Patent Publication Number: US-2003233110-A1

Title: Device and method for improved diagnosis and treatment of cancer

Description:
BACKGROUND OF THE INVENTION  
       [0001] For more than a century, it has been understood that breast cancers spread from the breast primarily by entering into and passing along lymphatic channels draining the breast. These channels pass into the armpit, into the skin and through the chest wall. Tumor spread is partly impeded by the presence of lymph nodes; in which tumor cells can remain and grow, or pass though and into the blood stream. Near the turn of the century, William Halsted proved the utility of this knowledge by surgically removing all possible lymphatic channels in addition to removing the breast. While this had the disadvantage of being a fairly mutilating procedure, he was able to reduce the rate of local recurrence of breast cancer to six percent from the previously reported recurrence rate of fifty to eighty-five percent when only the breast was removed.  
       [0002] Since the time of Halsted, surgical approaches have moved away from radical techniques toward tissue-sparing approaches. With the ability of earlier detection, minimal surgery; coupled with radiation and/or chemotherapy, has achieved similar results in preventing local recurrence. The problem of detection of tumor spread remains. Often, women who appear to have early stage disease will die of metastatic cancer despite a lack of evidence of spread. Therefore, breast cancer has been called a “systemic disease.” This is most likely because cancer cells can spread undetected through lymphatic pathways; often early in the disease.  
       [0003] The primary determinant of survival in breast cancer is the presence or absence of tumor cells within the axillary (armpit) lymph nodes. Axillary nodes are removed to detect tumor spread and prevent recurrence. Tumor spread into other lymphatics that drain the breast is still undetectable, and probably accounts for cases of metastasis when the axillary lymph nodes are free of cancer. Lymphatic flow is determined by pressure and osmolar gradients. Increases in interstitial fluid or in externally applied pressure will enhance lymphatic flow. Entry of tumor cells into lymphatics is an active process of the tumor cells. Once in the lymphatic channels, tumor cells are carried along passively by the flow of lymphatic fluid. Any increase in interstitial fluid or pressure will, therefore, increase the rate of tumor spread.  
       [0004] Breast cancer can recur many years after initial treatment. Presumably, this is because of the undetectable spread of small numbers of tumor cells. While it has been known for many years that cutting into tumors can enhance their spread, present techniques of needle and core biopsies do just this. It has been claimed that these maneuvers don&#39;t spread cancer; however, the truth of these claims might not be apparent for many years.  
       [0005] Presently, the modalities of palpation, x-ray, ultrasound, and MRI are used to detect human breast cancers. Some of these techniques are used also for image-guided biopsy of breast tissue. Mammography is the mainstay of current early detection of breast cancer. This technique requires the forceful compression of the breast between plates to achieve acceptable images. Other known detection techniques, as previously mentioned, include ultrasound, magnetic resonance imaging (hereinafter “MRI”), and computerized tomography (hereinafter “CT”). Ultrasound images of the breast are obtained using a probe placed directly against the skin of the breast. MRI images are made by placing the breast in a magnetic field, between coils or hanging into a well that is surrounded by a coil. The principles of MRI are known to those of ordinary skill in the art. A description may be found in U.S. Pat. No. 5,437,280 to Hussman entitled “Magnetic Resonance Breast Localizer” which is hereby incorporated by reference in its entirety. Stereotactic biopsy techniques are done in a similar fashion; with a patient lying prone, with the breast hanging through a hole in the table. All these methods have shortcomings related to the flaccid nature of the breast which leads to difficulty in manipulating and orienting the organ. Additionally, some of these methods are very uncomfortable for the patient. The pain often associated with the forceful compression of the breast between plates in mammography being a prime example.  
       [0006] Early detection of breast cancers has spurred increasing interest in early intervention. Open biopsy techniques have given way to more image-guided biopsy methods which currently require forceful compression of the breast for stabilization, and require the forceful passage of instruments into the breast which often cause considerable bleeding; especially once the compression has been released. The tissue is in a distorted state and accurate removal of a specific volume of breast tissue is difficult. Present techniques for image-guided biopsy of the breast are limited by the size of the lesion to be removed, and by continuing challenges of bleeding and spread of tumor cells. Removal of lesions greater than a centimeter is generally not possible by these methods.  
       [0007] One object of the present invention is to allow for improved imaging and intervention in diagnosis and treatment of cancer, particularly early stage human breast cancer. Another object of the present invention is to allow for the accurate removal of tissue in a minimally bleeding or bloodless field.  
       SUMMARY OF THE INVENTION  
       [0008] One embodiment of the invention is a fixation apparatus for a breast comprising a cup-like body having a side wall with an open top end and an open bottom end and a fluid evacuation duct. The body defines a chamber adapted to receive a portion of the breast. A gasket is attached to the bottom end and is adapted to provide a substantially fluid tight seal between the body and an area of skin around the breast. A suction ring is attached to the top end and is adapted to provide a substantially fluid tight seal between the body and a second area on the breast. The apparatus may further include a hose attached to the fluid evacuation duct and connected to a pump capable of evacuating fluid in the cup-like body and mounted on the breast such that the gasket and suction ring provide a substantially fluid tight seal between the body and the first and second areas.  
       [0009] Another embodiment of the present invention is also a fixation apparatus for a protuberance of a body that comprises a cup-like body having a continuous wall and a port. The wall is open at one end and the wall defines a volume adapted to receive the protuberance without the protuberance contacting the wall. A gasket is attached to and adapted to provide a substantially fluid tight seal between the body and an area of skin around the protuberance. The fixation apparatus may further include a tubular member connecting the port to a pump for removing fluid to create a reduced or negative pressure within the volume and a pressure gauge connected to the fixation apparatus to monitor the pressure in the cup-like body.  
       [0010] Another embodiment of the present invention is a minimally invasive tissue saw. The tissue saw comprises a shaft extending along a first axis between a proximal end and a distal end and has a first cross section at the distal end. The tissue saw has a cutting head extending between a connecting end and a cutting end. The connecting end is pivotally connected to the distal end of the shaft so that at least a portion of the cutting head is able to swivel back and forth substantially along a second axis, the second axis in a direction transverse to the first axis. The cutting head has a cutting surface at the cutting end and extends across a width in the second axis and is able to swivel back and forth to cut a slit in tissue. The slit has a second cross section with the cutting head having at least one insertion surface substantially adjacent the cutting surface. The insertion surface extends between the connecting end and the cutting end and tapers from the first cross section at the connecting end to the second cross section at the cutting end. A portion of the insertion surface is a cauterizing element and extends around a strip of the insertion surface for cauterizing the tissue surrounding the slit.  
       [0011] In yet another embodiment the present invention is a minimally invasive device for removing a specimen of tissue with a cylinder extending along and rotatable around a first axis defined between a proximal end and a distal end. The cylinder has an interior surface and an exterior surface with a plurality of cutting arms. Each arm has an inner surface and an outer surface with the surfaces extending between a forward edge, and a trailing edge. A portion of the forward edge defines a cutting edge and the cutting edge extends past the distal end of the cylinder to cut tissue. The arms are pivotally connected to the cylinder at the distal end and pivot between an open position and a closed position. The inner surface of each arm is adjacent to and substantially overlaps the exterior surface of the cylinder in the open position. A portion of the inner surface of each arm extends beyond the distal end of the cylinder and is adjacent tissue in the closed position.  
       [0012] Another embodiment of the invention is a minimally invasive tissue biopsy device comprising a cannula having a proximal end and a distal end and a first longitudinal axis defined between the ends. The device also includes a means for cutting a slit in tissue with the slit being in a second axis substantially transverse to the first longitudinal axis. The device further includes a trailing means for cauterizing substantially all of the tissue surrounding the slit.  
       [0013] Another embodiment of the invention is a method comprising: providing a retaining sleeve and a tissue saw. The retaining sleeve has a proximal and a distal end with the retaining sleeve having a first cross-section at the distal end. The tissue saw has an oscillating cutting head and a trailing coagulating element. The head has a cutting edge and a tapering insertion surface for advancing the retaining sleeve and the tissue saw along a first axis toward a lesion while the cutting edge oscillates back and forth and cuts an entry wound in tissue. The entry wound is a substantially linear slit having a second cross-section. The entry wound is distorted from the second cross-section of the slit to the first cross-section of the retaining sleeve. The tissue surrounding the slit is cauterized with the trailing coagulating element. The cauterization occurs as the tissue saw and retaining sleeve are advanced toward the lesion.  
     
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
     [0014]FIG. 1 illustrates the prior art form of breast fixation using compression plates.  
     [0015]FIG. 2 is a side view partially in cross-section of an embodiment of the breast fixation apparatus of the present invention.  
     [0016]FIG. 3 is a partial sectional view of an alternative embodiment of the breast fixation apparatus of the present invention.  
     [0017]FIG. 4 is a enlarged perspective view of a portion of the embodiment of FIG. 3.  
     [0018]FIG. 5 illustrates an embodiment of a tissue saw and retaining sleeve being introduced into an incision in the breast while held by a fixation apparatus of the present invention.  
     [0019]FIG. 6A illustrates a cross-section of the opening in the tissue cut by an embodiment of the tissue saw of the present invention.  
     [0020]FIG. 6B shows the transition between the cross-section of the opening cut into the tissue by a tissue saw of the present invention and the cross-section of the shaft or retaining sleeve which trails the cutting surface of the tissue saw.  
     [0021]FIG. 7A is a top cross-sectional view of an embodiment of the tissue saw of the present invention.  
     [0022]FIG. 7B is a side cross-sectional view of the embodiment of FIG. 7A.  
     [0023]FIG. 8A is an end view of FIG. 7A along the lines  1 - 1 .  
     [0024]FIG. 8B is an end view of the embodiment of FIG. 7A along the lines  2 - 2 .  
     [0025]FIG. 9 is a top cross-sectional view of one example of a driving mechanism for the tissue saws of the present invention.  
     [0026]FIG. 10 is a perspective view of one embodiment of the coring device of the present invention.  
     [0027]FIG. 11A is an end view of the coring device of FIG. 10 in the open position.  
     [0028]FIG. 11B is an end view of the coring device of FIG. 10 in the closed position.  
     [0029]FIG. 12 is an illustration of the tissue saw being withdrawn through the retaining sleeve prior to encountering the lesion.  
     [0030]FIG. 13 is an illustration of the coring device of the present invention being advanced through the retaining sleeve toward the lesion.  
     [0031]FIG. 14 illustrates the path the coring device of one embodiment of the present invention cuts into the tissue surrounding the lesion to be excised and the shape of the specimen of tissue cut.  
     [0032]FIG. 15 illustrates the coagulated cavity and coagulated collapsing slit left behind after the withdrawal of the devices of the present invention.  
     [0033]FIG. 16 is a top view of another embodiment of the tissue saw of the present invention.  
     [0034]FIG. 17A is a side view of another embodiment of the coring device of the present invention.  
     [0035]FIG. 17B is an end view of the embodiment of the coring device of FIG. 17A.  
     [0036]FIG. 18A is a side view of the coring device of FIG. 17A in the closed position.  
     [0037]FIG. 18B is an end view of the embodiment of the coring device of FIG. 17A in the closed position.  
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS  
     [0038] For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiment illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates.  
     [0039] All of the above-mentioned methods, such as mammography, ultrasound, MRI, etc., have shortcomings related to the flaccid nature of the breast which leads to difficulty in manipulating and orienting the organ. Additionally, some of these methods are very uncomfortable for the patient. One particular and well known discomfort is that associated with mammography as illustrated in FIG. 1. Breast  10  has a nipple  14  surrounded by an areola  12  which in turn is surrounded by periareolar skin  13 . Breast  10  protrudes from chest wall  16  and is shown forcefully compressed between compression plates  5 ,  6  which is necessary to achieve acceptable images. This is in contrast to the situation found in various embodiments of the present invention.  
     [0040] With reference to FIG. 2, an embodiment of the fixation device of the present invention in its simplest form is shown. The device comprises a cup-like body  20  defining a volume  21  containing the breast  10 . It should be understood that the term cup-like body may include a variety of different shapes. These shapes include, but are not limited to, a frustospherical, frustoconical, generally hemispherical, funnel shaped, pyramidal, or even rectangular configurations which the cup-like body  20  may possess so long as it is capable of enclosing at least a portion of the breast  10 . The breast  10  again has an areola  12  and nipple  14 . The breast  10  is attached to the chest wall  16  as shown in FIG. 2. The cup-like body  20  is attached to the chest wall  16  by means of a flexible flanged gasket  22 . It should be understood that if cup-like body  20  is appropriately shaped at its bottom end where gasket  22  is shown, the gasket  22  may instead be omitted and an adhesive applied directly to cup-like body  20  to attach it to the skin of the chest wall  16  or the breast  10 . When such is the case, medical grade solvents may be applied at a later time to remove the apparatus.  
     [0041] The cup-like body  20 , surrounding the breast  10 , can be evacuated to varying degrees of negative pressure. While the flexible flanged gasket  22  is shown applied to the skin of the chest wall  16  around the breast  10 , it is understood that the gasket  22  may also be attached directly to the skin of the breast  10  if so desired. The gasket  22  allows a fluid-tight seal to be formed in the cup-like body  20 . Air or other fluids are removed from the volume  21  containing breast  10  by means of a vacuum pump  24  while a distending pressure is monitored by a pressure gauge  25 . As the cup-like body  20  is evacuated, the breast  10  is drawn into the cup-like body  20  toward the top surface  27  and away from the chest wall  16 .  
     [0042] Since negative pressure is applied to all surfaces of the breast  10  evenly (as illustrated in FIGS. 2 and 3 with outwardly directed arrows), the breast  10  will expand to its maximum volume and remain in a fixed position away from the chest wall  16 . In this position, the breast  10  can be placed in an imaging or interventional device  26 . It should be understood that imaging or interventional device  26  may include, but is not limited to, devices such as an MRI coil, an ultrasound device, a CT scanner, or a radiation beam with any of these devices placed around or at a distance from the breast  10 . Since fixation of the breast  10  is not dependent on gravity, the patient need not lay prone, but instead may be placed in many different positions for optimal advantage in imaging or irradiation as well as patient comfort.  
     [0043] With references to FIGS. 3 and 4, another embodiment of the present invention is shown which facilitates image-guided intervention of the breast  10 . In this embodiment, the cup-like body  30  again has a gasket  32  which together enclose a volume  31 . As in the previous embodiment, cup-like body  30  may take a variety of configurations and shapes. The volume  31  enclosed includes at least a portion of the breast  10 . As before, the cup-like body  30  may include one or more hoses  33  connected to a vacuum pump  34 . In both embodiments, the cup-like body  20 ,  30  will have an evacuation duct or port of some kind to which the flexible tubular member or hose may be attached to allow for evacuation of air or other fluids from within the body  20 ,  30 . It is again preferable to attach cup-like body  30  to the chest wall  16  by means of gasket  32  (with or without the use of an adhesive as desired).  
     [0044] In this preferred embodiment, however, the periareolar skin  13  is preferably left exposed. Thus, surgical intervention by a variety of instrumentation devices, one embodiment of which will be discussed further below, is possible through the periareolar skin  13 . This is accomplished by providing a suction ring  38  which is applied to the periareolar skin  13  around the areola  12  of the breast  10 . When the ring  38  is applied, it provides access to the periareolar skin  13  of the breast  10  outside the cup-like body  30 , while maintaining negative pressure and fixation of the breast  10 . Again, the distending pressure is preferably monitored by a pressure gauge  35 . While suction ring  38  is shown applied to periareolar skin  13 , it should be understood that a variety of sizes and locations for suction ring  38  are contemplated as within the scope of the invention. For example, suction ring  38  might be oval in configuration and not centered directly on the areola  12  thus exposing skin of breast  10  adjacent to the periareolar skin  13  if such is preferred for easier access during surgical intervention. Similarly, ring  38  might be larger in diameter and placed lower down on the breast  10  exposing more skin for easier access as required. It should also be understood that such variations in size and configuration are equally applicable to gasket  32 . Thus, gasket  32  may be placed to create a substantially fluid tight seal between both the skin of the breast  10  as well as the skin of the chest wall  16  as desired.  
     [0045] The suction ring  38  is mounted on a adjustable stage  40  that can be adjusted for varying sizes of breast  10 . The adjustable stage  40  acts as a platform for a variety of image-guided devices. It should be understood that a variety of other platforms are contemplated as within the scope of the invention that may contain alternative translational and/or rotational mechanisms for image-guided interventional devices. By way of small incisions, in or around the areola  12  and periareolar skin  13 , various instruments and biopsy devices can be placed into the breast: guided by images from x-ray, ultrasound, MRI, or CT.  
     [0046] With reference to FIGS. 3 and 4, it is seen that one such adjustable stage  40  includes the ability for a 360 degree circumferential adjustment as indicated by the arrow  44  as well as an extensible holder which allows for adjustment in the azimuth direction as indicated by the arrow  42 . In its simplest form, the adjustable stage  40  has a first portion  41  and a second portion  43 . The first portion  41  may be extended or retracted for adjustment in the azimuth direction and terminates in a first end  45  in which a variety of image-guided devices may be attached. The second end  46  of first portion  41  is connected to the second portion  43  of adjustable stage  40 . The second portion  43  of adjustable stage  40  is generally ring shaped and first portion  41  may be rotated about the circumference of second portion  43  and locked into position as desired. Similarly, the amount of extension of first portion  41  is also adjustable.  
     [0047] It is contemplated as within the scope of the invention that the suction chamber defined by cup like body  20 ,  30  can be of various sizes to accommodate equipment, coils, stages and the like. It should be understood that the chamber may detach from the imaging or interventional devices or both so that the breast could maintain a static position in space, as when being placed, first, in an imaging device and then into a targeting biopsy device. It should be further understood that the unique aspect of the present invention is the ability to stabilize the breast or other bodily protuberance in a position in space and that a wide variety of configurations of the chamber are contemplated as within the scope of the invention for achieving this end.  
     [0048] In one preferred embodiment the patient is lying prone and slightly tilted, bringing the breast into position with the suction chamber defined by the cup-like body. Then the imaging device may be arranged to be inside or outside the chamber, depending upon its particular requirements (e.g.—“surface coils” for MRI). As disclosed above, in one embodiment a secondary suction ring maintains exposure of the areola for entry using a variety of interventional devices, in particular biopsy devices. The secondary suction ring, being placed on an adjustable stage, aids in permitting a wide variety of configurations in arranging the chamber, imaging device, and interventional device as appropriate for particular surgical applications.  
     [0049] As shown in FIGS. 3 and 4, after the cup-like body  30  is evacuated, and the breast  10  fixed, imaging devices  36  may be used to locate precisely lesion  47  and then an interventional device shown as a line  48  in FIGS. 3 and 4 is inserted into the breast to precisely locate and excise the cancerous cells or tumor forming the lesion  47 . A wide variety of interventional devices are contemplated for use in place of line  48  in FIGS. 3 and 4. Such devices may include, but are not limited to, those biopsy devices disclosed in U.S. Pat. Nos. 5,111,828, 5,197,484, and 5,353,804 all to Kornberg et al. as well as U.S. Pat. No. 5,795,308 to Russin and U.S. Pat. No. 5,817,034 to Milliman et al. all of which are hereby incorporated by reference. The preferred interventional devices, however, will be disclosed below as yet another embodiment of the present invention.  
     [0050] Thus, by way of small incisions, in or around the areola  12 , various instruments and biopsy devices (guided by images from such things as x-ray, ultrasound, MRI, or CT) may be used to precisely treat the lesion  47  (or lesions) in the breast  10  which has been fixed in space. As is known by those of ordinary skill in the art, anatomically the breast is arranged radially in duct-lobule units spreading out from the nipple-areolar complex. (See pages 20-21 of  The Breast Cancer Survival Manual  by John Link, M.D., published by Henry Holt and Company, Inc., 1998, these pages are herein incorporated by reference). The fixation device of the present invention allows directed intervention along radial anatomic compartments, and consequently, allows more precise anatomic alignment for diagnostic and therapeutic intervention. It is seen that the various embodiments described above of the present invention may be used to fix the breast in a distended, stable position using negative pressure. The stable fixation of the breast in space is advantageous for breast imaging, tissue biopsy and specific local therapy.  
     [0051] Additional utility of the present invention derives from its ability to temporarily minimize or halt lymphatic flow from the breast and, thereby, halt the spread of tumor cells via the lymphatics. This is in contrast to present techniques which generally involve the forceful (and potentially painful) compression of the breast between two plates. This externally applied pressure enhances lymphatic flow (thus having the potential to increase the rate at which tumor cells spread) as opposed to minimizing or halting it. It is understood by those of ordinary skill in the art that cancerous cells are less dangerous if they remain intraductal. If a cancer becomes invasive or interductal, there is greater opportunity for the cancerous cells to spread. Every time a breast is compressed to the extent necessary to perform mammography, pressure in the system is increased. Increasing the pressure in the system increases the likelihood that the cancerous cells will either (1) be forced through the walls of the ductal tissue; and/or (2) increase the rate of lymphatic flow so that the cancer cells will filter through the labyrinth of the lymph nodes and the lymphatic system allowing the disease to spread to other portions of the body and progress to the systemic stage from localized. Thus, in addition to deriving utility from minimizing or halting lymphatic flow, the fixation device of the present invention is advantageous simply because it does not increase the pressure on the system, as is the case with many conventional techniques. The invention has further utility in applications such as those involving external beam radiation treatment. Both of the above disclosed embodiments for a breast fixator draw the breast  10  away from the chest wall  16  into a position more favorable to safe and specific treatment. It should be understood that the dimensions and materials of the above described embodiments can and will vary widely depending on the particular needs of the imaging or treatment modality. It should be further understood that the dimensions and materials of the device may also vary based on the size of the organ of the patient being treated.  
     [0052] Other advantages of the fixation device of the present invention are numerous. For example, a breast fixator provides the ability to stabilize the breast in space, both for imaging and for intervention. A fixation device as disclosed in the present application has particularly advantageous features for use with MRI. With the breast fixed in space, different modalities can be applied and the patient can be moved from place to place. For example, MRI imaging takes some time, and keeping a patient in the scanner while doing a procedure wastes time for other imaging. However, by using a fixator to stabilize the breast as in the present invention, the breast can be imaged and the data/set of information about the breast can be stored and regenerated and manipulated. Once the data set is fixed, and the points on the fixator are referenced, the breast can be manipulated in a different place with different and cheaper localizing devices. In one preferred embodiment, the breast is fixed within a fixator which itself has coordinate markings. The breast is then imaged along with the coordinating marks. The patient is then removed to an interventional area where, using ultrasound guidance within the superimposed data sets of ultrasound and MRI, the areas to undergo surgical intervention can be targeted. It is even possible to integrate MRI, ultrasound, and CT images of the breast and use all that information simultaneously. It should be understood that variations of the above described method of use of the breast fixation of the present application that would be known to those of ordinary skill in the art, are contemplated as within the scope of the invention. In particular, a variety of different imaging devices in connection with the interventional devices discussed above as well as the preferred embodiment discussed below are contemplated as within the scope of the invention.  
     [0053] With reference to FIGS.  5 - 18 , there are illustrated various embodiments of a tissue saw and coring device for use in a minimally invasive procedure in a minimally bleeding or bloodless field and for removing a specimen of tissue. The specimen of tissue to be removed is that surrounding and including a lesion  80  found using the early detection methods of present technology. As previously indicated, the various embodiments of the tissue saw and coring devices disclosed below are intended to be used in conjunction with the breast fixation device of the present invention. It should be understood, however, that the devices and methods disclosed below may be used independently of the fixation device described above. It should be further understood that the tissue saw and coring devices discussed below will find utility with a wide variety of imaging devices including MRI. One preferred embodiment for use with MRI imaging modalities is if the tissue saw and/or the coring device, as well as any retaining sleeve used, are made of MR transparent materials. These MR transparent materials may include titanium, plastic (polycarbonate), and other materials known to those of ordinary skill in the art.  
     [0054] With respect to FIGS.  5 - 9 , there is illustrated one embodiment of a minimally invasive tissue saw  101  for permitting access to a lesion  80  in a minimally bleeding or bloodless field. The tissue saw  101  is preferably first inserted through retaining sleeve.  103 . The retaining sleeve  103  may be held, for example, by the previously disclosed movable stage  40  (not shown) in the first portion  41  at the first end  45 . The movable stage  40  (not shown) is aligned so that the tissue saw  101  lines tip with an incision  90  in periareolar skin  13  and/or adjacent areola  12  and nipple  14 , in its simplest form, the tissue saw  101  comprises a shaft  105  with an attached cutting head  110 . The shaft  105  may be either a generally hollow cylinder or a solid rod (with passages as necessary for cables or other means for swiveling the cutting head  110 ) extending through the retaining sleeve  103 . The retaining sleeve  103  is essentially a cylinder or cannula. A wide variety of shapes and forms other than the generally circular form shown for both the shaft  105  and retaining sleeve  103  are contemplated as within the scope of the invention.  
     [0055] Shaft  105  has a proximal end  106  and a distal end  107 . Shaft  105  has a first cross-section  109  at distal end  107 . The cutting head  10  has a connecting end  112  and a cutting end  114 . The connecting end  112  of cutting head  10  is attached to the distal end  107  of shaft  105 . As illustrated in FIGS. 5 and 6, the shaft  105  has a first cross-section  109  that is generally circular with a diameter  109   a . The shaft  105  extends between the proximal end  106  and distal end  107  along a first longitudinal axis  108 . The tissue saw  101  is intended to cut a slit  122 . Slit  122  is cut by the cutting surface  120  of cutting head  110 . Cutting surface  120  is shown with serrations  121 . It should be understood that the use of serrations  121  at the cutting end of cutting surface  120 , while preferred, is not necessary for operation of the present invention. Slit  122  is a long narrow aperture of minimal thickness having a width  125 . Width  125  is defined in a plane of the second axis  116  which cutting head  110  creates by swiveling back and forth of cutting surface  120  in the direction of the arrows  124  (see FIGS. 5 and 7A).  
     [0056] While cutting surface  120  is illustrated as having serrations  121 , it should be understood that alternative embodiments wherein the cutting surface is a generally smooth blade are contemplated as within the scope of the invention. In one embodiment, cutting surface  120  is an arc of a circle and has a width  125  (in the second axis  116  transverse to the first axis  108 ) equal to the diameter of either shaft  105  or retaining sleeve  103 . It should be understood, however, that a variety of configurations and widths for cutting surface  120  are contemplated as within the scope of the invention. For example, cutting surface  120  may be an arc of a circle, a straight blade, polygonal, or some combination of the foregoing as known to those of ordinary skill in the art. It should be further understood that the cutting surface  120  may be a portion of the continuous perimeter of a generally circular bandsaw. This bandsaw may possess a wide variety of shapes and sizes. For example, the bandsaw may have a diameter at least equal to π/2 times the diameter of the shaft  105  or retaining sleeve  103  in which case no pivoting of the bandsaw would be necessary to cut a slit sufficiently large to encompass the retaining sleeve  103  or shaft  105 . In an embodiment where the bandsaw had a diameter at least equal to π/2 times the diameter of shaft  105 , the shaft  105  could be a generally hollow cylinder and the bandsaw could be detachable from the distal end  107  of the shaft  105 , the bandsaw being collapsible so that it could be retracted through the shaft  105  and/or the retaining sleeve  103  as necessary. It is also contemplated as within the scope of the invention that a bandsaw might be used with a diameter equal to the diameter of the shaft  105  or retaining sleeve  103 . In this embodiment, the bandsaw would need to pivot from side to side as discussed further below. The bandsaw could be rotated by various driving mechanisms known to those of ordinary skill in the art. One driving mechanism for a circular bandsaw would be an electric motor rotating in a continuous loop driving the circular bandsaw.  
     [0057] Cutting head  110  has an insertion surface  130  which provides a transition from the first cross-section  109  of shaft  105  to the second cross-section  123  of the slit  122 . In the embodiments illustrated in the figures of the present application, insertion surface  130  is generally shown as comprising a first upper surface  132  having a first cauterizing plate or element  133  and a second lower surface  134  having a second cauterizing plate or element  135 . It should be understood, however, that insertion surface  130  may be an integral whole extending around the entirety of the cutting head  110  and transitioning between first cross-section  109  and second cross-section  123 . It should also be understood that instead of two surfaces  132  and  134 , the insertion surface  130  may instead be made up of a plurality of surfaces as opposed to merely two. The transition between the first cross-sectional shape  109  of the shaft  105  and the second cross-sectional shape  123  of the substantially linear slit  122  may take a variety of configurations.  
     [0058] While upper surface  132  and lower surface  134  are shown as a straight line taper from the cutting surface  120  to the distal end  107  of shaft  105 , it should be understood that a variety of profiles for the transition from the first cross section  109  of shaft  105  to the second cross section  123  of slit  122  are contemplated as within the scope of the invention. For example, upper surface  132  and lower surface  134  may be a series of steps, or a graduated transition that is concave or convex in shape or some combination of these and other configurations known to those of ordinary skill in the art. In either case, the upper surface  132  and lower surface  134  act to spread the tissue sliced by cutting surface  120  from the substantially linear slit  122  having second cross-sectional shape  123  into a shape corresponding to the first cross-sectional shape of shaft  105  or retaining sleeve  103 .  
     [0059] The cutting head  110  is preferably pivotally connected to the distal end  107  of shaft  105 . In one embodiment, the entire cutting head  110  will pivot. In other embodiments, however, only a portion of the cutting head  110  will be pivotally connected, such as the cutting surface  120 . It should be understood that the term pivotally connected encompasses those situations in which cutting surface  120  slides along a track or other guide path located in between first upper surface  132  and second lower surface  134 . In such an embodiment, the cutting surface  120  will pivot from side to side generally along the second axis  116 . It should be understood by those of ordinary skill in the art that the width  125  of slit  122  is preferably, but not necessarily, at least a minimum distance to gain maximum benefit of the improvements of the present invention. Namely, basic geometric principles (see FIG. 6B) reveal that the circumference of the shaft  105  should be approximately equal to twice the width  125  of the slit  122 . Thus, to introduce the retaining sleeve  103  up to the point of the lesion in a minimally bleeding or bloodless environment, a cutting surface  120  of cutting head  110  with a width  125  equal to the diameter of retaining sleeve  103  should have the ability to pivot to each side a distance of (π/4−0.5) times the diameter of the retaining sleeve  103  to be introduced into the body.  
     [0060] As previously mentioned, either the cutting head  110  in its entirety may swivel back and forth, or merely the cutting surface  120 . In either situation, a variety of mechanisms are contemplated as within the scope of the invention for inducing the cutting surface  120  or cutting head  110  to swivel back and forth the necessary amount. For example, with reference to FIGS. 7A and 8B, there is illustrated one driving mechanism for the swivel action of cutting head  110 . In this embodiment, cables  140   a  and  140   b  running through cable shafts  142   a  and  142   b  are used to cause the necessary swiveling action. With respect to FIG. 9, there is shown a potential driving mechanism for the cables  140   a  and  140   b  running through cable shafts  142   a  and  142   b . In this case, the driving mechanism utilizes a spring block  144  and a cutting trigger  146  intended to be moved back and forth along an axis as indicated by the arrows  147   a  and  147   b.    
     [0061] It should be understood that an essential element of the tissue saw is the use of a cauterizing plate or element. The cauterizing plate or element may be placed on the cutting head  110 , preferably, but not necessarily, adjacent the cutting surface  120 . Thus, as the tissue saw  101  is advanced along the first axis  108 , the tissue is first severed by the cutting surface  110  and then quickly cauterized by, for example, first cauterizing plate or element  133  and second cauterizing plate or element  135  so as to provide a minimally bleeding or bloodless field. This aids in preventing the spread of any tumor cells that might otherwise be released to flow elsewhere in the body by the cutting of the tissue, in particular the tissue surrounding or near a lesion  80 . The cauterizing elements  133  and  135  both destroy any tumor cells encountered as well as causing coagulation in the tissue surrounding the slit  122 .  
     [0062] The cauterizing elements  133 ,  135  may act to cauterize in a variety of manners including being an electrically resistive material so that they may act as an electric cauterizer, or as a conduit for fiber optic cables for laser coagulation and other mechanisms known to those of ordinary skill in the art. It should be understood that alternative locations for the cauterizing plate or elements are contemplated as within the scope of the invention. For example, while the cauterizing plate or elements  133 ,  135  may be located either adjacent cutting surface  120  or elsewhere on the cutting head  110 , it should be understood that the strip of material acting as a cauterizing element may be placed in a variety of locations. For example, the cauterizing element could be a continuous strip of material placed around the circumference of the distal end  107  of shaft  105  or might even be placed around the circumference of a distal end of the retaining sleeve  103 . It should be further understood in some situations the shaft  105  will be a hollow cylinder and may also be acting as the retaining sleeve  103 . In any case, the essential element of the tissue saw is that the cutting surface be followed by a trailing coagulating plate or strip of material which acts to cauterize the tissue surrounding the opening cut into the body by the cutting surface  120 . It should also be understood that the first cauterizing element  133  and second cauterizing element  135  in the embodiment illustrated in the figures as well as discussed in the preceding text may be either affixed to the insertion surface  130  or first surface  132  and second surface  134  (or the exterior of the shaft  105  or retaining sleeve  103  as may be the case) in a variety of manners known to those of ordinary skill in the art such as adhesives, welding, or being bolted on. Alternatively, it should also be understood that the cauterizing elements may be integrally formed upon whatever surface or surfaces are selected for their location.  
     [0063] With respect to FIGS. 10 and 11, one embodiment of the coring device for removing the specimen of tissue containing the suspected lesion  80  is illustrated. The device includes a cylinder  160  having a proximal end  161  and a distal end  162 . The cylinder  160  extends generally along a first axis  159 , the cylinder  160  rotating around the first axis  159 , both to cut a circumference of a circle in tissue as well as rotating when cutting the bullet-shaped specimen  81  (see FIG. 14B) free as discussed below. Cylinder  160  has an interior surface  163  and an exterior surface  164 . Cylinder  160  is preferably received within retaining sleeve  103  so that the exterior surface  164  of cylinder  160  is adjacent the interior surface  104   a  of the retaining sleeve  103 .  
     [0064] It is understood that while it is preferred that the coring device be inserted up through the interior of the retaining sleeve  103 , it is also possible to use a coring device with a cylinder  160  having a diameter  160   a  such that the cylinder  160  may be rotated around the exterior surface  104   b  of retaining sleeve  103 . This is a less preferred embodiment, however, since the slit, (e.g., slit  122  with second cross-section  123 ) while having been distended by the insertion surfaces (such as first upper surface  132  and second lower surface  134 ) to the shape of the shaft  105  and/or the retaining sleeve  103 , would require additional cutting and cauterizing to pass the cylinder  160  around the exterior  104   b  of retaining sleeve  103 . In contrast, passing cylinder  160  through the interior of retaining sleeve  103  permits the introduction of the coring head  166  to the specimen of tissue  81  surrounding the suspected lesion  80  to be removed without further trauma.  
     [0065] With respect to FIGS. 10 and 11, there are illustrated various details of coring head  166 . In the illustrated embodiment, coring head  166  is shown with first cutting arm  170  and second cutting arm  180 . First cutting arm  170  has an inner surface  171   a  and an outer surface  171   b  extending between first forward edge  172  and first trailing edge  173 . At least a portion of first forward edge  172  comprises a cutting edge  174  which may or may not be serrated as desired. Additionally, at least a portion of the first outer surface  171   b  of first cutting arm  170  acts as a first cauterizing element  175 . The first cauterizing element  175  may be a coagulating plate or other means known to those of ordinary skill in the art for rapidly cauterizing the tissue cut by first cutting surface  174 . First cutting arm  170  is generally swiveled around a first hinge  178  near first pivoting end  176 . Distal from first pivoting end  176  is first far end  177 . A first cable (or rod)  190  may be pulled so that first cutting arm  170  swivels from its open position (see FIG. 11A) to its closed position for a completed cut (see FIG. 11B).  
     [0066] In a similar manner, second cutting arm  180  has a second inner surface  181   a  and a second outer surface  181   b  extending between a second forward edge  182  and a second trailing edge  183 . Second forward edge  182  has a second cutting edge  184  along at least a portion of second forward edge  182 . It should be understood that second cutting edge  184 , similar to first cutting edge  174 , may or may not be serrated as desired. Also, second cutting arm  180  has a second cauterizing element  185  which, similar to first cauterizing element  175 , may be attached or integrally formed with second outer surface  181   b . As seen in FIGS. 10 and 11, second cutting arm  180  swivels from an open position to a closed position around a hinge  188  attached nearer to pivoting end  186  than to far end  187 . Second cutting arm  180  is pivoted from its open position to its closed position using a second cable (or rod)  191  which is preferably attached near the pivoting end side of the second cutting arm and pulled, or which may instead be attached near the second far end  187  of second cutting arm  180  and pushed to force the second cutting arm  180  to swivel from its open position to its closed position. In the open position, second inner surface  181   a  is substantially adjacent the exterior surface  104   b  of retaining sleeve  103 . In the closed position, the cutting edge  184  and cauterizing element  185  will have cut a bullet shaped specimen  81  (see FIGS.  14 A-B) and cauterized the tissue surrounding the specimen  81  to be removed. It should be understood that first and second cauterizing elements  175 ,  185  are preferably, but not necessarily, found only on first and second outer surfaces  171   b ,  181   b , respectively. Thus, the tissue specimen  81  being removed is preserved for microscopic analysis and further examination.  
     [0067] The cables  190 ,  191  will cause first and second arms  170 ,  180  to swivel across an approximately 90 degree arc from the open position to the closed position. A variety of mechanisms are contemplated as within the scope of the invention for causing the far ends  177 ,  187  of the first and second arms  170 ,  180  to curve inwardly toward one another and toward the first axis  159  about which the cylinder  160  rotates. One mechanism would be to manufacture the first and second arms  170 ,  180  out of a material having a memory. The memorized shape would be the inwardly curved shape of the closed position. As the first and second arms  170 ,  180  extended past the distal end of the cylinder  160 , they would take on their memorized shape and the far ends  177 ,  187  would bend inwardly toward one another while rotating to cut free the dome shape at the end of the bullet-shaped specimen of tissue  81  to be removed. The arms may be made of a variety of materials such as stainless steel having a sufficient elastic strength, or even a shape memory material, such as nickel titanium alloy. Alternatively, a pair of springs (not shown) could be placed between the inner surfaces  171   a ,  181   a  of first and second cutting arms  170 ,  180  and the exterior surface  164  of cylinder  160 . These springs would drive the pivoting ends  176 ,  186  away from the exterior surface  164  of cylinder  160  and would simultaneously cause the far ends  177 ,  187  to move inwardly toward the first axis  159  around which cylinder  160  rotates. It should be understood that a supporting armature which prevents the first and second cutting arms  170 ,  180  from returning to their memorized shape may be an apparatus attached to the cylinder  160  or the cylinder  160  itself may act as the supporting skeleton or framework.  
     [0068] The following is a description of the method of use of one embodiment of the above-described devices for use in permitting access to tissue surrounding a lesion in a minimally bleeding or bloodless field. The following also describes a method of use of one embodiment of devices in excising a specimen of tissue surrounding a lesion. Variations using other embodiments of devices disclosed above and below and other devices known to those of ordinary skill in the art are contemplated as within the scope of the invention.  
     [0069] For example, in one method of use, the second suction ring  38  is mounted on the movable stage  40  which has a targeting assembly ( 41 ,  42 ), which will adjust to 360 degrees and variable azimuth. Once the breast  10  is fixed in space, and the coordinates for the lesion  80  are determined, an incision  90  is made in or around the areola  12 . Generally, incision  90  will be made by the surgeon using an ordinary scalpel or other cutting means known to those of skill in the art to preserve the skin&#39;s contour. Practicing surgeons will understand that the incision  90  and the scar it leaves behind are often the only visible measure a patient will have to use to judge the quality of the surgeon&#39;s work. Thus, it is preferable if incision  90  is made in a manner to preserve the skin&#39;s contour. It should be understood, however, that if desired, the tissue saw  101  may be used to create the incision  90  as well. After the incision  90  is made, the tissue saw  101  is advanced into the breast  10  toward the lesion  80 . Around the tissue saw  101  is also advanced the retaining sleeve  103 . It should be understood in some embodiments of the device the shaft  105  will be a hollow cylinder through which the cutting head  110  and other diagnostic and interventional devices may be extended through and retracted as necessary. In such cases, there may not be any need for a separate retaining sleeve  103 .  
     [0070] It should also be understood that a wide variety of shapes and contours for the interior and exterior surfaces of the retaining sleeve  103  are contemplated as within the scope of the invention. For example, the retaining sleeve  103  may have an exterior surface  104   b  with a plurality of notches in it to act as a locking mechanism for more secure fixation to the targeting assembly ( 41 ,  42 ) and in particular whatever holding mechanism the first end  45  of the first portion  41  of movable stage  40  may have. Alternatively, it should be understood that the exterior surface  104   b  of retaining sleeve  103  may also be smooth and first end  45  may be a clamp permitting infinite variation in adjusting the position of retaining sleeve  103  with respect to the first end  45 . A tissue saw  101  has an oscillating cutting head  110  with a leading cutting surface  120 , which is preferably, but not necessarily provided with a plurality of serrations  121 . The cutting head  110  has a trailing double coagulating plate ( 133 ,  135 )—the tissue being first cut, and then exposed to cautery on both faces of the slit  122 . Again, it is understood that the cauterizing element may be adjacent the cutting surface  120  or located some distance from it. Additionally, it should be further understood, that as previously discussed, the coagulating plate or other cauterizing element while preferably located on cutting head  110 , may instead be located on shaft  105  or retaining sleeve  103 .  
     [0071] As the tissue saw  101  is advanced, the substantially linear slit  122  will be enlarged to the cross-section  109  of shaft  105 . The tissue saw  101  has a cutting edge  120  which is pivoted back and forth using a driving mechanism such as cables  140  run in the shaft  105 . It should be understood that the cutting head  110 &#39;s coagulation mechanism of first cauterizing plate  133  and second cauterizing plate  135  could be replaced with other mechanisms known to those of ordinary skill in the art such as a laser coagulating strip, or a series of fiber optic parts for trailing coagulation. The tissue saw  101  enables the placement of the retaining sleeve  103 . The tissue saw  101  is then withdrawn (see FIG. 12) before the lesion  80  is encountered and the coring head  166  is preferably advanced (see FIG. 13) through the sleeve  103 . It should be understood that retaining sleeve  103  permits introduction of other excisional devices and/or other diagnostic tools in a minimally bleeding or bloodless field.  
     [0072] In particular, it should also be understood that the coring head  166  could instead be advanced around the exterior surface  104   b  of retaining sleeve  103  as opposed to through the interior of the retaining sleeve  103 . This is a less preferred embodiment, however, since the coring head  166  would then have to be rotated in its open position (see FIG. 11A) around the exterior surface  104   b  of the retaining sleeve  103  until it reached the distal end of the retaining sleeve  103 . This would be less preferred to some extent since the coring head  166  would be inducing further trauma to the tissue as it was rotated and sliced through the tissue that was formerly adjacent the slit  122 . However, such would not be unacceptable since coring head  166  also includes cauterizing elements or coagulating plates  175  and  185  on first cutting arm  170  and second cutting arm  180 , respectively. Thus, the goal of a minimally bleeding or bloodless field would still be achieved. Additionally, the exterior surface  104   b  of the retaining sleeve  103  would in this embodiment act as an armature or supporting framework which would prevent the first cutting arm  170  and second cutting arm  180  from moving to their closed position until the extended past the distal end of retaining sleeve  103 . This varies somewhat from the preferred embodiment in which a supporting skeleton or framework may be necessary at the distal end of the cylinder  160  around which the first cutting arm  170  and second cutting arm  180  are pivoted from their open position (see FIG. 11A) to their closed position (see FIG. 11B). It should also be understood that in some embodiments the cylinder itself will act as the armature supporting first cutting arm  170  and second cutting arm  180 .  
     [0073] The remainder of the description of the method of use will be directed to the more preferred embodiment in which the coring head  166  is inserted through the retaining sleeve  103  as opposed to around the exterior surface  104   b  of retaining sleeve  103 . It should be understood, however, that the less preferred embodiments and their variations are contemplated as within the scope of the invention and that the variations in the method of use between the below disclosure of the method of use for the most preferred embodiment and that for the less preferred embodiments will be readily apparent to those of ordinary skill in the art. At the end of the retaining sleeve  103 , the coring head  166  will encounter the tissue and will begin to rotate. The two cutting arms  170 ,  180  will cut a cylinder of tissue using the cutting surfaces  174 ,  184 , which preferably, but not necessarily include serrations, and as the first and second cutting arms  170 ,  180  are advanced and further rotated, the tissue will encounter the single external coagulating trailing plates  175 ,  185 .  
     [0074] The 90 degree arc cutting arms  170 ,  180  are opposite each other across the diameter  160   a  of the coring head  166 . As the coring head  166  is advanced beyond the lesion  80 , the cutting arms  170 ,  180  are rotated beyond the end of the cylinder  160  as the cylinder  160  is no longer advanced. The arms will cut a “dome” (see FIG. 14A) beyond the end of the lesion plug  80  producing a bullet-shaped specimen  81  (see FIG. 14B). The entire device, along with the specimen  81 , is withdrawn leaving a bullet-shaped coagulated cavity  82  and a coagulated collapsing slit  122  (see FIG. 15). It should be understood that the cutting arms  170 ,  180  may be rotated beyond the end of the cylinder by a variety of mechanisms. These mechanisms include such things as cables  190  and  191  attached near the pivoting ends of the respective cutting arms, or rods attached near the far ends of the respective arms to force them away from the distal end of the cylinder  160 . Additionally, further forces directing the cutting arms from the open to the closed position may be generated by the use of springs placed in between the interior surface of the pivoting end of the cutting arms and the exterior surface of the cylinder  160 .  
     [0075] With reference to FIG. 16, an alternative embodiment cutting head  210  is shown with like elements labeled as previously. Cutting head  210  has upper surface  232  and lower surface  234 . In this embodiment, after the tissue encounters cauterizing elements  233 ,  235 , it would then encounter a series of orifices  238  on the upper surface  232  and lower surface  234  of cutting head  210 . These orifices  238  provide an injection port for the injection of anti-cancer agents, blood coagulation materials, and perhaps even polymeric substances to allow for the slow and somewhat controlled release of anti-cancer agents. The anti-cancer agents may include standard chemotherapeutic agents such as anti-metabolites which interrupt cell division. The anti-cancer agents may also be more specific surface receptors known to those of ordinary skill in the art such as tamoxifen or monoclonal antibodies. A description of one combination of blood coagulation agent, anti-cancer agent, and polymers is found in U.S. Pat. No. 4,536,387 to Sakamoto et al. which is hereby incorporated by reference. Due to the extreme toxicity of some anti-cancer agents, the application of the anti-cancer agents is thus made directly to the tissue surrounding the area of the lesion to be excised.  
     [0076] With reference to FIGS. 17 and 18 there is illustrated another embodiment of the coring device of the present invention. A coring device includes a barrel or cylinder  260  extending along a first axis  259  about which it rotates. The barrel  260  extends along first axis  259  between proximal end  261  (not shown) and distal end  262 . The barrel  260  has an interior surface  263  and an exterior surface  264 . At the distal end  262  of barrel  260  is the coring head  266 . Coring head  266  includes first, second and third cutting arms  270 ,  280 ,  290  each having inner surfaces  271   a ,  281   a ,  291   a  and outer surfaces  271   b ,  281   b ,  291   b  extending between near ends  276 ,  286 ,  296  and far ends  277 ,  287 ,  297 , respectively. The far ends  277 ,  287 ,  297  of each cutting arm  270 ,  280 ,  290  having cutting tips  274 ,  284 ,  294  for severing the tissue as barrel  260  is rotated around first axis  259  and advanced along the first axis  259  toward the targeted tissue. Trailing the cutting tips  274 ,  284 ,  294  on the outer surface  271   b ,  281   b ,  291   b  of the cutting arms  270 ,  280 .  290  is a cauterizing element  275 ,  285 ,  295 . Each of the cutting arms  270 ,  280 ,  290  has a supporting armature  272 ,  282 ,  292  (not shown) to hold the respective cutting arms in the open position. As the cutting tips  274 ,  284 ,  294  and the rest of the arm is extended past the respective armature, the arms  270 ,  280 ,  290  will go from the open position (see FIGS. 17A and 17B) to the closed position (see FIGS. 18A and 18B). It should be understood that the presence of armatures  272 ,  282 ,  292  extending from the distal end  262  of barrel  260  is just one of many variations contemplated as within the scope of the invention. As previously mentioned, the exterior surface  264  of barrel  260  may also act as a supporting skeleton or framework for the respective arms, thus obviating the need for any separate armature. It should be further understood that the wide variety of mechanisms previously discussed for inducing the cutting arms to curve inwardly are equally applicable in the present embodiment.  
     [0077] The above described embodiments of a biopsy device are intended for use with the previously described embodiments of a lymphostatic breast stabilizing device, which fixes the breast in space using negative pressure, and allows anatomical access to all parts of the breast using an image guided targeting device. The various embodiments of the biopsy device allow accurate removal of tissue cores from the breast; up to several centimeters in diameter; in a bloodless field. Other advantageous features include precise removal of cylindrical or bullet-shaped portions of the breast by a combination of cutting strategies using a unique tissue saw and coring device.  
     [0078] While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiment has been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected.