Abstract:
An apparatus for withdrawing a tissue specimen being held by a grasping instrument through an endoscope includes an endoscope having an endoscopic shaft with proximal and distal ends and a lumen extending therebetween. The apparatus also includes first and second hoop-like support members which are selectively slideable within the lumen from a first position to at least one second position. Each of the hoop members includes a diameter which is variable from a first diameter to at least one different diameter. The apparatus also includes a pouch having first and second ends which attach to respective first and second hoop members. The pouch defines a container therein for retaining the tissue specimen. A pair of drawstrings are attached to the first and second ends of the pouch, respectively, and are remotely operable to close the ends about the tissue specimen.

Description:
CROSS REFERENCE TO RELATED APPLICATION:  
       [0001]    This application claims the benefit of priority to U.S. Provisional Application Serial No. 60/455,261 filed on Mar. 17, 2003 by Joseph P. Orban, III entitled “ENDOSCOPIC TISSUE REMOVAL APPARATUS AND METHOD” the entire contents of which is hereby incorporated by reference herein. 
     
    
     
       BACKGROUND  
         [0002]    1. Field of the Invention  
           [0003]    The present disclosure relates to an endoscopic tissue retrieval apparatus and method for utilizing the same. More particularly, the present disclosure relates to a remotely-operated tissue retrieval apparatus which utilizes an expandable pouch or bag to retrieve tissue through an endoscope during minimally invasive surgical procedures.  
           [0004]    2. Background of the Art  
           [0005]    Over the past several decades, modern medicine has witnessed tremendous advances in less invasive and less traumatic surgical procedures which has provided numerous physical and economical benefits to the modern patient. For example, more and more surgeons are abandoning traditional open methods of gaining access to vital organs and body cavities in favor of endoscopes and endoscopic instruments which access organs through small puncture-like incisions.  
           [0006]    Laparoscopic and endoscopic surgical procedures are minimally invasive procedures in which operations are carried out within the body by means of elongated instruments inserted through these small incisions in the body. The opening is typically created by a tissue piercing instrument such as a trocar. Endoscopic instruments are inserted into the patient through a cannula or port which maintains the incision opening in the body during the procedure. A lumen is typically defined through the endoscope and enables the surgeon to selectively introduce various endoscopic instrumentation into the operating cavity as needed.  
           [0007]    Because the interior dimension of the lumen is relatively narrow only small instruments can be inserted therethrough which limits certain surgeries. However, new endoscopic designs and procedures are enabling more and more complex and intricate surgeries to be performed through these minimal access incisions. For example, a surgeon can remotely introduce these small sophisticated endoscopic instruments into the surgical cavity and excise or resect relatively large volumes of tissue, tumors, organs and the like from outside the surgical cavity as needed during a particular surgical procedure, e.g., nephrectomy, cholecystectomy. Unfortunately, the extraction and removal of such excised tissues, tumors, organs or the like has proven to be somewhat complicated due to the relative size of the excised tissue, tumors, organs compared to the interior dimensions of the endoscope lumen. In addition, the removal of certain malignant (non-benign) tissue, i.e., infected/contaminated tissue, cancerous tumors, etc., tends to be even more complicated due to the need to contain the malignant tissue during removal to prevent further infection.  
           [0008]    Several prior art devices have been developed to facilitate removal of the tissue specimen after resection. For the most part, these devices relate to entrapment-like devices in which the tissue specimen is dropped into a specimen bag which is then withdrawn through the incision. For example, U.S. Pat. No. 5,465,731 and U.S. Pat. No. 5,647,372 both relate to a specimen removal pouch made from a flexible membrane which includes a drawstring disposed circumferentially round the end of the pouch. Once a piece of tissue is resected, the specimen is dropped into a pouch and the drawstring is pulled which closes the mouth of the pouch about the specimen. The neck of the pouch is then positioned against the distal end of the cannula and the whole assembly is subsequently removed. The entire disclosure of both of these applications is hereby incorporated by reference herein.  
           [0009]    Although entrapment bags are useful, there remains a need for an improved specimen retrieval apparatus which facilitates endoscopic tissue containment and removal in minimally invasive surgical procedures.  
         SUMMARY  
         [0010]    The present disclosure relates to an apparatus for withdrawing a tissue specimen and includes an endoscope having an endoscopic shaft with proximal and distal ends and a lumen extending therebetween. The tissue withdrawing apparatus also includes at least one hoop-like support member which is selectively slideable within the lumen from a first position wherein the hoop like member has a first diameter to at least one second position wherein the hoop-like member has a second diameter which is different from the first diameter. A pouch is also included which has first and second ends. The first end of the pouch is an open end which is attached to the at least one hoop-like support member. The pouch defines a container therein for retaining the tissue specimen. A remote actuator is also included and is disposed proximate the proximal end of the endoscopic shaft. The remote actuator is selectively actuateable to close the first end to encapsulate the tissue specimen.  
           [0011]    In one embodiment according to the present disclosure a second hoop-like support member is included and the second end of the pouch is an open end attached to the second hoop-like support member. In another embodiment, the pouch includes at least one strut disposed between the hoop-like support members for further defining the container for retaining the tissue specimen.  
           [0012]    Preferably, the diameter of the second hoop-like support member is selectively expandable from a first diameter within the lumen to a second diameter outside the lumen. In yet another embodiment according to the present disclosure, the diameter of the first hoop-like support member is selectively contractible from a first diameter within the lumen to a second diameter within the lumen.  
           [0013]    The present disclosure also relates to an apparatus for withdrawing a tissue specimen through an endoscope wherein the endoscope includes a shaft with proximal and distal ends and a lumen extending therebetween. The apparatus of the present disclosure also includes first and second hoop-like support members, which are selectively slideable/translatable within the lumen from a first position to at least one second position. Each of the hoop members includes a diameter which is variable from a first diameter to at least one different diameter. A pouch is included which has first and second ends which attach to respective first and second hoop members. The interior of the pouch defines a container for retaining the tissue specimen. A pair of drawstrings are attached to the first and second ends of the pouch, respectively, and are remotely operable to close the ends about the tissue specimen. Preferably, the pouch includes at least one strut disposed between the hoop members for further defining the container for retaining the tissue specimen.  
           [0014]    In one embodiment according to the present disclosure, the diameter of the second hoop member is selectively expandable from a first diameter within the lumen to a second diameter outside the lumen. Preferably, the second hoop member is disposed in a pre-loaded configuration within the lumen such that the diameter of the second hoop member automatically expands when the second hoop member is extended from the distal end of the endoscopic shaft. In another embodiment, the diameter of the first hoop member is selectively contractible from a first diameter within the lumen to a second diameter within the lumen. In yet still another embodiment, the hoop members include a pair of arcuate portions which slidingly reciprocate one another to vary the diameter of each respective hoop member.  
           [0015]    The present disclosure also relates to a method for withdrawing a tissue specimen through an endoscope and includes the steps of providing: a grasping instrument; an endoscope including an endoscopic shaft having proximal and distal ends and a lumen extending therebetween; first and second hoop-like support members, each of the hoop members being selectively slideable within the lumen from a first position to at least one second position, each of the hoop members including a diameter which is variable from a first diameter to at least one different diameter; and a pouch having first and second ends which attach to respective first and second hoop members, the pouch defining a container therein for retaining the tissue specimen.  
           [0016]    The method further includes the steps of: grasping the tissue specimen with the grasping instrument; sliding the first and second hoop-like members from the first to second position such that the diameter of the second hoop-like member expands and encapsulates the tissue specimen; closing the second end of the pouch about the tissue specimen; withdrawing the grasping instrument through the lumen; closing the first end of the pouch about the tissue specimen; and withdrawing the tissue specimen and pouch proximally through the lumen.  
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0017]    Embodiments of the presently disclosed endoscopic tissue removal apparatus and method are described herein with reference to the drawings, wherein:  
         [0018]    [0018]FIG. 1A is a schematically-illustrated, side view showing an endoscopic tissue removal apparatus in accordance with the present disclosure shown in deployed orientation with a grasping instrument disposed within a specimen retrieval pouch;  
         [0019]    [0019]FIG. 1B is an enlarged schematic view of the tissue removal apparatus of FIG. 1 showing a pair of drawstrings which are remotely operable to selectively close the distal and proximal ends of the specimen pouch; and  
         [0020]    [0020]FIGS. 2A-2E are schematically-illustrated views of the tissue removal apparatus of FIG. 1 grasping, containing and removing a tissue specimen through a lumen disposed within an endoscopic instrument. 
     
    
     DETAILED DESCRIPTION  
       [0021]    Referring now in specific detail to the drawings in which like reference numerals identify similar or identical elements throughout the several views, one embodiment of an endoscopic tissue retrieval apparatus is shown in FIGS. 1A-2E and is generally identified as retrieval apparatus  10 .  
         [0022]    The endoscopic retrieval apparatus  10  includes an endoscopic shaft  12  having proximal and distal ends  15  and  13 , respectively, and a lumen  17  which extends therethrough between the proximal  15  and distal ends  13 . The lumen  17  is internally dimensioned to reciprocate an endoscopic grasper or forceps  20  along a longitudinal axis “A” defined therethrough as explained in more detail below with respect to the operation of the tissue retrieval apparatus  10 . As can be appreciated, the lumen  17  may also be dimensioned to allow selective reciprocation of other surgical instruments therethrough which may be utilized during a typical tissue removal procedure, e.g., a resector, a biopsy instrument, an electrosurgical pencil, or the like. As will be explained in more detail below, one or more of these instruments may be utilized to cut the tissue specimen  100  from the body for subsequent grasping and removal from the operating cavity.  
         [0023]    The retrieval apparatus  10  also includes a retrieval pouch or bag  40  which is disposed within the lumen  17 . The pouch  40  is preferably made from a flexible membrane or other bio-compatible material. Pouch  40  includes a pair of hoop-like support members  35  and  65  located at the distal and proximal ends thereof. As explained in more detail below with respect to the operation of the tissue retrieval apparatus  10 , the pouch  40  is initially positioned within the lumen  17  in a manner suitable for deployment from a distal end  13  of the endoscopic shaft  12 . More particularly, at least the distal hoop member  35  is selectively expandable from a first, pre-deployed orientation inside the lumen  17  to a second, deployed configuration when positioned outside the lumen  17 . Both hoop members  35  and  65  are selectively collapsible to contain the tissue specimen  100  which is explained in more detail below with respect to the operation of the instrument below. As can be appreciated, the configuration of hoop members  35  and  65  does not impede longitudinal reciprocation of the grasping instrument  20  (or, other type of endoscopic instrument) within the lumen  17  to grasp or otherwise manipulate the tissue specimen  100 . It is also envisioned that either a proximal hoop member  65  or distal hoop member  35  may be used so that the retrieval apparatus has only one hoop.  
         [0024]    A series of support structures or struts  28  are disposed between the proximal and distal hoop members  65  and  35  to further define the pouch  40  and to facilitate deployment and positioning of the pouch  40  from the distal end  13  of the endoscopic shaft  12 . As best illustrated in FIG. 2B, the support struts  28  and the hoop members  35  and  65  form a generally conical structure having its apex defining a first opening  52  in the proximal end  39  of the pouch  40  and a second opening  50  at the distal end  41  of the pouch  40 . The dimensions of each of the openings  50  and  52  are generally defined by the dimensions of the hoop members  35  and  65 , respectively.  
         [0025]    The support struts  28  are configured to extend proximally through the lumen to allow a user to remotely deploy the specimen retrieval pouch  40  from the shaft  12  to collect and encapsulate a specimen  100  as needed during the procedure (See, e.g., FIGS. 2A-2E). It is also envisioned that the pouch  40  could be formed from material having suitable structural integrity to maintain the pouch  40  in a deployed configuration without the need for the support struts  28 . As can be appreciated, in this embodiment the pouch  40  would include a mechanical interface (not shown) which attaches to the pouch  40  to permit remote deployment of the pouch  40  from the shaft  12 . Preferably, the struts  28  are integrated with the overall structure of the pouch  40  and are made from materials having the requisite strength and flexibility to support the pouch  40  during deployment and encapsulation of the tissue sample  100 .  
         [0026]    As best illustrated in FIGS. 2A-2E, the distal hoop member  35  is configured to be selectively expandable between a first diameter inside the lumen  17  of shaft  12  to a second, expanded diameter when positioned outside shaft  12 . More particularly, when disposed in the first configuration, hoop member  35  is biased or pre-loaded such that, once released from the distal end  13  of shaft  12 , the hoop member  35  automatically expands to the second, larger diameter. As can be appreciated, the larger diameter of second opening  50  facilitates encapsulation of the tissue sample  100  within pouch  40 . The struts  28  maintain the sides of the pouch  40  in an open configuration between the hoop members  35  and  65  which facilitates encapsulation of the tissue specimen  100 .  
         [0027]    Preferably, the distal hoop member  35  is configured to include a pair of telescoping or inter-engaging arcuate portions  37  and  39  which slidingly reciprocate one another to permit expansion and contraction of the hoop member  35  as needed. More particularly and as mentioned above, prior to deployment, hoop member  35  is held in a pre-loaded orientation within lumen  17 . Once deployed, i.e., hoop member  35  is forced via support strut  28  from the distal end  13  of shaft 12 , the distal ends of the arcuate portions  37  and  39  move away from one another (i.e., biased outwardly) to allow for hoop member  35  to freely expand to the second, larger diameter to encapsulate the tissue specimen  100  (See. FIGS. 1B and 2B).  
         [0028]    After the tissue specimen  100  is encapsulated, a drawstring or suture  30  (or the like) is pulled to contract the hoop member  35  and contain the tissue specimen  100  as explained in more detail below. As can be appreciated, the hoop member  35  may be contracted beyond the hoop member&#39;s  35  original, preloaded configuration within the lumen which further closes the distal opening  50  of the pouch  40  to securely retain the tissue specimen  100  thereinside (See FIGS. 2C-2E). For example, hoop member  35  is desirably biased toward the expanded configuration. The drawstring  30  preferably has suitable strength to overcome the bias of the struts  28  and the hoop member  35  to close the distal opening  50  of the pouch  40  for withdrawal.  
         [0029]    Likewise, the proximal opening  52  is also desirably configured for selective closure. More particularly, the proximal hoop member  65  also includes arcuately-shaped telescopic members  67  and  69  which slidingly reciprocate one another to permit a user to remotely contract the proximal hoop member  65  via suture  60  (or the like) as needed after the tissue specimen  100  is collected. It is envisioned that the hoop members  35  and  65  may be selectively expanded and contracted in other mechanical or electromechanical manners, e.g., iris valves, shape memory alloys, balloons, piezoelectric alloys, etc. It is also contemplated, that proximal hoop member  65  may be configured in a pre-loaded configuration such that the arcuate members  67  and  69  of the hoop member  65  automatically contract once activated either mechanically or electro-mechanically. The hoop members may be biased toward the expanded or contracted configuration.  
         [0030]    It is envisioned that one or both hoop members, e.g., proximal hoop member  65  and the pouch  40  are removably connected to the distal end  13  of the shaft  12  such that, upon contraction, the hoop member  65  or the pouch  40  disengages from the distal end  13  of the shaft  12  to close opening  52  about the tissue specimen  100 . As can be appreciated, this facilitates withdrawal of the tissue specimen  100  through the lumen  17 .  
         [0031]    In use and as best illustrated in FIGS. 2A-2E, the endoscopic shaft  12  is inserted through a cannula (not shown) and into the operating cavity. A biopsy instrument, a resection instrument, scissors, or the like is inserted through the lumen  17  to separate the tissue specimen  100  from the surrounding tissue such as in a biopsy, nephrectomy, cholecystectomy, etc. Once the tissue specimen has been resected, the endoscopic forceps  20  is inserted through the lumen  17  to manipulate and grasp the tissue specimen  100 .  
         [0032]    The forceps  20  includes jaw members  24   a  and  24   b  which are selectively movable relative to one another from a first approximation position to a second closed position to grasp tissue  100  therebetween. This enables the surgeon to position the tissue for encapsulation. It is envisioned that numerous types of endoscopic forceps may be utilized to grasp and retain the tissue specimen  100 . Moreover, it is also contemplated that a combination instrument may be utilized to both resect and retain the tissue specimen  100  for withdrawal. Preferably, the forceps  20  is selectively translatable along and rotatable about longitudinal axis “A” to facilitate manipulating of the tissue specimen  100  (See FIG. 1A). It is also contemplated that the forceps  20  may include an articulation feature which rotates the jaw members  24   a  and  24   b  relative to longitudinal axis “A” to further facilitate manipulation and positioning of the tissue specimen  100 .  
         [0033]    Once the specimen  100  is grasped, the operator remotely actuates the support struts  28  to deploy the specimen pouch  40 . More particularly, the struts  28  are pushed distally in the direction “B” to force hoop member  35  from the distal end  35  of the shaft  12 . As best shown in FIG. 2B, once the hoop member  35  extends beyond distal end  13 , the pre-loaded or arcuate portions  35  and  37  deploy (i.e., freely move away from one another) and expand the diameter of the second opening  50  in the direction “C”. The proximal hoop member  65  remains within lumen  17  of shaft  12 . As a result thereof, the pouch  40  expands into a generally conical configuration and encapsulates, i.e., captures, the tissue specimen  100 .  
         [0034]    Once the pouch  40  has been deployed about the tissue specimen  100 , the user pulls the first drawstring  30  in the proximal direction which cinches and closes the distal opening  50  in the direction “E” to contain the specimen  100 . More particularly, pulling the drawstring  30  in the direction “D” telescopically reciprocates arcuate portion  39  within arcuate portion  37  (or vice versa) which reduces the diameter of the opening  50  as best illustrated in FIG. 2C.  
         [0035]    After the distal opening  50  has been closed, the user actuates the grasping instrument  20  to release the tissue specimen  100  and thereafter withdraws the grasping instrument  20  from the operating site in the direction “F” through lumen  17  (See FIG. 2D). Once the grasping instrument  20  has been withdrawn, the user pulls the second drawstring  60  in the proximal direction “G” which closes the proximal opening  42  in the direction “H” to contain the tissue specimen  100  (See FIG. 2E). The tissue specimen pouch  40  is then withdrawn from the operating site through lumen  17 . Preferably, drawstring  60  may also be utilized to withdraw specimen  100  through lumen  17 .  
         [0036]    It is contemplated that the proximal end  42  of pouch  40  may be configured such that pulling drawstring  60  also disengages the proximal end  42  from hoop member  65  to facilitate removal of the pouch  40  through lumen  17  (See FIG. 2E). In this instance, hoop member  65  would remain within lumen  17  for subsequent removal after the endoscope is withdrawn from the operating site.  
         [0037]    From the foregoing and with reference to the various figure drawings, those skilled in the art will appreciate that certain modifications can also be made to the present disclosure without departing from the scope of the same. For example and as mentioned above, it is contemplated that the proximal hoop member  65  and the pouch  40  may be selectively removable from one another to facilitate removal of the specimen. More particularly, pouch  40  may be configured such that controlled axial rotation of the hoop member  65  relative to the pouch  40  disengages the proximal end  42  of the pouch  40  from the hoop member  65  to allow the proximal end  42  of the bag to close about the specimen  100 . Alternatively, the pouch  40  could be sutured to the hoop member  65  and the sutures withdrawn to disconnect the hoop member  65  from the pouch  40 .  
         [0038]    In a further embodiment, the retrieval apparatus is as discussed above with respect to FIGS. 1A-2E except that a tubular member is used in place of endoscope  12 .  
         [0039]    In an alternate embodiment, the grasping instrument  20  is integrated with the pouch  40  such that the grasping instrument  20  and the pouch  40  are removed simultaneously through the lumen  17 . It is also contemplated that the hoop members  35  and  65  may be fabricated from bio-absorbable materials and configured to separate from the pouch  40  once cinched. Moreover, the support struts  28  may also be fabricated from a bio-absorbable material and removably connected to the hoop members  35  and  65 .  
         [0040]    Preferably, the longitudinally aligned struts  28  are biased to an arcuate shape and are positioned on or within the material of the pouch  40  to give the sides of the pouch  40  suitable structural integrity.  
         [0041]    While certain embodiments of the disclosure has been described herein, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of a preferred embodiment. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.