Echogenic needle for transvaginal ultrasound directed reduction of uterine fibroids and an associated method

Abstract

The invention is a transvaginal ultrasound probe having an attached echogenic needle that is useful in the treatment of uterine fibroids. The echogenic needle has an echogenic surface near its tip that allows the physician to visualize its location using ultrasound imaging. In one embodiment, the needle has an active electrode at its distal end. The active electrode supplies radio frequency energy to a fibroids causing necrosis of the targeted fibroid or by destroying the fibroid's vascular supply. The radio frequency needle preferably has a safety device that shuts-off energy if the needle punctures the uterine wall. In a second embodiment, the needle has a cryogen supply tube and cryogen supply. This embodiment destroys fibroid tissue by freezing it or its vascular supply when the tissue comes in contact with the needle's frozen distal end. The invention further includes the method of using the ultrasound probe with the attached needle.

1 . An echogenic medical needle comprising: 
 a tubular outer member having a distal end and proximal end, said tubular outer member being positionable into a needle guide that is attached to a vaginal ultrasonic probe;    an echogenic surface disposed proximal to said distal end;    a cryo-insulation sheath disposed on said outer tubular member and defining a distal segment of said outer member that is cryo-noninsulated so that said distal end can be placed in cryogenic contact with uterine fibroids; and    a cryogen supply tube extending from said proximal end to said distal end through which a cryogenic supply is provided to said distal end.    
   
   
       2 . The medical needle according to  claim 1 , further comprising a cryogen supply that is in communication with said tube whereby said cryogen supply is delivered to said distal end.  
   
   
       3 . The medical needle according to  claim 2 , wherein said cryogen supply comprises a cryogenic liquid.  
   
   
       4 . The medical needle according to  claim 1 , wherein said cryogen supply tube is disposed in an interior of said tubular outer member.  
   
   
       5 . The medical needle according to  claim 1 , wherein the echogenic surface comprises one or more of grooves, recesses, bumps, indentations, or coatings formed on the surface of said tubular outer member proximal to said distal end.  
   
   
       6 . The medical needle according to  claim 1 , wherein said distal end further comprises a sharpened point for penetrating tissue.  
   
   
       7 . The medical needle according to  claim 1 , wherein said cryo-noninsulated segment is capable of producing a cryogenic effect in targeted tissue.  
   
   
       8 . An echogenic medical needle for transvaginal ultrasound directed cryoablation of uterine myomas and fibroids comprising: 
 a tubular outer member having an inner surface, a distal end having an echogenic surface, and a proximal end;    a cryo-insulation sheath surrounding a surface of a segment of said outer member, said cryo-insulated segment extending from said proximal end of said outer member to, but not including, said distal end of said outer member, such that said distal end can be placed in cryogenic contact with uterine fibroids;    a cryogen supply tube extending from said proximal end of said outer member to said distal end of said outer member; and    a vaginal ultrasonic probe having an attached needle guide whereby said medical needle is positionable in said needle guide.    
   
   
       9 . The medical needle according to  claim 8 , further comprising a cryogen supply that is in communication with said tube whereby said cryogen supply is delivered to said distal end of said outer member;  
   
   
       10 . The medical needle according to  claim 8 , wherein said distal end further comprises a sharpened point for penetrating tissue.  
   
   
       11 . The medical needle according to  claim 8 , wherein the length of said outer member is about 25-50 centimeters.  
   
   
       12 . The medical needle according to  claim 8 , wherein the length of said outer member is about 30 to 40 centimeters.  
   
   
       13 . The medical needle according to  claim 8 , wherein the diameter of said outer member is about 12-18 gauge.  
   
   
       14 . The medical needle according to  claim 8 , wherein the diameter of said outer member is about 16-18 gauge.  
   
   
       15 . The medical needle according to  claim 8 , wherein said proximal end further comprises a finger grip for manually directing said distal end.  
   
   
       16 . The medical needle according to  claim 8 , wherein said attached needle guide is a plastic or metal clamp fitted around said probe and having an opening through which the needle is insertable.  
   
   
       17 . The medical needle according to  claim 8 , wherein the echogenic surface comprises one or more of grooves, recesses, bumps, indentations, or coatings formed on the surface of said tubular outer member proximal to said distal end.  
   
   
       18 . A method for the cryoablation of myomas and fibroids in the uterus using a transvaginal ultrasound directed echogenic medical needle comprising the steps of: 
 a) providing an ultrasound probe having a transducer and a needle guide attached to said probe;    b) providing an echogenic needle, the echogenic needle including a tubular outer member having a distal end having a echogenic surface, a proximal end, a cryo-insulation sheath surrounding a surface of a segment of said outer member, said cryo-insulated segment extending from said proximal end of said outer member to, but not including, said distal end of said outer member, a cryogen supply tube within said outer member, said tube extending from send proximal end of said outer member to said distal end of said outer member, and a cryogen supply that is in communication with said tube whereby said cryogen supply is delivered to said distal end of said outer member;    c) inserting said ultrasound probe into a uterus;    d) inserting said echogenic needle into said uterus through said needle guide;    e) sensing the location of said fibroids and said echogenic needle within said uterus with said ultrasonic probe;    f) guiding said echogenic needle to a surface of said fibroids using the ultrasound imaging;    g) positioning said echogenic needle on said surface of said fibroid; and    h) delivering a controlled amount of said cryogen supply to the surface of said myoma to cause cryoablation of said fibroid.    
   
   
       19 . The method according to  claim 18 , wherein the step of positioning the echogenic needle in contact with said fibroid further includes the step of penetrating said surface with said distal end of said echogenic needle.  
   
   
       20 . The method according to  claim 18 , wherein the step of positioning the echogenic needle in contact with said fibroid further includes the step of positioning the echogenic needle in contact with the fibroid's vascular supply.