Patent Document

CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application claims benefit of priority to U.S. Provisional Patent Application No. 61/116,955, filed on Nov. 21, 2008, the content of which is incorporated herein by reference in its entirety. This application also relates to U.S. patent application Ser. No. 12/138,348 (Attorney Docket No. USGINZ05600), filed Jun. 12, 2008, the content of which is also incorporated herein by reference in its entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates to methods and apparatus for managing one or more instruments and/or tools used during endoscopic diagnostic and therapeutic procedures. More particularly, the present invention relates to methods and devices used to facilitate instrument management and use during procedures where flexible endoscopic instruments are advanced into a patient body via one or more natural orifices or other access ports. 
       BACKGROUND OF THE INVENTION 
       [0003]    Endoscopic procedures and surgery typically entail the advancement and use of one or more instruments through the natural orifices and/or other access ports of a patient body and through the tortuous endoscopic pathways to reach the tissue regions of interest. Even procedures performed in body spaces within the patient may entail entry and advancement through one or more openings created in the patient body to gain entry into the desired body space, e.g., entry through a percutaneous opening or a gastrotomy to gain entry into the peritoneal space of the patient. 
         [0004]    Because endoscopic surgery may involve the use of multiple instruments through a single conduit into the patient body, efficient management and use of these instruments may be difficult in part not only because of the number of instruments utilized, but also because these multiple instruments typically converge from a single conduit, which may be limited by the cross-sectional profile of the body lumen, organ, orifice, passageway, etc., in which the conduit is disposed. At the same time, advances in therapeutic endoscopy have led to an increase in the complexity of endoscopic operations attempted, as well as the complexity of tools advanced through the working lumens of these conduits. 
         [0005]    Because of the number of instruments which converge typically from a single conduit, difficulties may arise in effectively handling and managing the placement, positioning, and use of these multiple instruments in an effective and safe manner. 
         [0006]    For example, flexible endoscopes and flexible endoscopic instruments provide the ability for an operator to intubate the patient and to provide therapy to the internal anatomy by way of non-straight access pathways. Typical endoscopes have the ability to steer at the tip and provide light and visualization, gas insufflation, and lens rinsing. Such endoscopes will typically include one or two instrument channels. These instrument channels include an angled interface on the handle of the endoscope having a bend of about 45 degrees on a relatively short section of the handle. One result of this configuration is that any instrument that is to be inserted into the endoscope instrument channel must include a shaft that is flexible over its entire length. 
         [0007]    Accordingly, there is a need for methods and devices for facilitating the introduction and management of all the instruments advanced through the relatively small conduits for performing endoscopic procedures. 
       SUMMARY OF THE INVENTION 
       [0008]    An endoscopic tissue manipulation assembly may comprise, at least in part, a distal end effector assembly disposed or positionable at a distal end of a flexible and elongate body. Examples are described in further detail in U.S. Pat. Pub. No. 2005/0272977 A1, which is incorporated herein by reference in its entirety. A handle assembly may be connected to a proximal end of the elongate body and include a number of features or controls for articulating and/or manipulating both the elongate body and/or the distal end effector assembly. The elongate body may optionally utilize a plurality of locking or lockable links nested in series along the length of the elongate body which enable the elongate body to transition between a flexible state and a rigidized or shape-locked configuration. Details of such a shape-lockable body may be seen in further detail in U.S. Pat. Nos. 6,783,491; 6,790,173; and 6,837,847, each of which is incorporated herein by reference in its entirety. 
         [0009]    One or more various instruments may be passed through the elongate body for deployment through its distal end by introducing the instruments through one or more corresponding tool ports located in the handle assembly. One instrument in particular which may be used to endoscopically visualize procedures and tissue regions of interest may include an endoscope or imaging system having a flexible shaft which may be introduced into the elongate body via a side port, e.g., Y-Port, located along the elongate body and distal to the handle assembly. 
         [0010]    Because of the number of different instruments and the different types of tools which may be utilized in the endoscopic tissue manipulation assembly, tool or instrumentation management is one consideration for the practitioner or practitioners to facilitate efficient surgical and/or endoscopic procedures when performed upon a patient. Additionally, the division of responsibility for instrumentation management between one or more practitioners is highly desirable to ensure patient safety and procedure facilitation. Table-mounted or stand-alone instrument support members, such as instrument clamps, stands, or other devices may be used to assist with management of endoscopic access devices, tools, and/or instruments. 
         [0011]    Aside from table-mounted or stand-alone instrument supporting members, additional instrument management systems may be employed which a single operator or user may utilize. In a first aspect, a multi-instrument support arm extending proximally from the handle assembly generally comprises a stiffened multi-lumen channel having a straight support channel extending proximally and one or more angled or curved support channels projecting at an angle therefrom support arm. Because the multi-instrument support arm is relatively stiff, it may be engaged to the handle assembly and used to support and separate its respective instruments leaving the operator to hold a single handle during a procedure. Other variations include a pivoting multi-instrument support having one or more individual instrument ports pivotably positioned within an open channel. Still other variations include a manifold that is attachable to the handle assembly and that supports one or more elongated straight docking sections each defining a substantially straight lumen for receiving an instrument shaft in a slidable docking configuration. 
         [0012]    Another method for facilitating instrument management utilizes forming rigid portions of the instrument shafts. The elongate shaft is generally configured as a flexible length so as to traverse through the elongate body and within the patient body via endoluminal pathways. In another aspect, a portion of the elongate shaft extending between the handle and flexible length is configured as a rigid section, and may include a rigid sleeve made, e.g., from stainless steel or some other rigid metal or polymer, which is formed over the portion of the shaft extending from the handle. Alternatively, the rigid portion is formed integrally with the elongate shaft, e.g., as a section reinforced by woven metallic braids or inserts. In use, the flexible length of the elongate shaft is advanced through a tool port and through the handle assembly. The rigid section extending from the handle is advanced at least partially into the tool port such that the handle is supported or held in a linear configuration relative to the tool port and handle assembly by the rigid section. 
         [0013]    The interface between the rigid portion(s) of the instrument shaft(s) and the straight sections of the tool port(s) provided in the handle assembly provides the operator with the ability to slidably dock the instruments within the endoscopic access device. The slidable docking interface provides several benefits. For example, the operator is able to release the instrument to use his hand for other purposes without having the instrument drop or flop downward, as would be the case with a flexible shafted instrument. In addition, the slidable docking interface facilitates instrument management using only a single support arm for the endoscopic access device, rather than requiring separate support for each instrument inserted into the device. Further, rigid shafted instruments provide improved force transmission and the slidable docking interface reduces or eliminates the possibility that an exposed shaft will bend or buckle. Still further, having a substantially straight tool port lumen in the handle assembly retains the ability to use flexible shafted instruments, if desired. Finally, having a substantially straight tool port lumen in the handle assembly facilitates insertion of instruments having longer rigid working lengths and/or larger shaft diameters. For example, a typical endoscope has an instrument channel with an inlet having a 45 degree bend. All tools used in the channel must be sufficiently flexible to pass the 45 degree bend. Having a substantially straight lumen provides the ability to use many instruments that could not be used through the instrument channel of a conventional endoscope. 
         [0014]    Another variation of the instrument management system includes the provision of a flexible joint or flexible section of the instrument shaft between the handle and a rigid proximal section of the shaft. The flexible joint/section allows the handle to be flexed away from other instruments but retain sufficient rigidity that the handle does not droop. In this manner, the instrument handles are able to be flexed apart to prevent or reduce clashing. 
         [0015]    In still another aspect, an endoscopic instrument management manifold is attachable to the handle assembly and provides one or more elongated pathways for passage of a flexible instrument shaft. In several embodiments, the one or more elongated pathways are defined by one or more extension tubes that extend from the proximal end of the handle assembly. In several other embodiments, the elongated pathways are defined by one or more extension tubes that are capable of being manipulated to assume a desired shape or orientation. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0016]      FIGS. 1A and 1B  shows assembly and end views, respectively, of an endoscopic tissue manipulation system and examples of the various endoscopic instruments which may be advanced therethrough. 
           [0017]      FIG. 2  shows the endoscopic manipulation system of  FIG. 1A  disassembled into its separate instrument components for illustrative purposes. 
           [0018]      FIGS. 3 to 5  illustrate side views of a tissue manipulation assembly operable via a launch tube member which may be advanced through the endoscopic system. 
           [0019]      FIGS. 6 and 7  illustrate perspective and top views, respectively, of a stiffened multi-instrument support arm having one or more angled or curved support channels projecting therefrom. 
           [0020]      FIGS. 8 and 9  illustrate perspective and top views, respectively, of another stiffened multi-instrument support arm having a straight tubular member and one or more angled or curved support channels. 
           [0021]      FIGS. 10A to 10C  illustrate perspective, top, and end views, respectively, of another variation for a pivoting multi-instrument support having a fanned or angled lumen enclosure. 
           [0022]      FIGS. 11 and 12  show top views illustrating examples for altering the entry lumen angle of the individual instrument ports. 
           [0023]      FIGS. 13 and 14  show perspective views of a manifold supporting a pair of elongated docking sections that is attachable to the proximal end of an endoscopic access device. 
           [0024]      FIGS. 15A to 15C  illustrate side views of an instrument management system utilizing rigid portions of an instrument shaft for providing support to the instrument projecting from a handle assembly. 
           [0025]      FIGS. 16 and 17  show end and top views, respectively, of tool ports having tapered entries for facilitating the insertion of instruments therethrough. 
           [0026]      FIGS. 18A and 18B  show exploded and perspective views of a rotating clamp adapted to be attached to an endoscopic access device. 
           [0027]      FIGS. 19A and 19B  show an endoscopic device having a straight, elongated docking lumen formed in the handle, and an instrument having a rigid shaft section near its proximal end. 
           [0028]      FIGS. 20A and 20B  show top views of an endoscopic device handle assembly having a plurality of instruments extending from its proximal end. 
           [0029]      FIGS. 21A and 21B  show top views of a physician using an endoscopic device during a procedure being performed on a patient. 
           [0030]      FIGS. 22A and 22B  are side views of an endoscopic device having a pair of endoscopic instrument management manifolds. 
           [0031]      FIGS. 23A and 23B  are a side view and an endoscopic view, respectively, of an endoscopic access device having instruments extending therethrough. 
           [0032]      FIGS. 23C ,  23 D, and  23 E are a side view and two endoscopic views, respectively, of the device of  FIGS. 23A and 23B  in a retroflexed position. 
           [0033]      FIGS. 24A and 24B  are a side view and an endoscopic view, respectively, of an endoscopic access device in a retroflexed orientation and having instruments extending through endoscopic instrument management manifolds that are also in a retroflexed orientation. 
           [0034]      FIGS. 25A and 25B  are a side view and an endoscopic view, respectively, of an endoscopic access device in a retroflexed orientation and having instruments extending through endoscopic instrument management manifolds that are in a crossed-over orientation. 
           [0035]      FIG. 26  is a cross-sectional view of a telescoping endoscopic instrument management manifold. 
           [0036]      FIGS. 27A to 27C  are side views of an instrument, a manifold, and an instrument inserted into a manifold, respectively, illustrating an interlocking feature. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0037]    With reference to  FIG. 1A , the endoscopic tissue manipulation system  10  as described herein may comprise, at least in part, a distal end effector assembly  12  disposed or positionable at a distal end of a flexible and elongate body  14 . Examples of the tissue manipulation system  10  are described in further detail in U.S. Pat. Pub. No. 2005/0272977 A1, which is incorporated herein by reference in its entirety. Additional examples of endoscopic access devices and systems incorporating such devices are described in further detail in U.S. patent application Ser. No. 12/061,951, filed Apr. 2, 2008, which is also incorporated herein by reference in its entirety. A handle assembly  16  may be connected to a proximal end of the elongate body  14  and include a number of features or controls  26  for articulating and/or manipulating both the elongate body  14  and/or the distal end effector assembly  12 . 
         [0038]    As shown, the system  10  may comprise a number of various instruments and devices utilized in various combinations with one another to effect any number of different procedures. Accordingly, each of the instruments and devices may require manipulation or some degree of handling by the practitioner. 
         [0039]    The elongate body  14  may optionally utilize a plurality of locking or lockable links nested in series along the length of the elongate body  14  which enable the elongate body  14  to transition between a flexible state and a rigidized or shape-locked configuration. Details of such a shape-lockable body may be seen in further detail in U.S. Pat. Nos. 6,783,491; 6,790,173; and 6,837,847, each of which is incorporated herein by reference in its entirety. Alternatively, elongate body  14  may comprise a flexible body which is not rigidizable or shape-lockable but is flexible in the same manner as a conventional endoscopic body, if so desired. Additionally, elongate body  14  may also incorporate additional features that enable any number of therapeutic procedures to be performed endoscopically. Elongate body  14  may be accordingly sized to be introduced per-orally. However, elongate body  14  may also be configured in any number of sizes, for instance, for advancement within and for procedures in the lower gastrointestinal tract, such as the colon. 
         [0040]    Elongate body  14 , in one variation, may comprise several controllable bending sections along its length to enable any number of configurations for the elongate body  14 . Each of these bending sections may be configured to be controllable separately by a user or they may all be configured to be controlled simultaneously via a single controller. Moreover, each of the control sections may be disposed along the length of elongate body  14  in series or they may optionally be separated by non-controllable sections. Moreover, one, several, or all the controllable sections (optionally including the remainder of elongate body  14 ) may be rigidizable or shape-lockable by the user. 
         [0041]    In the example of endoscopic tissue manipulation system  10 , elongate body may include a first articulatable section  18  located along elongate body  14 . This first section  18  may be configured via handle assembly  16  to bend in a controlled manner within a first and/or second plane relative to elongate body  14 . In yet another variation, elongate body  14  may further comprise a second articulatable section  20  located distal of first section  18 . Second section  20  may be configured to bend or articulate in multiple planes relative to elongate body  14  and first section  18 . In yet another variation, elongate body  14  may further comprise a third articulatable section  22  located distal of second section  20  and third section  22  may be configured to articulate in multiple planes as well, e.g., 4-way articulation, relative to first and second sections  18 ,  20 . 
         [0042]    As mentioned above, one or each of the articulatable sections  18 ,  20 ,  22  and the rest of elongate body  14  may be configured to lock or shape-lock its configuration into a rigid set shape once the articulation has been desirably configured. Detailed examples of such an apparatus having one or multiple articulatable bending sections which may be selectively rigidized between a flexible configuration and a shape-locked configuration may be seen, e.g., in U.S. Pat. Pub. Nos. 2004/0138525 A1, 2004/0138529 A1, 2004/0249367 A1, and 2005/0065397 A1, each of which is incorporated herein by reference in its entirety. Although three articulatable sections are shown and described, this is not intended to be limiting as any number of articulatable sections may be incorporated into elongate body  14  as practicable and as desired. Moreover, one or multiple sections may be comprised of a series of nested-links which allow the one or more sections  18 ,  20 ,  22  to be articulated or deflected relative to one another along their lengths and optionally rigidized to conform and hold any particular shape. 
         [0043]    Handle assembly  16  may be attached to the proximal end of elongate body  14  via a permanent or releasable connection. Handle assembly  16  may generally include a handle grip  24  configured to be grasped comfortably by the user and an optional rigidizing control  28  if the elongate body  14  and if one or more of the articulatable sections are to be rigidizable or shape-lockable. Rigidizing control  28  in this variation is shown as a levered mechanism rotatable about a pivot  30 . Depressing control  28  relative to handle  24  may compress the internal links within elongate body  14  to thus rigidize or shape-lock a configuration of the body while releasing control  28  relative to handle  24  may in turn release the internal links to allow the elongate body  14  to be in a flexible state. Further examples of rigidizing the elongate body  14  and/or articulatable sections may again be seen in further detail in U.S. Pat. Pub. Nos. 2004/0138525 A1, 2004/0138529 A1, 2004/0249367 A1, and 2005/0065397 A1, incorporated above by reference. Although the rigidizing control  28  is shown as a lever mechanism, this is merely illustrative and is not intended to be limiting as other mechanisms for rigidizing an elongate body, as generally known, may also be utilized and are intended to be within the scope of this disclosure. 
         [0044]    Handle assembly  16  may further include a number of articulation controls  26 , as described in further detail below, to control the articulation of one or more articulatable sections  18 ,  20 ,  22 . Handle  16  may also include one or more ports  32  for use as insufflation and/or irrigation ports, as so desired. 
         [0045]    Furthermore, one or more various instruments may be passed through elongate body  14  for deployment through distal end  12  by introducing the instruments through one or more corresponding tool ports  34  located in handle assembly  16 . As mentioned above, a number of different endoscopic and/or endoluminal instruments having a flexible body may be delivered through system  10  to effect any number of endoscopic procedures. 
         [0046]    One example of such an instrument may include an endoscopic tissue manipulation and securement assembly  36 , as described in further detail below, which may be introduced into system  10  via instrument lumen  100 , as shown in the end view of distal end  12  in  FIG. 1B . Any number of additional instruments may also be inserted through the system  10 . An example of such an instrument includes an elongate tissue engagement tool  74  having an elongate flexible shaft  76  with a removable handle or grip  78  located on its proximal end. The tissue engagement tool  74  may be positioned within an instrument lumen  102  adjacent to instrument lumen  100 . The distal end of flexible shaft  76  may include a rotatable helical tissue engager  80  used to temporarily engage and manipulate tissue. The helical tissue engager  80  may further include a number of visual indications or markers near or at the distal end of flexible shaft  76 . Examples of tissue engagement tool  74  are described in further detail in U.S. patent application Ser. No. 11/303,521 filed Dec. 16, 2005, which is incorporated herein by reference in its entirety. 
         [0047]    In use, tissue manipulation assembly  40  and helical tissue engager  80  may be advanced distally out from elongate body  14  through their respective lumens  100 ,  102 . Tissue engager  80  may be advanced into contact against a tissue surface and then rotated via its proximal handle  78  until the tissue is engaged. The engaged tissue may be pulled proximally relative to elongate body  14  and tissue manipulation assembly  40  may be actuated via its proximally located handle into an open expanded jaw configuration for receiving the engaged tissue. 
         [0048]    Additional instruments may also be introduced through elongate body  14 , such as conventional endoscopic instruments including graspers, scissors, needle knives, snares, etc., through a corresponding instrument lumen  104 . In one example, an endoscopic instrument  82  having a flexible shaft  84  with a manipulatable handle or control  86  at its proximal end and a scissor mechanism  88  at its distal end may be introduced through the elongate body  14  for performing tasks such as cutting of tissue and/or sutures. 
         [0049]    To endoscopically visualize procedures and tissue regions of interest, an endoscope or imaging system  90  having a flexible shaft  92  may be introduced into the elongate body  14  via a side port, e.g., Y-Port  96 , located along the elongate body  14  and distal to handle assembly  16 , as shown in  FIG. 1A . Flexible shaft  92  may be advanced through visualization lumen  98  such that its distal end is advanced distally of the elongate body distal end  12  or it may be parked at the terminal opening of the visualization lumen  98  for providing imaging of a procedure. Although shown as an endoscope  90  in this illustration, other variations may include an imaging chip such as a CCD imager integrated into the distal end  12  of elongate body  14 . A cable  94  extending from endoscope  90  may be connected to a processor and monitor (not shown) for providing the images. 
         [0050]    Endoscope  90  may be introduced directly through handle assembly  16  in other variations; however, positioning the imaging system  90  through a distally located Y-Port  96  relative to handle assembly  16  may allow for a longer length of the shaft  92  to be introduced through visualization lumen  98  into the patient body. As elongate body  14  is advanced into the patient body, e.g., per-orally and into the stomach, the Y-Port  96  remains outside the patient body. 
         [0051]      FIG. 2  shows endoscopic manipulation system  10  disassembled into its separate instrument components for illustrative purposes. As seen, the handle  42  of tissue manipulation assembly  40  and its flexible shaft  38  may be removed from elongate body  14 . Removable needle deployment assembly  60  with its needle assembly control or housing  62  and its elongate shaft extending through flexible shaft  38  and terminating in needle assembly  66  may also be removed from elongate body  14 . Also shown is anchor assembly  68  comprising, e.g., distal tissue anchor  70  and proximal tissue anchor  72 , which may be deployed from needle assembly  66  through flexible shaft  38 . 
         [0052]    Also shown is helical tissue engager  80  disposed upon flexible shaft  76  and endoscopic instrument  88 , e.g., endoscopic scissors, disposed upon flexible shaft  84 , removed from elongate body  14  and handle assembly  16 . Further shown is endoscope  90  with endoscope shaft  92  removed from Y-Port  96 . 
         [0053]    As mentioned above, tissue manipulation assembly  40  is further described in detail in U.S. patent application Ser. No. 11/070,863 filed Mar. 1, 2005 and published as U.S. Pat. Pub. 2005/0251166 A1. An illustrative side view of one example is shown in  FIG. 3 , which shows assembly  36 . The assembly  36  generally comprises a flexible catheter or tubular body  38  which may be configured to be sufficiently flexible for advancement into a body lumen, e.g., transorally, percutaneously, laparoscopically, etc. Tubular body  38  may be configured to be torqueable through various methods, e.g., utilizing a braided tubular construction, such that when handle  42  is manipulated and/or rotated by a practitioner from outside the patient&#39;s body, the longitudinal and/or torquing force is transmitted along body  38  such that the distal end of body  38  is advanced, withdrawn, or rotated in a corresponding manner. 
         [0054]    Tissue manipulation assembly  40  is located at the distal end of tubular body  38  and is generally used to contact and form tissue folds, as mentioned above.  FIG. 4  shows an illustrative detail side view in which tissue manipulation assembly  40  may be seen connected to the distal end of tubular body  38  via a pivotable coupling  44 . Lower jaw member  46  extends distally from the pivotable coupling  44  and upper jaw member  48 , in this example, may be pivotably coupled to lower jaw member  46  via jaw pivot  52 . The location of jaw pivot  52  may be positioned at various locations along lower jaw  46  depending upon a number of factors, e.g., the desired size of the “bite” or opening for accepting tissue between the jaw members, the amount of closing force between the jaw members, etc. One or both jaw members  46 ,  48  may also have a number of protrusions, projections, grasping teeth, textured surfaces, etc.,  50  on the surface or surfaces of the jaw members  46 ,  48  facing one another to facilitate the adherence of tissue between the jaw members  46 ,  48 . 
         [0055]    Launch tube  54  may extend from handle  42 , through tubular body  38 , and distally from the end of tubular body  38  where a distal end of launch tube  54  is pivotally connected to upper jaw member  48  at launch tube pivot  56 . A distal portion of launch tube  54  may be pivoted into position within a channel or groove defined in upper jaw member  48 , to facilitate a low-profile configuration of tissue manipulation assembly  40 . When articulated, either via launch tube  54  or other mechanism, as described further below, jaw members  46 ,  48  may be urged into an open configuration to receive tissue in jaw opening  58  between the jaw members  46 ,  48 . 
         [0056]    Launch tube  54  may be advanced from its proximal end at handle  42  such that the portion of launch tube  54 , which extends distally from body  38 , is forced to rotate at hinge or pivot  56  and reconfigure itself such that the exposed portion forms a curved or arcuate shape that positions the launch tube opening perpendicularly relative to upper jaw member  48 , as shown in  FIG. 5 . Launch tube  54 , or at least the exposed portion of launch tube  54 , may be fabricated from a highly flexible material or it may be fabricated, e.g., from Nitinol tubing material which is adapted to flex, e.g., via circumferential slots, to permit bending. 
         [0057]    Once the tissue has been engaged between jaw members  46 ,  48 , a needle deployment assembly  60  may be urged through handle  42  and out through launch tube  54  by introducing needle deployment assembly  60  into the handle  42  and through tubular body  38  such that the needle assembly  66  is advanced from the launch tube and into or through approximated tissue. The needle deployment assembly  60  may pass through lower jaw member  46  via needle assembly opening defined in lower jaw member  46  to pierce through the grasped tissue. Once the needle assembly  66  has been passed through the engaged tissue, a distal and proximal tissue anchor  70 ,  72  of the anchor assembly  68  may be deployed or ejected on one or opposing sides of a tissue fold for securing the tissue. 
         [0058]    Anchor assembly  68  is normally positioned within the distal portion of tubular sheath  64  which extends from needle assembly control or housing  62 . Once the anchor assembly  68  has been fully deployed from sheath  64 , the spent needle deployment assembly  60  may be removed from assembly  36  and another needle deployment assembly may be introduced without having to remove assembly  36  from the patient. The length of sheath  64  is such that it may be passed entirely through the length of tubular body  38  to enable the deployment of needle assembly  66  into and/or through the tissue. 
         [0059]    Because of the number of different instruments and the different types of tools which may be utilized in endoscopic tissue manipulation system  10 , tool or instrumentation management is one consideration for the practitioner or practitioners to facilitate efficient surgical and/or endoscopic procedures when performed upon a patient. Additionally, the division of responsibility for instrumentation management between one or more practitioners is highly desirable to ensure patient safety and procedure facilitation. Several device management systems are described in U.S. patent application Ser. No. 12/138,348 (Attorney Docket No. USGINZ05600), filed Jun. 12, 2008, which was previously incorporated by reference herein. The systems described in the foregoing application include trays, stands, tables, clamps, belts, and other supports used to support or hold the endoscopic tissue manipulation system  10  or one or more portions of the system. 
         [0060]    Several of the instrument management system embodiments described herein and in the &#39;348 application referenced above facilitate use of the endoscopic access system by the operator in either a “hands on tools” mode with the system retained in the stand or support arm, or a “hand on scope/hand on tool” mode in which the operator holds the handle  24  in one hand and an instrument with the other hand. Those skilled in the art will recognize that the “hands on tools” mode corresponds generally with the manner in which laparoscopic procedures are typically performed, while the “hand on scope/hand on tool” mode corresponds generally with the manner in which endoscopic procedures are performed. Each of these modes of use are facilitated using the instrument management systems described herein. For example, many surgical instrument holders are configured to clamp onto the shaft of a 5 mm or 10 mm instruments. By providing a 5 mm or 10 mm cylindrical post on the handle  24  of an endoscopic access system, the handle  24  may be selectively clamped onto and removed from the instrument holder by the operator. In this way, the operator can simply place the post in the holder and lock it in place to use the system in a “hands on tools” mode, or remove it from the holder and use the system in a “hand on handle/hand on tool” mode. 
         [0061]    Aside from or in addition to table-mounted or stand-alone instrument supporting members, additional instrument management systems may be employed which a single operator or user may utilize. One example is shown in  FIGS. 18A and 18B , which show perspective views of a handle  24  and a rotating clamp mechanism  300  that serves as a functional interface between a support arm (e.g., a stand or other holder) and the endoscopic access system. The clamp  300  includes a generally cylindrical housing  302 , a backing plate  304 , an upper clamp half  306 , and a lower clamp half  308 . The housing  302  is generally cylindrical in shape, having a central through hole having a size sufficient to allow the handle  24  to pass therethrough. The housing  302  also includes a channel formed on its inner surface and adapted to receive the upper clamp half  306  and lower clamp half  308 , each of which has a generally semi-circular shape to facilitate rotational movement within the housing channel. The backing plate  304  is attached to each of the upper clamp half  306  and lower clamp half  308  and the combined unit is fixed to the outer surface of the handle  24 . As a result, the handle  24  is allowed to rotate within the clamp housing  302  while being supported by the clamp mechanism  300 . A post  310  is attached to the clamp housing  302 . The post  310  has a size and shape that facilitates attachment to a clamp or other mechanism contained on the stand, support arm or other mechanism, thereby providing the ability to mount the endoscopic access system on the stand or support arm while providing free rotation of the handle  24  relative to the stand or support arm. 
         [0062]    Another instrument management system is shown in  FIG. 6 , which shows a perspective view of handle  24  having a multi-instrument support arm  190  extending therefrom. Support arm  190  may generally comprise a stiffened multi-lumen channel having a straight support channel  192  extending proximally and one or more angled or curved support channels  194 ,  196  projecting at an angle from support arm  190 . Although two angled support channels are shown in this illustration, additional support arms may be utilized as practicable and as desired depending upon the number of tools advanced through elongate body  14 . In the example, handle  42  of tissue manipulation assembly  40  is positioned through the straight support channel  192  while instrument shafts  76 ,  84  are positioned through their respective support channels  194 ,  196 . 
         [0063]    As shown in the partial cross-sectional view of  FIG. 7 , each support channel may have a corresponding separate lumen defined therethrough. For instance, straight support channel  192  may have instrument lumen  198  defined therethrough, while angled support channels  194 ,  196  may have respective instrument lumens  200 ,  202  defined therethrough. Because multi-instrument support arm  190  is relatively stiff, e.g., support arm  190  may be comprised of a metal such as stainless steel or a stiffened polymeric material or plastic, support arm  190  may be engaged to handle  24  and used to support and separate its respective instruments leaving the operator to hold a single handle  24  during a procedure. 
         [0064]    In an alternative configuration, portions of or the entire support arm  190  is formed of a relatively flexible material, such as a rubber or polymeric material. The flexibility of the support arm  190  allows instruments having relatively rigid shafts to pass through the instrument lumens  198 ,  200 ,  202  despite the presence of any non-linear portions of the lumens. For example, the support arm  190  is sufficiently flexible that the support channels  194 ,  196  are able to flex in response to the rigid instrument shaft as it passes through any non-linear portions of the lumen. 
         [0065]    Another example of a multi-instrument support arm  210  is shown in the perspective view of  FIG. 8 , which illustrates a straight tubular member  210  which defines a lumen therethrough  218  and having one or more angled or curved support channels  212 ,  214 ,  216  each defining an instrument lumen therethrough, as shown in the partial cross-sectional view of  FIG. 9 . In an alternative embodiment, each of the support channels  212 ,  214 ,  216  provides access to a separate instrument lumen extending through the support arm  210 , the handle  24 , and the elongate body  14 . In this variation, each of the instruments, positioned through each respective channel, may be supported by the support arm  210  and separated for individual control and manipulation. As above, support arm  210  may be made from a stiff material to enable manipulation of handle  24  while support arm  210  supports the various instruments during a procedure. 
         [0066]    In yet another variation, a pivoting multi-instrument support  220  is illustrated as generally having a support arm  222  with a fanned or angled lumen enclosure  224  extending therefrom, as shown in  FIG. 10A . Enclosure  224  may define an open channel  226  within which one or more individual instrument ports  228 ,  230 ,  232  may be pivotably positioned, as shown in the top and end views of  FIGS. 10B and 10C , respectively. The instruments to be advanced through elongate body  14  may be passed into their respective instrument ports, each of which may be individually pivoted within open channel  226  respect to one another. 
         [0067]      FIGS. 11 and 12  show examples of how each individual instrument port  228 ,  230 ,  232  may be pivoted into a straightened lumen to facilitate handling or articulation of an individual instrument positioned within a respective port. For instance, as shown in  FIG. 11 , instrument port  228  may be pivoted within enclosure  224  to straighten its lumen. If another instrument, which may be positioned within instrument port  232 , were to be straightened within enclosure  224 , e.g., for withdrawal or advancement, each instrument port may be pivoted within enclosure  224  until the selected port  232  were positioned into its straightened configuration, as shown in  FIG. 12 . 
         [0068]    Turning to  FIGS. 13 and 14 , an alternative multi-instrument support mechanism  320  includes a manifold  322  that is attached to the handle  24  of an endoscopic access system. In the embodiment shown, the manifold  322  includes an elongated tab  324  having a hole  326  that attaches to a post  310  on the handle  24 . The manifold  322  supports a plurality of elongated docking sections  328   a ,  328   b , each of which extends from an instrument port  34  of the handle  24 . Each docking section  328   a ,  328   b  comprises a rigid tube having an elongated straight section adapted to receive a flexible instrument and route the instrument shaft into the respective instrument port  34  and through the handle  24  and elongate body  14  of the endoscopic access system. The docking sections  328   a ,  328   b  may optionally include a bend or other feature, such as the bends shown in the embodiment shown in  FIGS. 13 and 14 . The bends provide a spread alignment of the instruments retained within the docking sections  328   a ,  328   b  to thereby reduce or prevent clashing of the instrument handles. The spread alignment may take several optional forms. For example, all of the instruments retained in the docking sections  328  may be extended an equal length beyond the proximal end of the handle  24  and spread in a single plane or in multiple planes. For illustrative purposes, the system shown in  FIGS. 13 and 14  illustrates a spread in a single plane but with a central instrument extended a shorter length from the proximal end of the handle  24 . In alternative embodiments, the docking sections  328   a ,  328   b  are separately positionable so as to provide the user with a desired spread or orientation. 
         [0069]    Another method for facilitating instrument management utilizes forming rigid portions of the instrument shafts. An example is shown in the side view of  FIG. 15A  which illustrates handle  42  and a proximal portion  250  of the elongate shaft of the tissue manipulation assembly  40 . The elongate shaft is generally configured as a flexible length  252  so as to traverse through elongate body  14  and within the patient body via endoluminal pathways. A portion of the elongate shaft extending between handle  42  and flexible length  252  may be configured as a rigid section  254 . Rigid section  254  may include a rigid sleeve made, e.g., from stainless steel or some other rigid metal or polymer, which is formed over the portion of the shaft extending from handle  42 . Alternatively, the rigid portion  254  may be formed integrally with the elongate shaft, e.g., as a section reinforced by woven metallic braids or inserts. Rather than having the rigid section  254  extend directly from handle  42 , rigid section  254  may be positioned between two flexible lengths  252 ,  258 , as shown in the rigidized elongate body  256  in  FIG. 15B . 
         [0070]    In use, the flexible length of elongate shaft  252  may be advanced through a tool port  34  and through handle assembly  16 . Rigid section  254  extending from handle  42  may be advanced at least partially into tool port  34 , as shown in  FIG. 15C , such that handle  42  is supported or held in a linear configuration relative to tool port  34  and handle assembly  16  by the rigid section  254 . The absence of rigid section  254  from flexible shaft  252  would allow handle  42  to flex and bend relative to tool port  34  in an uncontrolled manner. In the case where a configuration as shown in  FIG. 15B  is used, rigid section  254  may be positioned to extend from the entry of tool port  34  to provide some support to handle  42  while the proximal flexible section  258  extending between rigid section  254  and handle  42  may still allow for some limited flexibility in moving or articulating handle  42  in a non-linear manner relative to tool port  34  and handle assembly  16 . 
         [0071]    Additionally, one or more visual markings or indicators  260  may be provided along the length of rigid section  254 , as shown in  FIG. 15C . These visual indicators  260  may correspond to the depth which the tissue manipulation assembly  40  has been inserted into the patient body or the length which tissue manipulation assembly  40  has been advanced past the distal end of the rigidizable elongate body  14  within a body lumen of a patient. 
         [0072]    In addition to the various device and instrument management tools and systems described above, tool ports  34  in handle assembly  16  may also be configured to facilitate device management. As shown in the end and top views of handle assembly  16  in  FIGS. 16 and 17 , respectively, the entry to tool ports  34  may be configured as a tapered instrument port  270 . Tools and instruments may be inserted through the enlarged entry  272  and guided into the narrower tool lumen  274  by the narrowing tapered surface of port  270 . 
         [0073]    Several of the features of the tools and systems described above in relation to  FIGS. 6-17  are further described in relation to  FIGS. 19A and 19B , which illustrate the slidable docking feature of an endoscopic access device and a flexible instrument. Referring to  FIG. 19A , an endoscopic access device  320  is shown, the device having a handle  24  with an eyepiece  328  and steering controls  321 . The device includes an instrument channel  322  extending through the handle  24  that is elongated and substantially straight through at least a proximal section. The instrument  332  includes a shaft having a substantially rigid proximal section  334  and a substantially flexible distal section  336 . As described above, the slidable docking interface provided between the instrument channel  322  and the rigid proximal shaft  334  allows the operator to release the instrument, upon which the instrument will remain stably docked within the handle  24  of the access device  320 . In several embodiments, the length L of the rigid proximal section  334  of the instrument shaft is no longer than the rigid length of the instrument channel  322  so as not to interfere with the flexibility of the flexible section of the endoscopic access device  320  when the instrument shaft is inserted into the device to its intended extent. The length L of the rigid proximal section  334  should, however, be sufficient to provide additional overlap so that slidable docking occurs (i.e., no backing out to the flexible shaft section  336 ) during normal operation of the instrument. 
         [0074]    As shown in  FIG. 19B , the elongated and substantially straight section of the instrument channel  322  extending through the handle  24  need not be in line with longitudinal axis of the flexible section  14  of the endoscopic access device. In the embodiment shown in  FIG. 19B , the docking section of the instrument channel  322  is inclined at an angle α relative to the longitudinal axis of the flexible section  14 . The flexible portion of the instrument shaft  336  is sufficiently flexible to accommodate the bend created by the differential. 
         [0075]    In addition to the other instrument management tools and systems described herein, another mechanism for reducing or eliminating clashing of instrument handles is shown in  FIGS. 20A and 20B . An endoscopic device handle  24  includes a plurality of instruments  342 ,  344 ,  346  extending from a plurality of instrument ports  34  located on the proximal end of the handle. As shown in  FIG. 20B , two of the instruments include a flexible joint  350  located adjacent to the instrument handle between the handle and the rigid portion  334  of the instrument shaft. The flexible joint  350  are sufficiently flexible to allow the handle to be bent away from handles of other instruments received in the device while retaining sufficient rigidity to prevent drooping. In this manner, the handles of adjacent instruments may be flexed apart rather than clashing. 
         [0076]    Turning next to  FIGS. 21A-B , another embodiment of an endoscopic instrument management system is shown. In the embodiment, one or more selectively attachable and detachable instrument management manifolds  400  allow the user to use the endoscopic manipulation system  10  either with a compact handle (such as when not using multiple instruments), but then to attach the manifold to obtain a spread lumen configuration (such as when using multiple tools). Preferably, the endoscopic manipulation system  10  is held in a fixed or positionable stand when the tool spreading manifold is in use and multiple tools are in use so as not needing a hand to hold the system. 
         [0077]    The instrument management manifolds  400  shown in  FIG. 21B  are capable of being configured to take on a desired shape or orientation. For example, as shown in  FIGS. 21A-B , a female patient P is in the lithotomy position and the endoscopic manipulation system  10  is placed in a location relative to the female patient P to have the distal section of the system be introduced through the vagina in order to perform a gynecological examination or therapeutic procedure. In the embodiment shown in  FIG. 21A , the instruments  402   a ,  402   b  are introduced into the system  10  by insertion directly into tool ports  34  in the handle  24 . This orientation requires that the physician or other user be located in the position shown in  FIG. 21A , between the legs and toward the feet of the patient P. In the embodiment shown in  FIG. 21B , the instruments  402   a ,  402   b  are introduced into the system  10  by way of a pair of instrument management manifolds  400   a ,  400   b  that are attached to the proximal side of the handle  24 . Each manifold  400   a ,  400   b  is attached at a first end to a port  34  of the handle  24 . The manifold has a generally “U”-shape or other curved shape that extends proximally from the handle  24  and then generally up and laterally to the side of the patient P. This orientation allows the physician or other user U to be located at the flank of the patient P in a conventional laparoscopic stance with the monitor at the feet of the patient P and the physician facing the monitor. In some circumstances, this positioning may be preferred to provide advantageous instrument access, comfort and/or freedom of movement of the physician, or improved monitor and/or patient visualization and control of the instruments for the physician. 
         [0078]    Turning to  FIGS. 22A-B , the manifolds  400   a ,  400   b  are generally tubular structures defining a lumen that extends through the length of the manifold. In some embodiments, the manifold is formed of a substantially rigid material that is resistant to bending or other deformation, such as stainless steel. In other embodiments, such as shown in  FIGS. 22A-B , the manifolds  400   a ,  400   b  are formed of a material that is capable of bending or other deformation under manipulation by the physician or other user, such as a semi-rigid metallic or polymeric material. Examples of materials suitable for the malleable manifold structures include interlocking rolled metal structures used in conventional microphone stand gooseneck devices, or Loc-Line® modular hose system materials available from Lockwood Products, Inc. of Lake Oswego, Oreg. The Loc-Line® system products include a plurality of press-fit jointed structures defining a central lumen therethrough. 
         [0079]    In some embodiments, the instrument management manifold  400  is transformable so that the relative positions of the lumens may be altered. For example, a manifold  400   a ,  400   b  having the jointed or other malleable structure is able to be bent or otherwise deformed to meet specific procedural needs. For example, the lumens defined by the manifolds  400   a ,  400   b  may be positioned straight and relatively close together during insertion of tools through the manifolds and/or the endoscopic manipulation system  10  (see, e.g.,  FIG. 22A ), and then bent or deformed to a working position in which the manifolds  400   a ,  400   b  are no longer straight (see, e.g.,  FIG. 22B ). 
         [0080]    Positionable or bent manifold lumens also are advantageous with regard to the relative hand positions of the clinician manipulating the tools or instruments  402  and what is displayed on a visualization monitor. A phenomenon of “switching” occurs when an endoscopic delivery device is steered into a retroflexed position. The retroflexed position of the device causes the image to turn upside down and reversed. For example, compare  FIGS. 23A-B  in which the delivery device has a generally straight orientation, with  FIGS. 23C-E  in which the delivery device is steered into a retroflex position. The endoscopic view shown in  FIG. 23D  is reversed and upside down relative to the endoscopic view shown in  FIG. 23B . To correct the image, the endoscope (located in one of the working lumens of the delivery device) is first rotated 180 degrees in order to make the image no longer appear upside down. Next, after the upside down correction is made, the instruments  402   a ,  402   b  extending through the access device will appear on the opposite side of the screen relative to the hands being used to manipulate the instruments  402   a ,  402   b , as shown in  FIG. 23E . This “switching” effect will frequently cause disorientation to the physician or other user of the device. 
         [0081]    The “switching” phenomenon is corrected using the instrument management manifolds  400  in the following ways, as shown in  FIGS. 24A-B  and  25 A-B. The instrument management manifolds  400   a ,  400   b  are curved or deformed into a retroflexed orientation relative to the exit ports  34  of the handle  24  of the delivery device  10 . This puts the instruments  402   a ,  402   b  back into the correct visual and spatial configuration. See  FIGS. 24A-B . Alternatively, the instrument management manifolds  400   a ,  400   b  are crossed or crossable with a similar result. See  FIG. 25 . 
         [0082]    In some embodiments, the endoscopic instrument manifold  400  has a construction that allows it to telescope. See  FIG. 26 . For example, instead of having a rigid telescoping interface, the manifold  400  has a construction of nesting or accordionizing tubing, including a first tube  410  that is attached (directly or indirectly) to the handle  24  of the access system  10 , and a second tube  420  that is slidable within and extends proximally of the proximal opening of the first tube  410 . The first tube  410  includes an inwardly directed flange  412  formed on or attached to its proximal end, and the second tube  420  includes an outwardly directed flange  422  formed on its proximal end. The flanges  412 ,  422  prevent the first tube  410  and second tube  420  from becoming separated from one another. An o-ring  414  seals the tubes relative to one another. In other embodiments, more tube sections are used and/or the relative diameters of the tubes are reversed to allow the first tube  410  to telescope within the second tube  420 . Other variations are also possible. 
         [0083]    In still other embodiments, the instrument  402  inserted into a manifold  400  is adapted to interlock with the manifold  400  entrance, preferably at the instrument handle. See  FIGS. 27A-C . For example, a handle interlocking portion  430   a  is provided on the shaft or handle of the instrument  402 , and a mating manifold interlocking portion  430   b  is provided on the proximal opening of the manifold  400 . The interlocking portions  430   a ,  430   b  are configured to mate and/or interlock to form an interlocking member  430  in which the instrument  402  is selectively attached to the proximal tube  420  of the manifold  400 . Advancement, retraction, and rotation would then be allowed and supported by the telescoping manifold  400 . 
         [0084]    The foregoing descriptions of instrument management tools and systems includes descriptions of several components (and embodiments of components) that may be used in a standalone manner or in combination with other components. For example, a preferred embodiment of an instrument management system suitable for use with the endoscopic tissue manipulation system  10  shown in  FIG. 1A  includes a support stand having a base that is attachable to a bed rail or other fixed location, a first support arm having a clamp or other fixture attachable to the handle  24  of the endoscopic access device, and a second support arm that is attachable to a handle of the endoscope  90 . The first support arm and second support arm of the support stand are configured to be selectively fixed in place or to have effectively free range of motion, such as may be provided by having one or more ball joints or other pivotable connections that allow the user to selectively fix or release the system. Alternatively, the second support arm comprises a boom that is held in a fixed relationship to the first support arm, thereby allowing movement of the endoscopic access device and the endoscope  90  as a single unit. In the embodiment, a holder interface, such as a rotating clamp  300  is used to detachably attach the handle  24  to the first support arm via a post  310 , thereby providing a rotational movement capability between the handle  24  and the support stand. Another holder interface, such as a C-clamp that is detachable from the second support arm, may be used to attach the endoscope  90  to the second support arm. Further, the endoscopic access device includes a plurality of instrument lumens that support slidable docking of instruments in the handle  24 , with one or more of the instruments living a rigid proximal shaft section  254 . 
         [0085]    Although a number of illustrative variations are described above, it will be apparent to those skilled in the art that various changes and modifications may be made thereto without departing from the scope of the invention. Moreover, although specific configurations and applications may be shown, it is intended that the various features may be utilized in various combinations and in various types of procedures as practicable. It is intended in the appended claims to cover all such changes and modifications that fall within the true spirit and scope of the invention.

Technology Category: a