Patent Publication Number: US-8114105-B2

Title: Instrument for surgically cutting tissue and method of use

Description:
This application is a continuation of U.S. patent application Ser. No. 10/365,809, filed Feb. 13, 2003, now U.S. Pat. No. 7,481,817. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to an instrument (and method) for surgical cutting of tissue in the body of a patient, and in particular, to remote surgical cutting of tissue in the body of a patient to a precise length, width, and depth, and overall shape. The invention is useful for surgical removal of tissue from a site in the body of a patient, including, the lining of tubular structures, such as the gastrointestinal tract (e.g., the esophagus or stomach), urinary tract, or vascular structures, but may also be used to remove tissue from any tissue surface (e.g., surface of the liver, lining of the peritoneal cavity), or within soft tissue structures (e.g., from within breast or brain tissue). 
     BACKGROUND OF THE INVENTION 
     A need exists for an improved surgical instrument to enable safe and efficacious removal of living tissue during diagnostic and therapeutic medical interventions. While instruments have been designed with simple blades and rotors for cutting or chopping tissue, they do not provide precision removal of a tissue specimen of a predetermined length, width and depth. It is also difficult for such instruments to harvest tissue from a patient under realistic clinical conditions and to safely access remote locations in the patient. Further, such instruments lack the capability to effect separation of tissue planes at a site prior to tissue removal, or to deliver therapeutic agents to tissue. For example, devices for removal of arterial blockage, often called artherectomy catheters, have distal ends with cutting blades of various types, such as longitudinal, helical, or circular cup-shaped blades. Often such blades are presented through opening(s) at the distal end of the devices. Examples of artherectomy catheters may be found in U.S. Pat. No. 4,979,951, 5,074,841, or 5,643,296. Other surgical cutting device, such as useful in endoscopic bone surgery, have helical shaped rotatory cutters extending in through a tube having multiple openings to receive tissue, such as described in U.S. Pat. No. 4,867,157. Although such devices may be useful for their particular limited applications, they do not generally control for precise tissue sample size or cutting depth, mechanical tissue engagement, preservation of biopsy specimen for subsequent examination, or injectable fluid delivery. 
     One application for removal of tissue relates to the esophagus, and in particular Barrett&#39;s esophagus, a disease associated with GERD or gastroesophageal reflux disease representing a precancerous condition of the mucosal lining the esophagus. It is important that in diagnosing Barrett&#39;s esophagus, cancer, or other abnormality in the esophageal lining, that a biopsy be taken for examination. Currently, a flexible endoscope or gastroscope is used to locate the suspected tissue in the esophagus. Through a narrow (1 to 3 mm) channel in the endoscope, long, thin biopsy forceps (typically two sharp edged hemispheres that close onto each other) are passed and used to engage and collect few small bites of the tissue at different esophageal locations. Accurate forceps placement remains problematic as does frequent bleeding at the biopsy site, further obscuring accurate tissue harvest. As such imprecise biopsy forceps sampling may miss diseased tissue, it would be desirable to obtain a larger, well controlled specimen of tissue from the esophagus, thereby reducing the risk of misdiagnosis. 
     The physical location of such tissue in the esophagus makes alternative non-invasive medical intervention along the gastrointestinal tract difficult. One approach is to inject saline submucosally using a flexible endoscope, and then a snare to capture an area of tissue. However, this approach may be limited to capturing nodular areas, rather than a long segment of the esophageal lining. A further approach described in U.S. Published Patent Application No. 2001/0049509, filed Dec. 6, 2001, provides an endoscopic treatment system for treating and removal of mucosal lining from the esophagus by tools extending through endoscopic channels, such as a syringe needle for localized injections of the mucous membrane, forceps for gripping mucous membrane, and knives(s) for peeling or cutting off the mucous membrane. 
     Like other surgical cutting instruments described earlier, it is difficult using these approaches to remove tissue to precisely control the cutting depth into the esophageal lining, which can result in inadequate removal of mucous membrane or inadvertent removal of sub-mucosal layers leading to possible esophageal wall perforation. Further in the case of U.S. Published Patent Application No. 2001/0049509, the use of forceps and knifes represents a manual time consuming process prone to human error. A further problem of these approaches is that if the wound in the esophageal lining is to be closed, such as by suturing (i.e., stitches) or other closure devices, there may not be proper tissue edges on either side of the wound to appose, resulting in failure of stitches or tearing of stitches through the tissue, and may lead to failure of primary healing. Thus, it would further be desirable to remove tissue from the lining of the esophagus with a single instrument enabling remote location in the esophagus with precise control of the cutting shape and depth, and moreover can provide tissue edges on either side of the resulting wound that can be well apposed for primary closure of the wound site. Such proper apposition of tissue edges is necessary when a wound is closed to induce primary healing, and thereby rapidly provide a strong more durable wound closure than where accurate wound edge apposition is not present. Such wound closure in tubular structures having mucosal lining is especially difficult due to the slippery nature of such tissue, thus, it would still further be desirable to stabilize the tissue prior to being cut. 
     SUMMARY OF THE INVENTION 
     Accordingly, it is a principal object of the present invention to provide an instrument for surgically cutting tissue enabling control removal of a specific dimensions and volume (i.e., length, width, depth, and shape) of tissue in the body of a patient. 
     It is another object of the present invention to provide an instrument for surgically cutting tissue at remote sites in tubular structures, such as the esophagus, stomach, urinary tract, or vascular structures, or from any tissue surface or soft tissue in a patient&#39;s body which is naturally or surgically accessible. 
     It is another object of the present invention to provide an instrument for surgically cutting tissue which enables large tissue biopsies to be taken at a certain depth to facilitate diagnosis of possible abnormal tissue. 
     A further object of the present invention is to provide an instrument for surgically cutting tissue in which the shape of the cut in the tissue facilitates accurate apposition of the edges of the tissue for wound closure which promotes primary healing. 
     It is another object of the present invention to provide an instrument for surgically cutting tissue which mechanically holds the tissue to be cut by suction and needles upon a tissue engaging surface at the instrument&#39;s distal end. 
     A yet further object of the present invention is to provide an instrument for surgically cutting tissue and enabling the infusion of a fluid which promotes separation of the tissue layers. 
     A still further object of the present invention is to provide an instrument for surgically cutting tissue and enabling the infusion of a fluid which provides therapeutic or pharmaceutical agents (e.g., epinephrine for hemostasis and/or lidocaine for local analgesic). 
     Another further object of the present invention is to provide an instrument for surgically cutting tissue of the body having a substantially flexible shaft with a distal end locatable at remote sites of the body (e.g., within the gastrointestinal tract, peritoneal cavity, breast or brain) in which instrument is remotely controlled. 
     Briefly described, the present invention embodies an instrument for the precise surgical cutting of tissue to remove a predetermined length, width, depth, and shape of tissue at a site in a patient&#39;s body. The instrument has a housing at its proximal end and a substantially flexible shaft extending from the housing to a distal end. The distal end has an opening to a cavity into which tissue is receivable. Suction can be communicated from a port along the shaft to the distal end for distribution in the cavity utilizing a manifold member having a tissue engaging surface with sufficient openings distributing the suction across the cavity, thereby pulling tissue adjacent the distal end into the cavity against the tissue engaging surface of the manifold member. One or more hollow needles are extendable from the housing through the shaft into the cavity to assist in stabilization of tissue and the delivery or infusion of fluid, such as saline and/or therapeutic or pharmacological agents, to tissue located therein. A blade in the distal end is extendable over the manifold member, through the cavity, and across the opening thereto, to cut the tissue located in the cavity held by suction and stabilized by needles against the tissue engaging surface. The depth of the tissue cut is in accordance with the contour of the tissue engaging surface in the cavity and size of the cavity. Dimensions of length, width, and overall shape of the tissue cut are in accordance with the size and shape of the cavity at the distal end and contour of the tissue engaging surface. 
     The tissue so removed by the instrument may represent a tissue specimen for biopsy for subsequent diagnostic evaluation (e.g., histologic review). If the entire pathologic element of the tissue sample is completely removed by one or repeated use of the instrument, the process may be considered therapeutic and no further patient interaction may be required. When appropriate, resulting wound edges at the site of the removed tissue can be apposed to further augment healing of the wound closure. 
     The blade may represent a rotatable tubular blade or an oscillating blade member translatable in the distal end sufficient to cut the tissue extending therein across the opening to the cavity. The application (or removal) of suction, translation (forward or backward) of the blade, extension (or retraction) of needles, and delivery of fluid via such needles, are each independently and remotely controlled at the proximal end of the instrument. 
     The invention also provides a method for cutting for removal of tissue from a patient&#39;s body. The method includes: locating the distal end of the instrument in a patient&#39;s body adjacent the tissue to be cut (or removed); providing suction to pull tissue via the opening at the distal end into the cavity of the distal end against a tissue engaging surface having slots for distribution of the suction; partially extending one or more hollow needles through the cavity in the tissue therein; delivering pressurized fluid through the needles into such tissue sufficient for tissue plane separations; fully extending the needles through the cavity; and then cutting the tissue in the cavity adjacent the opening. The cut tissue represents a tissue specimen that may be removed from the distal end by retracting the blade and needles, and removal of suction, to release the tissue. Removal of tissue may occur while the distal end is in the patient body, or after removal of the instrument from the patient&#39;s body. The method may be repeated to remove multiple tissue samples with the same instrument. 
     The instrument may be located into the patient&#39;s body, such as in a tubular structure, via an accessory tube coupled to an endoscope, a channel of an endoscope, or may be coupled along its shaft by guide members to the shaft of an endoscope. The instrument may be used without an endoscope, and may optionally include a system for optical or ultrasonic imaging, or other imaging modalities, to obtain images at its distal end for use in locating tissue to be removed by the instrument and observing instrument operation. Further, an optional mechanism for steering the distal end from the housing of the instrument may be provided. 
     Thus, the instrument of the present invention provides precision removal of tissue of a predetermined depth and volume (length, width, and height). A mechanical means securely gain purchase on targeted tissue and appropriately hold it throughout the removal process, such as is provided herein with the vacuum (suction), needle and blade combination, enables effective tissue capture and retrieval at more remote locations within the body and without requiring direct manual manipulation by a health care provider, such as a surgeon. The use of needles for the remote injection of mixtures of sterile fluids, not only provides for a convenient and reliable way of delivering soluble pharmaceutical agents (such as epinephrine, a hemostatic agent, to control blood loss, and lidocaine, a local anesthetic, to minimize related discomfort), it also provides for accurate bulk fluid delivery (e.g., a normal saline carrier) to enable mechanical tissue plane separations using pressurized fluid volume injections. Further, the instrument is useful for removing tissue from specified locations in tubular structures, such as in the gastrointestinal or urinary tract, or vascular structures of a patient, or in any other tissue surface or soft tissue in a patient&#39;s body which is naturally or surgically accessible. Also, the instrument enables large specimen harvest and more complete removal of intact tissue specimens which can provide therapeutic relief. The instrument and method addresses a persistent problem by enabling precision tissue removal with minimizing patient morbidity while maximizing the health care provider&#39;s effectiveness. 
     The instrument may also be used for incising tissue to a controlled length and depth by replacing the tubular or oscillating blade with a linear blade translatable across cavity in the distal end of the instrument. The linear blade provides a longitudinal cut in tissue engaged against the manifold member. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The foregoing objects, features and advantages of the invention will become more apparent from a reading of the following description in connection with the accompanying drawings, in which: 
         FIG. 1  is a perspective view of the instrument of the present invention; 
         FIG. 2  is a perspective view of the instrument of  FIG. 1  when inserted in an accessory tube coupled to the shaft of a flexible endoscope; 
         FIG. 2A  is a partial view of distal end of shaft of the endoscope of  FIG. 2  showing the attachment of a tube guide to the endoscope and the distal end of the instrument of  FIG. 1 ; 
         FIG. 3  is a side view of the instrument of  FIG. 1 ; 
         FIG. 4  is an exploded perspective view of the instrument of  FIG. 1  in which the right cover of the housing is removed; 
         FIG. 5  is a detailed perspective view of the part of the instrument showing the adapter, needle spreader, and gasket member of the instrument of  FIG. 1 ; 
         FIG. 5A  is a cross-sectional view through lines  5 A- 5 A of  FIG. 5  showing the gasket member of the instrument of  FIG. 1  without drive tube or needle tubes; 
         FIG. 5B  is an end view of the gasket member of  FIG. 5  without drive tube or needle tubes; 
         FIG. 6  is a cross-sectional view along lines  6 - 6  of the instrument of  FIG. 3 ; 
         FIG. 7  is a cross-sectional view along lines  7 - 7  of the instrument of  FIG. 3 ; 
         FIG. 8  is a cross-sectional view along lines  8 - 8  of the instrument of  FIG. 3 ; 
         FIG. 9  is a cross-sectional view along lines  9 - 9  of the instrument of  FIG. 3 ; 
         FIG. 10  is a cross-sectional view along lines  10 - 10  of the instrument of  FIG. 3 ; 
         FIG. 11  is a cross-sectional view along lines  11 - 11  of the instrument of  FIG. 3 ; 
         FIG. 12  is a cross-sectional view along lines  12 - 12  of the instrument of  FIG. 3 ; 
         FIG. 13  is a cross-sectional view along lines  13 - 13  of the instrument of  FIG. 3 ; 
         FIG. 14  is a cross-sectional view along lines  14 - 14  of the instrument of  FIG. 3 ; 
         FIG. 15  is a cross-sectional view along lines  15 - 15  of the instrument of  FIG. 3 ; 
         FIG. 16  is a cross-sectional view along lines  16 - 16  of the instrument of  FIG. 3 ; 
         FIG. 17  is an exploded view of the distal end of the instrument of  FIG. 1 ; 
         FIG. 17A  is a broken view of the assembled distal end of the instrument of  FIG. 1 ; 
         FIG. 17B  is a broken view of the assembled distal end of the instrument of  FIG. 1  from a different perspective than of  FIG. 17A ; 
         FIG. 18  is a partial detailed view of the vacuum assembly mounted on the shaft of the instrument of  FIG. 1 ; 
         FIG. 19  is a cross-sectional view along lines  19 - 19  of  FIG. 18 ; 
         FIG. 20  is a cross-sectional view along lines  20 - 20  of  FIG. 19 ; 
         FIGS. 21 and 22  illustrate the operation of the instrument of  FIG. 1  to communicate suction to its distal end; 
         FIG. 23  is an exploded view of components of the instrument of  FIG. 1  showing the path of fluid through needles to the distal end of the instrument; 
         FIGS. 24 ,  25 , and  26  are side views of the instrument of  FIG. 1  illustrating the operation of the instrument for infusion fluid at its distal end and the use of needles and to enhance tissue stabilization at the instrument&#39;s cavity; 
         FIG. 27  is a side view of components of the instrument of  FIG. 1  for driving and retracting a cutting blade at the distal end of the instrument; 
         FIG. 28  is an exploded view of components of the instrument of  FIG. 1  for driving and retracting a cutting blade at the distal end of the instrument; 
         FIG. 29  is a more detailed exploded view of the tube blade coupling of  FIG. 28 ; 
         FIGS. 30 ,  31 ,  32 , and  33  are side views of the instrument of  FIG. 1  illustrating the operation of the instrument for driving and retracting a cutting blade at the distal end of the instrument; 
         FIG. 34  is a cross-sectional side view of the distal end of the instrument of  FIG. 1  with the needles partially extended; 
         FIGS. 35 ,  36 ,  37 ,  38 ,  39 ,  40 ,  41 ,  42 ,  43 , and  44  are side views illustrating the operation of the instrument of  FIG. 1  at the distal end thereof; 
         FIG. 45  is a perspective view of the distal end of the instrument after operation of the instrument of  FIG. 1  showing removal of the tissue from the distal end; and 
         FIGS. 46 ,  47 ,  48 ,  49 ,  50 ,  51 ,  52 ,  53 ,  54 , and  55  show an example of the views through an endoscope during the operation of the instrument of  FIG. 1 ; 
         FIG. 56  is an example of the instrument of  FIG. 1  positioned in the gastroesophageal tract of a patient using an accessory tube coupled to an endoscope; 
         FIG. 57  is a perspective view of the instrument of  FIG. 1  passing through the channel of a flexible endoscope; 
         FIG. 57A  is a partial view of the distal end of the instrument of  FIG. 57 ; 
         FIG. 58  is a perspective view of the instrument of  FIG. 1  with an optional larger distal end to cut a larger tissue sample, optional guide members along the shaft of the instrument for coupling the instrument to an endoscope, and another cutting mechanism having an oscillating blade; 
         FIG. 58A  is an enlarged partial view of the distal end of the instrument of  FIG. 58 ; 
         FIGS. 58B and 58C  illustrate the operation of the oscillating blade of the cutting mechanism in the instrument of  FIG. 58  under control of a trigger at the handle of the instrument; 
         FIG. 59  is another embodiment of the instrument of the present invention for use in breast biopsy having an imaging transducer at the instrument&#39;s distal end in which the instrument is passed over a guide wire located in the breast of a patient; 
         FIG. 59A  is a partial view of the distal end of the instrument of  FIG. 59 ; 
         FIG. 60  illustrates the instrument of  FIG. 1  with optional integrated steering mechanism and imaging system; 
         FIG. 60A  is an enlarged partial view of the distal end of the instrument of  FIG. 60 ; 
         FIG. 61  is a perspective view of the instrument of  FIG. 1  with another cutting mechanism having a linear blade for incising tissue to a controlled length and depth; 
         FIGS. 61A ,  61 B, and  61 C are enlarged partial views of the distal end and the control knob at the proximal end of the instrument of  FIG. 61  to illustrate the controlled advancement of the linear blade at the distal end of the instrument; 
         FIG. 61D  is a side schematic view of the instrument of  FIG. 61  with the linear blade shown at a retracted position at the distal end of the instrument; and 
         FIGS. 61E and 61F  are side schematic views of the instrument of  FIG. 61  with the shaft partially broken showing the advancement of the linear blade at the distal end of the instrument by rotation of the control knob. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Referring to  FIG. 1 , the instrument  10  of the present invention is shown having a housing  12  and a shaft  14  extending from the housing  12  to a distal end  16 . The shaft  14  has a first rigid section  14   a  and then a second flexible section  14   b  to facilitate location of the distal end  16  along the curvature of a tubular structure, such as along the gastrointestinal tract, urinary tract, or vascular structures of a patient&#39;s body. The shaft  14  is of a cylindrical cross-sectional shape with an outer diameter enabling the shaft to be inserted in a tubular structure to locate the distal end  16  in such tubular structure of a patient. The housing  12  has a body shaped like a pistol having a handle portion  13 , and may be made of a two-piece construction of molded plastic. At the distal end  16  of the shaft  14  is a distal housing  18  with an opening  19  to a cavity  20 . The instrument  10  has a vacuum port  22  along shaft  14  for applying suction to the distal end  16 , a turn screw  26  for controlling a cutting blade at the distal end  16 , and a pivotable lever  28  to extend and retract two hollow needles at the distal end  16  capable of infusing fluid in tissue provided via a fluid insertion port  24 . Another port  29  provides for insertion or removal of fluid through the same passages which communicate suction along shaft  14  to distal end  16 . Ports  24  and  29  are shown closed in  FIG. 1  by luer caps  24   a  and  29   a , respectively. 
     As shown in  FIGS. 2 and 2A , the instrument  10  may be used in conjunction with an accessory tube  30  coupled to an endoscope  32 , such as a gastroscope, or any other type of flexible endoscope having a shaft  33 . The accessory tube  30  is described in more detail in International Application No. PCT/US02/02791, filed Feb. 1, 2002, published under WO 02/062200 A2, and having priority to U.S. patent application Ser. No. 09/776,431, filed Feb. 2, 2001, and both applications are herein incorporated by reference. The instrument  10  may be inserted in the accessory tube  30  as shown in  FIG. 2 , and is removable from the accessory tube  12 . The accessory tube  30  is useful, as it can be placed with the endoscope  32  in a tubular structure, such through the mouth of a patient into the gastrointestinal track, to facilitate location of the distal end of the instrument  10  to sites therein. In brief, the accessory tube  30  is coupled to the endoscope shaft  33  by tube guides  34 , and has a cannula  36  with an opening through which shaft  14  of instrument  10  may pass into the accessory tube. At the distal end of accessory tube  30  is an attachment tip  37  having two openings  38   a  and  38   b . One opening  38   a  receives the accessory tube  30 , and the other opening  38   b  receives the distal end  35  of endoscope shaft  33 . Attachment tip  37  is shown in more detail in  FIG. 2A . Endoscope  32  may be a typical endoscope having a video display system coupled to its upper end, via a cable  40 , to allow viewing of tissue from optics at its distal end  35 , and in particular to assist an operator in locating and observing the instrument&#39;s distal end  16 . Other viewing means may also be used for locating and observing the instrument&#39;s distal end  16 , such as ultrasound, x-ray, or other imaging techniques. Although use of the instrument  10  is preferably used with the accessory tube  32 , the instrument may be used without the accessory tube by placement of the shaft in a tubular structure of the body of a patient, or in an overtube as often used in endoscopic gastrointestinal procedures. 
     Referring to  FIGS. 3-34 , the assembly of the shaft and housing of the instrument is shown. In housing  12 , lever  28  has two pins  42  extending into holes  43  in the sides of housing  12  upon which the lever  28  is pivotally mounted in the housing. Lever  28  has a portion which extends through an opening  44  in housing  12  to enable pivotal movement about pins  42 . An extension spring  45  is provided which hooks at one end in a notch  46  of lever  28  and is wound at the other end around a pin  48  located in holes  49  in the sides of housing  12 , such that the lever  28  is spring biased to retain the lever normally in a forward position, as shown for example in  FIG. 1 . The body of housing  12  has a front portion  12   a  providing a stop that limits the forward pivotal movement of lever  28 . 
     A needle coupler  52  is received and mounted for rotation in a curved slot  50  at the top of the lever  28 . As best shown in  FIG. 23 , the needle coupler  52  is a cylindrical tube having closed ends  52   a , and has an opening  53  representing an inlet port, and two openings  53   a  and  53   b  representing outlet ports. One end of an inlet tube  54  is attached to the needle coupler  52 , and other end of the inlet tube  54  is coupled into a fill tube  56 . The fill tube  56  may be plastic tubing which extends from inlet tube  54  through an opening  12   b  of housing  12  into a hole  58   a  extending through a connector or fitting  58 . Notches  12   c  ( FIG. 4 ) along the interior of the left side of housing  12  may be provided for fill tube  56  as it extends through the housing. 
     Two needle tubes  60   a  and  60   b  are attached to needle coupler  52  at openings  53   a  and  53   b , respectively, and two hollow needles  62   a  and  62   b  extend through the needle tubes  60   a  and  60   b , respectively. These needles  62   a  and  62   b  extend from the needle coupler openings  53   a  and  53   b  through the assembly of the shaft  14  to their needle tips  67   a  and  67   b , respectively, located at the distal end, as will be described below. Two parallel grooves of slots  51   a  and  51   b  are also at the top of the lever  28  and extend to slot  50 . Needles  62   a  and  62   b  in their respective needle tubes  60   a  and  60   b , respectively, extend from needle coupler  52  through slots  51   a  and  51   b . Openings  53   a  and  53   b  are of the same diameter, but are smaller than the diameter of opening  52   a , such that the needle coupler  52  under fluid pressure equally distributes the fluid to the needles. The outer diameter of the needles  62   a  and  62   b  are slightly less than the interior diameter of needle tubes  60   a  and  60   b , and are fixed in the needle tubes  60   a  and  60   b  by attachment, such as welding or brazing, at the ends  61   a  and  61   b  of the needle tubes  60   a  and  60   b , respectively. The needles may also, or instead, be attached to the needle tubes  60   a  and  60   b  at the site where each tube is attached to needle coupler  52 . The inlet tube  54 , needle coupler  52 , and needle tubes  60   a  and  60   b  may be of stainless steel tubing, and may be attached, as described above, by welding or brazing. 
     Turn screw  26  represents a rotatable control knob having a textured rotatable cap  26   a  attached to a threaded rod or shaft  26   b , which is inserted into a threaded hole  26   c  of the cap, as best shown in  FIGS. 3 ,  27  and  28 . One end  63   a  of drive tube  63  is inserted and attached, such as welded or brazed, into a hole  26   d  which at least partially extends into shaft  26   b . A nut  27  is fixably mounted by two flanges  27   a  in the sides of housing  12 , and has a threaded hole  27   b  extending there through for receiving shaft  26   b . By rotating cap  26   a , shaft  26   b  of the turn screw rotates in threaded hole  27   b  to rotate and move the drive tube  63  forward, or backward, depending on the direction of rotation. 
     In the housing  12 , the needles  62   a  and  62   b  in their respective needle tubes  60   a  and  60   b , pass from needle coupler  52  through an adapter  64 . Adapter  64  is mounted in housing  12  by two flanges  64   a . The adapter  64  has a bore  65  extending there through into which a needle spreader  66  is located. Needle spreader  66  has two channels  66   a  and  66   b  into which needles  62   a  and  62   b  in their needle tubes  60   a  and  60   b  are respectively located to increase the distance between the needles as they extend toward needle coupler  52 , such that the needles in their needle tubes are properly aligned to slots  51   a  and  51   b  and needle coupler openings  53   a  and  53   b . The drive tube  63 , which extends from the turn screw  26 , passes through the needle spreader  66  and adapter  64  along channel  66   c  of the needle spreader  66 . 
     Next, a gasket member  68  has two holes  68   a  and  68   b  through which extends needles  62   a  and  62   b , respectively, in their respective needle tubes  60   a  and  60   b , and a hole  68   c  through which the drive tube  63  extends. The gasket member  68  may be made of medical grade rubber, such as Santoprene. 
     After gasket member  68 , a longitudinal guide member  72  is provided with multiple tracks along its length, including two needle tracks  72   a  and  72   b  for needles  62   a  and  62   b , in their respective tubes  60   a  and  60   b . A track  72   c  in the guide member  72  is provided for the drive tube  63 . The guide member  53  may be made of extruded flexible material, such as Tecoflex®, or other flexible plastic. Needle tubes  60   a  and  60   b  are movable in channels  66   a  and  66   b  of the needle spreader  66 , holes  68   a  and  68   b  of gasket member  68 , and tracks  72   a  and  72   b  of the needle guide  72  when needles are extended or retracted in the instrument. The drive tube  63  is also movable in channel  66   c  of the needle spreader, hole  68   c  of gasket member  68 , and tracks  72   c  of the needle guide  72 . 
     A rigid tube  70  is then provided into which the gasket member  68  is first loaded and then guide member  72 . The D-shaped end  70   a  of tube  70  is registered into a corresponding shaped opening  65   a  to bore  65  in adapter  64 , and a nut  71  with a threaded opening  71   a  screws onto the threaded end  64   b  of the adapter  64  to secure tube  70  to housing  12 . The rigid tube  70  extends through opening  12   d  of housing  12 . Tracks  72   a ,  72   b , and  72   c  of the needle guide  72  each form a channel with the interior surface of rigid tube  70 . Rigid tube  70  may be made of stainless steel, or other rigid material.  FIG. 5  shows the gasket member  68  prior to being positioned in abutment to needle spreader  66  and in end  70   a  of rigid tube  70 . Inside rigid tube  70 , gasket member  68  has a ring  68   d  which frictionally engages the interior surface of tube  70  to form a seal therein. 
       FIGS. 5A and 5B  show gasket member  68  in more detail. Holes  68   a  and  68   b  are of a larger diameter than the needle tubes  60   a  and  60   b , respectively, except for a small section of holes  68   a  and  68   b  where the diameter reduces to form annular flaps  68   e  and  68   f , respectively, of gasket material which seal around needles  62   a  and  62   b , respectively. This enables movement of the needles in their respective needle tubes  60   a  and  60   b  back and forth while maintaining a seal about each needle tube. Similarly, hole  68   c  of the gasket member  68  has an annular flap  68   g  to enable movement of the drive tube  63  as it is rotated back and forth which maintaining a seal around drive tube  63 . One feature of the gasket member  68  is that it enables sealing the shaft  14 , such that negative pressure, i.e., suction, may be selectively applied down the shaft, as described later below. A cross-section through gasket member  68  and adapter  64  is shown in  FIG. 6 , while  FIG. 8  is a cross-section of shaft  14  with guide member  72 . 
     Next, a longitudinal flexible body  76  has an end  76   d  abutting end  70   b  of rigid tube  70 . Flexible body  76  represents a three lumen tube having three longitudinal channels  76   a ,  76   b , and  76   c . Flexible body  76  may be formed of extruded flexible material, such as Tecoflex®, or other flexible plastic. As needle guide  72  ends at end  70   b  of the rigid tube  70 , needles  62   a  and  62   b  exit and continue through channels  76   a  and  76   b  of the flexible body  76 , respectively. Needle tubes  60   a  and  60   b  extend from needle coupler  52  and end along the needle guide  72  prior to end  70   b  of rigid tube  70 , where the needles  62   a  and  62   b  exit their tubes  60   a  and  60   b  and continue down shaft  14 , as illustrated in the cross-section of  FIG. 9 . Also, the drive tube  63  exits end  70   b  of the rigid tube  70 , and is coupled to flexible tube  80 , via coupler member  78 , after entry into channel  76   c  of the flexible body  76 . The flexible tube  80  represents a flexible tube, such as of polyurethane or other plastic, having a mesh or weave of metal. The coupler member  78  represents a cylindrical metal tube  78   a  having a circular opening  78   b  extending there through, and an annular flange  78   c  at one end. The drive tube  63  extends into opening  78   b  of tube  78   a , and attached thereto, such as by welding or brazing. The end  80   a  of flexible tube  80  is received onto other end  78   d  of the coupler member  78  until annular flange  78   d , and held thereupon by frictionally engagement provided by the expansion of the flexible tube&#39;s mesh, which prevents forward movement of the flexible tube  80  with respect to coupler member  78 , while flange  78   d  of the coupler member  78  provides a stop limiting backward movement of flexible tube  80  upon the coupler member. A cross-section of the shaft through the flexible body  76  at flange  78   c  is shown in  FIG. 11 , and then at end  78   c  in  FIG. 12 . The flexible tube  80  continues through flexible body channel  76   c  to the distal end  16 , as illustrated in the cross-section of the shaft in  FIG. 13 . The needles  62   a  and  62   b  are movable, and flexible tube  80  is rotatable forward and backward along their respective channels  76   a ,  76   b , and  76   c  in the flexible body  76 . 
     A splice tube  74  couples the flexible body  76  to the rigid tube  70 , in which the splice tube  74  is slid over the abutting ends of the flexible body and rigid tube, and partial extends over both flexible body and rigid tube. As the outer diameter of the flexible body  76  is substantially the same as the outer diameter of the rigid tube  70  at end  70   b  where they abut each other, their ends substantially align with each other. The splice tube  74  may be composed of heat shrinkable material, such that it is secured in place by application of heat. Optionally, adhesive material may also be used which can be wicked under the splice tube  74 . A cross-section of the shaft  14  at the splice tube  74  over rigid tube  70  is shown in  FIG. 10 . 
     The end  76   e  of flexible body  76  is coupled to the distal housing  18  at the distal end  16 , as best shown in  FIGS. 17 ,  17 A,  17 B and  34 . Distal housing  18  is approximately cylindrical in shape and has a circular opening  88  extending there through between its ends  88   a  and  88   b , and two side openings  18   a  and  19  to opening  88 , where opening  19  is to cavity  20  of distal end  16 . The flexible body  76  extends into circular opening  88  at end  88   a  of the distal housing  18 , and is attached thereto, such as by adhesive or staking. The needles  62   a  and  62   b  then exit the flexible body  76  and increase in separation as they enter parallel longitudinal channels or tracks  90   a  and  90   b , respectively, which extend along the exterior surface of distal housing  88 , but are discontinuous at opening  19 . 
     The flexible tube  80  also exits the flexible body  76  in the distal housing opening  88 , where it is then is coupled to a tube blade  86  by a coupler member  82  and an expander tube  84 . As best shown in  FIGS. 27-29 , such coupling is provided by end  80   b  of flexible tube  80  being located in the opening  82   a  of coupler member  82 . Opening  82   a  has a diameter slightly less that the outer diameter of the flexible tube  80 . An expander tube  84  is then located in flexible tube  80 . The expander tube  84  has an outer diameter about the same as the interior diameter of the flexible tube  80 , thereby expanding the flexible tube to force it against the interior surface of opening  82   a  of coupler member  82 , thereby mechanically connecting the coupler member  82  to the flexible tube  80 . The coupler member  82  has outwardly extending protruding ribs or ridges. Two of these ridges form rectangular keys  82   b  which are received into corresponding openings  86   a  of the tube blade  86  to attach and lock the tube blade  86  to coupler member  82 . The remaining ridges  82   c  of the coupler member  82  lie against the interior surface of the tube blade  86  to assist in maintaining the cylindrical shape of the tube blade.  FIG. 14  is a cross-section of the coupling of the flexible tube  80  to the tube blade  86 , while  FIG. 15  shows a cross-section of the distal end of the tube blade  86  after such coupling. The tube blade  86  may represent a thin stainless steel tube having a sharp edge  87  capable of cutting tissue. As opening  88  has a diameter slightly larger than that of the outer diameter of tube blade  86 , the tube blade is rotatable and translatable forward and backward in the distal housing  18 . 
     Referring to  FIGS. 30-33 , the tube blade  86  when in a retracted position in the distal end provides an open cavity  20  ( FIG. 30 ). Rotating turn screw  26 , as indicated by arrow  89 , to first translate rotation to the drive tube  63 , which then translates the rotation to the flexible tube  80 , via coupler member  78 , and finally to the tube blade  86 , via coupler member  82 , to provide rotation of the tube blade with forward translation in opening  88  of the distal housing  18 , as indicated by arrow  89   a  ( FIG. 31 ), until in a fully extended position to close cavity  20  ( FIG. 32 ). When the turn screw  26  is then rotated in the opposite direction, as indicated by arrow  89   b , rotation is similarly translation to the turn blade  86  in the opposite direction, as indicated by arrow  89   c  to its retracted position in the distal end ( FIG. 33 ). 
     Distal housing  18  further has a grated manifold member  91  which extends from end  88   a  through cavity  20  partially though the distal housing. Manifold member  91  has a surface  91   e  facing opening  19  with one or more openings representing a grate. As best shown in  FIGS. 17 ,  17 A,  17 B, and  45 , manifold member  91  has two sets of projections  92 , each set extending upwards from opposing ledges  98  in two side walls  93 , and then curve towards each other along a circular arc generally in a direction of opening  19 . The gaps formed between adjacent projections  92  provide openings (or slots)  94  along the same side wall, and the gap formed between the two sets of projections  92  provides a central opening (or slots)  95 . The openings  94  are distributed along surface  91   e  in the manifold member, and preferably equally distributed. End  91   b  of the manifold member  91  is located before cavity  20 , and the other end  91   a  of the manifold member  91  is located at distal tip  18  of distal housing  18 . The side walls  93  curve as they extend in a direction opposite that of extending projections  92 , generally parallel to the interior circumferential surface of the distal housing  18 , and form ribs  96  about a central opening  97 . Also, the projections  92  extending from each of walls  93  meet and are continuous at each of the ends  91   a  and  91   b  of manifold member  91 , and having at such ends a continuous circular arc profile without central opening  95 , such that a channel  97   a  to central opening  97  is provided at end  91   b . Openings  94  and  95  in surface  91   e  can provide inlets through which suction can be communicated sufficient to engage tissue when located adjacent the instrument&#39;s distal end  16 , as described below, whereby surface  91   e  of the manifold represents a tissue engaging surface. Other manifolds or suction transfer means could also be used with different oriented openings towards opening  19  sufficient for distributing suction in cavity  20 . 
     The distal tip  18   b  of the distal end  16  is provided by a cap  99  having a rounded edge  99   a  along an annular flange  99   b . The cap  98  is sized to be received into opening  88  of the distal housing  18 , such that cap edge  99   a  abuts edge  88   c  of the distal housing, and a cutout or opening  99   c  of cap  98  receives end  91   a  of the grated manifold member  91 . A pin  100  extends through two holes  99  in the cap  99  and through a hole  91   c  in the manifold member  91  at its end  91   a , and through two holes  102  at end  88   a  of the distal housing, to retain the manifold member  91  and the cap  99  at distal end  16 . Preferably, the surface  99   e  of the cap about opening  88  lies continuous with surface  91   d  of the manifold member  91 , such as may be provided by polishing or grinding such surfaces when assembled together. In this manner, the manifold member  91  is only attached to the distal housing at its end  91   a . A back stop  104 , such as a C-shaped piece of rubber, is located in cap  99  adjacent end  91   a  of the manifold member  91 . The back stop  104  limits the forward extent of the tube blade  86  when fully extended in the distal housing  18 , and minimizes dulling of the blade if extended to pin  100 .  FIG. 16  shows a cross-section of distal end  16  through pin  100 . 
     The particular contour curvature or profile of the tissue engaging surface provided by surface  91   e  of the manifold member  91  is defined by projections  92  about central opening  95  and longitudinal ledges  98 , as shown in  FIGS. 16 ,  17 ,  17 A,  17 B and  45 , and is selected in accordance with the depth of the tissue to be cut by the instrument. The depth of the cut is also controlled by the size of the cavity  20  with respect to surface  91   e . Other dimensions of length, width, and overall shape of the tissue are primarily a function of the size of the cavity  20  and extent of opening  19  in the distal housing  18 , but may also be determined by the contour of surface  91   e . Thus, different sizes and depths of tissue may be removed by instrument  10  by changing the size of cavity  20  and/or the contour of surface  91   e  of manifold member  91 . 
     The manifold member  91  is sized smaller than the interior diameter of opening  88 , thereby providing a path for travel of the tube blade  86  across cavity  20  over end  91   b  of the manifold member  91 . The distal housing  20  and manifold member  91  may be manufactured using electrical discharge machining (EDM) processes. Manifold member  91  may alternatively be made of porous material, e.g., Porex®, manufactured by Porex Corp. of Fairfax, Ga., which could be injection molded, for transferring suction to properly engage the tissue at the specimen harvest site. Opening  18   a  is optional and can be used to assist in assembly of components in the distal housing, and is later sealed by shrink tube  73 , as will be described below. 
     Referring to  FIGS. 18-22 , suction can be communication via port  22  of a vacuum housing  106  coupled to shaft  14  to the distal end  18 . The vacuum housing  106  is coupled to rigid tube  70 , and has two openings  107   a  and  107   b  to a chamber  108  through the rigid tube  70  extends. The diameter of openings  107   a  and  107   b  is smaller than the outer diameter of rigid tube  70 , such that material about openings  107   a  and  107   b  sealingly engages the rigid tube. The vacuum housing  106  also has an extension  106   a  with a threaded opening  105  to chamber  108  for receiving a valve or stop cock fitting  110 . The valve  110  has an opening  110   a  extending there through from chamber  108  to port  22 , and a switch  110   b  to a valve therein to open and close such valve, as indicated by arrow  114 , to control the flow of air (under negative pressure) passing from chamber  108  via opening  110   a . A source of suction (or partial vacuum) may be coupled to port  22 . Vacuum housing  106  has another extension  106   b  to an opening  112  to port  29 . A luer cap  29   a  is provided upon port  29  so as to close the port  29  when not needed. A ring  29   b  may couple the luer cap  29   a  to port  29 . 
     The rigid tube  70  has two openings  70   c  along opposite sides of the tube  70  which are in communication with chamber  108 , and such openings  70   c  are aligned with two channels  72   d  of the needle guide  72  in rigid tube  70 . The vacuum housing  106  is rotatable around the rigid tube  70 , but is limited in longitudinal movement along shaft  14  by housing  12 , and a stop tube  111  disposed over the rigid tube adjacent opening  107   b . The stop tube  111  may be composed of heat shrinkable material, such that it is secured in place by application of heat. The vacuum housing  106  and valve  110  may be made of molded polypropylene plastic or other plastic. A cross-section of the shaft  14  through the stop tube  11  is shown in  FIG. 7 . 
     After the shaft is assembled as described above with vacuum housing  106  upon the rigid tube  70 , a plastic shrink wrap layer or tubing  73  is installed from over the stop tube  111  until opening  19  of the distal housing  18 , and then shrunk in response to applied heat onto exposed surfaces of shaft  14 . Alternatively, the shrink tubing  73  may be applied upon the rigid tube  70  prior to locating vacuum housing  106 , and extend from housing  12  until opening  19 , and then the tubing  73  is cut about rigid tube openings  70   c , and then the vacuum housing  106  and stop tube  111  placed over tubing  73 . The flexible body  76  substantially defines the extent of the flexible section  14   b  of shaft  14 , while the rigid tube  70  substantially defines the extent of the rigid section  14   a  of the shaft  14  after exiting housing  12 . 
     Referring to  FIGS. 21 and 22 , suction can be communicated via port  22  through chamber  104 , through openings  70   c  and through the rigid tube  70  along needle guide  72 , via needle guide channels  72   d , and through open spaces or regions about the needle tubes (or needles once exiting such needle tubes) and drive tube  63 . After the needle guide  72 , suction continues to be communicated along the flexible body  76 , including longitudinal channels  76   d , and through all open spaces or regions of the flexible body about the needles and flexible tube in channels  76   a - 76   c , to opening  88  of the distal housing and then to cavity  20 . In distal end  16 , suction is available through all open spaces of cavity  20 , such as through the tube blade  86 , needle channels  90   a  and  90   b , openings  94  and  95  of manifold member  91 , and gaps  124  between the sides of the manifold member  91  and the interior of the distal housing  18 . The direction of air flow is represented by arrows in  FIGS. 21-22 . Port  29  provides for insertion or removal of fluid through the same passages which communication suction along shaft  14  to distal end  16 , when suction is not being provided to shaft  14 . 
     Referring to  FIGS. 24-26 , the instrument  10  is first shown in  FIG. 24  in which a syringe  58  having a fluid  58   a  is attached to port  24  by removing luer cap  24   a  from the port. The luer cap  24   a  may be retained onto port  24  by a ring  29   b . Port  24  may be threaded to enable the syringe  58  to screw onto the port. Needles  62   a  and  62   b  are driven forward from a retracted position at the distal end  16  by backward pivoting of lever  28  towards handle  13  (as indicated by arrow  59 ) which drives needle coupler  52  forward and rotates the needle coupler in slot  50 , thereby driving the needles forward along their respective paths through the shaft  14 , and extending them into cavity  20  ( FIG. 25 ). Next, the plunger  58   b  of syringe  58  is moved gradually in the direction of arrow  59   a  forcing fluid  58   a  from syringe  58  through the fill tube  56 , needle coupler  52 , via openings  53 , into needles  62   a  and  62   b , via opening  53   a  and  53   b , down the needles in the shaft  14  and out needle tips  67   a  and  67   b . The driving or retracting of needles in instrument  10  is independent of fluid insertion. After fluid insertion, needles  62   a  and  62   b  may be further extended by pivoting lever  28  towards handle  13  through cavity  20  ( FIG. 26 ). To retract the needles, the lever  28  is pivoted back (in the opposite direction of arrow  59 ), which drives needle coupler  52  backwards and rotates the needle coupler  52  in the opposite direction in slot  50 , thereby retracting the needles  62   a  and  62   b  along their respective paths through the shaft  14  and back to their retracted position in the distal end  16 . 
     Referring to  FIGS. 35-45 , presented in cross-section, the operation of the instrument  10  at its distal end  16  for engaging and cutting tissue is shown after the instrument is located near the tissue  116  to be removed; the opposite wall  118  is provided to aid in understanding instrument distal end orientation within a tubular tissue structure  115 . As stated earlier, the tissue may represent the surface of a tubular structure of a patient body. The distal end  16  may be viewable to the operator on a display through an endoscope, which has optics at its distal end  16 , as illustrated in  FIGS. 46-55 . Such viewing optics may also be directly integrated into instrument  10 , as described below in connection with  FIGS. 60 and 60A . Such endoscope  32  may represent a gastroscope when located via the mouth into the gastrointestinal tract of a patient as shown for example in  FIG. 56 , where when the shaft  14  of instrument  10  passes through the accessory tube  30  coupled to the gastroscope, as described earlier in connection with  FIGS. 2 and 2A . Endoscope  32  is coupled to a video display system  120 , via a cable  40 , to allow viewing of tissue from its distal end on a display  121 , such as the mucosal layer of tissue lining the esophagus  122 . Steering of the endoscope and attached accessory tube  30  is controlled by a cable drive within the end, or by other typical steering means used by endoscopes, so as to locate distal end  16  passed through and out accessory tube  30  near the tissue to be removed. Such steering may also be integrated into instrument  10 , as also described below in connection with  FIGS. 60 and 60A . Any other endoscope, without accessory tube  30 , may also be used which is suitable for application in the particular tubular structure or tissue to be operated upon. 
     First, with the tube blade  86  and needles  62   a  and  62   b  retracted in the distal housing  18  below the cavity  20 , and the vacuum valve  110  in the off position, the shaft  14  of instrument  10  is inserted in the tubular structure  115  to locate distal end  16  adjacent the site of the tissue  116  to be cut and removed ( FIGS. 35 ,  36 ,  46  and  47 ). For purposes of illustration, the other side  118  of the tubular structure  115  is only shown in  FIG. 35 . The distal end  16  is then located such that its opening  19  lies adjacent the tissue  116  to be cut in the inner lining of the tubular structure ( FIGS. 36 and 47 ). With a vacuum source  123  coupled to port  22 , the vacuum valve  110  is turned to its open position to communicate suction (i.e., negative air pressure) down the shaft  14  to the distal housing  18 , as described earlier, pulling the tissue  116  into the cavity  20  via opening  19  ( FIGS. 37 and 48 ). The surface  116   a  of the tissue  116  is pulled against surface  91   e  ( FIG. 17A ) of the manifold member  91  to engage the tissue, such surface being provided by ledges  98  and the projections  92  extending therefrom about openings  94  and  95 , such that the tissue surface  116   a  substantially conforms to surface  91   e . As suction is applied to cavity  20 , suction will initially be strongest along one side  20   a  of the cavity  20 . This pulls the tissue into the cavity  20  first along its side  20   a , causing the suction to be directed into channel  97   a  via central opening  97  of the manifold member  91  distributing such suction to openings  94  and  95  down the manifold member to end  20   b  of the cavity  20  near the distal tip  18   b . Suction also occurs around the side walls  93  of the manifold member  91  along two gaps  124  ( FIG. 17A ) between the sides of manifold member  91  and interior of the distal housing  18 . 
     The needles  62   a  and  62   b  are then driven forward about halfway into the cavity  20  from their tracks  90   a  and  90   b , respectively, into the tissue engaged in cavity  20  by the operator pulling lever  28  about halfway to handle  13  ( FIGS. 38 and 49 ). Preferably, the needles  62   a  and  62   b  are then retracted slightly to assure that holes are left into the tissue  116  to facilitate fluid to be infused (or injected) into the tissue. Fluid  125 , such as a saline solution and/or a therapeutic agent, is then inserted via port  24  into the needles  62   a  and  62   b  ( FIGS. 39 and 50 ), as described earlier. This forms a welt  126  between the upper tissue layer  116   b  and the subtissue layer  117  of tissue  116 , thereby partially separating layer  116   b  from layer  117  in the tissue  116  to be cut. The fluid  125  may also contain a hemostatic fluid, such as epinephrine, or other therapeutic agent. During (or after) fluid  125  insertion, the needles  62   a  and  62   b  are then further driven forward to fully extend through cavity  20  into their tracks  90   a  and  90   b  near distal tip  18   b  by pulling level  28  to handle  13  ( FIGS. 40 and 51 ). Needles when fully extended may provide additional stability to the tissue  116  in the cavity  20  when the tissue is cut. 
     The tube blade  98  is then rotated forward in the cavity  20  by turning turn screw  26  to cut the specified harvested specimen tissue  116   c  by tube blade edge  87  from the underlying tissue substrate  117  ( FIGS. 41 and 51 ). The tube blade  86  then closes the opening  19  to the cavity  20  and when fully extended, part of tube blade edge  87  abuts against back stop  104  ( FIGS. 42 and 52 ). The harvested tissue specimen  116   c  so removed remains captured in the cavity  20  as the distal end  16  of the instrument is lifted from the tissue  116  ( FIGS. 43-44  and  53 - 55 ). The depth of the cut is controlled by the manifold member  91  with respect to tube blade  86  upon extension in cavity  20 . In applications for removal of the mucus layer of the esophagus, which may be represented by tissue layer  116   b , the depth of the tissue is selected to minimize damage to submucosa and adjacent esophageal muscle, which may be represented by tissue layer  117 . 
     To enable collection of removed tissue specimen  116   c , the entire instrument  10  is removed from the tubular structure  115 , and turn screw  26  is rotated in an opposite direction which retracts the tube blade  86  below the cavity  20 , the needles  62   a  and  62   b  are retracted below cavity  20  by pivoting the lever  28  away from handle  13 , and closing suction valve  110 , thereby releasing the tissue specimen  116   c  from the distal housing  18  of instrument  10  ( FIG. 45 ). Such collected removed tissue may represent a biopsy specimen. The biopsy specimen can be permanently marked, such as with ink, to indicate tissue orientation during harvest and subsequently analyzed using a variety of histopathologic techniques. If specimen removal and analysis is not required and multiple precision tissue cuttings are preferred in that patient, the tubular blade and needles can be retracted while the instrument remains in the patient near the harvest tissue site. Flushing the vacuum tract with pressurized irrigant can assist to remove the harvested specimen  116   c  from the distal end of the instrument. The harvested tissue specimens left near the harvest site could subsequently be passed out of the patient through natural means, such as defecation or micturation. Such flushing may be provided through port  29  to the distal end via the same passages in the shaft which communicate suction. This enables the potential for repeated use of this instrument without requiring removal of the instrument&#39;s distal end from the patient. 
     Port  29  may also be used to clean the site in the tubular structure before or after removal of tissue, or to remove debris in cavity  20  when suction is not being provided down shaft  14  via the same passages in the shaft which communicate suction. Further, although use of fluid to assist in separation of tissue layers is preferred, the instrument can operate to cut tissue by engaging tissue by suction and cutting such tissue without use of the fluid insertion or extension needles. Further, one needle, or any number of needles may be provided in the instrument, or the instrument  10  may be provided without needles. 
     This instrument overcomes many of the pre-existing challenges associated with the removal of abnormal tissue, such as in the case of Barrett&#39;s disease, from the human esophagus. Further the tissue edges on opposite sites  116   d  ( FIG. 55 ) of the wound  116   e  left in the tissue after operation of the instrument, are clean, straight and substantially parallel to each other enabling apposition of such edges for closure of the wound, if desired, by suture or other mechanical closure devices. For example, a suturing instrument represents the S EW -R IGHT® SR 5•™ manufactured by LSI  SOLUTIONS , Inc. of Victor, N.Y., may be used to apply suture, and free ends of the suture may be closed, such as with a knot placed by a surgeon, or using a suture securing instrument, such as the Ti-K NOT® TK 5® also manufactured by LSI  SOLUTIONS , Inc. Also, the suturing and suture securing instruments described in the above-incorporated patent applications may also be used. Such would edge apposition can induce primary healing yielding a plication or bolstering of a durable wound closure that may be useful in controlling pathologic processes like esophageal reflux disease. The instrument may take a single cut of the tissue or be operated as described above to obtain multiple cuts at multiple locations in a tissue structure. In addition to removing tissue from lining of tubular structures, the instrument may also be used to cut tissue from any tissue surface in a patient&#39;s body (e.g., surface of the liver, lining of the peritoneal cavity) or even soft tissue (e.g., from within breast tissue as shown below in  FIG. 59A , or brain tissue) which are surgically made accessible. 
     Although the operation of the instrument is described through an accessory tube, the instrument  10  may also be insertable through a channel  32   a  of an endoscope  32 , often called the working channel, when such channel has a diameter smaller than the diameter of the shaft  14  and distal end  16 , as shown in  FIGS. 57 and 57A . If the distal end  16  is of a larger diameter than the channel of the endoscope, but the shaft  14  is of a diameter insertable through such channel, the distal end  16  of the instrument  10  may be assembled on to the shaft  14  after the shaft  14  is passed through the channel of the endoscope, thereby integrating the instrument  10  with an endoscope. 
     Referring to  FIGS. 58 and 58A , instrument  10  is shown having a different distal end  16   a  with an enlarged distal housing  18  having an opening  19  extending over a wider circumference of the distal housing to enable larger widths of tissue to be cut. For example, in a tubular structure, such as the esophagus, the instrument can make a single cut of about 200 degrees over the interior surface of the esophagus. This is useful in removal of abnormal or suspect tissue from the esophagus since the instrument in a single cut can remove the mucosal lining from over half of a circumferential area of the esophagus. Later, such as two or more weeks to allow for sufficient healing, the instrument can be used to remove the mucosal lining from the other half of a circumferential area adjacent to the location where the first half was removed, thereby removing the mucosal lining over the inner circumference of the esophagus of the length of distal end cavity  20 . Optional guide members  34   a  similar to that of tube guides  34  ( FIG. 2 ) may be attached to the shaft  14  of instrument  10 . Such guide member  34   a  may couple shaft  14  to an endoscope&#39;s shaft similar to the manner in which tube guides  34  couple the accessory tube  30  to an endoscope of  FIG. 2 . Thus, such accessory tube is no longer needed to facilitate use of the instrument  10  with an endoscope. 
     The instrument  10  of  FIGS. 58 and 58A  may also have an oscillating blade member  130  to replace tubular blade  86  in the cutting mechanism at the distal end  16 . Blade member  130  has a sharp edge  131  capable of cutting tissue, and is held by a pin  132  through a hole  130   a  journalled in the sides of a coupler member  133 , as schematically illustrated in dashed lines in  FIG. 58A . One side of the blade  130  is coupled to one end of a spring  135  and the other end of the spring is attached to the distal housing  18  (such as by a pin) so as to bias rotation of the blade about the pin to the left, as shown in  FIG. 58B . The coupler member  133  may be a tube similar to earlier described coupler  82  for attachment of flexible tube  80  using tube  84 , but does not need keys  82   b  or protrusions  82   a . The blade  130  is rotatable in an oscillating (or reciprocating) motion about pin  132  against the bias of spring  135 , in response to pulling or releasing a cable  136  (e.g., wire) coupling to the other side of blade  130  to a trigger  134  mounted in the handle  13  of the instrument. Holes in the blade  130  are provided for attaching the respective ends of the cable and spring  135  to the blade. Cable  136  extends through shaft  14  via one of the channels (or an additional channel) through the flexible body  80  and needle guide  72  and out an opening in the rigid tube  70  in housing  12  to trigger  134 . This opening in rigid tube  70  may have a seal if needed to maintain vacuum when suction is communicated down shaft  14  to the distal end. Pulling trigger  134  rotates the blade  130  to the right against the bias of spring  135  as shown in  FIG. 58C , and releasing the trigger  134  rotates the blade  130  back to the left ( FIG. 58B ), as indicated by arrow  137 . This oscillating motion is controlled by the user of the instrument  10  via the trigger  134 , and the blade  130  is advanced forward (or backwards) by turn screw  26  in the same manner as advancing tube blade  86  so as to cut tissue when held by suction and stabilized by needles in cavity  20  against the tissue engaging surface. The width of the blade  130  is greater than the width of opening  19 , and the blade may be flat or curved. Either oscillating blade  130  or tubular blade  86  may be used in distal housing  18  or  18   a  of the instrument  10 , and such blades, like other components of the instrument  10  interfacing with a patient body, are made of stainless steel or other biocompatible material. 
     Referring to  FIGS. 59 and 59A , another embodiment of the instrument  10  is shown for use in obtaining a biopsy from the breast  141  of a patient. Typically, a flexible guide wire  142  is first inserted into the breast to locate abnormal or suspect tissue  140 . The flexible guide wire  142  may be drawn through the instrument  10 , via an opening in cap  99  at the distal end  18  under or through manifold  91 , through the distal housing  18  to one of the channels (or an additional channel) of the flexible body  80  and needle guide  72 , and then out an opening in the rigid tube  70  in housing  12  through an opening adjacent to opening  12   b  ( FIG. 4 ). The opening in rigid tube  70  may have a seal if needed to maintain vacuum when suction is communicated down shaft  14  to the distal end  16 . To facilitate passing the guide wire  142  through the instrument  10 , a lead wire (not shown) may be use which is loaded along the path over which the flexible guide wire will pass, and then is temporarily attached to the guide wire end not located in breast tissue, such that pulling the lead wire will pass the guide wire  142  through the instrument  10 . The path of guide wire  142  is represented by dashed lines through shaft  14  and housing  12  in  FIG. 59 . The instrument&#39;s distal end  16  can thus pass through a surgical opening  140  along the guide wire  142  into the patient&#39;s breast  141  near the site of tissue  140 . An image transducer  144 , such as an ultrasonic or other imaging means, is located in the distal housing  18 , to image tissue adjacent the distal end  16  so that all or part of tissue  140  can be suctioned into the instrument and cut to capture a biopsy specimen as described earlier. When the instrument is then removed from the breast  141 , the biopsy specimen can be removed from the distal end and evaluated. The image transducer  144  is sufficiently small to be located in the distal housing  18  along the gap  124  ( FIG. 17A ) sized for the transducer along the manifold  91 . The transducer  144  emits and receives signals for imaging through cable(s) extending through the instrument  10  to an image display system  145 , similar to that of a typical ultrasonic imager for viewing images on a display. Such cable(s) may extend through shaft  14  through one of channels (or an additional channel) of flexible body  80  and needle guide  72 , and then out an opening in the rigid tube  70  in housing  12 , to image display system  145 . This opening in the rigid tube  70  may have a seal to maintain vacuum when suction is communicated down shaft  14  to the distal end, if needed. The shaft  14  may be flexible or rigid. 
     Optionally, the instrument  10  may have an imaging system and/or steering mechanism shown in  FIGS. 60 and 60A . The distal housing  18  has an opening  146   a  for an illumination source  148  and another opening  146   b  for an image detector  149 . The image detector  149  may represent the end of a coherent bundle of optical fibers, lens, or an electronic image detector, such as a CCD. The image detector  149  is coupled by cable(s)  151  through the instrument  10  to a video display system  150  for viewing images from the distal end  16  on a display  152 . The illumination source  148  may also represent optical fiber(s)  153  coupled to a light source  154  for providing such illumination, but any illumination means may be used which provides sufficient illumination for enabling imaging by detector  149 . Cable(s)  151  or fibers(s)  153  may extend through shaft  14  via one of the channels (or additional channel(s)) through the flexible body  80  and needle guide  72  and out an opening in the rigid tube  70  in housing  12 , to trigger  134 . This opening in rigid tube  70  may have a seal, if needed, to maintain vacuum when suction is communicated down shaft  14  to the distal end. For example, the image system provided by illumination source  148 , image detector  149 , illumination  148 , and video display system  150 , may be similar to that used in a typical endoscope. Also, a steering mechanism is provided by multiple wires or cables  152 , such as four, which travel from the housing  12  in channels, tubes, or sheaves along outside length of shaft  14  and coupled to the distal end housing  18  and are movable in such channels or sheaves. Optionally, such wires  152  may pass through tubes or sheaves internal in shaft  14 . By controlling the length of one or more of the different wires  152  along shaft  14  using a controller or dials  154  mounted in the housing  12 , the distal end  16  is steerable. For example, the steering mechanism may be similar to that used by a typical endoscope, such as a gastroscope, for steering its distal end. Advantages of the integrated imaging and steering mechanisms are that an endoscope is no longer needed to assist in operating the instrument as described earlier in connection with  FIG. 2 , and the interface between the instrument and patient can be further miniaturized. 
     Referring to FIGS.  61  and  61 A- 61 E, instrument  10  is shown having distal end  16   a  and guide members  34   a  of  FIG. 58 , where a linear blade member  156  replaces oscillating blade member  130  in the cutting mechanism. The linear blade member  156  has a sharp edge  156   a , like a scalpel, and an end  156   b  coupled to a wire  158 . Wire  158  extends from the blade member  156  through shaft  14  and housing  12  to a ball or spherical member  160  rotatably mounted in a socket formed at the end of shaft  26   b  at turnscrew  26  ( FIG. 61D ). A retainer member may be used to retain the ball in such socket. An attachment of a wire to a turnscrew utilizing such a ball and socket joint is shown, for example, in U.S. patent application Ser. No. 10/095,842, filed on Mar. 12, 2002, which is incorporated by reference. However, other mechanical means may also be used to couple the wire to a turnscrew or rotatable control knob, which when rotated does not couple such rotation to the wire. Wire  158  replaces the drive tube  63 , coupler member  78 , flexible tube  80 , and tube  84  described earlier, and travels along the same path as such through housing  12  and shaft  14  to distal end  16   a . Wire  158 , for example, may be of stainless steel, and is sufficiently flexible to enable flexure along flexible section  14   b  of the shaft. Blade member  156 , for example, may also be made of stainless steel. The wire  158  may also be provided by two separate wires (or tubes) coupled together, one which is substantially rigid for passage through rigid portion  14   a  and another which is substantially flexible for passage through flexible section  14   b  of the shaft  14 . 
     The blade member  156  is disposed in distal housing  18  such that the blade member advances from a retracted position before cavity  20 , as shown in  FIG. 61D , along a linear path, centrally oriented, through the cavity to cut tissue engaged therein against manifold  91 . The length of edge  156   a  is such that when fully extended through the cavity, it is capable of producing a longitudinal incision across the length of cavity  20 .  FIGS. 61A ,  61 B, and  61 E show forward blade advancement in which full-extended position is shown in  FIGS. 61C and 61F . The path of blade member  158  is provided through channel  97   a  via opening  97  of manifold member  91  ( FIG. 17 ) such that the blade edge  156   a  extends upwards through central opening  95  ( FIG. 45 ) as it passes through cavity  20 . To allow blade member  156  to enter channel  97   a  and central opening  95 , an opening (or slit) extends through end  91   b  of manifold member  91  such that the blade member can pass into and through channel  97   a  and central opening  95 . The blade member  156  is advanced by rotating turn screw  26 , as indicated by the arrow  162 , to translate forward motion to blade  156  via wire  158 , as indicated by arrows  163 , but avoiding translation of rotation to the wire by use of ball and socket coupling to shaft  26   b . The incision made in tissue is of a length defined by the length of cavity  20 , and is of a depth from surface  91   e  of manifold  91  and height of blade edge  156   a  with respect to this surface. When turn screw  26  is then rotated in the opposite direction, the blade member  156  is translated in the opposite direction to retract the blade member. 
     One application of instrument  10  of  FIG. 61  is to make a controlled incision in tissue at remote locations for purposes of releasing constricted or narrowed tissue passageways. For example, the chronic burning of the distal esophagus in GERD can also cause pathologic scar formation (i.e., stricture) that reduces the luminal passageway of the esophagus and potentially restricts flow of the swallowed food. A common practice in surgical disease states is to longitudinally cut open a narrowed tube and suture it back closed in a transverse orientation to reestablish a wider lumen. This maneuver, sometimes called the Heineke-Mikulicz technique, utilizes redundant tissue length to overcome constricted tissue diameters. For example, a normal adult esophagus usually has an inner diameter of about 20 mm. When disease causes the diameter to narrow to less than 12 mm, swallowed material passage can become inhibited. The distal end  16   a  with linear blade member  156  may also be used in other tubular structures of the gastrointestinal tract, urinary tract, or vascular structures, and along any tissue surface or within soft tissue structures. 
     The instrument  10  is sized in accordance with the particular tissue structure into which the instrument will be inserted, and the distal end  16  may be sized in terms of the dimensions of the opening, cavity, and location and contour of manifold member therein for the particular size and depth of the tissue to be cut and removed when such tissue is held by suction and stabilized by the needles upon the tissue engaging surface provided by the manifold. Further, to obtain a longer or shorter shaft  14  with different lengths of the rigid and flexible sections  14   a  and  14   b  can be achieved by adjusting the length of the rigid tube  70  and the flexible body  76 . For example, in application of the instrument through the mouth into the esophagus of a patient, the shaft  14  of the instrument may be 75 cm in length to distal housing, both with a diameter of 6 mm. Although the apparatus  10  is described herein for use in human patients, it may also be used in animals with proper sizing of the shaft  14  and distal end  16 . 
     From the foregoing description, it will be apparent that an improved instrument and method for surgically cutting tissue is provided to remove tissue from remote sites in the body of a patient. Variations and modifications in the herein described an apparatus and method in accordance with the invention will undoubtedly suggest themselves to those skilled in the art. For example, although the instrument is directed for use in tubular structures, it may be used in other surgical application where remote cutting of tissue is required. Accordingly, the foregoing description should be taken as illustrative and not in a limiting sense.