Apparatus, System and Method for Excision of Soft Tissue

Abstract

Disclosed is a soft tissue excision apparatus having a handle and an elongated blade support member extending from the handle. The distal end of blade support member includes a first thermally conductive blade support arm and a second thermally conductive blade support arm. An electrically heatable blade is supported at and electrically isolated from the distal ends of the two thermally conductive blade support arms. A first electrically conductive lead extends from the proximal end of the thermally conductive blade support member to a first blade heater contact pad. A second electrically conductive lead extends from the proximal end of the thermally conductive blade support member to a second blade heater contact pad. First and second electrically conductive flexible leads extend from the proximal end of the thermally conductive blade support member to a controller.

I claim: 
     
         1 . An apparatus for the excision of soft tissue in one or more of the throat, oropharynx, nasopharynx, or larynx of humans, comprising:
 [a] a handle;   [b] an elongated blade support member having a distal end and a proximal end, and extending from the handle;   [c] the distal end of blade support member including a first thermally conductive blade support arm having a distal end and a proximal end, and a second thermally conductive blade support arm having a distal end and a proximal end;   [d] an electrically heatable blade supported at and electrically isolated from the distal ends of the first and second thermally conductive blade support arms;   [e] a first electrically conductive lead extending from the proximal end of the thermally conductive blade support member to a first blade heater contact pad;   [f] a second electrically conductive lead extending from the proximal end of the thermally conductive blade support member to a second blade heater contact pad; and   [g] a controller, wherein the first and second electrically conductive flexible leads extend from the proximal end of the thermally conductive blade support member to the controller.   
     
     
         2 . The apparatus of  claim 1 , wherein the heatable blade has at least one straight cutting edge for excising soft tissue. 
     
     
         3 . The apparatus of  claim 1 , wherein the heatable blade has at least one triangular shaped cutting edge for excising soft tissue. 
     
     
         4 . The apparatus of  claim 1 , wherein the heatable blade has an electrically conductive heating element that incorporates a conductive material having a high temperature coefficient of resistance of at least 400 ppm per degree C. 
     
     
         5 . The apparatus of  claim 1 , wherein the heatable blade has at least one cutting edge having a tip, wherein the heatable blade is covered with a non-stick coating except at the cutting edge tip. 
     
     
         6 . The apparatus of  claim 1 , wherein the elongated blade support member is malleable. 
     
     
         7 . The apparatus of  claim 1 , wherein the electrically conductive heating element of the heatable blade incorporates a ferromagnetic material having a Curie temperature in the range from 150 C to 600 C. 
     
     
         8 . The apparatus of  claim 1 , wherein first and second thermal barrier members are positioned between the heatable blade and the first and second distal ends of the thermally conductive blade support arms, respectively, to reduce conduction of heat. 
     
     
         9 . An apparatus for the excision of soft tissue in one or more of the throat, oropharynx, nasopharynx, or larynx of humans, comprising:
 [a] a handle;   [b] an elongated blade support member having a distal end and a proximal end, and extending from the handle;   [c] distal end of the blade support member including first and second thermally and electrically conductive blade support arms having distal ends and proximal ends;   [c] the first thermally and electrically conductive blade support arm being electrically isolated from the second thermally and electrically conductive blade support arm;   [d] an electrically heatable blade supported at the distal ends of the first and second thermally and electrically conductive blade support arms;   [e] a first electrically conductive lead extending from and in electrical communication between the distal end of the first thermally and electrically conductive blade support arm and a first blade heater contact pad;   [f] a second electrically conductive lead extending from and in electrical communication between the distal end of second thermally and electrically conductive blade support arm and a second blade heater contact pad; and   [g] a controller; and   [h] third electrically conductive flexible leads extending between the proximal ends of first and second thermally and electrically conductive blade support arms and the controller.   
     
     
         10 . The apparatus of  claim 9 , wherein the heatable blade has at least one straight cutting edge for excising soft tissue. 
     
     
         11 . The apparatus of  claim 9 , wherein the heatable blade has at least one triangular shaped cutting edge for excising soft tissue. 
     
     
         12 . The apparatus of  claim 9 , wherein the electrically conductive heating element of the heatable blade incorporates a conductive material having a high temperature coefficient of resistance of at least 400 ppm per degree C. 
     
     
         13 . The apparatus of  claim 9 , wherein the heatable blade has at least one cutting edge having a tip, wherein the heatable blade is covered with a non-stick coating except at the cutting edge tip. 
     
     
         14 . The apparatus of  claim 9 , wherein the elongated blade support member is malleable. 
     
     
         15 . The apparatus of  claim 9 , wherein the electrically conductive heating element of the heatable blade incorporates a ferromagnetic material having a Curie temperature in the range from 150 C to 600 C. 
     
     
         16 . The apparatus of  claim 9 , wherein first and second thermal barrier members are positioned between the heatable blade and the first and second distal ends of the thermally conductive blade support arms, respectively, to reduce conduction of heat. 
     
     
         17 . An apparatus for the excision of soft tissue in one or more of the throat, oropharynx, nasopharynx, or larynx of humans, comprising:
 [a] a handpiece comprising an elongated blade support member having a proximal end and a distal end, first and second blade support arms, and a heatable blade with at least one cutting edge for excising soft tissue;   [b] first and second electrical leads extending from the proximal end of the blade support member to first and second blade heater contact pads, respectively;   [c] a controller for maintaining a temperature of the heatable blade to an operator-selected set-point temperature; and   [d] a cable extending from and in electrical communication with the first and second electrical leads at the proximal end of the blade support member to the controller.   
     
     
         18 . The apparatus of  claim 17 , wherein the heatable blade incorporates a conductive material having a high temperature coefficient of resistance of at least 400 ppm per degree C. 
     
     
         19 . The apparatus of  claim 17 , wherein the heatable blade temperature is in the range of 70 C to 600 C. 
     
     
         20 . The apparatus of  claim 17 , wherein the heatable blade has a heating element that incorporates a ferromagnetic material having a Curie temperature in the range from 150 C to 600 C. 
     
     
         21 . The apparatus of  claim 17 , having a footpedal attached to the controller, wherein the footpedal comprising a first pedal to activate excision heating of the heatable blade during tissue excision and a second pedal to activate coagulation heating of the heatable blade to effect coagulation of blood vessels underlying excised soft tissue. 
     
     
         22 . The apparatus of  claim 17 , wherein the distal end of the blade support arms having a tissue contact surface that carry first and second electrodes, wherein third and fourth electrical leads extend from the proximal end of the blade support member to the first and second electrodes, respectively; and a cable extends from the first, second, third and fourth electrical leads at proximal end of blade support member within handpiece to the controller. 
     
     
         23 . A method for the excision of soft tissue in one or more of the throat, oropharynx, nasopharynx, or larynx of humans, comprising the steps of:
 [a] inserting a blade support member and heatable blade into a patient's mouth or throat while positioning the heatable blade adjacent to the soft tissue to be excised, wherein the heatable blade has a cutting edge;   [b] applying power to the heatable blade for sufficiently elevating the heatable blade to an elevated temperature to seal severed blood vessels during soft tissue excision;   [c] while applying power, also advancing the cutting edge of the elevated temperature heatable blade through the soft tissue to be excised to effect tissue excision while minimizing bleeding therefrom; and   [d] removing the heatable blade and blade support member from the patient's mouth or throat.   
     
     
         24 . The method of  claim 23 , wherein the heatable blade has a first surface and further comprising the step of urging the first surface of the elevated-temperature heatable blade against a surface of the tissue layer underlying the excised tissue to effect coagulation and sealing of blood vessels severed during excision. 
     
     
         25 . The method of  claim 23 , wherein the distal ends of the first and second blade support members carry a pair of spaced-apart electrodes, and the method further comprises the step of measuring electrical impedance of tissue located between the electrodes to identify when maximum tissue impedance has been achieved. 
     
     
         26 . The method of  claim 23 , for excision of tonsil tissue. 
     
     
         27 . The method of  claim 23 , for excision of adenoid tissue. 
     
     
         28 . The method of  claim 23 , wherein the elevated temperature heatable blade is advanced in step (c) at an angle of between about 15 and 30 degrees relative to the forward direction thereof to reduce the force required for soft tissue excision.