutting blade for cutting and coagulating tissue. 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. 
         [0007]    The present invention overcomes the drawbacks of the prior art and is directed to an improved ultrasonic surgical clamp coagulator shears apparatus that provides for a more ergonomic means for activating the shears by incorporating fingertip control on the handles. 
       BRIEF SUMMARY OF THE INVENTION 
       [0008]    An ultrasonic surgical clamp coagulator apparatus embodying the principles of the present invention is configured to permit hand activation for cutting, coagulation, and clamping of tissue during surgical procedures. In order to promote convenient and efficient use of the apparatus, the fingertip controls are provided directly into the disposal shears handle in a position that allows surgeons to activate the device without repositioning their hand. The two buttons provide independent control of the two power levels available from the generator, matching the two-foot pedal configuration. 
         [0009]    In one embodiment the buttons are a rocker style configuration where the buttons appear independent to the user, but are actually a single unit rotating about a central axis. This configuration eliminates dual activation of the buttons, which would cause an error condition at the generator. The buttons are also incorporated in a manner in which the angle of depression/activation is not parallel, but rather, angled toward a common point in space to improve ergonomic feel. Further, the buttons are spaced to allow the user to rest their trigger finger (e.g. the index finger) between the buttons. This configuration minimizes the opportunity of an inadvertent activation and provides a high degree of grip stability during grasping and manipulation of tissue. In combination with the rocker switch are dome switches integrated within a flex circuit to provide for the electrical contact and snap feel of the rocker switches. 
         [0010]    The invention further provides for an integrated electrical interface to the hand piece. A slip contact provides the required electrical interface between the shears and hand piece once the hand piece is securely mounted to the disposable shears device. In one embodiment, the electrical interface requires only two leads for control of both power levels. 
         [0011]    In accordance with the illustrated embodiment, the present ultrasonic surgical clamp apparatus includes a housing that preferably includes a handgrip portion. The apparatus further includes an elongated portion (which may be configured for endoscopic use), and a distal end positionable at the region at which tissue cutting, coagulation, and/or clamping is to be effected. In the preferred embodiment, two switches are mounted on the pistol grip for effecting activation of the generator to provide ultrasonic energy to the end-effector. 
         [0012]    The present apparatus includes a clamping mechanism for clamping tissue against the ultrasonic end-effector. The clamping mechanism includes a clamp arm pivotally mounted on the distal end of the outer tubular sheath for pivotal movement with respect to the end-effector. Tissue is clamped between the clamp arm and the end-effector, thereby ultrasonically coupling the tissue with the end-effector (when energized) or permitting grasping and clamping of tissue when ultrasonic energy is not being transmitted through the waveguide to the end-effector. The clamp arm is operatively connected to the reciprocal actuating member of the apparatus so that reciprocal movement of the actuating member pivotally moves the clamp arm with respect to the end-effector. 
         [0013]    An operating lever pivotally connected on the apparatus housing provides selective operation of the apparatus clamping mechanism. In the preferred embodiment, the operating lever, and associated handgrip portion of the housing are provided with a pistol-like configuration, thus permitting convenient movement of the operating lever by a user&#39;s thumb. The operating lever is interconnected with the reciprocal actuating member by a clamp drive mechanism so that pivotal movement of the operating lever reciprocally moves the actuating member for pivotally moving the clamp arm of the apparatus. Notably, the handgrip portion includes two pushbuttons for activating the end-effector, thus permitting the end-effector to be selectively activated by the surgeon&#39;s fingertip. 
         [0014]    Further features and advantages of the present invention will become readily apparent from the following detailed description, the accompanying drawings, and the appended claims. 
     
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         [0015]      FIG. 1  is a perspective view of an ultrasonic surgical system including an ultrasonic clamp coagulator apparatus embodying the principles of the present invention; 
           [0016]      FIG. 2  is an enlarged, elevation view fragmentary perspective view of a clamp mechanism of the clamp coagulator apparatus of  FIG. 1 ; 
           [0017]      FIG. 3  is a side elevation, partially cut-away view, of the clamp coagulator embodying the principles of the present invention; 
           [0018]      FIG. 4  is an assembly drawing of a clamp coagulator of the present invention; 
           [0019]      FIG. 5  is an exploded view of the handle incorporating the rocker switch, handpiece connector, two slip rings and flex circuit; 
           [0020]      FIGS. 6   a - b  are exploded views of the large slip ring and small slip ring, respectively; 
           [0021]      FIG. 7  is an exploded view of the handpiece connector; 
           [0022]      FIG. 8   a - b  is an exploded view of the flex circuit apparatus and the associated electrical schematic, respectively; 
           [0023]      FIG. 9  is a schematic view of the handle of an ultrasonic instrument of the present invention illustrating dimensional placement of the switches; and 
           [0024]      FIG. 10  is an exploded view of the switch assembly. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0025]    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. Furthermore, 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. 
         [0026]    The present invention is particularly directed to an improved ultrasonic surgical clamp coagulator apparatus which is configured for effecting tissue cutting, coagulation, and/or clamping during surgical procedures. The present apparatus can readily be configured for use in both open surgical procedures, as well as laparoscopic or endoscopic procedures. Versatile use is facilitated by selective use of ultrasonic energy. When ultrasonic components of the apparatus are inactive, tissue can be readily gripped and manipulated, as desired, without tissue cutting or damage. When the ultrasonic components are activated, the apparatus permits tissue to be gripped for coupling with the ultrasonic energy to effect tissue coagulation, with application of increased pressure efficiently effecting tissue cutting and coagulation. If desired, ultrasonic energy can be applied to tissue without use of the clamping mechanism of the apparatus by appropriate manipulation of the ultrasonic “blade” or end-effector of the device. 
         [0027]    As will become apparent from the following description, the present clamp coagulator 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 drive unit of a surgical system, whereby ultrasonic energy from the drive unit provides the desired ultrasonic actuation of the present clamp coagulator apparatus. It will be appreciated that a clamp coagulator apparatus embodying the principles of the present invention can be configured for non-disposable use, and non-detachably integrated with an associated ultrasonic drive unit. However, detachable connection of the present clamp coagulator apparatus with an associated ultrasonic drive unit is presently preferred for single-patient use of the apparatus. 
         [0028]    With reference first to  FIGS. 1 and 3 , therein is illustrated a presently preferred embodiment of a surgical system, generally designated  10 , which includes an ultrasonic clamp coagulator apparatus embodying the principles of the present invention. Preferred details of the ultrasonic generator and associated ultrasonic drive unit of the surgical system  10  will first be described, with subsequent detailed description of the fingertip activation of the end-effector, embodying the principles of the present invention. 
         [0029]    The surgical system  10  includes an ultrasonic generator  30  and an associated ultrasonic surgical instrument. The surgical instrument includes an ultrasonic drive unit, designated  50 , and an ultrasonic clamp coagulator apparatus  120  embodying the principles of the present invention. As will be further described, an ultrasonic transducer of the drive unit  50 , and an ultrasonic waveguide of the clamp coagulator  120 , together provides an acoustic assembly of the present surgical system, with the acoustic assembly providing ultrasonic energy for surgical procedures when powered by generator  30 . It will be noted that in some applications, the ultrasonic drive unit  50  is referred to as a “hand piece assembly” because the surgical instrument of the surgical system is configured such that a surgeon grasps and manipulates the ultrasonic drive unit  50  during various procedures and operations. The clamp coagulator apparatus  120  embodying the principles of the present invention preferably includes a pistol-like grip arrangement that facilitates positioning and manipulation of the instrument apart from manipulation of the ultrasonic drive unit  50 . 
         [0030]    The generator  30 , for example, a Generator 300 available from Ethicon Endo-Surgery, Inc., Cincinnati, Ohio, of the surgical system sends an electrical signal through a cable  32  at a selected current, frequency, and phase determined by a control system of the generator  30 . As will be further described, the signal causes one or more piezoelectric elements of the acoustic assembly of the surgical instrument to expand and contract, thereby converting the electrical energy into mechanical motion. The mechanical motion results in longitudinal waves of ultrasonic energy that propagate through the acoustic assembly in an acoustic standing wave to vibrate the acoustic assembly at a selected frequency and excursion. An end-effector at the distal end of the waveguide of the acoustic assembly is placed in contact with tissue of the patient to transfer the ultrasonic energy to the tissue. As further described below, a surgical tool, such as, a jaw or clamping mechanism, is preferably utilized to press the tissue against the end-effector. 
         [0031]    As the end-effector couples with the tissue, thermal energy or heat is generated as a result of friction, acoustic absorption, and viscous losses within the tissue. The heat is sufficient to break protein hydrogen bonds, causing the highly structured protein (i.e., collagen and muscle protein) to denature (i.e., become less organized). As the proteins are denatured, a sticky coagulum forms to seal or coagulate small blood vessels. Deep coagulation of larger blood vessels results when the effect is prolonged. 
         [0032]    The transfer of the ultrasonic energy to the tissue causes other effects including mechanical tearing, cutting, cavitation, cell disruption, and emulsification. The amount of cutting as well as the degree of coagulation obtained varies with the excursion of the end-effector, the frequency of vibration, the amount of pressure applied by the user, the sharpness of the end-effector, and the coupling between the end-effector and the tissue. 
         [0033]    As illustrated in  FIGS. 1 and 3 , the generator  30  includes a control system integral with the generator  30  and an on-off switch  34 . The power switch  34  controls the electrical power to the generator  30 , and when activated by the triggering mechanism  36   a - b,  the generator  30  provides energy to drive the acoustic assembly  40  of the surgical system  10  to drive the end-effector at a predetermined excursion level. The generator  30  drives or excites the acoustic assembly at any suitable resonant frequency of the acoustic assembly. 
         [0034]    When the generator  30  is activated via the triggering mechanism  36   a - b,  the generator  30  continuously applies electrical energy to a transducer stack  90 . A phase-locked loop in the control system of the generator  30  monitors feedback from the acoustic assembly. The phase lock loop adjusts the frequency of the electrical energy sent by the generator  30  to match the resonant frequency of the selected longitudinal mode of vibration of the acoustic assembly including the tissue load. In addition, a second feedback loop in the control system maintains the electrical current supplied to the acoustic assembly at a preselected constant level in order to achieve substantially constant excursion at the end-effector of the acoustic assembly. 
         [0035]    The electrical signal supplied to the acoustic assembly will cause the distal end of the waveguide, i.e., the end-effector, ( FIG. 2 ) to vibrate longitudinally in the range of, for example, approximately 20 kHz to 250 kHz, and preferably in the range of about 54 kHz to 56 kHz, and most preferably at about 55.5 kHz. The excursion of the vibrations at the end-effector can be controlled by, for example, controlling the amplitude of the electrical signal applied to the transducer assembly  40  by the generator  30 . Switch  36   a  provides for one level of amplitude and switch  36   b  provides for a second level of amplitude. 
         [0036]    As noted above, the triggering mechanism  36   a - b  of the generator  30  allows a user to activate the generator  30  so that electrical energy may be continuously supplied to the acoustic assembly. The triggering mechanism  36   a - b  preferably comprises a rocker switch that is positioned on handle  224  and electrically coupled or attached to the generator  30  by a cable or cord. Alternatively, the triggering mechanism  36   a - b  could be placed at other convenient locations, for example, on thumb ring  222  or on shroud  130 . 
         [0037]    Referring to  FIGS. 1 ,  3  and  4 , the handpiece  50  includes a multi-piece housing  52  adapted to isolate the operator from the vibrations of the acoustic assembly. The drive unit housing  52  can be shaped to be held by a user in a conventional manner, but it is contemplated that the present clamp coagulator  120  principally be grasped and manipulated by a pistol-like arrangement provided by a housing of the apparatus, as will be described. While the multi-piece housing  52  is illustrated, the housing  52  may comprise a single or unitary component. 
         [0038]    The housing  52  generally includes a proximal end, a distal end, and a cavity extending longitudinally therein. The distal end of the housing  52  includes an opening  60  configured to allow the acoustic assembly of the surgical system  10  to extend therethrough, and the proximal end of the housing  52  is coupled to the generator  30  by the cable  32 . 
         [0039]    The housing  52  is preferably constructed from a aluminum, however, it is also contemplated that housing  52  may be made from a variety of plastics, such as Ultem RTM. A suitable ultrasonic drive unit  50  is model no. HP054, available from Ethicon Endo-Surgery, Inc., Cincinnati, Ohio. Two gold-plated circumferential electrical connectors  111   a  and  111   b  are located at the distal end of drive unit  50  for communicating electrical control signals from switches  36   a - b  to the generator  30 . 
         [0040]    As shown in  FIGS. 3 and 5 , the handpiece  50  is preferably acoustically coupled to the second acoustic portion of the ultrasonic clamp coagulator apparatus  120 . The distal end of the drive unit  50  is preferably coupled to the proximal end of the second acoustic portion by an internal threaded connection near an anti-node, but alternative coupling arrangements can be employed. When drive unit  50  is inserted into housing  130  and connected thereto, the distal end of drive unit  50  passes through connector  300  and ring connectors  111   a - b  interface with slip ring connectors  310  and  320 , respectively, as is discussed in more detail below. 
         [0041]    Referring also now to  FIG. 4 , an exploded view of the ultrasonic clamp coagulator apparatus  120  of the surgical system  10  in accordance with a preferred embodiment is illustrated. The proximal end of the ultrasonic clamp coagulator apparatus  120  preferably receives and is fitted to the distal end of the ultrasonic drive unit  50  by insertion of the drive unit into the housing of the apparatus, as shown in  FIG. 3 . The ultrasonic clamp coagulator apparatus  120  is preferably attached to and removed from the ultrasonic drive unit  50  as a unit. The ultrasonic clamp coagulator  120  may be disposed of after a single use. 
         [0042]    The ultrasonic clamp coagulator apparatus  120  preferably includes a handle assembly or a housing  130 , preferably comprising mating housing portions  131 ,  132 , and an elongated or endoscopic portion  150 . When the present apparatus is configured for endoscopic use, the construction can be 5 dimensioned such that portion  150  has an outside diameter of about 5.5 mm. The elongated portion  150  of the ultrasonic clamp coagulator apparatus  120  extends orthogonally from the apparatus housing  130 . The elongated portion  150  can be selectively rotated with respect to the housing  130 . The elongated portion  150  preferably includes an outer tubular member or sheath  160 , an inner tubular actuating member  170 , and the second acoustic portion of the acoustic system in the form of a waveguide  180  having an end-effector 180°. Outer tube  160 , inner tube  170 , end effector 180° and clamp pad  190  are all operatively coupled with rotation knob  216  so that rotation of knob  216  causes corresponding rotation of the end effector 180° and clamp arm  190 . 
         [0043]    As illustrated in  FIG. 4 , the proximal end of the waveguide  180  of the second acoustic portion is preferably detachably coupled to the mounting device  84  of the ultrasonic drive unit  50  near an anti-node as described above. The waveguide  180  preferably has a length substantially equal to an integer number of one-half system wavelengths. The waveguide  180  is preferably fabricated from a solid core shaft constructed out of material that propagates ultrasonic energy efficiently, such as titanium alloy (i.e., Ti-6Al-4V) or an aluminum alloy. It is contemplated that the waveguide  180  can alternatively be fabricated from any other suitable material. 
         [0044]    With particular reference to  FIG. 2 , a clamping mechanism of the present clamp coagulator  120  is configured for cooperative action with the end-effector 180° of the waveguide  180 . The clamping mechanism includes a pivotally movable clamp arm  190 , which is pivotally connected at the distal end thereof to the distal end of outer tubular sheath  160 . A clamp pad  192 , preferably formed from Teflon or other suitable low-friction material, is mounted on the surface of the clamp arm for cooperation with the end-effector 180°, with pivotal movement of the clamp arm positioning the clamp pad in substantially parallel relationship to, and in contact with, the end-effector 180°. By this construction, tissue is grasped between the pad  192  and the end effector 180°. As illustrated, the pad  192  is preferably provided with a saw tooth-like configuration to enhance the gripping of tissue in cooperation with the end-effector 180°. As will be appreciated by those skilled in the art, end-effector  180 ′ and clamp pad  190  may take on any number of shapes, including a curved shaped as disclosed in U.S. Pat. No. 6,325,811. 
         [0045]    As is described in the U.S. patents previously incorporated by reference, the surgeon&#39;s thumb squeezes trigger  222  to cause the clamping mechanism to pivot the movable clamp arm  190 . One or more of the surgeon&#39;s other fingers may rest comfortably within handle  224 . In accordance with the current invention, the surgeon&#39;s index finger controls the operation of the generator  30  by selectively depressing switches  36   a - b.  Switches  36   a - b  are conveniently located such that the surgeon may energize end effector 180° and also cause rotation of the end effector 180° and clamp pad  190  via knob  216  using the same hand (fingers) for operation. 
         [0046]    Referring now to  FIGS. 5-8  and  10 , switches  36   a - b  are mechanically connected via a rocker arm  40  comprising an aperture  140   a  for accepting pivot post  42 . In this configuration, switches  36   a - b  cannot be simultaneously depressed, which, if were the case, would provide an error message from generator  30 . A flex circuit  330  provides for the electro-mechanical interface between switches  36   a - b  and the generator  30  via the drive unit  50 . Also referring to  FIG. 8   a , flex circuit  330  includes, at the distal end, two dome switches  332  and  334  that are mechanically actuated by depressing pins  142   a - b  of corresponding switches  36   a - b,  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. 8   b . Flex circuit  330  also comprises two diodes within a diode package  336 , also illustrated in  FIG. 8   b . Flex circuit  330  provides conductors, as is known to those in the art, that connect to slip ring conductors  310  and  320  via connector  300 , which in turn provide electrical contact to ring conductors  111   a - b,  which in turn are connected to conductors in cable  32  that connect to generator  30 . Ring conductors  111   a - b  are situated within the distal end of handpiece  50  as is generally described in U.S. Pat. No. 6,623,500 B1, the contents of which are incorporated by reference herein. 
         [0047]    With particular reference now to  FIGS. 6   a - b  and  7 , slip ring conductors  310  and  320  are generally open-ended O-shaped springs that slip onto mounting surfaces  302  and  304  of connector  300 , respectively. Each spring slip-ring comprises two pressure point contacts ( 312   a - b  and  322   a - b ) that contact the respective ring conductor  111   a - b  of handpiece  50 . The spring tension of the slip rings  310  and  320  cause positive contact between contacts  312   a - b,    322   a - b  and conductors  111   a - b.  It is evident that the slip-ring construction allows electrical contact to be made even as hand piece  50  may be rotated by the surgeon during use of the instrument. Posts  314  and  324  of the respective slip rings electrically connect to the respective conductor within flex circuit  330  to complete the electrical circuit as shown in  FIG. 8   b.    
         [0048]    Referring now to  FIG. 9 , switches  36   a - b  are preferably configured in such a way to provide an ergonomically pleasing grip and operation for the surgeon. In particular, the angle of depression/activation of switches  36   a - b  is not parallel, but the direction of activation for each switch define an angle of actuation θ1 with respect to a common point P within area of thumb placement of the thumb grip of trigger  222 , when the trigger  222  is in its normal state. The range of angle θ1 is from about 10° to about 30°, and more preferably from about 15° to about 20°. Switches  36   a - b  are also separated by a distance L 1 , which is sufficient to minimize inadvertent activation by the surgeon&#39;s finger resting on handle  224  between switches  36   a - b,  but at the same time provides for a high degree of grip stability during tissue grasping and manipulation functions. Distance L 1  is from about 1 inch to about 0.5 inches, and more preferably, from about 0.8 inches to about 0.6 inches. 
         [0049]    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.