Abstract:
A device and method for the obtaining a tissue biopsy and the delivery of a material to provide hemostatis, therapeutic agents or marker material is described that can be used in conjunction with either an aspiration biopsy or a cutting needle biopsy device. The device has an application chamber through which the biopsy mechanism, either a cutting needle device or aspiration needle, passes through. The mechanism for an aspiration biopsy has a biopsy cannula of constant cross section over its entire length connected to an aspiration and collecting chamber and at least one application channel of constant or varying cross section connected to a dispensing chamber integrally connected with the aspiration chamber. The cutting biopsy mechanism has a mechanical or electromechanical mechanism to rapidly fire a stylet with a biopsy trough into the intended tissue and then fire a biopsy cannula over the stylet to sever and retain tissue that has protruded into the biopsy trough. At least one application channel is formed by a tube centrically slipped over the biopsy cannula wall. To enable the collection of tissue specimens, the distal segment of the application channel forms a close fitting and concentric sheath around the biopsy cannula. The biopsy cannula wall projects out of the tube with its acute-angularly designed cutting edge and the tube end encloses an obtuse angle with the biopsy cannula. The proximal end of the application channel has a larger diameter than the distal end allowing for unobstructed flow of the application material past the biopsy cannula wall upon retraction of the biopsy cannula from the distal segment of the application channel. The versatility of the invention permits its use in many applications, including, for example, liver biopsies, breast biopsies, laparoscopic surgery, and lymphadenectomy procedures.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
       [0001]    The disclosed application is a conversion of, and takes benefit from, provisional Ser. No. 60/475,891 filed May 30, 2003 and provisional Ser. No. 60/475,891 filed Jun. 4, 2003 to a non-provisional file, the contents of which are incorporated herein as though recited in full. 
     
    
     
       FIELD OF THE INVENTION  
         [0002]    The present invention relates to a biopsy device that takes a biopsy sample of human or animal tissue and delivers a coagulant or other material to the biopsy incision track in order to plug the track and prevent bleeding as well as to provide a marker for future reference so that it can be located in a subsequent medical/surgical procedure.  
         BACKGROUND OF THE INVENTION  
         [0003]    In modem medical practice small tissue samples, known as biopsy specimens, are often removed from tumors, lesions, organs, muscles and other tissues of the body. Such removal of tissue samples can be accomplished by open surgical technique (i.e., removal of a small sample of tissue through a small surgical incision using a local anesthetic), or through the use of a specialized biopsy instrument such as a biopsy needle. After the tissue samples have been removed, they are typically subjected to diagnostic tests or examinations such as a) gross and microscopic examination to determine cytology and/or histology, b) biochemical analyses to determine the presence or absence of chemical substances which indicate certain disease states, c) microbiological culturing to determine the presence of bacteria or other microbes, and/or d) other diagnostic procedures. The information obtained from these diagnostic tests and/or examinations can then be used to make or confirm diagnoses and/or to formulate treatment plans for the patient.  
           [0004]    Special Considerations Relating to Biopsy and Plugging the Biopsy Track to Prevent Bleeding; Liver Biopsy  
           [0005]    Excision biopsy of the liver has traditionally been the gold standard for assessing the extent of injury and determining prognosis in chronic viral hepatitis and liver cancer. A significant complication that frequently occurs is bleeding from the biopsy site. Significant hemorrhage occurs in 0.35 to 0.5% of all procedures while evidence of sub-clinical bleeding, as detectable by ultrasound 24 hours post biopsy, has been reported in up to 23% of patients. A smaller amount of surface bleeding is almost universal and is frequently associated with mild to moderate pain.  
           [0006]    Excision biopsies from other organs, such as the lungs, also exhibit a relatively high complication rate due to hemorrhagic incidents and pneumothorax. Also with kidney biopsies and biopsies of other organs, perfuse bleeding is considered the most important complication.  
           [0007]    In order to prevent bleeding resulting from the biopsy, it has been proposed to plug the biopsy channel with a hemostatic agent. A typical haemostatic agent can be Gelfoam (Pharnacia &amp; Upjohn), Avitene (Davol, Inc), FloSeal (Fusion Medical Products) or other similar agent. The treatment of a biopsy track with an injectable absorbable coagulant to facilitate homeostasis in conjunction with procuring a biopsy provides substantial advantages in comfort over external pressure methods or the insertion of a pledget of Gelfoam foam as described in U.S. Pat. No. 6,086,607, which must be inserted through a catheter previously inserted. The insertion of a catheter involves a longer procedure and the risk of the catheter shifting while the operator switches or disconnects from the aspiration biopsy syringe to the coagulant delivery syringe. In addition, the present invention also provides advantages over the insertion of an absorbable sponge material in a dry state with an applicator. A dry piece of sponge material must be cut to the particular size of the biopsy track and does not swell to fill the track until the blood has sufficiently saturated the sponge material which can take significantly longer and provides inadequate local compression.  
           [0008]    Aspiration Technique  
           [0009]    The most common liver biopsy technique is by percutaneously inserting a needle into the liver for a fraction of a second and obtaining a tissue sample. The subsequent procedure for taking the biopsy varies according to whether the biopsy needle is of the aspiration or cutting type. The aspiration technique is probably the most widely used technique with the best known aspiration biopsy technique based on the principle indicated by Menghini. There a hollow needle having an average diameter of 1.4 mm and having a facility for attachment of a syringe is used, by which a negative pressure (suction) is applied upon piercing through the skin and prior to the organ puncture proper. The organ puncture (liver) then is realized with a sustained suction within a second.  
           [0010]    In order to obviate the reported complications, it was recommended to subsequently plug the needle track with resorbable material so as to eliminate, in particular, bleeding complications. Such techniques, however, imply a long residence time of the puncture needle in the organ, which again constitutes a cause of complications, in particular with liver punctures.  
           [0011]    From Austrian Pat. No. 384,165, a biopsy needle device of the initially defined kind is known, with which the cannula has a curved partition wall towards the internal limitation of the cannula lumina. Therein, the partition wall does not reach immediately to the front end of the cannula so that the biopsy channel and the application channel communicate in the region of the tip of the cannula. The multi-lumen biopsy device according to Austrian Pat. No. 384,165 enables the collection of tissue and the application of substances plugging the puncture track in coordination with the puncturing procedure in one operating cycle, thus largely shortening the time of intervention.  
           [0012]    U.S. Pat. No. 4,850,373 and related EP patents 243341 A, B1 etc., also describes a biopsy needle device having a two lumen cannula, a biopsy channel of constant cross section and one application channel. The application channel is formed by a tube eccentrically slipped over the biopsy channel wall. Furthermore, the biopsy channel is described as a non-circular tubular structure with its channel wall flattened in cross section such that an application channel is formed between the flattened side of the biopsy channel wall and the outer application tube. In addition, surface contact exists between the non-flattened side of the biopsy channel wall and the application tube.  
           [0013]    A common surgical material used to control bleeding is Gelfoam®, which is supplied in either a powder form or as an implantable sponge. Sterile sponges, such as Gelfoam®, are prepared in dry sterile sheets that are used as packing material during surgery for control of bleeding. The sponge sheets are left in the surgical site after surgery to stop bleeding and are absorbed by the body in 1 to 6 weeks. A number of techniques have used these absorbable sterile sponge materials to plug a biopsy track to minimize or prevent bleeding. The absorbable sponge provides a mechanical blockage of the track, encourages clotting, and minimizes bleeding though the biopsy track. Despite the advantages of using absorbable sponge to plug a biopsy track this technique has not achieved widespread use because of difficulty in preparing and delivering the sponge material into the biopsy track.  
           [0014]    One example of a biopsy wound closure device using an implantable sponge is described in U.S. Pat. No. 5,388,588. According to this patent, a circular sponge of an absorbable foam material is precut and inserted into a biopsy site by an applicator rod having the sponge positioned on the end. Once the sponge is implanted, the sponge absorbs blood and swells to fill the track preventing further bleeding at the biopsy site. However, the sponge is difficult to deliver and expands slowly once delivered. In addition, this delivery method can only deliver a sponge of a limited size that provides less local compression than desired and may incompletely fill the target site. Further, bleeding may continue along sections of the biopsy track where no sponge has been delivered.  
           [0015]    Another example of a Gelfoam® inserting device to facilitate hemostasis is described in U.S. Pat. No. 6,086,607. According to this patent, a method of cutting a piece of Gelfoam® sponge from a sheet of the material, folding the strip to form a pledget with one end of different cross section than the other end, and inserting the pledget in an adapter to compress the pledget and for attachment to a syringe for delivery of the pledget to the tissue. The adapter is attached to a cannula that was previously inserted into the organ being biopsied and the Gelfoam® is inserted into the tissue through the cannula.  
           [0016]    Cutting Needle Technique  
           [0017]    Many cutting biopsy surgical appliances are currently known. Typically, the instrument consists of a long, thin probe, termed a stylet, within a close-fitting hollow needle, termed a cannula. The stylet and cannula are contained within a firing device that first projects the stylet into the tissue, followed immediately by the cannula. The stylet has a notch into which tissue will prolapse when the stylet enters the tissue. As the cannula slides over the stylet, a small piece of tissue is then severed from the organ mass and captured within the notch of the stylet. The instrument is then withdrawn and the piece of tissue removed from the stylet for evaluation.  
           [0018]    Griffith, U.S. Pat. No. 3,477,423, was one of the first to describe an economical and simplified, biopsy needle device in which a cannula is projected forward over the stylet with a recessed collection notch such that the tissue within the notch is severed and retained within the cannula for retrieval. Improvements over the years have lead to single handed, semi automatic driving devices as described by U.S. Pat. No. 4,944,308, U.S. Pat. No. 5,368,045 and U.S. Pat. No. 5,951,489.  
           [0019]    Special Considerations Relating to Biopsy and Delivering a Marker Material: Breast Biopsy  
           [0020]    Breast cancer is presently the most common cancer in women and is the second leading cause of cancer deaths in women. Periodic physical and radiographic examination of the breasts (mammography) is important for early detection of potentially cancerous lesions in women over 40 years of age. In mammography, the breast is compressed between two plates while specialized x-ray images are taken. If an abnormal mass in the breast is found by physical examination or mammography, ultrasound may be used to determine whether the mass is a solid tumor or a fluid filled cyst. Cystic lesions are generally benign and the diagnosis of a cystic lesion is often confirmed by needle aspiration of fluid from the interior of the cyst and immediate diagnosis. However, solid masses are usually subjected to some type of tissue biopsy to determine if the mass is cancerous. This determination requires that the tissue be processed which may require 24 to 48 hours.  
           [0021]    Therefore in order to locate the site of the biopsy and cancerous tissue for removal or radiographic treatment at a subsequent procedure, the site is marked, either externally or internally, with a biopsy site marker. Various types of biopsy site markers have been known in the prior art. U.S. Pat. No. 2,192,270 (Carswell, Jr.) and U.S. Pat. No. 5,147,307 (Gluck) describes externally applied markers. Additionally, the prior surgical procedures have included radiographically visible markers that may be introduced into the biopsy site such as marker wires that are inserted through the biopsy needle after a tissue sample is removed and are thereafter allowed to remain protruding from the patient&#39;s body. U.S. Pat. No. 6,161,034 (Burbank) describes various chemical preparations and methods for marking biopsy sites which remain present and detectable for up to 5 to 8 months from the initial biopsy. A method for simultaneously taking the biopsy sample and delivering the marker material is not described.  
           [0022]    The disclosed device overcomes the forgoing problems by teaching the combination of the multi lumen, concentric needle device providing a biopsy channel and an application channel with a syringe assembly for obtaining the biopsy and delivering the application material. The prior art does not describe the combination of a cutting needle biopsy device with a syringe application device for delivery of the application material. In addition, the prior art does not describe an aspiration biopsy needle that translates within the application tube so that the application material will have an unobstructed passage into the biopsy track. The previous patents either describe the biopsy channel as being eccentrically positioned within the application tube as opposed to the disclosed concentric positioned biopsy or a separate device which delivers a hemostatic sponge or marking material to the biopsy track.  
         SUMMARY OF THE INVENTION  
         [0023]    The present invention provides a biopsy device with a view to enabling the collection of tissue specimens for biopsy and to apply auxiliary substances directly in the site of the puncture without tissue specimens getting into the application cannula, thus obstructing the same, or having to change instrumentation.  
           [0024]    In accordance with one aspect of the present invention, a syringe system comprised of a multi-chambered unit for taking the biopsy specimen and delivering a coagulating or marker material is described. The system includes a multi-syringed structure with at least one biopsy mechanism for obtaining a biopsy specimen either by using the aspiration needle technique, FIG. 1 or the cutting needle technique, FIG. 21.  
           [0025]    The disclosed device is formed by a syringe tube a and application channel formed by a tube of varying or constant cross section slipped over the biopsy mechanism channel wall. The biopsy mechanism is typically positioned within the plunger of the coagulant syringe  100  with the biopsy needle passing through the inner end of the plunger, the seal, coagulant chamber and the application channel. The application channel can also contain separate channels for fiber optic cables for the transmission of light or laser energy used in the photo initiation of delivered material.  
           [0026]    Using a commercially available biopsy device, a biopsy is achieved according to the invention in that after the tissue specimen is collected in the biopsy channel of the biopsy needle, the inner tube containing the tissue specimen is retracted within the concentric outer application tube thus allowing the application material to be injected into the biopsy track without obstruction. After obtaining a biopsy, the biopsy syringe is retracted within the application syringe plunger that is depressed by which the application material is expelled from the application chamber into the biopsy site. This may be facilitated according to the invention by a placing the biopsy device in another device that causes the translations and movements of the parts of the fore mentioned biopsy device. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0027]    [0027]FIG. 1 is an overall view of the assembled biopsy (aspiration syringe) device according to the invention.  
         [0028]    [0028]FIG. 2 is a section view of the application sheath;  
         [0029]    [0029]FIG. 3 is a section view of the application syringe body;  
         [0030]    [0030]FIG. 4 is a section view of the application plunger;  
         [0031]    [0031]FIG. 5 is a section view of the distal end of the application plunger  150  showing the plunger seal  
         [0032]    [0032]FIG. 6 is a section view of the aspiration needle;  
         [0033]    [0033]FIG. 7 is a section view of the aspiration syringe body;  
         [0034]    [0034]FIG. 8 is section view of the aspiration plunger;  
         [0035]    [0035]FIG. 9 is a section view of the distal end of plunger  250  showing the plunger seal;  
         [0036]    [0036]FIG. 10 is a section view of the assembled aspiration device after introduction through the chest wall of a patient and just penetration the organ to be biopsied;  
         [0037]    [0037]FIG. 11 is a section view of the device penetrating the organ and obtaining a biopsy specimen within the aspiration needle;  
         [0038]    [0038]FIG. 12 is a section view of the device after removal of the aspiration syringe and ejection of the application material into the biopsy track after taking a biopsy specimen;  
         [0039]    [0039]FIG. 13 is a section view of the application syringe being withdrawn and the application material being deposited within the biopsy track;  
         [0040]    [0040]FIG. 14 is an overall view of the cutting needle device;  
         [0041]    [0041]FIG. 15 is a section view of the cutting needle device in the “loaded” or “cocked” position;  
         [0042]    [0042]FIG. 16 is a detailed, section view of the distal end of the cutting needle device showing the trough formed within the stylet and sheath;  
         [0043]    [0043]FIG. 17 shows the cutting needle in the initial fired position whereby the stylet mechanism has been released by the button and is impacting the sheath holder. The distal end of the stylet is protruding out from the sheath;  
         [0044]    [0044]FIG. 18 shows a close up of the sectional view of the stylet mechanism striking the holding arms to disengage the holding arm from the cross arm to release the sheath mechanism;  
         [0045]    [0045]FIG. 19 is a cutaway view of the cutting device after the device has been activated such that the sheath has extended fully to enclose the specimen trough;  
         [0046]    [0046]FIG. 20 is a close up of the distal end of the cutting needle depicting a biopsy specimen retained within the specimen trough after the sheath was fired over the stylet;  
         [0047]    [0047]FIG. 21 shows the assembled cutting/application device containing the cutting biopsy device, the application syringe comprised of the syringe barrel, plunger and application cannula;  
         [0048]    [0048]FIG. 22 shows the application cannula comprised of the syringe hub for connecting to the syringe barrel using threaded connection or other customary means and a larger diameter sheath connecting to a smaller diameter sheath at a reducing point and ending at a tapered tip;  
         [0049]    [0049]FIG. 23 shows the application plunger comprised of a handle, a barrel and distal end on which a plunger seal is attached;  
         [0050]    [0050]FIG. 24 is a sectional view of the plunger;  
         [0051]    [0051]FIG. 25 is a sectional view of the complete device in the loaded position and inserted through the chest wall into an organ for a biopsy;  
         [0052]    [0052]FIG. 26 shows the stylet and stylet sheath passing through the application sheath and extending distally from the application sheath tip;  
         [0053]    [0053]FIG. 27 shows the complete device in the transition stage of activation whereby the stylet has advanced into the organ allowing the tissue to protrude into the trough;  
         [0054]    [0054]FIG. 28 is close up of the distal end of the complete device showing the extension of the stylet from the application sheath;  
         [0055]    [0055]FIG. 29 shows the complete device after the device has been fully activated and the stylet sheath has extended over the stylet and the specimen captured within the trough;  
         [0056]    [0056]FIG. 30 is a close up of the distal end of the device showing the extension of the stylet and sheath with the entrapped biopsy specimen;  
         [0057]    [0057]FIG. 31 shows the cutting device retracted from the application plunger resulting in the retraction of the stylet and stylet sheath from the biopsy tract;  
         [0058]    [0058]FIG. 32 is a close up of the application sheath showing the stylet and stylet sheath retracted past the application sheath restriction;  
         [0059]    [0059]FIG. 33 shows the injection of the application material into the biopsy tract by inserting the application plunger into the application syringe;  
         [0060]    [0060]FIG. 34 is a close up of the application sheath with the biopsy specimen enclosed within the stylet and stylet sheath after the application material has been deposited into the biopsy tract;  
         [0061]    [0061]FIG. 35 is a close up of the distal end of the biopsy device showing the single alignment track;  
         [0062]    [0062]FIG. 36 is an exploded view of an alternative catch and release mechanism for the stylet unit;  
         [0063]    [0063]FIG. 37 is a section view through the alternative catch and release mechanism.  
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0064]    The system of the present invention collects and retrieves a biopsy specimen and then delivers, with or without removal of the biopsy assembly, an application material to facilitate hemostasis of the biopsy track or other puncture wound in a simple and safe manner. The delivered application material can also be used to provide a marker for subsequent procedures such as radiation or surgical treatments. The apparatus for collecting the biopsy specimen and delivering a coagulant material will be described below in connection with procurement of a liver biopsy sample for the diagnosis of certain liver diseases. However, the invention can be used for the procurement of other biopsy specimens from other vascular organs as well as facilitating hemostasis of other types of puncture wounds or tissue access tracks to prevent bleeding of these wounds. The invention can also be used for the procurement of a biopsy specimen and the delivery of a marker, therapeutic or other substance into the biopsy site.  
         [0065]    The current means of obtaining a biopsy specimen from the liver are either using the aspiration technique or the cutting needle technique. The aspiration technique utilizes a common syringe and 15 to 18 gauge needle for obtaining the biopsy by the technique described by Menghini and Jamshidi. Briefly, the needle is inserted to the surface of the organ to be biopsied, penetrating slightly, suction is applied to the syringe and the needle is then advanced into the organ while maintaining suction. The needle is withdrawn from the body and the specimen flushed from the needle. In another means, a cutting needle is inserted into the organ and the mechanism activated causing a stylet with a specimen trough to penetrate deeper into the tissue. This is followed by a cutting sheath moving outward over the stylet to cut and entrap the tissue that had protruded into the trough. The needle is then withdrawn from the body and the specimen retrieved. A complication with either technique is that after removal of the biopsy device, the tissue bleeds from the resulting biopsy tract. In the liver, the biopsy site will typically bleed up to 5 minutes however, if a major artery within the liver is hit, the bleeding can be severe requiring immediate operative intervention. The invention described forthwith provides a means to take the biopsy specimen and deliver a haemostatic agent to minimize the bleeding from the biopsy tract.  
         [0066]    [0066]FIG. 1 illustrates the assembled aspiration biopsy device  10  of the invention including the application syringe assembly barrel  100 , application plunger  150 , biopsy syringe barrel  200 , biopsy plunger  250 , application sheath  130  and the distal tip of the aspiration needle  230  extending beyond the application sheath  130 . The individual components of the aspiration syringe are illustrated in FIGS. 2 through 9 and FIGS. 10 through 13 depicting the typical procedural steps of the application of the device in obtaining a biopsy.  
         [0067]    The apparatus of the first embodiment of the present invention is illustrated broken down into its individual parts in FIGS. 2-9. As seen in FIG. 2, the application sheath  130  consists of a cannula  132  having an application channel  133  with an open distal end  135  and proximal hub  131 . The proximal hub  131  is dimensioned for connection to the application syringe barrel  100  at the distal end connector  120  illustrated in FIG. 3. The application syringe assembly  100  shown in cross section in FIG. 3 has a cylindrical body  105  terminating at a truncated distal end wall  108  integral with a distal connector hub  120 . The proximal end of the application syringe assembly  100  has optional finger grips  106  and lip  107  for ease of use.  
         [0068]    The syringe plunger  150  of FIG. 4 is a tubular structure with cylindrical walls  152  terminating at an end wall  158 . The end wall  158 , as seen in detail in FIG. 5, contains a central opening  159  and an attachment member  153  for attaching a rubber plunger  175 . The central opening  159  of the disclosed plunger  150  is dimensioned to receive the biopsy needle  230  without binding while preventing excessive movement. Although the illustration of FIG. 5 shows the rubber plunger  175  overlapping the T-shaped attachment member  153 , other methods of affixing the rubber plunger  175 , or its equivalent, can be use and will be known to those skilled in the art. The plunger  150  is dimensioned to fit into the proximal end of the cylindrical body  100  to establish a fluid seal at the juncture  178  of the plunger  175  and the interior wall  112  of the cylindrical body  105 . The plunger  175  has a fluid-chamber face  177 , as illustrated in FIG. 5, that establishes a fluid chamber  110  within the syringe barrel  100 . Once the biopsy syringe unit, illustrated hereinafter, is inserted into the plunger  150 , the biopsy needle  230 , of FIG. 6, passes through the fluid chamber  110  and central opening  159 , piercing the rubber plunger  175 . FIGS. 6-9 exemplifies the biopsy syringe unit consisting of the biopsy needle  230 , the plunger  250 , and the syringe barrel  200 . The biopsy needle  230  is a long cannula  233  with an interior space  235 . The distal tip  234  of the cannula  233  is typically cut at an acute angle and an attachment hub  232  at the proximal end is dimensioned for attachment to the syringe barrel  200  at the distal connector hub  220 . The biopsy syringe barrel  200 , FIG. 7, is typically of a cylindrical structure with walls  205  terminating at the distal wall  214  to form the connecting hub  220  and interior channel  209 . The proximal end  207  and interior are dimensioned to receive the biopsy piston  250 . The biopsy piston  250  preferably has a distal finger grip end  251 , a central body  252  and a distal end  255  for attachment of a rubber plunger  275 . The piston  250  after having been fitted into the proximal end  207  of the cylindrical syringe barrel  200  establishes a fluid seal at the juncture of cylindrical side  278  of the plunger  275  and the interior wall  212  of the cylindrical body  205 . The distal end  255  of the plunger  275 , FIG. 9, has a fluid-chamber face  277  that establishes a fluid chamber  210  within syringe barrel  200 .  
         [0069]    The outer diameter of the syringe needle  233  is substantially smaller than the diameter of the central opening  159  of plunger  150  to enable the biopsy needle  233  to penetrate and pass through the plunger  175  This creates a slidable fluid seal at the juncture between the plunger  175  and the outer diameter of the needle  230 . The outer diameter of the biopsy needle  230  is sufficiently less than the inner diameter of the cannula  132  of the application sheath  130  to enable the biopsy needle  230  to so as to pass through the cannula  132  unobstructed  
         [0070]    The functional and operative position of the syringe apparatus is shown in FIGS. 10 through 13 for a liver biopsy using a coagulant application material. A user-defined volume of coagulant  115 , which will be evident to those skilled in the art, is drawn up into the fluid chamber  110  using customary techniques. Likewise, a suitable volume of sterile saline  215  or other fluid is drawn up into the fluid cavity  210  of the biopsy syringe assembly. The apparatus is assembled by inserting the biopsy syringe assembly into the cavity  155  of the application plunger  150  such that the needle  233  passes through the opening  159 , plunger  175 , the plunger fluid chamber  110 , opening  109 , and application cannula  130  resulting in the biopsy tip  234  protruding past the cannula end  134 .  
         [0071]    A suitable spot is identified on the patient and the needle inserted through the chest wall  50  until the capsule of the organ  60  to be biopsied is felt or identified by ultrasound or other means. The assembly is retracted slightly and the biopsy needle  230  flushed with the saline  215  and then inserted into the organ  60 , FIG. 10. The biopsy piston  250  is withdrawn slightly creating a negative pressure on the tissue sample within the needle  235 . While maintaining the negative pressure, the needle  230  and cannula  132  are advanced into the tissue an appropriate distance, FIG. 11. The biopsy assembly is withdrawn from the application syringe  105  while leaving the application cannula  132  in the biopsy tract  65 , FIG. 12. Once the biopsy assembly is withdrawn, the application plunger  150  is depressed injecting the application material  115  into the biopsy track  65  as the cannula tip  134  is withdrawn, FIG. 13.  
         [0072]    An alternative method of obtaining a biopsy specimen is the use of a cutting needle biopsy device. FIG. 14 illustrates the assembled cutting device  1000  of another embodiment of the invention. In the illustrated embodiment, the cutting biopsy device  1000  is comprised of a firing mechanism assembly comprising outer cases  420  and  450 , which can be separated by a center connecting section  440 . The outer cases can also be a single cylindrical unit with the locking components within the case. The proximal end unit  500  contains a movable release unit  550  that, as illustrated in more detail in FIGS. 15 and 16 and described in more detail hereinafter, interacts with the cutting system. Within the outer cases  420  and  450  are internal springs  775  and  875 , which apply pressure against the stylet units  700  and  800 . A distal end unit  600  connects an outer cannula  850 , and a stylet  750  to the stylet units  700  and  800 . As with standard cutting biopsy devices, the stylet  750  of the biopsy device  1000  has a specimen trough  775  to catch and retain the tissue specimen after the cannula  850  is rapidly slid over the stylet  750 .  
         [0073]    The principle of operation of the assembly is exemplified in FIGS. 15 through 20. As shown in FIG. 14, the distal end unit  600  contains a track  610  for alignment with a pin  970  within the plunger  950 , as illustrated in FIGS. 23 and 24. The pin  970  must be dimensioned to interact with the track  610 . The track  610  begins at the distal end of the distal end unit  600  and proceeds proximally and longitudinally for a prescribed distance A. Once the prescribed distance A is reached, a first, circumferential track  612  is reached which extends around the end unit  600  180 degrees to allow for rotation of the biopsy device  1000  relative to the plunger  950 . To fully insert the biopsy device  1000  further into the plunger  950 , the device  1000  is rotated  90  degrees from track  610  to place the pin  970  back into alignment with the track  610 ′ and the device  1000  inserted in the plunger  950 . Once the biopsy device  1000  is fully inserted, the device  1000  is rotated to place the pin  970  into the proximal, second circumferential track  614  at a prescribed distance B from track  612 . The distances A and B are critical to the operation of the disclosed device. When the pin  970  is positioned in the second circumferential track  614 , the biopsy device  1000  is in the ready to use position. When the biopsy device  1000  is loaded and ready to use, the pin  970  is placed and rotated fully in the proximal, second circumferential track  614 . When in this position, the stylet tip  752  and cannula tip  852  are protruding from the distal tip  921  of the cannula  920 . The distance of A and B is approximately equal to the distance C from the distal end  175  of the plunger  950  to the distal tip  921  when the coagulant sheath  920  is properly attached to the syringe  100  with the proper amount of coagulant material  115  drawn into the syringe chamber  110 .  
         [0074]    The second track  614  permits the biopsy device  1000  to be locked in position in order to deliver the coagulant contained in the syringe assembly  100 . By locking the biopsy device  100  into position, the user can inject the coagulant without removing the device  1000 . To permit the coagulant to flow through the concentric cannula  924 , the stylet  750  when in the fired position must be withdrawn past the transition segment  923  plus a distance greater than the distance the rubber seal  175  of plunger  950  is from the distal end  108  of the syringe chamber  110 , as shown in FIG. 32. Since the stylet  750  moves with the plunger  950 , the stylet  750  must remain clear of the transition segment  923  upon the completion of the coagulant injection, as seen in FIG. 34. If the stylet  750  is within the distal segment  922 , the coagulant will be prevented from being ejected.  
         [0075]    Alternatively, distal end unit  610 ′, FIG. 35 can contain only one longitudinal track  610 ″ and one circumferential track  612 ′ located at a distance D approximately equal to the length A+B at which point the biopsy device would need to be totally removed from plunger  950  prior to inserting the coagulant  115 . Additionally, markers, such as digital readouts or actual marks on the biopsy device or distal end unit, can be used on the biopsy device to indicated how far to remove the device to enable the coagulant to flow around the stylet.  
         [0076]    The biopsy device as shown in FIG. 15 is in the armed, or ready to use, position whereby the stylet unit  700  is retracted by pulling back, either manually or automatically using an automated device, on pull tabs  705  and  705 ′ towards the end cap  500  compressing the spring  775  to provide the releasable energy to propel the stylet  750  forward into the organ to take the biopsy. Likewise, the cannula unit  800  is retracted by pulling either manually or automatically using an automated device, on pull tabs  805  and  805 ′ towards the crossbar  445  such that the latch fingers  825  and  825 ′ catch on the crossbar  445  preventing the releasable energy of compressed spring  875  from propelling the cannula unit  800  forward.  
         [0077]    [0077]FIG. 16 details the proximal release mechanism of the device. The flange  553  of release unit  550  catches the latch fingers  726  and  726 ′ of latch arms  725  and  725 ′, respectively, of the stylet unit  700 . The latch fingers  726  and  726 ′ prevent the stylet unit  700  from being released when the slide  551  and flange  553  of the release unit  550  are inserted in the slot  503  of the end cap  500 . Once in place, the release unit  550  is held in place within the end cap  500  through the use of a pin  525 . The pin  525  passes through the end cap hole  502 , slot  551  of the release unit  550  and into the hole  502 ′. The pin  525  prevents the release unit  550  from escaping the end cap  500  due to the spring  760  that maintains the slide  550  in the closed position. When the release unit  550  is manually or by other means depressed, the latch fingers  726 ,  726 ′ are released from contact with the flange  553  through slots  552  and  552 ′, respectively. The stored energy in spring  775  propels the stylet unit  700  within the case  420  until the front section  715  of holder  710  impacts the latch fingers  825 ,  825 ′ of the stylet sheath unit  800  such that the stylet trough  775  is extended beyond the distal end of the stylet sheath  850 . This is seen in FIGS. 17 and 18 which detail the catch and release mechanism of the stylet sheath unit  800 ., Upon impact of the front section  715  with the incline surfaces  826  and  826 ′ of latch fingers  825  and  825 ′, the front section  715  forces the latch fingers  825  and  825 ′ to translate outward due to the incline surfaces  826  and  826 ′, respectively. With translation past the width of the crossbar  445 , the releasable energy of spring  875  is transferred to kinetic energy and movement of the stylet sheath unit  800  with attached sheath  850  until the front end  815  strikes the distal end unit  600 . The stylet sheath unit  800  is translated in a rapid manner distally, as seen in FIG. 19, such that the distal end of sheath  850  cuts the tissue  900  protruding from the trough  775  of stylet  750 , FIG. 20, thereby enclosing the tissue specimen.  
         [0078]    An alternative catch and release mechanism is shown in FIGS. 36 and 37. In this alternative, the stylet unit  780  provides adjustability for longitudinal positioning of the stylet  750 . The stylet is securely positioned in a screw  790  which is longitudinally inserted in the central distal end  782  of unit  780 . Pull tabs  785 ,  785 ′ are secured laterally to unit  780 . On the proximal end of unit  780 , the catch rod  580  is inserted. The catch rod  580  has a threaded segment  582  that inserts centrally in unit  780  and a catch knob  586  that is restrained by slider  565  after passing through openings  575  of the spacer  570  and circular opening  567  of segment  569  of slider  565  when manually or automatically depressed through opening  562  of end unit  560 . When the slider  560  is released, the internal energy of spring  570  forces the slider  560  laterally and entraps the catch knob  586  by means of slot  566  which is of smaller width than the catch knob  586  but greater than the width of catch segment  584 . The inclined surface  575  of spacer  570  provides alignment for the catch rod  580  when inserted into the slider  565  and slot  572  provides restraint for slider  560 . Screw  595  fastens spacer  570  to end unit  560  after passing through slot  568  thus restraining the lateral movement of slider  565  due to spring  564 . Other catch and release mechanisms, as apparent to those in the art, can be employed to employ the operation of the stylet  750  and stylet sheath  850  to obtain a biopsy specimen.  
         [0079]    [0079]FIG. 21 exemplifies the assembled cutting needle/coagulant hemostatic biopsy device incorporating a cutting needle biopsy device  1000  with the delivery syringe  100 , plunger  950  and application cannula  920 . The application cannula  920 , FIG. 22, is connected to the delivery syringe via a threaded or other customary connector on the proximal end of the attachment hub  927 . A generally concentric cannula  924  of sufficient length and diameter extends distally from the hub  927 . At an appropriate distance the cannula is reduced in diameter at a transition segment  923  to a small diameter distal segment  922  ending in a tapered or beveled tip  921 . The internal diameter of the distal segment  921  is dimensioned to permit frictionless passage of the outer cannula  850 , while at the same time preventing side-to-side movement.  
         [0080]    As seen in more detail in FIGS. 23 and 24, the application plunger  950  is a hollow cylindrical structure  960  having an interior cavity  962 , a handle  955  and a distal end  966  for attachment of a plunger seal  175  and central passageway  964 . The plunger  950  has an alignment pin  970  inserted through the wall of the structure  960  for mating with the alignment tract  610  to control the displacement of the cutting needle device  1000  relative to the application delivery assembly. The distal end  965  of interior cavity  962  can be tapered to facilitate the insertion of the stylet tip  752  during assembly. The plunger  950  has an optional depth stop  958  to prevent the inadvertent insertion of the plunger  950  into the application syringe  100  but still allow plunger insertion when required. The depth stop  958  is preferably manufactured from a compressible material and has a diameter slightly larger than that of the proximal end of the application syringe  100 . The material should have resistance to insertion into the application syringe but, with pressure, have the ability to compress sufficiently to permit insertion.  
         [0081]    The operation of the invention with respect to the cutting needle is described FIGS. 25 through 34 which are sectional views of the assembled device of FIG. 21.  
         [0082]    The functional and operative position of the cutting/syringe apparatus is shown in FIGS. 25 through 34 for a liver biopsy with a coagulant application material. A user-defined volume of coagulant  115  is drawn up into the fluid chamber  110  (FIG. 11) using customary techniques. The cutting biopsy device  1000  is armed to take a biopsy and inserted into the application assembly  950 . The stylet and cannula are inserted from the distal end of the plunger  950  through the cavity  962  (FIG. 24) of the application piston  950  such that the pin  970  follows the alignment track  610  (FIG. 19) and the stylet  750  and sheath  850  (FIG. 20) passes through the opening  964 , the plunger seal  175  (FIG. 24), the plunger fluid chamber  110  (FIG. 3), the delivery material  115 , opening  109  (FIG. 3) and the application cannula  920  such that the stylet tip  752  and sheath tip  852  protrudes past the cannula end  921 . At this point the stylet tip  752  and stylet sheath tip  852  are extended beyond the distal tip of the application cannula  921 , FIG. 26, and are penetrating the organ  60  to be biopsied, FIG. 25. The firing button  550  (FIG. 19) is depressed releasing the stylet  700  mechanism as described previously. As the stylet  750  enters the tissue, it causes the tissue to be locally compressed. The tissue then expands and fills the trough  775  distal to the stylet 750 . The stylet holder  700  releases the stylet sheath  800  (FIG. 19) from the catch bar  445  (FIG. 18) and is rapidly propelled forward over the stylet  750 , as illustrated in FIG. 29. The tissue  900  within the trough  775  is severed and captured by the outer cannula  850 , FIG. 30. The cutting device  1000  is rotated and retracted to the intermediate position relative to the plunger  950  using the alignment track  610  as shown in FIG. 31. This intermediate position places the stylet tip  752  of the stylet  750  proximal to the restriction  923  of the application cannula  920 , FIG. 32, insuring adequate space between the outer surface of outer cannula  850  and the inner surface of the application cannula  924  for flow of the delivery material  115  through the application cannula  920  when the plunger  950  is depressed into the syringe  100 , FIG. 33. The delivery material  115  is then delivered into the biopsy track  65 . The biopsy device is removed from the patient, FIG. 34, with the biopsy specimen  900  in the enclosed sheaths. The cutting assembly  1000  is removed and the biopsy specimen  900  retrieved for histological evaluation.  
         [0083]    As describe above, the application material can be delivered to the biopsy track through manual operation of the device or the device can be placed in an instrument that automatically manipulates the device to accomplish the required operations.  
         [0084]    As described above, the application material can be delivered to the biopsy track by holding the needle sheath  130  stationary and injecting the coagulant through the inner channel  133 . According to an alternative embodiment of the invention, the method of delivering the coagulant into the biopsy track can include withdrawing the needle sheath  130  during delivery of the coagulant in an elongated trail that follows the biopsy track. This technique places the absorbable coagulant material in a trail that fills the entire biopsy track and provides the added benefit of providing hemostasis along the entire biopsy track. This is particularly helpful for stopping the bleeding of biopsy tracks in organs that tend to have excessive bleeding such as the liver, kidney, spleen, and other vascular organs.  
         [0085]    The device can also be used to deliver a beneficial agent, such as contrast agent, thrombin, radiation treatment, or the like. The applicant material can also be used to deliver therapeutic agents, such as radioactive isotopes for localized treatment of tumors, anti-cancer agents, anti-metastatic agents, and the like. Examples of anti-cancer agents include 5-fluorouracil, cisplatin, prednisone, and others described in U.S. Pat. No.  4 , 619 , 913 , which is incorporated herein by reference.  
         [0086]    The present invention can be employed to deliver other materials other than coagulant material into a biopsy track or used to drain and fill an abscess.  
         [0087]    While the invention has been described in detail with reference to the preferred embodiments thereof, it will be apparent to one skilled in the art that various changes and modifications can be made and equivalents employed, without departing from the present invention.