Device and method for improved diagnosis and treatment of cancer

Abstract

A device, in several configurations, which fixes a breast in distended, stable position using negative pressure, and minimizes or halts lymphatic flow from the breast. The invention allows for improvement in imaging and intervention in diagnosis and treatment of early stage human breast cancer. An image-guided system which allows accurate and bloodless access to breast tissue; guided by MRI or CT; using a unique saw and cautery device; in linear and rotary configurations to remove small or large lesions from the breast.

What is claimed is:  
     
         1 . A fixation apparatus for a breast comprising: 
 a cup-like body, said body having a side wall with an open top end and an open bottom end and a fluid evacuation duct, said body defining a chamber adapted to receive therein at least a portion of said breast;    a gasket attached to said bottom end, said gasket adapted to provide a substantially fluid tight seal between said body and a first area of skin around said breast; and,    a suction ring attached to said top end, said ring adapted to provide a substantially fluid tight seal between said body and a second area on said breast.    
     
     
         2 . The fixation apparatus of  claim 1 , further comprising a hose attached to said fluid evacuation duct, said hose connecting said body to a pump capable of evacuating fluid in said cup-like body when said body is mounted on said breast such that said gasket and said suction ring provide a substantially fluid tight seal between said body and said first and said second areas respectively.  
     
     
         3 . The fixation apparatus of  claim 1 , wherein said cup-like body is frustospherical in shape.  
     
     
         4 . The fixation apparatus of  claim 1 , wherein said cup-like body is funnel shaped.  
     
     
         5 . The fixation apparatus of  claim 1 , wherein said fixation apparatus is manufactured of materials which are transparent to MRI.  
     
     
         6 . The fixation apparatus of  claim 1 , further including an adhesive to attach said gasket to said first area and to attach said suction ring to said second area.  
     
     
         7 . The fixation apparatus of  claim 2 , further including a pressure gauge to monitor the pressure within said cup-like body.  
     
     
         8 . The fixation apparatus of  claim 1 , further including an interventional device and an imaging device and an adjustable stage, wherein said suction ring is mounted on said adjustable stage, said adjustable stage securing said interventional device in an alignment, said imaging device for guiding the alignment of said interventional device.  
     
     
         9 . The fixation apparatus of  claim 1 , wherein said suction ring is mounted on a adjustable stage.  
     
     
         10 . The fixation apparatus of  claim 9 , further including an interventional device, said interventional device held in an alignment by said adjustable stage, said alignment permitting precise excision of a specimen of tissue from said breast.  
     
     
         11 . The fixation apparatus of  claim 10 , further including an imaging device, said imaging device for guiding the alignment of said interventional device.  
     
     
         12 . The fixation apparatus of  claim 10 , wherein said interventional device is a biopsy device.  
     
     
         13 . The fixation apparatus of  claim 9 , wherein said adjustable stage has a first portion with a first end and a second end and a second portion, said second portion of said adjustable stage being generally ring shaped, said second end of said first portion being connected to said second portion.  
     
     
         14 . A fixation apparatus for a protuberance of a body comprising: 
 a cup-like body having a continuous wall and a port, said wall being open at one end, said wall defining a volume adapted to receive therein said protuberance of said body without said protuberance contacting said wall; and    a gasket attached to said end, said gasket adapted to provide a substantially fluid tight seal between said body and an area of skin around said protuberance.    
     
     
         15 . The fixation apparatus of  claim 14 , further comprising a tubular member connecting said port to a pump, said pump for removing fluid from said volume to create a reduced or negative pressure within said volume and a pressure gauge connected to said fixation apparatus to monitor the pressure within said cup-like body.  
     
     
         16 . The fixation apparatus of  claim 14 , wherein said cup-like body is generally hemispherical in shape.  
     
     
         17 . The fixation apparatus of  claim 14 , wherein said cup-like body is funnel shaped.  
     
     
         18 . The fixation apparatus of  claim 14 , wherein said apparatus is manufactured of materials which are transparent to MRI.  
     
     
         19 . The fixation apparatus of  claim 14 , wherein said gasket is attached to said area of skin using an adhesive.  
     
     
         20 . A minimally invasive tissue saw comprising: 
 a shaft extending along a first axis between a proximal end and a distal end, said shaft having a first cross section at the distal end;    a cutting head extending between a connecting end and a cutting end, at least a portion of the connecting end pivotally connected to the distal end of said shaft so that at least a portion of said cutting head is able to swivel back and forth substantially along a second axis, the second axis in a direction transverse to the first axis; 
 said cutting head having a cutting surface at said cutting end, said cutting surface extending across a width in the second axis, said cutting surface being able to swivel back and forth to cut a slit in tissue, the slit having a second cross section;  
 said cutting head having at least one insertion surface substantially adjacent said cutting surface, said insertion surface extending between the connecting end and the cutting end, said insertion surface tapering from substantially the first cross section at the connecting end to substantially the second cross section at the cutting end; and,  
 wherein at least a portion of said insertion surface is a cauterizing element, said cauterizing element extending substantially around a strip of said insertion surface, said element cauterizing the tissue surrounding the slit.  
   
     
     
         21 . The tissue saw of  claim 20 , wherein said cutting surface is a serrated edge.  
     
     
         22 . The tissue saw of  claim 20 , said insertion surface being a first surface and a second surface, said first and second surfaces generally facing opposite directions, wherein at least a portion of said first surface is a first cauterizing element and at least a portion of said second surface is a second cauterizing element, each of said first and second surfaces are substantially adjacent the cutting surface.  
     
     
         23 . The tissue saw of  claim 22 , wherein said cutting surface is integrally formed with said first surface and said second surface.  
     
     
         24 . The tissue saw of  claim 22 , wherein said cutting surface is substantially adjacent said first and second cauterizing elements.  
     
     
         25 . The tissue saw of  claim 22 , wherein the portion of the cutting head pivotally connected to the distal end of said shaft is the cutting surface, and the first surface and the second surface remain fixed with respect to the shaft when said cutting surface swivels back and forth.  
     
     
         26 . The tissue saw of  claim 22 , wherein the first cauterizing element and the second cauterizing element are fixed to a portion of the first surface and second surface, respectively.  
     
     
         27 . The tissue saw of  claim 20 , wherein the entire cutting head swivels back and forth.  
     
     
         28 . The tissue saw of  claim 20 , wherein said first cross-section is a circle with a first diameter, the width of said cutting surface being equal to said first diameter, and wherein the cutting surface is able to pivot from side to side at least a distance of 0.2854 times the width of said cutting surface along the second axis.  
     
     
         29 . The tissue saw of  claim 20 , further including a retaining sleeve concentric with said shaft, said retaining sleeve enclosing said shaft.  
     
     
         30 . The tissue saw of  claim 20 , wherein said cutting surface is a generally circular bandsaw.  
     
     
         31 . The tissue saw of  claim 30 , wherein said bandsaw has a diameter at least equal to π/2 times the diameter of said shaft.  
     
     
         32 . The tissue saw of  claim 31 , wherein said shaft is a cylinder, and wherein said bandsaw may be detached from the distal end of said shaft, said bandsaw being collapsible so that it may be retracted through said shaft.  
     
     
         33 . The tissue saw of  claim 22 , wherein the first surface has a first taper from the first cross-section of the connecting end to substantially the second cross-section at the cutting end, and the second surface has a second taper from substantially the first cross-section at the connecting end to substantially the cross-section at the cutting end, and wherein the first and second tapers are linear in profile.  
     
     
         34 . The tissue saw of  claim 33 , wherein the first taper is different from the second taper.  
     
     
         35 . The tissue saw of  claim 20 , wherein the shaft is a cylinder, said tissue saw further comprising a plurality of cables for pivoting the cutting surface back and forth along the second axis.  
     
     
         36 . The tissue saw of  claim 20 , further including a plurality of orifices on said insertion surface for the injection of at least one chemical directly to the tissue surrounding a lesion to be excised.  
     
     
         37 . The tissue saw of  claim 20 , wherein said tissue saw is constructed of MR transparent material.  
     
     
         38 . The tissue saw of  claim 20 , further including a retaining sleeve, said retaining sleeve concentric with said shaft, and further including a coring head, said coring head sized to fit within said retaining sleeve.  
     
     
         39 . A minimally invasive device for removing a specimen of tissue comprising: 
 a cylinder extending along and rotatable around a first axis defined between a proximal end and a distal end, said cylinder having an interior surface and an exterior surface;    a plurality of cutting arms, each arm having an inner surface and an outer surface, said surfaces extending between a forward edge and a trailing edge, wherein at least a portion of the forward edge defines a cutting edge and wherein the cutting edge extends past the distal end of the cylinder to cut tissue; and,    wherein said arms are pivotally connected to said cylinder substantially at the distal end, said arms pivoting between an open position and a closed position, the inner surface of each arm adjacent and substantially overlapping the exterior surface of said cylinder in the open position, and wherein at least a portion the inner surface of each arm extends beyond the distal end of said cylinder and is adjacent tissue in the closed position.    
     
     
         40 . The device of  claim 39 , wherein at least a portion of the outer surface of each arm is a cauterizing element, the cauterizing element cauterizing the tissue surrounding the specimen of tissue to be removed.  
     
     
         41 . The device of  claim 39 , wherein each arm has a pivoting end and a far end, the forward edge and the trailing edge extending between the pivoting end and the far end, each of said arms pivoting substantially around the pivoting end.  
     
     
         42 . The device of  claim 41 , wherein the far end is adjacent and substantially overlapping the exterior surface of said cylinder in the open position, and wherein the far end has been pivoted 90 degrees in a direction away from the distal end of the cylinder in said closed position.  
     
     
         43 . The device of  claim 41 , wherein each of said arms is made of a material having a memory, said memory causing said arms to curve inwardly toward one another as the far end is pivoted from the open position to the closed position.  
     
     
         44 . The device of  claim 43 , wherein said arm is made of a shape memory material.  
     
     
         45 . The device of  claim 41 , further including a supporting armature attached to said cylinder, said arms curving inward toward one another as they move between said open position wherein said arms are substantially adjacent the armature to said closed position wherein at least a portion of each arm no longer overlaps the armature.  
     
     
         46 . The device of  claim 41 , further including a spring located between the pivoting end of the inner surface of each of said arms and the exterior surface of said cylinder, the spring causing the far end of each arm to curve inwardly as the far end is pivoted from the open position to the closed position.  
     
     
         47 . The device of  claim 45 , wherein said cylinder acts as the supporting armature.  
     
     
         48 . A minimally invasive tissue biopsy device comprising: 
 a cannula having a proximal end and a distal end;    a first longitudinal axis defined between said ends;    means for cutting a slit in tissue, the slit in a second axis substantially transverse to said first longitudinal axis; and    trailing means for cauterizing substantially all tissue surrounding the slit.    
     
     
         49 . The biopsy device of  claim 48 , further comprising means for coring a section of tissue adjacent the distal end of said cannula.  
     
     
         50 . The biopsy device of  claim 49 , wherein said means for coring is introduced to the system around the exterior of said cannula.  
     
     
         51 . The biopsy device of  49 , wherein said means for coring goes through said cannula after the removal of said means for cutting.  
     
     
         52 . The biopsy device of  claim 49 , wherein said means for coring goes through said cannula around said means for cutting.  
     
     
         53 . A method comprising: 
 providing a retaining sleeve having a proximal and a distal end, said retaining sleeve having a first cross-section at the distal end;    providing a tissue saw with an oscillating cutting head and a trailing coagulating element, said head having a cutting edge and a tapering insertion surface;    advancing said retaining sleeve and said tissue saw along a first axis toward a lesion while said cutting edge oscillates back and forth and cuts an entry wound in tissue, the entry wound being a substantially linear slit, the slit having a second cross-section;    distorting the entry wound from the second cross-section of the slit to the first cross-section of the retaining sleeve; and,    cauterizing tissue surrounding said slit with said trailing coagulating element, said cauterization occurring as said tissue saw and said retaining sleeve are advanced toward said lesion.    
     
     
         54 . The method of  claim 53 , further comprising removing said tissue saw through said retaining sleeve.  
     
     
         55 . The method of  claim 53 , further comprising halting the tissue saw and retaining sleeve along the first axis prior to reaching the lesion.  
     
     
         56 . The method of  claim 53 , further comprising providing and advancing an interventional device through said retaining sleeve to said lesion.  
     
     
         57 . The method of  claim 53 , further comprising providing and advancing a coring device up to a distal end of said retaining sleeve and coring out a specimen of tissue surrounding the lesion.  
     
     
         58 . The method of  claim 57 , further comprising cauterizing the tissue surrounding the specimen with said coring device.  
     
     
         59 . The method of  claim 58 , further comprising withdrawing the specimen of tissue through said retaining sleeve.  
     
     
         60 . The method of  claim 53 , further comprising withdrawing the retaining sleeve and allowing the entry wound to collapse from the first cross section to the second cross section.  
     
     
         61 . The method of  claim 53 , further comprising injecting anti-cancer agents into the tissue.