Patent Abstract:
The present disclosure relates to an electrosurgical suction coagulator and includes a housing having an elongated electrode and a fluid applicator. The elongated electrode includes distal and proximal ends and is adapted to connect to an energy source, for example, an electrosurgical generator. The proximal end of the elongated electrode is configured to operably couple to a distal end of the housing. Further, the distal end of the elongated electrode is configured to apply energy to tissue. The elongated electrode also includes a lumen defined therethrough, that is operably coupled to a vacuum source. The fluid applicator assembly is operably coupled to the elongated electrode and includes a container defining a reservoir. The reservoir is configured to contain a bioadhesive therein. The selectively dispensable from the container to deliver the bioadhesive to a surgical site.

Full Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of priority to U.S. Provisional Application Ser. No. 61/040,353 entitled “BIOADHESIVE APPLICATOR FOR ENT SURGERY” filed Mar. 28, 2008 by Sean T. Dycus, which is incorporated by reference herein. 
     
    
     BACKGROUND 
       [0002]    1. Technical Field 
         [0003]    The present invention relates generally to electrosurgical coagulators and, more particularly, to an electrosurgical suction coagulator having a medicinal fluid applicator assembly. 
         [0004]    2. Description of Related Art 
         [0005]    Electrosurgical suction coagulators that coagulate tissue have been available for some time. Generally, these devices include a conductive suction tube having an insulating coating over all but a most distal portion of the tube so that the distal portion forms a generally annular ablating electrode. A suction source is attached to a proximal portion of the tube for evacuating excess fluid and debris from the surgical site through the distal end of the tube. 
         [0006]    The coagulation of bleeding blood vessels and tissue using electrically conductive suction tubes is a technique, which has been widely used in the medical field, particularly electrosurgery, for some time. Typically, a combination electrocautery and suction device is employed during ear, nose and throat (ENT) surgery whenever excessive blood and tissue debris must be removed from the bleeding site in order to facilitate hemostasis of any bleeding vessels. After removing or treating tissue or organs, such as tonsils or adenoids, a medicinal fluid (e.g., bioadhesive fluid) may be applied to facilitate healing. 
         [0007]    Typically, the user must stop the coagulation and/or the suction procedure, remove the coagulation instrument, insert a bioadhesive applicator and release the bioadhesive material to or into the tissue. If the user decides to perform an additional coagulation and/or suction treatment, the coagulation instrument must be redeployed to the tissue site, thus making it more time consuming for the user and patient and possibly complicating the surgical procedure. 
       SUMMARY 
       [0008]    The present disclosure relates to an electrosurgical suction coagulator and includes a housing having an elongated electrode and a fluid applicator. The elongated electrode includes distal and proximal ends and is adapted to connect to an energy source, for example, an electrosurgical generator. The proximal end of the elongated electrode is configured to operably couple to a distal end of the housing. Further, the distal end of the elongated electrode is configured to apply energy to tissue. The elongated electrode also includes a lumen defined therethrough, that is operably coupled to a vacuum source. The fluid applicator assembly is operably coupled to the elongated electrode and includes a container defining a reservoir configured to hold a bioadhesive therein. The bioadhesive is selectively dispensable from the container to deliver the bioadhesive to a surgical site. 
         [0009]    In embodiments, the fluid applicator assembly includes a seal or valve to selectively regulate the flow of bioadhesive to the surgical site. Further, the fluid applicator assembly may include a container or bladder that is compressible to expel the bioadhesive from the container to the surgical site. The fluid applicator assembly may include an actuator that is moveable from a first position, wherein the bioadhesive is maintained in the container, to a subsequent position to incrementally dispense the bioadhesive to the surgical site. Such devices may include a plunger or syringe-like assembly. 
         [0010]    In other embodiments, the fluid applicator assembly may include an actuator that is motorized. For example, the actuator may include a motorized screw-like element that forces the bioadhesive from the container to the surgical site. A control switch, that is mounted on the housing, may operate the motorized actuator. The motorized actuator may be adapted to connect to the same electrical energy sources as the electrode or an independent electrical source. 
         [0011]    These and other objects will be more clearly illustrated below by the description of the drawings and the detailed description of the various embodiments. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]    The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present disclosure and, together with a general description of the disclosure given above, and the detailed description of the embodiments given below, serve to explain the principles of the present disclosure. 
           [0013]      FIG. 1  is a perspective view of one embodiment of a surgical coagulator in accordance with the present disclosure showing a bioadhesive material applicator assembly (in phantom) disposed within a housing of the surgical coagulator; 
           [0014]      FIG. 2A  is a perspective view of the bioadhesive material applicator assembly of  FIG. 1 ; 
           [0015]      FIG. 2B  is a perspective view of an alternate embodiment of a bioadhesive material applicator assembly; 
           [0016]      FIG. 3A  is a side view of a surgical coagulator showing an alternate embodiment of a bioadhesive applicator assembly in accordance with the present disclosure wherein the applicator assembly is disposed outside the housing of the surgical coagulator; 
           [0017]      FIG. 3B  is a side view of a surgical coagulator showing an alternate embodiment of a bioadhesive applicator assembly in accordance with the present disclosure having a syringe-like actuating pump for dispelling the bioadhesive to the tissue site; and 
           [0018]      FIG. 3C  is a side view of a surgical coagulator showing an alternate embodiment of a bioadhesive applicator assembly in accordance with the present disclosure having a motorized screw-like pump for dispelling the bioadhesive to the tissue site. 
       
    
    
     DETAILED DESCRIPTION 
       [0019]    Embodiments of the presently disclosed electrosurgical instrument are described in detail with reference to the drawing figures wherein like reference numerals identify similar or identical elements. As used herein, the term “distal” refers to that portion of the instrument, which is further from the user, while the term “proximal” refers to that portion of the instrument, which is closer to the user. 
         [0020]      FIG. 1  sets forth a perspective view of an electrosurgical coagulator according to the present disclosure and is depicted generally as  10 . The electrosurgical coagulator  10  includes a housing  12  having a handle  14  and proximal and distal ends  16  and  18 , respectively. An elongated suction tube electrode  30  is fluidly and electrically coupled to a port or opening  20  defined in the distal end  18  of the housing  12  and extends therefrom. Suction tube electrode  30  may be selectively engageable with housing  12  or integrally formed therewith depending upon a particular purpose. 
         [0021]    The suction tube electrode  30  includes an elongated tubular hollow shaft  32  having proximal and distal ends  34  and  36 , respectively that may, for example, be constructed from a conductive metal that is partially covered by an insulative material to prevent electrical continuity along shaft  32 . The distal end  36  is exposed to include a blunt electrode  38  that is configured and dimensioned to perform various electrosurgical coagulation procedures (e.g., tonsillectomy, adenoidectomy, etc.). The electrode  38  of the distal end  36  may be substantially blunt, rounded or include a pattern of protuberances to facilitate coagulation of tissue at or adjacent the distal end  36  when activated by the user. Suction tube electrode  30  is configured to electrically interface via the hollow shaft  32  to an electrosurgical generator  50  via one or more cables  52 . 
         [0022]    In embodiments, the generator  50  may control the amount of electrosurgical energy delivered to the tissue based on one or more electrical parameters via one or more sensors coupled to a feedback circuit. For example, the generator  50  may regulate, measure, monitor and/or control one or more of the following electrical or electromechanical parameters: electrical intensity, voltage, current, pulse rate, waveform, temperature and/or impedance. A return pad (not shown) may be utilized to complete the electrical circuit through the patient and the generator  50  may be configured to include patient return pad monitoring such as the system commonly sold under the trademark REM™ by Valleylab, Inc., of Boulder, Colo. 
         [0023]    Suction tube electrode  30  includes an aspiration port  38   a  defined through the distal end  36  of suction tube electrode  30 . Aspiration port  38   a  is configured to facilitate the removal of surgical fluids and debris from the surgical site. In embodiments, the aspiration port  38   a  may be disposed through a side of suction tube electrode (not shown). More particularly and as shown in  FIG. 1 , the suction tube electrode  30  is connected in fluid communication to a source of negative pressure, i.e., vacuum  60 , which draws air and fluid into the aspiration port  38   a  and into the vacuum via hose or tube  62  upon activation by the user. Aspiration port  38   a  may be chamfered, beveled or some other advantageous shape to create a smooth fluid stream therethrough and into the suction tube electrode  30  to facilitate fluid or debris removal. Moreover, suction tube electrode  30  may be made from a flexible and/or malleable material to give the user additional control of the coagulator  10  during use. 
         [0024]    Housing  12  of the electrosurgical coagulator  10  also includes one or more control switches  22   a  and  22   b  which regulate the electrosurgical energy to the suction tube electrode  30 . Either one of the control switches,  22   a  or  22   b , disposed on the housing  12  may be utilized to control coagulation of the instrument  10 , while the other control switch may be utilized to control suction of the instrument  10 . In embodiments, a rotating or sliding-type switch may be employed to accomplish this purpose. Moreover, a switch regulator or potentiometer (e.g., a voltage divider network—VDN) may be used to vary the electrosurgical energy and/or the relative suction through tube  30 . 
         [0025]    Coagulator  10  includes a bioadhesive applicator assembly  40  operatively associated with the coagulator  10 . Bioadhesive applicator assembly  40  generally includes a bladder or housing  41 , which defines a reservoir  42  for containing a medicinal fluid  48  (e.g., a bioadhesive material). Reservoir  42  is disposed in fluid communication with a delivery lumen  44  defined between the bladder  41  and the suction tube electrode  30 . Fluid  48  is defined herein to include fluids and gels that are suitable for or compatible with coagulation surgical procedures (e.g., prior to, during or after application of electrical energy). Some examples of medicinal fluids include bioadhesive fluids and gels which are biomaterial surgical sealants and adhesion barriers developed by hydrogel technology focused on adhesion prevention, tissue sealing and hemostatic clinical application, such as gels sold under the trademarks DURASEAL®, SPRAYGEL® and MICROMYST™, manufactured by CONFLUENT® Surgical, Inc. of Waltham, Mass. (a wholly owned subsidiary of U.S. Surgical, a Tyco Healthcare Company). Other bioadhesive examples include hemostatic matrices such as FLOSEAL™ manufactured by Baxter International, Inc. and SURGIFLO™.manufactured by Johnson &amp; Johnson. 
         [0026]    Turning now to  FIGS. 2A and 2B , alternative embodiments of the present disclosure are illustrated. The delivery lumen  144 , which includes proximal and distal ends,  144   a  and  144   b , respectively, is attached in fluid communication with a distal end  143  of the reservoir  142  such that the delivery lumen  144  and the port  120  (not shown) align. A seal or plug  146  is disposed between the port  120  and the lumen  144  to allow selective expulsion of fluid  48  from reservoir  142  and for preventing fluid  48  from prematurely escaping from the reservoir  142 . Seal  146  is disposed on the proximal end  144   a  of delivery lumen  144  in  FIG. 2A , while seal  246  may be disposed on the distal end  244   b  of delivery lumen  244 . In embodiments, seal  46 ,  146  and  246  may be disposed in any suitable location within bioadhesive applicator assembly  40 ,  140  and  240 , respectively, such that fluid  48  is contained for selective application within the respective reservoir  42 ,  142  and  242 . When pressure is applied by the user, the seal (e.g., seal  46 ) is configured to either break or open to force the bioadhesive material  48  from reservoir  42 . Seal  46  may be a valve, to allow the user to selectively control the expulsion of fluid from reservoir  42  (e.g., duck bill valve, iris valve, etc.). 
         [0027]    As seen in  FIGS. 3B-3D , alternative embodiments of electrosurgical coagulator  10  are shown generally as  300 ,  400  and  500 . The electrosurgical coagulators  300 ,  400 , and  500  are similar to the coagulator  10  and will only be discussed in detail to the extent necessary to identify differences in construction and operation. 
         [0028]    Electrosurgical coagulator  300  includes housing  312  and suction tube electrode  332  that is attached on the distal end  318  of the housing  312 . Suction tube electrode  332  fluidly and electrically couples to housing  312  in a similar fashion as described above, with reference to coagulator  10 . An external fluid applicator assembly  340 , that includes a container, well or bladder  341  defining a reservoir  342  for containing fluid  48  is operatively attached to housing  312  via delivery lumen  344 . The delivery lumen  344  has external and internal segments,  344   a  and  344   b , respectively. When the user manually squeezes (e.g., applies pressure) the external fluid applicator assembly  340  (e.g., a squeezable bulb), the fluid  48  contained within reservoir  342  is expelled through the external and internal delivery lumen,  344   a  and  344   b , respectively, into the suction tube electrode  332  to the surgical site. A seal  346  is included, which ruptures or regulates the flow of fluid  48  from reservoir  342 . 
         [0029]      FIG. 3B  shows an alternate embodiment of a coagulator  400  according to the present disclosure wherein a bioadhesive applicator assembly  440  is disposed within the housing  412  of suction coagulator  400 . The bioadhesive applicator assembly  440  includes a container  443  having a reservoir  442  with a syringe-like or plunger-like actuator  441  for dispensing the fluid  48  from reservoir  442 . More particularly, the plunger-like actuator  441  includes a plunger head  445  that is configured and dimensioned to slidably fit within reservoir  442 . The plunger head  445  is selectively movable from a first configuration wherein the fluid  48  is maintained within reservoir  442  to subsequent positions wherein incremental amounts of fluid  48  are dispensed through lumen  444  and tube  432  to the surgical site. In embodiments, the syringe reservoir  442  may be pre-packaged with a particular medicinal fluid  48  and then inserted within the housing  412 , either by the user or the manufacturer. In embodiments, the user manually operates the plunger head  445  to force the fluid  48  to break and/or open seal  446  similar to the seals described above. 
         [0030]      FIG. 3C  shows yet another embodiment of a coagulator  500  according to the present disclosure, which includes a motorized actuator for dispensing fluid  48  to the surgical site. More particularly, the bioadhesive applicator assembly  540  includes a motorized pump or actuator  541  that forces the fluid  48  from reservoir  542  through lumen  544 , into suction tube electrode  532  and to the surgical site, Any suitable motorized pump may be used to drive the fluid  48  to suction tube electrode  532 . Actuator  541  may be powered by the generator  50  ( FIG. 1 ) with one or more controllers or buttons  522   a ,  522   b  attached therebetween or to the housing  512 . A control wire or connector  560  may connect the button, e.g.,  522   a , to the actuator  541 . The motorized applicator assembly  540  may alternatively be separately powered (e.g., battery powered). As shown in  FIG. 3D , a screw-like actuator  541  rotates a screw gear  549  that drives fluid  48  from the reservoir  542  through the delivery lumen  544  and a seal  546 . The fluid  48  then flows through the delivery lumen  544  through the suction tube electrode  532  and to the surgical site. The user can selectively regulate the amount of fluid  48  dispensed by controlling the screw  549  or the seal  546  or combinations thereof. 
         [0031]    From the foregoing and with reference to the various figure drawings, those skilled in the art will appreciate that certain modifications can also be made to the present disclosure without departing from the scope of the present disclosure. For example, in embodiments, the coagulator may be manufactured such that the coagulator is disposable, reusable or reposable. Also in embodiments, a variety of different or interchangeable suction tube electrodes could be selectively attached to the distal end of the coagulator housing depending upon a particular purpose or to meet a particular surgical need. Additionally, in other embodiments, the suction coagulator, the electrode, and the fluid applicator assembly may be manually or remotely operated by the user by either a footswitch, or as mentioned above, a controller disposed on the instrument. 
         [0032]    Referring back to  FIG. 1 , the suction coagulator  10  is shown having an internal compressible reservoir  42  disposed within the housing  12 . As mentioned above, reservoir  42  may be disposed in any suitable location within the housing  12 . The bottom portion of the housing  12  may be rubberized and integrated with the reservoir  42 , so that when the user manually applies pressure to the reservoir  42 , the bioadhesive fluid  48  is forced out the length of the delivery lumen  44 , through the suction tube electrode  32  and out the aspiration port  38   a  for application to the surgical site. 
         [0033]    In addition and although not shown, one or more of the actuators described herein on the bladder shown in  FIG. 3B  may be configured to provide a small amount of negative pressure (e.g., take in fluid) when release to limit unintentional leakage of additional fluid  48  to the surgical site. 
         [0034]    Although the generator and vacuum are depicted as separate elements in  FIG. 1 , a vacuum may be included with the generator in particular embodiments. 
         [0035]    While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

Technology Classification (CPC): 0