Abstract:
A tissue isolation and removal device has a containment pouch that is opened and supported by the device. The pouch has two open/close portions both able to be closed and reopened. One portion positioned away from tissue being inserted in the pouch and covering the other portion to enclose or isolate any tissue captured in the other portion.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]     This application claims the benefit of U.S. Provisional Application No. 60/726,637, filed Oct. 14, 2005, the disclosure of which is hereby incorporated by reference as if set forth in full herein. 
     
    
     BACKGROUND  
       [0002]     This invention relates generally to apparatus and methods for capturing and retrieving tissue from body cavities and in particular to a specimen retrieval bag device.  
         [0003]     Laparoscopic surgery is typically performed through trocars, which provide access across the abdominal wall and into the abdominal cavity. In some of surgeries, tissue disposed within the abdominal cavity is cut and removed from the body. However, removal of such tissue from the body may prove difficult due to the limited confines inherent with laparoscopic surgery and the available laparoscopic surgical instruments. Also, such tissue may include an infected or cancerous mass or organ, as well as blood, bile and other liquids, all referred to herein as tissue, which may pose infection issues or other complications if left within the body.  
         [0004]     It is desirable to grasp, capture, retain and enclose this tissue while in the body cavity, and then remove the enclosed tissue through the trocar or incision. Containment of the tissue as quickly as possible with minimal disturbance to the surgical site is also desirable. A generally compact and single unit device would also prove desirable as devices generally bulky and complicated have several shortcomings and lack optimal efficiency in particular with the limited space in operating rooms and access ports in the body cavity. In general, such bulky or complicated device also lack optimal efficiency during insertion and removal of material and are deficient in maintaining directional orientation of the enclosed tissue during extracorporeal usage.  
       SUMMARY  
       [0005]     Generally, the present invention provides a tissue isolation and removal device. In one aspect, the tissue isolation and removal device comprises an elongate shaft having at least one support arm extending from one end of the elongate shaft, a containment bag having a first, second and third portion, the first portion of the containment bag supported by the at least one support arm, a first drawstring coupled to the first portion and a second drawstring coupled to the second portion.  
         [0006]     In one aspect, a tissue isolation and removal device comprises a containment bag has a first, second and third portion. The first portion of the containment bag supported by the at least one support arm, a first drawstring is coupled to the first portion and a second drawstring is coupled to the second portion of the bag.  
         [0007]     In one aspect, a tissue isolation and removal device comprises an elongate shaft, an actuator and a containment bag. The elongate shaft has a proximal end, a distal end, and a central core support. The central core support is substantially rectangular and movable out of the proximal end and the distal end of the shaft and has at least one support arm extending from the central core support. An actuator is connected to another end of the elongate shaft. The actuator has a trigger connected to a ratchet-clutch to regulate movement of the central core support. A containment bag has a first, second and third portion. The first portion of the containment bag is supported by the at least one support arm. The third portion of the bag is larger than the second portion of the bag and the second portion of the bag is foldable over the first portion. A first drawstring is coupled to the first portion of the bag and a clasp is connected to the first portion of the bag and the first drawstring. In one aspect, a reinforcement insert provides a reinforcing means for the at least one support arm that is releasable from the at least one support arm.  
         [0008]     Many of the attendant features of the present invention will be more readily appreciated as the same becomes better understood by reference to the foregoing and following description and considered in connection with the accompanying drawings in which like reference symbols designate like parts throughout.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0009]      FIG. 1  is an illustration of a laparoscopic surgical setting that uses a collection bag or pouch in accordance with various aspects of the present invention;  
         [0010]      FIG. 2  is a perspective view of a collection bag or pouch in accordance with various aspects of the present invention;  
         [0011]      FIG. 3  is a perspective view of a collection bag or pouch in accordance with various aspects of the present invention prepared for introduction through an access port;  
         [0012]      FIG. 4  is a perspective view of a collection bag or pouch in accordance with various aspects of the present invention in a closed condition;  
         [0013]      FIG. 5  is a perspective view of a collection bag or pouch in accordance with various aspects of the present invention prepared for retrieval through an access port;  
         [0014]      FIG. 6  is a perspective view of a collection bag or pouch and deployment device in accordance with various aspects of the present invention;  
         [0015]      FIG. 7  is a side view of a collection bag or pouch in accordance with various aspects of the present invention in for example a first, open condition;  
         [0016]      FIG. 8  is a side view of a collection bag or pouch in accordance with various aspects of the present invention in for example a second, open condition;  
         [0017]      FIG. 9  is a side view of a collection bag or pouch in accordance with various aspects of the present invention in for example a third, closed, sealed condition;  
         [0018]      FIG. 10  is a top view of a collection bag or pouch and a sealing member in accordance with various aspects of the present invention;  
         [0019]      FIG. 11  is a side view of a sealing member in accordance with various aspects of the present invention;  
         [0020]      FIG. 12  is a top view of a sealing member in accordance with various aspects of the present invention;  
         [0021]      FIG. 13  is a front end, distal view of a sealing member in accordance with various aspects of the present invention;  
         [0022]      FIG. 14  is an enlarged section view of a collection bag or pouch and sealing member in accordance with various aspects of the present invention;  
         [0023]      FIG. 15  is an enlarged top view of a collection bag or pouch and sealing member in accordance with various aspects of the present invention;  
         [0024]      FIG. 16  is an enlarged section view of a collection bag or pouch and sealing member in accordance with various aspects of the present invention;  
         [0025]      FIG. 17  is a side view of a collection bag or pouch and sealing member in accordance with various aspects of the present invention in, for example, a first condition;  
         [0026]      FIG. 18  is a side view of a sealing member in accordance with various aspects of the present invention in, for example, a second condition;  
         [0027]      FIG. 19  is a side view of a sealing member in accordance with various aspects of the present invention in, for example, a third condition;  
         [0028]      FIG. 20  is a side section view of a handle and actuator mechanism in accordance with various aspects of the present invention in, for example, a first condition;  
         [0029]      FIG. 21  is a side section view of a handle and actuator mechanism in accordance with various aspects of the present invention in, for example, a second condition;  
         [0030]      FIG. 22  is a side section view of a handle and actuator mechanism in accordance with various aspects of the present invention in, for example, a third condition;  
         [0031]      FIG. 23  is detailed side section view of a handle and actuator mechanism in accordance with various aspects of the present invention in, for example, a fourth condition;  
         [0032]      FIG. 24  is a side section view of a handle and actuator mechanism in accordance with various aspects of the present invention;  
         [0033]      FIG. 25  is a side section view of a handle and actuator mechanism in accordance with various aspects of the present invention;  
         [0034]      FIG. 26  is a side section view of a handle and actuator mechanism in accordance with various aspects of the present invention;  
         [0035]      FIG. 27  is perspective view of a hinged jaw mechanism in accordance with various aspects of the present invention in for example a closed condition;  
         [0036]      FIG. 28  is perspective view of a hinged jaw mechanism in accordance with various aspects of the present invention in for example an open condition; and  
         [0037]      FIG. 29  is an end view of a deployment device in accordance with various aspects of the present invention. 
     
    
     DETAILED DESCRIPTION  
       [0038]     Generally, the present invention provides a tissue isolation and removal device that isolates subject tissue and has a secondary closure member that covers the primary opening of the pouch or bag of the device so that removal of the device from the body cavity does not result in contamination of the incision or retrieval site. A user may insert the device through an access port of appropriate size and subsequently deploy and/or open the pouch or bag, place tissue into the bag, and subsequently close the pouch or bag in a series of sequential operations of a single handle-mounted lever. The pouch or bag is closed and a secondary cover shield or foldable/inverted portion is put in place, the device or portions thereof may be removed from the device and/or the access port. The closed pouch or bag may be withdrawn from the access site.  
         [0039]     In  FIG. 1 a  minimally invasive or laparoscopic surgical procedure set-up is shown. Access ports  40 , e.g., trocars, are inserted through a body wall  20  into a body cavity  30 , such as an abdomen. A positive gas pressure is introduced and maintained through the access ports  40 . A variety of elongated surgical instruments, such as graspers, scissors, knives, sponges, retractors and the like, may be used to accomplish the surgical procedure. Such instruments are designed to allow a surgeon to perform surgery in a closed environment rather than an open environment. The instruments can be designed to mimic those used in an open surgery but at a much smaller scale and at a much greater distance than that of open surgery.  
         [0040]     As illustrated, a laparoscopic surgical grasper  46  is holding a portion of tissue  300  or an organ to be deposited within a laparoscopic retrieval pouch or bag  200 . The pouch  200  has an open portion  220  and a closed portion  215  and an elongate shaft  170  that holds and supports the pouch or bag  200 . The specimen  300  is isolated from adjacent tissue by the material of the bag or pouch  200 , which in one aspect is gas and watertight. The bag or pouch  200  is closed when the specimen  300  is fully within the bag  200 . In one procedure, the access port or trocar  41  is removed so that the pouch or bag  200  may be withdrawn through the incision defect  42  in a closed and sealed condition. If the specimen  300  is too large or bulky, the top, open, portion  220  of the pouch or bag  200  may be drawn through the incision defect  42  and subsequently re-opened so that the contents  300  may be withdrawn from the pouch or bag  200  without contacting the incision defect  42  itself. In some cases, a chopper or morcellator may be introduced into the pouch or bag  200  to reduce the bulk of the contents  300  prior to withdrawal through the incision defect  42 .  
         [0041]     In  FIGS. 2 through 6 , a laparoscopic device  100  for isolating and removing tissue or organs  300  from a body cavity  30  comprises an elongate tubular body or shaft  170  having a proximal end  110  and a distal end  175 . In one aspect, the shaft  170  has a length sufficient for use through a laparoscopic access port, a movable central core support  149  comprises elongate support arms  150 ,  160  and a removable pouch or bag  200  associated with the support arms  150 ,  160  of the central core support  149 . The proximal end  110  of the shaft  170  is associated with an actuator  114  having a first stationary handle  115  and a second, opposed, movable handle  116 . The two opposed handles  115 ,  116  cooperate to provide a force to axially move the core support  149 . The core support  149  may be selectively moved between a first condition or position where the distal end portions of the support arms  150 ,  160  are contained within the shaft  170  and a second position where the distal end portions of the support arms  150 ,  160  are extended from the distal end  175  of the shaft  170 .  
         [0042]     As such, motion associated with the opposed handle members  115 ,  116  urges the central core member  149  to an extended position beyond the distal end  175  of the elongate body  170 . The central core support  149  generally comprises a pair of elongate support arms  150 ,  160  sized and configured to slide within the elongate shaft  170  axially without rotating. The lumen of the elongate shaft  170  is sized and configured to allow axial movement of the central core support  149  and prevent rotation of the central core support  149 . The distal end portion  151  of the first support arm  150  of the central core support  149  is configured to assume a shape as it is urged distally from the elongate shaft  170 . The distal end portion  161  of the second support arm  160  of the central core support  149  is configured to assume a shape as it is urged distally from the elongate shaft  170 . The two support arms  150 ,  160  of the central core support  149  are configured to separate at a distance so as to supply an opening force to an associated pouch or bag  200 . In one aspect, the support arms  150 ,  160  are formed from a rigid plastic having a generally rectangular cross-section. Each support arm  150 ,  160  in one aspect comprises a proximal end portion sized and configured to engage a portion of the actuator  114  thereby translating motion from the actuator to the support arms  150 ,  160 .  
         [0043]     The distal end portions  151 ,  161  of each of respective support arms  150 ,  160  of the central core support  149  are sized configured to fit within side-pockets or channels  270 ,  228  of the pouch or bag  200 . Additionally, the distal end portions  151 ,  161  are configured to maintain a preformed shape and distance apart from each other. The strength of the support arms  150 ,  160  to maintain the preformed shape and distance in one aspect is supplied, in part and one aspect, by reinforcement inserts  155 ,  165  that are pre-shaped to a particular or predetermined condition. The inserts  155 ,  165  may be of a spring metal, stainless steel or Nickel-Titanium having “shape memory” characteristics. The inserts  155 ,  165  are placed at a location along the length of the support arms  150 ,  160  where they will provide the particular or predetermined shape and separation between the two support arms  150 ,  160  and, additionally, allow, for example, a distal-most section of the distal end portions  151 ,  161  of the support arms  150 ,  160  to bend or conform to the tension of the associated containment pouch or bag  200 . In this way, in one aspect, a generally curved shape is maintained at the opening or open end  220  of the pouch or bag  200 . A reinforcement insert is releasably connected to the at least one support arm. As such, in one aspect, one or more reinforcement inserts  155 ,  165  are incorporated in a first hollow channel  225  and are arranged to receive at least one of the support arms  150 ,  160 . The reinforcement insert in one aspect is a sleeve having a proximal open end and a distal open end. As such, the at least one support arm can extend through and thus out of both ends. Additionally, a plurality of reinforcement inserts or sleeves may be provided to assist in supporting different and multiple areas of the bag and/or to provide different opening configurations or opening sections of the bag.  
         [0044]     In one aspect, the containment pouch  200  comprises a plastic bag having a closed end  215 , an open end  220  and an inverted portion  230 . The containment pouch  200  is provided with a first hollow channel  225  formed circumferentially about the open end  220  and a second hollow channel  235  formed circumferentially about the lip or open end  237  of the inverted portion  230 . The first hollow channel  225  in one aspect forms a continuous pocket for the support members  150 ,  160  of the deployment device  100  and a drawstring  255  for closing the containment pouch  200 . The second hollow channel  235  in one aspect forms a continuous channel for the drawstring  250  associated with inverted portion  230 . The drawstrings  250 ,  255  in one aspect each have a slipknot  236 ,  226  in position adjacent to the proximally facing openings of the hollow channels  235 ,  225  for drawing the openings  220 ,  237  of the pouch  200  closed.  
         [0045]     In preparation for use or prior to deployment of the bag, as shown in  FIG. 3 , the containment pouch or bag  200  may be rolled or folded so that it will fit through an access port or trocar. The rolled bag  201  is attached to the distal end  175  of the elongate shaft  170  of the deployment device  100 . In one aspect, the pouch or bag  200  is held in position by the drawstrings or tethers  250 ,  255  associated with the closing of the pouch or bag  200 . When the containment pouch  200  is fully extended beyond the distal end of an access port or trocar, it is allowed to unroll and assume a generally flat configuration. The support arms  150 ,  160  are subsequently extended distally to fill the side pockets  270 ,  228  formed by the first hollow channel  225  of the pouch  200 . The support arms  150 ,  160  assume a preformed shape upon extension from the distal end  175  of the elongate tubular shaft  170  of the deployment device  100 . The support arms  150 ,  160  hold the pouch  200  in a condition that provides a large opening or open end  220  for introduction of materials  300  into the containment pouch  200 .  
         [0046]     Referring now to  FIGS. 7-9 , the deployment device  100 , supports the introduction of the containment pouch  200  into a body cavity  30 , deploys the pouch  200  and provides an appropriate opening  220  of the pouch  200 . When the pouch  200  has been filled, the support arms  150 ,  160  are retracted. As the support arms  150 ,  160  retract, a tether or drawstring  250  associated with or attached to the central core support  149  begins to draw, unfold and invert a second or inverted portion  230  of the pouch  200  so that the inverted portion  230  of the pouch  200  covers the first opening portion  220  of the pouch  200 . The inverted portion  230  covers the contaminated lip of the first opening  220  into which tissue  300  was placed. The second drawstring or tether  250  further closes the inverted portion  230 . The first drawstring  255  simultaneously or sequentially moves as the second drawstring  250  moves to draw and close the first opening portion  220  of the pouch  200  allowing the pouch to be removed from a body cavity  30  without contaminating adjacent tissue or the incision site  42  through which it is withdrawn.  
         [0047]     In one aspect, as the support arms  150 ,  160  retract, the tether or drawstring  255  associated with or attached to the central core support  149  begins to draw the first opening portion  220  of the pouch  200  closed. When the pouch  200  is substantially closed, the second tether or drawstring  250  unfolds and inverts a second or inverted portion  230  of the pouch  200  so that the inverted portion  230  of the pouch  200  covers the first opening portion  220  of the pouch  200 . The inverted portion  230  covers the contaminated lip of the first opening  220  into which tissue  300  was placed. The second drawstring or tether  250  further closes the inverted portion  230  allowing the pouch to be removed from a body cavity  30  without contaminating adjacent tissue or the incision site  42  through which it is withdrawn.  
         [0048]     Tissue is placed through the open end  220  of the containment pouch  200  and comes to rest in the closed end  215  of the bag  200 . At the open end  220 , a lip  227  is formed. Sides  210  of the bag connect the open end  220  to the closed end  215 . As noted above, the bag in one aspect has an inverted portion  230 . The inverted portion  230  extends from the open end  220  but folds down or towards the closed end  215  of the bag ( FIG. 7 ). At the end of inverted portion  230 , an open end or lip  237  is formed. The inverted portion  230  extends along the outside of the bag or generally along the sides  210  of the bag. As such, the bag can be divided into three sections or portions  200   a,b,c . A first portion  200   a  holds or encompasses the open end  220  and/or the hollow channel  225 . The second portion  200   b  extends from the open end  220  and is or represents the inverted portion  230  and thus encompasses or holds the second hollow channel  235 . Likewise, the second portion  200   b  extends from the first portion along the outside of the bag and thus folds or covers over the first portion  200   a . The third portion  200   c  extends from the first portion to the closed end  215 . Thus, the third portion holds the tissue inserted into the bag. The third portion is larger than the first and/or the second portions. In one aspect, the sizes of the portions may vary to accommodate a smaller or larger bag, tissue or space in the body cavity and separation between the portions.  
         [0049]     The first portion  200   a  of the bag is connected to the second  200   b  and third portions of the bag and positioned between the second and third portions of the bag. Thus, the first portion acts as a dividing line or portion between the second and third portions. In one aspect, the first portion comprises the drawstring  255  and the second portion  200   b  comprises drawstring  250  and thus allows the third portion  200   c  to be closed while allowing access to an intermediate enclosure of the second and first portions between the drawstrings  250  and  255 . The intermediate enclosure in various aspects is arranged to hold additional tissue after the tissue first tissue is collected in the third portion  200   c  and/or inserted agents to test, absorb or shrink the tissue or portions of the tissue in the third portion. In one aspect, the drawstring  255  can be manipulated to reopen the bag or access to the third portion  200   c , such that for example additional tissue or agents from the intermediate enclosure are combined with the tissue in the third portion  200   c.    
         [0050]     Referring to  FIGS. 10-19  other aspects of a containment pouch or bag  200  are shown. The bag  200  comprises a plastic membrane formed into a watertight container having an open end  220 , a closed end  215  and sides  210  connecting the closed end  215  to the open end  220 . The first portion  200   a  and/or the open end  220  of the container is fitted with or formed with a seal retainer  321 . In one aspect, the seal retainer  321  comprises two complementary retainer sections or halves  370 ,  371 . The first retainer half  370  has one or more tongues, e.g., barbs or tongues  386 ,  387 , extending from the half that mates with one or more corresponding cavities or grooves, e.g., grooves  388 ,  389 , disposed in the second half  371  of the seal retainer  321 . The retainer halves  370 ,  371  are portions of or separate or integrated channels of the bag  200  disposed along the entire or a portion of the outer periphery of the open end  220 .  
         [0051]     A sliding clasp  320  captures the two seal retainer halves  370 ,  371  biasing or pressing the two halves together. In one aspect, the clasp  320  and retainer halves  370 ,  371  are integrated as a single component. The clasp  320  is movable sliding along the length of the opening  220  of the pouch or bag  200  from a distal position or point to a proximal point. A drawstring or tether  400  in one aspect is attached to the clasp  320  such that the clasp  320  may be drawn from the distal position to the proximal position. In one aspect, the retainer  370 ,  371  is connected to or integrated with a first portion of the bag near or at the opening end  220  of the bag and is also connected to the drawstring  400 . As such, the containment pouch  200  may be remotely closed while the bag is within a body cavity  30  by pulling upon the tether  400 .  
         [0052]     The retainer in one aspect comprises a pair of molded portions or halves  370 ,  371  arranged at the opening lip  227  of the pouch  200  that is sized and configured to receive the support arms  150 ,  160  within elongate support channels  380 ,  381  formed as part of the lip  227  of the pouch  200 . As such, the tether  400  to be pulled upon to close the pouch  200  while the support arms  150 ,  160  are within the elongate support channels  380 ,  381 . The tether  400  in one aspect is attached to the clasp  320  by threading it through, at least, a one or more apertures or loops, e.g., loops  382 ,  383 , formed in the clasp  320 . The clasp in one aspect is substantially rectangular and connected to first drawstring or tether  400  and in one aspect the clasp is made of a material that is different, e.g., harder or less resilient than, the drawstring or tether  400  and/or bag  200 . The clasp  320  in one aspect is generally U-shaped with one or more folded portions  318 ,  319  such that the clasp  320  substantially surrounds the seal retainer halves  370 ,  371 . The pouch  200  may be re-opened at any time by moving the clasp  320  distally. Thus, in one aspect, a movable clasp  320  is connected to the retainer  370 ,  371  and is movable from a first position (distal position) to a second position (proximal position) to close the bag and from the second position to the first position to open/re-open the bag.  
         [0053]     Specifically referring now to  FIGS. 17-19 , the retainer  321  is associated with a first closable portion or opening lip  227  of the pouch  200  and a drawstring  250  is associated with a second closable portion or inverted lip  237  of the pouch  200 . Also, as noted in  FIGS. 7-9 , the bag  200  may have three sections or portions  200   a,b,c  in which the first portion would hold the clasp  320 . The clasp  320  is pulled upon to close the open end  220  along the lip  227  of the pouch  200  and, subsequently or in one aspect simultaneously, the drawstring  250  is pulled upon to invert the inverted portion  230  that has been folded over to the outside of the bag  200 . As the inverted portion  230  inverts, the inverted portion  230  also draws closed along the lip  237  under the influence of the drawstring  250 . In one aspect, the inverted portion is deflectable or biased to reorient itself from a folded position to an extended position, which facilitates the inversion initiated by the drawstring  250 . As such, the inverted portion acts as or is a contamination or containment shield. The pouch or bag  200  in one aspect is released as the deployment device  100  is withdrawn. The support arms  150 ,  160  withdraw from the hollow channel  225  of the bag  200  as the arms are moved proximally within the deployment device  100 .  
         [0054]     With reference to  FIGS. 20-23 , in one aspect, a deployment device  410  is shown in operational phases. The deployment device  410  comprises an elongate tubular body  170 , a handle  405  and an actuator, such as a trigger, slide or lever  420 . The elongate tubular body  170  is sized and configured to operate through a laparoscopic access port or trocar. The proximal end of the elongate body  170  is attached to the handle  405 . The handle  405  comprises a generally hollow portion having a cavity  406  sized and configured to hold a deployment regulator  407 . In one aspect, the deployment regulator  407  has a reversible ratchet-clutch  460  that is coupled to and operable by the actuator  420 . The ratchet clutch  460  is movable along a first and second defined pathway  452 ,  453 .  
         [0055]     In one aspect, the proximal portion of one or both support arms  150 ,  160  of the central core member has a plurality of projections or teeth  166 ,  167  that are acted upon or engaged in response to movement of the actuator  420 . In one aspect, the actuator  420  is guided by, at least, a pathways  452 ,  453  acting as guide slots or ribs upon the support arms  150 ,  160  such that ratchet projections  462 ,  463  of the ratchet clutch  460  are selectively movable from a first, forward driving, condition to a second, rearward driving condition. The reversing of the driving conditions is timed by a reverse slot  450  of the pathways  452 ,  453  that forces the ratchet clutch  460  from a first position where the ratchet clutch  460  has a forward thrust to second position where the ratchet clutch  460  has a rearward thrust. A spring  470  attached between the ratchet clutch  460  and the actuator  420  provides a force that moves the ratchet clutch  460  distally along the first pathway  452  after it has been moved proximally by moving the actuator  420 . The actuator  420  may be manipulated multiple times in one aspect to fully deploy and open the associated pouch or bag  200 . When the pouch  200  is fully deployed and opened, the ratchet-clutch  460  moves to a second position along the second pathway  453  where the clutch  460  actively withdraws the central core support  149  and associated support arms  150 ,  160  from the pouch or bag  200 . The tethers or drawstrings  250 ,  255  in one aspect are coupled to the central core support  149  and thus are tensioned or pulled upon as the central core  149  is moved proximally. In one aspect, the tethers or drawstrings  250 ,  255  are operated separately or sequentially.  
         [0056]     The ratchet-clutch  460  in one aspect ensures that during closure of the bag  200  complete incremental closure of the bag and/or withdrawal of the support arms from the specimen bag are achieved. For example, by ensuring one way directional movement of the central core support  149  and/or support arms  150 ,  160 , these components may not be partially withdrawn from the bag and then reinserted into the bag. If, for example, the support arms are withdrawn and reinserted but are not aligned with the channel of the bag, the support arms may be pushed through the bag or not support the bag. As such, an actuator  420  connected to the shaft  170  and having a ratchet-clutch  460  positions or movement of the at least one support arm can be regulated or controlled relative to the shaft. The ratchet-clutch  460  also prevents reinsertion of the support arms  150 ,  160  into the body cavity after the bag has been detached from the device. Reinsertion of the support arms could decrease visibility within the body cavity or the support arms could become entangled with the cord loop or with another device in the body cavity. The ratchet-clutch  460  counteracts this tensile force to prevent movement of the central core support and bag  200  in the distal direction relative to the shaft  170 .  
         [0057]     In  FIGS. 24-26 , the deployment devices provide various actuators  305 - 308  with various deployment regulators used to advance and support the support arms  150 ,  160 . Moving an actuator, such as by rotating knob or thumb-wheel  305 , sliding switch  306  or pivoting lever/trigger  307 , 308 , causes or permits the central core support  149  and the support arms  150 ,  160  to move distally. For instance, the thumbwheel  305  associated with handle  315  rotates to advance or retract the central core support  149  and support arms  150 , 160 . In one aspect, the slide  306  associated with handle  316  is moved to advance or retract central core support  149  and support arms  150 ,  160 . Also, in one aspect, as shown, the handles  315 - 316  are in-line with the shaft  170  thereby reducing space occupied by the handles.  
         [0058]     Engagement with corresponding teeth or projections  311 - 312  of respective actuators  305 - 306  maintains the position of the support arms  150 ,  160  relative to the handles  315 - 316 . For instance, the thumbwheel  305  and the central core support  149  have corresponding mating notches and projections that are sized and configured to mate in a gear-like relationship or as a rack and pinion assembly. A user may rotate the thumbwheel in one direction to advance the support arms  150 ,  160  and subsequently rotate the thumbwheel in the opposite direction to retract the support arms. In one aspect, the slide  306  and the central core support  149  have corresponding mating notches and projections that are sized and configured to mate in a gear-like relationship or as a ratchet assembly. A user moves the slide in one direction to advance the support arms and subsequently move the slide in an opposite direction to retract the support arms. In one aspect, releasing or withdrawing the engagement or obstruction of the actuators  305  or  306  from the central core support  149  permits the movement of the core support  149  relative to the shaft  170 .  
         [0059]     In  FIG. 26 , a separate trigger or actuator  308  biased by spring  309  engages the central core support to frictionally maintain the position of the support arms  150 ,  160  relative to the handle. Releasing or withdrawing the engagement or obstruction of the actuator  308  from the central core support  149  permits the movement of the core support  149  relative to the shaft  170 . The central core support  149  is urged in one direction by actuating the trigger  308  and pushing or allowing the core support to move forward or distally. In one aspect, a return spring  329  released by lever  307  allows the spring to extend biasing the core support in the proximal direction.  
         [0060]     Releasing the trigger  308  holds the core support  149  in place axially. In one aspect, the central core support  149  and support arms  150 ,  160  retract as the lever  307  is actuated where it binds upon the central core support  149  causing the support to move rearward or proximally. The trigger  308  and a bind lock coupled to the lever  307  are sized and configured to be positioned between a generally perpendicular relationship with the central core support and an angular relationship with the central core support  149 . The generally perpendicular position allows the central core support to slide freely through an opening within the respective trigger  308  or bind lock coupled to lever  307 . When the trigger  308  or bind lock coupled to lever  307  is disposed or re-positioned to an angular orientation relative to the central core support, they bind upon the central core support in a traction-like relationship which holds the central core support and associate support arms  150 ,  160  in place until movement of the lever  307  and/or trigger  308 .  
         [0061]     In  FIGS. 27-28 , in one aspect, the deployment device  100  has one or more hinges  176  coupled to the support arms  150 ,  160  or extensions that are sized and configured to fit into the side channels formed by the first hollow channel  225  of the containment pouch. A movable handle or lever  116  associated with the actuator  114  urges the support arms  150 ,  160  from a first, closed condition to a second, open condition and subsequently returns the arms  150 ,  160  to a closed condition. The hinge or hinges  176  in conjunction with slots  178  in the shaft  170  allow the arms to pivot back and forth to the open and closed conditions. The arms  150 , 160  may be formed of a flexible material that provides support in specific regions. For instance, a rigid plastic material having a rectangular cross-section may allow the extended support arms  150 ,  160  to flex within the hollow channel  225  so that the opening  220  of the pouch  200  is generally rounded, but restrict deformation at a right angle to the opening plane of the containment pouch  200 . In one aspect, the support arms  150 ,  160  are strengthened by reinforcement inserts  155 ,  165  placed at specific locations along each support arm  150 ,  160  that provides planar support. The support arms  150 ,  160  in one aspect comprise rigid metal members fitted with sleeves that provide a flexible distal portion for each support arm  150 ,  160  to aid in shaping the opening of the containment pouch  200  into a specific condition.  
         [0062]     In  FIG. 29 , the outer surface  171  of the tubular body or shaft  170  is generally smooth and symmetrical so that it may have a sealing relationship with the seals of a trocar in a working arrangement. In one aspect, there are three lumens  172 ,  173 ,  174  associated with the body  170 . One of the lumens, the major lumen  172 , in one aspect is rectangular in cross-section and is sized and configured to receive and hold, in alignment, the central core support  149  and support arms  150 ,  160  of the deployment device  100 ,  410 . Two of the other lumens, minor lumens  173 ,  174 , are positioned alongside the major lumen  172  on each side thereof to accommodate and/or guide the tethers or drawstrings  250 ,  255  associated with the containment pouch or bag  200 . A construction of the elongate body  170  in one aspect comprises an extrusion of rigid plastic or metal, such as aluminum. The distal end  175  of the elongate body  170  is substantially open.  
         [0063]     With reference to the various aspects described throughout, the containment pouch  200  comprises a plastic bag having a closed end  215 , an open end  220  and an inverted portion  230 . The containment pouch  200  is provided with a first hollow channel  225  formed circumferentially about the open end  220  and a second hollow channel  235  formed circumferentially about the open end of the inverted portion  230 . The first hollow channel  225  forms a continuous pocket for the support arms  150 ,  160  of the deployment device  100  and a drawstring  255  for closing the containment pouch  200 . The second hollow channel  235  forms a continuous channel for the drawstring  250  associated with inverted portion  230 . The drawstrings  250 ,  255  may have slipknots  236 ,  226  in position adjacent to the openings of the hollow channels  235 ,  225  for drawing the openings of the pouch  200  closed. In various aspects, multiple clasps  320  and/or retainer  321  may be used in multiple portions of the bag or instead of slipknots. Likewise, the bag may have a single section or multiple sections having multiple drawstrings, slipknots and/or retainers. In one aspect, the containment pouch  200  is fitted onto the support arms  150 ,  160  and therefore comprises a disposable portion whereas the deployment device  100  may be reusable and sterilizable. Several containment pouches  200  in one aspect are packaged with one deployment device for use in a single surgical case.  
         [0064]     Although the present invention has been described in certain specific aspects, many additional modifications and variations would be apparent to those skilled in the art. It is therefore to be understood that the present invention may be practiced otherwise than specifically described, including various changes in the size, shape and materials, without departing from the scope and spirit of the present invention. Thus, embodiments of the present invention should be considered in all respects as illustrative and not restrictive.