Frictional tissue sampling and collection method and device

Abstract

In an embodiment of the invention, a frictional tissue sampling device with a head designed to be rotated without rotating off the designated site can be used to obtain tissue biopsy samples. A frictional tissue sampling device with a head designed to be rotated without rotating off the designated site can be used to obtain an epithelial tissue biopsy sample from lesions. The device can be otherwise used to sample specific locations. In various embodiments, the head of the device is narrow and pointed with a hybrid pear shaped diamond facet. The facet contour can be concave, convex or flat. Abrasive material can be adhered to the facet contour.

What is claimed is: 
     
         1 . A method for obtaining a biopsy of a transformation zone comprising:
 (a) selecting a Frictional Tissue Sampling and Collection (FTSC) head with a facet in the FTSC head, where the FTSC head is received in a handle;   (b) inserting the FTSC head into the non-dilated cervix;   (c) waiting for the cervix to at least partially dilate;   (d) further inserting the FTSC head into the partially dilated cervix;   (e) incrementally repeating steps (c) and (d) until the facet at least partially rests against the transformation zone;   (f) rotating in a first direction one or both the handle and the FTSC head to frictionally abrade the transformation zone; and   (g) removing the FTSC head from the cervix.   
     
     
         2 . The method of  claim 1 , where one or more of FTSC head size, facet contour, facet shape and FTSC head shape are selected based on the curvature of the cervix to be sampled to biopsy the cervix without causing discomfort to the patient. 
     
     
         3 . The method of  claim 1 , where the facet contour selected is concave when the cervix has a convex shaped contour. 
     
     
         4 . The method of  claim 1 , where the facet contour selected is convex when the cervix has a concave shaped contour. 
     
     
         5 . A device for obtaining a transformation zone biopsy comprising:
 (a) a head including:
 a first portion with a proximal end, a distal end, a first facet extending from the proximal end to the distal end, a smooth surface extending from the proximal end to the distal end and having a first main axis of rotation from the proximal end to the distal end; and 
 a second portion with a second facet and having a second main axis of rotation perpendicular to the first main axis of rotation, where the first portion and the second portion intersect at a point; 
   (b) a handle with a proximal end, a distal end and a main axis of rotation parallel with the first main axis of rotation, where the point is located at the distal end;   (c) a plurality of loops secured to the first facet; and   (d) a plurality of loops secured to the second facet.   
     
     
         6 . The device of  claim 5 , where the first facet is cut at an angle relative to the first main axis of rotation of between:
 a lower limit of approximately 2 degrees; and   an upper limit of approximately 30 degrees.   
     
     
         7 . The device of  claim 5 , where the first facet has a shape selected from the group consisting of pear-shaped, triangular, diamond and hybrid diamond-pear-shape. 
     
     
         8 . The device of  claim 5 , where the first facet has a length between:
 a lower limit of approximately 4×10 −3  m; and   an upper limit of approximately 3×10 −2  m.   
     
     
         9 . The device of  claim 5 , where the second facet is cut at an angle relative to the second main axis of rotation of between:
 a lower limit of approximately 2 degrees; and   an upper limit of approximately 30 degrees.   
     
     
         10 . The device of  claim 5 , where the second facet has a shape selected from the group consisting of pear-shaped, triangular, diamond and hybrid diamond-pear-shape. 
     
     
         11 . The device of  claim 5 , where the second facet has a length between:
 a lower limit of approximately 4×10 −3  m; and   an upper limit of approximately 3×10 −2  m.   
     
     
         12 . The device of  claim 5 , where the first portion has a perimeter at the distal end smaller than the perimeter at the proximal end. 
     
     
         13 . The device of  claim 5 , where the first facet has a railing around a perimeter, where the railing can be used to form a pool of adhesive prior to the adhesive being cured. 
     
     
         14 . The device of  claim 13 , where the pool of adhesive is used to attach the plurality of loops onto the first facet. 
     
     
         15 . The device of  claim 13 , where the pool of adhesive holds the plurality of loops intact on the first facet. 
     
     
         16 . The device of  claim 5 , where the second facet has a railing around a perimeter, where the railing can be used to form a pool of adhesive prior to the adhesive being cured. 
     
     
         17 . The device of  claim 16 , where the pool of adhesive is used to attach the plurality of loops onto the second facet. 
     
     
         18 . The device of  claim 16 , where the pool of adhesive holds the plurality of loops intact on the second facet. 
     
     
         19 . A method for obtaining a biopsy of a transformation zone comprising:
 (a) selecting a head including:
 a first portion with a proximal end, a distal end, a first facet extending from the proximal end to the distal end, a smooth surface extending from the proximal end to the distal end and a first main axis of rotation from the proximal end to the distal end; and 
 a second portion with a second facet and a second main axis of rotation perpendicular to the first main axis of rotation, where the first portion and the second portion intersect at a point, where the head is received in a handle, where the head is selected to insert into the cervix; 
   (b) inserting the head into the cervix;   (c) ceasing insertion once the first facet and the second facet at least partially rest against the transformation zone;   (f) rotating in a first direction the handle to frictionally abrade the transformation zone, where the smooth surface facilitates rotation of the head; and   (g) removing the head from the cervix to retrieve the biopsy.   
     
     
         20 . The method of  claim 19 , where one or more of the head size, the first facet length, the first facet contour, the first facet shape, the second facet length, the second facet contour, the second facet shape are selected based on the curvature of the cervix to be sampled.