Abstract:
A system for treating a target tissue includes (a) an instrument head sized and shaped for insertion into a hollow organ of a living body, the instrument head including a working chamber movable between an open position in which the working chamber is exposed to an exterior of the head and a closed position in which the working chamber is substantially sealed with respect to an exterior of the instrument head, the instrument head including a first imaging device having a field of view extending distally of a distal end thereof and a second imaging device having a field of view within the working chamber; (b) a handle which, during use, remains outside the living body, the handle including an actuator; (c) a steering mechanism coupled to the actuator for steering the instrument head within the hollow organ based on actuation of the actuator; and (d) a controller coupled to the first and second imaging devices for processing the image data received from the first and second imaging devices and providing images to an operator.

Description:
PRIORITY CLAIM 
     The present application is a Continuation of U.S. patent application Ser. No. 11/940,367 filed on Nov. 15, 2007 (now U.S. Pat. No. 8,062,318) which is a Continuation of U.S. patent application Ser. No. 10/453,367 filed Jun. 3, 2003, (now U.S. Pat. No. 7,300,445) which is a Continuation of U.S. patent application Ser. No. 09/994,518 filed Nov. 26, 2001 (now U.S. Pat. No. 6,605,078). These patents are expressly incorporated herein, in their entirety, by reference. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to full thickness resection devices for performing localized resections of lesions. 
     BACKGROUND OF THE INVENTION 
     Resection procedures involve excising a portion of an organ, approximating the surrounding tissue together to close up the hole created by the excision, and removing excess tissue. Various conventional devices and procedures are available for resectioning lesions in organs. 
     For example, several known resection devices and procedures require at least one incision in an area near the portion of the organ to be excised for access to the lesion or treatment site (because, for example, these resectioning devices may lack steering and/or viewing capabilities). Thus, an incision is required to allow a physician to access the organ section to be excised and guide the device to that section. Alternatively, when the organ section to be excised is beyond the reach of the surgical device, or if the surgical device is not flexible enough to wind through the organ to the site to be excised, an incision is required to position the device for the procedure. Of course, these incisions are painful and may involve a partial or entire loss of mobility while recuperating from the incision, in addition to the discomfort associated with the resectioning procedure itself. In addition, these incisions may add significantly to the recovery time required for the procedure. 
     One type of conventional resection procedure utilizes a circular stapling instrument in which a tubular section of a substantially tubular organ is excised, resulting in the organ being separated into first and second segments. The open ends of these first and second segments are then tied in a purse-string fashion, approximated toward one another and stapled together. The tissue radially inside the stapled areas (i.e., the “purse-stringed” end sections) is then cut off to open the interiors of the two segments to one another. In this full circle resectioning procedure, at least one incision must be made near the section to be excised in order to cut and “purse string” the end sections of the first and second segments. Also, a second incision is necessary to place one part of the resectioning device in the first segment and a corresponding second part of the device in the second segment. Thus, this type of resectioning procedure involves the drawbacks mentioned above in regard to procedures requiring invasive incisions. In addition, the separation of the organ into two segments creates the risk of spillage of non-sterile organ contents into the sterile body cavity, which may cause severe infection and possibly death. 
     An alternative resectioning device includes a stapling and cutting assembly on a shaft which may be bent or formed into a desired shape and then inserted into a patient&#39;s body cavity. Once the shaft has been bent into the desired shape, the rigidity of the shaft ensures that the shape is maintained throughout the operation. This arrangement limits the effective operating range of the device as the bending of the shaft into the desired shape before insertion and the rigidity of the shaft once bent require the physician to ascertain the location of the organ section to be removed before insertion, and deform the shaft accordingly. Furthermore, the rigidity of the shaft makes it difficult to reach remote areas in the organ—particularly those areas which must be reached by a winding and/or circuitous route (e.g., sigmoid colon). Thus, an incision may be required near the organ section to be excised in order to position such a device at the organ section to be excised. 
     A full-thickness resection system has been disclosed by the present Applicant along with others in U.S. Pat. No. 6,126,058, the disclosure of which is expressly incorporated herein by reference in its entirety. The system utilizes a flexible endoscope slidably received through at least a portion of a stapling mechanism. 
     SUMMARY OF THE INVENTION 
     The present invention is directed to an operating head for a full thickness resection device, comprising a first optical device disposed on a distal portion thereof, the first optical device having a viewing area extending distally of the distal portion and a second optical device mounted within a working chamber extending within an exterior wall of the operating head, wherein a first portion of the exterior wall is moveable with respect to a second portion thereof to selectively open the working chamber to an exterior of the operating head. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  shows a side view of a full thickness resection device according to one embodiment of the present invention; 
         FIG. 2  shows a front view of the full thickness resection device shown in  FIG. 1 ; 
         FIG. 3  shows a side view, in partial cross section, of the full thickness resection device shown in  FIG. 1 , where the device is in the open position; 
         FIG. 4  shows a side view, of the full thickness resection device as shown in  FIG. 3 , where a lesion has been pulled into the device; 
         FIG. 5   a  shows a schematic cross-sectional view of a full thickness resection device having a movable door, according to another embodiment of the invention; 
         FIG. 5   b  shows a schematic cross-sectional view of a full thickness resection device as shown in  FIG. 5   a  where the movable door is in the open position; 
         FIG. 6   a  shows a side view of a device according to a further embodiment of the invention moving through a body organ along a guide wire; 
         FIG. 6   b  shows a cross-sectional front view of the device according to  FIG. 6   a;    
         FIG. 7  shows a cross-sectional view of an insertion sheath including an integral custom endoscope according to one embodiment of the present invention; and 
         FIG. 8  shows a cross-sectional view of an insertion sheath including an endoscope receiving lumen according to a further embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION 
     As shown in  FIGS. 1 and 2 , an optical full thickness resection device  10  according to one embodiment of the present invention includes an openable instrument head  14  which is preferably formed from a front portion  14   a  and a rear portion  14   b . The head  14  may be egg-shaped as shown in  FIG. 1 . Such a shape allows for the head  14  to be smoothly inserted into and removed from an organ  50 . However, it is understood that many other shapes of the head  14  may be employed to ease insertion and removal from the organ  50 . For example, the head  14  may be bullet-shaped or, alternatively, may be relatively more spherical. In the illustrated embodiment, the head  14  may preferably have a diameter in the range of 10 to 35 mm. 
     Those skilled in the art will recognize that the organ  50  may include the colon, the small bowel, the esophagus, or a variety of other organs in which endoscopic procedures have been conducted. 
     Conventional endoscopes employed with prior endoscopic full thickness resection devices incorporated certain functional limitations which frustrated attempts to reduce their size. These devices were employed in a wide variety of procedures and included features which were not utilized in the full thickness resection procedure. For example, these endoscopes included one or more working channels through which an operator might perform therapeutic and/or diagnostic tasks. Furthermore, these endoscopes may also incorporate an insertion tube shaft to enable the operator to push the endoscope through a body lumen. These working channels and the insertion tube add significantly to the diameter of the endoscope. As discussed below, the present invention proposes an endoscope-like device in which these elements are eliminated as unnecessary to the full thickness resectioning procedure. 
       FIG. 2  shows a cross-sectional view of the front end of a front portion  14   a , including additional features of the device  10 . In one embodiment, a movable optic device  12  and an irrigation source  13  are provided on the front portion  14   a  with the optic device  12  providing an interior view of the organ  50  to an operator of the device  10 . The irrigation source  13  allows a solution such as saline to be introduced into the organ  50  in order to clear debris therefrom improve the operator&#39;s view. Additionally provided are light sources  22  for illuminating the organ  50  so that the optic device  12  captures a satisfactory image for the operator. In one embodiment, the optic device  12  may include a vision chip which may include, for example, both photosensors and parallel processing elements. According to an exemplary embodiment of the device  10 , an infusion port  24  allows the operator to inject air or an inert gas into the organ  50  to insufflate the organ. This insufflation of the organ  50  may further improve the operator&#39;s view by distending the walls of organ  50 . 
     In the illustrated embodiment, an insertion sheath  40  serves to propel the head  14  through tubular organ  50 . In this instance, the insertion sheath  40  which may be formed of a flexible polymeric material such as, for example, polypropylene, is part of an insertion sheath propulsion system and constructed, for example, as described in U.S. Pat. Nos. 5,259,364 and 5,586,968 to Bob et al., the entire disclosures of which are hereby incorporated by reference. The insertion sheath  40  is slidably received around an insertion tube  18  which is of reduced diameter relative to the head  14 . 
     As described more fully below in regard to  FIG. 7 , the insertion tube  18 ′ may preferably be constructed substantially similarly to known endoscopes including similar steering and other operating mechanisms but with a reduced diameter with respect to these known endoscopes as no insertion tube is required. Those skilled in the art will understand that the diameter of the insertion tube  18 ′ may be further reduced if no working channels are required therein. That is, although  FIG. 7  shows a single working channel  72 , for certain operations this working channel  72  may be unnecessary. Thus, an insertion tube  18 ′ for use in such operations may include an integral endoscope  100  with no such working channel  72  and the diameter of the endoscope  100  (and, consequently, that of the insertion tube  18 ′, may be further reduced. 
     If a propulsion system is to be used, the column strength of the insertion tube  18  may be substantially reduced as the column strength necessary to allow a standard endoscope to be pushed through an organ is no longer necessary. Furthermore, as the insertion tube  18  is received within the insertion sheath  40 , no separate insertion tube shaft is incorporated therein as would be the case in a standard endoscope, thereby enabling the diameter of the insertion tube  18  to be further reduced with respect to conventional endoscopes. Thus, the diameter of the insertion tube  18  may preferably be in the range of 5 to 25 mm with an outer diameter of the insertion sheath  40  being between 10 and 30 mm. Of course, those skilled in the art will understand that these values may be made larger or smaller as desired so long as the flexibility and steering capacity of the insertion tube  18  in conjunction with the insertion sheath  40  substantially matches that of conventional endoscopes. 
     The insertion sheath  40  is longitudinally flexible so as not to impair the flexibility of the insertion tube  18  and the steerability of the device  10  generally. Thus, when a distal end of the insertion sheath  40  abuts against a proximal end of the head  14  and an operator engages the insertion sheath  40  distally into the organ  50 , the head  14  is advanced further into the organ  50 . 
     However, it is understood that other propulsion arrangements may be used with the device  10 . For example, a crawler system (not shown) may be used to move head  14 . Such a crawler system may be constructed, for example, as described in U.S. Pat. No. 5,398,670 to Ortiz et al., and U.S. Pat. No. 5,906,591 to Dario et al. the entire specifications of which are hereby incorporated by reference. In yet another embodiment as shown in  FIGS. 6   a  and  6   b , a guidewire  60  is placed in the organ  50  using a conventional endoscope as is known in the art. The guidewire  60  is then strung through the device  10  via a guidewire opening  62  at the front portion  14   a  of head  14  and the device  10  is pushed along the guidewire  60  to the desired location within the organ  50 . In order to accommodate the force exerted on the device  10  as it is pushed into the organ  50 , the insertion tube of the device  10  according to this embodiment is formed with an increased column strength relative to embodiments in which a propulsion system is employed. 
     As shown in  FIGS. 3 and 4 , in one embodiment, fins  16  are disposed at a proximal end of rear portion  14   b . Preferably two or more fins  16  are provided on opposing sides (180° degrees apart) of the rear portion  14   b . Alternatively, one fin  16  may be used. The fins  16  provide a solid surface against which the insertion sheath  40  may abut to push device  10  through the organ  50 . Also, the fins  16  serve to prevent portions of the tubular organ  50  from becoming entangled with the insertion sheath  40 . 
     Now turning to  FIG. 3 , the head  14  is shown in an open position in which the front portion  14   a  is slid forward to expose an interior work area  15 . A main optic device  32  is provided at the rear of the rear portion  14   b . Preferably, the device  32  points in a generally forward direction as shown in  FIG. 3 . A base portion  25  of the interior work area  15  may include an auxiliary optic device  26  that points in a direction generally perpendicular to the direction of main device  32 . The optic devices  32  and  26  may be illuminated by illumination sources  34  and  28 , respectively, to help provide a satisfactory image for the operator. As with the exterior optic device  12 , the optic devices  32  and  26  may preferably include vision chips. As will be discussed in connection to the operation of the device  10 , the multiple viewing angles provided by the optic devices  32  and  26  allow for an improved method of resectioning tissue. In a preferred embodiment, a suction lumen  36  extends from the proximal end of the device  10  to a port  35  that opens into the work area  15  so that, when suction is drawn therethrough, tissue adjacent to the head  14  is drawn into the work area  15 . An anvil  64  is positioned in the work area  15  to work in conjunction with a stapler  62  for stapling tissue received therein. Furthermore, a knife  66  is movably mounted within the work area  15  to cut tissue received therein radially inward with respect to a perimeter of staples delivered by the stapler  62 . 
     A controller  21  is also provided for controlling each of the components discussed above. The controller  21 , which may be used by the operator as a handle, may include a plurality of actuators coupled to the head  14  and, in turn, to the various components thereof by a one or more wires or flexible drive cables  19  as would be understood by those of skill in the art. The cables  19  may pass through the insertion tube  18  and into the head  14 . Alternatively, the actuators of the controller  21  may be coupled to these components by electric cables and/or by means of remote control (e.g., radio transmission) to actuate electric motors, as would be understood by those of skill in the art, to drive the components as desired by the operator. By manipulating the actuators of the controller  21 , the operator may, for example, adjust the optic devices  26  and  32 , the illumination sources  28  and  34  as well as any other components of the head  14 . 
     In an alternative embodiment of the invention shown in schematic views in  FIGS. 5   a  and  5   b , the head  14  includes a door  70  instead of the separable front and rear portions  14   a  and  14   b  of the previously described embodiment. The door  70  is movable between open and closed positions so that, in the open position, the interior of the organ  50  is accessible to the interior work area  15 , as described in the previously described embodiment. With the exception of this difference the apparatus according to this embodiment may function substantially similarly to the other embodiments. 
     In operation, the head  14  is maintained in the closed position, as shown in  FIG. 1 , while the device  10  is being maneuvered to the desired location within the organ  50 . When the desired location has been found using the exterior optic device  12 , with the aid of illumination from light source  22 , to view the interior of the organ  50 . As described above, to further aid in locating the site, an operator may wash debris away from areas being viewed using the irrigation source  13  and/or by insufflating the organ  50 . As described above, resectioning at this desired location may be necessary due to, for example, the presence of a lesion  52  as shown on the wall of the organ  50  in  FIGS. 3 and 4 . 
     Once the head  14  has been positioned as required, the interior work area  15  may be exposed by sliding the front portion  14   a  away from the rear portion  14   b  of the head  14  using the controller  21 . In this position, the optic device  26  on the base portion  25  may be used to view the lesion  52 . Moreover, the light source  28  provides the portion of organ  50  with the necessary illumination to provide a satisfactory image to the operator. The operator then draws a partial vacuum in the work area  15  through the use of the suction device  35  to draw the lesion  52  into the work area  15  under visual control of the operator via the optic device  32  and the light source  34 . Based on this observation, the operator may also reposition or reorient the head  14 , as required. However, once the lesion  52  has been sufficiently drawn into the resectioning chamber  31 , the view from the optic device  32  may be obscured by the lesion  52  itself. At this time, the optic device  26  may be used to provide continuing observation of the lesion  52  and its geometry with respect to the organ  50 . 
     The tissue surrounding the lesion  52  may now be stapled using the stapler  62  in conjunction with the anvil  64  and, after the stapling operation has been completed, the knife  66  may be actuated to cut the lesion  52  from the organ  50 . The operator then utilizes the controller  21  to slide the front portion  14   a  toward the rear portion  14   b  of the head  14  until the head  14  is sealed in the closed position. The lesion  52  is then retained within the work area  15  until the head  14  has been removed from the patient&#39;s body, at which time it may be further studied to aid in the patient&#39;s diagnosis and/or treatment. 
     As shown in  FIG. 7 , an insertion tube  18 ′ according to a first embodiment of the invention may include an integral endoscope  100 . The custom endoscope  100  includes a steering mechanism which include control wire guides  80  (in this case  4  guides  80 ) which are coupled to a distal tip of the integral endoscope  100  as is known in the art. In addition, the integral endoscope  100  includes a single, optional working channel  82 , an optic member  84 , an irrigation channel  86 , one or more light source members  88  (in this case  2  light source members  88 ) and a suction/insufflation lumen  90 . As would be understood by those of skill in the art, the optic member  84  may be either a fiber optic cable or an electric cable depending on the type of optic system employed. Similarly, the light source members  88  may be fiber optic light cables or electric cables if, for example, one or more LED light source members are employed at the distal tip of the integral endoscope  100  to illuminate a viewing area of the optic member  84 . Those skilled in the art will understand that the irrigation channel may be employed to supply irrigation fluid to a distal end of the optic member  84  (e.g., a lens) to clean the distal end to maintain the field of vision for an operator of the device. 
       FIG. 8  shows an alternate embodiment of an insertion tube  18 ″. The insertion tube  18 ″ includes a central endoscope receiving lumen  92 , optional working channels  94  and a suction/insufflation lumen  96 . Thus, this insertion tube  18 ″ may be employed with a custom endoscope (not shown) constructed substantially as shown in  FIG. 7  including an optic member, an irrigation channel and light source members. As the insertion tube  18 ″ includes working channels  94  and the suction/insufflation lumen  96 , these items may be eliminated from the custom endoscope for use with this insertion tube  18 ″ thereby reducing the diameter of the endoscope. The use of this insertion tube  18 ″ allows the custom endoscope inserted through the endoscope receiving lumen  92  to be reused, as would be understood by those of skill in the art. 
     Those skilled in the art will further appreciate that while the apparatus of the present invention has been described with reference to a full thickness resection of the colon, the apparatus may be utilized in other digestive tract transluminal procedures, and may be introduced transorally as well as transanally. Also, while certain embodiments have been described with reference to custom endoscopes, it will be appreciated that the specific configurations of the custom endoscopes/stapler embodiments may be varied. For example, different arrangements of lumena and control wires, and different coupling means for coupling the control wires to the driving gears may be provided with similar results obtained. Also, the control wires may be replaced, for example with flexible cables or hydraulic fluid channels. It will therefore be appreciated by those skilled in the art that yet other modifications could be made to the provided invention without deviating from its spirit and scope as so claimed.