Abstract:
The embodiments presented herein present a single needle core biopsy instrument and modification required that convert the single needle core biopsy instrument to a dual needle core biopsy instrument. Depending on the design, the dual needle core biopsy instrument permits the simultaneous extraction of tissue or bone specimens taken at between 0.1 mm and 3 mm apart.

Description:
[0001]    This application claims the benefit of the U.S. Provisional Patent Application No 62/049783 filed Sep. 12, 2014 by the present inventor. This provisional patent application is incorporated herein by reference. 
     
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not Applicable 
       REFERENCE TO SEQUENCE LISTING, TABLE, OR A COMPUTER PROGRAM LISTING 
       [0003]    Not Applicable 
       COMPACT DISK APPENDIX 
       [0004]    Not Applicable 
       BACKGROUND OF THE DISCLOSURE 
       [0005]    The era of Molecular diagnostics and personalized medicine is now upon us and it will continue to rapidly grow into the next decade. Novel techniques for the diagnosis and treatment of Cancer and other diseases are evolving in an exponential basis as the genetic code of disease is dissected from tissue and blood samples. 
         [0006]    As more and more molecular markers are discovered, we are able to subdivide all cancer types into different genetic subtypes. We are discovering that many morphologically identical tumors responded differently to the same treatment regimens. When many of these tumors are compared genetically, there are sometimes specific differences that would predict which patients would respond well to a particular treatment while also predicting which patients will not respond. Treatments destined to fail impart increased morbidity, unnecessary side effects, and leave the patient more compromised and still in need of an alternate treatment protocol. Ineffective treatment also wastes both medical resources and dollars. By identifying the genetic subtypes of many cancers, patients can be treated with the most appropriate protocols. 
         [0007]    The realization of personalized medicine is upon us as more and more cancers can be classified on their genetic signatures. These subtypes can be targeted with tailored treatments that more effectively can combat the cancer and significantly reduce the overall side effects. 
         [0008]    There are many techniques that can test for the different genetic subtypes of cancers and the most reliable material to use in many tests is an actual sample of fresh tumor. Needle core biopsies are usually the first choice in acquiring tissue for diagnosis. They are minimally invasive, require little if any recovery time, and provide diagnostic tissue for pathologic evaluation. Core biopsies are small and needed for pathologic diagnosis. If additional core biopsies are available for molecular studies, there is no guarantee that each individual core will have diagnostic tissue present. This presents the possibility of false negative molecular results. 
         [0009]    Genetic subtypes of tumors can be best evaluated with tissue samples. Needle core biopsies are suitable for these tests, however, without microscopic confirmation, it is impossible to guarantee that the sample taken for genetic testing adequately represents the tumor being biopsied. Multiple core biopsies could be taken from a tumor, but there can often be some variation in the location sampled. Some cores may or may not have any tumor. It would be preferable that the tissue being sent for molecular testing was confirmed (microscopically) to truly have tumor cells present. 
       SUMMARY OF THE DISCLOSURE 
       [0010]    A dual needle core biopsy instrument that can take two samples directly adjacent to each other at exactly the same time. This instrument would ensure that two samples of the tissue taken for biopsy would be representative of each other. One would be sent for microscopic diagnostic evaluation and the second would be submitted for genetic studies. The instrument will also ensure that only diagnostic tissue would be sent for the more expensive molecular testing. If the tumor tissue was not represented by microscopy, the molecular test would not be processed. 
         [0011]    The novel design concept is based on two (instead of just one) core sample needles incorporated into a single triggering instrument. These core needles would be separated no more than 0.1 mm to 3 mm apart. This would ensure that two adjacent representative samples of tissue are taken simultaneously. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]      FIG. 1  is a front perspective view of a single needle core biopsy instrument. 
           [0013]      FIGS. 2   a  and  2   b  illustrate sectional view of a portion of the needle and the cannula cylinder with the needle in a retracted and extended position respectively. 
           [0014]      FIG. 3  is a sectional view of the needle core biopsy instrument. 
           [0015]      FIGS. 4 through 8  illustrate the five steps of using the single needle core biopsy instrument in obtaining a biopsy tissue sample. 
           [0016]      FIG. 9  illustrates a front perspective view of the dual needle core biopsy instrument. 
           [0017]      FIGS. 9   a  and  9   b  illustrate sectional views of a portion of the dual needle and the dual needle cannula cylinders with the dual needles in a retracted and extended position respectively. 
           [0018]      FIG. 10  is a sectional view of the dual needle core biopsy instrument. 
           [0019]      FIGS. 11 through 15  illustrate the five steps of using the dual needle core biopsy instrument in simultaneously obtaining two biopsy tissue samples. 
       
    
    
     DETAILED DESCRIPTION 
     Single Needle Core Biopsy Instrument 
       [0020]    The detailed description will first present the design and use of a single needle core biopsy instrument  100 . It will then modify this design to illustrate how a dual needle core biopsy instrument  200  may be obtained by modifying the single needle core biopsy instrument design. 
       FIRST EMBODIMENT 
       [0021]      FIG. 1  is a front perspective view of a single needle core biopsy instrument  100 . Illustrated in  FIG. 1  is a case  102 , a first sliding button  104 , a second sliding button  106 , a cannula cylinder  114 , a plunger  110 , and the needle  112 . In the following, the term forward means towards the needle  112  end and the term backward means towards the plunger  110  end. Similarly, the terms clockwise and counterclockwise refer to the figure under discussion. 
         [0022]      FIGS. 2   a  and  2   b  illustrate sectional views of a portion of the needle  112  and the cannula cylinder  114  with the needle  112  in an extended and retracted position respectively. The needle  112  has a tissue receiving recess  113  that collects the tissue material during the biopsy collection process. 
         [0023]      FIG. 3  is a sectional view of the needle core biopsy instrument, the section indicated in  FIG. 1 . It has a case component  107 , a cannula component  108 , a needle component  120 , and a trigger component  128 . The case component  107  has a case  102  and a case barrier  140 . The case has a cylindrical shape and the case barrier has the shape of a cylindrical disk imbedded within the case with its disk sides perpendicular to the longitudinal axis of the case cylinder. Both the case and case cylinder have holes that facilitate the movements of the needle and the cannula cylinder. 
         [0024]    Referring again to  FIG. 3 , the cannula component  108  is comprised of a cannula cylinder  114  and a cannula cylindrical back  116 . The cannula cylinder  114  is attached to the cannula cylindrical back  116  and is slidingly mounted in case  102 . Also included in the cannula component  108  is first sliding button  104  mounted on the case  102 . The first sliding button  104  can slide the cannula component  108  forward towards the needle end of the biopsy instrument and backwards towards the plunger end of the biopsy instrument. It also has a lock that can lock the cannula component  108  in place. The cannula spring  124  sits between the case barrier  140  and the cannula cylindrical back  116 . A lever  125  engages the first sliding button. 
         [0025]    Referring again to  FIG. 3 , the trigger component  128  is comprised of a second sliding button  106 , a wedge  130 , a swivel  132  rotationally mounted on case  102 , and a swivel spring  134  The needle component  120  is comprised of a needle  112 , a plunger spring  122 , the plunger  110 , and needle cylindrical back  126 . 
         [0026]      FIGS. 4 through 8  illustrate the use of the single needle core biopsy instrument  100  in obtaining a biopsy tissue sample, 
         [0027]    Step 1. Cocking the single needle core biopsy instrument  100  ready for firing:
   Referring to  FIG. 4 , the first sliding button  104  is pushed forward and locked, holding the cannula component  108  in a forward position. The plunger  110  is pulled towards the backward direction, compressing the plunger spring  122 . The second sliding button  106  is pushed in a forward direction. This causes the wedge  130  to disengage with the swivel  132 . The swivel spring  134  then forces the swivel  132  to rotate around the swivel pin  138  in a clockwise direction, forcing the swivel tip  136  downward engaging the needle cylindrical back  126 . The single needle core biopsy instrument  100  is then cocked, ready for firing.   
 
         [0029]    Step 2. Firing the single needle core biopsy instrument  100 :
   Referring to  FIG. 5 , the user positions the needle  112  at the patient&#39;s body part ready for the biopsy sample to be taken. The second sliding button  106  is pushed backward, forcing the wedge  130  backward, causing the swivel  132  to rotate counterclockwise, thereby raising the swivel tip  136 , and disengaging from the needle cylindrical back  126 . This causes the plunger spring  122  to fire the needle  112  forward. The needle  112  is then thrusted towards the patient&#39;s body, penetrates the body and collects a tissue specimen in the tissue receiving recess  113 .   
 
         [0031]    Step 3. Firing the dual needle cannula component:
   Referring to  FIG. 6 , once the plunger spring  122  fires the needle  112  forward (Step 2), the user presses the first sliding button  104 , causing the lever  125  to release the cannula spring  124 , thereby firing the cannula component  108 . This cause the cannula cylinder  114  to thrust forward, enclosing the needle tip and capturing the tissue collected in the tissue receiving recess  113 .   
 
         [0033]    Step 4. Withdrawing the needle:
   First, the needle  112  enclosing the tip of the cannula cylinder  114  is removed from the patient. Then, referring to  FIG. 7 , the plunger  110  is pulled backward, and the second sliding button  106  is pushed forward. This causes the needle component  120  to move backward, and the swivel  132  to rotates clockwise until the swivel  132  tip engages the needle cylindrical back  126 , keeping the instrument in a cocked position. The biopsy sample is contained in the tissue receiving recess  113 .   
 
         [0035]    Step 5. Extracting the Biopsy Tissue Sample:
   Referring to  FIG. 8 , to extract the biopsy tissue specimen, the first sliding button  104  is pushed backward, moving the cannula component  108  backward. This exposes the tissue receiving recess  113  containing the biopsy tissue specimen, which may then be removed by the user.   
 
         [0037]    This completes the description and use of the single needle core biopsy instrument  100 . 
       Dual Needle Core Biopsy Instrument  
       [0038]    The dual needle core biopsy instrument  200  is a modification of the single needle core biopsy instrument  100 .  FIG. 9  illustrates a front perspective view of the dual needle core biopsy instrument  200 . In the following discussion the numerals used in the single needle core biopsy instrument  100  will be used for the dual needle core biopsy instrument  200  where the parts are essentially unchanged. New numerals will be used for the dual needle core biopsy instrument  200  when the parts are modified. 
       SECOND EMBODIMENT 
       [0039]    Referring to  FIG. 9 , the dual needle core biopsy instrument  200  is comprised of a dual needle case  202 , a first sliding button  104 , a second sliding button  106 , dual cannula cylinders  214 , a plunger  110 , and dual needles  212 . Similar to the description for the single needle core biopsy instrument  100  the term forward means towards the dual needles  212  end and the term backward means towards the plunger end. 
         [0040]      FIGS. 9   a  and  9   b  illustrate sectional views of a portion of the dual needle  212  and the dual cannula cylinders  214  with the dual needles  212  in an extended and retracted position respectively. Note that the dual needles  212  each has a tissue receiving recess  113  that collects the tissue material during the biopsy collection process. 
         [0041]      FIG. 10  is a sectional view of the dual needle core biopsy instrument  200 , the section indicated in  FIG. 8 . It has a dual needle case component  207 , a dual cannula component  208 , a dual needle component  220 , and a trigger component  128 . 
         [0042]    Referring to  FIG. 10 , the dual needle case component  207  has a dual needle case  202  and a dual needle case barrier  240 . The dual needle case  202  has a cylindrical shape and the dual needle case barrier  240  has the shape of a cylindrical disk imbedded within the case with its disk parallel sides perpendicular to the longitudinal axis of the case cylinder. Both the dual needle case  202  and dual needle case barrier  240  have holes that facilitate the movements of the dual needles and the dual needle cannula cylinders. 
         [0043]    Referring again to  FIG. 10 , the dual cannula component  208  is comprised of dual cannula cylinders  214  and a dual needle cannula cylindrical back  216 . Although not illustrated in  FIG. 10 , the dual cannula cylinders  214  have the shape analogous to a shotgun barrel. The dual cannula cylinder  214  is attached to the dual needle cannula cylindrical back  216  and is slidingly mounted in dual needle case  202 . Also included in the dual cannula component  208  is first sliding button  104  mounted on the dual needle case  202 . The first sliding button  104  can slide the dual cannula component  208  forward towards the needle end of the biopsy instrument and backwards towards the plunger end of the biopsy instrument. It also can lock the dual cannula component  208  in place. 
         [0044]    Referring again to  FIG. 10 , the trigger component  128  is comprised of a second sliding button  106 , a wedge  130 , a swivel  132  rotationally mounted on case  102 , and a swivel spring  134 . The needle component  120  is comprised of a needle  112 , a plunger spring  122 , the plunger  110 , and dual needle cylindrical back  226 . 
         [0045]      FIGS. 11 through 14  illustrate the use of the dual needle core biopsy instrument  200  for simultaneously obtaining two biopsy tissue samples. This five step process is analogous to the five step process of the single needle core biopsy instrument  100 . 
         [0046]    Step 1. Cocking the dual needle core biopsy instrument  200  ready for firing:
   Referring to  FIG. 11 , the first sliding button  104  is pushed forward and locked, holding the dual cannula component  208  in a forward position. The plunger  110  is pulled towards the backward direction, compressing the plunger spring  122 . The second sliding button  106  is pushed in a forward direction. This causes the wedge  130  to disengage with the swivel  132 . The swivel spring  134  then forces the swivel  132  to rotate around the swivel pin  138  in a clockwise direction, forcing the swivel tip  136  downward engaging the needle dual cylindrical back  226 . The dual needle core biopsy instrument  200  is then cocked, ready for firing.   
 
         [0048]    Step 2. Firing the dual needle core biopsy instrument  200 :
   Referring to  FIG. 12 , the user positions the dual needles  212  at the patient&#39;s body part ready for the dual biopsy samples to be taken. The second sliding button  106  is pushed backward, forcing the wedge  130  backward, causing the swivel  132  to rotate counterclockwise, thereby raising the swivel tip  136 , and disengaging from the dual needle cylindrical back  226 . This causes the plunger spring  122  to fire the dual needles  212  forward. The dual needles  212  therefore enters the patient&#39;s body part, and penetrates the biopsy body tissue, collecting two tissue specimens in the two tissue receiving recesses  213 .   
 
         [0050]    Step 3. Firing the dual needle cannula component:
   Referring to  FIG. 13 , once the plunger spring  122  fires the dual needle component  220  forward (Step 2), the user presses the first sliding button  104 , causing the lever  125  to release the cannula spring  124 , thereby firing the dual cannula component  208 . This cause the dual cannula cylinders  214  to thrust forward, enclosing the dual needle tips and capturing the tissue collected in the two tissue receiving recesses  113 .   
 
         [0052]    Step 4. Withdrawing the needle:
   Referring to  FIG. 14 , the plunger  110  is pulled backward, and the second sliding button  106  is pushed forward. This causes the dual needle components  220  to move backward, and the swivel  132  to rotate clockwise until the swivel  132  tip engages the dual needle cylindrical back  226 , keeping the instrument in a cocked position,   
 
         [0054]    Step 5. Extracting the Biopsy Tissue Sample:
   Referring to  FIG. 15 , to extract the two biopsy tissue specimens, the first sliding button  104  is pushed backward, moving the dual cannula components  208  backward. This exposes the two tissue receiving recesses  213  containing the two biopsy tissue specimens, which may then be removed by the user.   
 
         [0056]    The dual needles  212  in embodiment  2  will each have length and diameter similar to the single needle biopsy instrument used for the same application. The distance between the needles will be typically between 0.1 mm and 3 mm apart. 
         [0057]    This completes the description of the second embodiment. 
       Discussion 
       [0058]    The two embodiments presented above are simple biopsy instrument designs apply to collecting tissue samples. Other embodiments are consistent with the inventive concept presented herein. Almost any single needle core biopsy instrument may be adapted to handle the dual needle concept. The examples presented above apply to tissue specimens. Other designs can apply to taking bone specimens. 
         [0059]    The disclosure presented herein gives embodiments of the invention. These embodiments are to be considered only as illustrative of the invention and not a limitation of the scope of the invention. Various permutations, combinations, variations and extensions of these embodiments are considered to fall within the scope of this invention. Therefore the scope of this invention should be determined with reference to the claims and not just by the embodiments presented herein.