Abstract:
This invention relates generally to the targeting and biopsy of tissue for medical purposes, and more particularly to a targeted biopsy system which allows planning of tissue to be sampled, targeting of specific areas of tissue in reference to the plan, capturing the tissue sample and recording the source location of the tissue sample, particularly for use in collecting tissue samples from the prostate gland. A further purpose of this invention is to provide a targeted treatment system which allows planning of tissue to be treated, targeting of specific areas of tissue in reference to the plan, and delivering the treatment to the targeted tissue.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
       [0001]    This application is a continuation of patent application Ser. No. 12/214,163, which was filed on Jun. 17, 2008, and which is a divisional patent application that claims priority to the non provisional patent application having Ser. No. 11/895,228, which was filed on Aug. 23, 2007, and which issued as U.S. Pat. No. 7,833,168 on Nov. 16, 2010, which claims priority to the nonprovisional patent application having Ser. No. 10/842,652 that was filed on May 10, 2004, now abandoned, which claims priority to the provisional patent application having Ser. No. 60/494,910, filed Aug. 13, 2003. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    Prostate health is a significant concern for men over the age of fifty. If prostate cancer is suspected from either a physical examination or because of a Prostate Specific Antigens test, a biopsy is performed to collect tissue samples from the prostate for evaluation by a pathologist. Prostate tumors are small growths scattered about the prostate. For this reason, a physician will take multiple tissue samples from different areas of the prostate, typically between 9 and 18 samples. 
         [0003]    The normal procedure for obtaining biopsy samples with ultrasound guidance is called Transrectal Ultrasound (TRUS) Guided Prostate Biopsy. An end-fire ultrasound probe is used, which generates a pie-shaped image plane. Some end-fire probes are manufactured with a biopsy needle channel, which passes through the body of the probe at an angle, such that a biopsy needle set inserted through the biopsy needle channel exits the channel at a slight angle relative to the body of the probe. Most probes require a needle set guide tube to be affixed to the probe body, such that a needle set placed through the guide tube parallels the axis of the probe and the needle set can be extended beyond the end of the probe. In use for both, the physician inserts the ultrasound probe into the rectum, and moves the probe around until the specific area of the prostate to be sampled is identified. The physician then bends the probe upward, pointing the biopsy needle channel or biopsy needle set guide at the targeted area of the prostate. A needle set is inserted into and through the needle channel or guide, pushed through the rectum wall and into the prostate. 
         [0004]    Standard coring biopsy needles sets are made from substantially rigid, coaxially aligned, stainless steel wire and tubing. They are comprised of two basic components; an inner solid wire stylet with specimen notch and a hollow outer cutting cannula. Once the needle set is correctly positioned relative to the area of tissue to be sampled, the inner stylet is quickly advanced under spring loaded or similar pressure into the prostate tissue. The tissue to be sampled then “prolapses” into stylet&#39;s sample notch cutout. Almost instantaneously the outer cutting cannula quickly advances, also under spring loaded pressure, which serves to sever and capture the tissue that had prolapsed into the stylet notch. The needle set is then removed from the tissue/patient so that the tissue sample can be extracted from the needle set and evaluated for the presence of cancer. The physician then moves the probe around within the rectum to identify the next area of the prostate to be sampled, and the process is repeated. As noted, between 9 and 18 samples are typically taken from different areas of the prostate. 
         [0005]    Existing biopsy methods suffer from a number of disadvantages. Because the probe must be physically moved about within the rectum by hand to identify and target the different areas of the prostate, it is difficult for physicians to precisely targeted biopsy sample locations, often causing the need for additional samples to be taken. Further, if a sample seems to confirm cancer, it is difficult for the physician to accurately know where in the prostate the sample was taken from, and so difficult to re-biopsy the same tissue location to confirm the cancer. 
         [0006]    A number of systems or devices have been proposed for the purpose of better targeting biopsies. Batten, et al, (U.S. Pat. No. 5,398,690) discloses a slaved biopsy device, analysis apparatus, and process. In Batten, an ultrasound device is inserted into the male urinary tract through the penis, with the biopsy and treatment device inserted transrectally. Chin, et al, (U.S. Pat. No. 6,179,249) discloses an ultrasound guided therapeutic and diagnostic device. Chin is a flexible ultrasound device used for laproscopic surgery. Lin (U.S. Pat. No. 6,261,234) disclosed a method and apparatus for ultrasound imaging with biplane instrument guidance. Lin&#39;s ultrasound device uses two transducers to create two image planes, and has a biopsy needle guide which directs a biopsy needle at the intersection of the imaging planes. Burney, et al (U.S. Pat. No. 6,447,477) discloses surgical and pharmaceutical site access guide and methods. Burney shows a biopsy device in which a thick needle with side exit ports is inserted into the targeted tissue. Biopsy needles are then inserted into the thick needle, exiting out the side to take samples. Further, a number of systems have specified the use of flexible biopsy needle kits. 
         [0007]    However, all of these inventions suffer from a number of disadvantages. All require specialized equipment, and do not make use of existing ultrasound systems and technology. All require the movement of the imaging device, making it more difficult to plan and target areas of the prostate for biopsy. Further, the flexible biopsy needles called out either require heating or additional force to cause them to fire, and are impractical for use with established prostate biopsy procedures and existing biopsy needle set firing devices. 
         [0008]    Therefore, users would benefit from a biopsy system to allow a biopsy to be planned prior to the tissue sampling, to allow the biopsy needle to be precisely inserted into a targeted area and which is able to record the precise location from which the tissue sample is collected while the imaging device remains stationary. Users would also benefit from a flexible needle set which may be easily “fired” while in a curved position. Further, users would benefit from a means of precisely delivering a treatment to a targeted area of an organ or tissue mass. 
       SUMMARY OF THE INVENTION 
       [0009]    It is the principal object of this invention to provide a device and method for precisely planning, undertaking and recording a multi-sample biopsy of a targeted tissue mass such as a prostate, improving physicians&#39; ability to diagnose cancer. 
         [0010]    Another object of the invention is to allow a biopsy plan to be formulated identifying the specific quadrants and areas of the prostate to be sampled. 
         [0011]    Another object of the invention is to allow this biopsy plan to be saved as a reference point. 
         [0012]    Another object of the invention is to allow a physician to adjust the biopsy needle guide to allow the physician to precisely insert the needle into the tissue at the planned location. 
         [0013]    Another object of the invention is to allow a physician to monitor the needle set as it is inserted into the tissue, to verify that the needle is in the planned location. 
         [0014]    Another object of the invention is to provide a biopsy needle guide which can be affixed to or associated with existing side-imaging transrectal ultrasound probes. 
         [0015]    A further object of the invention is to allow the transrectal ultrasound probe to remain stationary while the biopsy samples are gathered from different areas of the prostate, thereby improving the accuracy of the procedure. 
         [0016]    A further object of the invention is to allow the probe to remain stationary while the needle guide is moved longitudinally along the probe and is also rotated around the probe. 
         [0017]    A further object of the invention is to provide a needle set guide which can redirect the needle set such that the needle set can be curved while still maintaining the freedom of movement to allow the firing and collecting of tissue samples. 
         [0018]    A further object of the invention is to provide a biopsy needle set that may be redirected at an angle and further maintains its ability to be fired and so collect the tissue samples. 
         [0019]    An object of an alternative embodiment of the invention is to allow a treatment plan to be formulated identifying the specific areas of tissue or an organ to be treated. 
         [0020]    A further object of an alternative embodiment of the invention is to allow this treatment plan to be saved as a reference point. 
         [0021]    Another object of an alternative embodiment of the invention is to allow a physician to precisely insert a needle or treatment delivery means into the tissue at the planned location. 
         [0022]    Another object of the invention is to allow a physician to monitor the needle or treatment delivery method as it is inserted into the tissue, to verify that the needle or treatment delivery method is in the planned location. 
         [0023]    These and other objects, advantages and features are accomplished according to the devices and methods of the following description of the preferred embodiment of the invention. 
         [0024]    As noted the present invention relates to a biopsy targeting system for use with ultrasound imaging devices, and particularly for use in sampling prostate tissue. The biopsy targeting system consists of a redirecting biopsy needle guide which works in conjunction with a side-view or end-fire transrectal ultrasound probe, a cooperating software program which can be loaded and operated on a computer controlled ultrasound system, and a bendable needle set. 
         [0025]    In use, the transrectal ultrasound probe is placed in the cradle of a stabilizer. The redirecting needle guide positioning assembly is also affixed to the cradle. The physician then advances and adjusts the cradle to allow the transrectal probe to be inserted into the rectum of a patient. The physician generates an ultrasound image while positioning the probe to insure that the patient&#39;s prostate is viewable within the viewing area of the probe. Once the probe is correctly positioned, the physician then locks the probe in place in the stabilizer. 
         [0026]    With the transrectal probe in place, the physician initiates a full 3D scan of the prostate. The multiple image slices are captured by the ultrasound system. The physician then looks through these saved images, to identify possible problem areas of the prostate and further to decide which areas of the prostate to sample. Typically, physicians collect 9 to 18 tissue samples from different areas of the prostate. As part of this process, the physician is able to use the software program to project potential needle path lines onto the images of the prostate. These paths are shown as lines in views parallel to the needle path and as circles where the paths pierce the image plane. Each possible path is described by the positional settings of the redirecting needle guide. When the physician identifies a specific area to be sampled, the physician moves a projected needle path line to intersect the planed area to be biopsied. The physician continues to evaluate the prostate and target additional areas for sampling, again saving projected needle paths for each planned sample. Further, if the physician does not identify any possible problem areas, but wishes to take a standard biopsy, the physician can use a range of default setting on the computer program to project between 9 and 18 projected needle paths with a standard distribution throughout the prostate. 
         [0027]    Once the biopsy is planned, the physician initiates the biopsy. All of the needle paths for a given longitudinal image are displayed on the ultrasound monitor. The display shows the coordinates of the planned needle paths which correlate to the positional setting of the redirecting needle guide. The physician then advances and/or rotates the redirecting needle guide to the correlating coordinates for the first planned needle path. The physician then inserts a flexible biopsy needle kit into the redirecting needle guide&#39;s needle insertion point. The needle set is advanced by hand through the needle set channel, including through the redirecting curve within the needle guide. This redirecting curve causes the needle to exit the needle guide, within the rectum of the patient, at an angle relative to the transrectal probe. The physician pushes the needle guide through the tissue of the rectal wall and into the prostate, monitoring the progress of the needle on the ultrasound system and insuring that the actual path of the needle matches the planned needle path being projected on the image. When the biopsy needle set has achieved the correct depth of penetration, the physician uses a standard biopsy firing gun to “fire” the needle set, causing the stylet and cannula to quickly extend in sequence, cutting and capturing a slice of prostate tissue in the specimen notch of the needle set. Because the specimen notch is substantially longer than in standard biopsy needles and the cannula body is flexible, the needle set is very flexible and able to be fired even though bent. The specimen notch is extended to the curved portion of the needle set within the redirecting needle set guide, allowing the stylet to be quickly moved in reference to the cannula without binding. With the needle still in the prostate, the physician saves the ultrasound image(s) on the computer program, creating a permanent record of the biopsy tissue location. The physician then removes the biopsy needle with captured tissue sample. Once removed, the cannula is retracted from the stylet, allowing the tissue sample to be placed into a tissue specimen dish. The physician then advances or moves the redirecting biopsy needle guide to the next planned needle path location, and repeats the procedure. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0028]      FIG. 1  is a perspective view of targetable biopsy system in conjunction with an ultrasound imaging system and stabilizer. 
           [0029]      FIG. 2  is a perspective view of the redirecting needle set guide mounted on a side-imaging transrectal ultrasound probe. 
           [0030]      FIG. 3  is a side view of the redirecting needle set guide mounted on a side-imaging transrectal ultrasound probe, showing the guide positioning assembly. 
           [0031]      FIG. 3A  is a front view of the redirecting needle set guide mounted on a side-imaging transrectal ultrasound probe in the manner shown in  FIGS. 1 ,  2  and  3 . 
           [0032]      FIG. 4  is a planning software interface displayed on the monitor. 
           [0033]      FIG. 5  is a schematic of the biopsy planning process. 
           [0034]      FIG. 6  is a schematic of the biopsy procedure. 
           [0035]      FIG. 7  is a side view of an embodiment of the targetable biopsy guide. 
           [0036]      FIG. 8  is a side cutaway view of an embodiment of the targetable biopsy guide designed to be manufactured with an insertable metal tube. 
           [0037]      FIG. 9  is a side cutaway view of an alternative embodiment of the targetable biopsy guide. 
           [0038]      FIG. 10  is a side cutaway view of an alternative embodiment of the targetable biopsy guide with an enlarged bend channel. 
           [0039]      FIG. 11  shows a side view of a biopsy stylet with extended specimen notch. 
           [0040]      FIG. 12  shows a side view of an alternative embodiment of the stylet with dual extended specimen notches. 
           [0041]      FIG. 13  shows a side view of an alternative embodiment of the stylet with a tiered specimen notch. 
           [0042]      FIG. 14  shows a side view of an alternative embodiment of the stylet with multiple notches to facilitate bending. 
           [0043]      FIG. 14A  is a side view of a flexible biopsy needle set in accordance with the present invention. 
           [0044]      FIG. 15  shows a side view of an embodiment of the cannula in which the cannula tube has been ground down along its length to leave a flexible spine. 
           [0045]      FIG. 16  shows a side view of an embodiment of the cannula in which the cannula tube has been spiral-cut along its length to facilitate bending of the cannula. 
           [0046]      FIG. 17  shows a side view of an alternative embodiment of the cannula in which the tip of the cannula tube is uncut while the body of the cannula tube has been spiral-cut. 
           [0047]      FIG. 18  shows a side view of an alternative embodiment of the cannula in which sections of the cannula tube alternate between cut and uncut. 
           [0048]      FIG. 19  shows a side view of an embodiment of the cannula in which the cannula tube is encased in flexible tubing. 
           [0049]      FIG. 20  shows a perspective view of an embodiment of the flexible needle set. 
           [0050]      FIG. 21  is a side view of the traditional method of taking a prostate biopsy with a biopsy needle channel. 
           [0051]      FIG. 22  is a side view of the bendable needle and biopsy targeting system mounted on a side-fired probe taking a biopsy. 
           [0052]      FIG. 23  is a side view of the redirecting guide with a flexible needle set inserted and extending out of the guide such that the needle set is bent by the needle set channel bend. 
           [0000]    
         
           
                 
               
                 
                 
                 
               
             
                 
                     
                 
                 
                   Parts Numbers 
                 
                 
                     
                 
               
               
                 
                     
                 
               
            
             
                 
                     
                   Rectum 
                    1 
                 
                 
                     
                   Prostate 
                    2 
                 
                 
                     
                   redirecting guide 
                   10 
                 
                 
                     
                   alternative redirecting guide 
                         10A 
                 
                 
                     
                   positioning assembly 
                   11 
                 
                 
                     
                   targeting software system 
                   12 
                 
                 
                     
                   flexible needle set 
                   13 
                 
                 
                     
                   cradle 
                   15 
                 
                 
                     
                   stabilizer 
                   16 
                 
                 
                     
                   ultrasound system 
                   17 
                 
                 
                     
                   ultrasound system CPU side 
                   18 
                 
                 
                     
                   view transrectal probe 
                   19 
                 
                 
                     
                   monitor 
                   20 
                 
                 
                     
                   probe tip 
                   22 
                 
                 
                     
                   probe imaging window 
                   23 
                 
                 
                     
                   guide body 
                   30 
                 
                 
                     
                   needle set channel 
                   31 
                 
                 
                     
                   needle set insertion point 
                   32 
                 
                 
                     
                   needle set exit point 
                   33 
                 
                 
                     
                   front body guide extensions 
                   34A, 34B 
                 
                 
                     
                   imaging cutout 
                   35 
                 
                 
                     
                   needle set channel bend 
                   36 
                 
                 
                     
                   enlarged bend channel 
                   37 
                 
                 
                     
                   insertable metal tube 
                   38 
                 
                 
                     
                   rotational adjustment collar 
                   40 
                 
                 
                     
                   fixed collar 
                   41 
                 
                 
                     
                   longitudinal slides 
                   42 
                 
                 
                     
                   longitudinal position controller 
                   43 
                 
                 
                     
                   needle path location registry 
                   50 
                 
                 
                     
                   needle path lines 
                   51 
                 
                 
                     
                   needle path dots 
                   52 
                 
                 
                     
                   flexible stylet 
                   60 
                 
                 
                     
                   flexible cannula 
                   61 
                 
                 
                     
                   tip 
                   62 
                 
                 
                     
                   extended specimen notch 
                   63 
                 
                 
                     
                   stylet body 
                   64 
                 
                 
                     
                   cutting tip 
                   65 
                 
                 
                     
                   cannula body 
                   66 
                 
                 
                     
                   counter bore and taper 
                   67 
                 
                 
                     
                   bending notches 
                   70 
                 
                 
                     
                   tiered specimen notch 
                   71 
                 
                 
                     
                   segmented specimen notch 
                   72 
                 
                 
                     
                   removable needle set guide insert 
                   75 
                 
                 
                     
                   stylet hub 
                   76 
                 
                 
                     
                   cannula hub 
                   77 
                 
                 
                     
                   strip 
                   78 
                 
                 
                     
                   depth markings 
                   79 
                 
                 
                     
                   cannula sheath 
                   81 
                 
                 
                     
                   spiral cut 
                   82 
                 
                 
                     
                   non-spiral cut portion 
                   83 
                 
                 
                     
                   beveled edge 
                   84 
                 
                 
                     
                   Biopsy attachment angle selector 
                   201  
                 
                 
                     
                   and display 
                 
                 
                     
                   Biopsy attachment depth selector 
                   202  
                 
                 
                     
                   and display 
                 
                 
                     
                   needle path coordinates display 
                   204  
                 
                 
                     
                   window 
                 
                 
                     
                   Finished with Biopsy Planning 
                   206  
                 
                 
                     
                   button 
                 
                 
                     
                   Remove selected biopsy location 
                   207  
                 
                 
                     
                   from plan button 
                 
                 
                     
                   Add selected biopsy location to 
                   208  
                 
                 
                     
                   plan button 
                 
                 
                     
                   Select pre-planned template 
                   209  
                 
                 
                     
                   Sagittal image plane selector 
                   210  
                 
                 
                     
                   Transverse image plane selector 
                   211  
                 
                 
                     
                   Transverse image display 
                   212  
                 
                 
                     
                   Sagittal Image display 
                   213  
                 
                 
                     
                     
                 
               
            
           
         
       
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0053]    As seen in  FIG. 1 , the targeted biopsy system is comprised of a redirecting guide  10 , positioning assembly  11 , targeting software system  12  (loaded on CPU  18 ) and flexible needle set  13  (best seen in  FIG. 20 ). The positioning assembly  11  is affixed to cradle  15 , which is a part of stepper and stabilizer  16 . Working in conjunction with the targeted biopsy system is ultrasound system  17 , which is comprised of ultrasound system CPU  18 , side view transrectal probe  19  and monitor  20 . Side view transrectal probe is comprised of probe tip  22  and probe imaging window  23 . As seen in  FIGS. 2 ,  3 A and  7 , the redirecting guide  10  consists of guide body  30 , needle set channel  31 , needle set insertion point  32 , and needle set exit point  33 , front body guide extensions  34 A and  34 B, imaging cutout  35 . As seen in  FIG. 10 , needle set channel  31  may be provided with enlarged bend channel  37 . As seen in  FIG. 8 , the redirecting guide  10  may be provided with insertable metal tube  38 . In an alternative embodiment, the redirecting guide may contain one or more pathways may be used for insertion of the biopsy needle kit. The redirecting guide may be comprised of a movable device such that the opening through which the needle kit exits may be moved relative to the opening into which the biopsy needle kit is placed. In a further alternative embodiment, the redirecting guide may straighten a previously curved biopsy needle kit such that the biopsy needle kit re-curve when leaving the redirecting guide. 
         [0054]    As best seen in  FIG. 3 , positioning assembly  11  is comprised of rotational adjustment collar  40 , fixed collar  41 , longitudinal slides  42  and longitudinal position controller  43 . 
         [0055]    As best seen in  FIG. 4 , targeting software system  12  is comprised of transverse image display  212 , Sagittal Image display  213 , longitudinal projected needle path  51  and transverse projected needle path  52 , in addition to various controls. 
         [0056]    As best seen in  FIG. 20 , flexible needle set  13  consists of flexible stylet  60  and flexible cannula  61 . Stylet  60  may be affixed to stylet hub  76 , with cannula  61  affixed to cannula hub  77 . Further, cannula  61  may be provided with depth markings  79 . As seen in  FIGS. 11 and 14A , the preferred flexible stylet  60  consists of tip  62 , extended specimen notch  63  and stylet body  64  that is surrounded by the cannula body  66 . As seen in  FIG. 12 , an alternative preferred flexible stylet  60  consists of tip  62  and segmented specimen notches  72   a  and  72   b . Alternative embodiments of flexible stylet  60 , as seen in  FIGS. 13 and 14 , contain bending notches  70  and tiered specimen notch  71 . 
         [0057]    As seen in  FIG. 19 , the preferred embodiment of cannula  61  consists of cutting tip  65 , cannula body  66  and cannula sheath  81 . The cannula sheath may have beveled edges. As seen in  FIG. 15 , a portion of the body of flexible cannula  61  has been removed. As seen in  FIG. 16 , cannula body  66  may be provided with spiral cut  82  to facilitate bending. As seen in  FIG. 17 , in an alternative embodiment of cannula  61 , cannula body  66  may be provided with non-spiral cut portion  83  at cutting tip  65 , to facilitate the straight entry of the cannula into the tissue. As seen in  FIG. 18 , in a further alternative embodiment of cannula  61 , cannula body  66  may be provided with non-spiral cut portions  83  interspersed with spiral cuts  82 . In an alternative embodiment of flexible cannula  61  consists of a cutting tip inserted into the flexible cannula body. 
         [0058]    It should be noted that both the stylet cannula can be made from a range of flexible materials, including combinations of one or more materials, to facilitate the bendability. This may include traditional materials used in medical devices, such as stainless steel, as well as materials such an Nitinol®. Furthermore, the cannula design may mirror the stylet, such that portion or portions of the metal cannula tube are removed to create a metal component which has a metal cutting tip, a long spine consisting of only a portion of the cannula wall in the flexible part of the cannula and then the full tubular cannula. Furthermore, the machine cannula may be partially or wholly incased in a cannula sheath, which may be plastic or some other material. 
         [0059]      FIG. 21  shows a biopsy being performed using the standard method, using an end-fire ultrasound probe with a biopsy needle channel. The probe is inserted into the rectum, and then angled upward until the probe tip is pointed at the desired portion of the prostate. A needle set is then inserted through the biopsy needle channel guide into the prostate  2 . 
         [0060]    In use of the preferred embodiment of the invention, as seen in  FIGS. 1 and 22 , side view transrectal probe  19  is mounted on the cradle  15  of a stabilizer  16 . Redirecting guide  10  is also mounted on the cradle  15 , such that guide body  30  sits atop probe tip  22 . As seen in  FIG. 2 , front body extensions  34   a  and  34   b  partially wrap around probe tip  22  to help maintain the guide body  30  on the probe tip  22 . The cradle  15  is moved forward, with the probe tip  22  inserted into patient&#39;s rectum  1 . Probe tip  22  is generating ultrasound images, which are displayed on monitor  20 . The physician uses this image to insure that the entirety of prostate  2  is viewable by probe imaging window  23 . Once the probe tip  22  is correctly positioned, the physician locks in place cradle  15 . 
         [0061]    The biopsy planning process is illustrated in  FIG. 5 . A representative display of the biopsy information to the user is shown in  FIG. 4 . The process begins with the planning software obtaining a set of volumetric data  101 . The volumetric data consists of two sets of sampled images. One set is of longitudinal images sampled at a regular angular spacing, and the other is a set of transverse images sampled at regular depth spacing. If only one of the two sets is available, one may be interpolated from the other. The physician starts the planning process by pressing button  203  to satisfy step  102  of  FIG. 4 . For  103 , the planning system overlays a series of lines  51   a, b, c , etc. and dots  52   a, b, c,  etc. on the images in panes  212  and  213 . These lines and dots represent the available needle paths selectable with controls  40  and  43 , and show where the needle intersects with image planes. Each line and dot combination is labeled with a coordinate 50 corresponding to a unique pair of setting for controls  40  and  43 . The user can review the stored images using controls  210  and  211  to change the image viewed. For  104 , the user can “simulate” the effect of controls  40  and  43  using on-screen controls  201  and  202  to adjust the selected needle path. The current path is displayed by changing the color of the appropriate line and dot ( 51  and  52 , respectively). The user adds a specific needle path to the biopsy plan ( 105 ) by selecting button  208 . Each time a path is selected, a record is placed into needle path coordinates display window  204  showing the coordinates of the path. The user may also remove a specific path from the plan by selecting button  207 . When the plan is complete, the user clicks on the button  206  to send the planning process ( 106 ). 
         [0062]    Once the biopsy planning process has been completed, the physician or technician may then proceed with the biopsy procedure, to complete the series of precision located biopsy&#39;s to be taken through the usage of this instrument. For example, as can be noted in  FIG. 6 , once a biopsy procedure has been completed, the physician then determines whether any more biopsies are needed, and where the biopsy locations may be determined. This can be seen at  301 . If no additional biopsies are required, this is the end of the procedure. If additional biopsies are considered as needed, the physician then adjusts the redirection of the guide  10 , and the longitudinal controller  40 , to mass the desired biopsy coordinates, as provided upon the scanner. This can be noted at  302 . Then, the user inserts a needle set  13  into the channel  32 , to prepare for additional biopsies. The physician then inserts the needle into the patient, moving the needle in and out to adjust for depth, as determined by the scanner, as can be seen at  304 . Then, the physician can determine if the needle tip is at the correct depth, at  305 . If it is not, then the physician may move the needle and adjust its depth further. If it is, the physician then fires the needle of the biopsy instrument, as at  306 . Then the physician removes the needle set  13  from the patient, having taken the biopsy as required. Then, the tissue sample is removed from the biopsy needle notch, for further analysis by the lab. This can be noted at  308 . When this is completed, this concludes the conduct of biopsies upon the patient. 
         [0063]    As alternative to the procedure in  FIG. 4 , preplanned biopsy selection menu  209  allows the user to select a pre-determined needle pattern, typically 9-12 needle paths, without having to select each needle path manually. The needle paths generated could need to be adjusted for the specific size of the organ. The size of the organ can be input by various means. The planning process allows the physician to modify the needle paths as needed and to approve that they are correct. 
         [0064]    Projected needle paths  51   a ,  51   b , etc, include needle path location registry  50 , which indicate the horizontal and rotational position of the needle path in reference to the probe. Working from the saved biopsy plan, displayed in  204 , the physician rotates redirecting guide  10  using rotational adjustment collar  40 , and then advances the redirecting guide using longitudinal position controller  40 , both of which have position information which correlates to the needle path location registry  50 . As seen in  FIG. 18 , the physician inserts flexible needle set  13  into needle set insertion point  32  and into needle set channel  31 . When the needle set  13  reaches needle set channel bend  36 , the needle set  13  is redirected at an angle away from the axis of probe tip  22 : Needle set  13  exits needle set exit point  33 . Because of imaging cutout  35 , the physician is able to see the needle set in the ultrasound image as it exits exit point  33 , allowing the physician to insure that the needle set  13  is in the path marked by projected needle path  51   a . The physician monitors the depth of the needle set  13  as it is pushed through the rectum wall and into the prostate  2 . Once the desired depth is reached, the physician stops inserting the needle set  13 . Using a standard biopsy gun, the needle set  13  is “fired”. This causes flexible stylet  60  to rapidly advance a short distance, such that tissue from the prostate two prolapses into extended specimen notch  63 . Almost instantaneously flexible cannula  61  quickly advances, also under spring loaded pressure or other motivational means, which serves to sever and capture the tissue that had prolapsed into the extended specimen notch  63 . Because the extended specimen notch  63  extends to the point where flexible needle set  13  is bent in needle set channel bend, the stylet and cannula are able to fire without the two pieces binding together, allowing the specimen to be effectively captured. The physician then removes the flexible needle set  13  with the captured specimen. The specimen is removed from the flexible needle set, and the physician then resets the redirecting guide to the coordinates of the next saved projected needle path  51   b . The process is repeated until the physician has captured all of the samples as planned using the targeting software system  12 . 
         [0065]      FIG. 23  provides a side cut-away view of the redirecting guide with a flexible needle set inserted and extending out of the guide such that the extended specimen notch is bent by the needle set channel bend. 
         [0066]    In an alternative embodiment of the invention, the invention is used to plan and perform a targeted treatment of an organ or tissue mass. With the device in place, the process begins with the planning software obtaining a set of volumetric data. The planning system overlays a series of needle path lines and needle path dots on the images in panes  212  and  213 , which represent the available needle paths with coordinates that match the coordinates on rotational adjustment collar  40  and longitudinal position controller  43  of positioning assembly  11 . The user selects specific needle paths, which are saved the treatment plan. Preplanned treatment selections allow the user to select a predetermined needle pattern without having to select each needle path manually. 
         [0067]    Working from the saved treatment plan, the physician rotates redirecting guide using rotational adjustment collar, and then advances the redirecting guide using longitudinal position controller, both of which have position information which correlates to the needle path location registry. The physician then inserts a flexible needle set or treatment delivery means into needle set insertion point  32  and into needle set channel  31 . When the needle set or treatment delivery means reaches the needle set channel bend, the needle set or treatment delivery method is redirected at an angle away from the axis of probe tip  22 . Needle set  13  exits needle set exit point  33 . Because of imaging cutout  35 , the physician is able to see the needle set or treatment delivery method in the ultrasound image as it exits exit point  33 . The physician monitors the depth of the needle set or treatment delivery method as it is pushed into the targeted organ or tissue mass. Once the desired depth is reached, the physician is able to undertake the preferred activity. This may include using the delivery means to inject a solid, gas or liquid material or other treatment apparatus into the targeted organ or tissue mass. Further, the physician may insert an organism into the targeted organ or tissue mass. The material may be deposited and left in the targeted organ or tissue mass. Further, material previously deposited may be removed. The use of the deposited material may be as a treatment, a marker, or other uses. Further, the delivery means may be used to apply energy to a targeted organ or tissue mass, including but not limited to heat, cold, light and radiation. Once the treatment or marking is delivered, the physician then removes the flexible needle set or treatment delivery method, and then resets the redirecting guide to the coordinates of the next saved projected needle path. The physician has the option of saving the image of the treatment needle in the targeted organ or tissue mass, to record the location of the treatment as delivered. The process is repeated until the physician has treated or marked all of the targeted areas of the organ or tissue mass.