Abstract:
A biopsy device which is compatible for use with a magnetic resonance imaging machine. The device includes a non-metallic elongated substantially tubular needle having a distal end, a proximal end, a longitudinal axis therebetween, and a port on the elongated needle for receiving a tissue sample. The device further includes a sharpened distal tip for insertion within tissue. The sharpened distal tip is attached to the distal end of the needle and at least partially comprises a material which will leave an artifact under magnetic resonance imaging.

Description:
FIELD OF THE INVENTION  
         [0001]    The present invention relates, in general, to devices for tissue sampling and, more particularly, to improve biopsy probes for acquiring subcutaneous biopsies and for removing lesions.  
         BACKGROUND OF THE INVENTION  
         [0002]    The diagnosis and treatment of patients with cancerous tumors, pre-malignant conditions, and other disorders has long been an area of intense investigation. Non-invasive methods for examining tissue are palpation, Thermography, PET, SPECT, Nuclear imaging, X-ray, MRI, CT, and ultrasound imaging. When the physician suspects that tissue may contain cancerous cells, a biopsy may be done either in an open procedure or in a percutaneous procedure. For an open procedure, a scalpel is used by the surgeon to create a large incision in the tissue in order to provide direct viewing and access to the tissue mass of interest. Removal of the entire mass (excisional biopsy) or a part of the mass (incisional biopsy) is done. For a percutaneous biopsy, a needle-like instrument is used through a very small incision to access the tissue mass of interest and to obtain a tissue sample for later examination and analysis. The advantages of the percutaneous method as compared to the open method are significant: less recovery time for the patient, less pain, less surgical time, lower cost, less risk of injury to adjacent bodily tissues such as nerves, and less disfigurement of the patient&#39;s anatomy. Use of the percutaneous method in combination with artificial imaging devices such as X-ray and ultrasound has resulted in highly reliable diagnoses and treatments.  
           [0003]    Generally there are two ways to percutaneously obtain a portion of tissue from within the body, by aspiration or by core sampling. Aspiration of the tissue through a fine needle requires the tissue to be fragmented into small enough pieces to be withdrawn in a fluid medium. The method is less intrusive than other known sampling techniques, but one can only examine cells in the liquid (cytology) and not the cells and the structure (pathology). In core sampling, a core or fragment of tissue is obtained for histologic examination, genetic tests, which may be done via a frozen or paraffin section. The type of biopsy used depends mainly on various factors present in the patient, and no single procedure is ideal for all cases. However, core biopsies seem to be more widely used by physicians.  
           [0004]    Recently, core biopsy devices have been combined with imaging technology to better target the lesion. A number of these devices have been commercialized. One such commercially available product is marketed under the trademark name MAMMOTOME™, Ethicon Endo-Surgery, Inc. An embodiment of such a device is described in U.S. Pat. No. 5,526,822 issued to Burbank, et al., on Jun. 18 , 1996, and is hereby incorporated herein by reference.  
           [0005]    As seen from that reference, the instrument is a type of image-guided, percutaneous, coring, breast biopsy instrument. It is vacuum-assisted, and some of the steps for retrieving the tissue samples have been automated. The physician uses this device to capture “actively” (using the vacuum) the tissue prior to severing it from the body. This allows for sampling tissues of varying hardness. The device can also be used to collect multiple samples in numerous positions about its longitudinal axis, and without removing the device from the body. These features allow for substantial sampling of large lesions and complete removal of small ones.  
           [0006]    Co-pending application Ser. No. 08/825,899 filed on Apr. 2, 1997, which is hereby incorporated herein by reference, described other features and potential improvements to the device including a molded tissue cassette housing permitting the handling and viewing of multiple tissue samples without physical contact by the instrument operator. Another described therein is the interconnection of the housing to the piercing needle using a thumbwheel, to permit the needle to rotate relative to the housing, and preventing the vacuum tube from wrapping about the housing. During use, the thumbwheel is rotated so that the device rotates within the lesion, and samples can be taken at different points within the lesion.  
           [0007]    In actual clinical use for breast biopsy the instrument (probe and driver assembly) is mounted to the three axis-positioning head of an x-ray imaging machine. The three axis-positioning head is located in the area between the x-ray source and the image plate. The x-ray machines are outfitted with a computerized system which requires two x-ray images of the breast be taken with the x-ray source at two different positions in order for the computer to calculate x, y and z axis location of the suspect abnormality. In order to take the stereo x-ray images the x-ray source must be conveniently movable. The x-ray source therefore is typically mounted to an arm which, at the end opposite the x-ray source, is pivotally mounted to the frame of the machine in the region of the image plate.  
           [0008]    Recently, there has been a need for a hand held core sampling biopsy device. This need has been fulfilled by Ethicon-Endo-Surgery in U.S. Pat. No. 6,086,544 issued on Jul. 11, 2000, which is hereby incorporated herein by reference. The aforementioned patent discloses a hand held MAMMOTOME™ . The aforementioned invention is handpiece in that the handpiece on the MAMMOTOME™ may be held approximately parallel to the chest wall of the patient for obtaining tissue portions closer to the chest wall than my be obtained when using an instrument that may be obtained when using an instrument that is mounted is manipulated by the operator&#39;s hand rather than by an electromechanical arm. Thus, the operator may steer the tip of the handpiece on the MAMMOTOME™ with great freedom towards the tissue mass of interest. The surgeon has tactile feedback while doing so and can thus ascertain to a significant, degree, the density and hardness of the tissue being encountered. In addition, a hand held MAMMOTOME™ is desirable because the handpiece on the MAMMOTOME™ may be held approximately parallel to the chest wall of the patient for obtaining tissue portions closer to the chest wall than may be obtained when using an instrument that is mounted to an electromechanical arm.  
           [0009]    Recently, there has been a desire to use the above described biopsy devices with MRI imaging devices instead of x-ray imaging devices. However, existing medical biopsy sampling devices use small, multi-lumen probes extensively fabricated mostly if not entirely from metal. The metallic nature of these probes has many drawbacks. Typically these metal probes are electrically conductive and often magnetically weak, which interferes with their use under MRI guidance. The electrically conductive and magnetically weak nature of metal probes often work to create field distortions, called artifacts, on the image. The image of the lesion will show the metal probe, and this is problematic because the image of the probe can obscure the image of the lesion. Therefore, there has been a desire to have generally non-metallic biopsy probe of the type described above. However, elimination of the artifact created by the metal probe entirely is also problematic because physicians rely extensively on some type of artifact to notify them as to where the tip of the probe is relative to the lesion.  
         SUMMARY OF THE INVENTION  
         [0010]    In accordance with the present invention there is provided a biopsy device which is compatible for use with a magnetic resonance imaging machine. The device includes a non-metallic elongated substantially tubular needle having a distal end, a proximal end, a longitudinal axis therebetween, and a port on the elongated needle for receiving a tissue sample. The device further includes a sharpened distal tip for insertion within tissue. The sharpened distal tip is attached to the distal end of the needle and at least partially comprises a material which will leave an artifact under magnetic resonance imaging. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0011]    The novel features of the invention are se forth with particularity in the appended claims. The invention itself, however, both as to organization and methods of operation, together with further objects and advantages thereof, may best be understood by reference to the following description, taken in conjunction with the accompanying drawings in which:  
         [0012]    [0012]FIG. 1 is an isometric view of a hand held vacuum assisted biopsy device constructed in accordance with a preferred embodiment of this invention.  
         [0013]    [0013]FIG. 2 is an isometric view of the elongated needle of the hand held vacuum assisted biopsy device of FIG. 1.  
         [0014]    [0014]FIG. 3 is an isometric view of the right body member of the elongated needle of the hand held vacuum assisted biopsy device of FIG. 1. A cutter tube liner is illustrated in assembly with the elongated needle.  
         [0015]    [0015]FIG. 4 is an exploded isometric view of the separated left body member and right body member of the elongated needle of the hand held vacuum assisted biopsy device of FIG. 1.  
         [0016]    [0016]FIG. 5 is an exploded isometric view of the two member needle tip on the elongated needle of the hand held vacuum assisted biopsy device of FIG. 1 as viewed from the proximal side thereof.  
         [0017]    [0017]FIG. 6 is an exploded isometric view of the two member needle tip of the elongated needle of the hand held vacuum assisted biopsy device of FIG. 1 as viewed from the distal end thereof. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0018]    [0018]FIG. 1 shows a hand-held vacuum assisted biopsy device  10  comprising a needle assembly  20  and a holster  15 . Needle assembly  20  is detachably connected to holster  15 . Together they constitute a lightweight, ergonomically shaped, hand manipulatable portion referred to as handpiece  12 . Since handpiece  12  is manipulated by the operator&#39;s hand rather than by an electromechanical arm, the operator may steer the handpiece  12  with great freedom towards the tissue mass of interest. The surgeon has tactile feedback while doing so and can thus, ascertain to a significant degree, the density and hardness of tissue being encountered. In addition, handpiece  12  may be held approximately parallel to the chest wall of a patient for obtaining tissue portions closer to the chest wall than may be obtained when using an instrument mounted to an electromechanical arm.  
         [0019]    The device includes a means for obtaining a tissue sample. Holster  15  includes a forward button  16  which may be used to move cutter  21  (shown in FIG. 1) distally though cutter lumen  32  and sever tissue collected in port  36 . Holster  15  further includes a reverse button  17  which may be used to move cutter  21  proximally through cutter lumen  32  and thereby moving the tissue sample in port  36  to a tissue collection surface  19 . A vacuum button  18  on holster  15  is used to open or close first and second vacuum lines,  27  and  28 , for activating a vacuum lumen  34  so as to cause tissue to become disposed within port  36 .  
         [0020]    Referring now to FIG. 2 there is shown an isometric view of the needle assembly  20  of the hand held vacuum assisted biopsy device  10  of FIG. 1. Needle assembly  20  includes an elongated needle  30  having a distal end  31 , a proximal end  33  and a longitudinal axis therebetween. Needle assembly  20  has a needle tip  60  at its distal end for penetrating the soft tissue of a surgical patient. Elongated needle  30  comprises a cutter lumen  32  and a vacuum chamber lumen  34 .  
         [0021]    At the distal end of the elongated needle  30  is a needle tip  60 , which is sharpened and is preferably made from an MRI compatible resin such as Ultem or Vectra. Needle tip  60  is designed to penetrate soft tissue, such as the breast of a female surgical patient. In this embodiment, needle tip  60  is a three-sided pyramidal shaped point, although the needle tip  60  configuration may also have other shapes.  
         [0022]    Referring now to FIG. 3, elongated needle  30  is preferably made from a thermoplastic material such as Vectra A130 or B130 liquid crystal polymer, although other MRI compatible resins may be available from Ticona of Summit, N.J. Elongated needle  30  includes a cutter lumen  32  which houses the cutter  21  (shown in FIG. 1). Adjacent the distal end  31  of the cutter lumen  32  is a port  36  for receiving the tissue that is extracted from a surgical patient by the cutter  21 . Joined alongside the cutter lumen  32  is a vacuum chamber lumen  34 . The vacuum chamber lumen  34  receives vacuum from the second vacuum line  28  which is connected the vacuum chamber lumen  34  on the elongated needle  30  by the vacuum manifold  26  which is located at the proximal end  33  of elongated needle  30 . Also located at the proximal end of the elongated needle  30  is a flange  38 , which allows the elongated needle  30  and needle assembly  20  to interlock with the handpiece  12  on the hand-held vacuum assisted biopsy device  10 . Changing from a stainless steel needle to a polymer may require a change in wall thickness, for example from 0.008″ to 0.030″. The liner  22 , discussed below, is also made from a MRI compatible material, preferably a polypropylene such as Prolene available from Ethicon, Inc., Somerville N.J., or a material known as Radel-5000, available from British Petroleum, London UK.  
         [0023]    As seen in FIG. 4, elongated needle  30  is formed from a left body member  40  and a right body member  50  on either side of the longitudinal axis. The edges of the halves  40  and  50  are gated for easy part filling, and the edges are stepped with ridges that allow the two halves  40  and  50  to attach together with ease. Preferably needle  30  is molded from a very stiff thermoplastic, such as Vectra A130 or Vectra B130 liquid crystal polymer. Other glass fiber reinforced resins known to those skilled in the art could also be used. Preferably the probe is made from a polymer material having the combination of high stiffness, low viscosity, and low mold shrink rate, such as LCP resins.  
         [0024]    During assembly of one potential embodiment the elongated needle  30 , the left body member  40  and right body member  50  of the elongated needle  30  are pushed together. Once the left body member  40  and the right body member  50  are pressed together, a thin-walled sleeve of high strength tubing is slipped over the elongated needle and is shrink fitted into place. The shrink tubing holds the left body member  40  and the right body member  50  together for easier handling prior to adhesive curing. In addition, the shrink tubing makes the exterior of the elongated needle  30  smoother for reduced insertion forces. (show shrink tubing in FIG. 2)  
         [0025]    Referring back to FIG. 3, there is shown the right body member  50  of the elongated needle  30 , separated from the left body member  40 , which has been omitted from this figure for clarity. The right body member  50  has upper and lower ends comprising alternating male and female portions or members,  42  and  52 , which alternate and are arranged axially along the length of the right body member  50  of the elongated needle  30 . In addition to the male and female members,  42  and  52 , there is an upper female distal member  54  and a lower male distal member  45 , both of which are located at he distal end of the right body member  50 . The upper female distal member  54  is located just below the distal end of the cutter lumen  32  and above the distal end of the vacuum chamber lumen  34 . At the proximal end of the right body member  50  are three female receivers  56  which surround the vacuum manifold  26  at the proximal end of the right body member  50 .  
         [0026]    Still referring to FIG. 3, needle  20  includes a cutter tube liner  22 , which helps keep adhesive out of the lumen to provide a smooth surface thereon. Liner  22  generally abuts in the inner surface of cutter  20  along lumen  32 . The distal end  31  of liner  22  is proximal to port  36  but otherwise is disposed along the length of lumen  32 . The cutter tube liner  22  is formed from a thin-walled extrusion of a low-friction, abrasion-resistant plastic, such as polypropylene, polyetherimide or polyethersulfone. The cutter tube liner  22  provides a smooth, low-friction, abrasion-resistant surface for the cutter  21 . The cutter tube liner  22  also acts as an aid for sealing vacuum and fluid leakage in that it isolates the cutter lumen  32  from the vacuum chamber lumen  34  and ensures that fluid and material from the cutter lumen  32  does not get sucked into the vacuum chamber  34  by vacuum suction in the vacuum chamber lumen  34 . Isolating the cutter lumen  32  from the vacuum chamber lumen  34  may be preferable because the cutter lumen  32  and vacuum line  27 , and the vacuum chamber lumen  34  operates on the second vacuum line  28 .  
         [0027]    Still referring to FIG. 3, another feature that is included in the preferred design of the invention to enhance performance is the outside diameter of the left body member  40  and right body member  50  could be stepped very slightly, if needed, to compensate for the thickness of the cutter tube inner  22 . This is, the cutter lumen  32  would be very slightly larger than the inside diameter of the cutter tube liner  22 , which is a thin walled structure.  
         [0028]    Referring again to FIG. 4 there is shown an exploded isometric view of the elongate needle  30  of the and held vacuum assisted biopsy device  10  of FIG. 1. Both the left body member  40  and the right body member  50  of the elongated needle  30  are shown. The female features  52 , which are arranged axially on the right body member  50 . Also, the male features  42 , which are arranged axially on the left body member  40 , mate to the female features  52 , which are arrange axially on the right body member  50 . Also, the male features  42  are arranged axially on the right body member  50  mate to the female features  52  which are arranged axially on the left body member  40 .  
         [0029]    In addition to male and female members,  42  and  52 , which are arranged axially and mate, the left body half  40  and right body member  50  have additional features that mate at both the proximal and the distal ends. At the proximal end of the right body member  50  are three female receivers  56  which surround the vacuum manifold  26 . At the proximal end of the left body member  40  are three male bosses  46  which surround the vacuum manifold  36  and correspond to the three female receivers  56  on the right body member  50 . When the left body member  40  and the right body member  50  are pushed together, the three female receivers  56  on the proximal end of the left body member  40 . The proximal end of the elongated needle  30  is thus, retained by the three female receivers  56  and three male bosses  46 , which mate at the proximal end of the elongated needle  30 .  
         [0030]    The needle tip  60  at the distal end of the elongated needle  30  is retained by the upper female distal part  54  and the upper male distal  44  and the lower female distal portion  55  on the left body member  40 . On the left body member  40  is and upper male distal portion  44  and a lower female distal part  55 . The upper male distal portion  44  is located above the cutter lumen  32  at the distal end on the left body member  40 , and the lower female distal part  55  is located below the cutter lumen  32  and above the vacuum chamber lumen  34  at the distal end of the left body member  40 . On the right body  50  is an upper female distal part  54  and a lower male distal portion  45 , which correspond to the upper male distal portion  44  and the lower female distal part  55  on the left body member  40 . The upper female distal part  54  is located above the cutter lumen  32  at the distal end of the right body member  50 , and the lower male distal portion  45  is located below the cutter lumen  32  and above the vacuum chamber lumen  34  at the distal end of the right body member  50 .  
         [0031]    Still referring to FIG. 4, not only do the male and female members,  42  and  52 , secure the body of the elongated needle  30 , and the proximal and distal ends of the elongated needle  30 , both female and female members,  42  and  52 , also form the interlumen vacuum holes  23 , which are located below the port  36  on the distal end of the elongated needle  30 . The male and female members  42  and  52 , on the right body member  50 , which are located below the port  36  in between the cutter lumen  32  and vacuum chamber lumen  34 , mate with a male and female members,  42  and  52 , on the left body member  40 , which are also located below the port  36  in between the cutter lumen  36  and vacuum chamber lumen  34 . When these male and female members,  42  and  52 , on the left body member  40  and right body member  50  mate, the interlumen vacuum holes  23  on the needle  30  are formed. The interlumen vacuum holes  23  are six cylindrically shaped holes which are open to port  36 , so that the tissue can be severed by the cutter  21 , which rotates and advances. The cutter  21  deposits the tissue into the tissue collection surface  19  by retracting proximally.  
         [0032]    Still referring to FIG. 4, during assembly of the elongated needle  30 , sufficient adhesive is applied to the left body member  40  and right body member  40  and right body member  50 , to fill the narrow axial spaces between the male and female members,  42  and  52 , which mate. After this, the left body member  40  and right body member  50  are pressed together. The adhesive that is used should be cured using light, heat, or other appropriate means for the particular types of adhesive that is being used. For a light cured adhesive, light could be directed inside of the cutter lumen  32  and the vaccum lumen  34  using light stick optics if necessary.  
         [0033]    Still referring to FIG. 4, the male and female members,  42  and  52 , which mate and are located on the left body member  40  and the right body member  50  have a number of distinct advantages. The male and female members,  42  and  52 , on the left body member  40  and right body member  50  orient the left body member  40  and right body member  50  during assembly of the elongated needle  30 .  
         [0034]    The male and female members,  42  and  52 , which mate, are also key factors in increasing both the strength and lateral bending stiffness of the elongated needle  30 . When the needle  30  is subjected to a lateral bending moment, nearly all of the material being loaded axially is the high-strength, high stiffness body material. Only the small amount of adhesive that is used to fill the axial clearances between the male and female members,  42  and  52 , which mate, is of a lower stiffness. A conventional bonded joint would result in the bond line being loaded in a manner similar to that used for adhesive peel strength testing, which is the most severe type of loading for an adhesive joint. In contrast to this, the male female members,  42  and  52 , which mate, would create lateral bond surfaces along the elongated needle  30 . This substantially increases the bond line length of the elongated needle  30 . Because of significant portions of the bond line being loaded in shear, the strength and lateral stiffness of the elongated needle  30  is increased. This is improved over a single piece molded cylinder in that with the bond line loaded in shear, the elongated needle  30  will be able to sustain bending moments of its joints rather than at its base, which decreases the possibility of breakage.  
         [0035]    [0035]FIG. 5 shows and exploded isometric view of the needle tip  60  of the elongated needle  30  of the hand held vacuum assisted biopsy device  10  of FIG. 1 as viewed from the proximal side thereof. The needle tip  60  has two halves; a composite tip member  70 , and a composite hub member  80 . Both the composite tip member  70  and the composite hub member  80  are preferably molded from a magnetic Resonance Imaging (MRI) compatible resin such as Ultem or Vectra ceramic or other MRI compatible materials known to those skilled in the art is sharp. The composite tip member  70  has a three-sided pyramidal shaped point, but may also have other shapes. The composite tip member  70  has a hollow cavity  74  and protruding connectors  76 . The two protruding connectors  76  are inserted into the two receiving holes  82  on the composite hub member  80  when the composite hub member  80  is pushed into the composite tip member  70  during assembly. Cavity preferably contains a capsule  90  made from a material which will leave and MRI artifact. Having a capsule  90  made from and MRI artifact leaving material is necessary because since the elongated needle  30  is made of an MRI compatible resin, the elongated needle  30  does not show up on an MRI scan. Therefore, it is difficult for a physician to discern the orientation of the elongated needle  30  during and MRI scan MRI artifact leaving material  90  solves the aforementioned problems in that a needle tip  60  leaves a small, but not troublesome artifact on an MRI scan. This small, artifact indicates the orientation of the elongated needle  30  relative to the sight of biopsy, and where the tissue receiving bowl begins during and MRI scan. The MRI artifact leaving material  90  that is preferred is a capsule of Gadolinium. However, there are other materials that could be put into the hollow cavity  74  of the composite tip member  70  that would leave and acceptable MRI artifact. These include, but not limited to: liquid Gadolinium, Titanium Wire, Aluminum, Copper, Brass Iron, and Bronze.  
         [0036]    [0036]FIG. 6 shows an exploded isometric view of the needle tip  60  of the elongated needle  30  of the hand held vacuum assisted biopsy device  10  of FIG. 1 as viewed from the distal end thereof. This figure clearly illustrated the components on the composite hub member  80 . On the distal end of the composite hub member  80  is a male part  84 , which pushes the MRI artifact leaving material  80  down into the hollow cavity  74  on the composite tip member  70 . Also located on the distal end of the composite hub member  80  is a knock out boss  86 , which pushes a collected breast tissue sample into the end of the cutter tube  21  the hand held vacuum assisted biopsy device  10  during a breast biopsy. The two receiving holes  82  on the composite hub member  80  receive the two protruding connectors  76  on the composite tip member  70  when the composite tip member  70  and composite hub member  80  are pushed together. The reception of the two protruding connectors  76  on the composite tip member  70  by the two receiving holes  82  on the composite hub member  80  locks the composite tip member  70  and the composite hub member  80  together, and seals the MRI artifact leaving material  90  in the hollow cavity  74  in between the composite tip member  70  and composite hub member  80 .  
         [0037]    In using the hand member vacuum assisted biopsy device  10 , as shown in FIG. 1, for a breast biopsy in an MRI environment, physician will first positioned outside of the MRI magnet, the patient is moved into the MRI magnet and imaging of the breast is performed. During imaging of the breast, serial slices of the breast are examined, and a contrast agent is administered to highlight suspicious areas of breast tissue. At this time, the location of the suspicious breast tissue is determined relative to the compression grid.  
         [0038]    After the location of the suspicious breast tissue is determined, the patient is moved outside the magnet. Local anesthesia is administered to the patient and the probe  20  is inserted into the area of suspicious breast tissue.  
         [0039]    After the probe is inserted into the suspicious area of breast tissue, the patient is moved back into the MRI magnet and a set of images of the breast are taken. The sets of images confirm that the probe  20  is adjacent to the suspicious breast tissue, the patient is moved outside of the MRI magnet and the hand held vacuum assisted biopsy device  10  of FIG. 1 is then inserted into the sleeve, replacing the obturator.  
         [0040]    After the hand held vacuum assisted biopsy device  10  of FIG. 1 is inserted through the sleeve; multiple tissue samples are taken. In taking multiple tissue samples, the needle tip  60  as the distal end of the elongated needle  30  on the hand held vacuum assisted biopsy  10 , of FIG. 1, penetrates the breast in the area that is adjacent of the suspicious breast tissue. Prior to, and during penetration by the needle tip  60 , the cutter  21  is fully forward, and is advanced forward through the cutter lumen  32  by pressing the forward button  16  on the holster  15  of the vacuum assisted biopsy device  10  of FIG. 1.  
         [0041]    Once the elongated needle  30  is positioned in the area adjacent to the suspicious breast tissue, vacuum suction is applied to he vacuum chamber lumen  34 . The vacuum suction is applied by pressing the vacuum button  18  on the holster  15  of the hand held vacuum assisted biopsy device  10  of FIG. 1. Pressing the vacuum button  18  on the holster  15  opens the second vacuum line  28 , which transports vacuum suction through the handpiece  12  of the hand held vacuum assisted biopsy device  10  and into the vacuum chamber lumen  34  on the elongated needle  30 . The second vacuum line  28  runs through the handpiece  12  of the hand held vacuum assisted biopsy device  10  and into the elongated needle  30  through the vacuum manifold  24  at he proximal end of the elongated needle  30 . The vacuum suction that is applied to the vacuum chamber lumen travels from the proximal, of the distal end of the vacuum chamber lumen  34 , below the interlumen vacuum holes  23 . The interlumen vacuum holes  23  receive suction from the vacuum chamber lumen  34 .  
         [0042]    The suction from the interlumen vacuum holes  23  actively pulls breast tissue through the port  36  and into the cutter lumen  32  on the elongated needle  30 . After the breast the tissue is pulled into the elongated needle  30  through the port  36 , the cutter  21  begins to rotate and advances through the breast tissue until a sample has been obtained. After the breast tissue sample has been obtained, the elongated needle  30  is rotated to position the port  36  toward a different clockwise position in preparation for obtaining the next tissue sample. After the elongated  30  is rotated, the cutter  21  is withdrawn backwards within the cutter lumen  32  on the elongated needle  30  and the breast tissue sample is carried back to a knock-out boss  86 , which pushed the collected breast tissue sample out into a tissue collection surface  19  on the handheld vacuum assisted biopsy device  10 . Vacuum suction is then reapplied to the vacuum chamber lumen  34  from the second vacuum line  28 , and the aforementioned process is repeated continuously until the elongated needle  30  has been rotated clockwise once around the entire clock.  
         [0043]    After multiple breast tissue samples have been obtained from the patient, the patient is moved back into the MRI magnet. Once in the MRI magnet, a set of images of the breast are taken in order to confirm that the suspicious breast tissue has been removed. The artifact in the probe tip is a useful point of reference to confirm after the biopsy site is marked, the breast biopsy in an MRI environment is complete.  
         [0044]    While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the present invention. Accordingly, it is intended that the invention be limited only by the spirit and scope of the appended claims.