Biopsy devices and methods

Abstract

A method of marking and optionally treating a tissue sample, the method comprising the steps of: (a) providing an instrument including a needle having an opening and a clip delivery device within the needle, wherein the clip delivery device includes an opening coexisting with the opening of the needle; and (b) delivering a clip to a biopsy site, wherein the clip includes an encasement adapted to provide treatment to the tissue sample; wherein delivery of the clip is essentially free of a step of longitudinal re-positioning of greater than about 3 mm by the user of the needle or clip delivery device so that the clip is precisely deployed to a central portion of the biopsy site.

What is claimed is: 
     
         1 - 13 . (canceled) 
     
     
         14 . A method of marking and optionally treating a tissue sample, the method comprising the steps of:
 (a) providing an instrument including a needle having an opening and a clip delivery device within the needle, wherein the clip delivery device includes an opening coexisting with the opening of the needle; and   (b) delivering a clip to a biopsy site, wherein the clip includes an encasement adapted to provide treatment to the tissue sample;   wherein delivery of the clip is essentially free of a step of longitudinal re-positioning of greater than about 3 mm by the user of the needle or clip delivery device so that the clip is precisely deployed to a central portion of the biopsy site.   
     
     
         15 . The method of  claim 14 , wherein the opening of the needle and the delivery device is located on a side portion of the same, and wherein the side tube opening includes a center located at about 8 to about 16 mm from the leading end of the clip delivery device. 
     
     
         16 . The method of  claim 15 , wherein delivery of the clip is free of a step of longitudinal re-positioning of the needle or clip delivery device by the user. 
     
     
         17 . The method of  claim 16 , wherein the treatment is selected from lubricants, collagen, antibiotics, antiseptics, radiation seeds, chemotherapeutic agents, thrombosis activating agents and any combinations thereof. 
     
     
         18 . The method of  claim 16 , wherein the treatment includes providing information regarding the tissue sample using Radio Frequency Identification system. 
     
     
         19 . The method of  claim 16 , wherein the treatment includes performing cryoblation. 
     
     
         20 . The method of  claim 16 , wherein the treatment includes monitoring the growth or changes in a tissue sample. 
     
     
         21 . The method of  claim 14 , wherein the clip delivery device comprises:
 1) an elongated delivery tube including:
 a. a longitudinal axis, 
 b. a leading portion with a forward end, and 
 c. sidewall including: the opening, having a center, in the elongated delivery tube axially spaced from the leading portion; 
   2) an elongated push rod including a portion that slides within the elongated delivery tube and within the opening in the sidewall of the elongated delivery tube;   3) a ramp guide surface located in the tube; the ramp guide surface being inclined so that the ramp guide surface defines a rear end of the leading portion; and the ramp guide surface being located in the opening in the sidewall of the elongated delivery tube;   wherein the clip is located in the elongated delivery tube and axially forward of the push rod,   wherein a center of the opening in the sidewall of the elongated delivery tube is located about 5 mm to about 10 mm from the forward end of the leading portion, and   wherein the encasement at least partially surrounds the clip so that the encasement protects the clip from forces encountered during deployment of the clip.   
     
     
         22 . The method of  claim 14 , wherein during delivery of the clip to the biopsy site a push rod is extended to the end of the clip delivery device and through the opening of the clip delivery device. 
     
     
         23 . The method of  claim 14 , wherein the elongated push rod has an end portion that deforms along the ramp guide surface during deployment of the clip. 
     
     
         24 . The method of  claim 14 , wherein marking and optionally treating the tissue sample is performed using a stereotactic technique. 
     
     
         25 . The method of  claim 21 , wherein the clip has a largest dimension of less than about 1 cm. 
     
     
         26 . The method of  claim 21 , wherein the clip is generally two back to back C shaped segments. 
     
     
         27 . The method of  claim 14 , wherein the encasement has a diameter of between about ⅓ mm and about 2 mm. 
     
     
         28 . The method of  claim 14 , wherein the clip comprises:
 an axis between a first end and a second end and comprising a metal structure consisting essentially of:   a first arc segment having a first end located at the first end of the clip and a second end located at the second end of the clip;   a second arc segment having a first end located at the first end of the clip and a second end located at the second end of the clip, the second arc segment being coplanar with the first arc segment;   an apex disposed along the clip axis defining where the first and second arc segments adjoin and converge; and   wherein the encasement includes or comprises agents adapted to assist in the treatment of tissue, enclosing a portion of the clip, and exposing the first and second ends of the first and second arc segments after deployment;   wherein after being driven through the opening of the clip delivery device, the metal structure is configured to engage breast tissue, wherein the metal structure is configured so that
 (i) it resides entirely within the clip delivery device prior to being driven through the opening, 
 (ii) it deploys through the opening of the clip delivery device, and 
 (iii) in both an original pre-deployment state and a post-deployment state:
 the first ends of the first and second arc segments project in a direction outward relative to the clip axis, and the second ends of the first and second arc segments project in a direction outward relative to the clip axis, while residing within the clip delivery device, 
 the first ends of the first and second arc segments project in a direction generally away from the second ends of the first and second arc segments; 
 
 (iv) while it resides within the clip delivery device prior to being driven through the opening, and after being driven though the opening the first and second arc segments are arcuate; and 
 (v) the first ends and the second ends of the first and second arc segments engage breast tissue after being driven through the opening of the delivery tube, and thereby substantially preventing migration of the clip within the breast tissue. 
   
     
     
         29 . The method of  claim 21 , wherein the clip comprises:
 an axis between a first end and a second end and comprising a metal structure consisting essentially of:   a first arc segment having a first end located at the first end of the clip and a second end located at the second end of the clip;   a second arc segment having a first end located at the first end of the clip and a second end located at the second end of the clip, the second arc segment being coplanar with the first arc segment;   an apex disposed along the clip axis defining where the first and second arc segments adjoin and converge; and   wherein the encasement includes or comprises agents adapted to assist in the treatment of tissue, enclosing a portion of the clip, and exposing the first and second ends of the first and second arc segments after deployment;   wherein after being driven through the opening of the clip delivery device, the metal structure is configured to engage breast tissue, wherein the metal structure is configured so that
 (i) it resides entirely within the clip delivery device prior to being driven through the opening, 
 (ii) it deploys through the opening of the clip delivery device, and 
 (iii) in both an original pre-deployment state and a post-deployment state:
 the first ends of the first and second arc segments project in a direction outward relative to the clip axis, and the second ends of the first and second arc segments project in a direction outward relative to the clip axis, while residing within the clip delivery device, 
 the first ends of the first and second arc segments project in a direction generally away from the second ends of the first and second arc segments; 
 
 (iv) while it resides within the clip delivery device prior to being driven through the opening, and after being driven though the opening the first and second arc segments are arcuate; and 
 (v) the first ends and the second ends of the first and second arc segments engage breast tissue after being driven through the opening of the delivery tube, and thereby substantially preventing migration of the clip within the breast tissue. 
   
     
     
         30 . The method of  claim 14 , wherein the needle having an opening is inserted into a breast, a biopsy is performed, and then the clip delivery device is inserted into the needle. 
     
     
         31 . The method of  claim 30 , wherein the opening of the clip deliver device and needle are generally longitudinally align when the clip delivery device is inserted into the needle. 
     
     
         32 . The method of  claim 14 , wherein the method is free of monitoring the deployment using an ultrasonic device in order to determine the position of the deployment device prior to deployment of the clip. 
     
     
         33 . The method of  claim 31 , wherein the method is free of monitoring the deployment using an ultrasonic device in order to determine the position of the deployment device prior to deployment of the clip.