Abstract:
An embodiment of the invention includes a device for collecting body tissue. The device may include an inner member comprising a hollow portion to collect body tissue and a distal end configured to both penetrate body tissue and define an opening of the hollow portion. The device may further include an outer member, co-axially and slidably disposed around the exterior of the inner member, comprising a distal end portion. The distal end portion of the outer member may be configured to penetrate body tissue, prevent body tissue from exiting the hollow portion of the inner member, and allow the distal end of the inner member to extend beyond the distal end of outer member. The opening of the hollow portion of the inner member may be disposed in a plane that is not perpendicular to the longitudinal axis of the inner member.

Description:
This is a continuation application of U.S. patent application Ser. No. 10/361,684, filed Feb. 11, 2003 now U.S. Pat. No. 7,137,956, which is continuation application of U.S. patent application Ser. No. 09/801,746, filed Mar. 9, 2001 now U.S. Pat. No. 6,551,254, which is a continuation application of U.S. patent application Ser. No. 09/406,917, filed Sep. 28, 1999 now U.S. Pat. No. 6,248,081, the entirety of all of which are incorporated herein by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates to surgical instruments and, particularly, to an instrument for biopsy sampling of tissue. Still more particularly, the present invention relates to an endoscopic biopsy instrument that obtains core biopsy samples and integrates two or more biopsy-sampling modalities. 
     2. Background of Related Art 
     Biopsy is the removal and study of body tissue for medical diagnosis. Typically, physicians obtain biopsy samples in order to detect abnormalities such as cancer and determine the extent to which cancerous tissue has spread. They use various biopsy instruments to acquire tissue samples from different areas of the body. Many current biopsy instruments, however, cannot retrieve full core samples of tissue, do not provide versatility in sampling methods, or are overly intricate in design and manufacture. 
     During a biopsy tissue-sample procedure performed on a body lumen, a physician generally uses an endoscope to provide a passageway for entry of the biopsy instrument into the body. Having thus secured access to the biopsy site, the physician uses some device to extract a tissue sample from the wall of the target body lumen. Usually, the walls of body lumen, such as the esophagus, the gastrointestinal tract, or the urinary tract, have three layers: the surface mucosal or epithelial layer comprised of mucus; the submucosal layer, which is below the mucosal layer; and the muscle layer. Many current biopsy devices can only take tissue from the surface mucosal layer and also cannot retrieve full core samples. 
     In many situations, physicians may desire full core samples because, with larger cross-sections of tissue types, they can more accurately determine the extent to which cancer has spread. It is also desirable to obtain full, clean core samples that have not been crushed by devices penetrating into tissue. Moreover, it may be desirable to obtain a full core sample without having to penetrate past a desired depth of tissue in order to obtain a corresponding desired depth of core sample. It would be preferable to insert a biopsy needle only as far as necessary to obtain a full core sample to minimize trauma to the patient. 
     Further, many current devices lack versatility. Many devices today extract tissue samples through aspiration, brush cytology, or pinch biopsy. In the case of aspiration, a physician inserts a very fine needle into the wall of the target tissue and draws fluid, typically saline, through the needle. The physician thus collects some surface tissue cells. In the case of brush cytology, a physician introduces a brush through the lumen of the endoscope to collect tissue cells by scraping the surface of the target site. In the case of pinch biopsy, a physician inserts a bioptome, having a pair of opposed jaw cups, through the lumen of the endoscope, to the tissue site. The physician may then close the jaws around the target surface and pinch away a sample from the surrounding tissue. 
     Typically, current devices may employ only one of these methods to obtain tissue samples. Thus, a physician who desires tissue samples obtained through both aspiration and brush cytology, for example, must insert one instrument, take a sample, retrieve the instrument, insert a second instrument, take a second sample, and then retrieve the second instrument. Such practice is time consuming and leads to procedural inefficiency. 
     Many current instruments also have an overly complex design. Devices that might otherwise fulfill one of the aforementioned needs, such as the need to capture core samples, for example, often employ complex cutting mechanisms held in sheaths or housings requiring very exact tolerances. 
     In light of the foregoing, there exists a need for a biopsy tissue-sampling device that effectively obtains a full core tissue sample, accommodates multiple sampling modes, and is simple in design and inexpensive to manufacture. 
     SUMMARY OF THE INVENTION 
     It is therefore an object of the invention to provide a surgical instrument that is able to obtain a full core biopsy tissue sample with minimal trauma to the patient. 
     It is a further an object of the invention to provide a surgical instrument that integrates two or more biopsy tissue sampling modalities. 
     It is another object of the invention to provide a surgical instrument that integrates three biopsy tissue sampling modalities. 
     Additional objects and advantages of the invention will be set forth in the description which follows and, in part, will be obvious from the description or may be learned by practice of the invention. The objects and advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. 
     To achieve the objects and in accordance with the purpose of the invention, as embodied and broadly described herein, the invention comprises an instrument for collecting body tissue, comprising: a needle having an axial center, an exterior surface, a hollow interior, a distal end and a proximal end, wherein the distal end is capable of penetrating body tissue; a flexible cutting extension coaxially and slidably disposed around the exterior surface of the needle, the cutting extension including a blade surface having a cutting edge wherein the blade surface is biased toward the axial center of the needle such that the cutting extension moves toward the axial center of the needle when urged past the distal end of the needle and the edge cuts tissue located at the distal end of the needle and the blade surface covers the distal end of the needle so that tissue that has entered the hollow interior of the needle is trapped in the hollow interior of the needle. 
     In a preferred embodiment, the cutting extension comprises a symmetrical arrangement of blade surfaces biased toward the axial center of the needle. 
     In another preferred embodiment, the cutting extension includes a plurality of blade surfaces biased toward the axial center of the needle. 
     In another preferred embodiment, the blade surface of the flexible cutting extension forms an opening and at least part of the surface forming the opening forms the cutting edge. 
     In another preferred embodiment, the instrument further comprises: a first tubular member having a proximal end and a distal end connected to the proximal end of the needle; a second tubular member coaxially disposed around the first tubular member, the second tubular member having a proximal end and a distal end connected to the proximal end of the cutting extension; and a handle mechanism connected to the proximal ends of the first and second tubular members, the handle mechanism having a housing and a means for extending the cutting extension beyond the distal end of the needle. 
     In another preferred embodiment, the means for extending the cutting extension comprises a resilient member connected between the handle housing and the second tubular member for extending the cutting extension connected to the second tubular member distally beyond the distal end of the needle. 
     In still another preferred embodiment, the means for extending the cutting extension comprises a first hub connected to the first tubular member and a second hub connected to the second tubular member, the second hub slidable relative to the first hub to extend the cutting extension relative to the needle. 
     In another preferred embodiment, the instrument further comprises a third tubular member coaxially disposed around the first and second tubular members and having a proximal end connected to the handle housing. 
     In yet another preferred embodiment, the instrument further comprises a fourth tubular member disposed within the third tubular member a brush coaxially disposed in the fourth tubular member. 
     In another preferred embodiment, the instrument further comprises a brush coaxially disposed in the first tubular member. 
     In another preferred embodiment, the proximal end of the first tubular member is connected to a vacuum source for cell aspiration. 
     In another preferred embodiment, an instrument for collecting body tissue is provided, comprising: a tubular cutting member having an exterior surface, a proximal end and a distal end capable of penetrating body tissue; a flexible cutting extension coaxially and slidably disposed around the exterior surface of the cutting member, the flexible cutting extension having a proximal end and a distal end capable of cutting tissue located at the distal end of the cutting member and covering the distal end of the cutting member so that tissue that has entered the needle is retained in the cutting member; a first tubular member connected to the cutting member; a second tubular connected to the cutting extension; a handle mechanism connected to the first and second tubular members such that the flexible cutting extension may be extended beyond the distal end of the cutting member. 
     In another preferred embodiment, an instrument for collecting body tissue is provided, comprising: a needle having an axial center, an exterior surface, a hollow interior, a proximal end and a distal end capable of penetrating body tissue, a flexible cutting extension coaxially and slidably disposed around the exterior surface of the needle, the flexible cutting extension including at least a blade surface having a cutting edge and being biased toward the axial center of the needle such that the flexible cutting extension moves toward the axial center of the needle when urged past the distal end of the needle and the edge cuts tissue located at the distal end of the needle and the blade surface covers the distal end of the needle; a first tubular member having a proximal end and a distal end connected to the proximal end of the needle; a second tubular member coaxially disposed around the first tubular member, the second tubular member having a proximal end and a distal end connected to the proximal end of the cutting extension and being moveable relative to the first tubular member to provide relative movement between the needle and the flexible cutting extension. 
     It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive of the invention as claimed. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments of the invention and, together with the description, serve to explain the principles of the invention. 
         FIG. 1  is a side elevation view of an endoscopic bioptome according to a preferred embodiment of the present invention. 
         FIG. 2  is a sectional side view of an end effector cutting mechanism according to the present invention. 
         FIG. 3A  is a side view of an end effector cutting mechanism according to the present invention. 
         FIG. 3B  is a cross-sectional bottom, end view of the end effector cutting mechanism of  FIG. 3A  taken along line  1 - 1 . 
         FIG. 3C  is a cross-sectional side view of the end effector cutting mechanism of  FIG. 3A  taken along the line  2 - 2  shown in  FIG. 3B . 
         FIG. 3D  is a top view of the end effector cutting mechanism of  FIG. 3A . 
         FIG. 3E  is an side elevational view of the end effector cutting mechanism of  FIG. 3A . 
         FIG. 3F  is an enlarged view of the distal end of the end effector cutting mechanism of  FIG. 3E . 
         FIG. 4A  is a side view of a needle portion of an end effector cutting mechanism according to the present invention. 
         FIG. 4B  is a cross-sectional bottom, end view of the needle of  FIG. 4A  taken along the line  3 - 3 . 
         FIG. 4C  is cross-sectional side view of the needle of  FIG. 4A  taken along the line  4 - 4  shown in  FIG. 4B . 
         FIG. 4D  is a cross-sectional top, end view of the needle of  FIG. 4A . 
         FIG. 4E  is a bottom elevational view of the needle of  FIG. 4A . 
         FIG. 4F  is a side elevational view of the needle of  FIG. 4A . 
         FIG. 4G  is an enlarged view of the distal end of the needle of  FIG. 4G . 
         FIG. 5A  is a side view of an outer cutting mechanism of an end effector cutting mechanism of the present invention. 
         FIG. 5B  is a cross-sectional side view of the outer cutting mechanism of  FIG. 5A . 
         FIG. 5C  is side elevational view of the outer cutting mechanism of  FIG. 5A . 
         FIG. 5D  is top elevational view of the outer cutting mechanism of  FIG. 5A . 
         FIG. 5E  is a cross-sectional end view of the outer cutting mechanism of  FIG. 5A . 
         FIG. 6  is a side elevational view of an end-effector cutting mechanism according to another embodiment of the present invention. 
         FIG. 7A  is a side elevational view of an end effector cutting mechanism according to another embodiment of the present invention. 
         FIG. 7B  is a side view of the end effector cutting mechanism of  FIG. 7A . 
         FIG. 7C  is a cross-sectional side view of the end effector cutting mechanism of  FIG. 7A . 
         FIG. 7D  is a top, end view of the end effector cutting mechanism of  FIG. 7A . 
         FIG. 8A  is a side view of a needle portion of an end effector cutting mechanism according to the present invention. 
         FIG. 8B  is top view of the needle of  FIG. 8A . 
         FIG. 8C  is a cross-sectional end view of the needle of  FIG. 8A . 
         FIG. 9A  is a side view of a cutting extension portion of an end effector cutting mechanism according to the present invention. 
         FIG. 9B  is an elevation side view of the cutting extension of  FIG. 9A . 
         FIG. 9C  is a top end view of the cutting extension of  FIG. 9C . 
         FIG. 9D  is a side elevational view of a float portion of an end effector cutting mechanism according to the present invention. 
         FIG. 10A  is a side view of an end effector cutting mechanism attached to a tubular member. 
         FIG. 10B  is a cross-sectional end view of the tubular member of  FIG. 10A . 
         FIG. 11A  is an elevational view of a handle assembly according to the present invention. 
         FIG. 11B  is a sectional side view of the handle assembly of  FIG. 11A . 
         FIG. 11C  is a sectional top view of the handle assembly of  FIG. 11A . 
         FIG. 11D  is a top elevation view of the handle assembly of  FIG. 11A . 
         FIG. 11E  is a side view of the handle assembly of  FIG. 11A . 
         FIG. 11F  is a bottom, end view of the handle assembly of  FIG. 11A . 
         FIG. 12A  is an elevational view of the housing portion of the handle assembly of  FIG. 11A . 
         FIG. 12B  is an elevation view of a first hub portion of the handle assembly of  FIG. 11A . 
         FIG. 12C  is an elevational view of a second hub portion of the handle assembly of  FIG. 11A . 
         FIG. 12D  is an elevational view of a tab portion of the handle assembly of  FIG. 11A . 
         FIG. 12E  is a cross-sectional side view of a mechanism for attaching a second tubular member to a second hub. 
         FIG. 13  is a handle assembly according to an embodiment of the present invention. 
         FIG. 14A  is a partial sectional side view of an end effector, brush and tubular member according to the present invention. 
         FIG. 14B  is a partial sectional side view of the brush of  FIG. 14A  in use. 
         FIG. 14C  is a partial sectional side view of the needle of the end effector cutting mechanism of  FIG. 14A  being inserted into a tissue site. 
         FIG. 14D  is a partial sectional side view of the cutting extension of the end effector cutting mechanism of  FIG. 14A  extended over the needle. 
     
    
    
     DETAILED DESCRIPTION 
     Reference will now be made in detail to the present preferred embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible the same reference numbers are used in the drawings and the description to refer to the same or like parts. 
     The present invention is directed to a surgical instrument, particularly an endoscopic instrument for obtaining a biopsy of submucosal tissue. The instrument described in detail below uses a unique end effector to obtain full core biopsy samples and integrates multiple modalities of biopsy tissue sampling. The instrument integrates aspiration and brush cytology with full core biopsy sampling. 
     The instrument according to the present invention is shown generally at  10  in  FIG. 1 . Instrument  10  includes three main sections: a handle assembly  12  at its proximal end; an end effector assembly  14  at its distal end; and a tubular section  13  extending between handle  12  and end effector assembly  14 . End effector  14  generally includes inner and outer coaxial cutting members. Tubular section  13  and end effector  14  may be deployed to the tissue site through the working channel of an endoscope or other delivery mechanism. 
     As illustrated in FIGS.  2  and  3 A- 3 F, end effector  14  includes an inner cutting mechanism preferably consisting of a needle  15  having a sharpened distal end for penetrating tissue and an outer cutting mechanism  25  biased inwardly to cut tissue located within the interior of needle to retain the tissue within the interior of needle  15 .  FIGS. 3A-3F  illustrate various views of end effector  14 .  FIG. 3F  illustrates an enlarged view of the distal end of end effector  14 . 
     As embodied herein, and as illustrated in  FIGS. 4A-4G , needle  15  has an axial center  16 , an exterior surface  17 , a hollow interior  18 , a proximal end  23 , and a distal end  19  capable of penetrating body tissue. At least a portion, and preferably all, of the distal end of needle provides a sharpened cutting surface  20 . As needle  15  is advanced into body tissue, sharpened distal end  19  cuts tissue that enters the hollow interior  18  of needle  15  to provide a full core biopsy sample. In the embodiment shown in  FIGS. 4A-4G , cutting surface  20  of needle  15  is formed to a pointed, angular, cutting surface. 
     Needle  15  may also be provided with a hub  21  toward its proximal end  23 . Hub  21  serves as a stop for a catheter or other tubular member received on the proximal end  23  of needle  15  and for outer cutting mechanism  25 . The end of a catheter or other tubular member, which forms part of tubular section  13 , may abut the hub portion  21  of needle  15  and may be retained on the needle by adhesive or other fixing mechanism. Needle  15  may also be formed integrally with a catheter or other tubular member. Needle  15  is preferably a flexible needle, such as a flexible sclerotherapy needle, but may also be rigid. While the inner cutting mechanism has been described as a needle, it is not limited to such and it should be recognized that any suitable tubular member having a sharpened distal end for penetrating tissue may be used. 
     In the embodiment shown in  FIGS. 5A-5E , outer cutting mechanism  25  includes a flexible cutting extension  26 , coaxially and slidable disposed around the exterior surface  17  of needle  15 . Cutting extension  26  includes a proximal portion  29 , and a distal blade surface  27  having a sharpened edge  28 . Sharpened edge  28  extends along at least a portion, and preferably all, of the perimeter of blade surface  27 . Cutting extension  26  is biased radially inward toward the axial center  16  of needle  15  such that cutting extension  26  moves toward the axial center of needle  15  when it is extended beyond the distal end of needle  15 . Blade surface  27  also covers the distal end of needle  15  when it is extended such that tissue that has entered needle  15  is trapped within the hollow interior  18  of needle  15 . Cutting extension  26  and blade  27  are preferably made from a metallic alloy, either machined, cast, or stamped to obtain the desired shape and structure. It should be recognized that other suitable materials may be used. 
     Proximal portion  29  of cutting mechanism  25 , preferably has a reduced diameter for receiving the end of a catheter or other tubular member, which forms part of tubular section  13 . The tubular member may be retained on the proximal end portion  29  by adhesives or other fixing mechanism. When cutting extension  26  is disposed over needle  15 , proximal portion  29  may abut hub portion  21  on needle  15  when cutting extension  26  is in the retracted position and needle cutting surface  20  is exposed. In this instance, the hub portion  21  acts as a back stop mechanism limiting rearward movement of the outer cutting mechanism. Alternatively, a tubular member may be connected to the cutting mechanism through a float as will be described in connection with  FIGS. 7A-7D . 
     As shown in  FIG. 6 , cutting extension  26  may alternatively be provided with a circular hole  35  corresponding to the opening formed in the distal end of needle  15 . Hole  35  has a cutting surface  36 , extending along at least a portion, and preferably the entire, circumference surface of hole  35 . In operation, cutting extension  26  is extended over needle  15  such that hole  35  allows access to the hollow interior  18  of needle  15 . Instrument  10  may then be advanced into the tissue site to be sampled and needle cutting surface  20  and/or cutting surface  36  of hole  35  cuts the tissue as the instrument is advanced causing the tissue to enter the hollow interior  18  of the needle  15 . Cutting extension  26  may then be retracted causing cutting surface  36  of hole  35  to cut the tissue at the distal end of needle  15  trapping the tissue sample in the hollow interior  18  of needle  15 . Alternatively, cutting extension  26  may be further extended, causing cutting surface  36  of hole  35  to cut the tissue at the distal end of the needle  15 . 
     Another end effector cutting mechanism is shown in  FIGS. 7A-7D ,  8 A- 8 C, and  9 A- 9 D. As shown in these figures, needle  15  includes sharpened distal end portion  40  having cutting surface  41 . Cutting surface  41  preferably forms a wavy conical-shaped surface having rounded roots and preferably extends along the entire distal end portion  40 . Outer cutting mechanism  25  includes cutting extension  45 . Cutting extension  45  includes multiple cutting surfaces, shown here as four cutting blade surfaces  46  having edges  47 , arranged radially around an axial center  48  of cutting extension  45 . Blade surfaces  46  are all biased toward the axial center  16  of needle  15 . Blade surfaces  46  are flexible and move toward the axial center  16  of needle  15  when cutting extension  45  is extended beyond the distal end  40  of needle  15 . Blade surfaces  46  also cover the distal end  40  of needle  15  so that tissue that has entered needle  15  is trapped in the hollow interior  18  of needle  15 . As shown in  FIGS. 9A-9C , edges  47  of blade surfaces  46  preferably contact each other to cover the opening of the hollow interior  18  of needle  15 . Cutting extension  45  and blade surfaces  46  are preferably made from thin metallic material, preferably stamped and formed, but possibly machined and cast, into a circular tubular shape. It should be recognized that other suitable materials may be used. While cutting extension  45  is illustrated with four cutting surfaces it should also be recognized that fewer or additional cutting surfaces could be used. 
     As illustrated in  FIG. 7C , needle  15  may be provided with a front hub  22 , as well as rear hub  21 , that act as a front stop and back stop limiting the movement of the cutting extension. Cutting extension  45  may be connected to or formed integrally with a float  30  slidably displacable between front stop  21  and back stop  22 . When cutting extension  45  is in the retracted position wherein blades are biased outwardly on needle  15 , hub or back stop  21  interacts with float  30  to limit the rearward travel of cutting extension  45 . When cutting extension  45  is extended over needle  15 , wherein blades  46  move inwardly over distal end  40  of needle  15 , hub or front stop  22  limits the forward travel of cutting extension  45  relative to needle  15 . By limiting the movement of the cutting extension, the stops prevent the cutting extension from being unnecessarily advanced into tissue beyond the distal end of needle  15  and retracted along the proximal end of needle  15  thereby creating a compact system despite any slack in the catheter assembly that allows for consistent sampling. It should be recognized that a float and front stop  22  could be used with the embodiments described in  FIGS. 1-6 . 
     Also in accordance with the present invention, tubular section  13  is provided to connect end effector assembly  14  to a handle assembly. As shown in  FIGS. 2 and 12E , tubular section  13  includes a first tubular member  55  connecting needle  15  to handle assembly  12  and a second tubular member  56  coaxially disposed around first tubular member  55  connecting outer cutting mechanism  25  or  45  to handle assembly  12 . First tubular member  55  may be connected to proximal end  23  of needle  15  through any suitable connection such as adhesives or a retaining ring. Alternatively, first tubular member  55  could be formed integrally with needle  15 . Second tubular member  56  is preferably connected to float  30 , connected to cutting mechanism  25  or  45  such that second tubular member  56  abuts the proximal end of the cutting mechanism. Alternatively, second tubular member  56  may be connected directly to the proximal end of cutting mechanism  25  or  45 , as shown in  FIG. 2 . Second tubular member  56  may be connected to float  30  or the cutting mechanism through any suitable connection such as adhesives or a retaining ring. Second tubular member  56  may also be connected to float  30  or the cutting extension through connection wires  57  as shown in  FIGS. 10A and 10B . Connection wires  57  may be placed in second tubular member  56  during extrusion of second tubular member. Distal ends  58  of connection wires  57  may be connected to outer cutting mechanism  25  or  45  through any suitable connector mechanism. 
     The second tubular member is preferably sized so as to pass through the working channel of an endoscope. The first tubular member is preferably sized so as to pass through the lumen of second tubular member and allow collection of and passage of biopsy tissue samples. First and second tubular members  55  and  56  are preferably flexible, such as flexible catheters, so that they may pass through the working channel of an endoscope or other delivery mechanism. First and second tubular members  55  and  56  may be made from polymer tubing, braided polymeric tubing, or other suitable material. While first and second tubular members are preferably flexible, the present invention is not limited to such and either one or both of the tubular members could be a rigid tubular member such as a trocar. 
     Handle assembly  12  is connected to the proximal ends of first and second tubular members  55  and  56  to allow relative movement between needle  15  and outer cutting mechanism  25  or  45  and to actuate the cutting extension. In accordance with an embodiment of the present invention as shown in  FIGS. 11A-11F  and  12 A- 12 E, handle  12  includes a housing  60  having a distal end opening  61 , a proximal end opening  62 , a slot  63  on one surface of the housing, a notch  64 , and an interior portion  65 . Notch  64  is enlarged at one end  66 . 
     Handle assembly  12  also includes a first hub  70 , and a second hub  80 . First hub  70  has an opening  71  at its proximal end, an opening  72  at its distal end, a body portion  73  in between, and an interior passageway  74 . Body portion  73  of first hub  70  generally includes a first portion  76  sized to fit within the interior of second hub  80  and an enlarged second portion  77  adapted to grasped by a user. Second portion  77  includes a ridge  78  adapted to fit within notch  64  of housing  60 . Ridge  78  has an enlarged end  79  such that it fits within enlarged end  66  of notch  64 . First tubular member  55  may be connected to first hub  70  to provide communication between the interior of first tubular member  55  and needle  15  and to provide movement of first tubular member  55  and needle  15  when first hub  70  is moved. First tubular member  55  may connected to the interior passageway  74  through any suitable mechanism, such as by gluing or fastening means. First tubular member  55  may also be glued or fastened to the inside of proximal opening  71  of the first hub  70 , or it may be fastened to the outside of proximal opening  71  through a retaining ring or cap or other mechanism. 
     Proximal opening  71  may be provided with a removable cap  75  to limit access to the interior of first tubular member  55  and needle  15 . Proximal opening  71  may be connected to a source of aspiration or may provide access for other tools, such as a brush for brush cytology, thereby providing multiple sampling modalities. 
     Second hub  80  has a proximal end opening  81 , a distal end opening  82 , an opening  83  on one surface thereof and a hollow interior  84 . Second tubular member  56  may be connected to distal end opening  82  such that the interior of second tubular member  56  communicates with the opening and that second tubular member  56  and cutting mechanism  25  or  45  are moved when second hub  80  is moved.  FIG. 12E  illustrates a preferred embodiment for attaching the second tubular member  56  to the handle assembly  12 . Second tubular member  56  may be provided with a flared section  561 . Flared section  561  may be positioned coaxially around distal end opening  82  so that flared section  561  rests on the outside of distal end opening  82 . A tightener cap  562  may be placed over second tubular member  56  and positioned so that it rests on the flared section  561 . Tightener cap  562 , or other suitable retaining ring, may then be tightened to clamp the flared section  561  onto the outside of the distal end opening  82 . It should be recognized that other suitable attachment mechanisms may be used. 
     First portion  76  of first hub  70  is adapted to slidably fit within the hollow interior  84  of second hub  80  as shown by the arrow on enlarged portion  77  of first hub  70  in  FIGS. 11D and 12B . Both first and second hubs  70  and  80  fit within housing  60  with enlarged portion  77  of first hub  70  extending from proximal opening  62  in housing  60 . 
     Handle assembly  12  also includes a tab  85  having a pin  86  or other fastening means, such as a screw or some adhesive. Pin  86  of tab  85  is adapted to slidably fit within slot  63  of housing  60 . Pin  86  also fits into opening  83  in second hub  80  to control movement of the second hub. 
     First and second tubular members  55  and  56  may be disposed in a housing tubular member, or third tubular member as described in connection with  FIGS. 14A-14D , connected to housing  60 . The housing tubular member may be retained on the distal end opening  61  of housing  60  with a retaining cap like the one described in  FIG. 12E  or it may be secured with other suitable retaining mechanisms. 
     In operation, a biopsy procedure may start with the needle in a retracted position in which enlarged portion  77  extends from housing  60  as shown. At this time cutting mechanism  25  is extended over needle  15  preventing tissue from entering the interior of needle  15 . When a tissue sample is desire, enlarged portion  77  of first hub may be urged forward allowing ridge  78  to slide within notch  64  in housing  60  until ridge  78  meets the end of notch  64  causing needle  15  to be extended from cutting mechanism  25  thereby exposing needle  15  for entering a tissue site. Because notch  64  has a narrowing  66  surrounded enlarged opening  65 , enlarged portion  79  of ridge  78  may be retained with notch  64 . Ridge  78  can be dislodged from notch  64 , but extra force is required to do so thereby preventing inadvertent withdrawal of needle  15 . After needle  15  has penetrated the tissue site through a process in which the end effector is manually pushed into the tissue by advancing the tubular members, tab  85  may be slid forward within slot  63  causing cutting mechanism  25  or  45  to be extended over needle  15  thereby cutting and retaining the tissue sample within the interior of needle  15 . This process may be repeated without removing needle  15  and cutting mechanism  25  and multiple full core samples of tissue may obtained. 
     In accordance with another embodiment of the present invention, as shown in  FIG. 13 , handle  12  includes a resilient body portion  90  designed to fit within the hand of the operator and be compressed by the hand of the operator, providing a tactile handle responsive to pressure from the operator. Body portion  90  includes a distal end  91 , a proximal end  96  and two side portions  95 . Distal end  91  of body  90  is connected to the proximal end of second tubular member  56 . A stabilization wire  92  is connected to the proximal end  96  of first tubular member  55  and the proximal end of body  90 . Wire  92  may be fastened within an opening  97  in the proximal end of body  90  through a screw  94  or other suitable fastener. Alternatively, the first tubular member may extend through the body portion and proximal portion  96  of handle  12 . When sides  95  of body  90  are compressed by the operator, second tubular member  56  and cutting mechanism  25  or  45  are extended. Needle  15  is retained in position relative to the proximal end of body  90  by wire  92  thereby allowing relative movement between cutting mechanism  25  or  45  and needle  15 . 
     As shown in  FIGS. 14A-14D , the present invention may used within in a third tubular member  101 , providing access for both the end effector cutting mechanism and a brush  102 . Brush  102  may be used to obtain cell samples from a surface  103  of a tissue site as shown in  FIG. 14B . The brush  102  may be disposed in a fourth tubular member  104  or alternatively may be disposed coaxially in the first tubular member  55 . The operation of outer cutting mechanism  25  and needle  15  is also illustrated in  FIGS. 14C and 14D . Outer cutting mechanism  25  is retracted from needle  15 , and needle  15  is advanced into the tissue site to obtain a full core biopsy sample, as shown in  FIG. 14C . Outer cutting mechanism  25  is then extended over needle  15 , cutting the tissue within needle  15  and holding the tissue within the interior of needle  15 , as shown in  FIG. 14C . It should be recognized that this procedure could be repeated thereby obtaining multiple full core biopsy samples. It should also be recognized, as described above, that the brush  102  could be delivered to the site through the first tubular member and the needle  15  and that the handle  12  could be connected to a vacuum source to aspirate tissue through the needle  15 . 
     It will be apparent to those skilled in the art that various modifications and variations can be made to the structure and methodology of the present invention without departing from the scope or spirit of the invention. In view of the foregoing, it is intended that the present invention cover modifications and variations of this invention provided they fall within the scope of the following claims and their equivalents.